Reliable Storage For Medical Technology

24th May 2013
ES Admin
The reliability of electronic storage modules is an absolute must in medical technology. However, high innovation pressure and ever shorter lifecycles frequently present a problem for device manufacturers – by the start of production, qualified components are often no longer available on the market. For the optimization of the Dialog+ dialysis system, manufacturer B. Braun Avitum therefore placed its trust in a partner that stands out distinctly from the competition in terms of product quality and long-term availability.
The Dialog+ series from B. Braun Avitum offers flexible treatment for dialysis patients thanks to versatile options and an extensive range of accessories. Intelligent hardware and software solutions are deployed, such as the “Adimea” real-time monitoring process, which guarantees reliable and continuous control of the dialysis dose (Kt/V). Using UV technology, it analyses the reduction of substances in the dialysate that have to be excreted in urine and enables doctors and nursing staff to adjust the treatment parameters even during the treatment. The automatic presetting of the dialysis machine applies a data management system that gathers and stores all necessary patient and treatment data, such as patient weight and target Kt/V, on an individual patient chip card. This allows Adimea to independently start the measurement and monitoring of the dialysis and, after the treatment, to use the determined values for the next treatment session.

In order to optimize the reliability and performance of the dialysis machine technology, B. Braun Avitum decided to exchange the previously used mechanical drive (hard disk drive) for a reliable and fast CompactFlash data storage device. In the search for the right product, the long-term availability of the device was first and foremost. “As we provide our customers with replacement parts for longer than average, only a company with a comparable corporate philosophy was possible,” says Rolf Hollstein of B. Braun Avitum’s development team. For the selection of appropriate components, the manufacturer first contacted Texim Europe. “As a distributor, we are often the first point of contact for technical and commercial questions to do with choosing products,” explains Michael Jeremias, Regional Sales Manager North, in relation to the role of Texim in decision making. He presented an initial selection of storage solutions that fulfilled the requirements of the customer. From these, B. Braun Avitum selected a solution from storage manufacturer Swissbit.

The Swiss company has been producing storage solutions exclusively for the industrial market since 2006. Long product lifecycles of several years, depending on the model, are therefore a matter of course at Swissbit. Its consistent focus on the industrial market can also be seen in the long service life and reliability of the DRAM and flash storage devices due to high product and manufacturing quality. A long partnership links the storage manufacturer with the distributor Texim. “Swissbit’s profound and extensive expertise in the area of storage has often been proven to us,” says Jeremias from Texim. “Therefore we could only recommend Swissbit as a partner for the project.”

CompactFlash cards – reliable, proven, and fast

In the development of a new data storage device and following consultation with Swissbit, B. Braun Avitum decided on CompactFlash storage as the basic model. With CompactFlash storage technology, a distinction is essentially made between the variants single-level cell, multi-level cell, and triple-level cell. Swissbit focuses almost exclusively on the SLC variant. In contrast to MLCs or TLCs, it stores only one bit of data in each flash storage cell, which ensures higher reliability with a lower error rate, longer data preservation, and up to 50 times better resistance to deterioration. Even in the case of a power failure, stored data is never lost, thanks to the intelligent FW architecture. The flash solution therefore meets all of the requirements that are essential for the Dialog+ series at all times, 24 hours a day.

In comparison to the HDD storage previously used, the CF card has no mechanically rotating components, and is therefore many times more robust and reliable. In daily clinical use, it withstands not only high humidity, but also high and, most importantly, fluctuating operating temperatures. It also has high shock and vibration resistance, so it is protected against potential jolts. The absence of moving parts also reduces the noise emissions from the device and increases the comfort of the patients in the dialysis center. As the storage of information is purely electronic in this type of medium – and not (as with conventional HDDs) carried out via magnetic disks and a moving read/write head – the CF card has significantly shorter access times across the entire storage area and is distinctly faster at processing information on patient figures and treatment data.

After deciding on a CompactFlash card, the application engineers at Swissbit and B. Braun Avitum began implementing this storage solution in the Dialog+ dialysis machine. Distributor Texim supported the process by clarifying technical details and fine-tuning proposals for general reference designs in relation to file systems, partitioning, electrical connections, etc. Working together with the manufacturer and customer, Texim provided guidance throughout the project, with both telephone and on-site support. The result of the six months of intensive teamwork is the card in the C-300 series with the article name SFCF1024H1BK1TO-I-MS-553-SMA. The high-performance 1GB CF storage card fulfils all criteria for durable and absolutely reliable operation in the harsh environment of a dialysis machine.

A poor-quality storage module will not usually be noticed until some time after it has been deployed. Therefore the next step for Swissbit was to subject the CF card to a defined qualification and testing process, in order to qualify the product for use in medical devices. In simulation tests, the expert team at Swissbit tested the stability of the storage when repeatedly overwriting and deleting data, using this to calculate its theoretical service life. “There are very few manufacturers that calculate life expectancy by means of write/delete operations in applications, and can credibly prove it,” states Hollstein. “Intelligent wear-leveling algorithms ensure uniform wear across all of the storage device. This is the only way that this storage technology can be subjected to the increased requirements of many years of continuous operation and yet still have reserves at the end.” Finally, the results obtained by Swissbit were confirmed and even exceeded in some cases in stress testing carried out by B. Braun Avitum. Not one of the storage cards failed. To further increase security and reliability, Swissbit added the LifeTimeMonitoring feature to the CF card. This displays the lifetime status of the storage device, warns of impending failures, and therefore prevents unexpected loss of data. The relevant information can be read via the S.M.A.R.T. (Self-Monitoring, Analysis and Reporting Technology) structure.

Production is assured thanks to long-term availability

B. Braun Avitum was extremely happy with the implementation of the project. “We were impressed by the prompt response to all of the questions and the open and transparent communication in the links between customer, distributor, and manufacturer,” reports Mabel Nieland from Strategic Purchasing at B. Braun Avitum. Thanks to the collaboration with Texim, even in the face of changing requirements, both partners can respond flexibly to customer requests and coordinate in-time deliveries precisely. Sufficient provisioning and forward-looking internal logistics processes such as Material Requirement Planning ensure reliable delivery within the shortest time.

The CompactFlash card has a long-term availability of several years. “As long as our customer needs the product, we will have it available,” promises Wilfried Freibothe of Technical Sales at Swissbit. “We will also provide service for additional years.” Swissbit strategically stockpiles critical memory and storage components itself, and has special air-conditioned facilities, with a nitrogen supply for wafer storage. This enables customers to procure not only the latest technology, but also legacy products as they need them. B. Braun Avitum can also be sure that all of the flash storage for the Dialog+ series is of the same construction as the sample – both in terms of the components used and the integrated firmware. With its fixed bill of material, Swissbit guarantees this for all products. In the event of changes being required, the article name changes correspondingly and a product change notification informs customers at an early stage. This enables the manufacturer and distributor to check compatibility before installing the modified storage medium in new series of dialysis machines.

Long-term availability is a crucial criterion on which great importance is placed, not only by customers in the medical industry, but also in aviation and aerospace, in automation technology, and in the automotive field, for example. B. Braun Avitum is using the high-performance CompactFlash card successfully in the new dialysis machines, with no end to this partnership in sight. “We will further develop our Dialog+ series together with Swissbit and Texim using the latest flash technologies,” states Hollstein. In addition to the new flash storage for Dialog+, in the service area the manufacturer of pharmaceutical and medical products has also changed over to Swissbit USB sticks. These sticks with SLC flash and a long service life ensure optimal maintenance of the dialysis machines and increase the reliability and service life of the new Dialog+ series.

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