Injectors, Contrast Media, Angiography; CT; MRI

5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA  Tel +1 (610) 825-6000  Fax +1 (610) 834-1275  Web www.ecri.org  E-mail [email protected] UMDNS Information This Product Comparison covers the following device terms and product codes as listed in ECRI Institute’s Universal Medical Device Nomenclature System™ (UMDNS™):  Injectors, Contrast Media, Angiography [15-284]  Injectors, Contrast Media, Computed Tomography [17-969]  Injectors, Contrast Media, Magnetic Resonance Imaging [18-158]  Injectors, Contrast Media, Angiography; CT; MRI Scope of this Product Comparison This Product Comparison covers automatic electromechanical contrast media injectors for angiography, computed tomography (CT), and magnetic resonance imaging (MRI) procedures; manual injectors are excluded. Purpose Contrast media injectors introduce viscous fluids into an artery or vein through a small catheter, making vessels in an angiogram, CT scan, or MRI study contrast with their surroundings. Angiography is a specialized radiographic procedure designed to evaluate vascular disease by producing well-defined images of the vascular anatomy. The American College of Radiology and the Society of Interventional Radiology consider angiography the “diagnostic standard by which the accuracy of other vascular imaging modalities should be judged.” Angiographic procedures examine the vasculature of the brain, the heart and great vessels, coronary and renal arteries, abdominal organs, and extremities. Such examinations provide information that is useful for diagnosing pulmonary emboli, localized circulatory disorders, anatomic anomalies, herniations, aneurysms, constrictions, and trauma of the vasculature, as well as for detecting increased vascularization associated with tumors. By assuming that the blood and the injected contrast medium flow at nearly the same velocity, physicians can also use angiography to measure blood flow and to evaluate the effectiveness of vascular grafts. In chronic hemodialysis patients, who often require arteriovenous shunts, angiography can expose shunt abnormalities and aid in selecting appropriate therapy or vessels for recannulation. Injectors are also used to introduce contrast media in CT and MRI procedures for routine body, vascular, cerebral, and perfusion imaging. For additional information on CT and MRI, see the Product Comparisons titled Scanning Systems, CT, Full-Body and Scanning Systems, MRI. Principles of operation Automatic contrast media injectors incorporate electromechanically driven syringes to deliver contrast media. In electromechanical syringe assemblies, a jackscrew connected to an electric motor moves the syringe piston into and out of the syringe barrel. Typical electromechanical injectors deliver a given volume of contrast medium at a preselected rate, independent of variations in catheter length or diameter, the viscosity of the contrast medium, or Injectors, Contrast Media, Angiography; CT; MRI 2 ©2009 ECRI Institute. All Rights Reserved. the characteristics of blood flow at the injection site. These constant-flow injectors automatically regulate the pressure developed during an injection to achieve and maintain the selected rate and volume. In addition to synchronizing the start of an injection with the x-ray exposure, electromechanical injectors permit the user to delay the start time of the injection and/or the exposure and to regulate the amount of time between them. This feature allows a series of x-ray images to be taken before, during, and after an injection. Flow control of the delivered contrast medium is a primary consideration in any angiography or CT procedure. As it enters the bloodstream, the contrast medium is diluted to an extent determined by several factors, including the blood vessel selected—the larger the blood vessel, the greater the flow needed to maintain the proper concentration of contrast medium. Inadequate flow will not produce sufficient opacity for good contrast and may necessitate a repeat procedure, thereby exposing the patient to increased procedural risks and radiation. On the other hand, excessive flow can injure the patient or damage the catheter. The rate chosen also depends on the type of procedure and the nature of the disease. The flow rate can range from 0.01 to 50 mL/sec. It is difficult to determine an acceptable upper limit for the pressure created by a contrast media injector. Improperly regulated pressure can damage the catheter and injure the patient. Maximum pressure ratings for angiographic catheters range from 34.5 to 83 bar (500 to 1,203.5 pounds per square inch [psi]). Pressure and flow rate are also affected by the viscosity of the contrast medium, which is affected by temperature. Most automatic injectors are equipped with a heater to maintain the contrast medium at or near body temperature to minimize trauma to the patient. The heater is usually located on the injector head, near the syringe. The temperature of the syringe is thermostatically controlled and is usually preset at the factory. Rise time refers to the amount of time required to achieve the proper pressure or flow after initiating an injection. If pressure or flow increases too quickly, high-energy jets of contrast medium exit the catheter, causing it to recoil, or whip. Gradually adjusting the rise time minimizes this risk, reducing the incidence of catheter dislocation and vascular trauma. Most currently available injectors have both disposable and reusable syringes made of polycarbonate, polypropylene, or glass. Syringe capacity varies among manufacturers, and syringes may not be interchangeable among different manufacturers’ units. Two manufacturers offer an injection system that is designed to allow a portion of the disposable kit to be reused for up to five procedures while maintaining sterility. The design is intended to reduce cost by conserving the contrast medium remaining in the bottle and syringe that is typically discarded at the end of each procedure. In addition, the volume and flow rate of injection of at least one of these models is controlled by the physician, who uses a disposable handpiece and varies the thumb pressure on a button; when more pressure is applied, more contrast medium is delivered at a higher flow rate. These units also have automatic refilling, purging, rearming features and a touchscreen interface in the sterile field that enables the physician to adjust injection and other parameters to deliver the minimum amount of contrast medium necessary. Contrast media injectors are maneuverable and can be placed in a variety of positions. Electromechanical injectors have a pivoting head, permitting several syringe positions. Some injectors feature a detachable injector head with a separate set of controls. An attachment allows the injector head to be mounted on a pedestal, a Injectors, Contrast Media, Angiography; CT; MRI ©2009 ECRI Institute. All Rights Reserved 3 special-procedures table, or the ceiling, with the console located in a control room. Rack mounting is available for consoles, electronic controls, and optional modules. One manufacturer has designed a double-syringe assembly: when one syringe is empty, the plunger retracts and the assembly turns 180° to position the second preloaded syringe. This allows the loading of two different contrast agents, which are needed for some procedures, and can also facilitate high throughput. Safety features usually include an arming switch, secondary to the power on/off switch, which prevents the accidental triggering of an injection. For additional protection, another switch initiates or terminates an injection when the injector is armed. Acceleration regulators control the acceleration rate of the syringe drive motor; the user selects an appropriate pressure rise time to minimize catheter whip. Pressure-limiting devices control the maximum pressure that can be generated in the syringe, thereby ensuring the safety of even low-pressure catheters. Most automatic injectors are designed to be triggered with the head pointed downward, which allows air to collect opposite the outlet end of the syringe and decreases the risk of injecting air into the patient. Syringe transparency can also be considered a safety feature because it allows air bubbles to be seen more easily and purged before the injection. To prevent the excess delivery of contrast medium, most injectors use a mechanical or electronic backup stop, secondary to the volume setting, that prevents plunger movement beyond a preset position. A dual-syringe system is utilized in multidetector computed tomography (MDCT), in which multislice scanners can acquire 64 slices of a large exposure area in high resolution. In this setup, one syringe is used for administering contrast medium and the other is used for administering saline solution chaser, which flushes residual medium out of the injector system or arm veins to optimize the contrast medium bolus in the imaging area. The saline chaser helps to ensure image quality and prevents costly contrast medium from being wasted. The dual-injection system used in MRI is configured similarly to a CT injector, with an injector head/stand and a control console. A touchscreen allows programming of repeatable injection parameters and protocol storage. The system is constructed of nonferromagnetic, MRI-compatible materials that are safe to use in the MR environment and do not cause artifacts or interfere with magnet operation if used in accordance with the manufacturer’s labeling. Another MRI infusion system consists of dual double-peristaltic pumps connected by a fiberoptic cable or wirelessly to a remote-control console; contrast medium is administered using intravenous administration sets (i.e., cannulae). System software allows time schedules for administering contrast medium and initiating imaging to be calculated and allows patient data, region of interest, and other parameters to be input. Both systems feature a keep-vein-open function and automatic saline flushing of tubing. Reported problems Like any invasive procedure, contrast media injection is not without risks. The most common complication is the formation of hematomas, which are usually not serious. Accidental injection of air may result in a potentially fatal air embolism, which is usually the result of human error and can occur with any contrast injector. Manufacturers recommend following procedures for inspecting and purging the syringe of air before injection, and prescribed loading sequences to be performed before arming is allowed. Manufacturers have recently developed both hardware and software functions that help reduce the incidence of air embolism caused by human error. However, no safety system is 100% effective and staff training and good protocols remain the most important means to reducing the chances of air embolism. When using a constant-flow injector, the clinician must select the rate carefully to avoid traumatizing the catheterized vessel with an overinfusion; a sudden, high-velocity jet of contrast medium could not only dislocate the catheter, but could also cause injury to the vessel wall. Care must be taken to avoid injecting contrast medium directly into the vessel wall, which could cause dissection or occlusion of the vessel. New catheter designs have been introduced that are reported to enable high flow while avoiding turbulence at the catheter terminus. Clinicians should take steps to avoid extravasation (the leaking of contrast media from the veins into Injectors, Contrast Media, Angiography; CT; MRI 4 ©2009 ECRI Institute. All Rights Reserved. surrounding tissue) and compartment syndrome (the resultant increase in pressure inside the tissue). The increase in pressure may present significant problems by preventing blood flow into the tissue, and large-volume extravasation can cause severe tissue damage. Injectors with an extravasation detection system should be considered to reduce this risk. Toxic or anaphylactic reactions to contrast agents have been reported, including minor nausea and vomiting, skin rashes, cardiac arrest, bronchospasm, ventricular fibrillation, renal insufficiency, and death. A recent U.S. Food and Drug Administration (FDA) advisory discusses a possible link between the use of gadolinium- containing contrast agents for magnetic resonance angiography (MRA) and the development of nephrogenic systemic fibrosis/nephrogenic fibrosing dermopathy (NSF/NFD) in patients with moderate to end-stage kidney failure. Facilities should refer to accepted standards when implementing a policy governing use of high- osmolality versus low-osmolality and nonionic contrast agents. U.S. facilities should consult the American College of Radiology standards for guidance in selecting agents. Purchase considerations ECRI Institute recommendations Included in the accompanying comparison chart are ECRI Institute’s recommendations for minimum performance requirements for angiography, CT, and MRI contrast injectors. All injectors should have disposable syringes, selectable pressures in increments of 10 psi, and an adjustable volume stop in 1 mL increments. Injectors used for angiography should have a syringe capacity of at least 100 mL (preferably 200), a flow range of up to 40 mL/sec, and a delivery pressure range of 14 to 82 bar (200 to 1,200 psi). Units used for CT scanning should have a syringe capacity of 125 mL, a flow range of 0.1 to 7 mL/sec, a delivery pressure range of 0 to 20 bar (0 to 300 psi), and an x-ray generator. MRI injectors should have a syringe capacity of 60 mL, a flow range of 0.1 to 7 mL/sec, and a delivery pressure range of 0.7 to 13.8 bar (20 to 200 psi). MRI and CT injectors with saline flush are preferred. Other considerations Some physicians prefer hand-driven syringes for delicate procedures. The hand syringe may provide a feel for resistance not possible with an automatic injector; however, automatic injectors deliver more consistent flow. Buyers should consider the injector’s capabilities, including programmability (e.g., volume, flow rates) and x- ray generator synchronization, as well as available configurations (i.e., pedestal, ceiling, or table mounting), to determine whether the injector is suitable for the types and numbers of procedures performed. The pricing and supply of disposable syringes and administration sets should be negotiated with the supplier before a purchase is made. Suppliers may also offer unit doses with prefilled syringes. In addition, some systems may have contrast media conservation features that could result in significant cost savings. Before purchasing an MRI injection or infusion system, buyers should make sure that the system is MRI compatible. The system should be tested on-site or at a demonstration site before purchase. Stage of development Contrast media injectors have evolved from hand-operated syringes to remote-controlled electromechanical units incorporating safety checks with an accurate contrast media delivery system. No standardized safety mechanisms exist that can completely prevent air embolisms, although recently, some manufacturers have integrated gross air-detection systems into their injectors that warn the user if air is detected in the syringe. In addition, extravasation detection devices are now becoming more widely available. Injection for contrast-enhanced sonography is typically performed manually; however, one company manufactured a commercially available automated system (now discontinued). Injectors, Contrast Media, Angiography; CT; MRI ©2009 ECRI Institute. All Rights Reserved 5 Bibliography American College of Radiology. Injection of contrast material and radiopharmaceuticals [policy statement]. 1987 (revised 1997). Low osmolar contrast agent reimbursement [policy statement]. 1989 (renewed 1999). Practice guideline for the performance of diagnostic arteriography in adults. 1993 (revised 2002). Auler MA, Heagy T, Aganovic L, et al. Saline chasing technique with dual-syringe injector systems for multi- detector row computed tomographic angiography: rationale, indications, and protocols. Curr Probl Diagn Radiol 2006 Jan-Feb;35(1):1-11. Bellin MF, Jakobsen JA, Tomassin I, et al. Contrast medium extravasation injury: guidelines for prevention and management. JBR-BTR 2004;87:93-6. Benson LS, Sathy MJ, Port RB. Forearm compartment syndrome due to automated injection of computed tomography contrast material. J Orthop Trauma 1996;10(6):433-6. Brummett D, Fidler J, Stark D. Power injectors for MRI. Appl Radiol 1999 May;28(5):16-20. Chen KT, Chen CJ, Chang PY, et al. A nosocomial outbreak of malaria associated with contaminated catheters and contrast medium of a computed tomographic scanner. Infect Control Hosp Epidemiol 1999 Jan;20(1):22-5. Dawson P, Strickland N, Allison D. Use of contrast media beneficial to angioplasty. Diagn Imaging 1991 Feb;13(2):91-8, 146. ECRI Institute. Air-detection systems on cardiac catheterization power contrast injectors won’t always prevent air emboli. Health Devices 2008 Aug;37(8):254-5. Computed tomography for cardiovascular disease screening. In: Health Technology Forecast [database]. 2006 Nov. Contrast media: ionic versus nonionic and low-osmolality agents [clinical overview]. Health Devices 1993 Nov;22(11):511-2. Use of contrast injectors requires constant vigilance [hazard report]. Health Devices 2006 Dec;35(12):461-2. Grabowski EF. A hematologist’s view of contrast media, clotting in angiography syringes and thrombosis during coronary angiography. Am J Cardiol 1990 Oct 26;66(14):23F-25F. Haage P, Schmitz-Rode T, Hübner D, et al. Reduction of contrast material dose and artifacts by a saline flush using a double power injector in helical CT of the thorax. AJR Am J Roentgenol 2000 Apr;174(4):1049-53. Hansen EC, Hawkins MC, Hawkins IF Jr, et al. New high-flow “cloud” catheter for safer delivery of contrast material. Radiology 1989 Nov;173(2):461-4. Hendee WR, Ritenour ER. Medical imaging physics. 4th ed. New York: Wiley-Liss; 2002. Kerns SR, Hawkins IF Jr. Carbon dioxide digital subtraction angiography: expanding applications and technical evolution. AJR Am J Roentgenol 1995 Mar;164(3):735-41. Müller-Schimpfle M, Brix G, Layer G, et al. Recurrent rectal cancer: diagnosis with dynamic MR imaging. Radiology 1993 Dec;189(3):881-9. Snopek AM. Fundamentals of special radiographic procedures. 5th ed. Philadelphia: WB Saunders; 2006. Injectors, Contrast Media, Angiography; CT; MRI 6 ©2009 ECRI Institute. All Rights Reserved. Supplier information ACIST ACIST (Europe) bv A Bracco Group Co [384773] Becanusstraat 13 Maastricht NL-6216 BX The Netherlands Phone: 31 (3) 433281318 Fax: 31 (3) 433281329 Internet: http://www.acistmedical.com E-mail: [email protected] ACIST Medical Systems Inc A Bracco Group Co [352947] 7905 Fuller Rd Eden Prairie, MN 55344 Phone: (952) 941-3507, (888) 667-6648 Fax: (952) 941-4648 Internet: http://www.acistmedical.com E-mail: [email protected] COVIDIEN Covidien (US) [452294] 15 Hampshire St Mansfield, MA 02048 Phone: (508) 261-8000, (800) 346-7197 Internet: http://www.covidien.com Covidien (Singapore) Div Covidien (US) [452450] 26 Ang Mo Kio Industrial Park 2 #04-01 Singapore 569507 Republic of Singapore Phone: 65 64820100 Fax: 65 64820300 Internet: http://www.covidien.com E-mail: [email protected] Covidien (Deutschland) Div Covidien (US) [452451] Gewerbepark 1 Neustradt/Donau D-93333 Germany Phone: 49 (9445) 9590 Fax: 49 (9445) 959155 Internet: http://www.covidien.com E-mail: [email protected] Covidien (Australia) Div Covidien (US) [452440] Level 1 166 Epping Road Lane Cove 2066 Australia Phone: 61 (2) 94189611 Fax: 61 (2) 94189622 Internet: http://www.covidien.com E-mail: [email protected] MEDEX BIOMEDICAL Guerbet (France) [452687] 15 rue des Vanesses Zone Paris Nord II Villepinte F-93420 Injectors, Contrast Media, Angiography; CT; MRI ©2009 ECRI Institute. All Rights Reserved 7 France Phone: 33 (1) 45915000 Fax: 33 (1) 45915199 Internet: http://www.guerbet.com E-mail: [email protected] MEDRAD Medrad Europe bv [152536] Postbus 205 Beek NL-6190 AE The Netherlands Phone: 31 (43) 3585600 Fax: 31 (43) 3656598 Internet: http://www.medrad.com E-mail: [email protected] Medrad Inc [105381] 100 Global View Dr Warrendale, PA 15086 Phone: (412) 767-2400, (800) 633-7231 Fax: (412) 767-4120 Internet: http://www.medrad.com E-mail: [email protected] Medrad Asia Pte Ltd [184519] Block 5000 Ang Mokio Avenue 5 #05-08 Techplace II Singapore 569870 Republic of Singapore Phone: 65 67525318 Fax: 65 67525807 Internet: http://www.medrad.com E-mail: [email protected] Medrad Do Brasil Ltda [342080] Avineda Nove de Julho 5109-110 andar Jardim Paulista Sao Paulo-SP 01407-200 Brazil Phone: 55 (11) 37026000 Fax: 55 (11) 30784026 Internet: http://www.medrad.com E-mail: [email protected] MEDTRON MEDTRON AG [285910] Hauptstrasse 255 Saarbruecken D-66128 Germany Phone: 49 (681) 970170 Fax: 49 (681) 9701720 Internet: http://www.medtron.com E-mail: [email protected] SIAS SIAS SpA [177705] via Minghetti 9-11 Cadriano di Granarolo (BO) I-40057 Italy Phone: 39 (057) 6020211 Fax: 39 (059) 6020218 Internet: http://www.sias-spa.it E-mail: [email protected] Injectors, Contrast Media, Angiography; CT; MRI 8 ©2009 ECRI Institute. All Rights Reserved. ULRICH MEDICAL Ulrich GmbH & Co KG [177198] Buchbrunnenweg 12 Ulm D-89081 Germany Phone: 49 (731) 96540 Fax: 49 (731) 9654199 Internet: http://www.ulrichmedical.com E-mail: [email protected] Note: The data in the charts derive from suppliers’ specifications and have not been verified through independent testing by ECRI Institute or any other agency. Because test methods vary, different products’ specifications are not always comparable. Moreover, products and specifications are subject to frequent changes. ECRI Institute is not responsible for the quality or validity of the information presented or for any adverse consequences of acting on such information. When reading the charts, keep in mind that, unless otherwise noted, the list price does not reflect supplier discounts. And although we try to indicate which features and characteristics are standard and which are not, some may be optional, at additional cost. For those models whose prices were supplied to us in currencies other than U.S. dollars, we have also listed the conversion to U.S. dollars to facilitate comparison among models. However, keep in mind that exchange rates change often. Need to know more? For further information about the contents of this Product Comparison, contact the HPCS Hotline at +1 (610) 825-6000, ext. 5265; +1 (610) 834-1275 (fax); or [email protected] (e-mail). Last updated May 2009 Injectors, Contrast Media, Angiography; CT; MRI ©2009 ECRI Institute. All Rights Reserved 9 Policy Statement The Healthcare Product Comparison System (HPCS) is published by ECRI Institute, a nonprofit organization. HPCS provides comprehensive information to help healthcare professionals select and purchase diagnostic and therapeutic capital equipment more effectively in support of improved patient care. The information in Product Comparisons comes from a number of sources: medical and biomedical engineering literature, correspondence and discussion with manufacturers and distributors, specifications from product literature, and ECRI Institute’s Problem Reporting System. While these data are reviewed by qualified health professionals, they have not been tested by ECRI Institute’s clinical and engineering personnel and are largely unconfirmed. The Healthcare Product Comparison System and ECRI Institute are not responsible for the quality or validity of information derived from outside sources or for any adverse consequences of acting on such information. The appearance or listing of any item, or the use of a photograph thereof, in the Healthcare Product Comparison System does not constitute the endorsement or approval of the product’s quality, performance, or value, or of claims made for it by the manufacturer. The information and photographs published in Product Comparisons appear at no charge to manufacturers. Many of the words or model descriptions appearing in the Healthcare Product Comparison System are proprietary names (e.g., trademarks), even though no reference to this fact may be made. The appearance of any name without designation as proprietary should not be regarded as a representation that is not the subject of proprietary rights. ECRI Institute respects and is impartial to all ethical medical device companies and practices. The Healthcare Product Comparison System accepts no advertising and has no obligations to any commercial interests. ECRI Institute and its employees accept no royalties, gifts, finder’s fees, or commissions from the medical device industry, nor do they own stock in medical device companies. Employees engage in no private consulting work for the medical device industry. About ECRI Institute ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research in healthcare to uncover the best approaches to improving patient care. As pioneers in this science for over 40 years, ECRI Institute marries experience and independence with the objectivity of evidence-based research. More than 5,000 healthcare organizations worldwide rely on ECRI Institute’s expertise in patient safety improvement, risk and quality management, healthcare processes, devices, procedures, and drug technology. ECRI Institute is one of only a handful of organizations designated as both a Collaborating Center of the World Health Organization and an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and Quality. For more information, visit http://www.ecri.org. Injectors, Contrast Media, Angiography; CT; MRI 10 ©2009 ECRI Institute. All Rights Reserved. Product Comparison Chart MODEL ECRI INSTITUTE'S RECOMMENDED SPECIFICATIONS 1 ECRI INSTITUTE'S RECOMMENDED SPECIFICATIONS 1 ECRI INSTITUTE'S RECOMMENDED SPECIFICATIONS 1 ACIST Contrast Media Injectors, Angiography Contrast Media Injectors, CT Contrast Media Injectors, MRI CMS2000 Cardiovascular Management System WHERE MARKETED Select countries in Asia; not available in Europe or USA FDA CLEARANCE Yes CE MARK (MDD) Yes TYPE Angiographic DRIVE MECHANISM Electromechanical INJECTOR HEAD MOUNTING OPTIONS Not specified SYRINGES Disposable Yes Yes Yes Yes Reusable Yes Fluid heating Not specified SYRINGE CAPACITY, mL Disposable 100 125 60 99.9 Reusable 99.9 FLOW RANGE, mL/sec Up to 40 0.1-7 0.1-7 0.8-40, 0.1 mL/sec increments VOLUME RANGE, mL 0.8-99.9 DELIVERY PRESSURE RANGE, bar (psi) 14-82 (200-1,200) 0-20 (0-300) 0.7-13.8 (20-200) 13.8-82.8 (200-1,200) SELECTABLE PRESSURE Yes Yes Yes Yes Increments 10 psi 10 psi 10 psi 1 psi ADJUSTABLE RISE TIME Yes ADJUSTABLE VOLUME STOP TYPE Yes Yes Yes Programmable Increments, mL 1 1 1 0.1 SALINE FLUSH Preferred Preferred Not specified SAFETY FEATURES Extravasation detection No Air detection Not specified OPERATOR ALERTS Air, manifold valve position, others This is the first of two pages covering the above model(s). These specifications continue onto the next page. Injectors, Contrast Media, Angiography; CT; MRI ©2009 ECRI Institute. All Rights Reserved 11 Product Comparison Chart MODEL ECRI INSTITUTE'S RECOMMENDED SPECIFICATIONS 1 ECRI INSTITUTE'S RECOMMENDED SPECIFICATIONS 1 ECRI INSTITUTE'S RECOMMENDED SPECIFICATIONS 1 ACIST Contrast Media Injectors, Angiography Contrast Media Injectors, CT Contrast Media Injectors, MRI CMS2000 Cardiovascular Management System SYNCHRONIZATION X-ray generator Yes Yes No CONTROLS Type Not specified Wireless No Touchscreen Yes CONSOLE SIZE, H x W x D, cm (in) 20 x 33 x 8 (8 x 13 x 3) WEIGHT, kg (lb) 3.4 (7.5) console, 18.8 (41.5) head VOLTAGE, VAC 100-120; optional 220-240 LIST PRICE Injector system $39,950 Disposables Not specified WARRANTY 1 year; optional 3 years OTHER SPECIFICATIONS Designed for both small and large injections; injection parameters selectable from sterile field; built-in sensors monitor system integrity; syringe can be used for up to 5 separate patient procedures while maintaining sterility; meets requirements of CUL, ISO 9001, and UL. UMDNS CODE(S) 15284 17969 18158 15284 LAST UPDATED May 2009 Supplier Footnotes 1 These recommendations are the opinions of ECRI Institute's technology experts. ECRI Institute assumes no liability for decisions made based on this data. 1 These recommendations are the opinions of ECRI Institute's technology experts. ECRI Institute assumes no liability for decisions made based on this data. 1 These recommendations are the opinions of ECRI Institute's technology experts. ECRI Institute assumes no liability for decisions made based on this data. Model Footnotes Data Footnotes Injectors, Contrast Media, Angiography; CT; MRI 12 ©2009 ECRI Institute. All Rights Reserved. Product Comparison Chart MODEL ACIST ACIST ACIST ACIST CVi Contrast Delivery System EmpowerCT Injector System EmpowerCTA Injector System EmpowerMR Injector System WHERE MARKETED Worldwide Worldwide Worldwide Worldwide FDA CLEARANCE No Yes Yes Yes CE MARK (MDD) Yes Yes Yes Yes TYPE Angiographic CT CT MRI DRIVE MECHANISM Ball screw Electromechanical Electromechanical Hydraulic INJECTOR HEAD MOUNTING OPTIONS Not specified Floor and ceiling mounted Floor and ceiling mounted Floor mounted SYRINGES Disposable Yes Yes Yes Yes Reusable Yes No No No Fluid heating Not specified Optional Optional No SYRINGE CAPACITY, mL Disposable 99.9 200 200 100 Reusable 99.9 NA NA NA FLOW RANGE, mL/sec 0.8-40, 0.1 mL/sec increments 0.1-10 0.1-10 0.1-10 VOLUME RANGE, mL 0.8-99.9 1-200 1-200 1-100 DELIVERY PRESSURE RANGE, bar (psi) 13.8-82.8 (200-1,200) 1.4-20.7 (20-300) 2.8-20.7 (40-300) 2.8-20.7 (40-300) SELECTABLE PRESSURE Yes Yes Yes Yes Increments 1 psi 1 psi 1 psi 1 psi ADJUSTABLE RISE TIME Yes No No No ADJUSTABLE VOLUME STOP TYPE Programmable Automatic Automatic electronic Automatic electronic Increments, mL 0.1 1 1 1 SALINE FLUSH Not specified No Yes Yes SAFETY FEATURES Extravasation detection No Optional Optional No Air detection Not specified NA NA NA OPERATOR ALERTS Air, manifold valve position, others Voice prompts on remote Voice prompts on remote Voice prompts on remote This is the first of two pages covering the above model(s). These specifications continue onto the next page. Injectors, Contrast Media, Angiography; CT; MRI ©2009 ECRI Institute. All Rights Reserved 13 Product Comparison Chart MODEL ACIST ACIST ACIST ACIST CVi Contrast Delivery System EmpowerCT Injector System EmpowerCTA Injector System EmpowerMR Injector System SYNCHRONIZATION X-ray generator Yes, validated for major manufacturers Yes (Philips, Siemens, Toshiba) Yes (Philips, Siemens, Toshiba) No CONTROLS Type Not specified Injector and remote Injector and remote Injector and remote Wireless No No No No Touchscreen Yes Yes, remote control Yes, remote control Yes, remote control CONSOLE SIZE, H x W x D, cm (in) 20 x 33 x 8 (8 x 13 x 3) 17.8 x 33 x 30.5 (7 x 13 x 12) 17.8 x 33 x 71.1 (7 x 13 x 28) 27.9 x 33 x 10.2 (11 x 13 x 4) WEIGHT, kg (lb) 3.4 (7.5) console, 18.8 (41.5) head 5 (11) 8.2 (18) 4.5 (10) VOLTAGE, VAC 100-120; optional 220-240 100-240 100-240 100-240 LIST PRICE Injector system $39,950 $19,500-25,000 $34,500-40,500 ~$42,900 Disposables Not specified ~$550/50 (syringe) $550/50 (syringe) ~$1,000/50 (syringe) WARRANTY 1 year; optional 3 years 1 year; optional 2 or 3 years 1 year; optional 2 or 3 years 1 year; optional 2 or 3 years OTHER SPECIFICATIONS Designed for cardiac and vascular angiography procedures including coronaries, ventricle, aorta, and peripheral vasculature; injection parameters selectable from sterile field; built-in sensors monitor system integrity; saline KVO feature; modular design to enhance convenience; multiuse syringe for up to 5 separate patient procedures; meets requirements of CUL, ISO 9001, and UL. Voice prompts; arming at injector; help system; 50 programs; full system safety monitoring; front-load syringe; modular flexibility; Injector Reporting Information System (IRiSCT); extravasation detection optional. Meets requirements of BSI, CSA, IEC 60601-1, ISO 9000, and UL 2601-1. Able to inject contrast followed by saline; voice prompts; arming at injector; help system; 50 programs; full system safety monitoring; front-load syringe; modular flexibility; Injector Reporting Information System (IRiSCT); optional extravasation detection. Meets requirements of BSI, CSA, IEC 60601-1, ISO 9000, and UL 2601-1. Hydraulic system does not require batteries; fully MR compatible up to 7T; connectivity to Injector Reporting Information System (IRiS) contrast management tool. UMDNS CODE(S) 15284 17969 17969 18158 LAST UPDATED May 2009 May 2009 May 2009 May 2009 Supplier Footnotes Model Footnotes Data Footnotes Injectors, Contrast Media, Angiography; CT; MRI 14 ©2009 ECRI Institute. All Rights Reserved. Product Comparison Chart MODEL ACIST COVIDIEN COVIDIEN COVIDIEN Voyager Cardiovascular Management System Angiomat Illumena CT 9000 ADV Optistar Elite 1 WHERE MARKETED Select countries in Asia; not available in Europe or USA Worldwide (with limited exceptions) Worldwide (with limited exceptions) Worldwide, except Japan; other limited exceptions FDA CLEARANCE Yes Yes Yes Yes CE MARK (MDD) Yes Yes Yes Yes TYPE Angiographic Angiographic, CT CT MRI DRIVE MECHANISM Electromechanical Electromechanical Electromechanical Electromechanical INJECTOR HEAD MOUNTING OPTIONS Not specified Ceiling, pedestal, or table mounts Not specified Not specified SYRINGES Disposable Yes Empty and prefilled Empty and prefilled Empty and prefilled Reusable Yes Yes (150 mL) No No Fluid heating Not specified Available Available Available SYRINGE CAPACITY, mL Disposable 99.9 50, 75, 100, 125, 150, 200 50, 75, 100, 125, 200 10, 15, 20, 30, 60 Reusable 99.9 150 NA NA FLOW RANGE, mL/sec 0.8-40, 0.1 mL/sec increments 0.1-40 (angiographic), 0.1- 10 (CT) 0.1-40 (angiographic), 0.1- 10 (CT) Side A: 60 mL syringe: 0.1- 10 mL/sec; 10, 15, 20, 30 mL syringe: 0.1-8; side B: 0.1-10 mL/sec in increments of 0.1 mL VOLUME RANGE, mL 0.8-99.9 0.1-200 0.1-200 0.1-60 DELIVERY PRESSURE RANGE, bar (psi) 13.8-82.8 (200-1,200) 5.2-82.8 (75-1,200) 1.7-20.7 (25-300) 10, 15, 20, 30, 50 mL prefilled syringes at 13.8 (200); 60 mL empty syringes at 10.3 (150) SELECTABLE PRESSURE Yes Yes Yes Yes Increments 1 psi 1 psi 25 psi 10 psi ADJUSTABLE RISE TIME Yes 1-10 sec No No ADJUSTABLE VOLUME STOP TYPE Programmable Automatic electronic Automatic electronic Automatic, electronic Increments, mL 0.1 0.5 1 1 SALINE FLUSH Not specified NA NA Yes SAFETY FEATURES Extravasation detection No No No No Air detection Not specified Yes, Air Detection and Warning System (ADAWS): acts to aid detecting accidental air injection through sensor at tip of injector Used syringe indicator: requires user to verify that proper syringe filling has occurred between injections NA OPERATOR ALERTS Air, manifold position, others Used syringe warning Used syringe warning Check for air in syringe and tubing This is the first of two pages covering the above model(s). These specifications continue onto the next page. Injectors, Contrast Media, Angiography; CT; MRI ©2009 ECRI Institute. All Rights Reserved 15 Product Comparison Chart MODEL ACIST COVIDIEN COVIDIEN COVIDIEN Voyager Cardiovascular Management System Angiomat Illumena CT 9000 ADV Optistar Elite 1 SYNCHRONIZATION X-ray generator Yes Yes Yes No CONTROLS Type Not specified Hand startswitch Hand startswitch Hand startswitch Wireless No NA NA NA Touchscreen Yes Yes Yes Yes CONSOLE SIZE, H x W x D, cm (in) 20 x 33 x 8 (8 x 13 x 3) 21.6 x 31.8 x 6.4 (8.5 x 12.5 x 2.5) 21.6 x 31.8 x 6.4 (8.5 x 12.5 x 2.5) 21.6 x 31.8 x 6.4 (8.5 x 12.5 x 2.5) WEIGHT, kg (lb) 3.4 (7.5) console, 18.8 (41.5) head 2.6 (5.8) 2.6 (5.8) 2.6 (5.8) VOLTAGE, VAC 100-120; optional 220-240 110-120 or 220-240, 50-60 Hz 100-120 or 220-240, 50-60 Hz 100-120 or 220-240, 50-60 Hz LIST PRICE Injector system $39,950 $25,000 $20,000 $44,000 Disposables Not specified Not specified Not specified Not specified WARRANTY 1 year; optional 3 years 1 year parts and labor, extended service plans available 1 year parts and labor, extended service plans available 1 year parts and labor, extended service plans available OTHER SPECIFICATIONS Designed for use in peripheral vascular procedures; same features as those listed for CMS2000, including multiprocedural-use capabilities; saline KVO feature. Versatile exam modes: can switch between cardiac, angiographic, and CT modes. Accommodates Ultraject prefilled syringes; ADAWS optional. Meets requirements of CSA, CUL, ISO 9001, Shonin, TUV, and UL. Optional OptiBolus software provides exponentially decelerating flow rate to give extended period of uniform enhancement; upgradable to dual-head injector for saline flush; accommodates Ultraject syringes. Meets requirements of CSA, CUL, ISO 9001, Shonin, TUV, and UL. Battery-free power source, Patency Check software, status indicator line on console, dual syringe with multiple user-defined phases; color coordinated push rods and touchscreen. Meets requirements of CUL, ISO 9001, TUV, and UL. UMDNS CODE(S) 15284 15284, 17969 17969 18158 LAST UPDATED May 2009 May 2009 May 2009 May 2009 Supplier Footnotes Model Footnotes 1 Optistar Elite was formerly listed as Optistar LE. Data Footnotes Injectors, Contrast Media, Angiography; CT; MRI 16 ©2009 ECRI Institute. All Rights Reserved. Product Comparison Chart MODEL COVIDIEN COVIDIEN MEDEX BIOMEDICAL MEDRAD Optistat Optivantage DH SBI 500 Avanta Fluid Management Injection System WHERE MARKETED Worldwide, except Japan; other limited exceptions Worldwide (with limited exceptions) Europe Worldwide FDA CLEARANCE Yes Yes No Yes CE MARK (MDD) Yes Yes CE 0459 by G-MED, France Yes TYPE CT CT Dual-fluid CT injector Angiographic and cardiac DRIVE MECHANISM Electromechanical Electromechanical Hydraulic power station Electromechanical piston for contrast, peristaltic pump for saline INJECTOR HEAD MOUNTING OPTIONS Not specified Not specified Not specified Table mount or pedestal SYRINGES Disposable Empty and prefilled Empty and prefilled KSB25, KSB50, and KSB/I/S when combined with MEDEX patented safety patient line Yes Reusable No No Ref RPVARD/20 Up to 5 patients Fluid heating Available Available Not specified Yes SYRINGE CAPACITY, mL Disposable 125, 130 50, 75, 100, 125, 200 250, 500, 250 plus 250 mL saline 150, with automatic or manual refill from attached bulk source Reusable NA NA Ref RPVARD/20 Up to 5 patients FLOW RANGE, mL/sec 0.1-6 0.1-10 0.5-10 1-10 in 0.1 mL/sec increments (variable flow), 1-45 in 1 mL/sec increments (fixed flow) VOLUME RANGE, mL 1-130 1-125 or 1-200 depending on syringe size 1-200 per injection 1-150 in 1 mL increments, refillable from attached bulk source of up to 1 L contrast DELIVERY PRESSURE RANGE, bar (psi) Pressure limit is variable dependent on the flow rate up to 15.5 (225) 1.7-22.4 (25-325) 0-21 (300) 20.68-82.74 (300-1,200) SELECTABLE PRESSURE No Yes Yes 300-1,200 psi Increments NA 1 psi 1 KPA (~0.1 bar) 1 psi ADJUSTABLE RISE TIME No No No Yes, 0-9.9 sec (fixed flow) ADJUSTABLE VOLUME STOP TYPE Automatic electronic Automatic electronic Pause available during injection User-adjustable electronic Increments, mL 1 1 1 1 SALINE FLUSH NA Yes Not specified Yes SAFETY FEATURES Extravasation detection No No No NA Air detection NA Used syringe warning: prevents use of previously used syringe; enabling sequence ensures proper air purging Not specified Yes; also fluid level sensing OPERATOR ALERTS NA RFID technology used to transmit data between the Ultraject syringe and the Optivantage DH injector to prevent use of previously used syringes Not specified High flow rate and high volume injection, overpressure, contrast or saline depleted, air in line, others This is the first of two pages covering the above model(s). These specifications continue onto the next page. Injectors, Contrast Media, Angiography; CT; MRI ©2009 ECRI Institute. All Rights Reserved 17 Product Comparison Chart MODEL COVIDIEN COVIDIEN MEDEX BIOMEDICAL MEDRAD Optistat Optivantage DH SBI 500 Avanta Fluid Management Injection System SYNCHRONIZATION X-ray generator Yes Yes Dry contact input Yes, user-selectable scan delay or injection delay of 0- 99.9 sec CONTROLS Type NA Hand startswitch Not specified Not specified Wireless NA NA Not specified Not specified Touchscreen NA Yes Not specified Yes, true touchscreen with intuitive instructions for setup CONSOLE SIZE, H x W x D, cm (in) 15.2 x 5.1 x 4.6 (6 x 2 x 1.8) 21.6 x 31.8 x 6.4 (8.5 x 12.5 x 2.5) 24 x 29 x 24 (9.5 x 11.4 x 9.5) 30.9 x 41.2 x 23.6 (12.2 x 16.2 x 9.3) WEIGHT, kg (lb) 0.9 (2) 2.6 (5.8) 5.4 (11.9) console, 20 (44.1) head, 35 (77.2) power station 3.16 (7) VOLTAGE, VAC 100-120 or 220-240, 50-60 Hz 100-120 or 220-240, 50-60 Hz 230 100-240, 50/60 Hz LIST PRICE Injector system $9,500 $37,000-45,000 €35,333 (US$46,882) $42,000-45,000 Disposables Not specified Not specified €5.40, €5.55, €9 (US$7.16, US$7.36, US$11.94) Not specified WARRANTY 1 year parts and labor, extended service plans available 1 year parts and labor, extended service plans available 1 year 1 year OTHER SPECIFICATIONS Handheld system can be used independently for contrast injection, interface to CT 9000 ADV, or second Optistat for saline flush. Fully programmable powerhead touchscreen display; Patency Check injection to aid in extravasation detection; simple setup for dual-head or single-head protocols; optional interface for connection to CT scanners. Optional OptiBolus bolus shaping software improves CTA images and contrast agent utilization. Ceiling- and wall-mount system available; software upgrade by USB memory stick; logfile registers details of every injection; automatic bag-filler system provided. Dual air management with infrared level sensors and ultrasound gross air detectors; saline delivery at fixed rate of 1.25 mL/sec; bolus sharpness feature; ergonomic electromechanical hand controller; 5-patient reuse clearance for syringe and multipatient tubing set; automatic hemodynamic isolation for instantaneous change from injection status (no pressure) to hemodynamic status (pressure detection); rapid system start and disposables setup and exchange; memory of up to 40 user-definable protocols; automated processes that eliminate manual manifold. UMDNS CODE(S) 17969 17969 17969 15284 LAST UPDATED May 2009 May 2009 May 2007 May 2009 Supplier Footnotes Model Footnotes Data Footnotes Injectors, Contrast Media, Angiography; CT; MRI 18 ©2009 ECRI Institute. All Rights Reserved. Product Comparison Chart MODEL MEDRAD MEDRAD MEDRAD MEDRAD Mark V ProVis Injection System Spectris SolarisEP Injection System Stellant D Stellant Sx WHERE MARKETED Worldwide Worldwide Worldwide Worldwide FDA CLEARANCE Yes Yes Yes Yes CE MARK (MDD) Yes Yes Yes Yes TYPE Angiographic MRI CT CT DRIVE MECHANISM Electromechanical Electromechanical Electromechanical Electromechanical INJECTOR HEAD MOUNTING OPTIONS Not specified Not specified Not specified Not specified SYRINGES Disposable Yes Yes Yes Yes Reusable No No No No Fluid heating Not specified Not specified Not specified Not specified SYRINGE CAPACITY, mL Disposable 60, 150, 200 65, 115 200 200 Reusable NA NA NA NA FLOW RANGE, mL/sec 0.3-50, depending on increment and syringe size 0.01-10 0.1-10 0.1-10 VOLUME RANGE, mL 1-60, 1-150, 1-200 0.5-65, 1-115 Up to 200, integral autoload (user-defined contrast and saline volumes load automatically) Up to 200, integral autoload (user-defined contrast and saline volumes load automatically) DELIVERY PRESSURE RANGE, bar (psi) 6-82 (100-1,200) 0-22.4 (0-325) 3.5-22.4 (50-325) 3.5-22.4 (50-325) SELECTABLE PRESSURE Yes NA 50-325 psi 50-325 psi Increments 1 psi NA 50 psi 50 psi ADJUSTABLE RISE TIME Yes, 0.0-9.9 sec No NA NA ADJUSTABLE VOLUME STOP TYPE Mechanical Electrical Electronic Electronic Increments, mL 1 1 Not specified Not specified SALINE FLUSH Not specified Not specified Yes No SAFETY FEATURES Extravasation detection No Yes Yes Yes Air detection Not specified Not specified Not specified Not specified OPERATOR ALERTS Yes Maximum pressure reached Air, armed, scan and inject delay, overpressure, others Air, armed, scan and inject delay, overpressure, others This is the first of two pages covering the above model(s). These specifications continue onto the next page. Injectors, Contrast Media, Angiography; CT; MRI ©2009 ECRI Institute. All Rights Reserved 19 Product Comparison Chart MODEL MEDRAD MEDRAD MEDRAD MEDRAD Mark V ProVis Injection System Spectris SolarisEP Injection System Stellant D Stellant Sx SYNCHRONIZATION X-ray generator No No Yes, triggering interface with CT scanner Yes, triggering interface with CT scanner CONTROLS Type Not specified Not specified Not specified Not specified Wireless Not specified Not specified Not specified Not specified Touchscreen Not specified Not specified Yes Yes CONSOLE SIZE, H x W x D, cm (in) 27 x 48 x 32 (10.5 x 19 x 12.6), 119 x 66 x 66 (47 x 26 x 26 ) pedestal model 27.7 x 30 x 26.7 (10.9 x 11.9 x 10.5) 34.3 x 31.6 x 22.6 (13.5 x 12.5 x 8.9) 34.3 x 31.6 x 22.6 (13.5 x 12.5 x 8.9) WEIGHT, kg (lb) 20.4 (45) 6.8 (15) 8.1 (17.9) head only, 18 (39.7) system 5.4 (12) head only, 15.3 (33.8) system VOLTAGE, VAC 95-240 100-240 100-240, 50/60 Hz 100-240, 50/60 Hz LIST PRICE Injector system $24,500-26,600 $46,950 $34,500-38,500 (pedestal, OCS) $25,900-29,900 (pedestal, OCS) Disposables Not specified Not specified Not specified Not specified WARRANTY 1 year 1 year 1 year 1 year OTHER SPECIFICATIONS Automatic mechanical stop; double syringe; segmented control panel; multiphasic; table rack, overhead, and integrated pedestal with articulating arm; microprocessor based; 49 programs. Meets requirements of BSI, CSA, ISO 9001 and 9002, TUV, and UL. 6 user-defined injection phases for flexible programming; fiberoptic communication; integrated continuous battery-charging system; 3T compatibility; mobile configuration available. Meets requirements of CE, CSA, ISO 9001 and 9002, TUV, and UL. Patented P3T software (patient-specific injection protocols) for cardiac and abdomen studies; ability to deliver saline and contrast simultaneously; 1-6 phases per protocol, including saline as a test injection; flow profile enables at-a- glance program information; disposable syringe transfer set for optimal bulk contrast package management; embolism detection. Patented P3T software (patient-specific injection protocols) for abdomen studies; stopwatch feature for optimized delayed scanning sequences; 1-6 phases per protocol, including saline as a test injection; flow profile enables at-a-glance program information; 32 protocols may be stored; embolism detection. UMDNS CODE(S) 15284 18158 17969 17969 LAST UPDATED May 2009 May 2009 May 2009 May 2009 Supplier Footnotes Model Footnotes Data Footnotes Injectors, Contrast Media, Angiography; CT; MRI 20 ©2009 ECRI Institute. All Rights Reserved. Product Comparison Chart MODEL MEDRAD MEDTRON MEDTRON MEDTRON Vistron CT Injection System Accutron CT Injector Accutron CT-D Injector Accutron HP-D WHERE MARKETED Worldwide Worldwide Worldwide, except Canada and Japan Worldwide FDA CLEARANCE Yes No No No CE MARK (MDD) Yes Yes Yes Yes TYPE CT CT CT Angiographic (cardiovascular) DRIVE MECHANISM Electromechanical Electrical Electrical Electrical INJECTOR HEAD MOUNTING OPTIONS Not specified Standalone, ceiling/wall dual attachment suspension Standalone, ceiling/wall dual attachment suspension Standalone SYRINGES Disposable Yes Easy-Loading Syringe (ELS) Easy-Loading Syringe (ELS) Easy-Loading Syringe (ELS) Reusable No No No No Fluid heating Not specified Yes Yes Yes SYRINGE CAPACITY, mL Disposable 200 200 200 200 Reusable NA NA NA NA FLOW RANGE, mL/sec 0.1-9.9 0.1-10 0.1-10 0.1-30 VOLUME RANGE, mL 10-200 1-125, 1-200 1-200 1-200 DELIVERY PRESSURE RANGE, bar (psi) 3.5-20.7 (50-300) 5-21 (72.5-304.5) 5-21 (72.5-304.5) 5-83 (72.5-1,203.5) SELECTABLE PRESSURE 50-300 psi Yes Yes Yes Increments 25 or 50 psi 1 bar (14.5 psi) 1 bar (14.5 psi) 1 bar (14.5 psi) ADJUSTABLE RISE TIME No Not specified Not specified 0.1-10 sec in increments of 0.1 sec ADJUSTABLE VOLUME STOP TYPE Automatic electronic Automatic electronic Automatic electronic Automatic electronic Increments, mL 1 1 1 1 SALINE FLUSH No Not specified Not specified Yes SAFETY FEATURES Extravasation detection No Not specified Not specified Not specified Air detection Not specified Not specified Not specified Not specified OPERATOR ALERTS Armed, scan delay, overpressure Maximum pressure reached, venting, remaining volume too low, head tilt down Maximum pressure reached, venting, remaining volume too low, head tilt down Maximum pressure reached, venting, remaining volume too low, head tilt down This is the first of two pages covering the above model(s). These specifications continue onto the next page. Injectors, Contrast Media, Angiography; CT; MRI ©2009 ECRI Institute. All Rights Reserved 21 Product Comparison Chart MODEL MEDRAD MEDTRON MEDTRON MEDTRON Vistron CT Injection System Accutron CT Injector Accutron CT-D Injector Accutron HP-D SYNCHRONIZATION X-ray generator No Yes Yes, CANopen CIA 425 Yes, wireless CONTROLS Type Not specified Touchscreen Touchscreen Touchscreen Wireless Not specified Yes Yes Yes Touchscreen Not specified 1 on injection unit, 1 on remote control 1 on injection unit, 1 on remote control 1 on injection unit, optional remote control CONSOLE SIZE, H x W x D, cm (in) 12.7 x 35.6 x 26 (5 x 14 x 10.3) 25 x 25 x 5 (9.9 x 9.9 x 1.9) 25 x 25 x 6 (9.9 x 9.9 x 2.2) 29 x 27 x 5.5 (11.3 x 10.5 x 2.2) WEIGHT, kg (lb) 4.1 (9) head only, 7.3 (16) system 24 (52.9) 26 (57.3) 48 (105.8) VOLTAGE, VAC 100-240, 50/60 Hz 105-240, 50/60 Hz 105-240, 50/60 Hz 105-240, 50/60 Hz LIST PRICE Injector system $13,000-18,000 €14,900 (US$19,770) €26,500 (US$35,162) Not specified Disposables Not specified Not specified Not specified Not specified WARRANTY 1 year 1 year 1 year 1 year OTHER SPECIFICATIONS Autofill; remote monitor standard; 1-4 phases; scan delay; embolism detection. Meets requirements of BSI, CSA, ISO 9001 and 9002, TUV, and UL. 1 injector head; integrated heated syringe holder; prefilled syringes; optional wall- or ceiling-mounted support, up to 6 phases; wireless touchscreen remote control. 2 injector heads; integrated heated syringe holder; optional wall- or ceiling- mounted support, 6 phases; wireless touchscreen remote control, optional CANopen interface. First high-pressure double- head injector with 2 x 200 ml capacity; able to perform high-pressure real-time contrast media dilution for cross-sectional imaging; wireless touchscreen remote control; wireless scanner interface. UMDNS CODE(S) 17969 17969 17969 15284 LAST UPDATED May 2009 May 2009 May 2009 May 2009 Supplier Footnotes Model Footnotes Data Footnotes Injectors, Contrast Media, Angiography; CT; MRI 22 ©2009 ECRI Institute. All Rights Reserved. Product Comparison Chart MODEL MEDTRON MEDTRON MEDTRON MEDTRON Accutron MR Injector Injektron 82 CT Injector Injektron 82HP CT-Angio Injector Injektron CT2 CT Injector WHERE MARKETED Worldwide Worldwide Worldwide Worldwide FDA CLEARANCE No No No No CE MARK (MDD) Yes Yes Yes Yes TYPE MRI CT Angiographic, CT CT DRIVE MECHANISM Electrical Electrical Electrical Electrical INJECTOR HEAD MOUNTING OPTIONS Standalone Standalone, ceiling/wall suspension Standalone, ceiling mount Standalone, ceiling/wall suspension SYRINGES Disposable Easy-Loading Syringe (ELS) Easy-Loading Syringe (ELS) Easy-Loading Syringe (ELS) Easy-Loading Syringe (ELS) Reusable No No No No Fluid heating No Yes Yes Yes SYRINGE CAPACITY, mL Disposable 200 200 200 200 Reusable NA NA NA NA FLOW RANGE, mL/sec 0.1-10 0.1-7.5 0.1-30 0.1-15 VOLUME RANGE, mL 1-200 1-200 1-200 1-200 DELIVERY PRESSURE RANGE, bar (psi) 5-21 (72.5-304.5) 21 (304.5) max 5-83 (72.5-1,203.5) max 5-21 (72.5-304.5); optional 5-30 (72.5-435) SELECTABLE PRESSURE Yes Yes Yes Yes Increments 1 bar (14.5 psi) 1 bar (14.5 psi) 1 bar (14.5 psi) 1 bar (14.5 psi) ADJUSTABLE RISE TIME Not specified Not specified Yes Not specified ADJUSTABLE VOLUME STOP TYPE Automatic electronic Automatic electronic Automatic electronic Automatic electronic Increments, mL 1 1 1 1 SALINE FLUSH Not specified Not specified Not specified Not specified SAFETY FEATURES Extravasation detection Not specified Not specified Not specified Not specified Air detection Not specified Not specified Not specified Not specified OPERATOR ALERTS Maximum pressure reached, venting, remaining volume too low Maximum pressure reached Maximum pressure reached Maximum pressure reached This is the first of two pages covering the above model(s). These specifications continue onto the next page. Injectors, Contrast Media, Angiography; CT; MRI ©2009 ECRI Institute. All Rights Reserved 23 Product Comparison Chart MODEL MEDTRON MEDTRON MEDTRON MEDTRON Accutron MR Injector Injektron 82 CT Injector Injektron 82HP CT-Angio Injector Injektron CT2 CT Injector SYNCHRONIZATION X-ray generator No Yes Yes Yes, CANopen CIA 425 CONTROLS Type Touchscreen Keypad interface Keypad interface Keypad interface Wireless Yes Not specified Not specified Yes Touchscreen 1 on injection unit, 1 on remote control Not specified Not specified On remote control CONSOLE SIZE, H x W x D, cm (in) 25 x 25 x 6 (9.9 x 9.9 x 2.2) 20 x 17 x 7 (7.9 x 6.7 x 2.8) 20 x 17 x 7 (7.9 x 6.7 x 2.8) 18 x 26 x 6 (7.1 x 10.2 x 2.4) WEIGHT, kg (lb) 37 (81.6) 22.5 (49.6) 27.5 (60.6) 42 (92.6) VOLTAGE, VAC 105-240, 50/60 Hz 105-240 105-240 105-240 LIST PRICE Injector system €25,900 (US$34,366) €10,950 (US$14,530) €16,260 (US$21,574) €25,508 (US$33,845) Disposables Not specified Not specified Not specified Not specified WARRANTY 1 year 1 year 1 year 1 year OTHER SPECIFICATIONS 2 injector heads, 200 mL empty syringes; special features for MR angiography; up to 6 phases; prefilled syringes available; wireless touchscreen remote control. Phlebography mode; optional prefilled syringes; remote control available for €1,740 (US$2,353); wall- or ceiling-mounted support; integrated heated syringe holder. CT mode; optional prefilled syringes; remote control available for €1,740 (US$2,353); wall- or ceiling- mounted support; integrated heated syringe holder. 2 injector heads; integrated heated syringe holder; optional wall- or ceiling- mounted support, 6 phases; wireless touchscreen remote control, optional CANopen interface. UMDNS CODE(S) 18158 17969 15284, 17969 17969 LAST UPDATED May 2009 May 2009 May 2009 May 2009 Supplier Footnotes Model Footnotes Data Footnotes Injectors, Contrast Media, Angiography; CT; MRI 24 ©2009 ECRI Institute. All Rights Reserved. Product Comparison Chart MODEL SIAS SIAS ULRICH MEDICAL ULRICH MEDICAL CT 957 Diginjector 2002 Millennium CT injector missouri CT injector ohio tandem WHERE MARKETED Worldwide Worldwide Worldwide Worldwide FDA CLEARANCE No No Not submitted Not submitted CE MARK (MDD) Yes Yes Yes Yes TYPE CT Angiographic, CT CT CT DRIVE MECHANISM Peristaltic pump Electromechanical Roll pump Roll pump INJECTOR HEAD MOUNTING OPTIONS Not specified Not specified Movable stand version, space-saving ceiling suspension version Movable stand version, space-saving ceiling suspension version SYRINGES Disposable Yes Yes Patient hose Patient hose Reusable No No Pump hose for multidosing (24 hr); multidosing media containers: contrast agent bottles, prefilled syringes, scanbags (24 hr) Pump hose for multidosing (24 hr); multidosing media containers: contrast agent bottles, prefilled syringes, scanbags (24 hr) Fluid heating Not specified Yes Passive temperature preservation system riverside Passive temperature preservation system riverside SYRINGE CAPACITY, mL Disposable 500, 2 bottles 130, 260 5-15, patient hose 5-15, patient hose Reusable NA NA Up to 2,000, various multidosing media containers Up to 2,000, various multidosing media containers FLOW RANGE, mL/sec 0.1-10 0.1-40 (130 mL), 0.2-50 (260 mL) 0.2-8 0.2-8 VOLUME RANGE, mL 99 mL x 3 boluses 0-130, 0-260 1-400 1-400 DELIVERY PRESSURE RANGE, bar (psi) Not specified 6.9-82.8 (100-1,200) 16 (232) maximum, autoadjust 16 (232) maximum, autoadjust SELECTABLE PRESSURE No Yes Not specified Not specified Increments NA 1 bar (14.5 psi) Software adjusts pressure according to selected flow rate Software adjusts pressure according to selected flow rate ADJUSTABLE RISE TIME No Yes Software adjusts pressure according to selected flow rate Software adjusts pressure according to selected flow rate ADJUSTABLE VOLUME STOP TYPE No Automatic electronic Software Software Increments, mL NA 1 1 1 SALINE FLUSH Yes No Yes Yes SAFETY FEATURES Extravasation detection No No Yes Yes Air detection Not specified Not specified Yes Yes OPERATOR ALERTS Air bubble Over- and underflow, overpressure Touch terminal: alert sound and messages; control unit: alert lights Touch terminal: alert sound and messages; control unit: alert lights This is the first of two pages covering the above model(s). These specifications continue onto the next page. Injectors, Contrast Media, Angiography; CT; MRI ©2009 ECRI Institute. All Rights Reserved 25 Product Comparison Chart MODEL SIAS SIAS ULRICH MEDICAL ULRICH MEDICAL CT 957 Diginjector 2002 Millennium CT injector missouri CT injector ohio tandem SYNCHRONIZATION X-ray generator Yes Yes Yes Yes CONTROLS Type Not specified Not specified Touch terminal and control unit on injector, optional mouse Touch terminal and control unit on injector, optional mouse Wireless Not specified Not specified Not specified Not specified Touchscreen Not specified Not specified Yes Yes CONSOLE SIZE, H x W x D, cm (in) 16 x 45 x 31 (6.3 x 17.7 x 12.2) 115 x 50 x 56 (45.3 x 19.7 x 22) 25.2 x 33 x 12.6 (9.9 x 12.9 x 5) 25.2 x 33 x 12.6 (9.9 x 12.9 x 5) WEIGHT, kg (lb) 73 (161) with pump head and control console 72 (158.7) with control console 5.3 (11.7) console, 57 (125.7) 5.3 (11.7) console, 61 (134.5) VOLTAGE, VAC 230 230 100-240 100-240 LIST PRICE Injector system €20,000 (US$26,536) €27,000 (US$35,824) Not specified Not specified Disposables Not specified Not specified Not specified Not specified WARRANTY 1 year 1 year 1 year, extended on request 1 year, extended on request OTHER SPECIFICATIONS Injection course controlled by system ultrasound; no air-injection risk. Servo operating mode to drive injection flow by position of handswitch. None specified. Tandem function allows clinician to choose between 2 different contrast agents without changing media containers. UMDNS CODE(S) 17969 15284, 17969 17969 17969 LAST UPDATED May 2009 May 2009 May 2009 May 2009 Supplier Footnotes Model Footnotes Data Footnotes Injectors, Contrast Media, Angiography; CT; MRI 26 ©2009 ECRI Institute. All Rights Reserved. Product Comparison Chart MODEL ULRICH MEDICAL ULRICH MEDICAL ULRICH MEDICAL CT/MRI injector mississippi CT/MRI injector ohio M CT/MRI injector tennessee WHERE MARKETED Worldwide Worldwide Worldwide FDA CLEARANCE Not submitted Not submitted Not submitted CE MARK (MDD) Yes Yes Yes TYPE CT, MRI CT, MRI CT, MRI DRIVE MECHANISM Roll pump Roll pump Roll pump INJECTOR HEAD MOUNTING OPTIONS Movable stand version, space-saving ceiling suspension version Movable stand version, space-saving ceiling suspension version Movable stand version, space-saving ceiling suspension version SYRINGES Disposable Patient hose Patient hose Patient hose Reusable Pump hose for multidosing (24 hr); multidosing media containers: contrast agent bottles, prefilled syringes, scanbags (24 hr) Pump hose for multidosing (24 hr); multidosing media containers: contrast agent bottles, prefilled syringes, scanbags (24 hr) Pump hose for multidosing (24 hr); multidosing media containers: contrast agent bottles, prefilled syringes, scanbags (24 hr) Fluid heating Passive temperature preservation system riverside Passive temperature preservation system riverside Passive temperature preservation system riverside SYRINGE CAPACITY, mL Disposable 5-15, patient hose 5-15, patient hose 5-15, patient hose Reusable Up to 2,000, various multidosing media containers Up to 2,000, various multidosing media containers Up to 2,000, various multidosing media containers FLOW RANGE, mL/sec 0.2-8 0.2-8 0.2-8 VOLUME RANGE, mL 1-400 1-400 1-400 DELIVERY PRESSURE RANGE, bar (psi) 16 (232) maximum, autoadjust 16 (232) maximum, autoadjust 16 (232) maximum, autoadjust SELECTABLE PRESSURE Not specified Not specified Not specified Increments Software adjusts pressure according to selected flow rate Software adjusts pressure according to selected flow rate Software adjusts pressure according to selected flow rate ADJUSTABLE RISE TIME Software adjusts pressure according to selected flow rate Software adjusts pressure according to selected flow rate Software adjusts pressure according to selected flow rate ADJUSTABLE VOLUME STOP TYPE Software Software Software Increments, mL 1 1 1 SALINE FLUSH Yes Yes Yes SAFETY FEATURES Extravasation detection Yes Yes Yes Air detection Yes Yes Yes OPERATOR ALERTS Touch terminal: alert sound and messages; control unit: alert lights Touch terminal: alert sound and messages; control unit: alert lights Touch terminal: alert sound and messages; control unit: alert lights This is the first of two pages covering the above model(s). These specifications continue onto the next page. Injectors, Contrast Media, Angiography; CT; MRI ©2009 ECRI Institute. All Rights Reserved 27 Product Comparison Chart MODEL ULRICH MEDICAL ULRICH MEDICAL ULRICH MEDICAL CT/MRI injector mississippi CT/MRI injector ohio M CT/MRI injector tennessee SYNCHRONIZATION X-ray generator Yes Yes Yes CONTROLS Type Touch terminal and control unit on injector, optional mouse Touch terminal and control unit on injector, optional mouse Touch terminal and control unit on injector, optional mouse Wireless Not specified Not specified Not specified Touchscreen Yes Yes Yes CONSOLE SIZE, H x W x D, cm (in) 25.2 x 33 x 12.6 (9.9 x 12.9 x 5) 25.2 x 33 x 12.6 (9.9 x 12.9 x 5) 25.2 x 33 x 12.6 (9.9 x 12.9 x 5) WEIGHT, kg (lb) 5.3 (11.7) console, 53 (116.9) 5.3 (11.7) console, 66 (145.5) 5.3 (11.7) terminal, 54 (119) VOLTAGE, VAC 24 VDC (battery), 115/230 (charger) 24 VDC (battery), 115/230 (charger) 100-240, external power supply LIST PRICE Injector system Not specified Not specified Not specified Disposables Not specified Not specified Not specified WARRANTY 1 year, extended on request 1 year, extended on request 1 year, extended on request OTHER SPECIFICATIONS None specified. Tandem function allows clinicians to choose between 2 different contrast agents without changing media containers. Accumulator-free MRI injector. UMDNS CODE(S) 17969, 18158 17969, 18158 17969, 18158 LAST UPDATED May 2009 May 2009 May 2009 Supplier Footnotes Model Footnotes Data Footnotes