Announcement Deliverables Temp

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This document includes: Announcement Letter, FAQ, Brochures, In-Service Poster. I created all content, lay-out/design, and pre-press work using the Adobe Creative Suite of tools.

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Announcement Deliverables Temp

  1. 1. Argon Medical Devices 1445 Flat Creek Rd, Athens, Texas 75751 USA Tel: 903-675-9321 Fax: 903-677-9397 [insert date] Dear Argon Medical Devices Customer, On [insert date], Argon Medical Devices is announcing its next generation Patient Moni- toring (PTMO) family called the ArgoTrans. Inspired by your feedback, the ArgoTrans is an innovative family of disposable blood pressure transducers with a rich feature set. The ArgoTrans family of disposable transducers combines proven electronics with integrated components to provide a PTMO solution that produces a crisp, clear wave form. The cable configuration has changed from a semi-rigid, flat cable to a more flexible, pliable, round cable. The round cable design enables the clinician to move the cable, without many of the restrictions of a flat cable, to an angle that best suits the procedure. The straight, flow-through design and next generation Universal Steriflo™ flush device enables rapid priming and de-bubbling of the transducer. Also, the Universal Steri- flo™ flush device gives the clinician a choice of priming methods—pull tab or squeeze wings—from the same transducer. This is a unique feature not provided by other major disposable blood pressure transducer manufacturers. Over the next 90 days, Argon Medical Devices will be migrating all customers’ cus- tom transducer kits over to the next generation ArgoTrans family of disposable blood transducers. If you have custom transducer kits, there is nothing you need to do. The part numbers will remain the same. If you purchase the standard CDX and CDX- press kits today, you will be able to continue ordering these products during this period. Please see the attached PTMO brochure for the part numbers of the next generation ArgoTrans family from Argon Medical Devices. If you have any questions about these or any other Argon Medical Devices products, please contact your Argon Sales Representative or Argon’s Customer Service. Regards, Chris Haughey Product Marketing Manager
  2. 2. Argon Medical Devices 1445 Flat Creek Rd, Athens, Texas 75751 USA Tel: 903-675-9321 Fax: 903-677-9397 ArgoTrans Announcement Frequently Asked Questions 1. What is Argon announcing? Argon is announcing the following today: • ArgoTrans family of disposable blood pressure transducers; • Enhanced Safety products—Sharps–compliant Percutaneous Introducer needles and needle–less, swabable stopcock for closed sampling systems; • Line extensions of the Jawz and Percutaneous Introducer families; • On-line ordering capability for Argon customers to purchase standard products. 2. Why did Argon develop its next generation transducer family? Patient Monitoring (PTMO) is very important to Argon Medical Devices. As part of our central product strategy, PTMO products satisfy many groups within a hospital—cardiac catheter labs, ER, ICU, CCU, OR and post-oper- ation. After more than 10 years of experience satisfying the patient moni- toring needs in critical care, Argon asked its customers to comment on the current product family, as well as what they thought about Argon’s competi- tion. The ArgoTrans is the result of those discussions. 3. What are the benefits to the customer? There are three main benefit areas customers are expected to experience with the ArgoTrans family. First, Argon has combined proven electron- ics from the current CDX product line within a completely molded package. This should shorten the time required to qualify the ArgoTrans. Next, the straight flow-through path of the ArgoTrans when coupled with the innovative Universal Steriflo™ flush device (Model 2), flushing the line and zeroing the system is easier than ever. The ArgoTrans gives the clinician the flexibility to flush the system as he chooses—gently pull the tab or squeeze the side wings. However, in Argon’s Clinical Validation, using the side wings proved to be more popular than the pull tab—most
  3. 3. Argon Medical Devices transducer manufacturers feature a pull tab with their products. Third, the ArgoTrans has two base models as building blocks on which PTMO solutions can be built. Model 1 is a stand-alone transducer with a variety of cable lengths from 14” to 60”. Model 2 includes the Universal Steriflo™ flush device. From this model, very elaborate PTMO solutions can be created. Each ArgoTrans Model 2 comes standard with either a Macro or Micro-drip IV system. For more involved procedures, bifurcated and trifurcated configurations are avail- able. If the hospital is focused on using safety–engineered products, Argon of- fers ArgoTrans KeepSafe™ Closed Sampling systems. These enable the sampling of blood while minimizing the risk of needle-sticks or exposure to bodily fluids. 4. How does the ArgoTrans compare to the current Argon CDX III and CDX press transducers? ArgoTrans Model 1 vs. CDX III The ArgoTrans Model 1 is nearly identical to the CDX III in that both lever- age the same proven technology (Wheatstone bridge) to measure pressure, connect to the same monitoring cable connector and have a straight flow-through design. The main difference between the two is the shape of the cable. The ArgoTrans Model 1 has a round cable while the CDX III has a flat cable. ArgoTrans Model 2 vs. CDXpress The ArgoTrans Model 2 is nearly identical to the CDXpress in that both leverage the same proven technology (Wheatstone bridge) to measure pressure and connect to the same monitoring cable connector. The main differences are: ArgoTrans Model 2 CDXpress Straight, flow–through design 90o elbow flow path Priming device: pull tabs and squeeze wings Priming device: side button In-housing atmospheric venting Vent in the cable Completely molded package Flat, semi-rigid cable Round, pliable cable
  4. 4. Argon Medical Devices 5. Will customers be able to order both the CDX family and the ArgoTrans family of transducers? Yes. For the next 90 days, products from both families will be available for pur- chase to give customers the ability to purchase the current product while they evaluate the next generation ArgoTrans family of transducers. All custom kits will be migrated over to the ArgoTrans family of transducers during the same 90-day period. 6. When will the ArgoTrans family of transducers be available? At the time of announcement, all part numbers will be available for shipment. 7. Will the ArgoTrans family have the same configurations as the CDX family? No. The two CDX models with a Male/Male configuration will not be available in an ArgoTrans configuration. Also, the ArgoTrans has a 60” cable model. Safety First Initiative Announcement 8. What is a “Sharps–compliant needle?” A Sharps–compliant needle is a needle that, by design, minimizes the risk of a clinician’s injury from a needle-stick. 9. What Percutaneous Introducer needle is being announced today? Argon is announcing a family of Sharps–compliant, safety introducer needles called SecureLoc™ Safety Introducer Needles. These safety introducer needles feature an “intuitive safety guard” that secures the end of the introducer needle when it is removed from the patient. The SecureLoc™ safety introducer needles will be available in 18, 19 and 21 gauge versions of lengths from 2.0 to 3.5-inch- es in Seldinger and non-Seldinger configurations. 10. When will they be available? The SecureLoc™ safety introducer needles will be available from Argon [insert date]. They will be available as a single-sterile product in quantities of 25 units. SecureLoc™ is a trademark of Specialized Health Products, Inc. ®
  5. 5. Argon Medical Devices 11. Do clinicians need to learn a new way to perform procedures with SecureLoc™? No. SecureLoc™ is used the same way as a standard introducer needle. 12. What sampling system is being made available today? Argon is announcing the availability of an addition to its KeepSafe™ PTMO prod- uct family that gives clinicians a needle less, latex-free, Luer–activated stopcock from Elcam Medical that is designed to minimize a clinician’s fluid exposure while taking a blood sample. With the Luer–activated, swabable stopcock, the clinician now has an even safer solution by minimizing the needle-stick and latex expo- sure risk at the sample site. 13. How is the minimal, residual volume, Luer-activated stopcock (“Marvelous”) different from the current sample site? The Marvelous product from Elcam Medical is a latex-free, swabable, Luer–acti- vated sample site whose design enables automatic flushing of the side port and flow line—zero residual volume. The current sample site is a single-port manifold that requires a special needle cannula to take a sample. Also, the current sam- ple site is not latex free. The Marvelous product can also provide a cost savings over the current product in that there is no additional cannula required. 14. Can customers order the Marvelous separate from a PTMO solution like KeepSafe™? No. Because of the tight integration of monitoring systems and sampling sys- tems, the needle less, swabable stopcock will only be available with the purchase of PTMO solutions like KeepSafe™, CDX III, CDXpress or ArgoTrans from Argon. 15. How will customers integrate the needle less, swabable stopcock with their KeepSafe™ solution? When the KeepSafe™ monitoring solution is being installed, the current sample site is to be replaced with the latex-free, Luer–activated stopcock from Elcam. A standard Luer-based syringe can be used to take the sample. 16. How will the latex-free, Luer–activated stopcock from Elcam be shipped to customers?
  6. 6. Argon Medical Devices The needle less, swabable stopcock will be shipped to customers in single-sterile packs boxed in quantities of 20 units—the standard quantity for most transducer- based products. Announcement 17. What product is being announced? Argon is announcing an additional model to its already successful line of Endomyocardial biopsy (EMB) forceps. Responding to cardiologists’ requests for an extra long (105 cm), FEP coated, straight configuration forceps, Argon is ex- tending its line to meet this customer need. 18. When will this new product be available? The 7F, 105 cm is available at announcement. Its part number is 190086. Percutaneous Introducer Announcement 19. What percutaneous introducer is being announced today? Extending the already comprehensive percutaneous introducer line, Argon is announcing a 98 cm version of its long length, percutaneous introducer product family. Announced in March of this year, the Access-style long length introducer family has been very attractive to many Argon customers—health care providers and OEMs. 20. How many sizes are available at announcement? 4 and 5 French sizes are available at announcement. The addition of the 98 cm models extends the product family from 85 to 98 cm.
  7. 7. Argon Medical Devices The following tables represent all of the products being announced today by Argon Medical Devices. Please check with Customer Service for the latest availability of these and all other products from Argon Medical Devices. ArgoTrans Part # of Flush Cable Stopcock Monitoring Arterial IV Number Transducers Device Length Line Extension System 041516504A 1 14” 041517504A 1 42” 1-way 041587505A 1 60” 1-way 041582505A 1 • 14” 4-way 9” Macro 041595505A 1 • 14” 4-way 9” Micro 041583505A 1 • 14” 4-way 48” 9” Macro 041584505A 1 • 14” 4-way 48” 9” Micro 041585505A 1 • 14” 4-way 72” 9” Macro 041586505A 1 • 14” 4-way 72” 9” Micro 041589505A 2 • 14” (2) 4-way (2) 72” (2) 12” Macro 041591505A 3 • 14” (3) 4-way (1) Red 72” (3) 12” Macro (1) Blue 48” (1) Yellow 48” 041588505A 1 (Neonatal) • 14” (1) double 36” Safety First Initiative KeepSafe™ Closed Sampling Systems Standard kits include: ArgoTrans Model 2 transducer, 14” cable, 3cc/hr with Steriflo™ flush device, zero-port cap, and Macro drip IV system. Part Number Description (Standard features plus) 041592505 6” connection tubing, 10cc covered reservoir syringe, 48” monitoring line, sample site, 1-way stopcock and 9” arterial extension. 041593505 6” connection tubing, 10cc covered reservoir syringe, 72” monitoring line, sample site, 1-way stopcock and 9” arterial extension. 041594505 (2) Additional Model 2 transducers, trifurcated Macro drip IV system, 6” connection tubing, 10cc covered reservoir syringe, Red 72” monitoring line, Blue 48” monitoring line, Yellow 48” monitoring line, sample site, (3) 4-way stopcocks, and (2) 12” arterial extensions.
  8. 8. Argon Medical Devices Safety First Initiative Part Number Description 041240103 Latex free, zero residual volume, Luer-activated, swabable stopcock from Elcam Medical for PTMO applications requiring needle less access. S03018-275 18Gx2.75” SecureLoc™ Safety arterial needle S03018-275W 18Gx2.75” SecureLoc™ Safety arterial needle with Seldinger Wing S03018-350 18Gx3.5” SecureLoc™ Safety arterial needle S03019-275 19Gx2.75” SecureLoc™ Safety arterial needle S03021-275 21Gx2.75” SecureLoc™ Safety arterial needle S03021-275W 21Gx2.75” SecureLoc™ Safety arterial needle with Seldinger Wing S03021-200 21Gx2.75” SecureLoc™ Safety arterial needle New and Percutaneous Introducer Products Part Number Description 190086 Straight, FEP-coated, 105 cm long EMB forceps. It has a 7-French outer diameter and requires a 7-French Percutaneous Introducer. 800498 4-French, 98 cm Axcess-style introducer. These Axcess-style percutaneous introducers feature a long, Luer-locking hub with side port and stopcock. Also, it includes a 175 cm, 0.035”, double- ended (straight/3mm J), PTFE guide wire. 800598 5-French, 98 cm Axcess-style introducer. These Axcess-style percutaneous introducers feature a long, Luer-locking hub with side port and stopcock. Also, it includes a 175 cm, 0.035”, double- ended (straight/3mm J), PTFE guide wire. SecureLoc™ is a trademark of Specialized Health Products, Inc. ®
  9. 9. CDX/CDXpress Migration Path Corresponding ArgoTrans Models Model 1 Model 2 (w/flush device) CDX III 41500503 EOL* 41500913 EOL 41513503 00-041516504A 41516503 00-041507504A New: 60" cable, 1-way stopcock**: 00-041587505A CDXpress 41572504 00-041582505A New: 14" cable, 4-way stopcock**: 00- 041595505A 41574504 00-041583505A 41575504 00-041584505A 41576504 00-041585505A 41577504 00-041586505A 41578504 00-041588505A 41580505 00-041589505A 41581505 00-041591505A KeepSafe with CDXpress 41574566 00-041592505A 41576566 00-041593505A 41581566 00-041594505A Comments *These product codes will be EOL'd at end of transition period. **This is a new product/part number. It will continue after the transition period. These are new part numbers for the ArgoTrans corresponding to the CDX/CDXrpess product on the left.
  10. 10. ArgoTrans Disposable Blood Pressure Transducers Experience Innovation For over 10 years Argon The ArgoTrans transducer Medical Devices has features a straight flow-through continued to demonstrate an fluid path. When coupled with understanding of the monitoring the innovative Universal Steriflo™ needs of our critical care flush device (Model 2 only), customers. priming, zeroing and flushing the system is easier than ever. Proven Design Functionality With the ArgoTrans family of disposable blood The ArgoTrans family pressure transducers, Argon of transducers has two base has combined the accuracy Argon products: Model 1 and Model of proven electronics from 2. The Model 1 is a stand-alone its predecessor—CDX and transducer with cable lengths from CDXpress—with a completely 14” to 60”. The Model 2 has a integrated package. larger feature set and is used in clinical applications requiring more Medical Devices transducer functionality.
  11. 11. Flexibility With the integral Universal Steriflo™ flush device, ArgoTrans transducers give you the flexibility to flush the system as you choose— gently pull the tab or squeeze the side wings. Also, they are bundled with either a Macro or Micro IV drip system for immediate use. Both IV systems have a 60” drip line. The Macro flows at up to 60 drops/ min. while the Micro flows at up to 20 drops/min. For more involved procedures, bifurcated and trifurcated configurations are available. Part # of Flush Cable Stopcock Monitoring Arterial IV Number transducers Device Length Line Extension system 041516504 1 14” 041517504 1 42” 1-way 041587505 1 60” 1-way 041582505 1 • 14” 4-way 9” Macro 041583505 1 • 14” 4-way 9” Micro 041584505 1 • 14” 4-way 48” 9” Macro 041585505 1 • 14” 4-way 48” 9” Micro 041586505 1 • 14” 4-way 72” 9” Macro 041587505 1 • 14” 4-way 72” 9” Micro 041588505 2 • 14” (2) 4-way (2) 72” (1) 9”, (1) 12” Macro 041598505 3 • 14” (3) 4-way (1) Clear 72” (1) 9”, (2) 12” Macro (1) Blue 72” (1) Yellow 72” 041591505 1 (Neonatal) • 14” (1) double 14” KeepSafe™ Closed Sampling Systems Safety-First Standard kits include: ArgoTrans Model 2 transducer, 14” cable, 3cc/hr with Steriflo™ flush device, zero-port cap, and Macro drip OSHA and the CDC have IV system. demonstrated the cost of injuries Product Code Description (Standard features plus) resulting from blood-borne pathogens 041592505 6” connection tubing, 10cc covered reservoir to be very costly. To help customers, syringe, 48” monitoring line, sample site, 1-way Argon offers a number of products stopcock and 9” arterial extension. designed to support customers’ 041593505 6” connection tubing, 10cc covered reservoir Exposure Control programs. syringe, 72” monitoring line, sample site, 1-way stopcock and 9” arterial extension. KeepSafe™ Closed Sampling System 041594505 (2) Additional Model 2 transducers, kits with ArgoTrans Model 2 trifurcated Macro drip I/V system, 6” connection Transducers help to minimize the tubing, 10cc covered reservoir syringe, Red 72” clinician’s exposure to blood-borne monitoring line, Blue 48” monitoring line, Yellow 48” monitoring line, sample site, (3) 4-way pathogens. stopcocks, and (2) 12” arterial extensions. Argon Medical Devices 1445 Flat Creek Road Athens, Texas 75751 1-800-927-4669 Fax: 1-903-677-9396 http://www.argonmedical.com 96-6000-13/0607 Argon Medical Devices, Inc. Printed in the U.S.A.
  12. 12. ArgoTrans ? Refer to IFU Preparation Mount to the stand Description Argon Patient Monitoring (PTMO) Products are stand-alone components, stock kits or convenience kits built to user specifications. Products addressed by this Quick 1 • Remove trans- ducer kit from 2 Place transducer on pole-mount stand. Set-Up Guide include: monitoring sets, pressure transducers, patient mounted package. straps, continuous flush devices, stopcocks, manifolds, arterial extensions, IV • Check all accessories, sample plugs and KeepSafe™ Closed Sampling System options. connections and tighten as neces- Indications for Use sary. Argon PTMO products are indicated for physiological pressure measurement, invasive pressure monitoring, catheterization procedures, infusion of fluids and/or obtaining blood or other fluid samples. Connect the cables Connect IV line IV preparation Flushing the System 3 • Connect monitor cable to transducer. 4 • Connect IV line to bottom of transducer. 5 • Close roller clamp on IV line 6 With the stopcock in the “Up” po- sition, flush transducer with sa- • Rotate the locking ring • Turn stopcock to “Up” position • Connect IV spike to sa- line solution by gently squeezing clock-wise to secure. (off to patient) line solution the wings or pulling the pull tab • Loosen Zero-Port cap 1/4 turn. • Squeeze drip chamber on the front of the transducer. until chamber is half full. Pull or Squeeze Zero Port Flushing the system Flushing the system Connect to catheter 7 • Check the IV line and area of the trans- ducer above the Universal Flush Device to 8 • Connect the patient monitoring line to the top of the transducer. 9 Connect the patient monitoring line to the arterial catheter. ensure all air has been removed from the • Turn stopcock 90-degrees clockwise system. (open to patient line) • When saline drips from the Zero Port cap, • Flush system until air is out of patient tighten cap. monitoring line Zero the monitor Measure pressure If you have any questions, please refer to: 10 • Turn stopcock to “Up” position (off to the patient) 12 • Tighten the Zero-Port vent cap. • Instructions for Use (IFU) located in the shipping carton covers all Warnings, • Loosen Zero Port cap 1/4 turn • Turn the four-way stopcock Precautions, and Procedures for Use. • Zero monitor to manufacturer to the “On” position (handle’s • Visit our website: specifications “Off” is positioned over the http://www.argonmedical.com transducer’s vent port). • In the U.S., call Customer Service at: (800) 9-ARGON-9 or (800) 927-4669 Monday-Friday (7:00am-5:00 PM CST) • Your Argon Medical Devices sales representative. Inflate pressure bag 11 P/N: 999301580-07/0607 Inflate pressure bag to 300mmHg.
  13. 13. Save this Quick Set-Up Guide for Future Reference Refer to ArgoTrans ? IFU Description Preparation Mount to the stand Argon Patient Monitoring (PTMO) Products are stand-alone components, stock • Remove transducer kit Place transducer on pole- kits or convenience kits built to user specifications. Products addressed by 1 from package. 2 mount stand. this Quick Set-Up Guide include: monitoring sets, pressure transducers, pa- • Check all connections tient mounted straps, continuous flush devices, stopcocks, manifolds, arterial and tighten as necessary. extensions, IV accessories, sample plugs and KeepSafe™ Closed Sampling System options. Indications for Use Argon PTMO products are indicated for physiological pressure measurement, invasive pressure monitoring, catheterization procedures, infusion of fluids and/or obtaining blood or other fluid samples. Contraindications There are no known contraindications for these products. Connect the cables Connect IV line IV preparation Flushing the System • Connect monitor cable to • Connect IV line to bottom • Close roller clamp on IV line With the stopcock in the “Up” transducer. • Connect IV spike to saline solution position, flush transducer of transducer. 3 • Rotate the locking ring 4 • Turn stopcock to “Up” po- 5 • Squeeze drip chamber until cham- ber is half full. 6 with saline solution by gently clock-wise to secure. sition (off to patient) squeezing the wings or pulling • Loosen Zero-Port cap 1/4 the pull tab on the front of the turn. transducer. Pull tab Squeeze wings Zero Port www.argonmedical.com P/N: 96-6000-14/0607
  14. 14. Save this Quick Set-Up Guide for Future Reference Refer to ? IFU ArgoTrans Flushing the system Flushing the system Connect to catheter Zero the monitor • Check the I/V line and area of • Connect the patient monitoring • Turn stopcock to the “Up” posi- the transducer above the Universal Connect the patient moni- line to the top of the transducer. tion (off to the patient) toring line to the arterial 7 Flush Device to ensure all air has been removed from the system. 8 • Turn stopcock 90-degrees clock- 9 wise (open to patient line) catheter. 10 • Loosen Zero Port cap 1/4 turn. • Zero monitor to manufacturer • When saline drips from the Zero • Flush system until air is out of pa- specifications. Port cap, tighten cap. tient monitoring line Inflate pressure bag Measure pressure If you have any questions, Inflate pressure bag to • Tighten the Zero-Port vent cap. Quick • Turn the four-way stopcock to please refer to: 300 mmHg. • Instructions for Use (IFU) located 11 12 the “On” position (handle’s “Off” is positioned over the transducer’s in the shipping carton covers all Set-Up Guide vent port). Warnings, Precautions, and Pro- • Read pressure. cedures for Use. for the • Visit our web site: http://www.argonmedical.com • In the U.S., call Customer Service at: (800) 9-ARGON-9 or (800) 927-4669 ArgoTrans Monday-Friday (7:00am-5:00pm CST) • Your Argon Medical Devices sales representative. Patient Monitoring Products www.argonmedical.com P/N: 96-6000-14/0607

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