Its rapid tooling service enables Leoni to upgrade its portfolio as a system supplier and, while designing during the development phase, to provide more cost-effective, quicker and more flexible support with injection-moulded prototypes than with conventional methods. In this process, Leoni combines steel base frames with 3D-printed mould inserts made of acrylic resin. They are very robust and withstand both low and high-pressure injection moulding. Prototypes can be made within the shortest possible time and geometries can be optimised.

First, the design of the plug, the grommet or the y-splitter is swiftly agreed with the customer with the help of 3D models. The tool is then designed with direct gating and venting, and the mould insert pair is printed. Thanks to standardised dimensions, Leoni can easily incorporate its 3D tools in various types of equipment. The feed channel automatically sits in the right location. The efficiency boost thanks to standardised base frames with guide units is substantial and can be maximised even further through the additional use of swivel moulds.

Among all the plastics tested, Leoni has so far achieved the best results with PVC when making the prototypes and small productions runs using this process. The wall thickness of the moulded parts should meanwhile not be too great.

This step into Mexico and the United States is strategically an extremely important one to Business Unit Healthcare. The intention with having production in North America is to be able to serve local customers much more quickly and flexibly, and thereby to gain new customers. The workload on other production facilities in Europe and Asia is simultaneously to be eased. By having its own development office in Detroit, Leoni aims above all to boost its position as a systems supplier among OEMs operating globally. In North America, too, the aim is in the best way to support medical equipment manufacturers as early as the development phase in defining the ideal Leoni wiring. 

Production for Business Unit Healthcare at Leoni’s facility in Apaseo el Grande, in the Mexican state of Guanajuato, is scheduled to start in the spring of 2018. The first stage will involve production mainly of cable systems for imaging devices. That is why more than 80% of the manufacturing technology needed for production has already been set up locally.

Up to now, Leoni has only made wiring systems for the automotive industry at this plant located in central Mexico. While cable harnesses for medical equipment are made in comparatively smaller number, production of a cable system for an x-ray machine or a magnetic resonance scanner normally involves the use of more widely varying production technologies.

Shield attenuation describes the effectiveness of the cable’s shield against interfering signals. Rather like a Faraday cage, the shield protects the elements that lie beneath the shield against external electromagnetic influences to ensure EMC.

To test shield attenuation, Leoni fits a 3 m-long cable in the test set-up with a plug at one end and a terminating resistor at the other and feeds it into a measuring tube. Power is then fed into the cable. Energy now escapes from the cable shield and spreads out. The shielding and measuring tube are short-circuited at the end near the transmitter, while overlap of the wave running back and forth is measured at the opposite end. Shield attenuation should be understood as the logarithmic relationship between the power fed in and the power now measured.

Shield attenuation is measured based on the frequency, but remains largely constant on cables as of a few 10 MHz. As the wavelength at lower frequencies would be too long for the electrical measuring equipment, shield performance is determined from the transfer impedance at max. 100 MHz.

At this year’s Compamed trade fair, Leoni will show samples of overmoulded components made based on acrylic resin with the help of 3D-printed mould inserts. The systems supplier uses these methods to support its customers particularly in product development or when testing the suitability for mass production of certain geometries on prototypes. With application-specific designs as well as extremely rapid and cost-effective adaptations, Leoni supports its customers as early as the development phase in the design of medical technology systems and will itself carry out individual life-cycle tests as required. Small-scale, injection-moulded production runs made of PVC are also feasible using this method.

Irradiation services at Leoni

A high degree of sterility goes without saying in healthcare because living micro-organisms in materials or on objects can lead to serious complications.

Sterilisation by means of electron beams is an ISO 11137 standardised process and one proven by 30 years of usage that, in contrast to such other methods as treatment with heat or chemicals (using gas), provides crucial advantages: the use of beta rays (accelerated electrons) involves a cold process, meaning that it is also suitable, for example, for heat-sensitive products – they can then be immediately deployed thereafter, without further tests. Ionising radiation boasts high degrees of radiant energy and penetration (10 MeV), whereby germs or resistant spores are killed. Electron-beam sterilisation is furthermore energy-efficient and does not require any radioactive source. Leoni sterilises medical products, raw materials as well as packaging materials.

Solutions for endoscopy with optimised surfaces

At the Compamed trade fair, Leoni will also show cable systems for endoscopy, which the systems supplier develops, produces and tests to DIN ISO 13485 standards mainly with liquid silicone rubber (LSR) at its facility in Georgensgmünd, southern Germany. The solution made of LSR to be displayed at the fair boasts an optimised surface for improved stick-slip behaviour. It can also be safely disinfected and sterilised thanks to not having any grooves or cavities at the transition joints. To achieve the best design and provide dedicated service, Leoni supports its customers as early as the development phase of their systems in selecting the materials as well as the cable and system structure.

Upon request, these optimised silicone cables can also be made antimicrobial – to achieve this, Leoni uses an acid-based technology that gives the cable a germ-killing effect, which makes it resistant to perspiration and protein, and does not add any silver or copper to the cable jacket. In this way, Leoni ensures a long-term hygienic benefit. 

Making technologies available for a mid-price segment is an issue with respect to the global demographic trend and of key significance among medical technology OEMs. With its Cios family, Siemens Healthineers offers its customers high-performance and reliable, mobile C-arms at outstanding value for money. Dependable and robust design, easy handling, low maintenance and worldwide customer service – with its mobile C-arms, Siemens Healthineers facilitates the use of imaging systems in many types of equipment for everyday surgery.

Siemens Healthineers again trusted in Leoni for the wiring of this range of devices. As it was also previously the case in other projects, the systems supplier was involved with the Cios product family from the outset and, together with the customer, defined the specifications of the cable components as well as the ideal cable routing during the devices’ development phase. The Leoni products for the Cios family include existing and newly designed cables and cable systems for the trolley, chassis/system and C-arm wiring. In all these cases of Leoni development work, the focus was on disruption-free and electromagnetically compatible signal transfer for excellent image quality and highly dynamic demands on the raw cable with low abrasion. Due to the worldwide distribution of these Cios C-arms, furthermore, some components had to conform to certain UL styles.

Leoni is pleased to have received this renewed commendation as a ‘Best Supplier’ in terms of quality and logistics in 2016 because it awards the optimum functioning of its existing processes and the outstanding performance of its staff involved in Germany and Slovakia.

DIN EN ISO 13485 is an internationally recognised standard that harmonises the major legal requirements imposed on medical technology with the established quality management systems. By successfully passing DIN EN 13485 certification at its facility in Georgensgmünd, Leoni has proven that it fulfils its obligations with respect to product risks and how they are handled. The processes for assuring the quality of Leoni cables and cable systems for, among other things, endoscopy, ultrasound and catheter equipment with traceable documentation and risk management are enduringly effective. Leoni’s extensive range of products and services for the medical technology growth sector can be further expanded now that this certificate has been obtained.

High quality as the prime objective

LEONI elocab GmbH is a facility of Leoni’s Business Unit Healthcare, which has been developing and producing cables and cable systems for medical applications for more than 30 years. From bulk cable to individual components and through to ready-to-install systems, the developed products - most of which meeting specific customer requirements - are incorporated in an application-optimised design and taken to readiness for series production. The benchmark for every Leoni product is high quality of design with the choice of suitable materials and extensive testing. With this DIN EN ISO 13485 certification, Leoni has now proven the high product safety standards for its endoscopy, ultrasound and catheter equipment cable solutions.

From 14 to 17 November 2016, Leoni will display its system solutions for medical technology in Hall 8b, stand number L21.

LSR overmoulding prevents fertile ground for biofilm

By overmoulding with LSR, Leoni prevents gaps and notches at the connection points of endoscopy cable systems, which could otherwise be fertile ground for perilous biofilm. When overmoulding the connectors, ferrules and splitters of its endoscopy systems, the system supplier and cables specialist relies on its own material developed in-house, which is based on liquid silicone: Leoni Si-Tec. Overmoulding with this jacket material achieves perfect sealing of tricky spots. Grooves and crevices are eliminated. Incorporated connectors are furthermore moulded with such matched materials as epoxy resin, adhesive or silicon, thereby preventing penetration of fluids at these points. That makes Leoni endoscopic cable systems gas-tight, heat resistant up to 143°C and thus perfect for constant sterilisation by means of chemicals or in autoclaves. Simultaneous use of Leoni Si-Tec as the cable jacket improves the cable’s gliding properties and ensures that it is very good to handle without additional talcing. Cable system samples at the Compamed will illustrate the advantages of Leoni’s method of LSR-overmoulding the components of endoscopic connections and the simultaneous use of Leoni Si-Tec as the cable jacket.

Successful first DIN ISO 13485 certification

Leoni’s facility in Georgensgmünd was already successful in April 2016 with first-time DIN ISO 13485 certification issued by DQS. Here its Business Unit Healthcare makes primarily the connections for endoscopy, catheter and ultrasound devices in clean rooms. By having passed the audit, it was confirmed to Leoni that it fulfils its obligation concerning product risks and how they are handled. The processes for assuring the quality of Leoni cables and cable systems with traceable documentation and risk management are enduringly effective.

Hygienic through to antimicrobial

Leoni’s Business Unit Healthcare provides a broad range of antimicrobial cables and systems to avoid biofilm and to reduce the bacterial load in hospitals. The Amistec company based in Kössen, Austria owns the technology and is Leoni’s exclusive partner in making these products. Its managing director, Prof. Dr. J. Peter Guggenbichler, will describe the technology to manufacture antimicrobial surfaces in a 15-minute English-language presentation during the Medica Education Conference on 17 November 2016 at 2.10 pm in room 16. 

It is a stated objective of Ziehm Imaging’s development work to be a technology leader in mobile x-ray imaging. The manufacturer of medical C-arm x-ray devices since 2006 continues to repeatedly set benchmarks particularly in flat-detector technology.

More than five years ago, Leoni won its first contract from Ziehm Imaging to assemble hand switch cables. Collaboration between the two companies has since then been gradually expanded. Leoni now supplies tailor-made hybrid cables with optional strain relief and ready-to-install cable systems for various Ziehm Imaging mobile C-arms, such as the Vision and 8000 product family. In so doing, Leoni engineers support their customer as early as the devices’ development phase.

Ziehm Imaging has commended its cable system supplier as ‘Partner of the Year’ for the first time, basing this on the criteria of quality, adherence to delivery schedules and collaboration in 2016. Thomas Schultze, Vice President, Operations at Ziehm Imaging: “As a technological leader in the field of medical devices, our aspiration is also to set standards in terms of safety and quality. Our customers throughout the world trust us in this respect. Without dependable partners like Leoni and their technology transfer within our value-creation partnership it would be virtually impossible to retain customers as we now do. With many thanks for this commitment and this support, we look forward to continued, successful collaboration.”

Leoni staff members accepted the commendation in a ceremony held at Ziehm Imaging’s head office in Nuremberg on 22 July 2016.  

Leoni has optimised all the components for wired data transfer involving flexible use of Cat 5e cable. To achieve this, the system supplier first changed the material of a Leoni Cat 5e cable in such a way that it can be coiled. Secondly, assembled connectors were overmoulded. The parts that may be connected can be angle grommets with individually definable angles or an additional, shielded RJ45 terminal.

Leoni produces its coiled Cat 5e cables in any length and with an outer diameter of at least 25 mm. A cable jacket made of thermoplastic polyurethane (TPU) ensures high resistance to mechanical strain together with minor reset force. Under long-term testing, the Cat 5e transfer parameters of the assembled, coiled cable remained constant even after being repeatedly elongated. The cable also has UL Style 21527 (80°C/300 V) approval.

Leoni fits the latch and customised angle of the assembly-capable grommet as well as the terminal with an additional shield and overmoulds it at low pressure with thermal fusion adhesive. This protects the connection not only mechanically, but also in thermal and electrical respects.

The outcome of these modifications made by Leoni to existing components is a floating Cat 5e cable that is not only extremely flexible, but that also, in contrast to cables with RJ45 (gender changer) adapters, manages without an additional interface. It is particularly well suited to cable routing with vertical or horizontal paths. On stands or patient beds, for example, it can be a low-loss as well as space and cost saving alternative for mechanical cable routing.

In its production of cable systems for medical technology, Leoni uses various semi-automatic injection and overmoulding techniques to process thermoplastics, thermoplastic elastomers and LSR. In addition to the injection moulding machines at various of its production facilities, Business Unit Healthcare can draw upon a broad range of special hot-melt devices. The preferred material for overmoulded connectors, grommets and y-splitters for endoscopy systems is LSR. Combined with an LSR cable jacket, Leoni supplies flexible, gastight and autoclavable systems.

“We aim to offer our customers more overmoulded components in our ready-to-install systems solutions,” Siemen-Jannes Meinders, Head of Leoni’s Business Unit Healthcare, said in explaining the investment in more semi-automatic plant. “As a systems supplier, we focus on customised solutions for specific requirements, and do so starting from small lot sizes. That calls for a broad range of technologies and know-how.”

Leoni develops application-optimised component geometries and the necessary tools. Which processes and materials are deployed will depend on the application of the overmoulded components. The materials of the cable jacket and the overmoulding will normally match in order to achieve a good connection. Alongside silicone, Leoni also processes such other biocompatible materials as FEP, ETFE and TPU for near-patient applications. For mechanically demanding applications in device wiring, Leoni overmoulds its cables located outside or inside with such technical plastics as thermoplastics or thermoplastic elastomers, or overmoulds electronic components with (thermoplastic) thermal fusion adhesives. A further shield is added if required. Leoni can also overmould plastics that are up to 30 % glass fiber-strengthened in a high pressure process.

Leoni product examples

Having broadened its production technologies, Leoni now makes not only endoscopy systems that prevent formation of hazardous biofilms by avoiding grooves and crevices in the crossovers. The cable specialist’s overmoulded solutions are also found in many other applications: for instance, alongside a grommet with bracket for a Brainlab surgical navigation system, Leoni has already developed various sealing bulkhead receptacles and manual switch grommets for imaging devices. Further examples of overmoulded solutions include a flexible Cat 5e lead with an angled grommet and coiled cable as well as an overmoulded connector on a drag chain compatible HDMI cable for mechanically demanding applications in tightest of installation space. Not least and in addition to antimicrobial cables, Leoni also provides overmoulded components with an antimicrobial surface.