Zarlink ZL70102 Medical Telemetry Wireless Radio LabVIEW Example

Publish Date: May 08, 2013 | 0 Ratings | 0.00 out of 5 | Print | Submit your review

Overview

The Zarlink ZL70102 IC is designed for use in both implanted medical devices and base stations. Operating in the 402 – 405 MHz MICS (Medical Implantable Communications Service) band, this component is ideally suited for testing by NI PXI RF technologies. This document features an overview using LabVIEW to control the Zarlink Third Generation Medical Implantable RF Transceiver evaluation kit. To use the provided LabVIEW VI's, the Zarlink software driver evaluation distribution must be installed. To obtain the following example software from NI requires a completed non-disclosure agreement (NDA) with Zarlink (Microsemi). The discussed NI LabVIEW code calls API libraries defined by Zarlink which require limited distribution. You will need to show NI that you have a completed NDA with Zarlink before the example files will be delivered.

Table of Contents

  1. Medical Wireless Frequencies
  2. NI Technologies for Medical RF Telemetry Test
  3. Microsemi, Zarlink Medical Telemetry Starter Kit with the ZL70102
  4. Automation with NI LabVIEW
  5. Example LabVIEW Applications- Use Case Examples
  6. LabVIEW Front Panel Example
  7. Vendor Qualification per 21 CFR 820.50, Purchasing Controls
  8. Additional Information

1. Medical Wireless Frequencies

Every wireless medical device, implanted or worn on the body, falls within the Federal Communications Commission (FCC) authority to manage the electromagnetic spectrum. Under the FCC, wireless devices must be tested for conformance to various technical standards and authorized before they may be operated in the U.S.  The Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) regulate the market for medical devices.  Unlike the FCC which focuses on the interference potential of radio frequency devices, the FDA’s role is to ensure that devices are safe and effective for use. The range of devices that are classified and regulated as a medical device is very broad and can include information networks, cell phones programmed to remind users to take
medication, and any medical device fitted with radio communication capabilities.  Figure 1 lists the common standards used for medical RF communication.

 

Standard Frequency Data Rate  Range
Inductive Coupling < 1 MHz  1-30 kbps  <1m
Wireless Medical Telemetry System 608-614 MHz >250 kbps 30-60m
  1395-1400 MHz, 1427-1429.5 MHz    
Medical Device Radiocommunication Service 401-406 MHz 250 kbps  2-10m
Medical Micropower Networks (“MMNs”) 413-419, 426-432, 438-444, 451-457 MHz   <1m
Medical Body Area Networks (“MBANs”) 2360-2400 MHz 10Kbps-1Mbps <1m
802.11a Wi-Fi 5 GHz 54 Mbps  120m
802.11b Wi-Fi 2.4 GHz 11 Mbps 140m
802.11g Wi-Fi 2.4GHz  54Mbps 140m
802.11n Wi-Fi 2.4/5GHz 248 Mbps 250m
802.15.1 Bluetooth Class I 2.4 GHz 3 Mbps 100m
802.15.1 Bluetooth Class II 2.4 GHz  3 Mbps 10m
802.15.4 (Zigbee) 868, 915 MHz, 2.4 GHz 40 kbps, 250 kbps 75m
World Interoperability for Microwave Access (WiMAX) 2.5 GHz  70 Mbps (fixed), 40 Mbps (mobile) Several km

 

Figure 1. Common medical RF communication standards, frequencies and bandwidth

 

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2. NI Technologies for Medical RF Telemetry Test

NI PXI measurement technologies are ideally suited for medical product design and test due to flexibility and performance.  For example, per FDA guidance documents coexistence testing of a medical device's RF signal must be performed and documented.  A single NI RF Vector Signal Generator (VSG) can mimic the transmissions of multiple network nodes for coexistence test.  The NI LabVIEW software allows for full control over interference parameters such as power, frequency and network duty cycle, while the tests can be fully repeatable.  Testing different protocols requires only a change in NI VSG software.  A simple example shown in Figure 2 shares where NI RF can assist in reduced verification and product deployment.  To learn more visit: RF Wireless Coexistence Testing for Medical Devices

Figure 2. Example NI RF test setup

 

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3. Microsemi, Zarlink Medical Telemetry Starter Kit with the ZL70102

The Zarlink ZL70102 Application Development Kit (ADK) is a USB powered prototyping and development kit for medical RF telemetry.  As show in Figure 3 and within the Zarlink web site, both the Implant Unit (IM) and the Base Station Unit (BSM) are equipped with an Application Development Platform (ADP) Board that interfaces to the PC by way of USB.  The base station includes a MICS radio transceiver based on the ZL70102, an application microcontroller with on-board firmware and a Windows based C++ API to allow for communications and control. 

Figure 3. Zarlink IC Evaluation Kit

 

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4. Automation with NI LabVIEW

Automating the control of a Zarlink ADK Base Station module with LabVIEW can provide many benefits including assisting in evaluation/testing/verification of the ADK implant module, or testing with an end-user's actual early prototype. Other benefits include helping to correlate data sheet specifications to a customer’s measured data, while allowing for reuse of test methods between R&D, Product Engineering, Verification and Production.  See Figure 4. for an automated test diagram.

Figure 4. Automation of Test

Not only can LabVIEW be used to automate control of the base station module, NI FPGA technologies can be used to directly control or monitor the component IC by way of SPI or I2C.

Figure 5. SPI control of the Zarlink integrated component

 

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5. Example LabVIEW Applications- Use Case Examples

LabVIEW to Base Station Module (BSM) via USB Example 1:  

This example LabVIEW application connects to the Base Station Module (BSM) and MICS transceiver on the BSM adapter, then reads the ID, serial number and version. The example also connects to the BSM, then starts a session with the Implant Module(IM) on channel X, reading data from the IM.

Result: A developer can leverage the exiting ADK base station module and LabVIEW to control first prototype products in order to verify operation. Or, a developer can leverage LabVIEW to directly control the IM module for hardware-in-the-loop verification or firmware analysis.

LabVIEW to BSM and IM with NI RF Hardware Example 2:

This example connects to the BSM, then starts a session with the IM.  After connection, the example begins sending data between the IM and BSM while collecting real-time RF data with a NI PXI hardware signal analyzer.

Two types of measurements are shown in this example.  1) while switching between data rates and modulation modes, the NI RF hardware performs RF measurements such as power and adjacent channel.  2) while switching between data rates and modulation modes, the NI RF hardware adds interferer signals.  Measurements are made in the presence of the interferer signals generated by NI RF generator.

Result: A user can analyze antenna design, perform power profiles of firmware, and validate product efficiency.

LabVIEW to NI RF for Playback and Record Example 3:

This example sends pre-recorded data directly from the NI RF signal generator to the IM module.  The NI RF hardware then reads and decodes the resulting IM messages.

Result: NI RF hardware is calibrated to NIST traceable standards and serves as a backbone to quality control and statistical process control (SPC) methods.  Using a repeatable set of record/playback waveforms for Production test of the packaged implant modules ensures consistency and repeatability.  The use of an existing base station, or custom design of a base station for production use only, may represent challenges in consistency and repeatability of traceable data.

 

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6. LabVIEW Front Panel Example

Figure 6 shows a example LabVIEW Front Panel where NI LabVIEW is communicating simultaneously to the USB based base station module and controlling RF signal analyzers/generators.

Figure 6.  Integrated test and control using NI LabVIEW and NI PXI RF hardware

 

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7. Vendor Qualification per 21 CFR 820.50, Purchasing Controls

Customers use National Instruments hardware and software instrumentation products in a wide variety of applications across many industries, including as a sub-component in a medical product, or as a testing tool for a medical product.  The USA FDA Quality System Regulation 21 CFR 820.50, Purchasing Controls requires medical device manufacturers to evaluate third-party suppliers for their ability to meet certain requirements, including quality requirements.  When medical device manufacturers use third-party components such as NI hardware or software in their devices, or to test their device, the manufacturers are responsible for ensuring the ultimate safety and effectiveness of the medical device in which the components are used.  Similar supplier control requirements are mandated in countries that apply ISO13485 guidelines.


Medical device manufacturers ask that their suppliers provide information to assist them in meeting FDA requirements, to communicate product issues and changes, and to perform quality assurance and configuration management for the products.  NI has published information in a user requested document that medical device manufacturers may find helpful when working to qualify NI as a supplier for inclusion in compliance-related vendor qualification files and for use in premarket submissions to the FDA or other regulatory agency.


In the described document, NI summarizes and identifies information and services to assist medical device manufacturers in the following efforts:
• Evaluate and document NI and its products for the validation process, including quality criteria
• Use NI products in a safe and effective manner during medical device design and test
• Satisfy regulatory requirements for information in premarket submissions for off-the-shelf software and hardware components from NI.

To receive this document, please contact your local field engineer or one of the NI life science specialist. 

 

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8. Additional Information

Visit www.ni.com/medical 

Originally Authored By: Greg Crouch, National Instruments

 

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