Product Selection Buying a Laser
preparing to launch. Even if a laser is considered obsolete, it doesn’t mean it has to be immediately carted off to the dustbin (unless you can no longer get parts for it). If the laser is still performing well and both the practitioners and patients are still happy, keep on zapping. The differences between many of the older lasers and the newer ones are usually speed, software, system size, hand piece options, or additional wavelengths. Hence the old lasers can still be effective for years to come, maybe just not as fast or as comfortable to use as newer versions. Advantages of buying a used laser Saving money: New lasers are expensive so if you can find the right deal, you could end up saving a bundle. If you already have a laser that you are comfortable with using and are just looking to add another one to your clinic, the used market may be the place to go. You will need, however, to make sure it can be serviced by a third party if you don’t want to pay the extra fees most manufacturers now charge. Sometimes an older model may be better to consider because it’s likely to be a more basic system, making it easier to work on and get parts for. Also, there are typically more of them on the market and you can usually get a more reasonable price. Disadvantages of buying used Buying a used laser can either be a really good, or a really bad thing. I’ve seen it go both ways. Two big issues to consider when buying used are: Can you get the laser completely serviced? Is what you assume you’re buying, exactly what’s going to be delivered? Ask a lot of questions, get references, records of service, a checklist of any work that’s been done, and verify what you’re being told is true. There can be hidden pitfalls and unanticipated costs when buying used compared to buying new. Potentially the worst surprise someone buying a used laser may encounter is having to go back to the manufacturer for repairs and being hit with recertification fees that could cost anywhere from £1,000-£16,000. Unfortunately there are a few bad apples wherever you go. Some 60
Compliance with laser safety standards Laser protection advisor, and director of Bioptica Laser Aesthetics, Mike Regan explains that there are particular standards that lasers must adhere to in order to be classed as safe. He says, “Recent years have seen a significant amount of work being done by the various international and European bodies responsible for the definition of laser product safety standards. The main International Electrotechnical Commission (IEC) standard for medical and aesthetic laser products is IEC 60601-2-22.” Regan also explains that, with regard to laser safety eyewear in Europe, the standardisation body is CEN (European Committee for Standardisation) and the relevant standard required is EN 207. Laser consultant and technical officer at Lasermet, Peter Fishwick, details what these standards mean for practitioners looking to buy a laser. All laser products that are introduced for sale in the UK must comply with various standards. The current laser standard is BS/EN 60825-1:2014 ‘Part 1: Equipment classification and requirements’. Medical laser products must comply with the additional requirements in BS/EN 60601-2-22:2013 ‘Medical electrical equipment: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.’ These standards are functionally identical to the international standards produced by the International Electrotechnical Commission (IEC) of the same number. This means that products that comply with the international standard will also comply with standards in the UK. As the United States is not a signatory of the IEC, devices made in the US do not necessarily comply with BS/EN 60825-1 and 60601-22. In theory, the standards are enforced by various enforcement bodies such as Trading Standards to detect non-conformances and intervene where necessary. However, as manufacturers are able to self-certify it is very difficult for Trading Standards to find non-compliance in products that are coming in from overseas unless a product is reported to them by a consumer. When buying a laser these are the type of things you should be looking out for: What class is it? All laser products are classified from Class 1 to Class 4, where Class 1 is safe under normal operating conditions and Class 4 is potentially hazardous to both direct viewing and diffuse (scattered reflection). Class 4 is the most hazardous class and a large number of medical lasers fall into this category. Lasers in Class 1C, 3B and 4 will require additional training and safety infrastructure (LPS, LPA etc.) Is it correctly labelled? All lasers should have labelling or user information that details the output of the laser. This should include the wavelength and power as well as any pulse information (if required). Along with the class of the laser this information should be available to you before you buy the laser. Does it have the required safety features? For example, for a class 3B or 4 medical laser these include: interlock connectors, emission indicators, and requirements for any footoperated switch. There are also requirements for a remote interlock connector and key control. Viewing optics must have an emission below the Class 1 Limits, and there must be a Laser Ready indicator to tell you when the device is powered up, as well as an emission indicator to tell you when the device is emitting. The laser must have a target-indicating device and, if this is another laser, it must be less than Class 3R (Class 2 for Eyes). Also required are “Stand by/ready” controls, an emergency-stop facility, and a means of identifying emission levels. Approved laser safety enclosures are required to prevent unintentional exposure. Eyewear for laser protection should meet EN 207 and the wavelength and power density of the laser will determine the type of eyewear required. Consequently, different lasers require different eyewear and advice should be sought from a laser safety specialist. Certain products will require more training and an increased safety structure. Advice from an LPA, LPS or LSO should be sought when buying a Class 1C, 3B or 4 Laser. This will ensure you are compliant with the Control of Artificial Optical Radiation at Work regulations. If you need to know if a product you own, or are looking to buy, meets these standards you should contact Trading Standards or a UKAS approved test house that specialises in IEC 60825-1 and 60601-2-22. Many products are certified through test houses such as UL, ITS, SGS and BV, and these test houses will make sure that any product that bears their ‘mark’ will meet the required standards. Independent test houses such as Lasermet will provide information to both consumers and manufacturers alike.
Aesthetics | January 2015
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