This Standard Operating Procedure (SOP) governs the safe use of Class 4 medical lasers Fotona Dynamis (Er:YAG 2940 nm; Nd:YAG 1064 nm) and Fotona StarWalker (Q‑switched/picosecond Nd:YAG 1064/532 nm) in a dedicated laser room at Newcastle Cosmetic Doctor (NCD). It integrates Australian WHS legislation, laser safety standards, infection control and clinical governance requirements. 1 2 3 4 5
1. Roles & Responsibilities
- Laser Safety Officer (LSO): Appointed by the Medical Director; responsible for laser safety program, risk assessments, eyewear selection/verification, signage, training, audits, and incident review.
- Laser Operator (Doctor/Nurse): Credentialed for device/specific procedures; adheres to this SOP; completes pre‑use checks, parameter verification, and patient shielding.
- Assistant/Observer: Trained in room controls, PPE, plume capture, and emergency shutdown.
- Medical Director: Ensures compliance with WHS, Ahpra/Medical Board guidance, NSQHS standards, and maintains adequate insurance and ARTG documentation.
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2. Controlled Laser Area (Room Controls)
- Access control: Dedicated room; door kept closed during operation; entry restricted to trained staff/patient only; visitor log maintained.
- Warning systems: "DANGER – LASER IN USE" illuminated warning and hazardous laser door signage; wavelength/class posted; emergency contact displayed.
- Surfaces/windows: Non‑reflective finishes; windows covered or treated to prevent beam escape; remove/mask jewellery and reflective instruments.
- Interlocks & footswitch: Use door interlocks where available; footswitch protected; cables managed to prevent trip hazards.
- Fire safety: Keep non‑flammable drapes; allow alcohol preps to fully dry; hair secured/moistened; oxygen sources minimised; extinguishers available/checked.
- Plume control: Medical smoke evacuator with ULPA/HEPA + activated carbon filtration; capture nozzle within 2 cm of treatment site; filters changed per manufacturer.
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3. Personal Protective Equipment (PPE) & Eyewear
- Eyewear selection: Eyewear must be labelled with optical density (OD) appropriate to wavelength/energy: 1064 nm (Nd:YAG), 2940 nm (Er:YAG), and 532 nm (frequency‑doubled). All persons in room must wear wavelength‑appropriate eyewear; patients wear intra‑ocular metal shields for peri‑ocular work.
- Respiratory protection: For plume‑generating procedures, use smoke evacuator as primary control and consider P2/N95 respirators where indicated.
- Skin protection & attire: Non‑flammable drapes, protective gloves; avoid alcohol‑based products near beam path until dry.
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4. Equipment Checks & Maintenance
- Daily pre‑use checks: Key switch and emergency stop tested; aiming beam verifies alignment; handpieces/tips inspected; fibres and articulated arms checked; footswitch responsive; eyewear inspected for scratches/damage; smoke evacuator operational; room warning light functioning.
- Parameter verification: Confirm program/spot size/fluence/pulse duration/repetition rate match protocol and consent; double‑check patient identity and site.
- Maintenance: Follow manufacturer service intervals; maintain logs; retain ARTG inclusion and service reports.
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5. Patient Assessment, Consent & Photography
- Screen for photosensitising meds, pregnancy, keloid tendency, recent sun exposure/fake tan, active infection/herpes; assess Fitzpatrick skin type and risk of PIH.
- Explain benefits/alternatives/risks (burns, pigment change, scarring, infection, ocular injury) in plain English; offer cooling‑off as required; obtain written consent.
- Clinical photos stored as part of the medical record; separate explicit consent for any advertising use; manage per Australian Privacy Principles.
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6. Laser Procedure Protocol
- Time‑out: Confirm patient identity, procedure, site, device, parameters, eyewear, plume capture, fire precautions.
- Technique: Use appropriate spot size/fluence/pulse duration for indication; maintain controlled handpiece distance; avoid plume re‑circulation; keep nozzle close.
- Communication: Announce "laser on" when firing; restrict distractions; document settings used and any adverse responses.
- Post‑care: Cool skin as indicated; provide aftercare (SPF, avoid sun/heat, no picking); document batch/lot numbers for disposables.
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7. Plume Management (LGAC)
- Activate smoke evacuator for any ablative or pigment‑shattering treatment; place nozzle within 2 cm; ensure high‑efficiency filtration (ULPA/HEPA + carbon); replace filters per schedule.
- Maintain room ventilation; minimise staff in room; consider respirators if indicated; follow infection prevention principles.
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8. Emergency Procedures
- Ocular exposure: Stop immediately; shield device; urgent ophthalmology referral; document incident; notify HCCC/Ahpra as required; review eyewear controls.
- Skin burn/fire: Cease firing; remove ignition sources; cool burn with saline/water; manage per burn first aid; consider NSW Health referral; complete incident report.
- Smoke evacuator failure: Halt ablative/pigment procedures until fixed; escalate to LSO.
- Electrical fault: Power down using emergency stop; evacuate room if necessary; tag‑out device; service call.
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9. Training, Credentialing & Audit
- All operators must complete laser safety training referencing AS/NZS 4173 and local WHS law; competencies recorded; new staff supervised until signed‑off by LSO.
- Quarterly audits: eyewear OD match, room signage, interlocks/warning light, plume capture performance, emergency kit readiness, documentation completeness.
- Non‑conformances trigger corrective actions and re‑training.
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10. Device Inventory, ARTG & Maintenance
- Maintain a device register (model/serial/handpieces/software versions).
- Keep ARTG inclusion evidence and supplier service reports; ensure software updates and safety notices are actioned.
- Retain calibration/QA logs for each laser; review annually at governance meeting.
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11. Signage, Documentation & Records
- Door signage: class/wavelength, hazard pictograms, LSO contact.
- Records: consent forms, parameter sheets, adverse event logs, maintenance logs, eyewear OD matrix, smoke evacuator filter log, training log, visitor log.
- Privacy: photos and records handled per Australian Privacy Principles.
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