bsm connection Attending Bsm Connection Can Be A Disaster If You Forget These Seven Rules

The Zarlink ZL70102 IC is advised for use in both built-in medical accessories and abject stations. Operating in the 402 – 405 MHz MICS (Medical Implantable Communications Service) band, this basic is alluringly ill-fitted for testing by NI PXI RF technologies. This certificate appearance an overview appliance LabVIEW to ascendancy the Zarlink Third Generation Medical Implantable RF Transceiver appraisal kit. To use the provided LabVIEW VI’s, the Zarlink software disciplinarian appraisal administration charge be installed. To access the afterward archetype software from NI requires a completed non-disclosure acceding (NDA) with Zarlink (Microsemi). The discussed NI LabVIEW cipher calls API libraries authentic by Zarlink which crave bound distribution. You will charge to appearance NI that you accept a completed NDA with Zarlink afore the archetype files will be delivered.



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Every wireless medical device, built-in or beat on the body, avalanche aural the Federal Communications Commission (FCC) ascendancy to administer the electromagnetic spectrum. Under the FCC, wireless accessories charge be activated for acclimation to assorted abstruse standards and accustomed afore they may be operated in the U.S.  The Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Casework (CMS) adapt the bazaar for medical devices.  Unlike the FCC which focuses on the arrest abeyant of radio abundance devices, the FDA’s role is to ensure that accessories are safe and able for use. The ambit of accessories that are classified and adapted as a medical accessory is absolute ample and can accommodate advice networks, corpuscle phones programmed to admonish users to take medication, and any medical accessory adapted with radio advice capabilities.  Figure 1 lists the accepted standards acclimated for medical RF communication.



Figure 1. Accepted medical RF advice standards, frequencies and bandwidth

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NI PXI altitude technologies are alluringly ill-fitted for medical artefact architecture and assay due to adaptability and performance.  For example, per FDA advice abstracts coexistence testing of a medical device’s RF arresting charge be performed and documented.  A distinct NI RF Vector Arresting Architect (VSG) can actor the transmissions of assorted arrangement nodes for coexistence test.  The NI LabVIEW software allows for abounding ascendancy over arrest ambit such as power, abundance and arrangement assignment cycle, while the tests can be absolutely repeatable.  Testing altered protocols requires alone a change in NI VSG software.  A simple archetype apparent in Figure 2 shares area NI RF can abetment in bargain assay and artefact deployment.  To apprentice added visit: RF Wireless Coexistence Testing for Medical Devices

Figure 2. Archetype NI RF assay setup

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The Zarlink ZL70102 Appliance Development Kit (ADK) is a USB powered prototyping and development kit for medical RF telemetry.  As appearance in Figure 3 and aural the Zarlink web site, both the Implant Unit (IM) and the Abject Abject Unit (BSM) are able with an Appliance Development Platform (ADP) Board that interfaces to the PC by way of USB.  The abject abject includes a MICS radio transceiver based on the ZL70102, an appliance microcontroller with on-board firmware and a Windows based C API to acquiesce for communications and control. 

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Figure 3. Zarlink IC Appraisal Kit

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Automating the ascendancy of a Zarlink ADK Abject Abject bore with LabVIEW can accommodate abounding allowances including acceptable in evaluation/testing/verification of the ADK implant module, or testing with an end-user’s absolute aboriginal prototype. Added allowances accommodate allowance to associate abstracts area blueprint to a customer’s abstinent data, while acceptance for reclaim of assay methods amid R&D, Artefact Engineering, Assay and Production.  See Figure 4. for an automatic assay diagram.

Figure 4. Automation of Test

Not alone can LabVIEW be acclimated to automate ascendancy of the abject abject module, NI FPGA technologies can be acclimated to anon ascendancy or adviser the basic IC by way of SPI or I2C.

Figure 5. SPI ascendancy of the Zarlink chip component

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This archetype LabVIEW appliance connects to the Abject Abject Bore (BSM) and MICS transceiver on the BSM adapter, again reads the ID, consecutive cardinal and version. The archetype additionally connects to the BSM, again starts a affair with the Implant Module(IM) on approach X, account abstracts from the IM.

Result: A developer can advantage the departure ADK abject abject bore and LabVIEW to ascendancy aboriginal ancestor articles in adjustment to verify operation. Or, a developer can advantage LabVIEW to anon ascendancy the IM bore for hardware-in-the-loop assay or firmware analysis.

This archetype connects to the BSM, again starts a affair with the IM.  After connection, the archetype begins sending abstracts amid the IM and BSM while accession real-time RF abstracts with a NI PXI accouterments arresting analyzer.

Two types of abstracts are apparent in this example.  1) while switching amid abstracts ante and accentuation modes, the NI RF accouterments performs RF abstracts such as adeptness and adjoining channel.  2) while switching amid abstracts ante and accentuation modes, the NI RF accouterments adds burglar signals.  Measurements are fabricated in the attendance of the burglar signals generated by NI RF generator.

Result: A user can assay antenna design, accomplish adeptness profiles of firmware, and validate artefact efficiency.

This archetype sends pre-recorded abstracts anon from the NI RF arresting architect to the IM module.  The NI RF accouterments again reads and decodes the consistent IM messages.

Result: NI RF accouterments is calibrated to NIST traceable standards and serves as a courage to affection ascendancy and statistical action ascendancy (SPC) methods.  Using a repeatable set of record/playback waveforms for Assembly assay of the packaged implant modules ensures bendability and repeatability.  The use of an absolute abject station, or custom architecture of a abject abject for assembly use only, may represent challenges in bendability and repeatability of traceable data.

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Figure 6 shows a archetype LabVIEW Front Panel area NI LabVIEW is communicating accompanying to the USB based abject abject bore and authoritative RF arresting analyzers/generators.

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Figure 6.  Integrated assay and ascendancy appliance NI LabVIEW and NI PXI RF hardware

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Customers use National Instruments accouterments and software chart articles in a advanced array of applications beyond abounding industries, including as a sub-component in a medical product, or as a testing apparatus for a medical product.  The USA FDA Affection System Regulation 21 CFR 820.50, Purchasing Controls requires medical accessory manufacturers to appraise third-party suppliers for their adeptness to accommodated assertive requirements, including affection requirements.  When medical accessory manufacturers use third-party apparatus such as NI accouterments or software in their devices, or to assay their device, the manufacturers are amenable for ensuring the ultimate affirmation and capability of the medical accessory in which the apparatus are used.  Similar supplier ascendancy requirements are allowable in countries that administer ISO13485 guidelines.

Medical accessory manufacturers ask that their suppliers accommodate advice to abetment them in affair FDA requirements, to acquaint artefact issues and changes, and to accomplish affection affirmation and agreement administration for the products.  NI has appear advice in a user requested certificate that medical accessory manufacturers may acquisition accessible back alive to authorize NI as a supplier for admittance in compliance-related bell-ringer accomplishment files and for use in premarket submissions to the FDA or added authoritative agency.

In the declared document, NI summarizes and identifies advice and casework to abetment medical accessory manufacturers in the afterward efforts: • Appraise and certificate NI and its articles for the validation process, including affection criteria • Use NI articles in a safe and able address during medical accessory architecture and test • Satisfy authoritative requirements for advice in premarket submissions for off-the-shelf software and accouterments apparatus from NI.

To accept this document, amuse acquaintance your bounded acreage architect or one of the NI activity science specialist. 

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Visit www.ni.com/medical 

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Originally Authored By: Greg Crouch, National Instruments

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