ipl & laser safety protection plan

IPL & LASER SAFETY PROTECTION PLAN Rosaura l. Albert

IPL & LASER SAFETY PROTECTION PLAN

Assignment for partial fulfillmentOf the Subject

SIBBHRS705AAPPLY INTENSE PULSE LIGHT

AND LASER SAFETY PROTOCOLS

By

Rosaura Luminita Albert

12th May 2014

The Australian CollegeMHM EDUCATION & TRAINING

BROADWAY

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Background Information:

You have just been appointed the manager of a clinic that has two locations and operates from Monday to Friday from 9:00am to 7:00pm and on Sunday from 10:00am to 15:00pm. The treatments offered are all beauty therapy treatments but the clinic specializes in IPL and Laser treatments for hair removal. There are 20 staff, with varying qualifications. There are assistant managers at both clinics and they are responsible for ensuring that the treatments are offered in accordance with the clinics’ policies. However, they are not always on duty and the clinic staff needs clear and written advice on IPL and Laser safety. The clinic is planning to open a third location and you decide that the time is right to put in a formal IPL and Laser Safety Protection Plan.

Assignment:

You are to develop an IPL and Laser Safety Protection Plan (ILSPP) for the clinics. This document is to provide advice to salon staff on the safe use of the IPL and Laser devices. It should be easily read by all the staff members and will be available at all the clinic locations. It will need to include advice on how to use the devices in normal situations and what to do if there is an emergency such as an equipment malfunction or an incident involving IPL or Laser which leads to injury to a staff member or a client.

An IPL and Laser Safety Protection Plan reflect a best practice approach to the use of IPL and Laser devices for hair removal. It is intended to be a practical document that assists staff to identify the hazards and

take the correct action to minimize risks to clients, themselves and other staff.

The lasers and IPL equipment are used for the following treatments:• Hair removal• Vascular lesions• Acne• Rosacea• Tattoo removal• Brown pigmentation lesions• Fine lines/wrinkles• Photo aging2

1 LASER SAFETY OPERATIONAL GUIDELINES OFFICE DERMATOLOGY PROCEDURES POLICIES AND PROCEDURES.Gregory Absten Feb, 2006Professional Medical Education Association www.LaserTraining.org

2 LASER Safety Manual August 2007 Radiation Safety Office

Environmental Health and Safety2

http://www.LaserTraining.org/


This ILSPP assignment is to identify the following:

1. List all the IPL and Laser devices that are used in each clinic using the headings bellow: Complete one full list for Each devices you have in your clinics.

Laser se Medical Clinic is a well established establishment offering a range of laser and intense pulse light (IPL) treatments. The clinic is located on the Dora Road, Morisset and is close to local amenities and transportroutes.There is a waiting area and toilet facilities available for patient use.The clinic has the following equipment available:

IPL Equipment (Single Headed)

Manufacturer: ESC - Sharplan Model: Epilight Serial Number: 422898045 IPL: Single IPL head with interchangeable filters

Combined IPL & Laser Manufacturer: ESC - Sharplan Model: Vasculight Serial Number: SA 234 7001 Output Wavelength: Nd:YAG (1064nm) Laser Class: 4 IPL: Single IPL head with interchangeable filters

Dye Laser Manufacturer: Euphotonics Model: NLite - V Multifunction Laser Output Wavelength: 580 - 590nm Laser Class: 4

Nd YAG Laser Manufacturer: Cynosure Model: Affirm Serial No: AFRM0037 Output Wavelength: 1440nm Laser Class: 4

ND YAG Laser Manufacturer: Cynosure Model: Affinity QS Serial Number: QPA0470-0508 Output Wavelength: 1064nm & 532nm Laser Class: 4a

Ruby Laser (Not in Use) Manufacturer: Lambada Photometrics Serial Number: 5653RCU 019307

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Output Wavelength: Ruby (694nm) Laser Class: 43

2. A description of the hazards, that are associated with the use of Laser and an IPL device, including: eye exposure, fire and explosions, airborne contaminants, secondary burns and toxicity. In the case of eye hazards the description should include the wavelengths involved in the hazard. List a give description of at least 6 hazards.

SAFETY RULES FOR ALL LASERS, REGARDLESS OF OUTPUT POWER LEVEL

1. Avoid looking directly into any laser beam or at its reflection. 2. Remove all unnecessary specular (shiny) reflecting surfaces from the work area. 3. Operate lasers in well-defined areas to which

access can be controlled. The area should be posted with appropriate signs to alert persons passing by the area that a potential hazard exists.

4. The laser system should be operated only by or under the direct supervision of a person knowledgeable of the hazards and control methods for both beam and non-beam conditions. This individual is usually the laser safety officer (LSO) who is designated by the administration of the company, hospital, or educational institution. The LSO shall have the authority and the responsibility to effect monitoring and enforce the control of laser hazards and to achieve the knowledgeable control of laser hazards.

5. Any accident should immediately be reported to the responsible medical authority. If there is an accidental exposure to the eye, the services of an ophthalmologist should be sought.4

LASERLaser is an acronym for light amplification by stimulated emission of radiation. There are many uses of laser ranging from medical applications to military applications.

Laser devices are classified according to an international and Australian standard.Class 1 laser are completely safe to view and pose no risk to the eyes. Common examples would be laser disc players or laser printers.

Class 2 lasers do not pose any risk under normal viewing conditions. They emit radiation in the wavelength between 400 nm to 700 nm and could cause damage if directly viewed over a period of 15 minutes. Laser pointers and grocery food scanners are included in this category.Class 3 lasers are potentially hazardous if viewed directly. These devices require special training to operate and require special procedures to be taken in the workplace where they are used. Lasers used by beauty therapists fall into this category and are used for skin rejuvenation, hair removal.Class 4 lasers are the most hazardous and can cause injury from a direct, scattered or reflected laser beam to the eyes. These are the lasers that are used in cosmetic surgery and are tissue destroying.5

Laser Hair Removal

3 Regulation and Quality Improvement Authority 9th Floor Riverside Tower 5 Lanyon Place BELFAST BT1 3BT

QUALITY IMPROVEMENT PLAN ANNUAL ANNOUNCED INSPECTION LASERASE MEDICAL CLINIC 7 DECEMBER 2011

4 ‘Laser Safety’ Henderson, R. Schulmeister, K, Institute of Physics 2003 ISBN: 0 750 30859 1 http://www.laserinstitute.org/store/LSAFPUB/301

5 The radiation safety of lasers used for display purposes - Health & Safety Executive publication HS(G)95 1996 ISBN 0 7176 06914


In this method, a laser destroys hair follicles with heat. Sometimes it is recommended that a topical anesthetic product be used before a laser hair removal procedure, to minimize pain. In these cases, FDA recommends that consumers discuss with a medical professional the circumstances under which the cream should be used, and whether the use is appropriate. Those who decide to use a skin-numbing product should follow the directions of a health care provider and consider using a product that contains the lowest amount of anesthetic drugs possible. FDA’s Center for Drug Evaluation and Research has received reports of serious and life-threatening side effects after use of large amounts of skin-numbing products for laser hair removal. Side effects of laser hair removal can include blistering, discoloration after treatment, swelling, redness, and scarring. Sunlight should be avoided during healing after the procedure.6

Intense Pulsed light (IPL)

IPL is a more recent development and in 1995 the first no coherent, filtered flash lamp became available. IPL is particularly suitable for treatment of photo damaged skin but recently has also become popular and effective for hair removal. IPLs are increasingly thought of as equivalent to cosmetic laser systems.Both IPL and LASER equipment require advanced training for use by Beauty Therapists.

3. Responsibilities of the owner of the clinic including training of owner and employees, compliance with any conditions imposed by the state, selection criteria of IPL and Laser safety Officer, resources available to all staff, records and checklists, personal protective clothing/ equipment available to clients and staff. Create a list of what the owner must do to ensure staff and clients are not exposed to laser and IPL hazards.

EDUCATIONAL RECOMMENDATIONS FOR LASER USE BY NON-PHYSICIANS

Individual should be a licensed medical professional, and carry adequate malpractice insurance.

Individuals should be trained appropriately in laser physics, tissue interaction, laser safety, clinical application, and pre and post operative care of the laser patient.

Prior to the initiation of any patient care activity the individual should have read and signed the facilities policies and procedures regarding the safe use of lasers.

6 Optical Radiation Directive, published in the Official Journal of the European Communities on 27 April 2006 (Ref: L114) “Directive 2006/25/EC on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (artificial optical radiation)”

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Continuing education of all licensed medical professionals should be mandatory and be made available with reasonable frequency (including outside the office setting) to help insure adequate performance. Specific credit hour requirements will be determined by the state, and/or individual facility.

A minimum of TEN procedures of precepted training should be required for each laser procedure and laser type to assess competency. Participation in all training programs, acquisition of new skills and number of hours spent in maintaining proficiency should be well documented.

After demonstrating competency to act alone, the designated licensed medical professional may perform limited laser treatments on specific patients as directed by the supervising physician. 7

Owners need to keep records and have them available on site. Required records include:

Laser operator qualifications Laser operator educational and safety training Standard Operating Procedures (SOP) for laser use. Safety Checklist Setup of laser controlled area with signs, window barriers, etc. Confirmation of eyewear type and availability Client/patient protection Safety equipment such as smoke evacuator, fire safety equipment, etc. Protective eyewear information Previous safety inspections Staff Medical Examination results

Reports of accidents or incidents A record for each client showing the client's name, address, and dates of treatment along with type of treatment, etc. All records must be typed or legibly written in ink and retained.

4. Create a detailed position description of the duties of the IPL and Laser Safety Officer.

In all cases a laser safety officer must be designated and must have authority to carry out a laser safety program in the facility. This individual must have the necessary training and experience to administer a laser safety program. He/she must be authorized by the employer and be responsible for monitoring and overseeing the control of laser hazards.

Laser Safety Officer Qualifications, Duties and Responsibilities

Radiation Safety Office The Laser Safety Officer (LSO) will provide the following for each lab that houses operational lasers, in particular those of Class 3B or Class 4: An inventory of each Class 3B and Class 4 laser Hazard evaluations Determination of control measures Approval of Standard Operating and Alignment Procedures Aid in selecting protective equipment Aid in procuring signs and labels Safety feature audits Training Accident Investigation

Laser safety officer has qualifications that include training, experience and familiarity in the following areas:

Fundamentals of laser operation; Familiarity with the type of laser equipment

utilized at the facility; Biological effects of laser radiation on the eye

and skin; Laser and laser system classification; Control measures; Nonradiation hazards of lasers; Medical surveillance practices (if applicable); Laser terminology; and

Maximum Permissible Exposure (MPE) levels for eye and skin for all lasers and for all conditions of use of laser systems at the facility.

Every operator of a laser installation shall ensure that the following specific duties are carried out by the laser safety officer:

Establish and implement a program of laser radiation safety for effective compliance with the requirements of this Part.

Ensure that instructions concerning hazards and safety practices are provided to individuals who may

7 Approved by the Board of Directors American Society for Laser Medicine and Surgery, Inc. April 15, 1999

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be exposed to laser radiation and to individuals who operate lasers.

Permit, on behalf of the registrant, operation of lasers only by individuals who have:

Been trained in the safe use of the laser in accordance with Section 315.100 of this Part; and

Received copies of and instruction in the registrant's operating and emergency procedures.

AGENCY NOTE: In facilities where more than one practitioner or operator may use lasers, a laser safety committee should be formed to oversee laser activity, establish use criteria and approve operating policies and procedures.

The laser safety officer is responsible for: Establishing the laser treatment

controlled area. Approving standard operating

procedures (SOPs), administrative and procedural controls.

Recommending or approving protective equipment (i.e. eyewear, clothing, barriers, etc) as required assuring personnel safety.

Auditing the functionality of control measures periodically to ensure proper operation.

Approving the wording on area signs and equipment labels.

Assuring adequate safety education and training are provided to laser area personnel.

Determining the personnel categories (i.e. laser personnel or incidental personnel) for medical surveillance.

Laser personnel are those who work routinely in the laser environment and must be fully protected.

Incidental personnel are those whose work makes it possible but unlikely that they will be exposed to laser energy sufficient to damage their skin or eyes. For example clerical and/or supervisory personnel of staff who do not

work directly with lasers. Large facilities having an owner(s), employer and several employees, may designate a laser safety officer and give him/her the authority he/she needs to carryout their responsibilities. In smaller facilities however, the owner may also be the laser safety officer.

In all cases a laser safety officer must be designated and must have authority to carry out a laser safety program in the facility. This individual must have the necessary training and experience to administer a laser safety program. He/she must be authorized by the employer and be responsible for monitoring and overseeing the control of laser hazards.

Ensure that all laser systems in operation meet the requirements of this Part, and that prescribed control measures are in effect. The laser safety officer may recommend and approve substitute or alternative control measures when the primary control measures are not feasible or practical. Accordingly, if alternative control measures are instituted, those personnel directly affected shall be provided appropriate training.

Periodically audit the functionality of control measures in use.

5. Create a detailed list of responsibilities of all users.

Standard Operating Procedures Safety policies and procedures need to be established and copies kept posted. They should include authorizations for laser use, operating instructions, prior-to-use checklists, and maintenance/service instructions. Many lasers are computer based with ‘smart’ features, so that they will perform a number of these steps including calibration, safety checks and other

parameter tests upon startup and can notify the user of equipment problems. Newer lasers often come with sophisticated built-in safety features such as protective housings around the laser, interlocks on the protective housings, a key control and warning systems. Nevertheless, to prevent unauthorized operations your laser needs to be either securely stored when not in use or require a key or coded access to enable the laser.

Other safety features include: The switch which controls client exposure must be guarded to prevent inadvertent activation. Another way to accomplish this is to require two simultaneous actions, such as foot pedal depression and hand trigger, in order to operate. An emergency shutoff switch must be available to the operator or assistant to enable the rapid shutdown of equipment. Equipment must be serviced and maintained as recommended by manufacturer to ensure safeguards remain functional. The laser operator should periodically check electrical cords for damage.

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Check any skin coolant hoses supplied, for wear and any damage.

All testing of the laser should be done before the client enters room, by staff that are adequately protected.

c) Protective Eyewear The laser treatment area needs to be supervised and occupied only by trained staff or other authorized persons who are sufficiently protected. It is extremely important that all authorized personnel and patients entering this area be provided with personal protective equipment.

Seventy percent (70%) of all laser accidents have been related to:

a) not wearing protective eyewear, b) wearing inappropriate eyewear, c) wearing damaged protective eyewear while using high power lasers!!

Protective eyewear is the single most important piece of protective equipment needed by persons within the treatment area.

The laser personnel and the clients often wear different types of protective eyewear:

• Laser protective eyewear for the laser operator and staff: this allows visible light to pass through it so that the wearer can see adequately to perform their tasks safely, while at the same time preventing the wavelength emitted by the laser from passing through the eyewear. • Laser protective eyewear for clients: this allows access to the clients face during some procedures and is designed to protect the clients’ eyes from laser light coming from all directions since the client has no control over the laser.

Since most hair removal lasers emit the majority of their energy as a single invisible wavelength of infrared radiation, protective eyewear needs to protect against the specific wavelength that is emitted by the laser being used. In addition, protective eyewear for both the operator and the client needs to be able to stop laser radiation coming from all directions from striking the eye. This means the operator’s eyewear must have side and top guards and fit snugly around the nose. However the most important factor in selecting operator protective eyewear is that it must protect against the wavelength emitted by the laser. There is only one way to know whether the protective eyewear that you are using protects from the laser radiation that the laser is emitting. The protective eyewear must be labeled with the same wavelength of laser radiation that your laser is using! e.g. 810 nm (diode) or 1064 nm (Nd YAG), etc. The number that is printed on the eyewear lens, e.g., 810 nm, or 1064 nm, is the wavelength of laser radiation that the eyewear blocks.

Eyewear will NOT provide protection for lasers that emit radiation of a different wavelength from that which the eyewear is labeled with. Simple safety goggles or glasses must never be used for laser eye protection! In addition to providing protection for the appropriate wavelength of laser radiation, the protective eyewear must also be capable of reducing the intensity of laser radiation passing through the eyewear to a safe level. That is, the Optical Density or OD of the protective eyewear must be sufficient to provide the required protection. The following section on Optical Density addresses this requirement.

The classification labeling numbers are simply: 1, 2, 3 or 4 and are based upon maximum output power and/or energy available for the intended use. Class 1 lasers cannot emit harmful accessible laser radiation levels and are exempt from all control measures. To protect oneself around Classes 2, 3 and 4: a) READ the “signal word”, i.e. Danger, Caution, or Notice. b) READ the “class number” of the laser i.e. 2, 3, or 4 that is on the laser classification warning sign. c) COMPLY with the pertinent information written on the sign. This safety information is appropriate for the laser ontaining the label. d) CHECK the laser safety requirements specific to your laser in the equipment operating manual.

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Using the “signal word” and pertinent safety information on the labels will be straight forward, whereas the classification numbers need an explanation. The numbers 2, 3 or 4 indicate the laser’s potential for producing injury under conditions which include the possibility of a laser emission being concentrated by optical aids (such as with telescopes or binoculars) and entering the pupil of the eye, or burning exposed skin.

Class 2 represent lasers or laser systems emitting only visible beams, which can be viewed without injury for up to the normal blink aversion response time of an eye, which is 0.25 seconds. Skin will not be injured by unmagnified Class 2 laser beams.

Class 3 lasers and laser systems include lasers emitting invisible, ultraviolet or infrared beams. Viewing of the direct beams or mirror-like reflections of the beams is not normally safe. Class 3 is further subdivided into 3a and 3b. Class 3a in most cases may be treated as Class 2 lasers except when viewed with optically aided nstruments. Class 3b may not be viewed under any

circumstances. Skin will be injured by focused or magnified Class 3 laser beams.

Class 4 lasers and laser systems emit visible or invisible beams which cannot be safely viewed directly. Beams reflected off mirror-like surfaces and in some cases, diffusely reflected off matt surfaces may be hazardous to the eyes. Skin can be injured by the direct beam and fires can be started if flammable materials are exposed.

6. Access control.

Laser radiation exposure may be unsafe within a specific distance, beyond which it is not harmful as a result of the laser beam spreading out (divergence) and being attenuated or scattered by air. The distance beyond which it is safe to view or be exposed to a laser beam is unique for each type of laser.

Consequently knowledge of this distance can be used to protect oneself and others from laser exposure injury.Laser standards define the area inside this distance as the “Nominal Hazard Zone” (NHZ), being “the space within which the level of the direct, reflected, or scattered radiation during normal operation exceeds the applicable maximum permissible exposure”. Unfortunately most laser device manufacturers do not provide this distance in their operator information. Some lasers are provided a different measure of laser safety called the “Nominal Ocular Hazard

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Distance” (NOHD)8. This is “the distance along the axis of the unobstructed beam from a laser … to the human eye beyond which the irradiance or radiant exposure, during installation or service, is not expected to exceed the appropriate MPE”. For typical hair removal lasers the NOHD’s can be in the range 30 to 120 meters! Therefore distance alone cannot be used as ameans to protect operators or other persons against the laser beam if scattered from reflective materials inside the treatment room. The treatment room must be designed to prevent an inadvertent scattered beam from exiting the room through open doors, windows or other breaks in the treatment room enclosure. Access into the treatment enclosure must be restricted to essential personnel during treatments .9

7. Training needed to operate different devices in the clinic.

OPERATION GUIDELINES 1) Intrabeam viewing of laser beams is not allowed on campus. 2) Never look directly into any laser beam for any reason. 3) Enclose the laser beam path whenever possible. 4) Use appropriate laser protective eyewear for all laser beam alignments. 5) Restrict unauthorized access to laser facilities. 6) Do not operate lasers at sitting or standing eye level. 7) Shield all laser light pumping sources. 8) Remove all reflective or combustible materials from the beam path. 9) Use diffuse (non-reflective) beam stops, barriers and enclosures. 10) Use low beam power (or an alignment laser) for alignments. 11) Remove all keys from interlocks when the laser is not in operation.

12) Alert persons in the area when the beam is operating. 13) Be aware of and protect users from all non-beam hazards. 14) Never override any laser system safety interlock.

Eyewear Dos and Don’ts

1. Do put protective eyewear on BEFORE the laser is turned on.2. Do provide protective eyewear for everyone in the room.3. Do provide face sealing eyewear that protects the patient/client against laser radiation from all directions. 4. Do provide an extra pair of protective eyewear

located just outside the entry door for use in circumstances where a personmay need to enter the room urgently or in an emergency.

5. Do inspect protective eyewear regularly.6. Do follow the manufacturer’s recommendations on shelf life, storage conditions and appropriate cleaning methods.7. Don’t use eyewear that is cracked or loose, as light can pass through tiny gaps.8. Don’t wear eyewear which is not designed for laser safety and not suitable for the wavelength that you are using.9. Don’t use laser protective eyewear for intense pulsed light (IPL) systems. Protective eyewear appropriate to protect against IPL systems with their multi-wavelength emissions must be used.

Remember! Nothing can be done to repair or reverse a laser retinal injury!Wearing laser protective eyewear is much less of a discomfort than experiencing permanent eye damage!

8 ‘laser treatment controlled area’ within the facility. This is an area that the laser standards describe as a Nominal Hazard Zone or NHZ (see ‘Safety Zones’ above and ANSI Z136.1-2000 3.4.1).

9 Laser Hair Removal Devices: Safety Guidelines for Owners/Operators BC Centre for Disease Control September 2005

Adopted September 2011 by: Health Protection Branch Population and Public Health Division Ministry of Health Radiation Protection10


8. Safe work practices including:

a) Administrative requirements

Safety policies and procedures need to be established and copies kept posted. They should include authorizations for laser use, operating instructions, prior-to-use checklists, and maintenance/service instructions. Many lasers are computer based with ‘smart’ features, so that they will perform a number of these steps including calibration, safety checks and other parameter tests upon startup and can notify the user of equipment problems.Newer lasers often come with sophisticated built-in safety features such as protective housings around the laser, interlocks on the protective housings, a key control and warning systems. Nevertheless, to preventunauthorized operations your laser needs to be either securely stored when not in use or require a key or coded access to enable the laser.Other safety features include:• The switch which controls client exposure must be guarded to prevent in advertent activation. Another way to accomplish this is to require two simultaneous actions, such as foot pedal depression and hand trigger, in order to operate.• An emergency shutoff switch must be available to the operator or assistant to enable the rapid shutdown of equipment.• Equipment must be serviced and maintained as recommended by manufacturer to ensure safeguards remain functional.• The laser operator should periodically check electrical cords for damage.• Check any skin coolant hoses supplied, for wear and any damage.

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All testing of the laser should be done before the client enters room, by staff that are adequately protected.10

b) Instruction on how to safety use the Laser and IPL device, how to set up the laser controlled area, prepared the client, and prepare yourself for treatment.

A laser treatment controlled area is simply an area that is appropriately enclosed so that laser radiation which is above the maximum permissible exposure does not inadvertently escape the area to injure unsuspecting persons or ignite materials. The occupancy and activity of those within this area are subject to supervision for the purpose of protection against all hazards associated with the use of the laser(s). This laser treatment area is usually a separate room with a closeable door and covered windows. Appropriate warning signs such as those shown below MUST be identified at all entrances to the area. The entry warning sign(s) can be a large version of the laser warning label that is attached to the laser (i.e. as shown below). Note that the sign is the ANSI standard recommended sign and is the style required when interpreting the requirement of the Work Safe BC, Occupational Health & Safety Regulation.PATIENT INFORMATION AND LASER PROCEDURESPatients are clear about what procedures involve, the costs and the skills and experience of those carrying out the proceduresThe medical treatment protocols sets out:• Contraindications• Technique• Pre-treatment tests• Pre-treatment care• Post-treatment care• Recognition of treatment related problems• Procedure if anything goes wrong with the treatment• Permitted variation on machine variables• Procedure in the event of equipment failureThere was written confirmation of the appointment and duties of a certified LPA which is reviewed on an annual basis.

The clinic has local rules in place which have been developed by their LPA in January 2011 and systems are in place to review the local rules annually.The local rules cover:• The potential hazards associated with lasers• Controlled and safe access• Authorised operator’s responsibilities• Methods of safe working• Safety checks• Personal protective equipment• Prevention of use by unauthorised persons• Adverse incidents procedures

The name of the person who has overall responsibility for safety during laser or IPL treatmentsis recorded within the local rules.A list of authorised users is maintained and authorised users have signed to stated that they have read and understood the local rules and medical treatment protocols.The clinic has laser and IPL registers which are completed every time the equipment is operated and includes:• The name of the person treated• The date• The operator• The treatment given• The precise exposure• Any accident or adverse incidentSystems are in place to securely store patient care records.It is required that the management of records policy is updated to include the correct retention timescale of 10 years as outlined in the amended legislation.

c) Personal protective equipment.

10 Laser Hair Removal Devices: Safety Guidelines for Owners/Operators BC Centre for Disease Control September 2005

Adopted September 2011 by: Health Protection Branch Population and Public Health Division Ministry of Health Radiation Protection

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The human eye is designed to operate well under low lighting and bright lighting conditions. It does this by varying the size of its opening, the pupil. In low light the pupil opens wider letting more light into the eye. In bright light the pupil closes down, restricting the amount of light entering the eye. When light passes through the curved cornea, the pupil and the lens of the eye it is focused onto a small area of the retina called the fovea. The fovea is the center of the retina and provides our sharpest eyesight. This normal act of focusing laser light by the eye causes an increase in the amount of energy and/or power that is absorbed by the retina. Even though we cannot see it, near-infrared laser radiation from hair removal lasers also passes easily through the cornea, pupil and lens of the eye. It is focused on a small portion of the retina causing a very large amount of energy to be absorbed in a very small area. The energy or power per unit of area on the retina can be increased by 10,000 to 100,000 times! Brief exposures instantaneously burn the retina and other tissues around the impact area.Because the eye cannot see near-infrared radiation it will not respond to protect itself by blinking or by looking away from the laser radiation. Hence eye damage can occur to a person without them being aware of an exposure having taken place.

Light which is seen by the eye, i.e. visible light, has wavelengths between 400 nm and 700 nm. The colors purple and blue have wavelengths near 400 nm and red colored light is near 700 nm. Infrared radiations are those wavelengths greater than 700 nm which we cannot see. However, as mentioned above, these infrared wavelengths, from 700 nm to 1300 nm, although invisible, are nonetheless focused onto the retina. Injury may even occur from reflected laser radiation with sufficient energy entering the eye. A client’s eyes need to be protected from inadvertent exposure during treatment, by using a suitable method such as protective eye glasses, pads, or corneal shields.People can receive an eye injury when they are not using eye protection. Laser induced eye injury may interfere with vision either temporarily or permanently, in one or both eyes. Sometimes those who have received a laser eye injury have reported hearing a popping sound caused by a laser-induced explosion on the retina. Other symptoms of a laser burn in the eye will be a pain in the eye or a headache shortly after exposure, excessive watering of the eyes or the sudden appearance of floaters in one’s vision. Floaters are small specks or clouds that you may see moving in your field of vision. Individuals who had received laser eye injuries have reported seeing a “black” spot present in their field of view. A flash may be experienced during the actual exposure. Consequently, it is extremely important that all authorized personnel entering the area of the laser be provided with and WEAR protective eyewear.

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d) Non-beam hazards.

There are other hazards associated with laser systems which are just as dangerous, if not more so, than beam hazards. Examples of non-beam hazards are: Physical: electrical, high or low temperatures, x-rays, vibration and noise

Chemical: toxic and carcinogenic substances, irritants, dust and particulates, fire and explosions

Biological: microorganisms

Mechanical: high pressures, moving parts, sharp edges, trailing cables and pipes

Ergonomic: complexity of workstation layout and operations, emotional stress

e) Repair and maintenance (internal and external) requirements of devices listed in question nr.1

Maintenance of laser equipment The following precautions should be considered for inclusion in the Standing Orders.

o Before commencing the maintenance, the manual for the laser system should be consulted, to identify the recommended procedure.

o In the case of anything other than routine maintenance, and/or when the laser manual does not give a procedure, the advice of the equipment supplier should be sought. Some procedures may go beyond the competence of the laser user.

o The risks associated with the procedure should be assessed, the control measures reviewed, and the conclusions recorded. In the case of some regular maintenance procedures there may be an existing protocol that is suitable and sufficient.

o Maintenance involving the alignment of a laser beam inside a laser enclosure, for instance introducing the pump laser into a frequency mixing crystal, can lead to an increased risk of laser radiation exposure. A risk assessment for the procedure must be carried out. Service using external contractors

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Contractors must supply a method statement for approval before work can proceed. Key considerations in assessing the method statement include:

o If the alignment procedure is followed, are there any foreseeable circumstances where an accident could happen?

o Is the method of alignment clear and unambiguous?

o Does the procedure require the service engineer to remove laser safety eyewear? If so, is this justified and what safeguards are put in place to compensate? (These should be specific activities with no freedom of choice, only specific instructions).

o Are others (e.g. spectators) within the vicinity at risk?

N.B. The host organization retains a duty of care for all work on site even if waivers are given by the contractor.

Before permitting an external laser service engineer to conduct service work on site the responsible LRO must:

o Be satisfied that the person conducting the servicing is competent.

o Establish the boundaries of the hazard area and ensure the provision of appropriate PPE (laser safety eyewear etc.) for those in the area, and the means by which other personnel will be excluded.

o Review the hazards to be exposed and the procedures to be followed during servicing activities. This review should place particular emphasis on beam control and termination (e.g. large area beam stops), beam visualisation techniques for alignment, and the transfer of control, especially where servicing takes place at a point remote from the equipment controls.

o Review emergency procedures, including how the equipment would be isolated if there is a risk of injury from electrical or mechanical hazards, or how a fire would be extinguished if there are open Class 4 laser beams. This may involve the presence of a company employee (perhaps the LRO) during the servicing, and the safety of that employee must then also be considered.

o Review isolation procedures (e.g. Lock-Out-Tag-Out (LOTO)) for times when the service engineer may wish to leave the area.

o Review the safety of the proposed service activity (i.e. are the measures proposed in the risk assessment and method statement adequate?)

The LRO must issue a Permit to Work before work is allowed to proceed.

The LRO must impose a system of work for handing over the equipment to a service engineer and accepting it back when the work is completed.

After completion of the work the LRO must check:

o that the equipment has been restored to normal operation and is safe to use.

o that overrides and tools have been removed and protective covers replaced.

o that temporary warning signs have been taken down.

o That the log book for the equipment records the servicing operation, what was done and any consequent changes to the performance of the laser product.

Temporary set-ups 15


Subject to a risk assessment evaluation the following relaxations to the control measures may be applied to laser enclosures erected for service activities. Such temporary set-ups may also be used for maintenance and trials/demonstrations involving High Risk and Embedded lasers products.

High Risk lasers may be operated outside a DLA provided that a temporary laser hazard area is established with screens, coupled with laser warning signs and lights.

Warning signs and lights may be used in place of interlocks to control access to the laser hazard area.

Name of partsOn the surface panel1.Lock: general switch of the machine. Turn right to turn on, and turn left to turn off.

2.Emergent switch (red one): Push the switch to cut off the power. Turn right to make the switchin the upper status when turn on the machine.3.Control surface: computer control for operation.Side of the equipment4.Inlet for water: input enough water with the filler and pipe before using5. joint: for every cable connects( light cathode, anode, AC outlet chips, water pipes)6.Outlet for water: way out of water, open it before changing the new water.7.Water overflow hole; water will spill over from this hole when enough water been poured in tothe equipment.8.power switchOn the treatment handle:9.Button for light outputs: Press it to emit the light.10.Crystal for treatment

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Operate step1.Put the water in machine make the water is full of water box.When the water is out of overflow,Means the water is full!A-01/A-02 picture.2.Connect the power,turn on the power switch,You will heard soundfrom inside the machine,Means the water pump is working.A-03 picture

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3.Turn on the key switch and urgency stop button.The IPL system isworking,the display will start to working.Press UP and DOWN button to choice the therapy item.A-04/A-05

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4.When choice a therapy item,Press ENTER BUTTON,the lamp in handle piece will be turn on.Means the handle piece can work now. The system will be parameter display-A-06Press UP or DOWN to adjust the energy,Then press MANU BUTTON to select NO.1 pulse/NO. pulse width......There will be a pane in the parameter Number in display,Then press UP or Down to adjust it.When every parameter is ok,Press the enter,You can start to use the handle piece for therapy now.When finish the therapy,Press MANU BUTTON,The system return to Main interface-A6.and the lamp is trun off in this time.The circumgyrate the key and press urgency stop button(The water cool system is working yet!),turn off the Power switch in the back of machine. Every parts of machine stop working!

HAIR REMOVALHR skintype 1-2 very light skin colorPulse Number:6-9Pulse No.1:10 ms

Pulse Delay1:7.5 msPulse No.2:10 msPulse Delay2:7.5 msenergy up to pain max 35J

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HR skintype 3-4 darker skin colorPulse Number:6-12Pulse No.1:7.5 msPulse Delay1:25 msPulse No.2:7.5 msPulse Delay2:25 msenergy up to pain max 35JSKIN rejuvenationskintype 1-2 very light skin colorPulse Number:5-7Pulse No.1:10 msPulse Delay1:7.5 msPulse No.2:5 ms

Pulse Delay2:7.5 msenergy up to pain max 35Jskintype 3-4 darker skin colorPulse Number:3-5Pulse No.1:10 msPulse Delay1:15 msPulse No.2:5 msPulse Delay2:10msenergy up to pain max 30J (Use 15J to check the skin,Then add the energy step by step,When feelacceptable hurt,then adjust the other pluse parameter for best result)Dark Hair need increase Pluse width

thick Hair need increase Pluse widthHigher density hair need reduce energyAfter frist therapy,Need increase 2-3J energy for next therapy

Notice1.When frist time to startup the system, Need wait 15-20second to make the crystal be cool, this is better for maintenance system.2.If do not use the machine,Need turn off the power switch,It is better for machine Cool system.3.Do not use the machine in fulmination/lightning storm weather/Hard magnetic field, It will make the electric component be demolish.4.Tabu group:pregnant woman/Black skin person/epileptic/ serious dermatosis person/serious wound person5.Symptom after therapy(reasonable and will be disappear in 1-2days) hurt/erythema/bleb/Nothing happen6.Frist time after therapy,do not use cosmetic,Just use water(Cool)to clean the skin.Forbid Insolation during therapy period,The period is 3-4weeks. Total need 4-6times therapy to make hair removal by completed.7.Shave the hair,after 2-3days,the hair will grow be 1-2mm,It is better for absorb light,Better therapy result.8.For frist shot by gun,The doctor need shot to his hand for check the energy,It is safe for sufferer.Use 15J energy to check,then improve step by step,Just to acceptable energy,35-40J for hair removal.25-35J for skin rejuvenation.9.Do not shot to eyes!10.Better to put some GEL in skin for reduce the hurt,GEL thickness is about 1.5-2mm,Or use the ICE to make the skin be cold. 11.Do not open the cover of machine without professional.12.Need put the clean water in machine,25-30days need change the water,To keep the water system be clean.If need move the machine to far place,Please drainage all water from machine.13.The machine need put in 20-33 degree air condition room.14.forbid connect the machine to unstable voltage.

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How to change the lamp and crystal

1.Drainage all water of the machine.lift the handle piece be higher than machine,Make the water tube be straight,Becasue there are some water in the tube and handle piece.2.Open the handle piece by screw.Then open the screw A in the two bottomof metal parts.3.take out the rubber ring and lamp.4.Fix new lamp in the metal parts,then welder by iron5.Then put some insulated adhesive tape over the bare cable.

6.If need change the crystal,Just need take out the B screw.

Service register1.Turn on the power,key switch,urgency stop button,Nothing happen.Cause:The key swith or urgency broken.2.Enter main interface,The lamp of gun flash continuous.Cause:The electric engine is problem by unstable voltage.3.The crystal is not cool.The 5V switch in Machine have problem.Or the lower cable is broken.Or water pump is broken.4.The lamp in handle piece is not workRestart the machine,enter parameter display,Use 20J and wait10-15second.The crystal be cool,then press the button to try.Or need change the lamp.5.Turn on the power,key switch,urgency stop button,press the display and can cotrol nothing.(Just for touch display)Adjust the display

SAFE OPERATION OF LASERS AND INTENSE LIGHT SOURCES The clinic has a policy and procedure in place for the use of intense light sources. The environment in which the Iasers and IPL equipment are used was found to be safe and controlled to protect other persons while treatment is in progress. The controlled area is clearly defined and not used for other purposes, or as access to areas, when treatment is being carried out. When the lasers or IPL equipment are in use, the safety of all persons in the controlled area is the responsibility of the LPS. Laser safety warning signs are displayed when the lasers and IPL equipment are in use, as described within the local rules. Protective eyewear is available for the patient and operator as outlined in the local rules. The door to the treatment room is locked when the lasers and IPL equipment are in use but can be opened from the outside in the event of an emergency. There are systems in place to securely store the laser and IPL keys when not in use. There is a laser safety file in place that contains all of the relevant information relating to the lasers and IPL equipment. There are arrangements in place to service and maintain the lasers and IPL equipment in line with the manufacturer’s guidance. The most recent service reports were reviewed as part of the inspection process. The clinic’s LPA completed a risk assessment of the premises during his visit on 12 January 2011. A fire risk assessment has been undertaken.

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The incident policy was updated following the previous inspection to include reporting arrangements to RQIA. No adverse incidents have been recorded by the clinic since registration.

9. Operational checklists including a daily checklist, a prior to each treatment checklist, a monthly checklist and a six months checklist. You are required to develop these checklists ensuring they are detailed and cover all areas and devices in the clinics.

Open Beam Work The following initial safety checks for open beam work should be considered for inclusion in the Standing Orders for work with unenclosed High Risk laser beams. Before releasing High Risk laser beams: o Beam paths should be inspected for any objects that should not be there and any beam line components that may have been displaced or misaligned. o Any screens/enclosures or beam stops that have been removed should be replaced. o All optics should be checked for damage, and the stability of optics mounts verified prior to operation of laser. o Check that only authorized people are in the area. o Check that everyone in the area is wearing appropriate laser safety eyewear. o Give prior warning that the laser beam is about to be launched.

Beam alignment of open beam paths is the most common cause of laser eye injuries. The following guidelines should be considered for inclusion in the Standing Orders. o Only suitably trained and authorised Laser Nominated Persons may carry out alignment. o Alignment should be carried out with one or at most two authorised laser operators. All other persons should be excluded from the room during this procedure. o Watches, bracelets and other reflective jewellery should be removed. o Appropriate laser safety eyewear to be worn. o Initial alignment should be at the lowest possible power, preferably Class 2 or Class 1, by attenuating the laser or by use of an alignment laser. o Analyze each and every optical element in the beam path for stray reflections and install suitable beam blocks. (The blocks must be stable, preferably locked to the table.) o Restricted access, unauthorized personnel must be excluded from the room or area. o Under no circumstances must direct viewing of the laser beam be attempted even if the beam has been attenuated. The use of a video camera for remote viewing should be considered. o Alignment with a higher power beam should be carried out using laser safety eyewear. The table below gives examples of suitable techniques.

Owners need to keep records and have them available on site. Required records include: Laser operator qualifications Laser operator educational and safety training Standard Operating Procedures (SOP) for laser use. Safety Checklist Setup of laser controlled area with signs, window barriers, etc. Confirmation of eyewear type and availability Client/patient protection Safety equipment such as smoke evacuator, fire safety equipment, etc. Protective eyewear information Previous safety inspections Staff Medical Examination results Reports of accidents or incidents A record for each client showing the client's name, address, and dates of treatment along with type of treatment, etc.

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All records must be typed or legibly written in ink and retained.11 12

WEEK STARTING

AREAS OF CLINIC

MONDAY TUESDAY WEDNESDAY THRUSDAY FRIDAY SATURDAY SUNDAY DAILY CHECK

LIST

COMMENTS

10. Draft an incident report policy for your clinics. You must include a minimum of 6 actions performed.

Example:If a laser delivers 2 J in 100 ms (or 0.1 s) in a beam area of 1 cm2 area, it is equivalent to 2J/0.1s or 20 J/s = 20 W. Over an area of 1 cm2, this equals 20W/cm2. This could initiate a fire in an appropriate combustible material if exposed.

Statistically laser accidents are due to several factors: eye exposure unexpectedly during alignment, eye protection not being worn, equipment malfunction, high voltage mishandling, non-beam hazards, incorrect eyewear, inhalation of air contaminants, viewing of laser-generated plasmas, and in general using equipment incorrectly

The most common type of injury is to the eye (around 70%). There have been a few deaths, mostly caused by electrocution or fires. 13

Accident Prevention Substitute lower power lasers when possible, especially during alignment.

11 Standards of Training for Physicians for the Use of Lasers in Medicine and Surgery, American Society for Laser Medicine and Surgery, Inc. 1991.

12 Laser Hair Removal Devices: Safety Guidelines for Owners/Operators

13 American National Standard for the Safe Use of Lasers ANSI Z136.1 (2007), Laser Institute of America, ANSI, New York. – THE standard for laser safety

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Use engineering controls when feasible, such as enclosures, interlocks, and beam stops.

Always wear protective eyewear.

Be aware of non-beam hazards.

Follow all alignment and operational procedures, as well as all warning signs and signals.

Laser Accident Emergency Procedures Immediately call for medical assistance @ 000 Do not allow the injured person to drive him/herself for medical care Keep the injured person calm and reassured Ensure that the injured person sees an ophthalmologist Notify others in the work area and the supervisor Keep the injured person in a sitting position to reduce any further injury to the retina Turn off the laser system but leave the scene unaltered Contact the Radiation Safety Office and the LSO @ 206-543-0463

Examples of Laser Accidents The following are examples of accidents involving laser systems at other institutions:

1. A postdoctoral student was aligning a laser when his face was struck by a stray beam from an optic polarizer. He was not wearing protective eyewear and within 24 hours developed pain.

2. A researcher with 15 years experience was operating with another researcher a laser of 1 mJ, 500 Hz, femtosecond pulse length, and a beam size of several centimeters. The beam output was not lowered as a mirror was inserted into the beam path. An IR viewer was not used . The researcher inserting the mirror was struck by a reflection and immediately heard a popping sound from his eye. He then experienced swelling and then near-blindness in the injured eye. All laser work in this very large lab was halted for a month.

3. A research technician was working on a Class IX eCl excimer laser that was housed in a protective enclosure. Though his primary reason was to examine any electrical discharges and he was wearing eye protection, the technician opened the enclosure and was exposed to several laser pulses that had reflected off a beam splitter which he had just removed. The beam at a wavelength of 308 nm was not visible and the technician did not notice the exposure until hours later when four burns appeared on his neck. 14

11. Draft an incident report policy for your clinics.

12. Develop a checklist on what to do when a device malfunction.

14 American National Standard for the Safe Use of Lasers ANSI Z136.1 (2007), Laser Institute of America, ANSI, New York. – THE standard for laser safety

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ipl & laser safety protection plan

Documents

laser treatments

laser devices

use of ipl

range of laser

formal ipl

laser safety protocols

single ipl head

nm laser class