Injectors, Contrast Media, Angiography; CT; MRI

5/26/2018 Injectors, Contrast Media, Angiography; CT; MRI

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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 InformationThis Product Comparison covers the followingdevice terms and product codes as listed in ECRIInstitutes Universal Medical Device NomenclatureSystem (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; MRIScope 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.

PurposeContrast 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-BodyandScanning Systems, MRI.

Principles of operationAutomatic 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
http://members2.ecri.org/Components/HPCS/Pages/ScanningSystems,ComputedTomography,Full-Body.aspx?reportid=174073&chartId=-2147483648&type=charthttp://members2.ecri.org/Components/HPCS/Pages/ScanningSystems,ComputedTomography,Full-Body.aspx?reportid=174073&chartId=-2147483648&type=charthttp://members2.ecri.org/Components/HPCS/Pages/ScanningSystems,MagneticResonanceImaging.aspx?reportid=177965&chartId=-2147483648&type=charthttp://members2.ecri.org/Components/HPCS/Pages/ScanningSystems,MagneticResonanceImaging.aspx?reportid=177965&chartId=-2147483648&type=charthttp://members2.ecri.org/Components/HPCS/Pages/ScanningSystems,MagneticResonanceImaging.aspx?reportid=177965&chartId=-2147483648&type=charthttp://members2.ecri.org/Components/HPCS/Pages/ScanningSystems,MagneticResonanceImaging.aspx?reportid=177965&chartId=-2147483648&type=charthttp://members2.ecri.org/Components/HPCS/Pages/ScanningSystems,ComputedTomography,Full-Body.aspx?reportid=174073&chartId=-2147483648&type=chart


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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 primaryconsideration 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

selectedthe 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


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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 theaccidental 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 multislicescanners 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

manufacturers 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 problemsLike 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 byhuman 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


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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 considerationsECRI Institute recommendations

Included in the accompanying comparison chart are ECRI Institutes recommendations for minimumperformance 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 considerationsSome 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 injectors 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 developmentContrast 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).


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BibliographyAmerican 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

Radiol2006 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 cathetersand contrast medium of a computed tomographic scanner. Infect Control Hosp Epidemiol1999 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 wont always prevent air

emboli. Health Devices2008 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 Devices1993

Nov;22(11):511-2.

Use of contrast injectors requires constant vigilance [hazard report]. Health Devices2006 Dec;35(12):461-2.

Grabowski EF. A hematologists 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, Hbner 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 deliveryof contrast

material. Radiology1989 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 technicalevolution.AJR Am J Roentgenol1995 Mar;164(3):735-41.

Mller-Schimpfle M, Brix G, Layer G, et al. Recurrent rectal cancer: diagnosis with dynamic MR imaging.

Radiology1993 Dec;189(3):881-9.

Snopek AM. Fundamentals of special radiographic procedures. 5th ed. Philadelphia: WB Saunders; 2006.


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Supplier informationACIST

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


COVIDIENCovidien (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



Covidien (Deutschland) Div Covidien (US) [452451]

Gewerbepark 1

Neustradt/Donau D-93333

Germany

Phone: 49 (9445) 9590 Fax: 49 (9445) 959155



Covidien (Australia) Div Covidien (US) [452440]

Level 1 166 Epping Road

Lane Cove 2066

Australia

Phone: 61 (2) 94189611 Fax: 61 (2) 94189622



MEDEX BIOMEDICALGuerbet (France) [452687]

15 rue des Vanesses Zone Paris Nord II

Villepinte F-93420
http://www.acistmedical.com/http://www.acistmedical.com/http://www.acistmedical.com/mailto:[email protected]:[email protected]:[email protected]://www.acistmedical.com/http://www.acistmedical.com/http://www.acistmedical.com/mailto:[email protected]:[email protected]:[email protected]://www.covidien.com/http://www.covidien.com/http://www.covidien.com/http://www.covidien.com/http://www.covidien.com/http://www.covidien.com/mailto:[email protected]:[email protected]:[email protected]://www.covidien.com/http://www.covidien.com/http://www.covidien.com/mailto:[email protected]:[email protected]:[email protected]://www.covidien.com/http://www.covidien.com/http://www.covidien.com/mailto:[email protected]:[email protected]:[email protected]:[email protected]://www.covidien.com/mailto:[email protected]://www.covidien.com/mailto:[email protected]://www.covidien.com/http://www.covidien.com/mailto:[email protected]://www.acistmedical.com/mailto:[email protected]://www.acistmedical.com/


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France

Phone: 33 (1) 45915000 Fax: 33 (1) 45915199

Internet:http://www.guerbet.com


MEDRADMedrad Europe bv [152536]Postbus 205

Beek NL-6190 AE

The Netherlands

Phone: 31 (43) 3585600 Fax: 31 (43) 3656598

Internet:http://www.medrad.com


Medrad Inc [105381]

100 Global View Dr

Warrendale, PA 15086

Phone: (412) 767-2400, (800) 633-7231 Fax: (412) 767-4120



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



Medrad Do Brasil Ltda [342080]

Avineda Nove de Julho 5109-110 andar Jardim Paulista

Sao Paulo-SP 01407-200Brazil

Phone: 55 (11) 37026000 Fax: 55 (11) 30784026



MEDTRONMEDTRON AG [285910]

Hauptstrasse 255

Saarbruecken D-66128

Germany

Phone: 49 (681) 970170 Fax: 49 (681) 9701720

Internet:http://www.medtron.com


SIASSIAS 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

http://www.guerbet.com/http://www.guerbet.com/http://www.guerbet.com/mailto:[email protected]:[email protected]:[email protected]://www.medrad.com/http://www.medrad.com/http://www.medrad.com/mailto:[email protected]:[email protected]:[email protected]://www.medrad.com/http://www.medrad.com/http://www.medrad.com/mailto:[email protected]:[email protected]:[email protected]://www.medrad.com/http://www.medrad.com/http://www.medrad.com/mailto:[email protected]:[email protected]:[email protected]://www.medrad.com/http://www.medrad.com/http://www.medrad.com/mailto:[email protected]:[email protected]:[email protected]://www.medtron.com/http://www.medtron.com/http://www.medtron.com/mailto:[email protected]:[email protected]:[email protected]://www.sias-spa.it/http://www.sias-spa.it/http://www.sias-spa.it/mailto:[email protected]:[email protected]:[email protected]:[email protected]://www.sias-spa.it/mailto:[email protected]://www.medtron.com/mailto:[email protected]://www.medrad.com/mailto:[email protected]://www.medrad.com/mailto:[email protected]://www.medrad.com/mailto:[email protected]://www.medrad.com/mailto:[email protected]://www.guerbet.com/


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ULRICH MEDICALUlrich GmbH & Co KG [177198]

Buchbrunnenweg 12

Ulm D-89081

Germany

Phone: 49 (731) 96540 Fax: 49 (731) 9654199

Internet:http://www.ulrichmedical.com


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 theconversion 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 HPCSHotline at +1 (610)

825-6000, ext. 5265; +1 (610) 834-1275 (fax); [email protected](e-mail).

Last updated May 2009
http://www.ulrichmedical.com/http://www.ulrichmedical.com/http://www.ulrichmedical.com/mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]://www.ulrichmedical.com/


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Product Comparison ChartMODEL ECRI INSTITUTE'S

RECOMMENDEDSPECIFICATIONS1

ECRI INSTITUTE'SRECOMMENDEDSPECIFICATIONS1


ACIST

Contrast Media Injectors,

Angiography


CT


MRI

CMS2000 Cardiovascular

Management SystemWHERE MARKETED Select countries in Asia; not

available in Europe or USAFDA CLEARANCE YesCE MARK (MDD) YesTYPE AngiographicDRIVE MECHANISM ElectromechanicalINJECTOR HEADMOUNTING OPTIONS

Not specified

SYRINGESDisposable Yes Yes Yes YesReusable YesFluid heating Not specified

SYRINGE CAPACITY, mLDisposable 100 125 60 99.9Reusable 99.9

FLOW RANGE, mL/sec Up to 40 0.1-7 0.1-7 0.8-40, 0.1 mL/secincrementsVOLUME RANGE, mL 0.8-99.9DELIVERY 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 psiADJUSTABLE RISE TIME YesADJUSTABLE VOLUMESTOP TYPE

Yes Yes Yes Programmable

Increments, mL 1 1 1 0.1SALINE FLUSH Preferred Preferred Not specifiedSAFETY FEATURES

Extravasation detection NoAir detection Not specified

OPERATOR ALERTS Air, manifold valve position,

others

This is the first of two pagescovering the abovemodel(s). Thesespecifications continue ontothe next page.


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Product Comparison ChartMODEL ECRI INSTITUTE'S

RECOMMENDEDSPECIFICATIONS1



ACIST

Contrast Media Injectors,Angiography

Contrast Media Injectors,CT

Contrast Media Injectors,MRI

CMS2000 CardiovascularManagement System

SYNCHRONIZATIONX-ray generator Yes Yes No

CONTROLSType Not specifiedWireless NoTouchscreen Yes

CONSOLE SIZE, H x W xD, 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 220-240LIST PRICE

Injector system $39,950Disposables Not specified

WARRANTY 1 year; optional 3 yearsOTHER SPECIFICATIONS Designed for both small and

large injections; injectionparameters selectable fromsterile field; built-in sensorsmonitor system integrity;syringe can be used for upto 5 separate patientprocedures whilemaintaining sterility; meetsrequirements of CUL, ISO9001, and UL.

UMDNS CODE(S) 15284 17969 18158 15284LAST UPDATED May 2009Supplier Footnotes 1These recommendations

are the opinions of ECRI

Institute's technologyexperts. ECRI Instituteassumes no liability fordecisions made based onthis data.

1These recommendationsare the opinions of ECRI


1These recommendationsare the opinions of ECRI


Model Footnotes

Data Footnotes


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Product Comparison ChartMODEL ACIST ACIST ACIST ACIST

CVi Contrast DeliverySystem

EmpowerCT InjectorSystem

EmpowerCTA InjectorSystem

EmpowerMR InjectorSystem

WHERE MARKETED Worldwide Worldwide Worldwide WorldwideFDA CLEARANCE No Yes Yes YesCE MARK (MDD) Yes Yes Yes YesTYPE Angiographic CT CT MRIDRIVE MECHANISM Ball screw Electromechanical Electromechanical HydraulicINJECTOR HEADMOUNTING OPTIONS

Not specified Floor and ceiling mounted Floor and ceiling mounted Floor mounted

SYRINGESDisposable Yes Yes Yes YesReusable Yes No No NoFluid heating Not specified Optional Optional No

SYRINGE CAPACITY, mLDisposable 99.9 200 200 100Reusable 99.9 NA NA NA

FLOW RANGE, mL/sec 0.8-40, 0.1 mL/secincrements

0.1-10 0.1-10 0.1-10

VOLUME RANGE, mL 0.8-99.9 1-200 1-200 1-100DELIVERY 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 psiADJUSTABLE RISE TIME Yes No No NoADJUSTABLE VOLUMESTOP TYPE

Programmable Automatic Automatic electronic Automatic electronic

Increments, mL 0.1 1 1 1SALINE FLUSH Not specified No Yes YesSAFETY FEATURES

Extravasation detection No Optional Optional NoAir 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



13/27



Product Comparison ChartMODEL ACIST ACIST ACIST ACIST

CVi Contrast DeliverySystem

EmpowerCT InjectorSystem

EmpowerCTA InjectorSystem

EmpowerMR InjectorSystem

SYNCHRONIZATIONX-ray generator Yes, validated for major

manufacturersYes (Philips, Siemens,Toshiba)

Yes (Philips, Siemens,Toshiba)

No

CONTROLSType Not specified Injector and remote Injector and remote Injector and remoteWireless No No No NoTouchscreen Yes Yes, remote control Yes, remote control Yes, remote control


20 x 33 x 8 (8 x 13 x 3) 17.8 x 33 x 30.5 (7 x 13 x12)

17.8 x 33 x 71.1 (7 x 13 x28)

27.9 x 33 x 10.2 (11 x 13 x4)


5 (11) 8.2 (18) 4.5 (10)

VOLTAGE, VAC 100-120; optional 220-240 100-240 100-240 100-240LIST PRICE

Injector system $39,950 $19,500-25,000 $34,500-40,500 ~$42,900Disposables 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 yearsOTHER SPECIFICATIONS Designed for cardiac and

vascular angiographyprocedures includingcoronaries, ventricle, aorta,and peripheral vasculature;injection parametersselectable from sterile field;built-in sensors monitorsystem integrity; saline KVOfeature; modular design toenhance convenience;multiuse syringe for up to 5separate patientprocedures; meetsrequirements of CUL, ISO9001, and UL.

Voice prompts; arming atinjector; help system; 50programs; full system safetymonitoring; front-loadsyringe; modular flexibility;Injector ReportingInformation System(IRiSCT); extravasationdetection optional. Meetsrequirements of BSI, CSA,IEC 60601-1, ISO 9000, andUL 2601-1.

Able to inject contrastfollowed by saline; voiceprompts; arming at injector;help system; 50 programs;full system safetymonitoring; front-loadsyringe; modular flexibility;Injector ReportingInformation System(IRiSCT); optionalextravasation detection.Meets requirements of BSI,CSA, IEC 60601-1, ISO9000, and UL 2601-1.

Hydraulic system does notrequire batteries; fully MRcompatible up to 7T;connectivity to InjectorReporting InformationSystem (IRiS) contrastmanagement tool.

UMDNS CODE(S) 15284 17969 17969 18158LAST UPDATED May 2009 May 2009 May 2009 May 2009Supplier Footnotes

Model Footnotes

Data Footnotes


14/27



Product Comparison ChartMODEL ACIST COVIDIEN COVIDIEN COVIDIEN

Voyager CardiovascularManagement System

Angiomat Illumena CT 9000 ADV Optistar Elite1

WHERE MARKETED Select countries in Asia; notavailable in Europe or USA

Worldwide (with limitedexceptions)


Worldwide, except Japan;other limited exceptions

FDA CLEARANCE Yes Yes Yes YesCE MARK (MDD) Yes Yes Yes YesTYPE Angiographic Angiographic, CT CT MRIDRIVE MECHANISM Electromechanical Electromechanical Electromechanical ElectromechanicalINJECTOR HEADMOUNTING OPTIONS

Not specified Ceiling, pedestal, or tablemounts

Not specified Not specified

SYRINGESDisposable Yes Empty and prefilled Empty and prefilled Empty and prefilledReusable Yes Yes (150 mL) No NoFluid heating Not specified Available Available Available

SYRINGE CAPACITY, mLDisposable 99.9 50, 75, 100, 125, 150, 200 50, 75, 100, 125, 200 10, 15, 20, 30, 60Reusable 99.9 150 NA NA

FLOW RANGE, mL/sec 0.8-40, 0.1 mL/secincrements

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, 30mL syringe: 0.1-8; side B:0.1-10 mL/sec in incrementsof 0.1 mL

VOLUME RANGE, mL 0.8-99.9 0.1-200 0.1-200 0.1-60DELIVERY 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 mLprefilled syringes at 13.8(200); 60 mL emptysyringes at 10.3 (150)

SELECTABLE PRESSURE Yes Yes Yes YesIncrements 1 psi 1 psi 25 psi 10 psi

ADJUSTABLE RISE TIME Yes 1-10 sec No NoADJUSTABLE VOLUMESTOP TYPE

Programmable Automatic electronic Automatic electronic Automatic, electronic

Increments, mL 0.1 0.5 1 1

SALINE FLUSH Not specified NA NA YesSAFETY FEATURES

Extravasation detection No No No NoAir detection Not specified Yes, Air Detection and

Warning System (ADAWS):acts to aid detectingaccidental air injectionthrough sensor at tip ofinjector

Used syringe indicator:requires user to verify thatproper syringe filling hasoccurred between injections

NA

OPERATOR ALERTS Air, manifold position, others Used syringe warning Used syringe warning Check for air in syringe andtubing

This is the first of two pagescovering the above

model(s). Thesespecifications continue ontothe next page.


15/27



Product Comparison ChartMODEL ACIST COVIDIEN COVIDIEN COVIDIEN

Voyager CardiovascularManagement System

Angiomat Illumena CT 9000 ADV Optistar Elite1

SYNCHRONIZATIONX-ray generator Yes Yes Yes No

CONTROLSType Not specified Hand startswitch Hand startswitch Hand startswitchWireless No NA NA NATouchscreen Yes Yes Yes Yes


20 x 33 x 8 (8 x 13 x 3) 21.6 x 31.8 x 6.4 (8.5 x 12.5x 2.5)

21.6 x 31.8 x 6.4 (8.5 x 12.5x 2.5)

21.6 x 31.8 x 6.4 (8.5 x 12.5x 2.5)


2.6 (5.8) 2.6 (5.8) 2.6 (5.8)

VOLTAGE, VAC 100-120; optional 220-240 110-120 or 220-240, 50-60Hz

100-120 or 220-240, 50-60Hz

100-120 or 220-240, 50-60Hz

LIST PRICEInjector system $39,950 $25,000 $20,000 $44,000Disposables Not specified Not specified Not specified Not specified

WARRANTY 1 year; optional 3 years 1 year parts and labor,

extended service plansavailable

1 year parts and labor,


1 year parts and labor,


OTHER SPECIFICATIONS Designed for use inperipheral vascularprocedures; same featuresas those listed forCMS2000, includingmultiprocedural-usecapabilities; saline KVOfeature.

Versatile exam modes: canswitch between cardiac,angiographic, and CTmodes. AccommodatesUltraject prefilled syringes;

ADAWS optional. Meetsrequirements of CSA, CUL,ISO 9001, Shonin, TUV,and UL.

Optional OptiBolus softwareprovides exponentiallydecelerating flow rate togive extended period ofuniform enhancement;upgradable to dual-headinjector for saline flush;accommodates Ultrajectsyringes. Meetsrequirements of CSA, CUL,ISO 9001, Shonin, TUV,and UL.

Battery-free power source,Patency Check software,status indicator line onconsole, dual syringe withmultiple user-definedphases; color coordinatedpush rods and touchscreen.Meets requirements of CUL,ISO 9001, TUV, and UL.

UMDNS CODE(S) 15284 15284, 17969 17969 18158LAST UPDATED May 2009 May 2009 May 2009 May 2009

Supplier FootnotesModel Footnotes 1Optistar Elite was formerly

listed as Optistar LE.Data Footnotes


16/27



Product Comparison ChartMODEL COVIDIEN COVIDIEN MEDEX BIOMEDICAL MEDRAD

Optistat Optivantage DH SBI 500 Avanta Fluid ManagementInjection System

WHERE MARKETED Worldwide, except Japan;other limited exceptions


Europe Worldwide

FDA CLEARANCE Yes Yes No YesCE MARK (MDD) Yes Yes CE 0459 by G-MED, France YesTYPE CT CT Dual-fluid CT injector Angiographic and cardiacDRIVE MECHANISM Electromechanical Electromechanical Hydraulic power station Electromechanical piston for

contrast, peristaltic pump forsaline

INJECTOR HEADMOUNTING OPTIONS

Not specified Not specified Not specified Table mount or pedestal

SYRINGESDisposable Empty and prefilled Empty and prefilled KSB25, KSB50, and

KSB/I/S when combinedwith MEDEX patentedsafety patient line

Yes

Reusable No No Ref RPVARD/20 Up to 5 patientsFluid heating Available Available Not specified Yes

SYRINGE CAPACITY, mLDisposable 125, 130 50, 75, 100, 125, 200 250, 500, 250 plus 250 mL

saline150, with automatic ormanual refill from attachedbulk source

Reusable NA NA Ref RPVARD/20 Up to 5 patientsFLOW 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 dependingon syringe size

1-200 per injection 1-150 in 1 mL increments,refillable from attached bulksource of up to 1 L contrast

DELIVERY PRESSURERANGE, 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 psiIncrements NA 1 psi 1 KPA (~0.1 bar) 1 psi

ADJUSTABLE RISE TIME No No No Yes, 0-9.9 sec (fixed flow)ADJUSTABLE VOLUMESTOP TYPE

Automatic electronic Automatic electronic Pause available duringinjection

User-adjustable electronic

Increments, mL 1 1 1 1SALINE FLUSH NA Yes Not specified YesSAFETY FEATURES

Extravasation detection No No No NAAir detection NA Used syringe warning:

prevents use of previouslyused syringe; enablingsequence ensures properair purging

Not specified Yes; also fluid level sensing

OPERATOR ALERTS NA RFID technology used to

transmit data between theUltraject syringe and theOptivantage DH injector toprevent use of previouslyused syringes

Not specified High flow rate and high

volume injection,overpressure, contrast orsaline depleted, air in line,others



17/27



Product Comparison ChartMODEL COVIDIEN COVIDIEN MEDEX BIOMEDICAL MEDRAD

Optistat Optivantage DH SBI 500 Avanta Fluid ManagementInjection System

SYNCHRONIZATIONX-ray generator Yes Yes Dry contact input Yes, user-selectable scan

delay or injection delay of 0-99.9 sec

CONTROLSType NA Hand startswitch Not specified Not specifiedWireless NA NA Not specified Not specifiedTouchscreen NA Yes Not specified Yes, true touchscreen with

intuitive instructions forsetup


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 12.5x 2.5)

24 x 29 x 24 (9.5 x 11.4 x9.5)

30.9 x 41.2 x 23.6 (12.2 x16.2 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) powerstation

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 PRICEInjector system $9,500 $37,000-45,000 35,333 (US$46,882) $42,000-45,000Disposables 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 plansavailable

1 year parts and labor,extended service plansavailable

1 year 1 year

OTHER SPECIFICATIONS Handheld system can beused independently forcontrast injection, interfaceto CT 9000 ADV, or secondOptistat for saline flush.

Fully programmablepowerhead touchscreendisplay; Patency Checkinjection to aid inextravasation detection;simple setup for dual-heador single-head protocols;optional interface for

connection to CT scanners.Optional OptiBolus bolusshaping software improvesCTA images and contrastagent utilization.

Ceiling- and wall-mountsystem available; softwareupgrade by USB memorystick; logfile registers detailsof every injection; automaticbag-filler system provided.

Dual air management withinfrared level sensors andultrasound gross airdetectors; saline delivery atfixed rate of 1.25 mL/sec;bolus sharpness feature;ergonomicelectromechanical hand

controller; 5-patient reuseclearance for syringe andmultipatient tubing set;automatic hemodynamicisolation for instantaneouschange from injection status(no pressure) tohemodynamic status(pressure detection); rapidsystem start anddisposables setup andexchange; memory of up to40 user-definable protocols;automated processes thateliminate manual manifold.

UMDNS CODE(S) 17969 17969 17969 15284LAST UPDATED May 2009 May 2009 May 2007 May 2009

Supplier FootnotesModel Footnotes

Data Footnotes


18/27



Product Comparison ChartMODEL MEDRAD MEDRAD MEDRAD MEDRAD

Mark V ProVis InjectionSystem

Spectris SolarisEP InjectionSystem

Stellant D Stellant Sx

WHERE MARKETED Worldwide Worldwide Worldwide WorldwideFDA CLEARANCE Yes Yes Yes YesCE MARK (MDD) Yes Yes Yes YesTYPE Angiographic MRI CT CTDRIVE MECHANISM Electromechanical Electromechanical Electromechanical ElectromechanicalINJECTOR HEADMOUNTING OPTIONS

Not specified Not specified Not specified Not specified

SYRINGESDisposable Yes Yes Yes YesReusable No No No NoFluid heating Not specified Not specified Not specified Not specified

SYRINGE CAPACITY, mLDisposable 60, 150, 200 65, 115 200 200Reusable NA NA NA NA

FLOW RANGE, mL/sec 0.3-50, depending onincrement 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 andsaline volumes loadautomatically)

Up to 200, integral autoload(user-defined contrast andsaline volumes loadautomatically)

DELIVERY PRESSURERANGE, 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 psiIncrements 1 psi NA 50 psi 50 psi

ADJUSTABLE RISE TIME Yes, 0.0-9.9 sec No NA NAADJUSTABLE VOLUMESTOP TYPE

Mechanical Electrical Electronic Electronic

Increments, mL 1 1 Not specified Not specifiedSALINE FLUSH Not specified Not specified Yes NoSAFETY FEATURES

Extravasation detection No Yes Yes YesAir detection Not specified Not specified Not specified Not specified

OPERATOR ALERTS Yes Maximum pressure reached Air, armed, scan and injectdelay, overpressure, others

Air, armed, scan and injectdelay, overpressure, others



19/27



Product Comparison ChartMODEL MEDRAD MEDRAD MEDRAD MEDRAD

Mark V ProVis InjectionSystem

Spectris SolarisEP InjectionSystem

Stellant D Stellant Sx

SYNCHRONIZATIONX-ray generator No No Yes, triggering interface with

CT scannerYes, triggering interface withCT scanner

CONTROLSType Not specified Not specified Not specified Not specifiedWireless Not specified Not specified Not specified Not specifiedTouchscreen Not specified Not specified Yes Yes


27 x 48 x 32 (10.5 x 19 x12.6), 119 x 66 x 66 (47 x26 x 26 ) pedestal model

27.7 x 30 x 26.7 (10.9 x11.9 x 10.5)

34.3 x 31.6 x 22.6 (13.5 x12.5 x 8.9)

34.3 x 31.6 x 22.6 (13.5 x12.5 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 HzLIST 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 specifiedWARRANTY 1 year 1 year 1 year 1 yearOTHER SPECIFICATIONS Automatic mechanical stop;

double syringe; segmentedcontrol panel; multiphasic;table rack, overhead, andintegrated pedestal witharticulating arm;microprocessor based; 49programs. Meetsrequirements of BSI, CSA,ISO 9001 and 9002, TUV,and UL.

6 user-defined injectionphases for flexibleprogramming; fiberopticcommunication; integratedcontinuous battery-chargingsystem; 3T compatibility;mobile configurationavailable. Meetsrequirements of CE, CSA,ISO 9001 and 9002, TUV,and UL.

Patented P3T software(patient-specific injectionprotocols) for cardiac andabdomen studies; ability todeliver saline and contrastsimultaneously; 1-6 phasesper protocol, includingsaline as a test injection;flow profile enables at-a-glance program information;disposable syringe transferset for optimal bulk contrastpackage management;embolism detection.

Patented P3T software(patient-specific injectionprotocols) for abdomenstudies; stopwatch featurefor optimized delayedscanning sequences; 1-6phases per protocol,including saline as a testinjection; flow profileenables at-a-glanceprogram information; 32protocols may be stored;embolism detection.


Model Footnotes

Data Footnotes


20/27



Product Comparison ChartMODEL MEDRAD MEDTRON MEDTRON MEDTRON

Vistron CT Injection System Accutron CT Injector Accutron CT-D Injector Accutron HP-D

WHERE MARKETED Worldwide Worldwide Worldwide, except Canadaand Japan Worldwide

FDA CLEARANCE Yes No No NoCE MARK (MDD) Yes Yes Yes YesTYPE CT CT CT Angiographic

(cardiovascular)DRIVE MECHANISM Electromechanical Electrical Electrical ElectricalINJECTOR HEADMOUNTING OPTIONS

Not specified Standalone, ceiling/wall dualattachment suspension

Standalone, ceiling/wall dualattachment suspension

Standalone

SYRINGESDisposable Yes Easy-Loading Syringe (ELS) Easy-Loading Syringe (ELS) Easy-Loading Syringe (ELS)Reusable No No No NoFluid heating Not specified Yes Yes Yes

SYRINGE CAPACITY, mLDisposable 200 200 200 200Reusable NA NA NA NA

FLOW RANGE, mL/sec 0.1-9.9 0.1-10 0.1-10 0.1-30VOLUME RANGE, mL 10-200 1-125, 1-200 1-200 1-200DELIVERY 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 secADJUSTABLE VOLUMESTOP TYPE

Automatic electronic Automatic electronic Automatic electronic Automatic electronic

Increments, mL 1 1 1 1SALINE FLUSH No Not specified Not specified YesSAFETY FEATURES

Extravasation detection No Not specified Not specified Not specifiedAir detection Not specified Not specified Not specified Not specified

OPERATOR ALERTS Armed, scan delay,overpressure

Maximum pressurereached, venting, remaining

volume too low, head tiltdown







21/27



Product Comparison ChartMODEL MEDRAD MEDTRON MEDTRON MEDTRON

Vistron CT Injection System Accutron CT Injector Accutron CT-D Injector Accutron HP-D

SYNCHRONIZATIONX-ray generator No Yes Yes, CANopen CIA 425 Yes, wirelessCONTROLS

Type Not specified Touchscreen Touchscreen TouchscreenWireless Not specified Yes Yes YesTouchscreen Not specified 1 on injection unit, 1 on

remote control1 on injection unit, 1 onremote control

1 on injection unit, optionalremote control


12.7 x 35.6 x 26 (5 x 14 x10.3)

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 x2.2)

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 HzLIST PRICE

Injector system $13,000-18,000 14,900 (US$19,770) 26,500 (US$35,162) Not specifiedDisposables Not specified Not specified Not specified Not specified

WARRANTY 1 year 1 year 1 year 1 yearOTHER SPECIFICATIONS Autofill; remote monitor

standard; 1-4 phases; scandelay; embolism detection.Meets requirements of BSI,CSA, ISO 9001 and 9002,TUV, and UL.

1 injector head; integratedheated syringe holder;prefilled syringes; optionalwall- or ceiling-mountedsupport, up to 6 phases;wireless touchscreenremote control.

2 injector heads; integratedheated syringe holder;optional wall- or ceiling-mounted support, 6 phases;wireless touchscreenremote control, optionalCANopen interface.

First high-pressure double-head injector with 2 x 200ml capacity; able to performhigh-pressure real-timecontrast media dilution forcross-sectional imaging;wireless touchscreenremote control; wirelessscanner interface.


Model Footnotes

Data Footnotes


22/27



Product Comparison ChartMODEL MEDTRON MEDTRON MEDTRON MEDTRON

Accutron MR Injector Injektron 82 CT Injector Injektron 82HP CT-AngioInjector

Injektron CT2 CT Injector

WHERE MARKETED Worldwide Worldwide Worldwide WorldwideFDA CLEARANCE No No No NoCE MARK (MDD) Yes Yes Yes YesTYPE MRI CT Angiographic, CT CTDRIVE MECHANISM Electrical Electrical Electrical ElectricalINJECTOR HEADMOUNTING OPTIONS

Standalone Standalone, ceiling/wallsuspension

Standalone, ceiling mount Standalone, ceiling/wallsuspension

SYRINGESDisposable Easy-Loading Syringe (ELS) Easy-Loading Syringe (ELS) Easy-Loading Syringe (ELS) Easy-Loading Syringe (ELS)Reusable No No No NoFluid heating No Yes Yes Yes

SYRINGE CAPACITY, mLDisposable 200 200 200 200Reusable NA NA NA NA

FLOW RANGE, mL/sec 0.1-10 0.1-7.5 0.1-30 0.1-15VOLUME RANGE, mL 1-200 1-200 1-200 1-200DELIVERY 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); optional5-30 (72.5-435)

SELECTABLE PRESSURE Yes Yes Yes YesIncrements 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 specifiedADJUSTABLE VOLUMESTOP TYPE

Automatic electronic Automatic electronic Automatic electronic Automatic electronic

Increments, mL 1 1 1 1SALINE FLUSH Not specified Not specified Not specified Not specifiedSAFETY FEATURES

Extravasation detection Not specified Not specified Not specified Not specifiedAir detection Not specified Not specified Not specified Not specified

OPERATOR ALERTS Maximum pressurereached, venting, remainingvolume too low

Maximum pressure reached Maximum pressure reached Maximum pressure reached



23/27



Product Comparison ChartMODEL MEDTRON MEDTRON MEDTRON MEDTRON

Accutron MR Injector Injektron 82 CT Injector Injektron 82HP CT-AngioInjector

Injektron CT2 CT Injector

SYNCHRONIZATIONX-ray generator No Yes Yes Yes, CANopen CIA 425

CONTROLSType Touchscreen Keypad interface Keypad interface Keypad interfaceWireless Yes Not specified Not specified YesTouchscreen 1 on injection unit, 1 on

remote controlNot specified Not specified On remote control


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 x2.4)

WEIGHT, kg (lb) 37 (81.6) 22.5 (49.6) 27.5 (60.6) 42 (92.6)VOLTAGE, VAC 105-240, 50/60 Hz 105-240 105-240 105-240LIST 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 yearOTHER SPECIFICATIONS 2 injector heads, 200 mL

empty syringes; specialfeatures for MRangiography; up to 6phases; prefilled syringesavailable; wirelesstouchscreen remote control.

Phlebography mode;optional prefilled syringes;remote control available for

1,740 (US$2,353); wall- orceiling-mounted support;integrated heated syringeholder.

CT mode; optional prefilledsyringes; remote controlavailable for 1,740(US$2,353); wall- or ceiling-mounted support; integratedheated syringe holder.

2 injector heads; integratedheated syringe holder;optional wall- or ceiling-mounted support, 6 phases;wireless touchscreenremote control, optionalCANopen interface.

UMDNS CODE(S) 18158 17969 15284, 17969 17969LAST UPDATED May 2009 May 2009 May 2009 May 2009Supplier Footnotes

Model Footnotes

Data Footnotes


24/27



Product Comparison ChartMODEL SIAS SIAS ULRICH MEDICAL ULRICH MEDICAL

CT 957 Diginjector 2002 Millennium CT injector missouri CT injector ohio tandem

WHERE MARKETED Worldwide Worldwide Worldwide WorldwideFDA CLEARANCE No No Not submitted Not submittedCE MARK (MDD) Yes Yes Yes YesTYPE CT Angiographic, CT CT CTDRIVE MECHANISM Peristaltic pump Electromechanical Roll pump Roll pumpINJECTOR HEADMOUNTING OPTIONS

Not specified Not specified Movable stand version,space-saving ceilingsuspension version

Movable stand version,space-saving ceilingsuspension version

SYRINGESDisposable Yes Yes Patient hose Patient hoseReusable No No Pump hose for multidosing

(24 hr); multidosing mediacontainers: contrast agentbottles, prefilled syringes,scanbags (24 hr)

Pump hose for multidosing(24 hr); multidosing mediacontainers: contrast agentbottles, prefilled syringes,scanbags (24 hr)

Fluid heating Not specified Yes Passive temperaturepreservation system

riverside

Passive temperaturepreservation system

riversideSYRINGE CAPACITY, mL

Disposable 500, 2 bottles 130, 260 5-15, patient hose 5-15, patient hoseReusable NA NA Up to 2,000, various

multidosing mediacontainers

Up to 2,000, variousmultidosing mediacontainers

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 1-400DELIVERY 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 specifiedIncrements NA 1 bar (14.5 psi) Software adjusts pressure

according to selected flowrate

Software adjusts pressureaccording to selected flowrate

ADJUSTABLE RISE TIME No Yes Software adjusts pressureaccording to selected flowrate


ADJUSTABLE VOLUMESTOP TYPE

No Automatic electronic Software Software

Increments, mL NA 1 1 1SALINE FLUSH Yes No Yes YesSAFETY FEATURES

Extravasation detection No No Yes YesAir detection Not specified Not specified Yes Yes

OPERATOR ALERTS Air bubble Over- and underflow,overpressure

Touch terminal: alert soundand messages; control unit:alert lights




25/27



Product Comparison ChartMODEL SIAS SIAS ULRICH MEDICAL ULRICH MEDICAL

CT 957 Diginjector 2002 Millennium CT injector missouri CT injector ohio tandem

SYNCHRONIZATIONX-ray generator Yes Yes Yes YesCONTROLS

Type Not specified Not specified Touch terminal and controlunit on injector, optionalmouse

Touch terminal and controlunit on injector, optionalmouse

Wireless Not specified Not specified Not specified Not specifiedTouchscreen Not specified Not specified Yes Yes


16 x 45 x 31 (6.3 x 17.7 x12.2)

115 x 50 x 56 (45.3 x 19.7 x22)

25.2 x 33 x 12.6 (9.9 x 12.9x 5)

25.2 x 33 x 12.6 (9.9 x 12.9x 5)

WEIGHT, kg (lb) 73 (161) with pump headand control console

72 (158.7) with controlconsole

5.3 (11.7) console, 57(125.7)

5.3 (11.7) console, 61(134.5)

VOLTAGE, VAC 230 230 100-240 100-240LIST PRICE

Injector system 20,000 (US$26,536) 27,000 (US$35,824) Not specified Not specifiedDisposables Not specified Not specified Not specified Not specified

WARRANTY 1 year 1 year 1 year, extended on request 1 year, extended on requestOTHER SPECIFICATIONS Injection course controlled

by system ultrasound; noair-injection risk.

Servo operating mode todrive injection flow byposition of handswitch.

None specified. Tandem function allowsclinician to choose between2 different contrast agentswithout changing mediacontainers.

UMDNS CODE(S) 17969 15284, 17969 17969 17969LAST UPDATED May 2009 May 2009 May 2009 May 2009Supplier Footnotes

Model Footnotes

Data Footnotes


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Product Comparison ChartMODEL ULRICH MEDICAL ULRICH MEDICAL ULRICH MEDICAL

CT/MRI injector mississippi CT/MRI injector ohio M CT/MRI injector tennessee

WHERE MARKETED Worldwide Worldwide WorldwideFDA CLEARANCE Not submitted Not submitted Not submittedCE MARK (MDD) Yes Yes YesTYPE CT, MRI CT, MRI CT, MRIDRIVE MECHANISM Roll pump Roll pump Roll pumpINJECTOR HEADMOUNTING OPTIONS




SYRINGESDisposable Patient hose Patient hose Patient hoseReusable Pump hose for multidosing

(24 hr); multidosing mediacontainers: contrast agentbottles, prefilled syringes,scanbags (24 hr)



Fluid heating Passive temperaturepreservation system

riverside


riverside


riversideSYRINGE CAPACITY, mL

Disposable 5-15, patient hose 5-15, patient hose 5-15, patient hoseReusable Up to 2,000, various

multidosing mediacontainers



FLOW RANGE, mL/sec 0.2-8 0.2-8 0.2-8VOLUME RANGE, mL 1-400 1-400 1-400DELIVERY PRESSURE

RANGE, bar (psi) 16 (232) maximum,autoadjust



SELECTABLE PRESSURE Not specified Not specified Not specifiedIncrements Software adjusts pressure




ADJUSTABLE RISE TIME Software adjusts pressure


Software adjusts pressure


Software adjusts pressure


ADJUSTABLE VOLUMESTOP TYPE

Software Software Software

Increments, mL 1 1 1SALINE FLUSH Yes Yes YesSAFETY FEATURES

Extravasation detection Yes Yes YesAir detection Yes Yes Yes

OPERATOR ALERTS Touch terminal: alert soundand messages; control unit:alert lights



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covering the abovemodel(s). Thesespecifications continue ontothe next page.


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Product Comparison ChartMODEL ULRICH MEDICAL ULRICH MEDICAL ULRICH MEDICAL

CT/MRI injector mississippi CT/MRI injector ohio M CT/MRI injector tennessee

SYNCHRONIZATIONX-ray generator Yes Yes YesCONTROLS

Type Touch terminal and controlunit on injector, optionalmouse



Wireless Not specified Not specified Not specifiedTouchscreen Yes Yes Yes


25.2 x 33 x 12.6 (9.9 x 12.9x 5)

25.2 x 33 x 12.6 (9.9 x 12.9x 5)

25.2 x 33 x 12.6 (9.9 x 12.9x 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 powersupply

LIST PRICEInjector system Not specified Not specified Not specifiedDisposables Not specified Not specified Not specified

WARRANTY 1 year, extended on request 1 year, extended on request 1 year, extended on requestOTHER SPECIFICATIONS None specified. Tandem function allows

clinicians to choosebetween 2 different contrastagents without changingmedia containers.

Accumulator-free MRIinjector.

UMDNS CODE(S) 17969, 18158 17969, 18158 17969, 18158LAST UPDATED May 2009 May 2009 May 2009Supplier Footnotes

Model Footnotes

Data Footnotes

Documents

Injectors, Contrast Media, Angiography; CT; MRI