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To paraphrase a popular saying, usability testing should be
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To paraphrase a popular saying, usability testing should be done early and often. However, it doesn’t have to be an onerous process. Informative, practical, and engaging, Usability Testing of Medical Devices provides a simple, easy to implement general understanding of usability testing. It offers a general understanding of usability testing and reviews key concepts, highlighting the challenges of validating that protects against dangerous errors that could lead to patient injury and death. The book has been carefully designed to be concise and visually, easily read in one sitting or perused from one section to another as needed It begins with a review of human factors engineering and how usability testing fits in, and then discusses the government regulations and industry standards that have motivated many medical device manufacturers to conduct usability tests. It then covers the nitty-gritty of planning, conducting, and reporting the results of a usability test, making the process as smooth and painless as possible for the development team, and therefore making the medical devices they develop as safe, effective, and appealing as possible.As you read the book, keep in mind that, like snowflakes, each usability test is unique. And while 100 usability specialists working independently might take 100 different approaches to testing, albeit with considerable methodological overlap, there would also be meaningful differences that the practitioners would energetically defend as the best given the circumstances. To make your testing process easier, the authors, seasoned human factors specialists who have conducted thousands of test sessions involving medical devices used by physicians, nurses, therapists, technicians, and patients, have painstakingly put together an informative, practical, and engaging handbook for conducting usability tests of medical devices.
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This text was designed by Becker (Becker & Associates Consu
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This text was designed by Becker (Becker & Associates Consulting Inc.) and Whyte (Discovery Health Channel) as a resource for clinical professionals and regulatory specialists working in the field of new medical device development and marketing. The new edition has been updated to reflect technological and regulatory change and includes chapters on regulatory requirements for clinical studies of medical devices and diagnostics, requirements for Medicare coverage and reimbursement for medical devices, post-market requirements for significant risk devices, intellectual property protection for medical devices, compliance with the Health Insurance Portability and Accountability Act of 1996 in clinical research, developing drug-device combination products with unapproved component's, and Wall Street's perspective on medical device evaluation. It also contains nine case studies, all of which are new to this edition. Annotation ©2006 Book News, Inc., Portland, OR (booknews.com)
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Medical Alert Emergency Wall Communicator. This wireless wa
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Medical Alert Emergency Wall Communicator. This wireless water-resistant device is designed to mount on a wall. Mount one next to the bed-side table or even next to the shower in the bathroom. These permanent communicators allow for full two-way voice communication anytime an emergency occurs. Particularly handy if one forgets to carry their pendant with then to the bathroom in the middle of the night. Operates in standby well over a year on 4 AAA alkaline batteries - and provides over 5 hours of talk time.
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This title is part of the UniversityOfHealthCare/ Universit
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This title is part of the UniversityOfHealthCare/ UniversityOfBusiness Interactive Training Library, which offers authoritative, clearly written material in an interactive form for better comprehension and documentation of completion. Powerful Medical Device Sales is a comprehensive course with over 100 videos and animations for the medical device and pharmaceutical sales representative on sales skills to use with doctors and hospitals while observing correct procedures and building trust. It takes the attitude that consultative selling and considerate behavior create the most productive client relationships. It covers the structure of a hospital, medical staff, the hospital pharmacy, the hospital-based pharmacist, the nursing service, policies and procedures for hospital vendors, HIPAA essentials for the sales rep, sexual harassment, sales professionalism and building trust, customer management (with video interviews of doctors, a hospital pharmacist, and a medical assistant), and powerful sales communication (with a sales simulation). Estimated time: 10-20 hours. The course is divided into topics with their own tests so you can study and demonstrate your knowledge on different topics. The course results from the collaboration of an exceptional sales rep, a doctor, a nurse/MBA/marketing executive, and a media expert. 1228 pages on the CD. 126 pages in the manual. You must have Internet Explorer 4.0 or higher running on your computer. Supported operating systems are Windows 95, 98, 98 SE, ME, 2000, or XP. You will need Internet access to e-mail us your unique key and receive a password key. License is for one user on one computer. An additional computer owned by the same user will generally be approved at the discretion of the publisher. The manual accompanying the CD provides a summary of the major points of the CD in a handy format.
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The intent of this book (MDDR, for short) is to present an
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The intent of this book (MDDR, for short) is to present an introduction to, and overview of, the world of medical device regulation by the United States Food and Drug Administration (FDA), and the relationship of this regulatory scheme to the design and development of medical devices. In providing this information, the book covers the broad range of requirements, which are presented within eight major topics: background and regulatory environment, device design control, nonclinical testing, clinical testing, marketing applications, post-market requirements, quality systems/GMPs, and compliance/enforcement. This book provides students and professionals in the medical device industry with a road map to the regulation of medical devices. It provides a broad understanding of the breadth and depth of medical device regulation by collecting in one textbook coverage of the regulatory scheme for medical devices in terms that are suitable for engineers, scientists, and healthcare providers. The vast amount of information available on the subject is distilled into a concise and coherent presentation. There also are problems and projects at the end of each chapter. In addition to the usual questions requiring specific answers, the projects include the drafting of a device control plan, the development of a nonclinical test procedure, the resolution of a recall, the response to a Warning Letter, and the creation of a CAPA for a device deficiency. A solutions manual for these exercises is available to teachers who adopt the textbook for classroom use. Medical Device Design and Regulation (MDDR) also makes available over 100 complimentary live hyperlinks to web pages with additional relevant information, and offers users the opportunity to join and participate in the MDDR Users Group on LinkedIn.
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MDF® Professional Aneroid Sphygmomanometer 808B 100% Latex
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MDF® Professional Aneroid Sphygmomanometer 808B 100% Latex Free With its lifetime calibration, the MDF® Professional Aneroid Sphygmomanometer is ideal for medical professionals in all settings. Stress-tested over 3,000 times and calibrated 5 times before final assembly, it is one of the most durable, accurate, and dependable blood pressure measurement devices on the market. MDF® Professional Aneroid Sphygmomanometer is the most popular blood pressure monitor offering durability, portability and accuracy ideal for medical professionals in the hospital, nursing home, clinic, or emergency medical setting. A precise 300mmHg manometer attaining the accuracy of +/- 3 mmHg without pin stop The easily identifiable high-contrast Dial is imprinted with mmHg and kPa (kilopascal) measurements for instant conversion The die cast zinc manometer housing is finished in textured baked enamel and outfitted with a heavy-duty clip to easily attach to the gauge holder on the Cuff Cuff & Inflation Bag: Abrasion, chemical (chlorine and peroxide) and moisture resistant, the adult Velcro® Cuff is constructed of high-molecular polymer Nylon Sized to meet American Heart Association recommendations, the artery indicator label and index range further ensure proper cuffing to attain correct arterial compression The double tube seamless Inflation Bag is constructed of crack & stick-resistant, high-density hypoallergenic latex-free PVC The universal Bladder Tube enables compatible cuff exchange with all MDF® and other branded BP systems Chrome-plated brass screw-type Valve with delivers precise deflation control rate The Inflation Bulb is constructed of crack, stick-resistant, high-density hypoallergenic latex-free PVC
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Store Search search Title, ISBN and Author Medical Devices
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Store Search search Title, ISBN and Author Medical Devices for Respiratory Dysfunction: Principles and Modeling of Continuous Positive Airway Pressure (Cpap) by Ahmed Al-Jumaily Estimated delivery 3-12 business days Format Hardcover Condition Brand New Details ISBN 0791859770 ISBN-13 9780791859773 Title Medical Devices for Respiratory Dysfunction: Principles and Modeling of Continuous Positive Airway Pressure (Cpap) Author Ahmed Al-Jumaily Format Hardcover Pages 248 Publisher American Society o
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This is the kit tested, abused and approved by adventure ra
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This is the kit tested, abused and approved by adventure racers in the Eco Challenge, Primal Quest and Raid Galoiuses. This is your first aid kit if you are a multi-sport enthusiast who actively hikes, kayaks, mountain bikes, climbs or does other activities on a regular basis. Designed for life in the bottom of a pack, zippered nylon pouch has two inner Aloksak pouches to ensure contents are kept clean and dry. Recommended group size: 1-4, trip duration 1- 4 days. 8" x 5" x 3.5" Wt. 10 oz. Bandage Materials:3 Dressing, Gauze, Sterile, 3" x 3", Pkg./2 2 Dressing, Gauze, Sterile, 2" x 2", Pkg./2 1 Bandage, Conforming Gauze, 3" 5 Bandage, Adhesive, Fabric, 1" x 3" 2 Dressing, Non-Adherent, Sterile, 3" x 4" 3 Bandage, Adhesive, Fabric, Knuckle Bleeding:1 Gloves, Nitrile (Pair), Hand Wipe 1 Trauma Pad, 5" x 9" Blister / Burn:2 Moleskin, Pre-Cut & Shaped Duct Tape:1 Duct Tape, 2" x 50" Fracture / Sprain 1 Bandage, Elastic with Velcro, 2" Instrument: 3 Safety Pins 1 Splinter Picker/Tick Remover Forceps Medication:1 Aspirin (325 mg), Pkg./2 3 Antihistamine (Diphenhydramine 25 mg) 4 Diamode (Loperamide HCI 2 mg), Pkg./1 4 Ibuprofen (200 mg), Pkg./2 2 After Bite Wipe Wound Care: 3 Alcohol Swab 1 Tincture of Benzoin Topical Adhesive 1 Cotton Tip Applicator, Pkg./21 Syringe, Irrigation, 10 cc, 18 Gauge Tip1 Wound Closure Strips, 1/4" x 4", Pkg./106 After Cuts & Scrapes Anethestic/Antiseptic Wipe1 Tape 1" x 10 Yards
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Design Controls for the Medical Device Industry provides re
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Design Controls for the Medical Device Industry provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations. It also offers product development models for the production of safe, durable, and cost-efficient medical devices and systems. The book details procedures utilized by leading companies to successfully meet FDA and end-user requirements, manufacture high-quality products, and improve and generate profit. It presents blueprints for the application, evaluation, and refinement of quality assurance and performance practices, from product launch through engineering and assembly.
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Medical devices and surgical tools that contain micro and n
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Medical devices and surgical tools that contain micro and nanoscale features allow surgeons to perform clinical procedures with greater precision and safety while monitoring physiological and biomechanical parameters more accurately. While surgeons have started to master the use of nanostructured surgical tools in the operating room, this book addresses for the first time the impact and interaction of nanomaterials and nanostructured coatings in a comprehensive manner.Surface Engineered Surgical Tools and Medical Devices presents the latest information and techniques in the emerging field of surface engineered biomedical devices and surgical tools, and analyzes the interaction between nanotechnology, nanomaterials, and tools for surgical applications. Chapters of the book describe developments in coatings for heart valves, stents, hip and knee joints, cardiovascular devices, orthodontic applications, and regenerative materials such as bone substitutes. Chapters are also dedicated to the performance of surgica
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Case of 50 Feature anti-reflux valve, convenient twist-open
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Case of 50 Feature anti-reflux valve, convenient twist-open bottom drain. Four built-in buttons make attaching leg bag straps simple. Heavy vinyl film for durability and odor protection. Case of 50 Active Forever 10799 N. 90th St. Scottsdale, AZ. 85260
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Product DescriptionThis stand-assist lift by Drive Medical
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Product DescriptionThis stand-assist lift by Drive Medical provides patients with safe, stable assistance while standing, transferring or toileting. A extra-wide, non-skid foot plate forms a stable base for foot positioning and a soft, padded adjustable leg support includes a support strap to secure legs. The lift includes a convenient four sling attachment points that enable the lift to accommodate a variety of stand-up sling designs. Its 24 V DC motor is powerful and reliable, featuring an emergency stop button and manual lowering device. The motor includes a removable rechargeable battery that charges quickly to eliminate down time. The battery, complete with a charge meter, will alert you both when charging is complete or when it may be necessary (below 50%) with an audible tone. Even transportation is simplified with easy-roll 4" casters that provide stability and easy maneuverability over a variety of surfaces. A 4.5" under-bed clearance allows the lift access under most long-term care beds. (Unit includes: removable rechargeable battery (Model #13258); external charger (#13255) and wall-mounted bracket (#13260).)Features and BenefitsProvides stable assistance in standing, transferring an toiletingFour sling attachment points enable the lift to accommodate a variety of stand-up sling designsExtra-wide, non-skid foot plate provides a stable base for foot positioningSoft, padded adjustable leg support - includes a support strap to secure legs to the supportEasy roll 4" casters mean stability and easy maneuverability over a variety of surfaces.4. 5 under bed clearance provides access undermost long term care beds24 V DV motor provides power and reliabilityMotor has an emergency stop button an manual lowering featureFast charging, re-chargeable battery is removable to eliminate lift down-timeBattery has a charged and low-charge indicatorAudible tone when charge is completeBattery charge meter indicates the battery power status while in useAudible tone when battery power is below 50%Includes removable, rechargeable battery (item # 13258) charging station (item # 13255) and wall mount bracket (item # 13260)Product SpecificationBoom (Height): 26.2"-81.1".Base Opened (Width): 40.2".Base Closed (Width): 24.5".Base Clearance: 4.5".Casters: 3" Front/4" Rear.Model #13246
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Implementation of FDA's Design Control requirements (21 CFR
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Implementation of FDA's Design Control requirements (21 CFR 820.30) changed an entire industry. Quality System Requirements defined the approach to medical device validation. Product design, manufacturing process, and test method validation studies must be performed before or as a product is transferred to commercial production. Validation studies must demonstrate that product design, process, and test methods/requirements/specifications determined during development can be met in the environment of intended use. This book provides practical guidance on how to develop and validate product designs, manufacturing processes, and test methods that comply with the requirements of QSR.
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Spine-Worx is like having a Chiropractor in Your Home, and
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Spine-Worx is like having a Chiropractor in Your Home, and can help you be free of back pain in just 15 minutes a day! There is no reason to live with back pain. Thousands of people just like you have relieved their pain with this simple and effective home therapy product. Spine-Worx is a medical device which gently guides misaligned vertebrae into their correct positions and holds them there while tense muscles relax and stretch, to relieve back pain and related symptoms. ? Padded ridges and unique contours apply even pressure where it is needed ? Uses only your own body weight to control applied pressure ? Automatically matches each individual's requirements ? Feel fast relief. Remember: The central nervous system begins in the brain, courses into the spine and runs throughout the entire human body. If you shut down nerve supply, you shut down the body!
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The Warming Store is here with only the best winter gear you can find. We specialize in Hot Headz fleece hoods, Ice Cleats, Pet Warming Products and outdoor winter helpers.
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With quiet, smooth operation and a heavy-duty steel frame,
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With quiet, smooth operation and a heavy-duty steel frame, this full electric bariatric bed from Drive Medical ensures you peaceful rest without skimping on strength and safety.The split-pan design with removable bed end is easily set-up without tools and offers a larger sleep surface than a conventional bed, one with a weight capacity of 1,000 pounds. The hand-control device allows for multiple bed positioning, but an emergency manual crank also comes standard. A low air loss/alternating pressure mattress is available but not included. Features: Included: Full Electric Bed, 54" Heavy Duty Foam Mattress, 2 pair "T" Rails Bed: All steel construction. Larger sleep surface than conventional bed. Split pan design with removable bed ends is easy to set-up. No tools necessary for set-up. Hand control (included) provides for multiple bed positioning for patients. Emergency manual crank included. Mattress: Top cover: Unitek 11 Nylon. Bottom cover: Vinyl. Top layer: 2.5 lb density foam. Middle layer: 2.5 lb density foam. Base: 4 lb density foam. Weight Capacity: 1000 lbs. Bed Rails: Attractive brown vein finish. Constructed of 1" steel. Ideal protection without confining the patient. Provides maximum protection when bed is elevated. For use with most manufacturer's beds.
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The ScootaTrailer, unlike any other mobility device carrier
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The ScootaTrailer, unlike any other mobility device carrier, lets you transport the largest scooters and power wheelchairs on compact and subcompact cars! This includes vehicles like the Chevy Cavalier, Chrysler PT Cruiser, Ford Focus, Honda Accord, and Toyota Corolla. In fact, any vehicle with a class one trailer hitch is compatible with the ScootaTrailer because it only places 35 to 75 pounds of weight onto the hitch. What are the advantages of the ScootaTrailer and its universal design? Here are just a few: You don't need to buy a larger vehicle just to transport your scooter, power chair, or other mobility device. You can save gas by using a smaller vehicle. You can easily switch the ScootaTrailer from vehicle to vehicle because of the included Swivel Trailer Jack. The ramp height is very low, making loading easier than traditional vehicle lifts. An optional gas-strut makes it even easier to lower the ramp. You can still access the rear hatch of vans & SUVs or the rear trunk of cars. Traditional external lifts require you purchase a swing-away arm. Completely stable at highway speeds, it even has its own VIN number! With the optional lockable cover you get complete protection for your device and gas-strut assistance. Can be detached easily and rolled away into a carport or shed. Overall, the ScootaTrailer is the ideal solution for transporting scooters, power wheelchairs, and even small off-road vehicles. It offers safety, convenience, and tremendous compatibility.
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Prodigy Diabetes Care's Prodigy Pocket Meter Kit includes t
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Prodigy Diabetes Care's Prodigy Pocket Meter Kit includes the Prodigy Pocket Meter, Prodigy Control Solution (4ml), Sterile Lancets (10ct), One (1) 3 Volt CR 2032 Cell Battery, Lancing Device (with clear cap), Prodigy Test Strips (10ct), Complete Instructions and Carrying Case. The Prodigy Pocket is fast and accurate and does not require any coding, thus avoiding inaccurate test results as a result of coding errors.
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APPLIED MEDICAL 6F x 20cm SILHOUETTE XTRAFLOW DEVICE B3854
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APPLIED MEDICAL 6F x 20cm SILHOUETTE XTRAFLOW DEVICE B3854 QTY 1 NON STERILE, UNOPENED IN ORIGINAL PACKAGING AAA-2 BX 1 Palm Harbor Medical 2997 Post Rock Court Tarpon Springs, FL 34688 (800) 301-5376 (727) 937-4733 Fax
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This reference provides real-world examples, strategies, an
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This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations-offering product development models for the production of safe, durable, and cost-efficient medical devices and systems.Details procedures utilized by leading companies to successfully meet FDA and end-user requirements, manufacture high-quality products, and improve and generate profit.Design Controls for the Medical Device Industry contains valuable guidelines that enable readers to prepare for an FDA audit identify consumer needs, resolve project objectives, and process inconsistencies and discrepancies determine the compatibility of design specifications and manufacturing, installation, and servicing demands ensure that proper design, function, and performance stipulations are understood and met verify and validate design criteria and production schemes eliminate confusion and prevent communication breakdowns allocate and conserve resources perform risk assessment analyses predict potential hazards under normal and fault conditionsPresenting blueprints for the application, evaluation, and refinement of quality assurance and performance practices-from product launch through engineering and assembly-Design Controls for the Medical Device Industry is a clear and indispensable source for biomedical, quality assurance, reliability, software, product design, manufacturing, research and development, and industrial engineers; project directors and managers; biomedical technicians; and upper-level undergraduate and graduate students in these disciplines.
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Medical Alarm Monitoring, for less than $1 per day you can
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Medical Alarm Monitoring, for less than $1 per day you can be assured that you will always be connected to highly trained specialists who respond immediately in a friendly, calm manner and stay with you until help arrives. Comparing medical alarm companies can be hard. There are a lot of companies that claim to be offering a similar service. For a decision this important it is critical to make sure that you have all of the necessary information.
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This volume details current developments in industry practi
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This volume details current developments in industry practices and standards relating to medical device packaging. This edition offers entirely new as well as revised chapters on packaging materials, package validation and methods and integrity testing, bar-coding technology, environmentally sound packaging and disposal procedures, storage autoclave sytems, international standards, customer needs, regulatory aspects, and more.
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BRAND NEW BP MEDICAL TRACTION DEVICE AMBULANCE SPLINT Our T
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BRAND NEW BP MEDICAL TRACTION DEVICE AMBULANCE SPLINT Our Traction Device stores in a 9 1/2"L x 3 1/2?"W and weighs under 20 oz. You can now carry your traction device in a trauma box, or first aid kit. The traction pole length quickly adjusts for adult or pediatric application. The need for patient roll-over or unnecessary leg raising has been eliminated. There is no ischial bar, so all problems of needless pressure are a thing of the past. Antishock pants can be quickly and easily applied ove
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This analysis of methods for subjecting integrated circuits
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This analysis of methods for subjecting integrated circuits and semiconductor devices to electrical testing and stress testing will serve as a tutorial for engineers working with automatic test equipment. It shows how wafer-level testing during burn-in (WLTBI) helps lower product costs and increase quality in semiconductor manufacturing. Two introductory chapters offer background on testing and trends in WLTBI. The rest of the book details five methods, including resource-constrained testing of core-based SoCs, defect screening for mixed-signal SoCs, and power management by test-pattern ordering. The book also addresses the issue of testing next-generation products with previous-generation testers. A list of symbols and acronyms is included. Bahukudumbi is a quality and reliability test engineer at Intel Corporation. Chakrabarty teaches in the Department of Electrical and Computer Engineering at Duke University. Annotation ©2010 Book News, Inc., Portland, OR (booknews.com)
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