Alma Hybrid Operator's Manual
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Alma Hybrid Operator's Manual

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  • Page 1 Alma Manual...
  • Page 2 Alma Lasers. System specifications and the information contained in this document are subject to change without notice. Alma Lasers, its logo and Alma Hybrid are either registered trademarks or trademarks of Alma Lasers Inc. in the USA and/or other countries.
  • Page 3 Following appendixes provides clinical information of applicators: Clinical Guide – Clinical General Appendix A Appendix B Clinical Guide - HyLight Applicator Appendix C Clinical Guide - Pixel Applicator Appendix D Clinical Guide - ProScan Applicator Alma Hybrid - Instructions for Use...

  • Page 4: Table Of Contents

    System and Equipment Classifications and Compliance ....2-7 Labeling and Signs ..................2-8 System Description Introduction....................3-1 System Specifications ................3-2 System Components and Controls ............3-2 Ordering Information................3-6 Installation Introduction....................4-1 Equipment List................... 4-1 Alma Hybrid - Instructions for Use...

  • Page 5: Table Of Contents

    Service Information ................... 6-5 Troubleshooting Introduction ....................7-1 Troubleshooting Guides ................7-1 Electromagnetic Compatibility Cable Lengths and Replacements ............8-2 Manufacturer's declaration – Electromagnetic Emissions ....8-2 Manufacturer's declaration – Electromagnetic Immunity ....8-3 Alma Hybrid - Instructions for Use...

  • Page 6: System Overview

    System Overview Introduction The Alma Hybrid Laser System is a new laser system and a unique medical device. Alma Hybrid Laser System offers monochromatic and sequential radiation delivery of two wavelengths and is intended for a wide spectrum of medical and aesthetical applications. The Alma Hybrid Laser System incorporates two laser wavelengths: CO2 (10,600nm) and 1570nm lasers for the emission of non-fractional or fractional output .

  • Page 7: Physician Responsibility

    The physician will be responsible for the use and operation of the system and for all operator qualifications. Alma Lasers makes no representations regarding state or local laws or regulations that might apply to the use and operation of any medical system.

  • Page 8: Resale Inspection

    If any Alma Lasers system is resold by anyone other than an authorized sales representative, Alma Lasers offers a resale inspection by an Alma Lasers technician to assure that the system is working in accordance with manufacturer’s specifications. Using the system after it has been resold and before it has been inspected is a misuse of the system, which may result in injuries and voids all warranties, expressed and implied.

  • Page 9: Safety

    If an error occurs, the system displays a warning message to the operator and disables further operation. The patient should avoid contact with the ground or with parts that have appreciable capacitance to earth (e.g., operating table supports, etc.). Alma Hybrid - Instructions for Use...
  • Page 10 The emission is disabled if the coolant temperature becomes higher than the allowed tolerance. Caution Laser fume and/or plume may contain vaporized tissue particles, pathogens, and toxic gases emanating during CO2 laser procedures is an occupational hazard and may also obscure the operative fields. Alma Hybrid - Instructions for Use...

  • Page 11: The Treatment Room

    Access to the system treatment room should be allowed only to personnel essential to the procedure and who are well trained in the required safety procedures. Assure that all the treatment room personnel are familiar with the system controls and know how to shut down the system instantly. Alma Hybrid - Instructions for Use...

  • Page 12: General Precautions And Cautions

    Federal law (US) restricts this Device to sale by or on the order of a physician (applicable for USA only). • Only Alma Lasers authorized personnel may service the system. This includes making internal adjustments to the power supply, cooling system, optics, applicators etc. •...

  • Page 13: Warnings Related To Laser Emission

    • The safety eyewear and opaque eye protectors are supplied with the system and offer an adequate protection. For additional safety eyewear ordering please contact your Alma Lasers representative. Alma Hybrid - Instructions for Use...
  • Page 14 The system produces very high voltages in various components. Some components may retain a charge after the power supply has been turned OFF. No part of the exterior housing should be removed, except by Alma Lasers authorized personnel. • Never leave the system turned ON, open or unattended during system maintenance.

  • Page 15: System Safety Features

    Class I Equipment Degree of Protection against Electric Shock: Type BF Applied Part Protection against ingress of liquids: Ordinary equipment Not suitable for use in presence of flammable anesthetic mixture with air or nitrous oxide. Alma Hybrid - Instructions for Use...

  • Page 16: Labeling And Signs

    • Degree and type of protection against electric shock Figure 2-2. The Alma Hybrid Laser System (30W and 70W) Identification Labels Laser Class 4 label – located on the rear panel of the system. Alma Hybrid - Instructions for Use...
  • Page 17 Safety Figure 2-3. The Alma Hybrid Laser System (30W and 70W) Laser Class 4 Label Alma Hybrid - Instructions for Use...
  • Page 18 Federal (US) law restricts this device to sale by the order of a physician licensed by the law of the state in which he practiced to use or order the use of the device 2-10 Alma Hybrid - Instructions for Use...
  • Page 19 60% high and 10% low. Air Pressure Limitations - The symbol provides the storage and transport air pressure limit. In this case, indicating a low 90 kPa and a high 110 kPa. Alma Hybrid - Instructions for Use 2-11...

  • Page 20: System Description

    1570nm Fiber Laser Technology The fiber laser applicator comprises laser diodes, WDMs and taps, erbium ytterbium- doped fiber and the micro-processor-based controller for standalone operation. Communication is provided by a serial RS-232 link in the electrical interface. Alma Hybrid - Instructions for Use...

  • Page 21: System Specifications

    The beam delivery system is a lightweight, spring-balanced articulated arm. The articulated arm beam-delivery system provides maneuverability, variable working distance and full wrist motion. A connectors port/hub which is firmly affixed to the articulated arm, provides powering, identification, control and/or cooling for the connected applicators. Alma Hybrid - Instructions for Use...
  • Page 22 The key-switch is located on the front of the system. To switch the system into operational mode, the key-switch is turned a quarter of a turn, clockwise. Warning To avoid misuse of the system, do not leave the key while the system is unattended. Alma Hybrid - Instructions for Use...
  • Page 23 The service panel located on the rear side of the system and incorporates the following: Main Switch Current Indicator Circuit Breaker Power Cable Port Footswitch Port Interlock Port Vent Fill Figure 3-2. Service Panel Alma Hybrid - Instructions for Use...
  • Page 24 Energy emission is enabled only when the operator activates Ready mode and presses the footswitch; therefore, accidental lasing may only occur due to double error condition (minimum risk). Pressing the footswitch in other modes will not allow energy emission. Figure 3-3. Footswitch Pedal Alma Hybrid - Instructions for Use...

  • Page 25: Ordering Information

    System Description Ordering Information The following items by which you should place your orders with your Alma Lasers distributor. ✓ Applicators* ✓ System Console ✓ Opaque Eye Protectors ✓ System Operator’s Manual ✓ Footswitch Pedal ✓ Protective Glasses ✓ Laser Warning Sign ✓...

  • Page 26: Installation

    Before unpacking the system, ensure that the site meets the requirements described in the following sections. 4.3.1 Electrical Requirements Caution The system should be connected to a separate power line with separate circuit breakers. Alma Lasers cannot guarantee adequate performance unless the system is connected to a dedicated circuit. Warning Verify that the system is wired for the appropriate line voltage of your country.
  • Page 27 3.2.4. In order to guarantee proper ventilation, always keep the sides of the system at least 0.5m from the wall or from other obstructions to air flow. After positioning the system, lock the breaks on wheels. Alma Hybrid - Instructions for Use...

  • Page 28: Remote Interlock And Footswitch Connection

    Caution To avoid overheating and system malfunction, do not use any coolant other than the one which is provided by Alma Lasers. For assistance, always consult with Alma Lasers authorized service personnel before performing this procedure. Alma Hybrid - Instructions for Use...

  • Page 29: Moving The System

    Never pull or push the system by any part other than the system handle. Never use the applicator or the articulated arm to move the system. If the system is to be moved to another facility, consult your Alma Lasers service representative. To move the system within the clinic: Lock the articulated arm's end joint in its cradle.

  • Page 30: Operating Instructions

    Check the Beam Alignment before each use (see 6.3.2) Improper use or adjustment of this system may invalidate the system service warranty agreement. Please contact your authorized Alma Lasers distributor before attempting to use the system in any manner other than those specified in this manual.
  • Page 31 The Key Switch screen appears after few seconds of the system Power Up: Figure 5-1: Keyswitch Screen When prompted turn ON the Key Switch on the system's front panel; Start Screen appears: Figure 5-2: Start Screen Press the Start button. Alma Hybrid - Instructions for Use...
  • Page 32 To protect against eye damage, make sure that everyone present in the room is wearing Alma Lasers recommended protective eyewear. Never look directly at the laser pulse coming from the accessory, even when wearing appropriate protective eyewear.

  • Page 33: Operating The System

    The audible indicator sounds an alarm signal which is longer than the normal light or laser emission signals. In such a case you should shut the system down and restart it. If the problem still persists, refer to CHAPTER 7– Troubleshooting Chapter– for further instructions. Alma Hybrid - Instructions for Use...

  • Page 34: System Shut-Down

    Disconnect and Clean the applicator according to the instructions. Return the applicator to it carrying case. Warning Do not leave the key in the key-switch unattended. It may lead to unauthorized use of the system. Alma Hybrid - Instructions for Use...

  • Page 35: Maintenance

    The following routine service operations should be performed by Alma Lasers authorized technical personnel every 12 months: If periodic service is not performed according to schedule (every 12 months) by an Alma Lasers- authorized service provider, any warranty agreement of the system and its associated applicators and/or accessories will be invalidated.

  • Page 36: Routine Maintenance

    Check and clean internal optical components Every 12 months Alma Lasers Service Check optical alignment Every 12 months Alma Lasers Service As required if system does not Replace CO laser resonator Alma Lasers Service perform to specifications Alma Hybrid - Instructions for Use...
  • Page 37 Do not use the system if the pilot and treatment beams are not aligned or if the test burn is unacceptable; contact your local Alma Lasers service representative. Misalignment can result in laser exposure to nontarget tissues and possible injury.
  • Page 38 ▪ If the brightness of the pilot beam fluctuates greatly or if the pilot beam is not visible, the optical lens may be damaged or the articulated arm may be out of alignment; contact your Alma Lasers service representative. Repeat the beam alignment procedure. If the beam alignment is still unacceptable, contact your local Alma Lasers service representative.

  • Page 39: Service Information

    Questions or problems should be referred to your Alma Lasers representative, or to the Alma Lasers Service Center at: Alma Lasers Ltd.

  • Page 40: Troubleshooting

    Alma Lasers Service representative. Table 7-2 lists some probable system malfunctions for which no messages are displayed. If the corrective actions listed in the tables do not solve the problem, contact your Alma Lasers service representative. The following troubleshooting guides do not attempt to list all possible system failures. Any fault not listed should be referred to your Alma Lasers service representative.
  • Page 41 Electronic malfunction. If problem persists, call Alma Lasers Service. Turn system off, wait 1 minute and restart; resume normal operation. User Power Out of Range Electronic malfunction. If problem persists, call Alma Lasers Service. Alma Hybrid - Instructions for Use...
  • Page 42 If problem persists, call Alma Lasers Service. Turn system off, wait 1 minute and restart; resume normal operation. Scanner Not Detected Error Hardware malfunction. If problem persists, call Alma Lasers Service. Alma Hybrid - Instructions for Use...
  • Page 43 Set system to Ready mode. Laser emission does not occur • • when footswitch is pressed. Footswitch malfunction. Turn system off and contact Alma Lasers service. • Intensity setting too low. • • Adjust intensity setting (see Chapter 6). Optical system misalignment.

  • Page 44: Electromagnetic Compatibility

    The system needs special precautions regarding EMC and needs to be installed and maintained according to the instructions described in chapters Installation and Maintenance for maintaining basic safety and essential performance with regard to electromagnetic disturbances during the expected service life. Alma Hybrid - Instructions for Use...

  • Page 45: Cable Lengths And Replacements

    Manufacturer's declaration – Electromagnetic Emissions Emissions test Compliance Electromagnetic environment - guidance The Alma HYBRID uses RF energy only for its internal function. Therefore, its RF emissions are very low and are Group 1 RF emissions not likely to cause any interference in nearby electronic...

  • Page 46: Manufacturer's Declaration - Electromagnetic Immunity

    80 MHz to 2.7 GHz Radiated RF 385 MHz 27 V/m 450 MHz 28 V/m 710 MHz Proximity fields 745 MHz 9 V/m from RF wireless communications 780 MHz equipment 810 MHz 870 MHz 28 V/m 930 MHz Alma Hybrid - Instructions for Use...
  • Page 47 Electromagnetic Compatibility 1720 MHz 1845 MHz 28 V/m 1970 MHz 2450 MHz 28 V/m 5240 MHz 5500 MHz 9 V/m 5785 MHz Alma Hybrid - Instructions for Use...
  • Page 48 ALL FIELDS Overview This chapter is provided to aid professionals in the use of the The Alma Hybrid Laser System. Personnel operating the applicator must have a thorough understanding of its proper operation. This chapter has been prepared to aid medical personnel to understand the intended use, indications, contraindications and adverse events relating to use.
  • Page 49 Vaporization/coagulation of warts. Pixel The Alma Hybrid Pixel CO2 fractional applicator, with wavelength of 10600 nm is indicated for: The ablation, vaporization, and coagulation of soft tissue in dermatology and plastic surgery in the performance of skin resurfacing.
  • Page 50 Clinical Guide – all fields A.2.1 Contraindications (10600nm wavelength) • • Bacterial or viral infection Scleroderma • • Pregnancy and/or breastfeeding Extensive radiation therapy • • Impaired immune system Burns in the treatment area • • History of keloid scarring Poor healing in the treatment area •...
  • Page 51 Clinical Guide – all fields • Ectropion (a medical condition in which the lower eyelid turns outwards) • Koebner phenomenon/ koebnerization (appearance of skin lesions on lines of trauma) • Post-treatment pallor following fully ablative CO2 laser treatment may occur •...
  • Page 52 Clinical Guide – all fields • Discomfort (pain, tingling or burning sensation) may occur within 48 hours of treatment at the application site. • Change of Pigmentation -Hyperpigmentaton or hypopigmentation (Rare). Dark skin is more prone to pigmentation. Mild Post-Inflammatory Pigmentation (PIH) usually resolves within one to four months.
  • Page 53 IGHT PPLICATORS B.1 Introduction This chapter is provided to aid professionals in the use of The Alma Hybrid Laser System with the HyLight applicators. Personnel operating the applicators must have a thorough understanding of their proper operation. This chapter has been prepared to aid medical and technical personnel to understand and operate the applicators.
  • Page 54 HyLight Applicator B.2 Applicator Specifications Figure B-1: HyLight 50 Applicator label Figure B.1.1 The Alma Hybrid Laser System HyLight 50 Applicator Figure .1.2 The Alma Hybrid Laser System HyLight 50 Applicator tip label Page B-2...
  • Page 55 HyLight Applicator Figure B-2: HyLight 200 Applicator Figure B.2.1 The Alma Hybrid Laser System HyLight 200 Applicator label Page B-3...
  • Page 56 HyLight Applicator Figure B.2.2 The Alma Hybrid Laser System HyLight 200 Applicator tips labels Light Source 10600 Laser Tube 30W / 70W Wavelength [nm] 10600 Pilot Beam 650 [nm], 3mW Operation Modes: Repeat / Pulse / CW Type B or BF...
  • Page 57 HyLight Applicator B.3 Cleaning of the Applicator and Accessories Use a clean, tint-free cloth moistened with alcohol 70% to carefully clean the surfaces before use. B.3.1 Tip Disassembly The tip can be disassembled from the body of the applicator for the purpose of cleaning and sterilization. It is imperative that the optical lens remain clean and free of dirt during treatment.
  • Page 58 HyLight Applicator B.4 Operating Instructions 1. Connect one of the applicators to the system. 2. Turn on the system; the Treatments screen will appear: Figure B-3: Treatment Selection Screen 3. Choose the desired treatment mode; the selected treatment mode screen will appear: The elements description for the 10600nm described in the screen below.
  • Page 59 HyLight Applicator B.4.1 Treatment mode elements: The screen elements in figure below belong to the following treatments: ✓ Cut & Coagulate CO Refer to the numbered arrows for definitions and rules of navigation throughout the HyLight treatment illustration screen as described below: Figure B-4: Treatment Screen Elements 1.
  • Page 60 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 system. Once completed, personnel are considered trained for the operation of the system.
  • Page 61 HyLight Applicator B.5.3 Pre-Treatment Information General The following instructions should be carried out by the physician (or an authorized staff member) during the first visit: • A detailed patient medical history should be obtained and screened for contra-indications, including previous treatment modalities. •...
  • Page 62 HyLight Applicator B.5.4 Warnings- 10,600nm Wavelength General Warning • Surgical plume with vaporized tissue particles, pathogens, and toxic gases emanating during 10600nm laser procedures is an occupational hazard and may also obscure the operative fields. Therefore, a smoke evacuator and a facial mask should be used during 10600nm laser procedures Dermatological, and Plastic Surgery •...
  • Page 63 HyLight Applicator 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.
  • Page 64 HyLight Applicator B.5.7 Treatment Protocols Warning Surgical plume with vaporized tissue particles, pathogens, and toxic gases emanating during 10600nm laser procedures is an occupational hazard and may also obscure the operative fields. Therefore, a smoke evacuator and a facial mask should be used during 10600nm laser procedures If the patient cannot wear the protective eyewear and radiation is close to the eye, fit the patient with opaque eye protection that completely blocks light from the eyes.
  • Page 65 B.5.7.2 B.5.8 Post-Treatment Care and Follow-Up The measures presented below are Alma Lasers’ recommendations for follow-up. They may serve as a basis for defining your treatment regimen. The patient should be cautioned about limited sun exposure following the procedure.
  • Page 66 (such as hydroquinone) should be used to help obtain resolution. All adverse side effects should be reported to the treating personnel with a follow-up report sent to the Director of Clinical Operations at Alma Lasers: Alma Lasers Ltd. Alma Lasers Inc.
  • Page 67 IXEL PPLICATOR C.1 Overview This chapter is provided to aid professionals in the use of the The Alma Hybrid Laser System system with the Pixel applicator. Personnel operating the applicator must have a thorough understanding of its proper operation. This chapter has been prepared to aid medical and technical personnel to understand and operate the applicator.
  • Page 68 Pixel Applicator C.2 Applicator Specifications Figure C.2-1: Pixel 9x9 Applicator Figure C.2-2: Pixel 7x7 Applicator Figure C.1.1 The Alma Hybrid Laser System Pixel Applicator label Page C-2...
  • Page 69 Pixel Applicator Figure C.1.2 The Alma Hybrid Laser System Pixel Applicator tips label Light Source Laser Tube 30W/70W Wavelength [nm] 10,600 Pilot Beam 650 [nm], 3mW Operation Modes: Repeat/Pulse C.2.1 Cleaning of the Applicator and Accessories C.2.1.1 Tip Disassembly The tip can be disassembled from the body of the applicator for the purpose of cleaning and sterilization.
  • Page 70 Pixel Applicator C.2.1.3 Applicator Tip Cleaning and Sterilization Do not sterilize the lens housing; you may sterilize the tip only. Disinfectants containing peracetic acid or chlorine components should not be used. It is imperative that the optical lens remains clean and free of dirt during treatment. During long treatments, the operator should visually inspect the lens and clean it as necessary.
  • Page 71 Pixel Applicator C.3 Operating Instructions 1. Connect the applicator to the system. 2. Turn the system on; the applicator screen will appear: Refer to the numbered arrows for definitions and rules of navigation throughout the treatment screen: Figure C-3: Applicator Treatment Screen 1.
  • Page 72 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 system. Once completed, personnel are considered trained for the operation of the system.
  • Page 73 Pixel Applicator • Using the laser above the ablation threshold and at its focal point with a small spot size (for incision/excision), results in an extremely high energy density. Therefore, beware of prolong exposure on treatment area. • For superficial ablation of tissue, appropriate power levels and spot sizes must be selected in order to limit the depth of thermal injury or char.
  • Page 74 Pixel Applicator ➢ Block injections. ➢ Intravenous (IV) sedation (Ketamine, Midazolam, Propofol). • A filtered smoke evacuator system should be continuously used to suction vaporization plume. The smoke evacuator’s disposable accessories (e.g. filter, tubing) should be disposed of as biohazardous waste.
  • Page 75 Pixel Applicator Note Treatment protocols in this guide are provided only as recommended guidelines. The actual treatment should be carried out only according to the physician's professional judgment and discretion. 1. Clean the treatment area before starting the procedure. 2. Ensure that all personnel within the laser operating area wear appropriate eye protection. 3.
  • Page 76 Pixel Applicator C.4.5 Suggested Setup Parameters C.4.5.1 Skin Test The purpose of the skin test is to monitor patient's skin reaction and to rule out unexpected adverse side effects. A skin test should always be performed on the intended treatment area prior to the first treatment according to the following sequence: 1.
  • Page 77 Pixel Applicator C.4.6 Post-Treatment Care and Follow-Up The measures presented below are Alma Lasers’ recommendations for follow-up. They may serve as a basis for defining your treatment regimen. The patient should be cautioned about limited sun exposure following the procedure.
  • Page 78 (such as hydroquinone) should be used to help obtain resolution. All adverse side effects should be reported to the treating personnel with a follow-up report sent to the Director of Clinical Operations at Alma Lasers: Alma Lasers Ltd. Alma Lasers Inc.
  • Page 79 Appendix D PPLICATOR D.1 Introduction This chapter is provided to aid professionals in the use of The Alma Hybrid Laser System with the ProScan applicator. Personnel operating the applicator must have a thorough understanding of their proper operation. The applicator incorporates a thermoelectric cooling component. The metallic tip of the applicator cools the treatment area when in contact.
  • Page 80 D.2 Applicator Specifications Figure D-1: ProScan Applicator Figure D.1.1 The Alma Hybrid Laser System ProScan Applicator label Figure D.1.2 The Alma Hybrid Laser System ProScan Applicator tip label Light Source 10600 Laser Tube 30W / 70W and 1570 Fiber laser 15W...
  • Page 81 ProScan Applicator D.3 Cleaning the Applicator and Accessories Use a clean, lint-free cloth moistened with alcohol 70% to carefully clean the surfaces before use. D.3.1.1 Tip Disassembly The tip can be disassembled from the body of the applicator for the purpose of cleaning and sterilization. It is imperative that the optical lens remain clean and free of dirt during treatment.
  • Page 82 ProScan Applicator D.4 Operating Instructions 1. Connect the applicator to the system 2. Turn the system ON; the Treatments screen will appear: Figure D-2: Applicator Treatment Screen 3. Choose the desired treatment mode; the selected treatment mode screen will appear: Refer to the numbered arrows for definitions and rules of navigation throughout the treatment screen: Page D-4...
  • Page 83 ProScan Applicator D.4.1 ProScan 10600nm treatment mode: Figure D-3: 10600nm Grid Treatment Screen 1. Treatment Mode – Displays the operation mode. 2. Presets – Opens the Preset Selection Menu. Presets can be saved, edited or deleted. 3. Power (Watt) – To increase or decrease the power level, the > or < buttons should be pressed. 4.
  • Page 84 ProScan Applicator • Line: The system lases a line. • Square: The system lases in a full square area. • Dot: The system lases a single dot. • Circle: The system lases a full circular area. • Grid: The system generates a fractionated matrix of dots in square scanning pattern. The number of dots and the space between the rows and columns is controlled by the "Density"...
  • Page 85 ProScan Applicator D.4.2 ProScan 1570nm treatment mode: The screen elements of the ProScan 1570nm are the same as in section D.4.1 except the Accumulative Energy Accumulative Energy – The total energy that has been delivered since the beginning of treatment session.
  • Page 86 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 system. Once completed, personnel are considered trained for the operation of the system.
  • Page 87 ProScan Applicator • The patient should be informed that treatment may be associated with some discomfort and/or adverse effects. D.5.4 Warnings – Combined Technologies • Extreme care must be taken when using 10,600nm and 1570nm wavelength sequentially. Follow manufacturer's recommended settings •...
  • Page 88 ProScan Applicator • Any skin pathology such as scars, keratoses, rosacea, acne or dyschromias should be diagnosed and treated prior to a laser dermabrasion procedure. • If possible, it is recommended to keep the surface dry to minimize energy loss when using the CO2 laser •...
  • Page 89 ProScan Applicator • There is no guarantee that treatment with the 10,600nm or 1570nm wavelengths will eliminate any disease or condition. Repeated treatments or alternative therapies subsequently may be required. • Prior to a laser skin procedure, previous skin treatment such as chemical peels or mechanical dermabrasions may have already given the patient scars, texture or pigmentary changes which should be pointed out to the patient •...
  • Page 90 ProScan Applicator D.5.8.2 10,600nm and 1570nm Wavelengths Table D-1: Suggested treatment for Skin Resurfacing SkinType Shape Density CO2 [W] CO2 [msec] 1570 [W] 1570 [msec] Cooling Grid (Sequentially) HyGrid HyGrid D.5.8.3 1570nm Wavelengths Table D-2: Suggested treatment for Skin Resurfacing SkinType Shape Density...
  • Page 91 ProScan Applicator 3. Turn ON the cooling and wait 2 min in order to allow the applicator’s tip to properly cool. check that the tip is cooling 4. Set the initial parameters according to the skin test, clinical indication and skin type. 5.
  • Page 92 D.5.10 Post-Treatment Care and Follow-Up The measures presented below are Alma Lasers’ recommendations for follow-up. They may serve as a basis for defining your treatment regimen. Previous sun exposure with resultant photo-aging skin damage should be evaluated and the patient should be cautioned about limited sun exposure following the procedure.
  • Page 93 ProScan Applicator ® ® ® 2. Shortly after treatment, a topical emollient such as Aquaphor , Humatrix , Biafin or other equivalent occlusive ointment should be applied over the area. The occlusive ointment should be applied 3 times a day for one week or until the epidermis is completely healed. 3.
  • Page 94 (such as hydroquinone) should be used to help obtain resolution. All adverse side effects should be reported to the treating personnel with a follow-up report sent to the Director of Clinical Operations at Alma Lasers: Alma Lasers Ltd. Alma Lasers Inc.

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