COM and carrier board in next generation medical instrument
The H6049 Computer-On-Module, COM developed by Hectronic was placed on the table at the medical device company and plans finally fell into place. H6049 is a ready-made board with the complex parts of the computer design completed and verified. It’s designed to be mounted on a custom-made so-called carrier board with interfaces, functionality and dimensions to meet the requirements perfectly.
A replacement was needed for the obsolete PC104 board based on an X86 processor. The company had considered the options carefully. A COTS product, a standard Panel PC, a full custom design, in-house development and outsourcing were among the alternatives. The cooperation with Hectronic involved a little bit of all that.
The computer is embedded in a cardiology instrument which collects data from an invasive blood pressure sensor. The instruments are sold worldwide. The sensor is guided up through major blood vessels from the groin, through the aorta to the coronary arteries of the heart. From evaluating the pressure data Doctors are able to detect and pinpoint areas with early stages of coronary stenosis.
Such areas are treated with percutaneous coronary intervention which is a group of treatments including for instance inflating a balloon at the site of the blockage or bypassing it with grafting vessels from elsewhere in the body.
Implementing a semi-custom design
A COM is a small computer board containing processor, I/O hub, memory and additional components. The COM is always mounted on a tailor-made carrier board. A COM is a COTS product which is used in numerous end products of numerous customers. The carrier board is adapted to one particular end product of one individual customer. The semi-custom design balances advantages from the COTS product strategy (complex parts verified and ready to use directly) with the full custom strategy (adaptation to requirements unique to the application).
Hectronic developed the carrier board for the medical instrument. Two boards for communication were developed by the customer and so was the mechanics and encapsulation. The application required 8 USB ports. The H6049 COM offers 7 of them and the 8th was accomplished via a USB hub mounted on the carrier board. Additional interfaces in the specification of the carrier board is DVI/CRT, gigabit ethernet and an SD interface.
Additional parts and components from Hectronic partners were adapted and integrated. SMART Modular Technologies supplied the SD card and Mitsubishi Electric had the TFT-LCD module to meet the requirements of for example product longevity. The TFT-LCD module was integrated with a PCAP touch screen.
Adapting BIOS and Linux OS
The prior product generation used a Linux operating system and the customer saw no reason for a change and the plan was to reuse as much as possible of the application software. Minor adjustments to the BIOS for H6049 were made by Hectronic as well as development of a Linux operating system meeting customer requirements. The customer’s software needed adaptations to the GCC 4.4 compiler and to the Qt library. The application uses Qt to implement the user interface. The Linux OS included drivers for the PCAP controller and VGA/DVI controller among other things.
Integrating a TFT-LCD module and a PCAP touch display involves more activities and challenges than perhaps first comes to mind. A controller is required as well as bonding of display and touch screen, drivers and cables and finally the industrialization were the solution is prepared for production. Early on in the project one of Hectronics manufacturing partners was involved. They are certified according to ISO 13485 which specifies requirements for a quality management system in production of medical devices.
Ensuring quality in production
The manufacturer is stationed in Taiwan and uses one of the test systems developed by Hectronic. The other two is used by Hectronic and customer respectively. All three are identical which ensures reproduction of errors, identifying the problem and make corrections.
And when it comes to product reliability and production quality we are quite proud actually. 4000 units of the module and carrier board have been produced. 99.8% of the supplied units have worked flawlessly. The medical instrument is certified and sold worldwide. The challenge now is maintenance and manufacturing at the highest quality level for as many years as possible which along with development and industrialization are all parts of Hectronic’s expertize.