1. Radio-Frequency Wireless Technology in Medical Devices
The FDA guidance document on wireless technologies in medical devices addresses issues and concerns related to the safe and effective use of radio frequency (RF) wireless technology in medical devices, including: wireless coexistence, performance, data integrity, security and electromagnetic compatibility (EMC).
Since these issues affect all stages of the product life cycle, the FDA recommends a designer consider how RF will affect:identification, documentation, and implementation of product design requirements (21 CFR 820.30), design verification and validation (21 CFR 820.30), risk management processes and procedures.
The purpose of this document is outline how RF record and playback techniques can be used to gather and analyze wireless traffic from medical wireless products or within medical environments.
2. RF and Wireless Test Methods in Hospitals
Due to the nature of medical device safety, Hospitals are purchasing communications solutions from different vendors requiring different devices that operate over different wireless frequencies. Example wireless technologies include:
- Commercial/ Public radio services (FCC)
- Wireless Medical Telemetry Service (WMTS)
- Cell phones
- Wireless handheld computers
- Wireless local area networks (802.11.a/b/g) (future 802.11.ac)
- Personal area networks including 802.15.1 (Bluetooth), 802.15.4 (Zigbee)
- RF Identification (RFID) Bar code readers
The ANSI C63.18, American National Standard Recommended Practice for an On‐Site, AD HOC Test Method for Estimating Radiated Electromagnetic Immunity of Medical Devices to Specific Radio‐Frequency Transmitters is recommended for basic testing using a medial device on representative units of critical and life support medical equipment (ventilators, infusion pumps, anaesthesiology machines, etc.) to identify and characterize significant EMI issues.
The standard serves as a guide for Healthcare organizations in evaluating the radiated (RF) electromagnetic immunity of their existing inventories of medical devices. C63.18 can also be used as a pre-purchase evaluation of medical devices.
3. PXI based Record Playback
Solving New Applications with Record_Playback and FPGA Technologies- This document introduces NI RF hardware and software to help you achieve the best performance. It also contains example code specific to each section to help you integrate record and playback systems. This document specifically examines RF record and playback system considerations. If you are not familiar with RF record and playback basics, refer to the Introduction to Streaming white papers.
RF Record and Playback Resources- In this resource kit, you learn about National Instruments PXI RF Stream-to-Disk capabilities and explore applications that require continuous RF acquisition. The kit also provides LabVIEW example code that enables stream to disk with PXI instruments.
4. USB based Record Playback
Record and Playback Demo With NI USRP- This document describes how to construct an RF record and playback demonstration using the NI USRP™ (Universal Software Radio Peripheral) platform. NI has a broad spectrum of low cost RF hardware and software for record and playback applications to meet both cost and quality needs. This tutorial specifically covers the use of NI USRP as an affordable small form factor solution. You can use higher fidelity NI PXI solutions for the same application to achieve wider bandwidths and significantly improve signal quality. The following examples include code specific to each section to help you integrate record and playback systems.
5. Additional Information
See a Preconfigured RF Record and Playback System based upon NI PXI.