UTMB LASER SAFETY MANUAL

= <= span style=3D'mso-list:Ignore'>o&nb= sp;      Exposure of an individual for the purpose of research on humans is prohibited unless prior authorization is received from the institutional review board (IRB) and LSSC.

DEFINITIONS:

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Authoriz= ed laser user (ALU): A faculty member who, by virtue of their training and experience, has be= en designated by the LSSC as being qualified to use Class 3b and Class 4 lasers at UTMB.

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Class 1 = (I) laser: Any laser tha= t does not permit access during its operation to levels of laser radiation in excess of the accessible emission limits contained in Section 3.3.1 of American National Standards Institute (ANSI) Z136.1-2000, American National Standard for Safe Use of Lasers.

Class 2 = (II) laser: Any laser that permits access during its operation to levels of visible laser radiati= on (there are no Class 2 non-visible lasers) in excess of the accessible emission limits for Class 1 lasers, but does not permit access during = its operation to levels of laser radiation in access of the accessible emission limits contained in Section 3.3.2 of ANSI Z136.1-2000.

Class 3a (IIIa) laser: Any la= ser that permits access during its operation to levels of visible laser radiation in excess of the accessible emission limits for Class 2 lase= rs or levels of non-visible laser radiation in excess of the accessible emission limits for Class 1 lasers, but does not permit access during = its operation to levels of laser radiation in access of the accessible emission limits contained in Section 3.3.3.1 of ANSI Z136.1-2000.

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Class 3b (IIIb) laser: Any la= ser that permits access during its operation to levels of laser radiation = in excess of the accessible emission limits for Class 3a lasers, but does= not permit access during its operation to levels of laser radiation in acc= ess of the accessible emission limits contained in Section 3.3.3.2 of ANSI Z136.1-2000.

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Class 4 = (IV) laser: Any laser that permits access during its operation to levels of laser radiation in ex= cess of the accessible emission limits for Class 3b lasers.

Direct supervision: The Authorized User (or Technical Staff where appropriate) responsible for supervision of the person being trained is present in the room where t= he laser is being used.

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Intense = Pulsed Light (IPL) device: A device that emits radiation to energy density levels that could reason= ably cause bodily harm and is used for photothermolysis.

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Maximum permissible exposure (MPE): The level of laser radiation to which a person may be exposed without hazardous effect or adverse biological changes in the eye or skin. MPE values may be = found in ANSI Z136.1-2000.

SECTION ONE: GENERAL INFORMATION (CONTINUED)

Medical = event: Any adverse patient health ef= fect that is a result of failure or misuse of laser safety equipment.

Nominal = Hazard Zone (NHZ): The space within which the level of direct, reflected, or scattered radiation du= ring operation exceeds the applicable MPE.

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Permit administrator: The f= aculty member who acts as the point of contact for all correspondence regardi= ng activities under a laser use permit issued by the UTMB LSSC.

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Practiti= oner of the healing arts (practitioner): a person licensed to practice= the healing arts by either the Texas State Board of Medical Examiners as a physician; the Texas State Board of Dental Examiners; the Texas Board = of Chiropractic Examiners; or the Texas State Board of Podiatry Examiners. A practitioner’s use of a laser is limited to his/her scope of professional practice as determined by the appropriate licensing agenc= y.

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Registra= nt: The individual responsible fo= r the registration of a laser or group of lasers with the UTMB LSSC.

Technical staff: Non-faculty w= ho have met certain training and experience requirements as set forth in = this manual and whose laser use is under the general supervision of an ALU.=

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EXEMPTIONS:<= /b>

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Class 1 (I), Class 2 (II), Class 3a (IIIa) lasers= and IPL devices are exempt from the registration and permitting portions of this manual.

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Inoperable and lasers in transit or in storage incident to transit are exempt from this manual.

REGISTRATION OF CLASS 3b AN= D 4 LASERS:

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·        All Class 3b and Class 4 lasers used at UTMB facilities will be registered with the UTMB LSSC prior to use.

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·        A registration may be submitted for lasers o= wned by an individual or by a department. In the case of a department registration, one individual shall be designated by the department head as the registrant for the department.

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·        Registration will be accomplished by complet= ion and submission (to the UTMB Radiation Safety Office) of the UTMB Laser Registration Application Form.

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·        Submission of the Form is the responsibility= of the individual and Department that purchased, borrowed, arranged for demonstrat= ion, or otherwise obtained the laser.

SECTION ONE: GENERAL INFORMATION (CONTINUED)

·        Temporary registrations will be issued for a specified time period for lasers that are brought on campus for short term = use (e.g. borrowed lasers and lasers brought on campus for demonstration purposes).

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·        Registration of a laser intended for demonstration by a non-UTMB employee, shall be accompanied by a copy of the Certificate of Laser Registration issued to the individual or company provi= ding the laser by the Texas Department of State Health Services (DSHS) in accord= ance with the requirements of the Texas Administrative Code (25 TAC 289.301).

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·        Failure to register a Class 3b or Class 4 la= ser does not relieve UTMB faculty, st= aff and students from compliance with the requirements of this manual.

·        The Laser Registration Certificate may be terminated at the discretion of the LSSC.

RESPONSIBILITIES OF REGISTR= ANT:

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·        Notify the UTMB Radiation Safety Office (RSO= ) of any transfer or disposal of a registered laser.

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·        Notify the RSO of the movement of any fixed laser to a location not listed on the registration for that laser.

·        Ensure that registered lasers are properly maintained, aligned, calibrated and repaired by qualified persons.

<= span style=3D'font-family:"Courier New";mso-fareast-font-family:"Courier New"'><= span style=3D'mso-list:Ignore'>o&nb= sp;      Registrant shall not allow non-UTMB employee= s to provide such services without first obtaining a copy of documents indicating that the vendor/person is registered with the Texas DSHS to provide laser services. A copy of these doc= uments shall be sent to the Radiation Safety Office.

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·        Conduct an inventory of all lasers in their possession semiannually or annually, depending on the audit cycle for the specific registration, and provide a copy to the RSO. The RSO will provide registrants w= ith a form to use for this purpose.

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·        Ensure that only appropriately trained and authorized individuals use the lasers on their registration.

SECTION ONE: GENERAL INFORMATION (CONTINUED)

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·        Maintain a current list of individuals authorized to use the lasers on their registration.

·        Notify the RSO immediately upon discovery th= at a registered laser is stolen, lost or missing.

·        Notify the RSO of any changes in registration information (e.g. change of Registrant, Registrant address, etc.)

·        Comply with any and all terms and conditions listed on the Laser Registration Certificate.        =             &nb= sp;            =             &nb= sp;            =



TRAINING:

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All individuals who work with or in the vicinity = of lasers and IPL devices shall be knowledgeable about the devices in the= ir work area and the potential health hazards associated with the use of these devices.

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Technical staff shall have a minimum of:

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= <= span style=3D'mso-list:Ignore'>o&nb= sp;      Four (4) hours of classroom type training covering:

§         Fundamentals of lasers, types and characteristics

§         Effects of laser EM radiation on tissue (eyes and skin)

§         Laser applications

§         Laser safety

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= <= span style=3D'mso-list:Ignore'>o&nb= sp;      Two (2) hours of hands-on training with the class and wavelengths of lasers to be used.

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Technical staff shall complete one (1) hour of la= ser safety refresher annually.

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Faculty training requirements are listed in the sections for Human-use Permits and Non-human-use Permits.

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Documentation of training shall be in a manner approved by the LSSC.

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Exemptions from attending UTMB laser training cla= sses (this exemption does not apply to annual refresher training):

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o   &nb= sp;   Individuals who have documentation of compar= able training received prior to arriving at UTMB.

SECTION ONE: GENERAL INFORMATION (CONTINUED)

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o   &nb= sp;   Individuals who have documentation of compar= able training received outside of UTMB.

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o   &nb= sp;   Individuals who have completed training elsewhere but lack documentation acceptable to the LSSC who pass a written = exam administered by the UTMB Radiation Safety Office.

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o   &nb= sp;   Faculty members whose training and experience history has been accepted by the LSSC in the course of becoming an ALU.

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o   &nb= sp;   Individuals who have been granted exemption = by the LSSC.

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Documentation of hands-on training shall be signe= d by the preceptor.

PERMIT TO USE LASERS:

Faculty members who wish to use Class 3b or Class= 4 lasers at UTMB shall submit a Laser Use Permit Application to the LSSC.

A Laser Use Permit may be issued to a single facu= lty member or to a group of faculty members (see specifics in the sections= on Human Use of Lasers and Non-human Use of Lasers).

Permit Administrators shall immediately inform the Laser Registrants of any changes to the list of Authorized Laser Users= who are permitted to use the Registrant’s registered lasers.

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Those faculty members who, by virtue of their training and experience, have been designated by the LSSC as being qualified to use Class 3b and Class 4 lasers at UTMB shall be designat= ed as an Authorized Laser User (ALU).&nb= sp;

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Only Authorized Laser Users or individuals superv= ised by an Authorized Laser User may use Class 3b and Class 4 laser produci= ng devices at UTMB facilities.

Non-faculty who have met certain training and experience requirements as set forth in this manual shall be designated Technical Staff for Laser Use and may use lasers under the general supervision of an ALU.

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Permits will be issued for a period not to exceed four (4) years.

SECTION ONE: GENERAL INFORMATION (CONTINUED)

REQUIREMENTS FOR PROTECTION AGAINST CLASS 3b 0R 4 LASERS AND IPL DE= VICE RADIATION:

Installation, Service, Repair, Maintenance and Calibration

<= span style=3D'mso-list:Ignore'>o&nb= sp;      These activities shall only be performed by a qualified individual.

<= span style=3D'mso-list:Ignore'>o&nb= sp;      These activities shall be performed in accordance with the manufacturer’s documents (e.g. owners/operators manual, service manual, etc.)

<= span style=3D'mso-list:Ignore'>o&nb= sp;      These devices and their lasing media shall n= ot be altered to cause the device to operate outside the manufacturers intended operating parameters without prior authorization from the RSO.

·        Instructions to Personnel

<= span style=3D'mso-list:Ignore'>o&nb= sp;      Written instructions for proper and safe use= of these devices shall be provided to all personnel who operate them.

Engineering Controls

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= <= span style=3D'mso-list:Ignore'>o&nb= sp;      Protective Housing

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§         Each Class 3b or 4 laser shall have a protec= tive housing that prevents access during operation to laser and collateral radia= tion that exceeds the limits of Class 1 lasers.=

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-   &nb= sp;     If access to levels of laser radiation that exceed = the Class 1 limits is necessary for the intended use of the laser, then the accessible levels shall not exceed the limits of the lowest laser class necessary to perform the intended use of the laser.

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= §         These lasers shall not be operated with the protective housing removed unless authorized by the RSO.   In such cases, additional co= ntrol measures may need to be implemented.

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o   &nb= sp;   Safety Interlocks

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§         A safety interlock shall be provided for any portion of the protective housing that can be removed or displaced during normal operations or maintenance allowing access to radiation above the MPE limits. This interlock shall = ensure that radiation is not accessible above MPE limits.

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§         Any adjustment or modification of a laser containing interlocks shall not cause the interlocks to become inoperative = or the radiation to exceed the MPE limits except where a controlled area has b= een established that has the approval of the RSO.

SECTION ONE: GENERAL INFORMATION (CONTINUED)

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o   &nb= sp;   Viewing Optics and Windows

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§         All viewing ports, viewing optics, or display screens in a laser or laser product shall have an interlock, filters, or attenuators that will keep the laser radiation at the viewing position at or below the MPE during the use of the laser.

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§         All collecting optics, such as lenses, telescopes, microscopes, endoscopes, etc., used for viewing with a laser, s= hall have an interlock, filters, or attenuators to maintain the laser radiation transmitted through the collecting optics to levels at or below the appropr= iate MPE. <= st1:City w:st=3D"on">Normal or prescription eyewear is not considered collecting optics.

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o   &nb= sp;   Warning Systems

§         Each Class 3b or Class 4 laser or laser prod= uct shall provide visual or audible indication during emission of accessible la= ser radiation.

-   &nb= sp;     For Class (3b except those that allow access only to less than 5 mW peak visible laser radiation) and Class 4 lasers, this indication shall be given sufficiently prior to emission of radiation to al= low appropriate action to avoid exposure.

§         Visual indicators shall be clearly visible through the protective eyewear appropriate for the laser(s) involved.

§         If the laser and laser energy source are housed separately and can be operated at a separation distance of greater than 2 meters, both the laser and laser energy source shall have visual or audible indicators.

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§         The visual indicators shall be positioned so that viewing does not require human access to laser radiation in excess of = the MPE.

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o   &nb= sp;   Controlled Areas

§         A controlled area shall be established for a Class 3b (except those that allow access only to less than 5 mW visible peak power) or Class 4 laser when exposure to laser radiation in excess of the M= PE is possible.

§         Access to the controlled area shall be restricted to authorized personnel only.

§         The area shall be posted with appropriate si= gns, notices and labels approved by the RSO.

SECTION ONE: GENERAL INFORMATION (CONTINUED)

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§         For Class 4 indoor controlled areas, latches, interlocks or other appropriate control measures shall be established in accordance with the requirements of 25 TAC 289.301 to prevent unauthorized entry.

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o   &nb= sp;   Key Control

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= §         Each Class 3b or Class 4 laser and IPL device shall incorporate a key activated or computer actuated master control.

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= §         The key shall be removable and the Class 3b = or Class 4 or IPL device shall not be operable when the key is removed.

= §         When devices are not being prepared for operation or are unattended, the key shall be removed from the device and stored in a location away from the device.

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·        Personnel Protective Equipment (PPE)

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o   &nb= sp;   Eye protection shall:

§         Be worn by all individuals with access to Cl= ass 3 and/or Class 4 levels of laser radiation.

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§         Provide a comfortable and appropriate fit all around the area of the eye.

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§         Be in proper condition to ensure the optical filter and holder provide optical density or greater at the desired wavelengths, and retain all protective properties during use.

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§         Be suitable for the specific wavelength of t= he laser and be of optical density adequate for the energy involved.

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§         Be labeled with the optical density or densi= ties and associated wavelength permanently on the filters or eyewear.

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§         Be examined at intervals not to exceed 12 mo= nths to ensure reliability of protective filters and integrity of protective fil= ter frames.

-   &nb= sp;     Documentation of this inspection shall be made and maintained.

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-   &nb= sp;     Unreliable eyewear shall be discarded immediately.<= /p>

NOTE: It would be in the wearer’s = best interests to inspect the protective eyewear prior to each use to ensure reliability and unreliable units discarded at this time rather than wait fo= r the annual inspection.

SECTION ONE: GENERAL INFORMATION (CONTINUED)

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o   &nb= sp;   Skin Protection

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§         Protective gloves, clothing, or shield shall= be required when there is a possibility of exceeding the MPE limits for skin.<= /p>

NOMINAL HAZARD ZONE (NHZ):<= /i>

·        Where applicable, in the presence of unenclo= sed Class 3b and 4 laser beam paths, a NHZ shall be established.

CAUTION SIGNS, LABLES AND P= OSTING FOR LASERS AND IPL DEVICES:

·        All lasers and laser systems, except Class 1, shall have appropriate warning labels with the sunburst logotype symbol and= the appropriate cautionary statement in accordance with 25 TAC 289.301.

·        Labels shall be affixed to a conspicuous pla= ce on the laser housing or control panel.&nbs= p; Labels should be placed on both the housing and the control panel if these are separated by more than two (2) meters.

·        Controlled area signs shall be posted, and contain appropriate logo and wording in accordance with 25 TAC 289.301.

AUDITS:

·        Laser Registrations and Laser Use Permits sh= all be audited for compliance with 25 TAC 289.301 and the UTMB Laser Safety Man= ual at intervals not to exceed 6 months.

o   &nb= sp;   The audit interval may be extended to an interval not to exceed 12 months for specific Registrations and Permits at = the discretion of the UTMB Laser Safety Officer (LSO) based on their compliance history.

o   &nb= sp;   The audit interval shall revert to an interv= al not to exceed 6 months for Registrations and Permits that fail to maintain a satisfactory compliance history.

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NON-BEAM HAZARDS:

Electrical

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o   &nb= sp;   The risk of electrical shock and/or electrocution exists when the protective housing is removed.

o   &nb= sp;   Electrical wiring should have guards and be properly grounded.

SECTION ONE: GENERAL INFORMATION (CONTINUED)

o   &nb= sp;   Only authorized individuals should attempt to provide maintenance and/or service to lasers.

Biological

o   &nb= sp;   Airborne biological hazards may exist when personnel are exposed to contaminants generated from laser interaction with human tissue or other materials.

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o   &nb= sp;   Additional ventilation may be needed in the = area of laser use.

o   &nb= sp;   Personnel in the area may need to wear appropriate respiratory PPE.

Chemical

o   &nb= sp;   The lazing media in some lasers present a potential toxic and/or carcinogenic hazard to personnel performing service = and maintenance on the laser.

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o   &nb= sp;   Only authorized individuals should attempt to provide maintenance and/or service to lasers.

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o   &nb= sp;   Maintenance/service personnel should consult= the MSDS prior to handling the lazing media.

Fire

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o   &nb= sp;   Due to their high power output, Class 3b and= 4 lasers present a potential fire hazard.

o   &nb= sp;   Measures should be implemented to minimize t= he presence of flammable and combustible materials in the vicinity of laser us= e.

o   &nb= sp;   Extreme caution shall be exercised when lase= rs are used in the presence of combustible and/or flammable materials.

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§ Beam blocks should be appropriately sized to enable adequate heat dissipation of the absorbed laser beam.

SECTION ONE: GENERAL INFORMATION (CONTINUED)

EMERGENCY PROCEDURES:

Written emergency procedures=

o   &nb= sp;   Written emergency procedures, applicable to = the specific Class 3b and 4 lasers in use, shall be posted in the areas where C= lass 3b and 4 lasers are used.

o   &nb= sp;   All laser users shall familiarize themselves with these emergency procedures.

Medical attention =

o   &nb= sp;   Authorized Users and/or Technical Staff shall immediately seek appropriate medical attention for any individual injured by exposure to non-ionizing radiation from a Class 3b or Class 4 laser, or fro= m an IPL device.

·        Notification of injury or death

o   &nb= sp;   Any UTMB faculty, staff or student who becom= es aware of an incident resulting in the injury or death of an individual caus= ed by a Class 3b or 4 laser or an IPL device shall immediately notify the Radiation Safety Office.