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Caerwyn Ash School of Medicine, Swansea University Aesthetics Today Birmingham NEC 4th October 2008
Statement of Disclosure
The following potential conflict of interest relationships are germane to my presentation: Salary, equipment, and travel expenses paid by CyDen Ltd.
Treatments
IPL systems are becoming increasingly more versatile treatment devices
Acne Vulgaris Hair management now also on dark skin Photodamage Types I, II, (and III with PDT) Vascular lesions Pigmented lesions Psorasis Creams and potions Breast Firming
Absorption of Chromophores
Absorption of Chromophores
Regulations
Because there is no international standard for IPL systems, we dont know: If the stated fluence values are correct or when the IPL lamp is out of tolerance?
Key Parameters
Fluence Energy density (J/cm2)
Beam profile is the distribution of discharged energy across the treatment area
Lamp discharge profile - is an important factor as it bears importance to the change in fluence with the pulse duration Time resolved spectral data shows the change in spectral distribution and fluence with time
Measured Fluence
Fluence measured using an Ophir energy meter Class 4 laser standard states an industry tolerance of +/- 20%
Flashlamp Physics
IPL light source is a handmade flashlamp A flashlamp deteriorates with every discharge Manufacturers limit shot life to prevent energy decreasing to become clinically ineffective
30 IPL applicators were measured at maximum fluence of which 11 were more than 20% below and 8 were more than 10% above fluence levels given on the device display or claimed in user manuals, even where brand-new lamps were tested.
9 IPL devices out of 18 had applicators that were outside of the standard for medical Class 4 lasers (> +/-20%)
Filter Performance
Good, sharp 530 nm cut-off filter No significant UV. Spectrum analysis of light contains Discrete line structure Continuum radiation. Filter position measured different to that stated
Of 29 applicators 19 (65%) with cut-off filters that were inaccurate by more than 20 nm versus the claimed cut-off value given by the manufacturer. Only 10 applicators (35%) were within 20 nm of the stated cut-off.
Filter Performance
Patient dissatisfaction can be caused epidermal damage caused by significant UV or blue content. Dichroic filters become damaged through long term use by high energy IPL systems overloading a thin dichroic coating.
Filter Performance
Epidermal damage produced by significant UV / blue spectral content, caused by degraded filter Injury causes pain and discomfort - dissatisfaction to patient Possible legal proceeding against salon/clinic
Measurement of UV Content
Shorter wavelengths in the ultraviolet region of the spectrum may burn the patients skin or may be hazardous to the operators eyes and are therefore removed. Of the 30 applicators tested, 6 IPLs measured more than 1% and two measured more than 2% of unwanted UV output below 400 nm when cut-off filters were set significantly higher.
Only three systems measured possess a square pulse discharge Three systems proved not to have a square pulse Most systems utilise simple free discharge Others delivery methods stack pulses together to extend pulse duration
These images show time resolved profiles of the pulse durations of five well known wavelengths Dye, Ruby, Alexandrite, Diode, and Nd:YAG
Digital Revolution
Free Discharge
Square Pulse
time resolved video of 1ms frame capture of the difference in the temporal characteristics of a free discharge and partial discharge pulse system. Slowed in time to observe changes
Free Discharge
Manufacturer claims a 25ms pulse duration but when measured using time resolved spectrometer only circa 3ms of useful energy is present
Effective pulse duration for follicular damage = 20-40ms Melanin heated to circa 70C causes destroys follicular cells Surrounding tissue matrix spared from heating effect Free discharge systems are not optimum in delivering energy within such time regime
Fluence is delivered evenly during the pulse duration A controlled square pulse can produce pulse durations that are biologically effective and efficient All wavelengths in the spectrum are equally represented during the exposure Less adverse reactions
Pulse Stacking
Fluence decays during the pulse duration Pulse stacking is used by certain manufacture to extend total pulse duration Close stacked pulses are effectively a single pulse of decaying energy as the off time between pulses are short Spectral shift is highly present during exposure
Pulse Stacking
Fluence varies of each short pulse during the pulse train due to separate capacitors Pulse stacking is used by certain manufacturers to extend total pulse duration but with long off times, thermal energy that is absorbed by melanosomes is dissipated to surrounding tissue within off times. Greatest number of adverse reactions reported
Summary
Many manufacturers of IPLs make claims for fluence, pulse duration and spectral emission that are not substantiated as measured by this study - This may lead to increased risk of under- or over-treatment or burn injury to the IPL patient Manufacturers operating an ISO 9000 quality system (Medical CE-mark) showed greater consistency of stated and actual values for fluence, pulse duration and spectral cut-off filter accuracy over the stated lifetime of the applicator / lamps Square Pulse Systems: Produce the lowest possible intensity for a given fluence thus minimising discomfort and other side effects such as skin burns Free Discharge Systems: Produce high intensity energy in short pulse durations with spectral shift and less efficient spectral distribution
Summary
A time-resolved Spectral Footprint as shown in these measurements is helpful in determining the true pulse duration and spectral pattern of useful energy for optimized clinical efficiency This first serious attempt to measure IPL performance characteristics provides criteria that should be carried to national representatives of the competent regulatory body (IEC) to promote an international standard for measuring intense light devices
Thank you !