Successes in the development and production of medical products

Transcription

1 Functional Safe Control System for Jet Ventilator, Acutronic Medical Systems AG, Switzerland Successes in the development and production of medical products

2 Functional safe. Life supporting. Effective partnership for innovative products Cicor Electronic Solutions develops a functional safe control system for jet ventilator for Acutronic Medical Systems AG, Switzerland. ACUTRONIC Medical Systems AG, based in Hirzel (Switzerland), was founded in The firm made a name for itself through its development of jet ventilation, a special method of artificial respiration for patients undergoing surgery. The company now leads the way in this field and thanks to its innovative products, high precision and quality - enjoys an excellent reputation. Acutronic is a cofounder of the European Society for Jet Ventilation (ESJV). Jet ventilation is an artificial respiration technique for patients undergoing surgical interventions on their airways. It is used particularly in ENT and thorax surgery. Instead of using a large tube that fills up the trachea, ventilation is through a slender pipe that leaves enough room for instruments to be passed through to where they are needed. The machine s automatic heating and humidification system makes it extremely suitable for long-term use as well as for specific operations. Cicor Electronic Solutions designed and realized the control and operating system for Acutronic Medical Systems AG s new generation of jet ventilators. Acutronic is constantly aiming to expand its leading role in the world market for jet ventilation through innovative solutions. Cicor Electronic Solutions is a partner with broad technical expertise in hardware and software development and important for us in development processes that meet medical standards. Pius Cavelti, COO ACUTRONIC Medical Systems AG

3 Functional safe control innovative hardware design The required standards for electronic devices and systems used for medical applications (ISO60601) are extremely high. Reliability, system stability and functional safety are absolute requirements. The way the new control function is designed guarantees that these standards are met: On the main board, two microcontrollers monitor each other using their independent software, power supplies and peripherals, thus preventing undetected crashes. The main board is autonomous and is still working even without the operating panel. The jet ventilator is controlled by the main unit, which is designed for functional safety and is based on specially developed analog and digital circuits. Implemented filters, amplifiers and intelligent power switches take care of the integrated supervisory and control function. The operating unit is based on an embedded PC augmented by a base board developed by Cicor Electronic Solutions. The system offers various interfaces including CAN, USB, video signal from camera and Ethernet. The PCB and device assembly were designed by IPC-certified designers using state-of-the-art development methods. Thanks to its broad technical expertise in hardware and software development, Cicor Electronic Solutions can provide innovative solutions that meet all standards required for the development and production of sophisticated medical products. Cicor Electronic Solutions at Bronschhofen is certified under ISO We develop and produce medical devices under one roof. Our philosophy: Design to manufacture based on great skills and short lines of communications. Cicor Electronic Solutions

4 Cicor Electronic Solutions High standards for development processes CONSULTING PLANNING AND SPECIFICATION CONCEPT REALIZATION VERIFICATION DELIVERY/IQ VERFICATION/DQ PROTOTYPE SYSTEM TEST/ OQ, PQ In the medical industry, services and products have to meet high standards of reliability and dependability. The relevant ISO certification is a guarantee of these high standards. ISO13485 certification shows that the management system meets client requirements and complies with the applicable regulations. Hardware and software is designed in compliance with the ISO60601 standard (electronics and development standard for medical products). The software development process meets ISO62304 (software development standard for medical devices). Development processes are also subject to strict risk management standards as set out in ISO Comprehensive development documentation is produced to help with the approval of the device. Cutting-edge technologies, architectures and design methods are used to ensure these extensive regulatory requirements are met. Embedded Software Simulation Visualisation PC-Program Remote Access Design UML 2.0 C/C++ Code Graphic (BMP) WYSIWYG Design Compiler C-Code API Target Compiler Cicor Electronic Solutions works with a CASE tool that supports state-of-the-art software architecture and design with UML (Unified Modelling Language). The whole system is modelled in package and class diagrams and state charts. Complex software blocks can be simulated without hardware even in the concept phase. Clients can test the usability of the whole system, including the menu and display design, on a PC to avoid expensive development loops. Target Program Innovative development and reliable production for medical technology clients.

5 Creating functional safe solutions Example: High-frequency jet ventilator for Acutronic Medical Systems AG The challenge Medical device in risk class 2b according to 93/42/EEC Requirements and concept Formulating the requirements and operating concept Technical specifications and solution concept Reliability and functionality Functional safe system Patient safety Usability The requirements Developer expertise IPC-certified designer More than 20 engineers with broad range of specialist knowledge Standards expertise Safety Expert Active Medical Devices (TÜV) ISO13485 certification Own production Prototypes and series manufacturing Test engineering Industrialization Partnership The Cicor solution Functional safe system Architecture as distributed system Independent main unit with supervisor and main processor Operating panel as non-functional safe component State-of-the-art hardware design Analog amplifiers and filters Intelligent semiconductor switches uc system with peripherals Embedded PC PCB design according IPC Embedded Software Architecture and design with UML Win CE Interfaces USB Ethernet CAN RS-232 Video transmission and processing Benefits for Acutronic Reliable hardware and software Modern look and feel Development documentation complies with relevant standards for medical approval... for surgeons Modern operating concept with touch-screen Intuitive handling... for patients Life supporting Reliable operation

6 Global and local presence Cicor the dynamic, high-growth technology group Cicor worldwide Cicor is a globally active group of leading companies in the electronics industry. It is organized into four divisions: Printed Circuit Boards (PCB), Microelectronics (ME), Electronic Services (ES) and Asia. The group s companies provide complete outsourcing services and a broad range of technologies for the manufacture of highly complex printed circuit boards, 3D-MID solutions, hybrids and electronic modules. With around 1300 employees at 12 production sites and offices worldwide, the group supplies high-quality custom-made solutions to its clients in Europe, America and Asia. Contact Cicor Electronic Solutions Swisstronics Contract Manufacturing AG I 9552 Bronschhofen I Switzerland Tel I Fax I [email protected] Swisstronics Contract Manufacturing AG S.C. Systronics S.R.L Cicor Asia Pte Ltd. Cicor Management AG Industriestrasse 8 Zone Parc Industrial Nord F.N 45 Changi South Avenue 2 Leutschenbachstrasse Bronschhofen Arad #04-01 Singapore Zürich Schweiz Romania Schweiz Tel Tel Tel Tel Fax Fax Fax Fax [email protected] [email protected] [email protected] [email protected] 100% recycled paper, FSC I Climate-neutral printing I Cicor ES I Acutronic I 01.12