Health and Safety

Laser Safety

LASER SAFETY OFFICER (LSO)

System Safety Measures The Soprano Ice Platinum system was designed to maximize safety for both patients and personnel. The following are some of the Soprano Ice Platinum preventive safety measures:

Electrical Safety The following electrical safety features are incorporated in the Soprano Ice Platinum system. 1. A semi-automatic circuit breaker, located on the service panel, protects the system by tripping when power overload occurs. To resume normal operation, lift the circuit breaker handle and restart the system.

2. Software protection, includes: The software checks all safety related hardware after the system is switched on. Light/Laser energy emission timing is regulated by interrupts every 1 msec. A watchdog cycle continuously monitors operation of the system during treatment. If an error occurs, the system displays a warning message to the operator and disables further operation. A self-test of the attached module is performed when the system is turned on. The test includes module identification. A self-test of the electrical circuitry takes place after the system is turned on. The test circuits continuously monitor system operation during treatment.

Light and Laser Safety The following Light & Laser safety features are incorporated in the SopranoIce Platinum system. 1. Closed light guide geometry is used to transmit Light/Laser energy to the treatment site. Light/Laser energy is emitted only through the front plane of the light guide. 2. The system incorporates a safety remote interlock connector for connecting an external interlock on the entrance door to the treatment room. The external remote interlock is serially connected with the footswitch; when installed, it disables the system and prevents operation when the entrance door is opened. 3. An emergency shutoff knob expedites shutdown when necessary. When pressed, it immediately shuts down system operation. 4. The system can be turned on only when the key is inserted in the keyswitch. When not in operation, the key should be removed to prevent unauthorized use of the system. 5. A password on the service screen prevents unauthorized changes to the system's basic operating parameters. 6. The system features two emission indicators: a yellow emission indicator lamp located on the top of the control panel and a buzzer. 7. The yellow emission indicator lamp flashes when the system is ready to trigger pulses, and becomes a continuous light when a pulse is triggered. 8. A warning buzzer sounds when the system is ready to trigger a pulse. 9. Light emission is enabled only when the operator switches to Ready mode and presses the footswitch (minimum risk). 10. Laser emission is enabled only if both the footswitch and the module's trigger are pressed at the same time, reducing the risk of unintentional Light/Laser emission. 11. Water is circulated through the module as soon as the system is turned on in order to cool the light source. 12. The flow and temperature of the water are monitored in order to eliminate the risk of module overheating. Light/Laser emission is not permitted if the water flow stops or if the water temperature is equal to or higher than 40ºC (104ºF). 13. The system is equipped with a pneumatic footswitch for ease of use. It is pneumatic to eliminate the possibility of any short-circuiting in the footswitch's wiring and to increase its durability to fluids.

Warning • Any Light/Laser emitting device can cause injury if used improperly. High voltages are present inside the Lasersystem. Personnel who work with lasers must always be aware of the possible dangers and must take the proper safeguards as described in this manual. • Use carefully. May cause serious burns. Do not use over sensitive skin areas or in the presence of poor circulation. The unattended use of the Lasersystem by children or incapacitated persons may be dangerous.

Caution Laser fume and/or plume may contain viable tissue particulates

The Treatment Room The treatment room must be clearly labelled with signs indicating that high intensity light/laser energy is in use. The treatment room sign that is supplied with the Lasersystem.

The treatment room should not include any light reflecting objects such as a mirror. Access to the Lasertreatment room should be allowed only to personnel essential to the procedure and who are well trained in the required safety procedures. • Assure that all of the treatment room personnel are familiar with the Lasercontrols and know how to shut down the system instantly in case of emergency.

Warning Signs and Labels

Design of Signs

Sign dimensions and color, etc., shall be in accordance with image below. The minimum length for the legs of the equilateral triangle shall be 150 mm.

Symbols

The laser hazard symbol shall be a sunburst pattern consisting of two sets of radial spokes of different lengths and one long spoke, radiating from a common center.

Warning Labels

The minimum size of the label shall be 150 mm x 100 mm. The minimum height of the lettering shall be 5 mm.

The word “DANGER” shall be used with Class 3b and Class 4 lasers and laser systems and shall be located at the top of the panel).

Adequate space shall be left on all labels to allow the inclusion of pertinent information. Such information may be included during the printing of the sign or label or may be handwritten in a legible manner, and shall include the following:

For all Class 3b lasers and laser systems, “Laser radiation – Avoid Direct Eye Exposure to Beam”

For Class 4 lasers and laser systems, “Laser Radiation – Avoid Eye or Skin Exposure to Direct or Scattered Radiation”

The word “Radiation” on labels may be replaced by the word “Light” for lasers operating in the visible range of wavelengths greater than 400 nm and equal to or less than 700 nm. For lasers operating outside of this visible range the word “invisible” shall be placed prior to the word “radiation”.

Special precautionary instructions or protective action shall be included that may be applicable such as, Invisible Laser Radiation; Knock Before Entering; Do Not Enter When Light is On; Restricted Area; etc.

All signs and labels shall be conspicuously displayed in locations where they will best serve to warn of the laser hazard.

SEE BELOW IMAGE FOR SAFETY SIGNS TO BE DISPLAYED IN TREATMENT ROOMS:

Warnings Related to Light/Laser Energy Emission

Burn Hazards The Laseremits high-intensity light/laser radiation which is invisible to the human eye and can cause third degree burns.

Protective Equipment General

Enclosure of the laser equipment or beam path is the preferred method of control, since the enclosure will eliminate or minimize the hazard.

When other control measures do not provide adequate means to prevent access to direct or reflected beams it may be necessary to use personal protective equipment. It should be noted that personal protective equipment may have serious limitations when used as the only control measure with higher-power Class 4 lasers or laser systems; the protective equipment may not adequately reduce or eliminate the hazard, and may be damaged by the incident laser radiation.

Eye protection

Eye protection devices, which are specifically designed for protection against radiation from Class 4 lasers or laser systems shall be administratively required and their use enforced when engineering or other procedural and administrative controls are inadequate to eliminate potential exposure.

Laser protective eyewear may include goggles, face shields, spectacles or prescription eyewear using special filter material or reflective coatings (or a combination of both) to reduce the potential ocular exposure.

Laser protective eyewear shall be specifically selected to withstand either direct or diffusely scattered beams. In this case, the protective filter shall exhibit a damage threshold for a specified exposure time (typical 10 seconds). The eyewear shall be used in a manner so that the damage threshold is not exceeded in the “worst case” exposure scenario.

Safety Eyewear • The safety eyewear and opaque eye protectors supplied with the system offer adequate protection, and more can be ordered from your Lasers representative. • All personnel must use safety eyewear and must ascertain that the eyewear provides adequate protection: for the diode laser module OD>7 at wavelength range of 750-890nm, and for the NIR modules OD>3 at 600- 1800nm.

Eye Protection • It is essential that all people present in the treatment room during the treatment (patient and medical personnel) protect their eyes by wearing Beaulase Lasers recommended protective eyewear. • Diode Laser Module with PlatinumIce: All personnel must use safety eyewear and must ascertain that the eyewear provides adequate protection (OD>7). • NIR Module with PlatinumIce: The patient must be fitted with protective eyewear of at least OD 5+ The operator must wear protective eyewear of at least OD 3+ • It is good practice to instruct the patient to close their eyes during treatment even when wearing protective eye glasses.

Direct and Reflected Eye Exposure Hazards • It is essential that all people present in the treatment room during the treatment (patient and medical personnel) protect their eyes by wearing Beaulase Lasers recommended protective eyewear.

• It is good practice to instruct the patient to close their eyes during treatment even when wearing protective eye glasses. • If the patient cannot wear the protective eyewear, fit the patient with opaque eye protection that completely blocks light from the eyes. • If the treatment area is very close to the eyes (e.g. eyelids), protect the eyes with corneal shields. • The Ocular Hazard Distance (OHD) is 10 m.

5.14.3 Laser Protective Windows

Facility windows (exterior or interior) shall be provided with appropriate absorbing filter, scattering filter, blocking barrier or screen, which reduces any transmitted laser radiation to save levels. Such laser windows shall be specifically selected to withstand direct and diffusely scattered beams. In this case, the window barrier shall exhibit a damage threshold for beam penetration for a specified exposure time equal to the total hazard evaluation for the facility and specific application. Important in the selection of the window are the factors of flammability and decomposition products of the window material. It is essential that the window not support combustion or release toxic airborne contaminants following a laser exposure.

5.14.4 Laser Protective Barriers and Curtains

A blocking barrier, or screen, or curtain which can block or filter the laser beam at the entrance should be used inside the controlled area to prevent the laser light from exiting the area at hazardous levels.

Such laser barriers shall be specifically selected to withstand direct and diffusely scattered beams. In this case, the barrier shall exhibit a damage threshold for beam penetration for a specified exposure time equal to the total hazard evaluation for the facility and specific application.

Important in the selection of the barrier are the factors of flammability and decomposition products of the barrier material. It is essential that the barrier not support combustion or release toxic fumes following a laser exposure.

5.14.5 Skin Protection

In some laser applications, such as use of excimer lasers operating in the ultraviolet region, the use of a skin cover shall be employed if chronic (repeated) exposures are anticipated at levels at or near the applicable limits for skin exposure.

Skin protection can best be achieved through engineering controls. If the potential exists for damaging skin exposure, particularly for ultraviolet lasers (180 – 400 nm), then skin covers and or “sun screen” creams are recommended. Most gloves will provide some protection against laser radiation. Tightly woven fabrics and opaque gloves provide protection. A laboratory jacket or coat can provide protection for the arms. For Class 4 lasers, consideration shall be given to flame-retardant materials.

5.14.6 Other Personnel Protective Equipment

Respirators, additional local exhaust ventilation, fire extinguishers, and hearing protection may be required whenever engineering controls cannot provide protection from a harmful ancillary environment (see Section 8).

5.16 Modification of Laser Systems

Where deliberate modifications are made which could change a laser system’s class and affect its output power or operating characteristics so as to make it potentially more hazardous, the LSO shall ascertain whether any additional or modified control measures are required.

Explosion and Fire Hazards • The absorption of optical energy raises the temperature of the absorbing material. Take precautions to reduce the risk of igniting combustible materials in and around the treatment area. • 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. • 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 Lasersystem, allow it to dry thoroughly before operating the system. • Flammable materials must be kept at a safe distance from the system. • During treatment also pay attention to the possible danger of ignition of endogenous gases.

High Voltage Hazards The system utilizes 120/220/230 VAC. To avoid personnel injury, do not operate the system before ensuring that the exterior panels are properly closed. Do not attempt to remove or disassemble the exterior panels. The Lasersystem produces very high voltages in various components. Some components may retain a charge after the power supply has been turned off, so no part of the exterior housing should be removed, except by Beaulase Lasers authorized personnel. Whenever system maintenance is performed, never leave the Lasersystem turned on, open or unattended.

Grounding the System The system is grounded through the grounding conductor in the power cable and internal grounding pin.

Warning To avoid the risk of electric shock, this equipment must only be connected to a supply main with protective earth. System Safety Features The Laser system is equipped with a number of safety features. All treatment room personnel should be familiar with the location and operation of these safety features.

Emergency Shut-Off Knob This red knob is used for emergency shutdown. When pressed, it immediately shuts off power to the entire system. To release the emergency shut-off knob, turn it clockwise. Otherwise, the system will remain off.

Caution Use the emergency shut-off knob only in the event of an emergency.

Main Circuit Breaker A semi-automatic circuit breaker, located on the rear panel, protects the system against excessive current consumption. The circuit breaker disconnects power to the system in case of an electrical overload. To resume system operation, lift the circuit breaker handle.

Light/Laser Emission Indicators The system features two emission indicators: A Yellow Lamp located on top of the control console and a buzzer. The Yellow Lamp has three modes: • Off - when the system is turned on, and in Standby mode • Blinking – during Ready mode • Continuous – during light/laser emission (module's trigger and/or footswitch are pressed)

The buzzer beeps: • Once when the system switches to Ready mode • Intermittently during light/laser emission, at the same rate as the pulse repetition rate: i.e., if the repetition rate is 2 Hz (pulses per second); the buzzer will beep two times per second.

Remote Interlock Connector The system incorporates a safety remote interlock connector that should be connected to an external micro switch on the entrance door to the treatment room. The external remote interlock is serially connected with the footswitch; therefore, when installed, it disables the system and prevents operation when the entrance door is opened.

Double-Tiered Security for Laser Emission Diode laser beam emission is enabled only when the operator presses both the footswitch and module trigger; therefore, accidental lasing may only occur due to double error condition (minimum risk).

Footswitch The system is equipped with a pneumatic footswitch to eliminate the possibility of short-circuiting in the footswitch wiring and to increase its durability to fluids.

Tissue Cooling System The module light guide is cooled by a thermoelectric cooling method to reduce patient discomfort during treatment and to reduce post-procedure side effects, such as local skin redness and swelling. The tissue is cooled through a metallic ring and a cold sapphire window. The light guide’s temperature is reduced to 4ºC (39ºF) during system operation.

Module Design

Several aspects of the module design contribute to the safety of the SopranoIce Platinum system: • Since the Light/Laser energy is generated in the module itself and not in the console (as in conventional lasers), there is no need for an articulated arm or other beam delivery system with inherent beam quality and alignment concerns. Instead, the Lasermodules incorporate a one-piece light mixer that combines the emission from thousands of emitters to produce a uniform square beam. Since light/laser emission is confined to the module, there is no hazardous optical radiation in the console or the umbilical cable. • The lightguide is placed against the patient’s skin during the system use, reducing stray light/laser energy while increasing the therapeutic effect.

Equipment Classification and Compliance- (please note this is just for interest sake and does not need to be studied.)

The Laser system complies with the following standards: • US Federal Performance Standards 21 CFR 1040.10 and 1040.11 for Class IV Laser Products • European Committee for Standardization EN 1041: Information supplied by the manufacturer with medical devices, 2008 IEC 60601-1-4: Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems (incl. A1), Consolidated Edition 1.1 – 2000 IEC 60601-2-22: Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment, Edition 2.0 –1995 IEC 60825-1: Safety of laser products - Part 1: Equipment classification, and requirements, Edition 2.0 – 2007 • International Standards Organization EN ISO 13485: Medical devices - Quality management systems - Requirements for regulatory purposes – 2012 EN ISO 14971: Medical devices - Application of risk management to medical devices – 2012 ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process – 2009 ISO 15223-1: Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied – 2012 ISO 9001: Quality management systems – Requirements – 2008

Compliance

In compliance with these standards, the system is equipped with: • Light/laser emission indicators • Key switch • Fluence display • Emergency shut-off knob • Remote interlock connector • Footswitch connector • Trigger button (diode laser module) • Proper labelling

Device Labels System Labels The following Warning, Certification and Identification labels are adhered to the Lasersystem: • Identification – located on the system's rear panel. This label contains the following information: Manufacturer's details Name of the system Serial number and date of manufacture The system's electrical requirements CE-MDD compliance symbol

Caution: Consult Operating Instructions Identification Labels • Laser Emission Danger – including laser source type and radiation parameters, and indicating that the diode laser module is a Class IV device), located on the rear panel of the system. Laser Emission Danger Warning Label • Diode Laser Class 4 – located on the rear panel of the system Diode Laser Class 4 Label • Laser Emission Danger – located on the rear panel of the system warns against possible exposure to laser beam radiation. • The same label also is also adhered to the diode module, near the tip. Laser Emission Danger Label • Electrical Requirement and Hazard – located next to the power cable connection port Electrical Requirement and Hazard Labels • Grounded power cable warning label, located next to the power cable connection port:

8.6 Compressed Gases

Presently many hazardous gases are used in laser applications including chlorine, fluorine, hydrogen chloride, and hydrogen fluorite. Standard operating procedures should be developed for safely handling compressed gases. Typical safety problems that often arise when using compressed gases are:

(1) Working with free-standing cylinders not separated from personnel (2) Inability to protect open cylinders (regulator disconnected) from atmosphere and contaminants (3) No remote shutoff valve or provisions for purging gas before disconnect or reconnect (4) Labeled hazardous gas cylinders not maintained in appropriately exhausted enclosures (5) Gases of different categories (toxics, corrosives, flammable, oxidisers, inerts, high pressure, and cryogenics) not stored separately.

8.7 Laser Dyes

Laser dyes are complex fluorescent organic compounds that, when in solution with certain solvents, form a lasing medium for dye lasers. Certain dyes are highly toxic or carcinogenic. Since these dyes frequently need to be changed, special care must be taken when handling, preparing solutions, and operating lasers.

8.8 Noise

Noise levels from certain lasers, such as eximer lasers, may be of such intensity that noise control may be necessary.

8.9 Waste Disposal

Proper waste disposal of contaminated laser-related material, such as flue and smoke filters, organic dyes, and solvent solutions shall be handled in conformance with appropriate municipal guidelines.

8.10 Confining Space and Ergonomics

There must be sufficient room for personnel to turn around and maneuver freely. If LGAC’s are present when laser systems are used in a confined space, local exhaust and mechanical ventilation shall be provided and respiratory protection shall be used.

Ergonomic problems can exist in certain laser operations that can cause unique arm, hand, and wrist deviations. If such repetitive deviations occur for long periods of time medical problems can arise. The LSO should be aware of this problem and become familiar with appropriate user control measures.

Summary

 Electrical safety

 Light and laser safety  Eye protection

 Treatment room

safety  Pre-treatment advice  Homecare:

 Tanning  Skincare

 Next session

 Possible side

effects

 Client Tolerance  Managing client Well expectations Done!!