TZ Medical - December 2019

THE TIMES

DECEMBER 2019

THE PEOPLE WHO TAKE OUR PRODUCTS FROM CONCEPT TO REALITY MEET OUR TEAM OF BRILLIANT ENGINEERS ARC EXCLUSION AREA An exclusion area has been specifically developed to allow maximum clarity and legibility of the logo. The image below represents the exclusion area required around any application of the pri- mary logo. No type or graphic elements should intrude in this space. This area is measure by the capital width of the TZ letters incorporated in the primary coin logo. ARC EXCLUSION AREA An exclusion area has be n specifically developed to llow maximum clarity and legibility of the logo. The image below represents the exclusion area required around any application of the pri- mary logo. No type or graphic elements should intrude in this space. This area is measure by the capital width of the TZ letters incorporated in the primary coin logo. EXCLUSION AREA An exclusion area has be n specifically developed to llow maximum clarity and legibility of the logo. The image below represents the exclusion area required around any application of the pri- mary logo. No type or graphic elements should intrude in this space. This area is measure by the capital width of the TZ letters incorporated in the primary coin logo. EXCLUSION AREA An exclusion area has be n specifically developed to llow maximum clarity and legibility of the logo. The image below represents the exclusion area required around any application of the pri- mary logo. No typ or graphic lem nts should intrude in this space. This area is measure by the capital width of the TZ letters incorporated in the primary coin logo. EXCLUSION AREA An exclusion area has been specifically developed to allow maximum clarity and legibility of the logo. The image below represents the exclusion area required around any application of the pri- mary logo. No type or graphic elements should intrude in this space. This area is measure by the capital width of the TZ letters incorporated in the primary coin logo. EXCLUSION AREA An exclusion area has be n specifically developed to llow maximum clarity and legibility of the logo. The image below represents the exclusion area required around any application of the pri- mary logo. No type or graphic elements should intrude in this space. This area is measure by the capital width of the TZ letters incorporated in the primary coin logo. 17750 SW Upper Boones Ferry Rd., Ste. 150, Portland, OR 97224 | TZMedical.com | 800-944-0187 PROCEDURE LIGHTING ARC

SECONDARY LOGOS/ CATEGORY LOGOS

SECONDARY LOGOS/ CATEGORY LOGOS

HEMOSTASIS

SECONDARY LOGOS/ CATEGORY LOGOS

HEMOSTASIS

HEMOSTASIS SECONDARY LOGOS/ CATEGORY LOGOS ELECTROPHYSIOLOGY HEMOSTASIS SECONDARY LOGOS/ CATEGORY LOGOS

Inside TZ Medical’s Portland, Oregon headquarters, a series of high-tech laboratories hosts the three teams of engineers that take our innovative medical products from concept to reality. Though their work is done almost entirely behind the scenes, without these 14 people — three mechanical engineers, four electrical and computer engineers, six software engineers, and one intern — our devices would never make it to the cath lab. When a physician, nurse, or technologist sends a bright idea for a new medical product to our office, it falls almost immediately into the hands of our engineering team. It’s very rare that these ideas come fully formed. Instead, these brilliant sparks take a lot of careful coaxing to become full- fledged products. "There is a lot more work than just a design job,” explains Austin Ziegler, a mechanical design engineer who has been on TZ’s team for over two years. “There is a lot of risk-benefit analysis that needs to be done and regulatory information that needs to be considered. We ask, ‘Will this product’s benefits to the patient outweigh the risks?’ We do a lot of usability testing because we want to make it as easy as possible for the patient, doctor, and technologist.” Our engineers take each product through myriad phases, starting with design, then moving on to prototyping, testing, revision, packing, labeling, and instruction creation. Depending on the type of product and how fleshed out the original idea was, this process can take anywhere from three months to three years. For additional input, we’ll often send prototypes into the field with our sales representatives to be vetted by physicians in cath labs nationwide. Each product must pass two different sets of rigorous standards before leaving the lab: the Application of Risk Management to Medical Devices (EN ISO 14971:2012) and the Application of Usability Engineering to Medical Devices (EN 62366:2008). Explaining the first standard, Ziegler says, “What we have to do is go through all of these different potential hazards. There are 15 sections of potential hazards, and 11 potential failure TZMedical Sparkedbyyour ideas TZMedical Sparkedbyyour ideas PATIENT POSITIONING WORKPLACE SAFETY RADIATION PROTECTION TZMedical Sparkedbyyour ideas PROCEDURE LIGHTING PATIENT POSITIONING WORKPLACE SAFETY RADIATION PROTECTION TZMedical Sparkedbyyour ideas ROCEDURE LIGHTING PATIENT POSITIONING WORKPLACE SAFETY RADIATION PROTECTION TZMedical Sparkedbyyour ideas ARC PROCEDURE LIGHTING PATIENT POSITIONING WORKPLACE SAFETY RADIATION PROTECTION TZMedical Sparkedbyyour ideas ARC PROCEDURE LIGHTING PATIENT POSITIONING WORKPLACE SAFETY RADIATION PROTECTION TZMedic l Sparkedbyyour ideas ARC PROCEDURE LIGHTING PATIENT POSITIONING WORKPLACE SAFETY RADIATION PROTECTION TZMedic l Sparkedbyyour ideas TZMedical Sparkedbyyour ideas TZMedical Sparkedbyyour ideas TZMedical Sparkedbyyour ideas EXCLUSION AREA An exclusion area has been specifically developed to allow maximum clarity and legibility of the logo. The image below represents the exclusion area required around any application of the pri- mary logo. No type or graphic elements should intrude in this space. This area is measure by the capital width of the TZ letters incorporated in t e primary coin logo. EXCLUSION AREA An exclusion area has been specifically developed to allow maximum clarity and legibility of the logo. The image below represents the exclusion area required around any application of the pri- mary logo. No type or graphic elements should intrude in this space. This area is measure by the capital width of the TZ lett rs incorporated in the prim ry coin logo. EXCLUSION AREA An exclusion area has be n specifically d veloped to allow maximum clarity and legibility of the logo. The image below represents the exclusion area required around any application of the pri- mary logo. No type or graphic elements should intrude in this space. This area is measure by the capital width of the TZ letters incorporated in the primary coin logo. EXCLUSION AREA An exclusion area has be n specifically developed to allow maximum clarity and legibility of the logo. The image below represents the exclusion area required around any application of the pri- mary logo. No type or graphic elements should intrude in this space. This area is measure by the capital width of the TZ letters incorporated in the primary coin logo. EXCLUSION AREA An exclusion area has be n specifically developed to llow maximum clarity and legibility of the logo. The image below represents the exclusion area required around any application of the pri- mary logo. No type or graphic elements should intrude in this space. This area is measure by the capital width of the TZ letters incorporated in the prima y coin l go. MINIMUM SIZE The logo should meet the minimum size requirement of 3/8 in. wide for the logo with the tagline and 0.15 in. diameter for the logo without the tagline (the ‘coin’). When required in smaller sizes, use black (Positive) or White (reversed) versions of the logo. MINIMUM SIZE The logo should meet the minimum size requirement of 3/8 in. wide for the logo with the tagline and 0.15 in. diameter for the logo without the tagline (the ‘coin’). When required in smaller sizes, use black (Positive) or White (reversed) versions of the logo. MINIMUM SIZE The logo should meet the minimum size requir ment of 3/8 in. wide for the logo with the tagline and 0.15 in. diameter for the logo without the tagline (the ‘coin’). When required in smaller sizes, use black (Positive) or White (reversed) versions of the logo. MINIMUM SIZE The logo should m et the minimum size requirement of 3/8 in. wide for the logo with the tagline and 0.15 in. diameter for the logo without the tagline (the ‘coin’). When required in smaller sizes, use black (Positive) or White (reversed) versions of the logo. MINIMUM SIZE The logo should m et the minimum size requirement of 3/8 in. wide for the logo with the tagline and 0.15 in. diameter for the logo without the tagline (the ‘coin’). When required in smaller sizes, use black (Positive) or White (reversed) versions of the logo. ACCEPTABLE BACKGROUNDS Acceptable background images depend on how they are used. A good background will include the TZ Blue color or one of the tint color variations. (see page 17 for details on these colors.) The background should not be too distracting if there is a large amount of text. Keep the backgrounds simple and professional. ACCEPTABLE BACKGROUNDS Acceptable background images depend on how they are used. A good background will include the TZ Blue color or one of the tint color variations. (see page 17 for details on these colors.) The background should not be too distracting if there is a large amount of text. Keep the backgrounds simple and professional. ACCEPTABLE BACKGROUNDS Accept ble backgrou d images depend on how they are used. A good background will include the TZ Blue color or one of the tint color variations. (see page 17 for details on these colors.) The background should not be too distracting if there is a large amount of text. Keep the backgrounds simple and professional. ACCEPTABLE BACKGROUNDS Accept ble background images depend on how they are used. A good background will include the TZ Blue color or one of the tint color variations. (see page 17 for details on these colors.) The background should not be too distracting if there is a large amount of text. Keep the backgrounds simple and professional. ACCEPTABLE BACKGROUNDS Accept ble background images depend on how they are used. A good background will include the TZ Blue color or one of the tint color variations. (see page 17 for details on these colors.) The background should not be too distracti g if there is a large amount of text. Keep the backgrounds simple and professional.

modes. Each section has subsections — one might have six, another might have 11 — describing how the product could potentially pose a hazard or fail. Throughout, we need to create certification tests, go through which hazards will apply, and make sure to verify the product at the end. It’s a rigorous checklist.” The process is similarly comprehensive for the second standard, which tests the products for user-friendliness and ensures they’ll meet the needs of both patients and physicians. The Application of Risk Management testing is Ziegler’s favorite part of the process because it involves designing a range of secondary fixtures used to push the product to its breaking point. Usually, each product requires its own array of specific fixtures. “It’s very rare that we can reuse a fixture,” Ziegler says. “The majority of the time, I’d say 90%, we’re designing new ones because the tests are going to be different on different products.” A puncture test, for example, wouldn’t be necessary for some devices but is absolutely vital for others. Each engineer works on five to seven products at once, including a handful of complex mechanical devices and a few “white-label” products that are more advanced in the process. They pour time, energy, and effort into them for months or years, ferrying each small spark through to completion. Each device that comes out of our Portland office truly takes a village, and it’s thanks to the hard work of engineers like Ziegler that we’re able to change lives for the better in cath labs across the nation. Next time you visit TZMedical.com or call us to place an order, please remember just how much careful thought, testing, and planning went into each product — and consider thanking an engineer for your peace of mind. “If it passes that, then it’s a usable product,” Ziegler says.

ELECTROPHYSIOLOGY HEMOSTASIS SECONDARY LOGOS/ CATEGORY LOGOS

DEFIBRILLATION ELECTROPHYSIOLOGY HEMOSTASIS

MINIMUM SIZE The logo should meet the minimum size requirement of 3/8 in. wide for the logo with the tagline and 0.15 in. diameter for the logo without the tagline (the ‘coin’). When required in smaller sizes, use black (Positive) or White (reversed) versions of the logo. MINIMUM SIZE The logo should meet the minimum size requirement of 3/8 in. wide for the logo with the tagline and 0.15 in. diameter for the logo without the tagline (the ‘coin’). When required in smaller sizes, use black (Positive) or White (reversed) versions of the logo. MINIMUM SIZE The logo should m et the minimum size requirement of 3/8 in. wide for the logo with the tagline and 0.15 in. diameter for the logo without the tagline (the ‘coin’). When required in smaller sizes, use black (Positive) or White (reversed) versions of the logo. MINIMUM SIZE The logo should meet the minimum size requirement of 3/8 in. wide for the logo with the tagline and 0.15 in. diameter for the logo without the tagline (the ‘coin’). When required in smaller sizes, use black (Positive) or White (reversed) versions of the logo. MINIMUM SIZE The logo should m et the minimum size requirement of 3/8 in. wide for the logo with the tagline and 0.15 in. diameter for the logo without the tagline (the ‘coin’). When required in smaller sizes, use black (Positive) or White (reversed) versions of the logo. MINIMUM SIZE The logo should meet the minimum size requirement of 3/8 in. wide for the logo with the tagline and 0.15 in. diameter for the logo without the tagline (the ‘coin’). When required in smaller sizes, use black (Positive) or White (reversed) versions of the logo. ACCEPTABLE BACKGROUNDS Acceptable background images depend on how they are used. A good background will include the TZ Blue color or one of the tint color variations. (see page 17 for details on these colors.) The background should not be too distracting if there is a large amount of text. Keep the backgrounds simple and professional. ACCEPTABLE BACKGROUNDS Acceptable background images depend on how they are used. A good background will include the TZ Blue color or one of the tint color variations. (see page 17 for details on these colors.) The background should not be too distracting if there is a large amount of text. Keep the backgrounds simple and professional. ACCEPTABLE BACKGROUNDS Accept ble background images depend on how they are used. A good background will include the TZ Blue color or one of the tint color variations. (see page 17 for details on these colors.) The background should not be too distracting if there is a large amount of text. Keep the backgrounds simple and professional. ACCEPTABLE BACKGROUNDS Accept ble backgrou d images depend on how they are used. A good background will include the TZ Blue color or one of the tint color variations. (see page 17 for deta ls on these colors.) The background should not be too distracting if there is a large amount of text. Keep the backgrounds simple and professional. ACCEPTABLE BACKGROUNDS Acceptable background images depend on how they are used. A good background will include the TZ Blue color or one of the tint color variations. (see page 17 for details on these colors.) The background should not be too distracting if there is a large amount of text. Keep the backgrounds simple and professional. ACCEPTABLE BACKGROUNDS Accept ble backgrou d images depend on how they are used. A good background will include the TZ Blue color or one of the tint color variations. (see page 17 for details on these colors.) The background should not be too distracting if there is a large amount of text. Keep the b ckgrounds simple and professional.

ELECTROPHYSIOLOGY

DEFIBRILLATION ELECTROPHYSIOLOGY HEMOSTASIS

NEUROSURGICAL DEFIBRILLATION ELECTROPHYSIOLOGY

NEUROSURGICAL DEFIBRILLATION ELECTROPHYSIOLOGY

DEFIBRILLATION

CARDIAC MONITORS NEUROSURGICAL DEFIBRILLATION

CARDIAC MONITORS NEUROSURGICAL DEFIBRILLATION

COMFORT ZONE CARDIAC MONITORS NEUROSURGICAL

NEUROSURGICAL

COMFORT ZONE CARDIAC MONITORS NEUROSURGICAL

COMFORT ZONE CARDIAC MONITORS

COMFORT ZONE CARDIAC MONITORS

CARDIAC MONITORS

COMFORT ZONE

COMFORT ZONE

COMFORT ZONE OGOS/ CATEGORY LOG S

OGOS/ CATEGORY LOGOS

ARC

MOSTASIS

OGOS/ CATEGORY LOGOS

ARC

MOSTASIS

OGOS/ CATEGORY LOGOS

ARC

ARC

ECTROPHYSIOLOGY MOSTASIS OGOS/ CATEGORY LOGOS

PROCEDURE LIGHTING

ARC

MOSTASIS

PROCEDURE LIGHTING

ECTROPHYSIOLOGY

ARC

FIBRILLATION ECTROPHYSIOLOGY MOSTASIS

PATIENT POSITIONING PROCEDURE LIGHTING

PROCEDURE LIGHTING

PATIENT POSITIONING PROCEDURE LIGHTING

FIBRILLATION ECTROPHYSIOLOGY

WORKPLACE SAFETY PATIENT POSITIONING PROCEDURE LIGHTING

UROSURGICAL FIBRILLATION ECTROPHYSIOLOGY

WORKPLACE SAFETY PATIENT POSITIONING

UROSURGICAL FIBRILLATION

PATIENT POSITIONING

RADIATION PROTECTION WORKPLACE SAFETY PATIENT POSITIONING

RDIAC MONITORS UROSURGICAL FIBRILLATION

RADIATION PROTECTION WORKPLACE SAFETY

RDIAC MONITORS UROSURGICAL

RADIATION PROTECTION WORKPLACE SAFETY

MFORT ZONE RDIAC MONITORS UROSURGICAL

WORKPLACE SAFETY

MFORT ZONE RDIAC MONITORS

RADIATION PROTECTION

MFORT ZONE RDIAC MONITORS

RADIATION PROTECTION

MFORT ZONE

RADIATION PROTECTION

–The TZ Medical Team

MFORT ZONE

800-944-0187 | 1

www.tzmedical.com

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