Uploaded by Andrea Mejia Sierra

GUIA ACCENT PRIME INGLES

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www.almalasers.com
Planning Guide & Teaching Tool
ALMA LASERS, INC.
485 Half Day Road
Suite 100
Buffalo Grove, IL
Phone: 224-377-2000
Fax: 224-377-2050
10-13-16
VU10121602 Rev. A
The information contained in this manual is for use as
reference only and does not serve as a substitute for reading
the Operator Manual included with your system.
Table of Contents
Section 1 Using This Planning Guide
1
Section 2 Intended Use and Indications
2
Section 3 In-service Objectives
3
Section 4 Preparing your Patient for Successful Treatment
4-5
Section 5 Clinical Guide
6-14
Section 6 Safety Issues
15-16
Section 7 Forms
17-25
Section 8 Cleaning and Disinfecting the System
VU10121602 Rev. A
26
Alma Lase rs, Inc.
Section 1: Using This Planning Guide
The planning guide is eight sections for easy reference and review. An added feature is the
bolded areas listing important facts.
You will find key concepts and messages that help you use
Your Accent Prime System more efficiently and safely
PRIOR to the scheduled in-service study all sections. Be familiar with definitions, terminology
and forms.
Schedule appropriate patients for the in-service day. Schedule the in-service training at least 2
days after installation of your device. This will allow the Alma Representative time to set up and
test your equipment. This also allows your practice a window of time to prepare for your inservice day. Proper preparation and proper use of your in-service time will prove to be beneficial
to your long-term success.
Write down all your questions. Ask any questions pertaining to patient selection prior to the inservice day. Please contact the Alma Clinical Specialist assigned to your territory.
The Physician and All Staff should be present at the in-service that will either treat patients or
discuss the treatments available with your patients.
Ask your Clinical Specialist about additional programs available from Alma Lasers, Inc to expand
your system capabilities and technology advancement.
Note: You may copy this document for your staff, but you may not distribute
outside your office.
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Section 2: Intended Use and Indications
Congratulations on your purchase of the Accent Prime system. With proper operation and
maintenance, trained, qualified practitioners can use the system safely. The operator and all other personnel involved with patient care should be familiar with the maintenance, operation and
safety information that is provided during in-servicing and found in the Alma Operator’s Manual.
Understanding the terminology and principles behind the technology will allow you to provide
maximum benefits to your patients and your practice. During your in-service, the Clinical Specialist will review the Indications with you and, along with the Training Tool Manual, will guide
you through each modality.
The Accent Prime Unipolar RF module is intended to be used for use in dermatologic and general
surgical procedures. Application of the RF energy alone (without the massager ring) is intended
to provide: Topical heating for the purpose of elevating tissue temperature for the treatment of
selected medical conditions such as relief of pain, muscle spasms, and increase in local
circulation.
The Ultrasound module on the Accent Prime system is intended for use in applying ultrasound
energy for the temporary relief of muscle aches, pain, including facial muscle pain related to the
temporal mandibular joint and joint contractures.
The Accent Prime system with the Pixel RF module and Pixel RF tip is indicated for skin
resurfacing.
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Section 3: In-service Objectives
Our objective for the in-service is to provide appropriate on-site training to the physician and
staff members in the use of the Accent Prime system.
Upon completion of the in-service, the physician and his staff will have a reasonable understanding of:

Patient selection and screening

Technical use of the Accent Prime system

Understanding of RF Technology

Maintenance of the equipment and accessories

Correct protocol to establish and adjust treatments parameters

Managing appropriate patient expectations

Assessment of tissue and target reaction

RF physics and safety

Data requirements

Patient information, indications and contraindications

Sample treatment and patient evaluation forms
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Section 4: Preparing Your Patient For Successful Treatment
Planning for Time
You may accomplish your in-service in one full day including patient treatments. We recommend that you schedule 3 to 5 patients. You may schedule regular patients. However, you may
feel more comfortable beginning with staff, family members and friends. Please refer to this
planning guide to reference any patients who may not be a candidate for treatment.
Plan not to spend more than 45 minutes per patient. Establish proper expectations for treatment
with patients before your in-service day. Schedule your day as a regular office day, allowing for
15 minute intervals between patients. The didactic session is in the morning. Please discuss arrangements of your schedule with your Clinical Specialist when she contacts you to schedule
your in-service day.
The in-service is four main parts.

Didactic review of RF principles, technical aspects of operation, care and maintenance
of equipment, documentation of treatment, safety and questions. The entire staff that
will be involved with the system should be present. Previous laser experience with
competitive products does not relieve any staff member from the in-service day. Staff
members that do not attend all portions of the in-service will not be eligible to receive
Certificates of Attendance for the course.

Hands-on “buttonology” of the Accent Prime system.

Treatment of patients.

Time to summarize the events of the day and answer questions.
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Checklist for In-Service
ITEM
Y
N
Accent Prime system installed and all accessories available
Planning Guide and Training Tool read by all relevant staff
Operator’s Manual read by all relevant staff
Confirm date with all relevant staff
Treatment table or bed (height adjustable if available)
Stool for operator
4x4 gauze pads
Paper towels or tissues
Tongue blades
Vaseline Petroleum jelly for Ultrasound
Infrared Thermometer (CENTER® 350 series, or similar)
Surgical marker
Mirror
Photography stand
High resolution digital or 35mm film camera
Documentation forms if desired (including laser log)
Patient history forms
Informed consent
Schedule patients
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Section 5: Clinical Guide Ultrasound Applications
Introduction
This clinical guide is provided to aid professionals in the use of the Accent Prime system. It adds
to or reinforces information presented in the operator's manual concerning instructions for use,
precautions and warnings necessary to reduce the risk of injury. All operators must read the entire operator's manual before reviewing this appendix and before operating the system.
Training Requirements
The Accent Prime system is designed to be operated only by personnel properly trained in its
handling and use. All personnel who operate the system must read the operator’s manual. This
includes physicians, nurses, technical staff or other professional staff members.
Alma Lasers provides in-service training for the Accent Prime system. At the end of this inservice training, personnel are considered trained for the operation of the Accent Prime system.
The physician is responsible for contacting the local licensing agencies to determine any credentials required by law for clinical use and operation of the device.
Contraindications

Areas or lumps that may be suspected as cancerous or precancerous

Cancer

Active tuberculosis

Pregnancy (including IVF)

Psoriasis

Potentially malignant lesions, tumors malignant or benign

Infection

Central nervous system issue

Plastic components

Pacemakers

Acute and sub-acute thrombosis and thrombophlebitis

Uncontrolled bleeding or blood-thinning medication (Coumadin®)

Abdominal wall hernias

Diabetes

Hepatitis
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Cont.—Clinical Guide
Special Considerations

Smoking

Alcohol consumption

Dental metallic structure (i.e., bridge)

Recent surgical procedures

On-going medications

Acute Inflammation

Decreased sensation

Over implanted materials such as:
~ Metal (reflects 90% of incident US)
~ Plastic (respond like periosteum and it absorbs a larger percentage of US; generally safe
if the ultrasound head is kept moving).
Adverse Effects of Treatment
The use of the Accent Prime system may cause:

Heating sensation– patient may experience a heating sensation during or just following the treatment, however it is expected to be mild and to resolve within a few
minutes.

Erythema – may be present in the treated area and is likely to disappear within 24
hours.

Burns – can be avoided by strict adherence to the operating instructions, and are not
likely if the operating instructions are strictly followed. If a burn occurs, it should be
treated conventionally.

Dry skin – may occur during the first 12 hours post-treatment. Usually it will resolve
spontaneously within 48 hours. Lubrication with moisturizing cream can be helpful.
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Accessories and Equipment

Vaseline (petroleum jelly)

Template (15x10cm)

Surgical marker

Medical/office bed (an adjustable bed is recommended)

High resolution digital or 35mm film camera

Infrared Thermometer (CENTER® 350 series, or similar).
Pre-Treatment Information
General
During the first visit the physician (or an authorized staff member) should:

Take a detailed patient medical and acne history, including previous treatment modalities, and examine the dermatology condition for suitability of treatment with the Accent
Prime system.

Determine why the patient is seeking treatment and understand his/her expectations

Discuss the treatment regimen with the patient.
Counseling
During the first visit, the physician (or an authorized member of the staff) should inform the patient of the following:

Identify and discuss the skin condition and the desired treatment area with the patient.

Inform the patient that acceptable results will likely take a number of treatments
administered over several months.

There may be very mild discomfort associated with the treatment.

Transient erythema/edema may appear immediately following treatment.

No local anesthetic will be used anytime during the treatment regimen.

During the Ultrasound treatment an unpleasant sound may be heard, advise the patient to use a headset to distract from noise.
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Photography
It is recommended to take “before” and “after” photographs to document the treatment progress.
These photographs provide objective evidence, since many patients are not able to assess the progress of treatment with its gradual improvement.
Standard conditions and similar camera speed, flash and focal distance should be used to photograph all patients. This consistency enables an objective comparison of photos taken at different
times.
Number of Treatments, Treatment Intervals and Follow-Up
The recommended number of treatments is 4-6. Treatment intervals should be one to two weeks
(a treatment every 7 to 14 days). Follow-up period should be one week and again one month after
the last treatment.
Treatment
Practical Considerations of Operation and Technique
UltraSpeed Module
After selecting the UltraSpeed module from the control panel, the default parameters of the module will be displayed where the practitioner should set up the time (minutes) as recommended per
protocol.
1.
Resonance tuning: After switching ON the system, and when going from Standby to Ready
mode, the Accent Prime system is conducting self-calibration i.e., resonance tuning; a Resonance Tuning screen will replace the standard screen and will be displayed for the next ~ 30
seconds. After ~ 30 seconds of resonance tuning the original screen will be displayed and ready
for operation.
2. Every 4 minutes the system will automatically recalibrate itself i.e. perform resonance tuning;
this should take ~10 seconds; during this period, treatment should not be stopped.
3. The UltraSpeed module provides guided (Symmetric) ultrasonic waves which produce deep tissue heating and selective disruption of adipocytes membranes.
4. The treatment area should be marked with a 150cm2 x 4 grids.
5. Before commencing the ultrasound treatment, the sonotrod should be coated with thin layer of
petroleum jell (Vaseline). The ultrasound module tip should be positioned perpendicular to the
skin and touch the skin; The UltraSpeed module application requires the slow In-Motion technique where the module should be constantly moved in semi-circular movements on the skin.
The circular shaped tip of the module should be applied and moved inside the marked area for
the full duration of the treatment.
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Treatment Areas
The Ultrasound Module of the Accent Prime system can be used bilaterally in the following
areas:
• Abdomen
• Buttocks
• Thighs
• Calves.
Treatment Objective
The treatment objective is to irradiate ultrasonically each area for a fixed amount of time/
energy.
 To achieve and maintain the treatment area at a therapeutic temperature of 40-43°C.

End-Points

Transient erythema
Treatment Protocol
Pre-Treatment
1. Perform a medical history assessment and check for contraindications.
2. Establish the diagnosis/clinical condition – screen the patient for pain, muscle spasms, and
adiposis severity.
3. Use standard BMI (Body Mass Index) calculators to establish the patients BMI.
4. Standardize photography conditions and take pictures.
5. Establish the patient in a proper position, so that the area to be treated is most accurately
assessed and featured. Take measurements.
6. Remove all jewelry or pendants, including necklaces, bracelets, watches, earrings, piercing, etc.
7. Remove all makeup, moisturizers or oils from the treatment area.
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BMIChart
BMI < 18.80
Underweight
BMI < 16.00
Severe Thinness
BMI 16.00 - 16.99
Moderate Thinness
BMI 17.00 • 18.49
Mild Thinness
BMI18.80 - 24.99
NormalWeight
BMI 18.50 - 22.99
lower Range
BMI 23.00 • 24.99
Upper Range
BMI 25.00 - 29.99
Overweight I Pre-Obese
SUI 25.00 - 27.A9
Lower Range
BMI 27.50 - 29.99
Upper Range
BMI 30.00 • 34.99
Obese Class I
BMI 35.00 - 39.99
Obese Class II
BMI 40.00
Obese Class Ill
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Treatment Procedure UltraSpeed Module
1. Place the 15x10 cm grid on patient, mark and repeat 4 times to define treatment area and
size i.e., 300cm2 at each side of the median line of the abdomen.
2. The system default power and intensity settings should read HIGH and HOT.
3. Set the power and exposure time.
4. Press the Standby button to Ready mode.
5. Allow the system to conduct its Resonance Tuning routine (up to 30sec).
6. Place about half-spoon size of Vaseline on the center of the Ultra plate.
7. Position the module in the intended treatment area and start the module’s movement prior to
pressing the footswitch to allow spreading the Vaseline on the Ultra plate-skin surface area.
8. Press the footswitch to commence the treatment.
9. The treatment technique is In-Motion and should be maintained throughout the duration of
the treatment.
10. The In-Motion technique should drag/guide the Ultra on the skin with slow-to-moderate
random movements in the entire treatment area.
11. Applying the Ultra module in Stationary condition is prohibited.
12. The power can be adjusted (from HIGH to MEDIUM) during the treatment, depending on the
patient’s skin response and tolerability.
13. Use the infrared thermometer to monitor the temperature of the treated area every 3 minutes.
Maintain therapeutic temperature between 40-43°C.
Warning
The use of any water-based (ultrasonic) gel on the skin is prohibited!
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Post-Treatment and Follow-Up

Gently clean the Vaseline from the skin surface and dry it.

Let the patient rest for 10-15 minutes on the treatment bed.

Patient should drink two glasses of water immediately after the treatment.

It is recommended to drink a lot of water (at least 8-10 cups a day) for three days
following the treatment.

It is recommended to avoid consumption of alcoholic drinks for three days after treatment (alcohol might drain water firm the body and skin).

The number of treatments may vary according to the degree of skin irregularity, patient age, skin condition, smoking history, medical history and medications.

Repeat the treatment every 1-2 weeks for 4-6 treatments.

Treatment is complete when satisfactory results are obtained.

Patient should return for follow-up visit one month after the last treatment.
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Recommended protocol for measurements:
Abdomen:
1. Point A is 2 inches above the navel, mark and measure circumference.
2. Point B is 2 inches below the navel, mark and measure circumference.
Arms:
1. Measure from the elbow to the fullest part of the arm and mark.
2. Measure the circumference of the arm at that point.
3. Measure the same distance from the elbow for subsequent measurements.
Buttocks and Thighs;
1. Point A measure from the heel to the top of the Iliac crest, mark and record (the number of
inches becomes the base line measurement for each measurement). Same procedure for Left
leg.
2. Mark point A, drop down 4 inches and mark point B, 4 more inches point C and 4 more for D
& E. Same for Left leg.
3. Point A and B are total circumferences measurements for the buttocks and the rest of the
points are circumference measurements for the legs.
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Section 6:Safety Issues
Eyewear

If protective eyewear is used (not required), only plastic-made eyewear should be used!
Treatment Protocol

Remove all jewelry or pendants, including necklaces, bracelets, watches, earrings, piercing,
etc.

Remove all makeup, moisturizers or oils from the treatment area.

Inspect the entire handpiece, giving special attention to the tip to identify any damage or pulverized materials.

Make sure the staff is aware of the location of the emergency shut-off button.

Limit traffic control into the room.

The staff and physician are encouraged to read all the materials accompanying the Accent
Prime, specifically the Operator’s Manual. Only properly trained, qualified Staff should operate the system.

Do not leave the key in an unattended system.

Always turn off the system when it is not in use.

Never leave the system in READY mode unattended.
Burn Hazards

The Accent Prime system is a state-of-the-art radiofrequency system for medical, aesthetic
and cosmetic applications. The system emits radiofrequency energy that can damage the skin
is case of the use of excessive energy.
Explosion and Fire Hazards

The system is not suitable for use in the presence of flammable mixtures with air or oxygen.

Do not operate in the presence of volatile solvents such as alcohol, gasoline or other solvents.
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Cont.— Explosion and Fire Hazards

Do not use any flammable substances such as alcohol or acetone in the
preparation of the skin for treatment. If necessary, use soap and water to clean
before treatment.

If alcohol is used to clean and disinfect any part of the Accent system,
allow it to dry thoroughly before operating the system.

Flammable materials must be kept at a safe distance from the system.
Electrical Safety

Keep fluids away from the system to prevent the possibility of fluid spills
causing a short circuit.

Ensure electrical plugs and cords are in good working order.

Adequate amperage and voltage required by the system should be available.
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Section 7:Forms

Sample Medical History Form

Sample Accent Prime Consent Form

Patient Treatment Form

Follow-Up Treatment Forms
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Sample Medical History
Name:
Address:
Home Phone:
Age:
Work:
Cell:
Referred by:
Have you ever had the following?
 Current or history of cancer, especially malignant melanoma or recurrent non-melanoma skin cancer, or pre-cancerous
lesions such as multiple dysplastic nevi.
 Any active infection.
 Diseases which may be stimulated by light at 515 nm to 1200 nm, such as history of recurrent Herpes Simplex, Systemic
Lupus Erythematosus, or Porphyria.
 Use of photosensitive medication and/or herbs that may cause sensitivity to 515 - 1200 nm light exposure, such as Isotretinoin, tetracycline, or St. John's Wort.
 Immunosuppressive diseases, including AIDS and HIV infection, or use of immunosuppressive medications.
 Patient history of Hormonal or endocrine disorders, such as polycystic ovary syndrome or diabetes, unless under control.
 History of bleeding coagulopathies, or use of anticoagulants
 History of keloid scarring.
 Very dry skin.
 Exposure to sun or artificial tanning during the 3–4 weeks prior to treatment.
 Are you pregnant?  Yes No
 What medications are you taking (including aspirin)?
 Daily consumption of alcohol
 Allergies:
 Are you taking any herbal preparations?(St. John’s Wort, etc.)
If yes, list
 Do you wear contact lenses?  Yes  No
Skin type (when exposed to the sun without protection for about 1 hour)
 always burns, never tans always burns, sometimes tans
 sometimes burns, sometimes tans always tans
 Hispanic  Asian  Mediterranean  Middle Eastern
 Black
When were you last exposed to the sun (including tanning booth)?
Do you use chemical sun tanning lotions?
Are you planning a holiday in the sun?
Reason for visit (area to be treated)
Prior treatment (if any)
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Sample Accent Prime Informed Consent Form
Warning: The sample informed consent provided by Alma Lasers, Inc should be
used by the physician in the context of his or her experience and the laws of the
state in which he or she practices.
I understand that the Accent Prime incorporates two distinct applications technologies Ultrasound and Radiofrequency (RF) intended for applying selective Ultrasound Lipolysis and Radiofrequency (RF) which provides heating for the purpose of elevating tissue temperature. Both are
indicated for the treatment of selected aesthetic/medical conditions such as treatment of adiposis
and localized adiposity, cellulite, skin laxity, reduction in body circumference, body and face contouring. I understand that multiple treatments may be required and that there is no guarantee
that the above indications will be completely removed. I understand that there is a possibility of
short term (few seconds to hours) adverse effects such as heating sensation, erythema and dry
skin. Burns may occur in rare situations. These possible adverse effects have all been fully explained to me
(please initial).
I understand that the treatment by the Accent Prime system involves a series of treatments and
the fee structure has been fully explained to me.
I also understand that there are other options for treatment of adiposis and localized adiposity,
cellulite, skin laxity, reduction of body circumference, body and face contouring that are available
and each of these other options have fully been explained to me
(please initial).
With this in mind, I am choosing to try Accent Prime non-invasive treatment for
.
PHOTOGRAPHS :
I do
do not
give permission for photographs and other audiovisual and graphic materials to be used by the physician or Alma Lasers, Inc for marketing, education-promotion purposes. Although the photographs or accompanying material will not contain my name or any other identifying information, I am aware that I may or may not be identified by the photos.
Signature
I have read and understand this agreement and all my questions have been addressed and answered to my satisfaction. I agree to the terms of this agreement.
Patient’s Name:
Signature:
Date:
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Patient Treatment Form
Physician
Name:
Assistant
Name:
Patient Name:
Date of Procedure:
Location
 Face
 Chest
Leg:  Left  Right
Arms:  Left  Right
 Back
Abdomen:  Left  Right
Other:
Patient Skin Type:
Was test patch Performed:  Yes No
Results
Parameters recorded:  Yes No
Note any skin reaction discernible at end of procedure, i.e. edema, erythema, etc.
Form completed by:
Date:
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Follow-Up
Five Point Improvement Scale
1. No Improvement
4. 50-75% Improvement
2. 0-25% Improvement
5. 75-100% Improvement
3. 25-50% Improvement
Improvement Scale
(Circle one option)
FU #1 DATE
After 4 weeks
/
/
1
2
3
4
5
1
2
3
4
5
1
2
3
4
5
FU #2 DATE
After 8 weeks
/
/
FU #3 DATE
After 12 weeks
Signature:
/
/
Date:
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TREATMENT NOTES Ultra Small
Name:
BP:
/Temp:
/Weight:
Notes: remove jewelry & makeup, photo,
measurements, empty bladder, consents, avoid
tattoos, shave excessive hair.
Date
Treatment
UltraSmall
(150cm2 grid)
Watts
Time
Temp
Tx#1
Tx#2
Tx#3
Tx#4
Tx#5
Erythema: (1) Light (2) Moderate (3) Severe
Toleration Scale: (1) cool
(5) unable to tolerate
(2) some warmth (3) warm, but comfortable
(4) uncomfortable
NOTES:
Technician signature:
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TREATMENT NOTES UltraSpeed
Name:
BP:
/Temp:
/Weight:
Notes: remove jewelry & makeup, photo,
measurements, empty bladder, consents,
avoid tattoos, shave excessive hair.
Date of Tx
UltraSpeed
(300cm2 grid)
UltraSpeed
(300cm2 grid)
Measurements: A
B
R)C
L)C
R)D
R)E
L)E
Watts
Time
Temp
Tx#1
Tx#2
Tx#3
Tx#4
Tx#5
Tx#6
Erythema: (1) Light (2) Moderate (3) Severe
Toleration Scale: (1) cool
(5) unable to tolerate
(2) some warmth (3) warm, but comfortable
(4) uncomfortable
NOTES:
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TREATMENT NOTES UltraSpeed
Name:
BP:
/Temp:
/Weight:
Notes: remove jewelry & makeup, photo,
measurements, empty bladder, consents, avoid
tattoos, shave excessive hair.
Measurements: A
B
(measure 5cm above the umbilicus and 5cm below)
Date of Tx
UltraSpeed
(300cm2 grid)
UltraSpeed
(300cm2 grid)
Watts
Time
Temp
Tx#1
Tx#2
Tx#3
Tx#4
Tx#5
Tx#6
Erythema: (1) Light (2) Moderate (3)Severe
Toleration Scale: (1) cool
(5) unable to tolerate
(2) some warmth
(3) warm, but comfortable
(4) uncomfortable
NOTES:
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Section 8:
Maintenance
Introduction
Routine maintenance may be performed by clinic staff unless otherwise specified. Any maintenance
procedure not mentioned in this chapter must be performed only by Alma Lasers authorized technical
personnel. (Please refer to operating manual).
The system is designed to operate reliably without any need for operator maintenance. However, the
outer surfaces of the system should be kept clean for hygienic reasons and the applicator tips should be
cleaned between sessions to enable effective treatment.
Warning
Maintenance by the operator should be performed only when the system is shut down and disconnected from the mains power source. Performing maintenance procedures with the system turned on may
be hazardous to the operator and/or destructive to the system.
Routine and Preventive Maintenance
The following routine maintenance procedures should be performed by the clinic staff on a regular basis determined by the clinic protocol.
Warning
The Accent Prime system generates high voltages when powered up.
Always turn the system off and unplug the power cable before performing maintenance procedures.
The interior of the system or its components may be serviced only by Alma Lasers authorized
technical personnel
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VU10121602 Rev. A
Alma Lase rs, Inc.
Cleaning and Disinfecting the System
The outer surface of the system may be wiped clean with a soft cotton cloth swabbed in 70% alcohol.
Cleaning and Disinfecting the Modules
Caution
The coatings of the module applicator tips are very delicate. Take all necessary precautions in order to
prevent scratching the tips.
The Accent Prime modules, in particularly the applicator tips, are cooled intensively when the system
is in Ready mode. Water may condense on the applicator tip's surface which could affect the treatment
process and, under certain conditions, may produce sparks. Avoid water condensation on the applicator tip's surface. Wipe the surface of the applicator tip clean immediately before a treatment.
Following every treatment wipe the module with a soft cotton swab dipped in 70% alcohol.
On a weekly basis check the module tips for cleanliness. If necessary clean the module tips with a soft
cotton swab dipped in 70% alcohol.
Caution
Do not wet the module with water or immerse the module in any liquid.
During treatment use only the treatment oil recommended by Alma Lasers.
Page 26
VU10121602 Rev. A
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