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Measuring Key Parameters of Intense Pulsed Light (IPL) Devices - Town, Ash, Eadie, Moseley

Measuring Key Parameters of Intense Pulsed Light (IPL) Devices - Town, Ash, Eadie, Moseley

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Published by Caerwyn Ash

In 2007, We identified the Key parameters of IPL systems for safe and effective treatment. They are Fluence, Pulse duration, Wavelength, Treatment area, Temporal Profile and Spatial distribution.

In 2007, We identified the Key parameters of IPL systems for safe and effective treatment. They are Fluence, Pulse duration, Wavelength, Treatment area, Temporal Profile and Spatial distribution.

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Published by: Caerwyn Ash on Jan 03, 2013
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INDUSTRY REPORT
Measuring key parameters of intense pulsed light (IPL) devices
GODFREY TOWN
1
, CAERWYN ASH
2
, EWAN EADIE
3
& HARRY MOSELEY
3
1
Independent Laser Protection Adviser, Haywards Heath, West Sussex, UK,
2
School of Physical Sciences, University of WalesSwansea, Swansea, Wales, UK, and 
3
The Photobiology Unit, University of Dundee, Dundee, Scotland, UK 
Abstract
Background 
: Unlike medical lasers, intense pulsed light (IPL) devices are largely unregulated and unclassified as to degree of safety hazard. With the exception of most of the USA, the United Kingdom and parts of Europe, the Far East and Australia,the sale of IPLs is generally unrestricted, with the majority being sold into the beauty therapy and spa markets. Standardsare only imposed on manufacturers for technical performance data and operating tolerances determined by CE-complianceunder electrical safety standards or the EU Medical Device Directive. Currently, there is no requirement for measurementof key IPL performance characteristics.
Objective
: To identify the key IPL parameters, emphasize their importance in termsof safe and effective treatment and provide examples of preliminary measurement methods. These measurements canhighlight changes in an IPL device’s performance, improving patient safety and treatment efficacy.
Methods
: Five keyparameters were identified as having an important role to play in the way light interacts with the skin, and therefore animportant role in patient safety and effective treatment. Simple methods were devised to measure the parameters, whichinclude fluence, pulse duration, pulse profile, spectral output and time-resolved spectral output.
Results
: The measurementmethods permitted consistent and comparable measurements to be made by two of the authors at working clinic locationson 18 popular IPL devices and allowed assessment of output variations. Results showed discrepancies between themeasured IPL device outputs and those values displayed on the system or claimed by the manufacturers. The importance of these discrepancies and their impact is discussed.
Conclusions
: This study, of 18 popular devices in regular daily use inEngland and Wales, provides example methods for measuring key IPL device parameters and highlights the need for regularmeasurement of at least those five key parameters measured in this study. These methods can help service technicians tocheck performance and eliminate device malfunction.
Key words:
Energy density, fluence, optical hazard, spectral output, square pulse
Introduction
In Europe, medical lasers are governed by strictsafety standards (1,2). The European Standard EN60825 is designed to protect individuals from laserradiation in the wavelength range 180 nm to 1 mmby indicating safe working levels of laser radiationand introducing a system of classification of lasersaccording to their degree of hazard. The Standardrequires both user and manufacturer to establishprocedures and supply information so that properprecautions can be adopted. Medical lasers intendedfor irradiation of the human body require internalcontrols to measure radiation emission levels with anerror in measurement of no more than
¡
20% givenin SI units and instructions specifying a procedureand schedule for calibration of the measurementsystem (1). No such requirement exists for intensepulsed light (IPL) devices whether or not theycomply with the European Medical DeviceDirective. Technical Report IEC TR60825-9 con-firms risk factors and measurement practices appliedby specialists in the optical radiation field. Itidentifies retinal thermal hazard and blue lightphotochemical hazard as relevant in consideringthe safe use of incoherent light sources. However, atthe time of submission of this study, standards,which will deal specifically with IPL sources are stillonly at draft stage (3).This means that there is no incentive to performmeasurement, and no standard procedures in placeto help manufacturers. IPL devices are being usedwidely with limited accurate knowledge of theirperformance characteristics. Measurement of certainkey parameters could help reduce the risk of under-or over-treatment or burn injury to patients. The
Correspondence: Godfrey Town, 88 Noah’s Ark Lane, Lindfield, West Sussex RH16 2LT, UK. Tel: 44 1444 484295. Fax: 44 1444 484357. E-mail:godfreytown@csi.com
(Received 26 April 2007; accepted 3 May 2007)
 Journal of Cosmetic and Laser Therapy
2007, 1–13, iFirst article
ISSN 1476-4172 print/ISSN 1476-4180 online
#
2007 Taylor & FrancisDOI: 10.1080/14764170701435297
 
absence of any published standards for IPL safetyeyewear, used by the patient and the operator,increases the risk of eye injury (4).The issue of IPL safety was raised by experts at theASLMS Joint International Laser Meeting inEdinburgh, Scotland (21–23 September 2003),when Hode of the Swedish Laser Medical Societyconsidered the hazards of IPL sources (5).Clarkson has also documented the hazards of non-coherent light sources within the framework of IECTR-60825-9 (6).In England and Wales, the Care Standards Act2000, as amended by the Health and Social Care Act2001, treats establishments using IPL devices in asimilar way to users of Class 4 medical lasers. Thestatutory definition of an IPL states ‘an intense light,being broadband non-coherent light which is filteredto produce a specified range of wavelengths; suchfiltered radiation being delivered to the body withthe aim of causing thermal, mechanical or chemicaldamage to structures such as hair follicles and skinblemishes while sparing surrounding tissues’ (7).It is therefore clear that such high-power devicescan cause tissue damage in a similar way to medicallasers and should be subject to equivalent standardsto those provided for Class 4 medical lasers.The purpose of this study is to identify the key IPL parameters that impact on safety and treatmentefficacy, providing results from preliminary measure-ments carried out on 18 IPL devices. Clarkson (8,9)describes methods for measuring pulse duration andpulse profile; in a similar manner the methodsdescribed in this paper can be used as a simpleguide for service technicians to follow. It is acknowl-edged that these methods will not provide absolutevalues in terms of traceability to national standards;however, they will serve as a useful diagnostic toolenabling performance to be checked regularly duringdevice lifetime.The primary purpose of IPL devices is to destroytarget structures through controlled thermal absorp-tion in specific skin chromophores such as melaninand haemoglobin, resulting in the long-term reduc-tion of unwanted hair or the removal of benignvascular and pigmented lesions (10–17). IPLs mayalso be used to produce a photochemical effect aloneor in conjunction with topically applied photosensi-tive drugs such as 5-ALA (18–20), which is used tostimulate the production of naturally occurringporphyrins to destroy bacteria. IPLs may alsoprovide penetrating wavelengths of light to directlystimulate tissue regeneration through a woundhealing response (photobiomodulation or low levellaser therapy) at the mitochondrial level (21,22).It is therefore increasingly important that the usercan be assured of accurately measured and correctlydistributed energy at the skin surface. The pulseduration of delivered light and the associatedspectrum of light produced also play a key role incorrect targeting of key structures. There is littleobjective evidence provided by manufacturers evenin user and service manuals to validate claims forpulse features or stability of spectrum characteristics.The authors identified the following five keyparameters to measure:1. energy density (fluence) for various popularlyused pulse patterns over the claimed lifetime of the lamp and filter assembly to establishwhether there is any significant deviation ordeterioration compared with established stan-dards for medical lasers. Clearly, excessiveenergy density above stated values may resultin burns to patientsskin and low-energydensity may result in under-treatment andpatient dissatisfaction.2. pulse duration (or durations of sub-pulses in apulse train) of the intense light emitted from thexenon flashlamps. The pulse duration can becritical in the efficacy of the type of treatment,particularly where the pulse duration is to bematched to the thermal relaxation time of thetarget. Overstated pulse duration may result in amore aggressive treatment than was intended bythe operator with concomitant side effects.3. electrical discharge pulse shape, recorded as anoscilloscope trace, entering the lamp versusmanufacturers’ claims, to determine whetherthe discharge to the xenon lamp is constant(‘square pulse’) or variable (‘free discharge’).The input pulse energy pattern to the lamp ispivotal in determining the efficiency of thespectral output and determines output intensity.4. the average spectral output of the IPL toidentify undesirable wavelengths, as there isincreased risk of retinal, corneal and epidermaldamage from IPL systems that deliver wave-lengths below 500 nm. Accuracy and effective-ness of cut-off filters and the distribution of lightenergy at different wavelengths could alsoinfluence certain treatment outcomes.5. the time-resolved spectral output of the IPL across the entire pulse width to determine theextent of spectral shift and confirm that theoptical output reflects the profile of the elec-trical discharge claimed by the manufacturer.The time-resolved spectrum defines the effec-tive pulse duration during which the desiredwavelengths are delivered in the optimumintensity.
Materials and methods
The 18 devices and 36 applicators tested includedIPLs manufactured in the USA, UK, Israel, Sweden,Switzerland and Italy (markings on IPL ‘F’ sug-gested that it was originally manufactured in China).
G. Town et al.
 
All of the data were gathered over a 6-monthperiod by two of the authors. All measurements weremade on site in the IPL treatment rooms where theequipment was in daily use between scheduledpatient appointments. Where available, the followinggeneral information was recorded:
N
device identity (name, model, manufacturer,serial number, manufacturing date withheld)and coded for the study
N
maximum stated pulse energy and/or maximumstated fluence
N
CE classification (e.g. medical device or not) /labelling details
a
N
number of shots claimed in the company litera-ture, web site, user manual or system software.The following parameters were measured on up to18 devices and 36 applicators in common use in UK clinics:
N
fluence (energy density) for a range of popularprograms and energy settings including maximumfluence; this was compared with the claimedmaximum fluence
N
accurate pulse durations for different treatmenttypes / settings
N
electrical discharge across the xenon lamp (oscil-loscope trace)
N
spectral output
N
dimensions of glass transmission block.
a
CE mark for medical devices – explanatory note
The CE mark is a visible declaration by themanufacturer (or his representative, importer, etc)that the equipment which is marked conforms to therequired regulatory standards for safety and envir-onmental protection legislation under all of theapplicable European Union (EU) directives. Theletters ‘CE’ are initials for the French phrase‘Conformite´ Europe´ene’ (‘European Conformity’).IPL devices are normally classified as Class IIa/belectro-medical devices with medium risk. MedicalClass 3B and IV lasers must comply with theEssential Requirements of the European MedicalDevice Directive, which requires a device-specificCE mark certificate from a Notified Body.Manufacturers who register IPL devices underthis scheme issue a Declaration of Conformity tostandards, maintain a Quality Assurance monitoringsystem under ISO9000 and are obliged to report anyaccidents to the authorities. A medical CE mark canbe identified easily by the four-digit number next tothe official CE mark on the device identificationlabel, which denotes that the Notified Body that hasindependently evaluated the device.Medical authorities in several non-Europeancountries (including South Africa and Australia)recognize the medical CE mark as a requirement forelectro-medical equipment.
Energy density measurement 
IPL energy density (fluence) is the amount of lightenergy delivered per unit area and is measured in Joules per centimetre squared. For treatmentsutilizing ‘selective photothermolysis’, the light energyis absorbed by chromophores in the skin, such asmelaninandoxyhaemoglobin,andconvertedintoheatenergy. As energy is absorbed the temperature of thechromophore increases and tissue goes throughbiological changes. The ideal fluence will raise thetemperatureofthechromophoretoa levelthatcausesdamage to the target but does not lead to adverse sideeffects such as burns or blisters. Even the mostrestrictiveIPLdeviceswillatleastallowtheusersomecontroloverenergydensity,whichmakesreproduciblemeasurement very important to ensure consistentoutput and prevent under- or over-treatment.An isopropyl alcohol wipe and an optical clothwere used to thoroughly clean the IPL light guideand head aperture of the energy meter (OphirLaserStar Power Energy Monitor, Ophir L40 (150)A-DB-SH-NS Absorber Head: Ophir OptronicsLtd, Jerusalem 91450, Israel). The slightest frag-ment of dirt or a thin layer of dried ultrasound gelresidue can make a significant difference to thepassage of light from the handset applicator to theenergy meter absorber head. Clear optical couplingultrasound gel (Henleys Medical, Hertfordshire AL71AN, UK) was applied to the top of the energymeter IPL absorber unit glass without any airbubbles in the gel (Figure 1A). A 2 mm thick whitepoly-tetra-fluoro-ethylene (PTFE) plastic mask/spacer with a 4.84 cm
2
(2.2
6
2.2 cm) aperture wasused to prevent burning of the surface paint aroundthe energy absorber head and to fix the depth of gelbetween the absorber glass lens surface and theapplicator glass coupling block (0.1 mm). Theapplicator handset was placed in a horizontalposition above the absorber head using a laboratoryretort clamp and stand (Figure 1B). The applicatorhandset glass transmission block was in directcontact with the PTFE white spacer on the energymeter absorber unit and perfectly flat and horizontalon the absorber head glass aperture with no lateraltilting. The angle of the handset applicator positionis critical as the slightest movement can result in an8–10% difference in energy readings. As the wholeof the output from the transmission block usuallycannot be measured owing to the size limitation of the absorber head aperture, the IPL glass transmis-sion block was centred over the aperture to ensurethat maximum output energy was measured fromthe centre of the lamp plasma phase (Figure 1C).Firm downward pressure was applied to eliminateair bubbles, which will impede light passage by lightscattering, in the gel between the glass block and theenergy meter absorber head (Figure 1D). Sufficienttime was left between each lamp discharge to againprevent excess heat creating small bubbles in the
 Measuring IPL parameters

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