MEDICAL TRACEABILITY
of the process, at which point correcting errors was too late. Intelligent vision further reduces costs, improves quality, and reduces waste.
Lasers and challenges ‘Te UDI requires both a 2D matrix code and an alpha-numeric code when possible,’ noted Toms. ‘It’s a challenge with small parts, and quite oſten, is not necessarily human-eye readable. But with machine vision, it’s going to be right every time.’ Device manufacturers have to find sufficient
physical space on a small device to place the 2D matrix code and human-readable content. In many cases, that space is not available and the physical size of the mark has to be reduced. Here, accuracy becomes significantly more demanding, with laser marking equipment needing a precision of 0.1mm for inscribing content limited to a tightly defined area like the outer surface of a screw, according to Benayad-Cherif. ‘Validating the quality of the mark is as
critical as its placement,’ said Benayad-Cherif. Mark contrast is critical for performing optical
character verification, where every character is checked for presence and correctness. Laser quality and optical configuration help
to overcome these challenges. Foba’s new Y-series fibre laser marker product line offers nine different laser sources, which create the flexibility to find the best solution for any application. ‘Some sources are able to
generate short laser pulses that help minimise heat zone effects on certain materials, providing less damage to the area surrounding the mark,’ said Benayad-Cherif. Tis allows significantly better contrast for marking a variety of materials. Further, users can choose from different lasers equipped with a standard customer interface. Te new CP10 scan head of Foba’s Y-series
product line is faster and more accurate than previous lasers, which increases marking quality and speed. Including it with the fully integrated vision system ensures a much easier handling of multi-component projects. Amada Miyachi’s system includes tooling
long lasting as well as texture and corrosion free
The mark is
plates set up to ensure consistent positioning of the part for marking with an integrated pulsed fibre laser. Te correct configuration for a particular material and process is tailored by selecting the optical configuration, including laser, collimator, and focal lens, and optimising the laser parameters such as power, frequency, and mark speed. For example, a 100mm lens produces a very small marked spot size, critical to small features on the order of
50µm. ‘But this comes at the cost of a shallow depth of focus,’ added Boyle.
Tricks of the trade ‘Worldwide, we’ve probably sold 75 to 100 [Foba] systems to the medical industry in the last year,’ said Toms. Clients have used the marking system on hip replacements, knee replacements, and bone screws; indeed, anything that could be inserted or used in surgery requires traceability and serial numbering. How this is best achieved depends on the part and the material. Fibre lasers are well suited for corrosion
resistant marking of stainless steel surgical tools, banding various diameter tubes and cylindrical devices for depth measurements during surgery, and laser marking UDI codes on titanium implantable devices including pacemakers or anodised aluminium placards. Laser annealing generates a colour change
on metal surfaces, and is the preferred process for materials like stainless steel. Te heat effect of the laser beam causes a change in the material characteristics underneath the top surface, resulting in a black mark. ‘Te mark is long lasting as well as texture and corrosion free,’ said Benayad-Cherif. Te most commonly used materials for
Fibre laser (Foba Y.0021) with
integrated marking positioning vision system in a Foba M2000-P laser marking station
40 LASER SYSTEMS EUROPE ISSUE 31 • SUMMER 2016
medical parts are stainless steels, which have a natural, passive, corrosion-resistant layer that resists repeated sterilisation cycles, according to Boyle. Machining during the manufacturing process, however, can remove or degrade this passive surface. So the passive layer must be rebuilt, in a process that removes iron and thus potential corrosion sites from a part’s surface. Unfortunately, the process also tends to remove laser marks. ‘Tere is no universal solution for every part
and mark,’ added Boyle. Amada Miyachi’s system capabilities allow users to achieve a dark mark that is resistant to both passivation and repeated sterilisation cycles using nanosecond fibre, nanosecond ultraviolet,
@lasersystemsmag |
www.lasersystemseurope.com
FOBA
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