MEDICAL TRACEABILITY
marking technology. Te Medtec Europe conference in Stuttgart, Germany in April highlighted some of these systems.
Turning to laser marking Traditionally, medical devices were marked for identification either with ink, or with an engraving tool or etching pen. Etching posed the problem of requiring full-contact between tool and device, and offered limited resolution or repeatability. Ink posed the problem of requiring FDA approval, and by the time approval was achieved, in many cases the ink had gone out of production. Laser marking came into its
own in the mid- to late-1980s, offering a repeatable process with good contrast, clarity, and resolution that did not introduce impurities to the medical device. Of course, laser marking as a concept is
assist with scrap reduction and improve throughput,’ said Toms. Previously, separate systems would be required for pre-marking verification, laser marking, and post-marking confirmation. Now, state-of-the-art systems combine these steps in a simple, fully integrated user interface. If a part is laser marked at the end of an
laser] is dictated by the material, surface finish, and speed of the required mark
The right choice [of
nothing new, but ‘the main thing to consider is that 20 years ago, a laser would have been a pump flash Nd:YAG laser with a separate chiller. Its yearly power consumption was massive,’ said Andy Toms, director of TLM-Laser, a UK-based distributor of integrated laser systems. Now, fibre lasers provide a stable, low
power consumption option small enough to use in integrated systems and that require no service intervention. New short-pulse lasers can mark different types of materials, producing better contrast and well-controlled marks. Tey also reduce peripheral damage caused by heat, which can lead to long term mechanical defects and corrosion. ‘Lasers have helped create chemical-free
markings that ensure long-lasting marks with contrast that matches solvent-based ink printings,’ said Faycal Benayad-Cherif, business manager for vision and soſtware of Germany-based Foba laser marking and engraving solutions.
Integrated traceability Vital to medical device marking is ensuring that the correct part gets marked with the correct information. TLM-Laser distributes a system developed by Foba, which not only marks the varied and challenging surfaces of myriad medical devices, but also checks the part before and aſter marking. Before, laser marking was ‘a nuisance that
was required for getting the product out the door, but it never gave value. Now, we can
www.lasersystemseurope.com | @lasersystemsmag Hygienically laser marked drain tube, using a UV laser. The process takes 11.4 seconds ISSUE 31 • SUMMER 2016 LASER SYSTEMS EUROPE 39
expensive manufacturing process, it has already reached its maximum manufacturing cost. Correcting defective markings is cost- and labour-intensive, and can affect the mechanical performance of the device. Avoiding error in the first place is critical. Foba’s M1000 and M2000
work stations combine a rotary table with a camera system and laser to supply
the ‘mark accuracy the medical market demands, with the shortest processing time’, according to Benayad-Cherif. Te machine combines an intelligent marking positioning vision system and a point-and-shoot camera, with state-of-the-art fibre lasers. ‘Traditionally, you placed a part under the
laser and then marked it. But you had to use a scrap piece during each set-up,’ said Toms. ‘With the point-and-shoot system, you can place the part under the laser in real time and view an image.’ Te operator can then place the mark exactly where required on the part via a drag-and-drop function based on the camera images. Tis removes the need for expensive tooling, increases precision, and reduces scrap for one-off marking jobs.
As a step further, single-platform soſtware
makes the mark accurately. Foba’s intelligent marking positioning system views the part through a camera, and confirms that it matches the expected part in the correct position. It compensates for skewed positioning so that even if the part is misaligned, it can be marked correctly. Equally important, it avoids assigning a mark to non-existent parts that might be absent from a production line, and can reject incorrect parts. ‘What’s unique about it is that it looks directly through the same lens that the laser looks through. Tat offers very high accuracy, ±25µm,’ said Toms. In another example, Germany- and
Netherlands-based Amada Miyachi offers a laser marking workstation with a specialised user interface that interacts with both the production system and laser marking tools. ‘In this way, customers can get information into the marking file from their production database, mark the part, and create a logged record of the mark,’ said laser product engineer Mark Boyle. Te operator initiates the marking sequence by scanning barcodes containing information about the positioning and template, along with UDI serial identification information. Integrated barcode readers verify that a part has been properly marked, and operators confirm accuracy throughout the process via displayed images. Without careful checks, parts may be
marked twice or serial numbers repeated. Before integrated laser systems, marking too oſten relied on checking the parts at the end
FOBA
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