CCI 1050 Medical Device Test Station

6550 Wedgwood Rd. Maple Grove, MN 55311 763-694-4100 CCI 1050 Medical Device Test Station Configuration Guide USA, CANADA, MEXICO, MALAYSIA, CHINA, UNITED KINGDOM www.circuitcheck.com 1

CCI 1050 Medical Device Test Station The CCI 1050 board and product level test station is a part of the Circuit Check 1000 Series Configurable ATE Platform (see page 7). With a lower cost of ownership, the CCI 1050 allows medical device manufactures to build reliable and upgradable test systems that meet both internal quality standards and those outlined in 21 CFR Part 820. Based upon proven customer successes, the CCI 1050 system meets medical device manufacturing requirements for capability, quality and throughput. A unique differentiator of the CCI 1050 is its scalable product interface capabilities, enabling test of simple products to testing complex printed card assemblies that require through-connector measurements. The CCI 1050 automated fixture-to-board interfacing capabilities enable operator hands-off test for reduced handling points. Circuit Check CCI 1050 Modular fixturing and hands-off automated product interfacing lowers total cost of ownership while improving quality Smaller footprint fits floor space requirements Designed for verification and production test usage Deliverable with board/product functional, RF and flash modalities Accuracy and Performance CCI test systems for medical device test are based upon PXI modular hardware, user configurable modules and high-level user friendly test management software. CCI 1050 test stations can be deployed with board/product functional, RF and flash programming modalities. Once configured with measurement hardware, CCI can include all the tools needed to support the software development lifecycle, including requirements management, code analysis and traceability, and unit tests. These deliverables can be used as a component to satisfy risk assessment and mitigation strategies outlined internally or by 21 CFR Part 820. Compliance with Safety and Quality The CCI 1050 based test station plays an essential role in compliance with quality and safety standards, designed to reduce safety risks and improve product quality. A test execution engine allows transparency between the top floor and the shop floor across even the most widely distributed manufacturing processes. CCI configurable software architectures embed quality, environmental, and safety controls to help manage compliance. Configurability Adding a new range of design possibilities for test solutions, the CCI 1050 architecture supports shared instrumentation with asynchronous test execution that leverages traditional fixturing or complete board level automation (see Fixtures and Interfacing Options section). www.circuitcheck.com 2

CCI 1050 Configuration and Specifications This section outlines general configuration options for a CCI 1050 test station, comprising of the DUT measurement instrumentation interconnects, signal types and counts, and management software. Specifications and Configuration Half-height.75 meter test rack. Single, double or triple bay option Modular PXI instrumentation for reconfigurable test capabilities Rack: The CCI 1050 is configured with a single, double or triple half-height (.75 m) rack. This option depends primarily upon the need for multiple test fixtures, or the requirement to test multiple product in parallel. Number of source and measurement pins: Source and measurement instruments are shared resources with their I/O interconnects routed to device(s) under test (DUT) pins via multiplexer/matrix switches. The base CCI 1050 topology includes a single PXI chassis configured in a shared topology. Number of load channels: Signal path loading may be required during DUT testing to simulate actual load conditions. The CCI 1050 can be configured with a dedicated load-system that supports multiple channels at high-current loads. Selectable fixture mass interface: GR2270, MAC Panel, Virginia Panel Single to multi-unit product interface fixturing Modular software libraries hosted in a high-level test executive Single/multiple DUT testing: Volume and beat-rate requirements assist to determine the need for single fixture multi-dut parallel testing or the use of multiple-product fixtures (see Interfacing and Fixturing section below). Product interconnect: Modular drop-in product adapters from CCI support higher-mix product assemblies, while optional mass interconnect at the fixture back-side allows for complete test fixture interchange. Test software and test station communication: The CCI 1050 ships with ready-to-run test management software. CCI developed test sequences integrate code modules specific for medical device test, such as specifying execution flow, reporting, database logging, and connectivity to enterprise systems. Stimulus and measurement instruments: Test requirements will determine the instrumentation needed to supply and/or capture samples at the source and measurement pins. Common measurements: Pneumatic control and measurement; Humidity, Pressure and voltage control and measurement; Testing through the product card-edge or standard connector; Rapid switching isolation of shared sense/pulsed signals for Implantable Pulse Generators (IPG) and Implantable Cardioverter-Defibrillators (ICD) Medical Telemetry Bands include: Inductive coupling devices; Wireless Medical Telemetry Systems; Medical Device Radio Communication Services; 802.11 WiFi; 802.15.1 Bluetooth; 802.15.4 Zigbee; WiMAX Transmitter Tests: Output power; Carrier freq. drift; Modulation accuracy; Tolerance; Initial carrier freq.; Output spectrum freq. Receiver Tests: Sensitivity (BER/PER); Single/multi slot packets; Audio analysis RF coexistence tests: www.circuitcheck.com 3

CCI 1050 Interfacing and Fixturing Options This section outlines methods of interfacing and fixturing to the measurement instrumentation in the CCI 1050 test station. Interfacing and Fixturing Options Product Interfacing Selectable product interface options o Topside o Bi-Level and multistage o Through connector Direct connection to product: The CCI 1050 can be configured with adapters to interface to connectors that may be present on the product. CCI s patented fixture technologies allow the device under test connectors to be engaged and dis-engaged easily as the fixture is operated. CCI connector interfaces also are designed to be easily replaceable. Interchangeable product adapters inside the test fixture o CCI drop-in personalized plates Fully automated product-to-fixture interfacing Fully automated through-connector test Test probe connection to product: Figure 1. Example through-connector test interface A product test fixture is designed to make direct contact to test points on the surfaces of the PCB using spring loaded test probes. The PCB is placed in the test fixture, and upon the "test start" sequence the fixture engages the test probes to make electrical connections thus testing critical segments of the PCB. Test fixtures with RF shielding Product Fixturing Figure 2: Example wireless functional test fixture Mechanical and automated hold-down: The CCI 1050 supports a wide variety of fixturing schemes, differing in complexity and investment. In a mechanical system the product is engaged `into the spring probes by an operator actuated linear mechanical linkage. In an automated fixture, such as pneumatic, the product is engaged into the spring probes using pneumatic drive cylinders. Proper fixture design is key to distributing the spring probe forces during product engagement. www.circuitcheck.com 4

Interfacing and Fixturing Options (continued) CCI 1050 Computer System Validation Tools to support the Software Development Life Cycle (SDLC) for FDA regulated product test Tools to support documentation and test code requirements management Board handling automation: Figure 3. Example manual and pneumatic test fixtures To reduce risks associated with operator handling or to reduce manual multiconnector product interfacing, CCI automation fixtures improve quality with repeatable insertion, while reducing test time with parallel motion in product interfacing. Services to support static and dynamic testing as part of GxP sensitive environments Figure 4. Example fully automated through-connector test fixture Services to support GAMP (Good Automated Manufacturing Practice) deployment RF shielding: RF products are susceptible to sources of interference (nearby/adjacent systems, etc.) and often require shielding with a CCI supplied RF enclosure. Optional absorber material on the interior walls absorbs reflections and prevents reverberating waves, permitting reproducible and reliable measurements. Drop-in fixtures: Test fixture drop-in's allow the same system to be quickly reconfigured with different probe patterns for different products, maximizing equipment re-use. Figure 5. Example drop-in base and replaceable personalizer plates www.circuitcheck.com 5

CCI Test Systems Meeting Title 21 CFR Part 820 Circuit Check is based in Minneapolis, Minnesota, close to design and production headquarters of many medical device manufactures. With over 35 years experience in test and automation, Circuit Check has supplied many test solutions to medical device companies, from automating small bench tests to supplying turn-key manufacturing end-of-line systems. Other solutions include developing custom robotic and conveyorized line-automation and parametric measurement systems. Over the past 35 years, CCI has produced more than 100,000 in-circuit, functional, and ITA test fixtures, along with 1000 s of test systems. CCI 1050 Medical Device Test Station Example Circuit Check customers serve the fields of: cardiovascular radiology neurology radiology dental general hospital Engineer Services delivered by CCI follow similar guidelines as defined by ISO 9001 Quality Management System Requirements. CCI quality management documentation can be delivered upon request. Multiple internal design reviews, as well as customer facing preliminary and critical design reviews, are conducted with each customer project. All product development follows the CCI EQC (Engineering Quality Control) process prior to release to manufacturing. Final projects are verified to assure compliance to defined Specifications and Statement of Work (SOW). CCI Standards for each department are maintained in a CCI internal product lifecycle management (PLM) system. Documents for each project are maintained in a quality system and managed by executive management. A centralized system is used for controlling and sharing project data, including bills of materials (BOMs), design history files (DHFs), device master records (DMRs) and change orders. These tools help CCI to reduce errors and meet customer compliance requirements. All CCI personnel receive training and are expected to adhere to internal quality standards. CCI executives gather feedback regularly and provide feedback during regular scheduled meetings, project reviews, and performance reviews. CCI Project Managers (PM) work with customers from start of proposal through acceptance and final delivery. A process and resource map is developed at the start of a project by the PM. The PM is responsible for organizing teams as needed to meet customer requirements. CCI project teams are often comprised of a mechanical engineer, electrical engineer, procurement specialist, production manager, quality manager, and a project manager. A master schedule is built for each customer project and proposal. CCI uses its internal tools for project tracking, labor time entry, purchasing, and invoicing. These tools link to a project-dedicated folder which is controlled by the PM. www.circuitcheck.com 6

CCI 1000 Series Configurable ATE Platform The CCI 1000 Series Automated Test Equipment (ATE) configurable platform from Circuit Check was designed to give the modularity required for rapid and predictable functional test system development. The CCI 1000 uses hardware and software modules that can be configured easily to meet your exact functional test needs. It includes a standard base platform design with dropin/replaceable product fixture interfaces and pre-designed pneumatic, power distribution, and safety subsystems. Circuit Check 1000 Series Modular test platform for rapid build and ease of service. Configurable hardware and software modules Pneumatic, power, and safety subsystems Availability with single, double, and triple enclosure Instrumentation configurable from National Instruments, Keysight or other suppliers Modular software to simplify test program development Configurable Base with Three (3) Fixture Interfacing Options The CCI 1000 Series systems can be configured in one of three base sizes: single, double, and triple enclosure. A single enclosure configuration supports one detachable multiple-product test fixture and is used for lower volume and/or low complexity testing where the required instrumentation will fit within a single rack. A double enclosure system supports one larger or two smaller detachable fixtures and is used for mid-volume and/or mid-complexity testing. The triple enclosure accommodates up-to three fixtures and provides space for a large instrument set for higher volume/complexity applications. Modular Hardware Topologies To be consistent with Lean Manufacturing principles, CCI leverages concurrent test capabilities where possible, along with high speed test actions built into CCI s functional test libraries. CCI s architecture is built around modular instrument concepts, thus allowing for reduced instrumentation costs through parallel multi-dut fixture configurations. Open Software Architecture Circuit Check s modular test executive software delivers rapid program development and enables a single program to test multiple product part numbers concurrently and asynchronously while efficiently sharing test instrument resources. CCI test executive software includes many API s to simplify test-set generation. Industry Leading Functional Test Fixture Designs For over 35 years, CCI has been the leader in product test fixtures and interface automation. CCI test systems, with patented fixture design methods, are built to adapt to future requirements for new and next generation products with minimum upgrade cost and maximum utilization. Circuit Check- Worldwide Support Circuit Check supports all aspects of the system development including electrical and mechanical design, software development, fabrication, system integration, deployment and support. With a modular functional test system from Circuit Check you can accelerate the deployment of your production test strategy. www.circuitcheck.com 7

Appendix A: Terms and Conditions Notices: No part of this manual may be reproduced in any form or by any means including electronic storage and retrieval or translation into a foreign language without prior agreement and written consent from Circuit Check Inc. as governed by United States and international copyright laws. Warranty: The material contained in this document is provided as is, and is subject to being changed, without notice, in future editions. Further, to the maximum extent permitted by applicable law, Circuit Check Inc. disclaims all warranties, either express or implied, with regard to this material and any information contained herein, including but not limited to the implied warranties of merchantability and fitness for a particular purpose. Circuit Check Inc. shall not be liable for errors or for incidental or consequential damages in connection with the furnishing, use, or performance of this document or of any information contained herein. Should Circuit Check and the user have a separate written agreement with warranty terms covering the material in this document that conflict with these terms, the warranty terms in the separate agreement shall control. www.circuitcheck.com 8