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  • 1. Disposable Blood Pressure Cuff BFI Fall 2003 Semester Update Report Joshua Enszer, Andrew Kulie, Rachel Lubich, Todd Olson, and Brandee Walline bfi-l@mtu.edu
  • 2. Consumer Product Manufacturing c/o Chemical Engineering Department 1400 Townsend Dr Houghton, MI 49931 February 2, 2004 Karyn Dibb Kimberly-Clark Neenah, WI 54957 Dear Karyn and our other mentors: We have finished our BFI update report for the Fall 2003 semester. This report is the cumulative work of the entire CPM Enterprise for our first semester on this new project. The compiling of the report is a result of many hours of work by our BFI team. This report contains a summary of the work CPM has done and a summary of what we intend to do this semester. The memos that each team wrote to the BFI team are also included in this report. The BFI team has revised these memos in order to make this report professional and consistent. Please take note that there are three abbreviations used in this report. BP – blood pressure AHA – American Heart Association AAMI – Association for the Advancement of Medical Instrumentation Thank you for all of your time, commitment, and help that goes into CPM Enterprise. Sincerely, Rachel Lubich BFI Team Member PR Team Leader 2
  • 3. Table of Contents Contacts for this Report...................................................................................................4 Mentors for this Project...................................................................................................5 Summary of Work for Fall 2003 Semester......................................................................6 Prototype/Testing Team Reports.....................................................................................7 Marketing Team Reports.................................................................................................14 Production Team Reports................................................................................................18 Environmental Safety Health Team Reports...................................................................24 Appendices to Team Reports...........................................................................................27 Summary of Intent for Spring 2004 Semester.................................................................50 3
  • 4. Contacts for this Report Faculty Advisor Dr. Tony Rogers tnrogers@mtu.edu President Angel Taylor astaylor@mtu.edu Vice President Joshua Enszer jaenszer@mtu.edu Executive Board cpmexec-l@mtu.edu BFI Team bfi-l@mtu.edu Prototype/Testing Team prototest-l@mtu.edu Marketing Team market-l@mtu.edu Production Team production-l@mtu.edu Environmental Safety Health Team esh-l@mtu.edu Class List cpm-l@mtu.edu Website www.enterprise.mtu.edu/cpm/
  • 5. Mentors for this Project Prototype/Testing Team Christine Cowell Kimberly-Clark christine.cowell@kcc.com Karyn Dibb Kimberly-Clark karyn.dibb@kcc.com Katie Horosko Kimberly-Clark katie.horosko@kcc.com Tatum Northam Kimberly-Clark tatum.northam@kcc.com Hal Seppala Retired 3M & seppa@chartermi.net MTU Alumni Lee Wilhelm Kimberly-Clark lee.wilhelm@kcc.com Marketing Team Katie Horosko Kimberly-Clark katie.horosko@kcc.com Chandreyi Saha Kimberly-Clark chandreyi.saha@kcc.com Chris Worzalla Kimberly-Clark cworzalla@kcc.com Production Team Bill Dehn Kimberly-Clark bill.dehn@kcc.com Hal Seppala Retired 3M & seppa@chartermi.net MTU Alumni Tom Bowen Bowen Medical bowmed@compufree.net Environment Safety Health Team Patrick Downey Kimberly-Clark patrick.downey@kcc.com Tatum Northam Kimberly-Clark tatum.northam@kcc.com Lee Wilhelm Kimberly-Clark lee.wilhelm@kcc.com Chris Worzalla Kimberly-Clark cworzalla@kcc.com BFI Team Patrick Downey Kimberly-Clark patrick.downey@kcc.com Tatum Northam Kimberly-Clark tatum.northam@kcc.com Public Relations Team Chris Worzalla Kimberly-Clark cworzalla@kcc.com 5
  • 6. SUMMARY OF WORK FALL 2003 SEMESTER PROTOTYPE/TESTING • Researched and developed test methods applicable to BP cuffs • Completed an assessment of the intellectual properties surrounding BP cuffs • Began material research and ordered material samples • Created preliminary prototype designs in AutoCAD • Investigated multiple BP cuff designs MARKETING • Identified and analyzed the target market • Conducted preliminary interviews to determine marketing possibilities • Investigated competitive landscape for disposable BP cuffs PRODUCTION • Investigated equipment and processes used to manufacture BP cuffs and accessories • Compiled a list of equipment manufacturers • Outlined processes for prototyping ENVIRONMENTAL SAFETY HEALTH • Investigated FDA regulations concerning BP cuffs • Enforced lab safety regulations • Summarized the 510(k) pre-market approval process • Trained class members on use of lab equipment All teams maintained a lab notebook to document their findings, conclusions, and design processes. A Course Work Documentation binder with all inter-Enterprise communications has been maintained to detail individual contributions to this project. 6
  • 7. Memorandum To: Rachel Lubich, BFI From: Prototype/Testing Team Date: October 16, 2003 Subject: BFI Report #1 CC: BFI Team The Prototype/Testing team has created a design for a disposable BP cuff. Testing methods have been created for benchmarking of current BP cuffs on the market and CPM’s prototype. Team Objectives • Prototype and test a disposable BP cuff • Complete intellectual properties of BP cuffs • Complete materials research of low and high end costs • Assess performance characteristics of BP cuffs • Research and develop test methods applicable to BP cuffs Due to time constraints, not all of the objectives will be completed Fall 2003 semester. Attributes • Pouch for stethoscope • Wicking for cover (fluid absorption) • Imprinted outline indicating proper placement on arm • Non-woven/elastic material • Bladder and cover as one unit • Cost efficient • Cleansing and disinfecting option • Limited number of uses • Multi-functional product • Easy waste disposal • BP cuff on a roll • Emergency medical market • One size • Multiple covers on a single BP cuff to increase cuff life Initial Design Taking into account the above attributes, as well as the feedback from physicians interviewed by the Marketing team, the preliminary design was decided upon for the BP cuff. The BP cuff will be one unit containing the cover and bladder bonded by methods such as ultrasonic bonding or welding. The Production team is assisting the Prototype/Testing team with this research. The cover will need to constrain expansion of the bladder to maintain even pressure on the arm. It must also contain a layer of soft material for 7
  • 8. patient comfort. The bladder needs to be an air impermeable material that can withstand pressures up to 300 mmHg. The bladder must be elastic to allow air to enter and expand. An adapter may be needed to connect the tubing to the BP cuff. Ideally, the bladder and tubing will be one unit, eliminating the need for an adapter. However, it is currently unknown if this is possible with the available materials. Research will continue for this aspect until a final design has been established. The fastener will be a strong material used to affix the BP cuff in place. This is an area of potential for designing around existing patents. The pressure bulb, gauge, and tubing will be externally purchased and incorporated into the design. Final Design There are currently two design options the team is pursuing. The first design is similar, shown in Figure 1, to other designs on the market, consisting of a cover/bladder, tubing, and adapters as separate units assembled to make a complete cuff. CPM would manufacture the cover/bladder, but outsource the tubing and adapters. The second option, shown in Figure 2, is an integrated design in which the tubing is an extension of the cover/bladder component. This would reduce our cost and give us a potential feature to patent. 8
  • 9. Figure 1: Disposable BP Cuff Out Sourced Tubing 9
  • 10. Figure 2: Disposable BP Cuff Integrated Tubing 10
  • 11. The appropriate cuff dimensions were identified through the AHA and AAMI standards. They will be utilized to produce an AutoCAD drawing of both of the design options. A die for the press in the CPM laboratory will be manufactured for prototyping purposes. In addition to the die made for “cut-outs”, research is also being conducted for a heat- sealing die. This would consist of a heated flat surface in the shape of the cuff that would “press” two layers of the cover and bladder together and produce an air impermeable seal. Although the idea of injection molding for the adapters and rotational molding for the bladder was presented and researched, the high cost led the team to no longer pursue this option. Dr. Williams and Dr. Wright of Michigan Tech University were resources for information pertaining to polymer processing. Testing Plans A testing plan has been devised to evaluate the performance of potential materials for the BP cuff. These plans are outlined in Appendix A with the testing parameters in Appendix B. Formally written test methods (ASTM format) for the following test procedures are in Appendix C. • Fastener shear strength • Fastener shear strength – in use • Cover/Bladder air capacity/elasticity • Cover/Bladder air permeability • Cover/Bladder tensile strength • Fastener tensile strength • Blood Pressure Training System in use Next Steps By the end of the semester, all materials will be researched. These materials will be analyzed based on manufacturer’s information and materials for testing will be selected. Formal testing will begin at the beginning of spring semester. The top three material options for each component of the cuff will undergo testing. Based on the testing plans final materials will be identified. 11
  • 12. Memorandum To: Rachel Lubich, BFI From: Prototype/Testing Team Date: November 16, 2003 Subject: BFI Report #2 CC: BFI Team The Prototype/Testing team has finalized the design for the disposable BP cuff based on this semester’s research of current products. The focus was to identify a key feature that would make our product unique and patentable. The ultimate goal for the Prototype/Testing team is to be ready to formally begin testing at the start of spring 2004 semester. Several material options have been investigated for the cover, bladder, and fastener portions of the cuff. By semester’s end, the most promising three materials for each component will be identified. In order to reduce cost, we would ideally like to have one material serve as both a cover and bladder. If the bladder material is not aesthetically pleasing or comfortable, a lightweight and inexpensive cover material will be incorporated into the design Information regarding the potential materials will be available, such as a. Cover i. Bonding methods available (manufacturer) – cover will be bonded to itself or to bladder ii. Strength (manufacturer) iii. Cost (manufacturer) iv. Printability (manufacturer) v. Softness (qualitative assessment) b. Bladder i. Bonding methods available (manufacturer) – bladder will be bonded to itself ii. Strength (manufacturer) iii. Cost (manufacturer) iv. Air permeability (manufacturer) c. Fastener i. Bonding methods available (manufacturer) – fasteners will be bonded to cover ii. Bond strength (manufacturer) iii. Cost (manufacturer) Materials will be ordered from the manufacturer for prototyping and testing. It has not yet been determined from whom we will purchase the bulb and gauge. At this point, we will be outsourcing these components. 12
  • 13. Next Steps The team is in the process of completing the tasks discussed above. In addition to this work, we would like to evaluate the performance of current disposable blood pressure cuffs on the Blood Pressure Training System. This device has not yet been received, so this objective may need to be included for next term. Our final steps are to wrap up all the research that has been completed this term in order to fully be prepared to start testing and prototyping in the spring. 13
  • 14. Memorandum To: Rachel Lubich, BFI From: Marketing Team Date: October 16, 2003 Subject: BFI Report #1 CC: BFI Team The target demographic area for the disposable BP cuff has been established as the emergency medical system for the Mayo Clinic in Rochester, Minnesota and the surrounding area hospitals. Marketing research is well under way through interviews and Internet research. Team Objectives Our team objectives were to • Identify the target market and the size of the target market for a disposable BP cuff • Determine needs and desires of the health care profession regarding BP cuffs • Complete an assessment of the competitive landscape for BP cuffs Interview Summaries The key responses from the four interviews were that the size of the BP cuffs is extremely important, that the mechanical fastener is normally the first thing to wear out on the cuffs, that cost is a very high priority for prospective buyers. We also discovered that the survey questions need to be revised to focus on the more important issues. The other CPM teams have been made aware of the interview results and they have helped to revise the interview questions for future use. Paula Polso is head of the ICU/Medsearch center and the infection control coordinator at Portage Medical Center, in Hancock Michigan. During her interview, it was discovered that correct size is essential to taking accurate BP measurements. She said that some features she would like to see in disposable BP cuffs include cost efficiency, ease of cleaning, durability, and comfort. It was also learned that one blood pressure cuff can be used every two to three minutes for up to twenty four hours in an emergency situation. Fran Ricci is the head RN of emergency services at Portage Health System. Her primary concerns were cost and size issues. She recommends that BP cuffs be latex-free and that mechanical fasteners be used. She informed us, however, that the mechanical fasteners are usually the first thing to wear out on the BP cuff. Fran also advises that having a BP cuff that is compatible with a large majority of machinery is an essential marketing point. Jerald Primeau is an EMT with Calumet Ambulance. The feature he disliked most on the BP cuff he currently uses is the loop that makes it harder to strap on than mechanical fasteners. Jerald’s base already uses disposable BP cuffs. However, the BP cuffs are used on 4 to 5 patients before they are thrown out. He mentioned that there are six main sizes: Infant, Pediatric, Small Adult, Medium Adult, Large Adult and XL Adult. The 14
  • 15. larger sizes are used the most due to the national obesity level. He concluded by informing us that disposable BP cuffs are too expensive and will probably not be used exclusively in the near future. Steven Schaar is a Nationally Registered Emergency Medical Technician-Paramedic in Indian River, MI. He placed emphasis on the ease of use of BP cuffs with mechanical fastener closures, screw-release bulbs, and size range indications on the BP cuff. Steven’s overall impression is that disposable BP cuffs are not cost effective and are taxing on an already existing problem with waste. He believes that the only real need for disposable BP cuffs is in emergency departments, emergency medical systems, and infectious disease clinics where case-by-case considerations are made for its use. Based on our interviews and research, our recommendation to the Prototype/Testing team is to design the blood pressure cuff to be cost effective, comfortable, and easy to use (with a hook and loop fastener). The most important thing to focus on is being cost effective. The main reason more hospitals do not regularly use disposable blood pressure cuffs is because of the high cost. Outside Contacts The Marketing Team has made outside contacts with Chris Worzalla at Kimberly-Clark and Tom Bowen at Bowen Medical Services for help with marketing strategies. Tom Bowen gave a very detailed description regarding his marketing research; however, he also spent a few years on it. Since our time frame is one year, we will not be able to follow his marketing strategy. It was discovered that because a key demographic area has been chosen, it will be easier to focus the market research rather than using a “hit- and-miss” approach. Mayo Clinic General Information Research has uncovered that the Emergency Department of Mayo Clinic is located in St Mary’s Hospital in Rochester, Minnesota. The Emergency Department is a 51-bed facility and is open 24 hours a day, seven days a week. This Trauma Level I facility provides care for more than 75,000 patients each year and 20 percent of these patients are children. The vast majority of patients come from Olmsted and the six adjacent counties in southeastern Minnesota. Also, a high number of Emergency Department patients have acute or critical emergency needs. Next Steps Our next step is to continue market research within the key demographic area. With the information already uncovered regarding the Mayo Clinic Emergency Department and the use of public records, estimations can be made regarding such things as the number of blood pressure cuffs used per room per day. We also hope to conduct more interviews with larger hospitals in order to get a better idea of the number and types of blood pressure cuffs used and to get more information about the policies regarding blood pressures taken in emergency situations. 15
  • 16. Memorandum To: Rachel Lubich, BFI From: Marketing Team Date: November 16, 2003 Subject: BFI Report #2 CC: BFI Team The Marketing team’s progress can be seen in the research we have completed in our target demographic area and our future plans for research. Research Plan Our original plan was to focus on the Mayo Clinic area in Rochester, MN. However, this has been expanded to include not only the southeastern counties in MN, but also California and New York. This change in plans was decided upon after discussing comments made by Chris Worzalla at the teleconference on November 6th. The larger areas will be used as scaling factors as we feel it would be too hard to do complete market research on them given our available resources. The Marketing team plans on making contact with the emergency medical services of each state that we will be researching. We have found contact numbers for these states: Minnesota Emergency Medical Services Regulatory Board (619-627-6000), New York State Bureau of Emergency Medical Services (518-402-0996), and California Emergency Medical Service Authority (916-322-4336). We are focusing specifically on Rochester, MN, New York City, NY, and Los Angeles, CA. We will be asking for the number of trauma cases seen in their emergency medical services per year, the number of BP measurements taken within their emergency medical services per year, and the number of patients seen within their emergency medical services per year. We hope to make contacts within each of these demographic areas. Marketing Analysis Plan A template for our market analysis plan was created and is shown in Appendix D. This is a list of all the questions we need to answer and things we need to do to formulate our market analysis report. We investigated “marketing research” to learn what is necessary to complete a market analysis report. Next Steps The next steps for the marketing team include continuing to gather information on the target demographic area and interviewing people from the demographic area. We are also going to continue to gather information for the market analysis template. 16
  • 17. Memorandum To: Rachel Lubich, BFI From: Marketing Team Date: December 16, 2003 Subject: BFI Report #3 CC: BFI Team We will analyze the market for disposable BP cuffs, including an investigation of industry procedures and demographics. Industry Analysis The first patent for a disposable BP cuff was in 1973. Due to the rising number of hospital cases that include serious health issues, such as AIDS and SARS, there has been an increased interest in infection control. Because of this interest, disposable BP cuff research has expanded, and technological advances have rapidly grown in the past five years. Seventy-five percent of hospital visits require a BP measurement to be taken. We assume that the number of disposable BP cuffs used in these visits is quite low, but we expect that this number will rise due to the new interest in infection control. Customer Profile The typical customers for our product will be from emergency medical services. These customers include infectious control coordinators, emergency room coordinators, and emergency transport personnel. Potential customers are familiar with traditional BP cuffs, but see the need for disposable BP cuffs as infection control awareness is rising. Demographic We are primarily focusing on larger facilities in Los Angeles, CA, New York City, NY and Rochester, MN. LA and New York are both large areas that have frequent hospital visits, while Rochester is a smaller area but is known for its highly acclaimed Mayo Clinic. We expect that these facilities will buy our product because our product will be less expensive and more reliable than our competitors’. Competition/Competitive Roundup In order to analyze our competition, we have focused on four companies that produce disposable BP cuffs. Information regarding these companies can be found in Appendix E. 17
  • 18. Memorandum To: Rachel Lubich, BFI From: Production Team Date: October 16, 2003 Subject: BFI Report #1 CC: BFI Team The Production team is working to find machinery to set produce our disposable BP cuff. They are also researching processes to produce our cuff as a continuous process. Team Objectives The production team’s objectives were set at the beginning of the semester. • Compile a list of leading blood pressure cuff manufacturers • Investigate equipment/processes needed to produce blood pressure cuffs and accessories • Review preliminary business proposition, including investment required and potential return The production team will then use this information to choose the proper equipment to produce CPM’s disposable BP cuff. Tom Bowen of Bowen Medical Services, inventor of the Cuff-Guard, is working as a mentor to CPM. With the help of his advice, we are learning how to carry out designing and marketing our disposable BP cuff. BP Cuff Manufacturers The Production team has been in contact with a number of BP cuff suppliers. • Colin Disposable Cuff • Critikon Classic Cuff • Invivo Disposable Single-Lumen Blood Pressure Cuff • Phillips single-Patient Disposable NIBP Cuff • Zefon • Kimberly-Clark Sample BP cuffs have been ordered from some of these companies. Equipment Manufacturers Companies will not share with us what materials, processes, or machinery they use. By talking with Dr. Tony Rogers, Hal Seppala, and Dr. Debra Wright, the Production team learned about different procedures and machinery we could possibly use. By using CPM’s mentors as well as MTU faculty, the Production team has been able to determine what machines are needed for different processes and materials. The Production team is looking into equipment being used in current BP cuff manufacturing. Our K-C mentors are helping with this by providing information on the equipment they already use. The following machines have been located from several different manufacturers: • Slitter-Cameron Elite, Dusenbery Worldwide • Sheeter/Slitter-Contech (Automated Converting Systems), Rosenthal 18
  • 19. • Ultrasonic Welder-Herman Ultrasonics Inc., Dukane Corp., Sonobond Ultrasonics • Tandem Heat Sealers-Uline, Therm-o-seal • Adhesive Gun-Office Max Technology Assessment CPM has ordered samples of disposable BP cuffs currently on the market. We will dismantle these BP cuffs to learn how they were made. The average price for a disposable BP cuff ranges from $31.98-$58.97. A majority of Zefon’s income is from disposable BP cuff sales. They do not foresee the disposable BP cuff as the only cuff on the market; this is due to poor standards of manufacturing of other companies in the market. Cuff-Guard Tom Bowen patented the Cuff-Guard in 1996. Contamination of reusable BP cuffs was a major driving force in producing the Cuff-Guard. It is an inexpensive, latex-free protective cover for a BP cuff. The Cuff-Guard attaches easily and is compatible with most BP cuffs. It is made of Tyvek QC, from DuPont, which is a strong, impermeable, spun-bonded olefin fabric similar to plastic. Tyvek QC is coated with 1.25 mils of polyethylene, which makes it impervious and splash resistant against many bases, pesticides, inorganic acids, and blood. This material fulfilled FDA requirements. Tom Bowen pointed out that the FDA regulates all medical devices. To obtain a 510(k) premarket approval, accuracy tests, toxicology reports from an independent laboratory, intended advertising method, packaging, and a use/purpose for producing the device will have to be documented and submitted to the FDA. The FDA classified the Cuff-Guard as a Class II device. BP cuffs are also classified as Class II devices. Tom Bowen’s testing on his prototype consisted of doing accuracy tests on an artificial arm to prove that results did not vary. He also did human testing at a blood pressure check station in which subjects signed a consent form for a registered nurse to take blood pressure readings. Outside stimulations were eliminated and the blood pressure was checked with and without the Cuff-Guard using the same sphygmomanometer and BP cuff. This information has been relayed to the Prototype/Testing team for their use with the CPM disposable BP testing. 19
  • 20. Memorandum To: Rachel Lubich, BFI From: Production Team Date: November 16, 2003 Subject: BFI Report #2 CC: BFI Team The production team has been researching the processes and machinery needed to produce disposable BP cuffs. The team has decided on a few different scenarios for the production so that when the Prototype/Testing team has chosen a material and design, it will be easy to choose the correct process. Scenarios A) Manufacture Own Material • Need PVC resin/plasticizer mixer • Followed by an extruder to form sheets • Cut by a slitter into manageable sheets • Wound onto roll with a winder and would be followed by processes B B) Continuous High-Speed Production Line (No bladder) • Two rolls of heat-sealable material (eg. Plasticized PVC) • Unwound from two unwinds • Through a rotary set of hot rollers with one roller having the design of the heat seal imprinted on to it o Followed by a set of rotary set of rollers with a die which continuously cuts off the excess trim o Followed by a single step heat seal press with a single or multiple trim press or die Background on Equipment PVC Resin/Plasticizer Mixer If the material is to be PVC and it is to be manufactured on-site, a PVC/plasticizer mixer will be needed. The purpose of this mixer will be to compound the PVC with other additives to reach the determined material characteristics. PVC plastics are very rigid materials that need to be mixed with lubricating agents, called plasticizers1, to become flexible. The compounding process would consist of two steps: mixing the materials and forming the mixture1. In the case of the BP cuff the desired form of the materials would be a sheet. The sheets could be made with an extruder. There are two types of PVC mixers available. The first is called a Low Intensive Mixer and the second is called a High Intensive Mixer. 1. Low Intensive Mixer (LIM) LIMS are ribbon blender-type mixers that are jacketed for heating and cooling. They have closed barrels and spiral blades, which normally run about 25 to 75 RPM. The blades are designed to move the material to the 20
  • 21. center of the barrel providing good mixing. The tip speed is normally about 6meters per second. Frictional heating is very minimum. This causes large heat gradients within the ribbon blender. Depending on the hardness of the flexible PVC compound being made, mixing times can be from one to six hours. Batch size may be up to 5000 pounds. Heating and cooling must be provided to this type of mixer. 2. High Intensive Mixer (HIM) HIMs are like kitchen blenders with very high RPM's (500 to 1000). They achieve most of their heating from frictional heat. Depending on the manufacturer, one can have a variety of blades and blade designs. There are 2 to 4 blades in a normal mixer. Three blades are typical for flexible mixing and four blades for rigid mixing. The blades are designed to give homogenization to the resin and other ingredients. The tip speed is normally around 30-40 meters per second. Mixer size ranges from 10 to 1000 pounds. A typical cycle time will be from 4 to 10 batches per hour… …After mixing is complete, dropping it into a cooler must cool the powder material. Cooling is usually done in a low intensive mixer. Water is pumped through the water jacket to speed the cooling process. Coolers may be ribbon blenders, round-like pots, or barrel type, all of which are closed-type bowls. Some have blades or plows. The blades have an RPM of 50 to 100 with a tip speed of 6 meters per second. After cooling, the material should be screened for mixer build-up and foreign material. Screen size is normally from 10 to 30 mesh depending on the end product to be extruded.2 Extruder Extrusion is used to produce the materials that will be used for making the final product. They can be handheld machines (~$3000) or larger machines (~$10,000-$15,000). Purchasing and shipping the machines would cost too much for us to consider in the making of a prototype. If considering the grass roots plan, we could possibly use a machine of this size and cost. Also, most products from extruding are not hollow, and have thicker walls. This would not be ideal for our product’s intentions. Extruding could be used for the tubes on our product if we were to make a BP cuff with more than one part. Extrusion would be necessary if the CPM team chooses to produce many cuffs; but in turn we would also need to purchase a cooling roller and two winders rather than just one. Since our production is somewhat limited we will have no need to purchase an extruder, but should keep it in mind in case of a production increase. Currently it would also be more cost effective to order out material through another company due to our production levels. 21
  • 22. Several different companies produce extruders. These include; Battenfeld Gloucester, Diamond America, Logan, to name a few. Attached is a basic drawing of Battenfeld Gloucester’s Hydrocool Sheet/ Cast Extruder with a list of available dimensions (see Figure I). Winder/Unwinder This machine is very necessary in our expected application for production. The Production team is planning on using this machine to unwind our material to send it through what is our expected production line. The Production team is also planning on using this machine at the end of the production line to wind our product on a spool for easy access and easier mobility. This machine comes with many different options, including single, dual, and triple shaft torque winders. These machines all seem to look very much alike, but change in widths. The manufacturers of this machine are Battenfeld Gloucester and Automated Manufacturing Systems. Automated Manufacturing Systems had prices listed for their Single Shaft Torque Winder and their Dual Shaft Torque Winder. The single shaft was listed as $4,875 and the dual shaft was listed as $6,775. The Production team discussed using a dual shaft winder for the reason that it would prevent a brief halt of the production line to change material roll. Rotary Set of Rollers A rotary set of rollers would be used to transfer and/or seal two materials together. One roll would be heated by electricity and have a die embossed or engraved to cut and heat- seal the materials. The other roll would guide and pull the material from the unwinder/sheeter. Rollers are made from a wide variety of materials from metal to rubber and can be used in hot or cold environments. Heat Seal Press A heat seal press would be used to seal two layers of a non-woven web. The press could be used in conjunction with a die to make the heat seal pattern. It would be used after rotary set of rollers. A hand-held heat sealer would be used for quick prototyping. Dies Dies are used to cut the product from the trim. Dies can be embossed onto a roller or can be used in a hot stamp press. Investigation of a BP Cuff MABIS Single-Patient Sphygmomanometer & Inflation (Adult, 23-33 cm) From: ALCO Sales, 6851 High Grove Blvd., Burr Ridge, IL 60527 Ph. (800) 323-4282, www.alcosales.com Product Description: • 5 Per Box-$86.00+shipping, $17.20 each • Gauge separately-$12.95, Bulb & Valve Assembly-$3.95 • Latex-Free, Available in other Cuff Sizes 22
  • 23. The Production team has been able to classify some of the materials and processes in which the manufacturers of the MABIS cuff might have used. Speculation on the materials, processes, and machinery used are • One-piece cuff with no bladder, the bladder is the air pocket inside the outer layers • Probably made from some sort of plasticized PVC or PVA, rolls or sheets of these materials can be purchased which would be placed into an unwinder or sheeter, respectively. • The edges and creases of the cuff are either sealed by a hot stamp to make the heat seal pattern and cut it out of the trim with a die, or ran through a rotary set of electric, hot rollers which one has the heat seal pattern embossed/engraved onto it. Then it would run through a die press to cut out the cuff from the trim. This would heat seal all of the edges together to form the air pocket or bladder. They use a dual-seam heat seal. • The inlet/outlet for the bulb and gauge are made from soft plastic probably by injection molding or rotational casting. • The tubing done by extrusion with rubber. • Velcro used to seal cuff around arm, the whole backside of the cuff is made from a soft fabric that adheres to the Velcro. This makes it soft and comfortable. Strengths: • Very comfortable • Simple design but very effective • Inexpensive compared to other leading brands • Bulb and gauge are universal • Clever use of Velcro, fits large range of arm sizes • Durable by double-seam heat seal • Wiped clean for re-use Weaknesses: • May not be cost efficient to dispose tubing, bulb, and gauge, CPM can improve here by possibly making the tubing from the same material as the cuff itself • Velcro comes unattached eventually from high usage. Either the glue bond or heat seal on the back of the Velcro can be improved. Next Steps The Production team will continue to research specific equipment to narrow down the processes and machinery to choose from once the Prototype/Testing team has decided on a design and materials. The team is still waiting to receive more BP cuffs to examine and learn from. The team has learned a couple of great websites to research materials, such as plasticized PVC, which are www.matweb.com and www.atofina.com. The Production team will be making suggestions regarding equipment to the class by the end of the term. 1 http://online.sfsu.edu/~jge/html/body_methods_of_compounding.html 2 http://www.oxyvinyls.com/products/datasheets/ovtr52.pdf 23
  • 24. Memorandum To: Rachel Lubich, BFI From: Environment Safety Health Team Date: October 16, 2003 Subject: BFI Report #1 CC: BFI Team The ESH team has researched many aspects regulated by the FDA that are relevant to this project. A plan for completing the 510(k) premarket document has been put into action. The ESH team is maintaining lab safety and cleanliness. Team Objectives The ESH team has a wide variety of objectives for this semester. These objectives include • Research FDA regulations regarding BP cuffs • Research FDA regulations regarding the materials chosen for CPM’s BP cuff • Write a JSA for CPM’s melter • Complete life cycle analysis of CPM’s disposable BP cuff • Train CPM members on equipment in the lab • Keep a clean lab and regulate proper lab use and procedures • Research and write a 510(k) premarket document • Research industrial ESH departments Not all of these objectives will be covered this semester. Project/Team Highlights Regulations regarding BP cuffs and possible materials have been researched and the research found has shown the CPM has a large opening of possibilities for its design. The 510(k) document has been researched and a summary of the steps for completion of the document has been made. FDA Material Regulations One of the major pieces of information that has been found so far is the statement regarding the definition of a BP cuff. The statement is broad and leaves CPM with nearly endless options as far as material selection is concerned. The statement reads, ‘Device has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject’s blood pressure.’ There are also no restrictions on the use of latex in BP cuffs. However, it is only strongly recommended that when latex is used, a label be placed on the product stating that fact. 510(k) and Substantial Equivalence The purpose of a 510(k) is to present sufficient information for the FDA to be able to determine that the submitted device is Substantially Equivalent (SE) to other, similar, legally marketed devices (predicate devices). Substantial equivalence drives the 510(k) 24
  • 25. process. A device is SE if, in comparison to a predicate device, it has the same intended use as the predicate device and has the same technological characteristics as the predicate device, or has the same intended use as the predicate device with different technological characteristics and the information submitted to the FDA does not raise new questions of safety or effectiveness, and demonstrates that the device is as safe and effective as the predicate device. Substantial equivalence is to be established with respect, but not limited to, intended use, design, energy used/delivered, materials, performance, safety, effectiveness, labeling, and other applicable characteristics, such as sterility. 510(k) Outline There are four basic steps to preparing a 510(k) statement. Following these steps will ensure the best chance of obtaining FDA approval. The steps are as follows. 1) Finding a Predicate Device The FDA expects manufacturers to be able to identify a predicate device. Several sources to find predicates are available for use. Some sources are made available by non-government groups, and others are made available by the FDA. If possible, the 510(k) number for the predicate device should be found. This will make the process easier on the FDA, which in turn may speed up approvals. 2) Locating Guidance Documents The FDA has issued many guidance documents that pertain directly to 510(k). Many are specific to a device type, such as the piston syringe guidance. Others are generic, such as the biocompatibility guidance that applies to all devices that contact the patient or user. There are several Internet locations where such documents can be located. 3) Formatting and Content of a 510(k) A 510(k) may be formatted in sections, with page numbering, and must contain a number of required elements including • Cover Sheet or Cover Letter, • Table of Contents, • Description of the device, • Information on device specifications, • Labeling, • Testing data when required, • Comparison with a predicate device(s), and, if applicable, • Information on sterilization, • Computerized aspects, • Standards to which the device adheres, or • Manufacturing information. Tabs may be used to separate each section but in any case each section should begin on a new page. The order in which required elements are presented is less important than completeness. 4) Assembling a 510(k) A 510(k) should be put in a temporary binder. The document must not be permanently bound because the FDA will take the application out of whatever binding it was submitted in, 3-hole punch it, and put it in a 3-ring "jacket" for review. For this reason, all of the pages need to be labeled correctly. Two copies 25
  • 26. of the 510(k) need to be submitted to the FDA, and a third copy should be kept for the submitter’s records. The FDA does not return applications. 510(k) Submission Process When the FDA receives the application, it is date stamped and given a 510(k) number. An acknowledgment letter from the FDA, including the assigned 510(k) number, should be received within two weeks of delivery. Before any review takes place, the document is checked for correct completeness and appropriate formatting according to the FDA standards described above. If an application does not meet this initial check, it does not get seen by the review board. After the initial check, the application is sent to an FDA review division for assignment by a reviewer or review team. If more information is needed to complete the review, the FDA reviewer will contact the applicant. If the submitted device is deemed substantially equivalent to a predicate device, the FDA will send a copy of the SE letter to the applicant. This letter must be received from the FDA before the device may be marketed. It is very important to include contact information for the FDA to use if questions regarding the application arise. Ideally, all possible questions will already be answered in the documentation, but contact information ensures that the approval process is not held up. Applications should be submitted to the FDA by a method such as registered mail that returns a proof of delivery. Applications are sent to Food and Drug Administration Center for Devices and Radiological Health 510(k) Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850 Next Steps This document should be completed by the end of the semester. This objective hinges on the completion of a cuff design and the discovery of applicable predicate devices. 26
  • 27. APPENDIX A CPM Blood Pressure Cuff Testing Plan 1) Train all team members on the Blood Pressure Training System (BPTS) 2) Obtain samples of BP cuffs on the market and evaluate performance on the BPTS 3) Evaluate the performance of individual BP cuff components focusing on specific identified parameters (Appendix B) 4) Rank materials based on testing results 5) Choose top 1-2 materials from each category and produce prototypes 6) Evaluate performance of prototypes on BPTS and conduct human testing (CPM members) 7) Compare results to determine final prototype/design or continue material research/testing Note: Final prototype must meet AAMI standard requirements 27
  • 28. APPENDIX B CPM Blood Pressure Cuff Testing Parameters PARAMETER HOW TO EVALUATE Cover Cost* Manufacturer Bond strength Tensile Test Printability Manufacturer Softness Touch/Feel Material Strength Manufacturer Bladder Cost* Manufacturer Bond strength Tensile Test Air permeability Air Permeability Test Elasticity/Air Capacity Inflation Test Material Strength Manufacturer Fastener Cost* Manufacturer Shear Strength Shear Test In use Tensile Strength Peel Test Prototype/ Accuracy BP Training System Competitive * Cost is the most important attribute 28
  • 29. APPENDIX C Test Method to Assess Shear Strength of Fasteners Used to Secure the Disposable Blood Pressure Cuff (DBPC) on the Upper Arm 1. Scope 1.1 This test method provides a standard to measure the shear strength of fasteners by performing a controlled displacement tensile test. 1.2 Safety issues are not addressed in this standard; thus, it is the responsibility of the user to take the appropriate precautions. 2. Referenced Documents 2.1 ASTM Standards: D5169-98 Standard Test Method for Shear Strength (Dynamic Method) of Hook and Loop Touch Fasteners 3. Terminology 3.1 Definitions: 3.1.1 Shear strength – the resistance to forces that cause two contiguous parts of a body to slide in the same direction the forces are applied. 3.1.2 Velcro Hook #88 and Loop #1000 fastener – a reusable fastener that consists of two mating polymer strops: a hook strip and a loop strip. The surface of the hook strip, which is covered by small protrusions, hooks onto the surface of the loop strip. 3.1.2.1 This fastener provides an alternative method of joining two materials, without using an adhesive. The hook and loop fastener performs its function by pressing the two mating strips together, while separation is accomplished by peeling them apart. 3.1.3 Adhesive Emulsion (National Starch Company) – Easy Melt would be sprayed on one portion of the cuff and covered with a peel strip. When in use, the peel strip would be removed and the sticky surface can attach to the opposite portion of the cuff to hold it together. The cuff would only be adhered one time utilizing this method. 3.1.4 – 3M Fastening, Release, and Frontal Tape – A sticky tab would be attached to one end of the blood pressure cuff. When in use, the folded tab would be unpeeled exposing an adhesive surface similar to that on a baby diaper. The tab would then be applied to the appropriate portion of the cuff. This is the same tape fastener that is used for baby and adult diapers. 3.1.5 Tyvek (Type 14 and Type 16) – A polyethylene non-woven material. 3.1.6 3M Propore – A polypropylene non-woven made at 3M. 4. Summary of Test Method 4.1 A tensile testing machine shall be used, with the applied force parallel to the plane of contact of the fastener. 5. Significance and Use 5.1 This test provides a measure for the magnitude of the force that has to be applied parallel to the mating surface of the fastener to separate the fastener strips. Such knowledge is required for effective use of the fastener in the DBPC. 29
  • 30. 6. Apparatus 6.1 Testing machine- an 88,964N tension/compression machine shall be used. It has two clamps, aligned such that the ends of the specimen were contained in the same plane. The displacement between the clamps will increase at a constant rate of 1.3cm/min., and the load cell will be 4,448N. The machine will be connected to software to record load versus displacement data. 6.2 Machine calibration can be accomplished using the shunt method. Place a known load on the machine and verify that the software gives the correct output. 7. Sampling 7.1 For precision, 10 samples for each potential fastener should be tested. The samples should be prepared on the same day, from the same lot of materials, and in the same manner. 8. Specimen Preparation 8.1 Cut fastener material samples into 2.5cm squares with rounded edges. Each fastener will have two pieces – similar to hook and loop. Attach the “hook-like” component to the center of a 5cm x 10cm piece of disposable bib material (Cassaretto textile), with the use of hot glue adhesive. Cut another 5cm x 10cm piece of Cassaretto textile to serve as the “loop-like” part of the fastener (Figure 1). Figure 1. “Hook-like” part of the fastener glued onto Cassaretto textile (left), Cassaretto textile which functions as the “loop-like” Figure 2. Positioning of fastener on machine. Each rectangle represents one fastener component (“hook- like” or “loop-like”. Arrows denote the direction of force applied by the clamps. 9. Procedure 9.1 Fasten the “hook-like” part of the fastener (attached to a 5cm x 10cm piece of Cassaretto textile) to the second 5cm x 10cm piece of Cassaretto textile (“loop-like” component) by manually pressing the two together. 9.2 Fasteners will be tested in the same order they were prepared. (Note: any number of fasteners may be tested with this test method. In the first series of testing three different fastener options will be tested.) 9.3 Position clamps in the testing machine 7.6cm apart. 30
  • 31. 9.4 Place the free ends of the fastener in the clamps, and tighten them so no slack is apparent and no slippage occurs. Place the “hook-like” component in the moving clamp. It should be noted that the fastener specimen will be aligned perpendicular to the clamps. 9.5 Once both pieces of the fastener are in the machine, increase the distance between the clamps by 2.5cm/min. 9.6 The software will record the shear force data throughout the test. 10. Calculations 10.1 Record the shear force (maximum load) required to separate each fastener sample from the recorded data. 10.2 Calculate the average and standard deviation of the shear force data for each fastener sample. 11. Keywords 11.1 touch fastener; hook; shear; disposable blood pressure cuff 31
  • 32. Test Method to Assess Failure of Fasteners Used to Secure the Disposable Blood Pressure Cuff (DBPC) on the Upper Arm In-Use 1. Scope 1.1 This test method accompanies the shear strength fastener test method, and provides a way to assess the in-use shear strength of fasteners. 1.2 Safety issues are not addressed in this standard; thus, it is the responsibility of the user to take the appropriate precautions. 2. Referenced Documents 2.1 ASTM Standards: D5169-98 Standard Test Method for Shear Strength (Dynamic Method) of Hook and Loop Touch Fasteners 3. Terminology 3.1 Definitions: 3.1.1 Shear strength – the resistance to forces that cause two contiguous parts of a body to slide in the same direction the forces are applied. 3.1.2 Velcro Hook #88 and Loop #1000 fastener – a reusable fastener that consists of two mating polymer strops: a hook strip and a loop strip. The surface of the hook strip, which is covered by small protrusions, hooks onto the surface of the loop strip. 3.1.2.1 This fastener provides an alternative method of joining two materials, without using an adhesive. The hook and loop fastener performs its function by pressing the two mating strips together, while separation is accomplished by peeling them apart. 3.1.3 Adhesive Emulsion (National Starch Company) – Easy Melt would be sprayed on one portion of the cuff and covered with a peel strip. When in use, the peel strip would be removed and the sticky surface can attach to the opposite portion of the cuff to hold it together. The cuff would only be adhered one time utilizing this method. 3.1.4 – 3M Fastening, Release, and Frontal Tape – A sticky tab would be attached to one end of the blood pressure cuff. When in use, the folded tab would be unpeeled exposing an adhesive surface similar to that on a baby diaper. The tab would then be applied to the appropriate portion of the cuff. This is the same tape fastener that is used for baby and adult diapers. 3.1.5 Tyvek (Type 14 and Type 16) – A polyethylene non-woven material. 3.1.6 3M Propore – A polypropylene non-woven made at 3M. 4. Summary of Test Method 4.1 CPM DBPC prototypes, in addition to other DBPCs on the market, will be tested to assure that the fasteners on the CPM prototype will perform equally well or superior to competitive products. The cuffs will be inflated to 200 mmHg (maximum pressure in the bladder when taking a blood pressure reading) and held at that pressure for 10 seconds to determine if the fastener will fail. 5. Significance and Use 5.1 This test provides a way to assess the various fastener options in-use. This test will be used in conjunction with the shear strength fastener test method, so it can be 32
  • 33. determined if the best machine-tested fastener will be the best in-use tested fastener. Such knowledge is required for effective use of the fastener in the DBPC. 6. Apparatus 6.1 Attach a DBPC onto the arm of the human subject (CPM class member), in the standard way, following the American Heart Association (AHA) method for taking a blood pressure. The cuff will be inflated to 200 mmHg, and held at that pressure for 10 seconds (the approximate time to take a blood pressure reading). The cuff shall be held at 200 mmHg to simulate a worst-case scenario, as in a typical blood pressure reading, the cuff only withstands such a high pressure for a short time period. 6.2 At the end of the test, the experimenter shall determine if the fastener failed completely, failed partially, or did not fail. 7. Sampling 7.1 For precision, 10 samples for each potential fastener should be tested. The samples should be prepared on the same day, from the same lot of materials, and in the same manner. 8. Specimen Preparation 8.1 Cut fastener material samples into 2.5cm squares with rounded edges. Each fastener will have two pieces – similar to hook and loop. Attach the “hook-like” component to top piece of the DBPC with hot glue adhesive, and attach the “loop- like” component to the bottom piece that is touching the subject’s arm (Figure 1). “Loop-like” “Loop-like” component Portion of upper arm “Hook -like” “Hook-like” component Figure 1. Placement of fastener components in this experiment. 9. Procedure 9.1 Fasten the “hook-like” part of the fastener to the “loop-like” component by wrapping the cuff around the subject’s arm and manually pressing the two together. 9.2 Fasteners will be tested in the same order they were prepared. (Note: for consistency, it is important that the same DBPC be used when evaluating different fasteners.) 9.3 Follow the AHA method for taking a blood pressure, and gradually increase the cuff pressure to 200 mmHg, and hold for 10 seconds. 33
  • 34. 9.4 After 10 seconds, release the valve so the pressure decreases rapidly. 9.5 With the cuff still on the subject’s arm, determine if the fastener failed (two components completely separate from each other), if it partially failed (components still attached, but have been partially pulled apart), or if it did not fail (components are in their original state, completely attached to one another). 10. Calculations 10.1 Record the if the fastener failed, if it partially failed, or if it did not fail. 11. Keywords 11.1 touch fastener; hook; shear; disposable blood pressure cuff; in-use 34
  • 35. Test Method to Assess Air Capacity/Elasticity of the Bladder Used in the Disposable Blood Pressure Cuff (DBPC) 1. Scope 1.1 This test method provides a standard to measure the air capacity/elasticity of the bladder used in the disposable blood pressure cuff (DBPC), by performing an inflation test. 1.2 Safety issues are not addressed in this standard; thus, it is the responsibility of the user to take the appropriate precautions. 2. Referenced Documents 2.1 ASTM Standards 3. Terminology 3.1 Definitions: 3.1.1 Bladder – the component of the blood pressure cuff which is inflated to apply pressure evenly on the arm of the subject; an air impermeable bladder is necessary so air is contained and pressure is maintained. 3.1.2 Air capacity – a measure of the bladder’s ability to take in air and expand to an appropriate volume; recommended to be 200 cm3 as defined by the Association for the Advancement of Medical Instrumentation (AAMI) standard SP10:2002. 3.1.3 Air impermeable – a material which will not allow the passage of air through it. An air impermeable material is necessary for the bladder, because the bladder needs to inflate to the appropriate volume and maintain that volume. 3.1.4 Tyvek (Type 14 and Type 16) – A polyethylene non-woven. 3.1.5 3M Propore – A polypropylene non-woven material from 3M. 4. Summary of Test Method 4.1 The house air supply in the CPM lab, a pressure gauge, and a container filled with water will be used for this experiment. The air capacity/elasticity of the bladder will be assessed, as well as a qualitative assessment of air permeability. 5. Significance and Use 5.1 This test provides a measure for the air capacity/elasticity of the bladder used in the DBPC. This test is critical for design, as the bladder has to inflate and maintain an appropriate volume of air to function correctly. 6. Apparatus The bladder will be hooked to the house air supply with a 5/8” piece of tubing, and the bladder will be attached to the pressure gauge using an adapter and the hoses attached to the pressure gauge. The bladder will be submerged in a large container with a measurable scale, to assess the volume change of the bladder. A qualitative air permeability assessment will also be made – if air bubbles appear, the material is not air impermeable. 35
  • 36. 7. Sampling 7.1 Three bladder samples of each material should be used in this test. The samples should be prepared on the same day, from the same lot of materials, and in the same manner. 8. Specimen Preparation 8.1 The complete bladder (bladder material, tubing, adapter) will be used in this test. Cut two 13cm x 26 cm samples from each of the potential bladder materials, and seal them using a method to be determined (hot glue, heat sealing, etc.) 9. Procedure 9.1 Insert the 5/8” tubing, connected to the house air supply, to the bladder. 9.2 Turn the house air on, and gradually increase the volume until 200 cm3. (Assess the volume change by reading the scale on the container which holds the water.) If the bladder seal fails before 200 cm3, record it. 9.2 Once the bladder has been inflated to 200 cm3, turn the air off and gently hold the bladder down in the water for 10 seconds. Record the water volume. If the bladder seal fails before 10 seconds, record it. 9.3 After 10 seconds, record the new water volume and compare it to the water volume recorded in 9.2. If the value has decreased, the bladder has failed and is either air permeable or has a faulty seal. Also note any air bubbles – also an indicator of failure. 10. Calculations 10.1 Calculate the average and standard deviation of the water volume data for each bladder material specimen. Also note 1) any seal failures before the bladder inflates to 200 cm3, 2) if the seal fails during the 10-second period the bladder is submerged under water, and 3) if air bubbles are present. 11. Keywords 11.1 air bubbles; air capacity; elasticity; air permeability; pressure gauge; disposable blood pressure cuff 36
  • 37. Test Method to Assess Air Permeability of the Bladder Used in the Disposable Blood Pressure Cuff (DBPC) 1. Scope 1.1 This test method provides a standard to measure the air permeability of the bladder used in the disposable blood pressure cuff (DBPC), by performing a gas rotameter test. 1.2 Safety issues are not addressed in this standard; thus, it is the responsibility of the user to take the appropriate precautions. 2. Referenced Documents 2.1 ASTM Standards: 3. Terminology 3.1 Definitions: 3.1.1 Bladder – the component of the blood pressure cuff which is inflated to apply pressure evenly on the arm of the subject; an air impermeable bladder is necessary so air is contained and pressure is maintained. 3.1.2 Air permeability – a measure of a material’s ability to prevent air from passing through a material. An air permeability of 0 is ideal for a blood pressure cuff bladder, as that measure indicates no air passes through the material. 3.1.3 Tyvek (Type 14 and Type 16) – A polyethylene non-woven. 3.1.4 3M Propore – A polypropylene non-woven material from 3M. 4. Summary of Test Method 4.1 A gas rotameter shall be used for this test. The bladder material will be hooked to the machine, and any air permeability will be detected. 5. Significance and Use 5.1 This test provides a measure for the air permeability of the bladder used in the DBPC. This test is critical for design, as the bladder has to be air impermeable to function correctly. 6. Apparatus 6.1 A gas rotameter will be used, and will be connected to the house air supply in the CPM lab. Two different diameter tubes will be used; connect a 5/8” piece to the house air supply, and connect a 5/16” piece to the gas rotameter. This gives a known, constant air flow through the gas rotameter. The materials can be incorporated into this system, and a change in air permeability will be able to be detected. 7. Sampling 7.1 Three bladder samples of each material should be used in this test. The samples should be prepared on the same day, from the same lot of materials, and in the same manner. 37
  • 38. 8. Specimen Preparation 8.1 Cut one 4cm x 6 cm sample from each of the potential bladder materials. 9. Procedure 9.1 Wrap the 4cm x 6 cm bladder material specimen around the 5/16” diameter hose and insert it into the 5/8” diameter hose, forcing air through the material. Repeat the test three times for each bladder material specimen. 9.2 The gas rotameter will measure the air flow through the material – record this number. An absolute value is not necessary for this experiment, as a comparative reading will be sufficient to determine which materials are the most permeable. 10. Calculations 10.1 Calculate the average and standard deviation of the air permeability data for each bladder material specimen. 11. Keywords 11.1 air permeability; gas rotameter; disposable blood pressure cuff 38
  • 39. Test Method for Bond Strength and Tensile Strength of Materials (or Combination of Materials) Used in the Disposable Blood Pressure Cuff 1. Scope 1.1 This test method provides a standard to measure the tensile strength of the bond between the cover and bladder materials by performing a controlled displacement tensile test. 1.2 Safety issues are not addressed in this standard; thus, it is the responsibility of the user to take the appropriate precautions, if any. 2. References 2.1 ASTM Standards: D5169-98 Standard Test Method for Shear Strength (Dynamic Method) of Hook and Loop Touch Fasteners 3. Terminology Definitions specific to this standard 3.1 Blood pressure- The pressure of the blood in the main arteries which rises and falls as the muscles of the body cope with varying demands. There are two types of pressures measured: 1) systolic pressure, created by the contraction of the heart muscle pushing blood into the vessels, and 2) diastolic pressure, when the heart is at rest between beats. 3.2 Blood pressure cuff- a device usually placed around the upper part of the arm to measure blood pressure. 3.3 Tyvek (Type 14 and 16)- A polyethylene non-woven. 3.4 Cover- outer portion of the blood pressure cuff that contacts the skin. 3.5 Bladder- inner air-impermeable portion of the blood pressure cuff which inflates with air to create pressure on the arm. 3.6 Fastener- component that connects the end of the blood pressure cuff to the part of the blood pressure cuff already covering the arm. 4. Summary of Test Method 4.1 With the use of a tensile testing machine, forces parallel to the plane of contact of are applied. This test method will be used to test the tensile strength of:  Cover  Bladder  Currently-marketed cuffs (cover, bladder, cover/cover bond, bladder/bladder bond, cover/bladder bond, tested separately)  Bond strength between: o Two pieces of cover material o Two pieces of bladder material o Cover material and bladder material o The fastener and cover material 39
  • 40. 5. Significance and Use 5.1 This test provides a load-displacement curve that will allow measurement of the magnitude of force and displacement required to cause failure of the material and/or bond. Such knowledge is required for deciding upon specific materials for the cuff. 6. Apparatus 6.1 Testing machine- an 88,964N tension/compression machine will be used. It has two clamps, aligned such that the ends of the specimen are contained in the same plane. It should be noted that the displacement, between the clamps, is increased at a constant rate with respect to time, 1.3cm/min., and the load cell was 4,448N. The machine is connected to software that records load versus displacement data. 6.2 The machine is calibrated using the shunt method; a known load is placed on the machine and it verified that the software gave the correct output. 7. Sampling 7.1 For precision, 10 identical samples of each material (combination of materials if testing bond strength) will be prepared. They are prepared on the same day, from the exact same materials, and in the same way. 8. Specimen Preparation 8.1 Samples should be cut into 4 cm by 6 cm rectangles. In the case of bonded materials, the entire sample size will be 8 cm by 12 cm. The samples will be assigned a number and labeled (Figure 1, 2). Samples should not be taken from edges of material, and should be taken from different depths of the roll, and/or from different lots of material. Figure 2: Positioning of material on machine; arrows denote the direction the claps were pulling on Figure 1: Material samples bonded in center. 9. Procedure 9.1 The clamps will be positioned in the testing machine, and set about 6 cm apart. 9.2 The free ends of the material should be placed in the clamps, and tightened well so no slippage occurs. It should be noted that the specimen be aligned perpendicular to the clamps. 9.3 The distance between the clamps will be increased by 2.5 cm per minute. 40
  • 41. 9.4 The data recorded by the software should be observed, and the force (maximum load) required to separate the material recorded. 10. Calculations 10.1 The force required to separate each sample will be obtained from the data recorded from the software. Displacement data will also be obtained. The mean, standard deviation, and any other necessary variables or data will be recorded. Statistical analysis will be completed for all data. 11. Keywords 11.1 Blood pressure cuff, bond strength, tensile strength, cover, bladder, Instron 41
  • 42. Test Method for Tensile Strength of Various Fastener Options for the Disposable Blood Pressure Cuff 1. Scope 1.1 This test method provides a standard to measure the tensile strength of fasteners by performing a controlled displacement tensile test. The purpose of the fastener is to attach two material portions of the disposable blood pressure cuff together while an increased pressure is applied during measurement. 1.2 Safety issues are not addressed in this standard; thus, it is the responsibility of the user to take the appropriate precautions, if any. 2. Referenced Documents 2.1 ASTM Standards: D5170-98 Standard Test Method for Peel Strength (“T” Method) of Hook and Loop Touch Fasteners 3. Terminology: Definitions specific to this standard 3.1 Blood pressure- The pressure of the blood in the main arteries which rises and falls as the muscles of the body cope with varying demands. There are two types of pressure that are measured: 1) systolic pressure, created by the contraction of the heart muscle pushing blood into the vessels, and 2) diastolic pressure, when the heart is at rest between beats. 3.2 Blood pressure cuff- a device usually placed around the upper part of the arm to measure blood pressure. 3.3 Velcro Hook #88 and Loop #1000 fastener- a reusable fastener that consists of two mating polymer strips: a hook strip and loop strip. The surface of the hook strip, which is covered by small protrusions, hooks onto the surface of the loop strip. 3.4 Adhesive Emulsion (National Starch Company)- Easy Melt would be sprayed on one portion of the cuff and covered with a peel strip. When in use, the peel strip would be removed and the sticky surface can attach to the opposite portion of the cuff to hold it together. The cuff would only be adhered one time utilizing this method. 3.5 3-M Fastening, Release, and Frontal Tape- A sticky tab would be attached to one end of the BP cuff. When in use, the folded tab would be unpeeled exposing an adhesive surface similar to that on a baby diaper. The tab would then be applied to the appropriate portion of the cuff. This is the same tape fastener that is used for baby and adult diapers. 3.6 Tyvek (Type 14 and 16)- A polyethylene non-woven. 4. Significance and Use 4.1 This test provides a measure for the magnitude of the force that has to be applied normal to the mating surface of the fastener, in order to separate the strips. Such knowledge is required for effective use of the fastener. Measurements will be made for potential fastener materials as well as those of existing fasteners used on currently marketed disposable blood pressure cuffs for comparison. 42
  • 43. 43
  • 44. 5. Apparatus 5.1 Testing machine- an 88,964N tension/compression machine was used. It had two clamps, aligned such that the ends of the specimen were contained in the same plane. It should be noted that the displacement, between the clamps, was increased at a constant rate with respect to time, 2.5 cm/min., and the load cell was 4,448N. The machine was connected to software that recorded load versus displacement data. 5.2 The machine was calibrated using the shunt method; a known load was placed on the machine and it was verified that the software gave the correct output. 6. Sampling 6.1 For precision, 10 identical samples will be tested of each combination of fastener and cuff material. Fasteners on currently marketed cuffs will also be tested. They will be prepared on the same day and in the same manner. 7. Specimen Preparation 7.1 Both portions of the fastener will be cut into 6 cm by 8 cm rectangles with rounded edges. The fastener portions will be adhered to possible cover materials (8 cm by 10 cm), cut into and will be allowed to dry and set overnight. (Note: leave 1 cm at one end of each fastener not glued, as these free ends are placed in the tensile testing machine.) The samples will be assigned a number and labeled. (Figure 1). Hook Loop 8. Procedure 8.1 Before the test is performed the hook is attached to the appropriate loop material by pressing the two portions together. For the adhesive emulsion and 3M fastening, release and frontal tape, since there is only one portion, it is attached directly to one of the cover or bladder material options. 8.2 The fasteners are selected for testing in the same order as that they are prepared. Figure 1: Open fastener. For example, the Figure 2: Positioning of fastener on “hook” portion would be placed on the left and machine; arrows denote the direction the “loop” portion would be placed on the right. the claps were be pulling on 8.3 The clamps are positioned in the testing machine and set about 1 cm apart. 8.4 The free ends of the fastener specimen are placed in the clamps, which are tightened very well so no slippage occurred. It should be noted that the fastener specimen is aligned perpendicular to the clamps. 44
  • 45. 8.5 The distance between the clamps is increased by 2.5 cm per minute. 9. Calculations 9.1 The force required to separate each sample will be obtained from the data recorded from the software. Displacement data will also be obtained. The mean, standard deviation, and any other necessary variables or data will be recorded. Statistical analysis will be completed for all data. 10. Keywords 10.1 Fastener, hook, loop, tensile strength, Instron 45
  • 46. Test Method for Blood Pressure Training System 1. Scope 1.1 This test method provides a standard to measure the performance of various blood pressure cuffs both on the market and prototypes that will be developed. 1.2 Safety issues are not addressed in this standard; thus, it is the responsibility of the user to take the appropriate precautions, if any. 2. Referenced Documents 2.1 The user manual of the Gaumard Scientific Company, Inc. S410.100 Blood Pressure Training System with Speakers 3. Terminology: Definitions specific to this standard 3.1 Blood pressure- The pressure of the blood in the main arteries which rises and falls as the muscles of the body cope with varying demands. There are two types of pressure that are measured: 1) systolic pressure, created by the contraction of the heart muscle pushing blood into the vessels, and 2) diastolic pressure, when the heart is at rest between beats. 3.2 Blood pressure cuff- a device usually placed around the upper part of the arm to measure blood pressure. 4. Significance and Use 4.1 This test provides a means of evaluating the accuracy of blood pressure cuff performance. Due to the variability of a human blood pressure, it is difficult to verify the accuracy of a blood pressure measurement system. An individual’s blood pressure can vary due to activity level, time of day, and more importantly the number of times that the person has had their blood pressure taken within a certain time interval. 5. Apparatus 5.1 Testing machine- the Gaumard S410.100 Blood Pressure Training System with Speakers. 5.2 The machine was calibrated using the method advised in the instruction manual. If continual variances are seen with the device, recalibration may be required. Instructions can be found in the user manual. 5.3 An inflation device may be incorporated into the device to evaluate the long – term performance of the cuff. 6. Sampling 6.1 For precision, 3 samples of each of the three available disposable blood pressure cuffs will be evaluated on the device. Once prototypes of the CPM cuff have been designed and constructed, 3 of each will also be evaluated on this device. 6.2 When not using the original cuff with this system, minor modifications need to be made. The long, clear tubing needs to be incorporated into every cuff used on the device. The tubing connecting the gauge and sample cuff needs to be completed cut. 46
  • 47. The T-adapter and clear tubing needs to be removed from the original cuff and assembled into the tubing connecting the gauge and sample cuff. 7. Specimen Preparation 7.1 This testing will be the initial inflation for each of the samples. 8. Procedure 8.1 Place the arm on a clean and flat surface, and connect the cable of the arm to the BP Auscultation Tutor. 8.2 Connect the power supply cord to the Tutor and plug into an electrical outlet. 8.3 Connect the clear tubing from the cuff to the Tutor. 8.4 Connect speakers to the Tutor and plug into an electrical outlet. 8.5 Wrap the cuff around the arm approximately midway between the deltoid muscle and elbow. 8.6 Turn on the Tutor power. Place index and middle finger on the wrist of the arm and identify a pulse. 8.7 Apply a specific blood pressure to the device. To accomplish this press the Systolic button and press UP and DOWN until proper value is obtained, then press Systolic to set the value. 8.8 Complete the same procedure for the Diastolic reading. 8.9 Inflate the cuff until you can no longer feel a radial pulse, and then inflate about 10 mm beyond this point observing the reading on the gauge. 8.10 Slowly release the pressure on the bulb until the first Korotkoff sound is heard through the speakers- record the value of the gauge at this moment. This is the Systolic pressure. 8.11 Continue to release pressure in the cuff. Korotkoff sound 2 (K2), 3, and 4 can be heard. Finally K5 is silent. The value on the gauge at this point should be recorded- this is the Diastolic pressure. 8.12 Compare the values obtained through measurement and the value set for the device. 9. Calculations 9.1 The difference between the reading made by the individual and the reading set in BP auscultation tutor should be observed and recorded for each of the samples. (Actual-Tutor) 9.2 Three measurements will be made for each cuff type. The values should be added and divided by three to obtain an average error. 9.3 Complete this procedure for all cuff types. The cuff with the least average error value is the most accurate. 10. Keywords 10.1 blood pressure training, blood pressure measurement 47
  • 48. APPENDIX D Marketing Analysis Template Industry Analysis 1. What year did DBP market start? 2. Market growth 3. How many products per customer 4. Projection of market Market Segment 1. How many competitors? Overall, our region. 2. Improvements that have been made 3. Of the ____ customers, approximately ___% will use DBP Strengths 1. Strengths of our product in comparison 2. Technology advancements 3. Marketing, most powerful assets Weaknesses 1. Weaknesses in our product 2. Ways to reduce weakness Opportunities (Unexploited) 1) New application we would be marketing towards Threats 1. Internal threats 2. External threats Customer Profile 1. Typical customer for our product, field, what they currently use 2. Potential customers familiar with 3. How we are going to get them to readily accept our product 4. Any complementary product that would get people to buy our product Demographics 1. Different types of hospitals we are targeting a. Influence of that hospital on others b. Influences used to get them to buy product c. Income 2. Different people we would be targeting d. Hospital Managers, Administrators, Nurses, etc. 48
  • 49. Competition 1. Competitor’s strengths 2. Competitors weaknesses 3. Competitors strategy 4. Our strategy (how it is better) 5. Competitor’s prices 6. List things competitor’s have over us: location, quality, funding 7. Sales and profits of competitor 8. Any unique features others have that we do not 9. Ways our product is better 10. Ways our products compete Competitive Roundup 1. Pick three companies and do this 2. Do observations 49
  • 50. APPENDIX E Trimline Tempa-Kuff® • Competitively priced cuffs that are adaptable to all manual and electronic NIBP blood pressure measurement systems • Latex-free Tempa-Kuff® Soft Bladderless Cuffs help to reduce the risks associated with latex sensitivity • White, soft fabric cuffs have non-latex tubing and are secured with hook and loop closures • Available with single or double tubes, as well as with an economical bulb and valve. Made in the U.S.A. • price ranges from $5.83 to $7.98, with an average of $6.59 per cuff Critikon Soft-Cuf® • Soft, absorbent material for maxium patient comfort • Strong enough for repeated inflations • Economical enough for single-patient use • For all your monitoring needs Critikon CLASSIC-CUF® • Easy-to-clean vinyl surface • Strong enough for repeated inflations • Economical enough for single-patient use • For all your monitoring needs MABIS® cuff • Very comfortable • Simple design but very effective • Inexpensive compared to other leading brands • Bulb and gauge are universal • Clever use of Velcro, fits large range of arm sizes • Durable by double-seam heat seal • Wiped clean for re-use • May not be cost efficient to dispose tubing, bulb, and gauge, CPM can improve here by possibly making the tubing from the same material as the cuff itself • Velcro comes unattached eventually from high usage. Either the glue bond or heat seal on the back of the Velcro can be improved The actual design of the blood pressure cuff will be in the hands of the Prototype/Testing Team. Nonetheless, it can easily be seen from even these four DBP cuffs on the market, that we are going to need a cuff that is comfortable and durable while maintaining a competitive price. The Trimline Tempa-Kuff® with an average cost of $6.59 will be extremely hard to compete with; however, with a lot of research and innovative thinking, we believe that it can be done. 50
  • 51. SUMMARY OF INTENT CPM SPRING 2004 OBJECTIVES This semester, the CPM class will be divided into five teams including ESH, Prototype/Testing, Marketing, Production, and BFI. The following is a list of class accomplishments for the Fall 2003 semester: • Finalized format for the 510(k) document • Completed industry analysis • Determined appropriate machinery for cuff manufacture • Finalized and ordered materials for bladder, cover, and fastener PROTOTYPE/TESTING TEAM The Prototype/Testing team has the following objectives for this semester: • Train team on Blood Pressure Training System • Research and order heated die for use in hydraulic press • Perform testing on individual components and currently marketed BP cuffs • Create workable prototype and test The next steps are to: • Continue prototyping • Review marketing team interviews to gain information for the final design. • Conduct preliminary testing with sample materials. • Test disposable cuffs currently on the market. The timeline for the team is to have a prototype by week nine with testing to begin by week 10. All work is to be complete by Week 13 with the enterprise expo presentation during week 14. MARKETING TEAM The Marketing team has the following objectives for the semester: • Research the size of the disposable BP cuff market within the U.S. • Complete an assessment of the competitive landscape for BP cuffs • Organize a focus group • Widen market geography to entire United States The team is currently working on compiling surveys with health care professionals across the country. This semester they plan to contact more health care professionals to participate in a survey or possibly a focus group. Annual revenues and volumes will also be determined. PRODUCTION TEAM The Production team has the following objectives for the semester: • Develop process layout for a cuff manufacturing plant • Create costing/cash flow tables • Perform a profitability analysis 51
  • 52. • Review preliminary business proposition, including investment required and potential return Current work includes investigating CPM’s press to be used as a possible heat sealer and contacting companies inquiring about their process layouts. The next steps include working with the Prototype/Testing team on material selection and choosing machinery that would be used to run the manufacturing process. ESH TEAM The ESH team has the following objectives for this semester: • Use material information given by prototype-testing team to find FDA regulations and data • Complete 510(k) summary • Continue research on applicable predicate devices • Maintain lab cleanliness and equipment safety • Train class members on spray adhesive machine • Appoint safety officer to complete regular lab inspections, give updates, and offer suggestions The ESH team is currently collecting information for the 510(k) report. They are also continuing their research into any FDA regulations on any of the BP cuff’s components and information that they received from the Prototype-Testing team. The next steps are to: • Train CPM members on spray adhesive equipment • Compile list of predicate devices based on preliminary cuff design and make-up • Determine the restrictions and regulations on other components • Work with testing team to determine what other components will be needed to manufacture the cuff • Continue to maintain lab cleanliness and equipment safety BFI TEAM The BFI team has three main objectives this semester. They include completing the Fall 2003 report, completing the Spring 2004 BFI Report, and to outline an IRB document. Current due dates for team reports are tentatively set for 7th and 10th week. The final portion of the BFI team’s objectives is to have the report ready for the enterprise expo in April. 52

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