Overview: The Meditec catalogue by Steute Schaltgeräte GmbH & Co. KG provides a detailed overview of their range of intuitive operating systems for medical equipment, focusing on foot and hand controls. The document emphasizes the company's dedication to innovation, quality, and collaboration with customers to develop ergonomic and reliable control units for medical applications.

Company Background: Steute, based in East Westphalia, Germany, has over 50 years of experience in durable switchgear solutions. The company operates in four business fields: Wireless, Automation, Extreme, and Meditec, focusing on products that meet international standards and customer needs.

Product Offerings: The catalogue details various series of medical foot-operated controls, including 1-pedal, 2-pedal, 3-pedal, rocker, and multi-function controls. Each series is designed to meet specific ergonomic and operational requirements, with options for customization and wireless technology integration.

Development and Production: Steute emphasizes a systematic design process from idea to product, ensuring high quality and flexibility. The production process is certified under EN ISO 13485 and ISO 9001 standards, allowing for both large-scale and small-batch manufacturing.

Standards and Directives: The document highlights compliance with standards such as IEC 60601-1 and UL 60601, emphasizing risk management and product certification to ensure patient and user safety.

Applications: Typical applications for Steute's foot-operated controls include laser devices, high-frequency surgery, X-ray/MRI/CT equipment, operating theatre beds/chairs, ophthalmology, and dental equipment.

Innovation and Collaboration: Steute is committed to innovation, particularly in wireless control units, and collaborates closely with customers to develop tailored solutions that reflect their unique requirements.

Key Features: The catalogue lists features such as high mechanical stability, non-contact switching systems, and easy-to-clean designs. Products are available in various materials and colors, with options for special labels and connectors.

Specifications: The document outlines specifications for medical foot controls, including a maximum switching voltage of 25 VAC/60 VDC, switch-on current up to 5 A, and switching power up to 1250 VA. The supply voltage for Hall sensors ranges from 15 to 30 VDC with a maximum of 25 mA. The mechanical life of these controls exceeds 1 million operations.

Features and Options: The foot controls offer high mechanical stability, non-contact switching systems, and options for digital or analogue output signals. Additional features include push-buttons, LEDs, protective brackets, wireless signal transmission, and various RAL color options. They are designed for easy integration with Steute Wireless systems and provide protection against unintentional actuation.

Standards and Compliance: The products comply with standards such as IEC 60601-1, UL 60601-1, IEC 60529, and MPG 93/42/EEC. They are classified as approved medical devices (TÜV) and meet protection class IP X5, with options up to IP X8.

Materials and Construction: The pedals are made from shock-proof thermoplastic (UL 94-V0/-V2), and the consoles are constructed from GK-Al alloy or GD-Al alloy with enamel finishes. Protective shields and flaps are available in stainless steel or thermoplastic.

Switching Systems: The foot controls utilize reed contacts, micro switches, or Hall sensors. They support various switching systems, including 1-2 NO contacts, 1 change-over contact, and analogue outputs ranging from 0-10 VDC, 0-20 mA, to 4-20 mA.

Connection and Accessories: Standard connection is provided via a 2 m cable, with other lengths available as options. The document also mentions optional accessories and configurations for different series of foot controls.

Introduction to Wireless Footswitches: Wireless footswitches are increasingly preferred due to their hygienic design, safety, and flexibility in placement. They eliminate tripping hazards and can be easily cleaned.

Steute Wireless System: Steute has developed the "steute wireless" system specifically for medical equipment, offering low power consumption, rapid connection times, and cost efficiency. It operates on the 2.4 GHz frequency band, with power consumption reduced by up to 60% compared to other standards. The system features a sleep mode with minimal power usage and quick wake-up times, enhancing battery life.

Compliance with Medical Standards: The system meets stringent medical safety standards, ensuring reliable signal transmission even in challenging conditions. It is designed as a global radio standard for medical equipment.

Technical Features: The system supports point-to-point connections, frequency hopping, and bi-directional signal transmission. It is compatible with disposable or rechargeable batteries, featuring a management system for monitoring battery status.

Applications and Compatibility: Steute wireless technology can be integrated into various foot controls, including those for dental, surgical, and ophthalmology equipment. It is also used in hand controls, benefiting from its compact design and low power consumption.

USB Interface for Foot Controls: Steute offers foot controls with USB interfaces, allowing integration with PCs and enabling complex control procedures. The USB connection supports both digital and analogue inputs, enhancing transparency and user safety.

Application Fields: Steute foot controls are used in various medical applications, including laser devices, high-frequency surgery, X-ray/MRI/CT, operating beds/chairs, ophthalmology, and dental equipment. Each application has specific requirements for mechanical stability, protection class, and functionality.

Standards and Directives: Steute products comply with relevant medical standards and directives, including CE marking and IEC 60601 series. They are classified under the Medical Devices Directive (93/42/EEC) and meet protection class criteria up to IPX8.

Introduction: This document outlines the safety standards and regulations applicable to medical equipment, specifically focusing on medical handheld and foot-operated controls in Europe. It highlights the importance of adhering to high standards of quality and safety, including voluntary safety checks by competent authorities.

Regulations and Standards: The document discusses the EC directive for medical devices (MDD) and the German MPG, which set fundamental requirements for medical devices to ensure patient and user safety. It emphasizes the principles of integrated safety, including risk elimination, protection measures, and user instruction.

The IEC 60601 series of standards is highlighted as the international directive for the safety of electrical medical equipment. It includes requirements for functional safety and risk management, aligning with ISO 14971 for risk analysis and management.

Risk Management: Risk management is a critical component, involving risk analysis, risk control, and post-production information evaluation. The document stresses the importance of aligning product standards with current technology and verifying coverage of all product functions and components.

International Harmonization: The document notes the trend towards international harmonization of standards, with European and international standards serving as the basis for national standards. It mentions the correlation between IEC 60601 and the US product standard UL 60601.

Product Certification: The document includes a Certificate of Compliance for Steute Schaltgeräte GmbH & Co. KG, certifying their foot switches for use with medical electrical equipment. It specifies the product classes and standards evaluated, excluding certain requirements like electromagnetic compatibility and biocompatibility.

Company Overview: Steute develops and manufactures safe switchgear for demanding applications, including wireless, automation, extreme, and Meditec applications. The company is based in Löhne, Germany, with worldwide sales through subsidiaries and partners.