® A world of choice in silicone tubing and fluid handling products Platinum-cured USP Class VI ISO 13485 Certified ISO 14644 Certified ISO Class 7 and 8 Cleanrooms FDA Registered SILICONE TUBING SILICONE STOPPERS SILICONE GASKETS CUSTOM SERVICES ® Delivering quality silicone tubing and fluid handling products on time, on spec, and on budget The world’s leading pharmaceutical and medical device companies rely on HelixMark to deliver an extensive selection of high-quality silicone tubing and fluid handling products. Manufactured globally by Helix Medical, HelixMark products are available off-the-shelf in a wide array of product types and sizes. We also offer a broad range of silicones from all the major manufacturers. Best of all, we deliver all our products on time, on spec, and on budget. •PharmaFocus® Tubing • Standard Tubing • Braided Reinforced Tubing • Color Stripe Tubing • Close Tolerance Tubing • Peristaltic Pump Tubing •Stoppers •Gaskets • Custom Back-jacketed Tubing • Custom Assemblies • Custom Packaging THE CHOICE OF SILICONE YOU WANT HelixMark products are available with a choice of pharmaceutical- and medical-grade silicones made by industry leaders including Dow Corning, Wacker, NuSil, and Momentive. Blue Star is also available for custom applications. THE CUSTOM SERVICES YOU DESERVE Custom ID/OD sizing, custom labeling and certification, and a variety of packaging formats are available including bulk, spooled, and cut-to-length. Additional custom services include skiving, pad printing, bonding/gluing, punching, drilling, parylene coating, proprietary striping, and rapiopaque. Helix Medical offers custom extrusions in a wide variety of tubing types including multi-lumen, intricate cross sections, co-extrusion, wire coating, profiles, rods, tapes, and formed tubing. THE QUALITY STANDARDS YOU DEMAND HelixMark products have been developed as a result of over 28 years of medical device manufacturing experience. We apply an ISO 13485 medical device quality system to all production and inspection processes and include material certification and lot traceability with every product. Our products are fabricated in an FDA-registered facility with ISO 14644 Class 7 and 8 cleanrooms (USP Class VI, ISO 10993). PharmaFocus® Tubing Focused on quality THE RIGHT TESTING The platinum-cured silicone elastomer used for our PharmaFocus Tubing has been designed specifically to fit the needs of the pharmaceutical marketplace. This silicone undergoes a battery of biocompatibility tests appropriate for pharmaceutical applications, eliminating the costly extended implant studies typically performed on biomedical-grade silicones. The result: a more costeffective silicone tubing that delivers consistent quality and the right level of assurance. THE RIGHT SOURCE Helix Medical consistently strives to meet our number one goal: to instill confidence into every product we make. This drive to provide peak levels of assurance to our customers compels us to meet the highest standards available for our production areas. PharmaFocus Platinum-cured Silicone Tubing is available in 11 popular size combinations. Typical hardness: 50 Shore A. INSIDE DIAMETER inch OUTSIDE DIAMETER mm WALL mm ref number .1253.18 .2506.35 .0631.59 61-252-21 .1884.76 .3137.94 .0631.59 61-252-22 .1884.76 .3759.53 .0942.38 61-252-23 .250 6.35 .43811.11 .094 2.38 61-252-25 .250 6.35 .50012.70 .125 3.18 61-252-26 .313 7.94 .50012.70 .094 2.38 61-252-27 .375 9.53 .62515.88 .125 3.18 61-252-30 .500 12.70.750 19.05.125 3.18 61-252-32 .625 15.88.875 22.23.125 3.18 61-252-33 .750 19.05 1.000 25.40 .125 3.18 61-252-35 1.000 25.40 1.50038.10 .250 6.35 61-252-36 inch mm inch Values listed are typical. Please contact customer service for tolerances and custom size requests. PHARMAFOCUS TUBING RANGE SIZE INDICATOR S PECI F I C AT I O NS n s l t ISO 10993-I FDA 21CFR 177-2600 USP Class VI EP 3.1.9 50 Foot Coils (15.24 meters) • Packaged double bagged in crush-resistant boxes. • Material Certification and Lot Traceability included in every box. Largest Size: 1.0 ID X 1.5 OD Smallest Size: .125 ID X .250 OD (877) 308-0558 / helixmedical.com 1 Standard Silicone Tubing Full range of sizes, wide choice of silicones HelixMark Standard Silicone Tubing is offered in a full range of competitive sizes in four choices of silicone elastomer: Dow Corning, Wacker, NuSil, or Momentive. INSIDE DIAMETER inch All of our HelixMark Standard Silicone Tubing offerings are platinum-cured, and contain no additives, plasticizers, or peroxide components. The tubing is nonadherent and resists clotting, sticking, or encrustation. With the ability to operate at elevated temperatures, it will not oxidize or deteriorate. Rigorous testing, including expanded biocompatibility, provides quality assurance for the most demanding biomedical/pharmaceutical industry standards. HelixMark Standard Tubing can be sterilized with autoclave, ethylene oxide, or gamma radiation within the user’s validated cycles and exposure levels. STANDARD TUBING RANGE SIZE INDICATOR Dow Corning Silastic OUTSIDE DIAMETER mm inch mm WALL inch mm Wacker Nusil n s l t n s l n lt l s ref number ref number ref number ref number Momentive .012.31 .025.64 .006.15 60-011-01 60-411-40 60-795-01 60-805-01 .020.51 .037.94 .008.20 60-011-02 60-411-41 60-795-02 60-805-02 .025 .64 .0471.19 .011 .28 60-011-03 60-411-42 60-795-03 60-805-03 .030 .76 .0651.65 .018 .46 60-011-04 60-411-43 60-795-04 60-805-04 .040 1.02.085 2.16.023 .58 60-011-05 60-411-44 60-795-05 60-805-05 .058 1.47.077 1.96.009 .23 60-011-06 60-411-45 60-795-06 60-805-06 .062 1.58.095 2.41.016 .41 60-011-07 60-411-46 60-795-07 60-805-07 .062 1.58.125 3.18.032 .81 60-011-08 60-411-47 60-795-08 60-805-08 .078 1.98.125 3.18.024 .61 60-011-09 60-411-48 60-795-09 60-805-09 .1042.64 .0441.12 60-011-10 60-411-49 60-795-10 60-805-10 .132 3.35.183 4.65.026 .66 60-011-11 60-411-50 60-795-11 60-805-11 .1253.18 .2506.35 .0631.59 60-011-21 60-411-51 60-795-21 60-805-21 .1884.76 .3137.94 .0631.59 60-011-22 60-411-52 60-795-22 60-805-22 .1884.76 .3759.53 .0942.38 60-011-23 60-411-53 60-795-23 60-805-23 .2506.35 .3759.53 .0631.59 60-011-24 60-411-54 60-795-24 60-805-24 .250 6.35 .43811.11 .094 2.38 60-011-25 60-411-55 60-795-25 60-805-25 .250 6.35 .50012.70 .125 3.18 60-011-26 60-411-56 60-795-26 60-805-26 .313 7.94 .50012.70 .094 2.38 60-011-27 60-411-57 60-795-27 60-805-27 .375 9.53 .50012.70 .063 1.59 60-011-28 60-411-58 60-795-28 60-805-28 .375 9.53 .56314.29 .094 2.38 60-011-29 60-411-59 60-795-29 60-805-29 .375 9.53 .62515.88 .125 3.18 60-011-30 60-411-60 60-795-30 60-805-30 .500 12.70.688 17.46.094 2.38 60-011-31 60-411-61 60-795-31 60-805-31 .500 12.70.750 19.05.125 3.18 60-011-32 60-411-62 60-795-32 60-805-32 .625 15.88.875 22.23.125 3.18 60-011-33 60-411-63 60-795-33 60-805-33 .625 15.88.938 23.82.156 3.97 60-011-34 60-411-64 60-795-34 60-805-34 N/A 60-411-65 N/A N/A .750 19.05 .1924.88 1.00025.40 .125 3.18 TYPICAL PROPERTIES AS CURED Specific Gravity Durometer Hardness, Shore A pts Tear Strength, Die B, ppi Tensile Strength, Die C, psi Elongation, Percent 1.161.15 1.141.15 50 55 50 52 262 218 230 270 1473 1385 1350 1400 903771 810880 Please contact customer service for tolerances and custom size requests. Specification Writers: Values stated are typical values only and are not intended for use in preparing specifications. Largest Size: .750 ID X 1.0 OD Smallest Size: .012 ID X .025 OD S PECI F I C AT I O NS n ISO 10993-I s FDA 21CFR 177-2600 l USP Class VI 50 Foot Coils (15.24 meters) • Packaged double bagged in crush-resistant boxes. • Material Certification and Lot Traceability included in every box. 2 t EP 3.1.9 Color Stripe Tubing Recognize lines at a glance HelixMark Color Stripe Silicone Tubing is available with three choices of color striping: red, green, or white. Whether you want to recognize your lines at a glance by application, tubing size, or functional area, HelixMark Color Stripe Tubing gives you the flexibility to create your own system. Add nonstripe and custom colors to create as complex a system as necessary. Typical Hardness: 55 Shore A. INSIDE DIAMETER inch mm OUTSIDE DIAMETER inch mm WALL inch mm Red Stripe ref number Green Stripe ref number White Stripe ref number .1253.18 .2506.35 .0631.59 61-078-21 61-079-21 61-080-21 .1884.76 .3759.53 .0942.38 61-078-23 61-079-23 61-080-23 .250 6.35 .50012.70 .125 3.18 61-078-26 61-079-26 61-080-26 .313 7.94 .50012.70 .094 2.38 61-078-27 61-079-27 61-080-27 .375 9.53 .62515.88 .125 3.18 61-078-30 61-079-30 61-080-30 .500 12.70.750 19.05.125 3.18 61-078-32 61-079-32 61-080-32 Values listed are typical. Please contact customer service for tolerances and custom size requests. COLOR STRIPE TUBING RANGE SIZE INDICATOR Our proprietary process ensures that the silicone stripe is integrated into the tube wall, yet does not touch the inner bore. Largest Size: .500 ID X .750 OD Smallest Size: .125 ID X .250 OD S PECI F I C AT I O NS n s l ISO 10993-I FDA 21CFR 177-2600 USP Class VI 50 Foot Coils (15.24 meters) • Packaged double bagged in crush-resistant boxes. • Material Certification and Lot Traceability included in every box. (877) 308-0558 / helixmedical.com ® 3 Braided Reinforced Tubing Close Tolerance Tubing Ideal for increased pressure or high temperatures Superior flow for exacting applications Manufactured with our proprietary process incorporating strong polyester braiding between extrusions of platinum-cured silicone, our durable Braided Reinforced Tubing with the identifiable blue spiral is ideally suited for increased pressure and/ or high-temperature applications. HelixMark Braided Reinforced Tubing can be sterilized by autoclave, ethylene oxide, or gamma radiation within the user’s validated cycles and exposure levels. Typical hardness: 65 Shore A. INSIDE DIAMETER inch mm OUTSIDE DIAMETER inch mm Biomedical/pharmaceutical-grade platinum-cured silicone tubing, manufactured with Dow Corning, provides superior flow properties. HelixMark close tolerance silicone tubing ensures minimal dimension variation, making this tubing appropriate for exacting applications. It can be sterilized with autoclave or ethylene oxide as well as by gamma radiation within the user’s validated cycles and exposure levels. Typical hardness: 50 Shore A. MINIMUM BURST @ 70° F INSIDE DIAMETER PSI ref number inch inch mm WALL inch mm ref number .1253.18 .3659.27 705 60-664-20 .1253.18 .2506.35 .0631.59 60-111-21 .187 4.76 .447 11.35 655 60-664-30 .1884.76 .3137.94 .0631.59 60-111-22 .250 6.35 .520 13.21 630 60-664-40 .2506.35 .3759.53 .0631.59 60-111-24 .312 7.93 .592 15.04 555 60-664-45 .2506.35 .43811.13 .0942.38 60-111-25 .375 9.53 .655 16.64 505 60-664-50 .3759.53 .56314.29 .0942.38 60-111-29 .500 12.70 .800 20.32 430 60-664-60 .3759.53 .62515.88 .1253.18 60-111-30 .625 15.88 .965 24.51 355 60-664-70 .50012.70 .68817.46 .0942.38 60-111-31 .750 19.05 1.100 27.94 280 60-664-80 .50012.70 .75019.05 .1253.18 60-111-32 .875 22.23 1.235 31.37 255 60-664-90 .62515.88 .87522.23 .1253.18 60-111-33 1.000 25.40 1.360 34.54 230 60-664-100 Values listed are typical. Please contact customer service for tolerances and custom size requests. Values listed are typical. Please contact customer service for tolerances and custom size requests. S P E C I F I C AT I O N S S P E C I F I C AT I O N S n s l t ISO 10993-I n ISO 10993-I FDA 21CFR 177-2600 s l t USP Class VI USP Class VI EP 3.1.9 25 Foot Coils (7.62 meters) • Packaged double bagged in crush-resistant boxes. • Material Certification and Lot Traceability included in every box. 4 mm OUTSIDE DIAMETER FDA 21CFR 177-2600 EP 3.1.9 50 Foot Coils (15.24 meters) • Packaged double bagged in crush-resistant boxes. • Material Certification and Lot Traceability included in every box. Peristaltic Pump Tubing Longer life, superior strength, proven performance HelixMark Peristaltic Pump Tubing, manufactured with Wacker Silicones material, meets the strength and durability required for pump applications. Peristaltic Pump Tubing undergoes Helix’s special stabilization process, providing the additional benefits of superior strength, performance, and longer life. Our tubing offers proven longer wear and volumetric consistency over 8, 12, and 24 hour process runs and is the most reliable and consistent platinum-cured silicone tubing available today for pumping applications. Typical hardness: 60 Shore A. PUMPING CONSIDERATIONS AND PRECAUTIONS In pumping procedures, particularly those involving extracorporeal circuitry using a roller head, these items should be considered: 1. U nder certain conditions, microscopic particles (spallation) can be generated with any pump head tubing. In-line filtration is highly recommended; if not feasible, further safety and efficacy testing should be conducted. 2. O ver-occlusive settings should be avoided. Adjust pump head rollers with the pump manufacturer’s recommended procedure. 3. Care should be taken to avoid cuts or nicks. 4. Tubing should not be twisted when placed in the raceway of the pump. 5. S ilicone fluid or silicone grease should not be used to lubricate silicone tubing as these may swell and weaken the tubing. 6. R outine maintenance is recommended for roller bearings. Tests have demonstrated that improperly maintained rollers can cause increased drag and spallation. Caution: In roller pump applications, the use of nominal tolerance tubing is not recommended. If the total occlusive setting of the head exceeds the actual combined wall thickness of the tubing, close tolerance wall tubing is recommended. The information and data contained herein are based on information we believe reliable. You should thoroughly test any application and independently conclude satisfactory performance before use. PERISTALTIC PUMP TUBING RANGE SIZE INDICATOR S P E C I F I C AT I O N S n s l ISO 10993-I FDA 21CFR 177-2600 USP Class VI 25 Foot Coils (7.62 meters) • Packaged double bagged in crush-resistant boxes. • Material Certification and Lot Traceability included in every box. (877) 308-0558 / helixmedical.com INSIDE DIAMETER inch mm DIAMETER inch mm WALL inch mm .0200.51 .1463.71 .0631.60 .0310.79 .1573.99 .0631.60 .0390.99 .0631.60 .0120.31 .0591.50 .0992.52 .0200.51 .0631.60 .1894.80 .0631.60 .0631.60 .2516.38 .0942.39 .0792.01 .1193.02 .0200.51 .0992.52 .1393.53 .0200.51 .1183.00 .1584.01 .0200.51 .1253.18 .2516.38 .0631.60 .1253.18 .3137.95 .0942.39 .1584.01 .2145.44 .0280.71 .1884.78 .3147.98 .0631.60 .1884.78 .3769.55 .0942.39 .1884.78 .3889.86 .1002.54 .188 4.78 .43811.13 .125 3.18 .2506.35 .3769.55 .0631.60 .250 6.35 .43811.13 .094 2.39 .250 6.35 .45011.43 .100 2.54 .250 6.35 .50012.70 .125 3.18 .250 6.35 .52013.21 .135 3.43 .313 7.95 .43911.15 .063 1.60 .313 7.95 .50112.73 .094 2.39 .313 7.95 .62915.98 .158 4.01 .3759.53 .56314.3 .0942.39 .375 9.53 .62515.88 .125 3.18 .375 9.53 .64516.38 .135 3.43 .375 9.53 .74919.03 .187 4.75 .473 12.01.789 20.03.158 4.01 .500 12.70.750 19.05.125 3.18 .500 12.70.770 19.56.135 3.43 .500 12.70.874 22.20.187 4.75 .625 15.88.875 22.23.125 3.18 .625 15.88.999 25.38.187 4.75 .630 16.00.946 24.03.158 4.01 .750 19.05 1.12428.55 .187 4.75 1.00025.40 1.374 34.90 .187 4.75 1.00025.40 1.400 35.56 .200 5.08 Values listed are typical. Please contact customer service for tolerances and custom size requests. Largest Size: .750 ID X 1.0 OD Fits Pump Tube Size ref number #11260-825-15 #1360-825-23 60-825-27 60-825-37 #1460-825-43 #11960-825-45 60-825-51 60-825-63 60-825-70 #1660-825-79 #12060-825-82 60-825-93 #2560-825-104 #1560-825-108 #15TW60-825-110 #12360-825-112 #1760-825-130 #2460-825-133 #24TW60-825-136 #2660-825-139 #26TW60-825-141 #1860-825-160 #35/12160-825-163 #18560-825-166 #36/12260-825-191 #7360-825-194 #73TW60-825-197 #70/19060-825-200 #18660-825-230 #8260-825-243 #82TW60-825-245 #8860-825-248 #18460-825-262 #18960-825-270 #18760-825-288 #19160-825-310 #9260-825-420 #92TW60-825-428 TW = Thick Wall (variance between competition pump numbers) Smallest Size: .020 ID X .146 OD ® 5 Silicone Stoppers Silicone Clamp Gaskets For tight, reliable seals Crevice-free, protrusionfree, and biocompatible Pharmaceutical-grade Silicone Stoppers are ideal for a tight, reliable seal when used with glass tubes, vials, and flasks. These platinum-cured silicone stoppers have full traceability to raw materials, contain no peroxide catalysts, and are autoclavable. Available in 14 standard sizes. Please contact customer service with inquiries about stoppers with pre-drilled holes. STOPPER SIZE TOP DIAMETER BOTTOM DIAMETER Biomedical/pharmaceutical-grade Silicone Gaskets are made with our proprietary molding process and engineered geometry to promote crevice-free and protrusion-free processing. The gaskets have exceptional biocompatibility and contain no contaminants or leachables. Clamp gaskets are sterilizable by autoclave, ethylene oxide, or gamma radiation within the user’s validated cycles and exposure levels. HEIGHT TYPE INSIDE DIAMETER inch mm ref number Mini 0.5 12.70 70-400-05 Mini 0.75 19.05 70-400-07 Standard 1.0 25.40 70-400-10 70-416-01 Standard 1.5 38.10 70-400-15 .98425 70-416-02 Standard 2.0 50.80 70-400-20 .945 24 .709 18 .98425 70-416-03 Standard 2.5 63.50 70-400-25 4 1.02426 .787 20 .984 25 70-416-04 Standard 3.0 76.20 70-400-30 5 1.06327 .906 23 .984 25 70-416-05 Standard 4.0 101.60 70-400-40 6 1.26032 1.18130 .984 25 70-416-06 Standard 6.0 152.40 70-400-60 7 1.45737 1.18130 .984 25 70-416-07 Values listed are typical. Please contact customer service for tolerances and for custom size requests. 8 1.61441 1.29933 .984 25 70-416-08 9 1.77245 1.45737 .984 25 70-416-09 10 1.96950 1.65442 .984 25 70-416-10 12 2.52064 2.12654 .984 25 70-416-12 inch mm inch mm inch mm ref number 000 .512 13 .315 8 .98425 70-416-99 00 .591 15 .394 10 .98425 70-416-90 0 .669 17 .512 13 .98425 70-416-00 1 .748 19 .551 14 .98425 2 .787 20 .630 16 3 Values listed are typical. Please contact customer service for tolerances and custom size requests. S P E C I F I C AT I O N S S P E C I F I C AT I O N S n s l t n s l t ISO 10993-I FDA 21CFR 177-2600 USP Class VI EP 3.1.9 Packaged 12 per zip bag in crush-resistant boxes. Material Certification and Lot Traceability included in every box. 6 INSIDE DIAMETER ISO 10993-I FDA 21CFR 177-2600 USP Class VI EP 3.1.9 Packaged 25 per zip bag in crush-resistant boxes. Material Certification and Lot Traceability included in every box. Custom Services Excellence is customary CUSTOM ASSEMBLIES Dedicated to saving time Utilize Helix Medical’s dedicated assembly expertise to free up valuable employee time. Combine tubing, stoppers, and gaskets with complementary parts such as barbed tubing connectors, tri-clamp compatible fittings, or luer adapters. Options can include full preassembly or simply component inclusion. Please contact our sales department for a quote. CUSTOM BLACK-JACKETED TUBING CUSTOM PACKAGING For photosensitive drugs and light-sensitive fluids A full array of options Black-jacketed tubing is a custom extrusion offered by Helix Medical. The tubing is manufactured to your exact specifications (ID/OD sizing and packaging format) and contains an opaque exterior layer to block all light, so it’s ideal for photosensitive drugs or light-sensitive fluids. The pigmented silicone exterior does not touch the fluid path. Black-jacketed Tubing is available with a choice of Dow Corning, Wacker, Nusil, Momentive, or Blue Star USP Class VI silicones. Material certification and lot traceability included in every package. Whether you want to reduce bag and box waste or eliminate timely cutting of tubing to specified lengths, Helix Medical can accommodate your needs. Consider our array of alternative packaging options, including: (877) 308-0558 / helixmedical.com • S pooling (amount on spool determined by tubing outside diameter) • Bulk coil packaging (multiple standard coils in each box) • P re-cut lengths (as short as mere fractions of an inch to many feet, cut to your specified tolerance) Please contact our sales department for a quote. ® 7 Technical Specifications Terms & Conditions of Sale QUALIFICATION/TECHNICAL SUPPORT Any customer wishing to fully evaluate the cost/performance advantages of Helix Medical products is encouraged to contact our friendly and helpful customer service representatives at (800) 266-4421. We will gladly furnish interested parties with documentation, samples and the required technical support to assist in the qualification of our materials. PAYMENT TERMS/FREIGHT POLICY Payment is Net 30 days from date of invoice. VISA, Mastercard, and American Express also accepted. All shipments are FOB plant/distribution center. INDICATIONS FOR USE Caution: The materials which comprise the HelixMark product lines are not certified by the FDA for implant devices and are not intended to be used in medical applications involving permanent implantation or permanent contact with body fluids and tissues within the human body. Failure to comply with this may lead to serious bodily injury or death. Important: It is the user’s responsibility to ensure the suitability and safety of HelixMark products for all intended uses, including the verification of compatibility of any fluids or chemicals that may be used with, or come into contact with, HelixMark products. The user is responsible for conducting the appropriate testing in accordance with the applicable requirements in order to determine the safety and effectiveness for use in their desired applications. If intended for medical use, the user is responsible for ensuring that the HelixMark products that have been identified for use comply with all applicable medical regulatory requirements. CLEANING Silicone tubing may be cleaned in a solution of hot water and mild soap. Synthetic detergents or oil-based soaps should not be used as they may be absorbed and subsequently leached out into transported fluids. If it is necessary to use a brush, only a soft bristle one should be used. Rinse thoroughly in purified (distilled) water, taking care to flush the lumen of the tubing. Autoclave before the interior becomes dry. It is important that moisture be present on the inside of the tubes to avoid air locks during autoclaving. STERILIZATION Steam: HelixMark manufactured medical grade silicone tubing is able to withstand all common steam autoclave sterilization cycles without adverse effects to the tubing. Autoclave cycles should be qualified by the user to their product configuration prior to sterilization. Ethylene Oxide (EtO): The tubing is sterilized by normal EtO cycles that have been qualified by the user; aeration times must also be set by the user in accordance with product configuration. Dry Heat: Any usual dry heat sterilization method, qualified by the user, also may be used to sterilize the silicone tubing. Radiation: Silicone has been shown to withstand gamma radiation sterilization within the usual exposure levels qualified by the user. Some physical properties may be slightly changed as a result of this form of sterilization. Effects that have been sometimes seen include: Tensile strength remains essentially unchanged; Minimal but measurable increase seen in durometer and tensile modulus at 200% elongation; Tear strength (Die B) and elongation may be slightly decreased. CUSTOMER SERVICE/ORDERS USA and Canada Toll Free Tel: (800) 266-4421, Monday — Friday, 8am to 5pm, Pacific Time Customer Service E-mail: customerservice@helixmedical.com Sales Inquiries E-mail: info@helixmedical.com FAX: (805) 684-1934 INTERNATIONAL Tel: (+1) 805 684-3304, Monday — Friday, 8am to 5pm, Pacific Time Customer Service E-mail: customerservice@helixmedical.com Sales Inquiries E-mail: info@helixmedical.com FAX: (+1) 805 684-1934 TAXES All prices are exclusive of sales, use, occupational, excise, income or similar taxes and charges. Any such taxes and charges, wherever levied and whenever imposed, shall be paid by the Buyer. CANCELLED ORDERS Cancellation of fabricated or custom-made orders will be subjected to a cancellation fee. The cancellation fee will be determined by the amount of tooling and production work done at the time of the cancellation. Any changes to the order must be completed more than 30 days prior to dock date. RETURNS No product will be accepted for return after 30 days from date of shipment. Goods must be in “as sold” condition. To return merchandise, please contact our customer service department at (800) 266-4421 for a Return Material Authorization (RMA) number. All returns must be authorized by Helix Medical, no returns will be accepted without an RMA number. Any merchandise accepted for credit will be subject to a 25% restocking charge. To insure you receive credit, you must include with each return: •Your name, address and purchase order number. •Helix Medical shipping order number, date of invoice, and catalog number(s). •Your Return Material Authorization (RMA) number and your reason for the return. We cannot accept for return any of the following: •Product provided by Helix Medical on a “Special Order.” •Discontinued products. •Product that has exceeded the 30 days return time-frame. DAMAGED SHIPMENTS/DISCREPANCIES Please inspect your shipment upon receipt. If it shows any external damage, accept it only after the driver has noted the damage on both his and your copies of the delivery receipt and you have requested an inspection by the carrier. If, upon opening a shipment, you find a shortage or damage, you must request inspection by the carrier within 15 days of delivery or you will relinquish your right to make a claim. Any claims for shipment discrepancies must be made within one week of receipt. Please contact our customer service department at (800) 266-4421 to report a claim. LIMITED WARRANTY Products are warranted to be free from defects in material and workmanship. Helix Medical’s entire liability and Buyer’s exclusive remedy shall be limited to the replacement of or credit for defective products, as determined by Helix Medical. DISCLAIMER OF WARRANTY AND LIABILITY Helix Medical, LLC disclaims all other warranties or guarantees with respect to any products purchased from Helix Medical, LLC, whether statutory, written, oral, express or implied, including, without limitation, any warranty of merchantability, suitability or fitness for a particular purchase. In no event shall Helix Medical, LLC be liable or responsible for any exemplary, punitive, special, indirect, incidental or consequential damages (including, but not limited to loss of profits, use, or goodwill) of any kind whether based on contract, tort (including negligence), strict liability, or any other theory or form of action even if Helix Medical, LLC has been advised of the possibility thereof. Helix Medical, LLC sole liability and customer’s sole remedy for any claim relating to any products purchased from Helix Medical, LLC is as set forth in the limited warranty. GOVERNING LAW The contract arising from acceptance of Helix Medical’s offer shall be governed by the laws of the state of California. (877) 308-0558 / helixmedical.com 8 ® Silicone Chemical Compatibilities • Denotes NOT compatible with silicone Acetaldehyde Acetamide Acetic acid, cold • Acetic anhydride • Acetone Acetylene • Acrylonitrile Aliphatic hydrocarbon solvents Alum Aluminum chloride Aluminum salts Aluminum sulphate Ammonia gas, cold Ammonia gas, hot Ammonium hydroxide Ammonium nitrate Ammonium phosphate Ammonium salts Ammonium sulphate • Amyl acetate • Amyl alcohol • Amyl borate • Amyl chloride • Amyl chloronaphthalene • Amyl naphthalene Aniline, cold • Aniline hydrochloride Aromatic hydrocarbons • Asphalt Barium chloride Barium hydroxide Barium salts Beer Beer wort Beet sugar liquors • Benzaldehyde • Benzene Benzoic acid Bleaching liquors Blood Borax Boric acid • Brighteners, electroplating • Bromine • Bromobenzene • Butane • Butyl acetate Butyl alcohol • Butraldehyde Calcium bisulphide Calcium chloride Calcium hydroxide Calcium hypochlorite Calcium nitrate Calcium salts Cane sugar liquors Carbitol • Carbolic acid Carbon dioxide Carbon monoxide • Carbon tetrachloride Carbonic acid Castor oil Caustic soda up to 50% • Chlorinated solvents • Chlorine, dry • Chlorine, wet • Chlorobenzene • Chlorobromomethane • Chloroform • Chloronaphthalene • Chlorosulphonic acid • Chlorotuluene Chrome plating solutions • Chromic acid Citric acid Coconut oil Cod liver oil Copper salts Corn oil • Creosote • Creosote oil • Cresols • Cyclohexane Detergent solutions Dextrose Diacetone alcohol Diatomaceous slurry • Dibutyl Carbitol • Dibutyl phthalate • Dichlorobenzene • Diethyl ether Diethylamine Diethylene glycol • Diisopropyl ether Dimethyl formamide Dioctyl phthalate Dioxane • Diphenyl ether “Downtherm” fluids • Esters Ethanolamine Ethers Ethyl acetate Ethyl acetoacetate Ethyl alcohol • Ethyl cellulose • Ethyl chloride Ethylene • Ethylene chlorohydrin Ethylene diamine • Ethylene dichloride Ethylene glycol • Ethylene oxide • Ethylene trichloride • Fatty acids Ferric chloride Ferric salts • Fluorobenzene Formaldehyde Formic acid • Fuel oils Fumaric acid • Gasoline Gelatine Glucose Glycerine Glycols Green sulphate liquor • Halowax oil Hexaldehyde • Hexane • Hydraulic oil • Hydrazine • Hydrobromic acid • Hydrochloric acid, cold • Hydrochloric acid, hot Hydrocyanic acid • Hydrofluoric acid, cold • Hydrofluoric acid, hot • Hydrofluorosilicic acid • Hydrogen gas Hydrogen peroxide • Hydrogen sulphate, dry • Hydrogen sulphate, wet Isobutyl alcohol • Isooctane Isopropyl alchohol • Isopropyl nitrate • Kerosene • Ketones Lactic acid, cold Lard • Lead acetate Lead nitrate Linseed oil • Lithium hydroxide 5% • Lubricating oils Lye solution (KOH & NaOH) Magnesium ammonium sulphate Magnesium chloride Magnesium salts Magnesium sulphate Manganese salts Melamine Mercury • Mesityl oxide • Methane gas Methyl alcohol (methanol) Methyl bromide • Methyl chloride • Methyl diphenyldiisocyanate Methyl ethyl ketone Methyl formate • Methyl isobutyl ketone Methyl methacrylate • Methylene chloride Milk Mineral oils • Monochlorobenzene Mustard • Naptha • Napthalene Natural gas Nickel chloride Nickel salts • Nitric acid Source: Rubber Products Handbook, Rubber Products Manufacturers Association • Nitrobenzene • Nitroethane Nitrogen • Nitrogen oxides Oils, animal • Oils, lubricating • Oils, mineral Oils, vegetable • Oleic acid Oxalic acid Oxygen, cold Ozone • Paraffin • Perchloric acid Perchloroethylene • Petrol • Phenol • Phosphoric acid Phthalic acid • Picric acid Pinene Potassium carbonate Potassium chlorate Potassium cyanide Potassium dichromite • Potassium hydroxide Potassium iodide Potassium nitrate Potassium salts Producer gas • Propane Propyl alcohol • Pyridine Pyrrole Rubber latex Sea water Sewage • Silicone oil Silver nitrate Soap solutions Soda ash Sodium bicarbonate Sodium bisulphate Sodium bisulphite Sodium borate Sodium chloride Sodium cyanide Sodium dichromate Sodium hydroxide Sodium hypochlorite • Sodium nitrate Sodium nitrite Sodium perborate • Sodium peroxide • Sodium phosphates Sodium silicate Sodium sulphate Sodium sulphide Sodium sulphite Sodium thiosulphate Soybean oil Stannic chloride Stannous chloride Stearic acid • Stoddards solvent • Styrene Sulphur • Sulphur chloride Sulphur dioxide Sulphur hexafluoride Sulphur dioxide, dry Sulphur trioxide, dry • Sulphuric acid 10% cold • Sulphuric acid 10% hot • Sulphuric acid 10-75% cold • Sulphuric acid 10-75% hot • Sulphuric acid 75-95% cold • Sulphuric acid 75-95% hot • Sulphurous acid Tannic acid Tar Tartaric acid • Terpineol Tertiary butyl catechol • Tertiary butyl mercaptan Thionyl chloride Tin chlorides • Toluene • Trichlorethane • Trichlorethylene • Tricresyl phosphate • Turpentine Urea Vegetable oils Vinegar Water Water, fresh Water, sea Whisky Wine Wort • Xylene • Xylol Yeast ® You’ll Find Helix Medical All Around the World Since 1984, Helix Medical has been a custom manufacturer for the world’s leading medical device and healthcare companies. Medical manufacturing capabilities include design and development, silicone and thermoplastic molding and extrusion, complex catheter systems, component and product assembly, packaging and labeling, and comprehensive engineering services. We operate FDA-registered, ISO 13485 certified medical device facilities, with Class 7 and 8 cleanrooms. Helix Medical manufacturing locations are all around the world: California, Indiana, Massachusetts, Minnesota, Costa Rica, Germany, Ireland and China. A LEAN MANUFACTURING/SIX SIGMA PARTNER Using Lean Manufacturing and Six Sigma Methodology, Helix Medical delivers value-added solutions to reduce lead-times and maximize efficiency. Some of the tools and methods include Kaizen, value stream mapping, 3P, VA/VE, and dedicated Lean and Six Sigma management. (877) 308-0558 / helixmedical.com © 2015 Helix Medical, LLC – 150502