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Stellant® CT Injection System

201071 Rev. J

Stellant® CT Injection SystemOperation Manual

2009, 2012, 2013 MEDRAD, INC. All rights reserved.Reproduction of this manual is strictly prohibited without express written consent of MEDRAD, INC.For more information about MEDRAD products and services, please visit WWW.MEDRAD.COM

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Table of Contents

Table of Contents1 - Introduction ........................................................................................................................ 1-1

Certifications ....................................................................................................................... 1-1Intended Use ....................................................................................................................... 1-1Contraindications ................................................................................................................ 1-1Restricted Sale .................................................................................................................... 1-1Required Training ............................................................................................................... 1-1Trademarks ......................................................................................................................... 1-1Disclaimers ......................................................................................................................... 1-2The Equipotential Connector (EPC) .................................................................................... 1-2MEDRAD Contact Information ............................................................................................ 1-2Symbols .............................................................................................................................. 1-2

Display Buttons and Icons ............................................................................................. 1-3Injector Head Icons ....................................................................................................... 1-4

Pressure Limit ..................................................................................................................... 1-5Pressure ........................................................................................................................ 1-5Flow Rate ...................................................................................................................... 1-5Injector Duration ............................................................................................................ 1-5The Basics .................................................................................................................... 1-5How the Injector is Designed ........................................................................................ 1-6How to Recognize if a Pressure Limit Condition Occurs ............................................... 1-6

Response to Occlusions ..................................................................................................... 1-6Volume and Rate Protection ............................................................................................... 1-6Definition of Terms .............................................................................................................. 1-6Warnings ............................................................................................................................. 1-7Cautions .............................................................................................................................. 1-8

2 - System Basics ................................................................................................................. 2-11About the Injection System ............................................................................................... 2-11Moving the System Within the Room ................................................................................ 2-11Stellant Models ................................................................................................................. 2-11Basic Features .................................................................................................................. 2-11Display Control Unit (DCU) ............................................................................................... 2-12Single Stellant Injector (S and SX) .................................................................................... 2-13

Single Stellant Injector Head Overlays ........................................................................ 2-13Dual Stellant Injector (D) ................................................................................................... 2-14

D model Injector head overlay .................................................................................... 2-14Injector Head Control ........................................................................................................ 2-15

Manual Knob ............................................................................................................... 2-16Arm Lights ................................................................................................................... 2-17Hand Switch ................................................................................................................ 2-17Heat Maintainer ........................................................................................................... 2-17

Applying Power ................................................................................................................. 2-17System Logo ..................................................................................................................... 2-18Safety Screen ................................................................................................................... 2-18Main Screen ...................................................................................................................... 2-18Procedure Data ................................................................................................................. 2-19

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Patient ID .................................................................................................................... 2-19Contrast Concentration ............................................................................................... 2-19 Pressure Limit ............................................................................................................ 2-20Delay ........................................................................................................................... 2-21Iodine Summary .......................................................................................................... 2-21

Setup ................................................................................................................................. 2-22Date/Time ......................................................................................................................... 2-23Help ................................................................................................................................... 2-24Reset ................................................................................................................................. 2-24

3 - Preparing to Inject ........................................................................................................... 3-25Minimizing Air Embolization Risks .................................................................................... 3-25Using the Stellant Pedestal with Integrated IV Pole .......................................................... 3-26Stellant Connector Tubing ................................................................................................ 3-27Loading and Priming a Syringe ......................................................................................... 3-27

Priming Mode Selection .............................................................................................. 3-28Priming Volume - LPCT Type ..................................................................................... 3-28

Manual Loading and Priming a Syringe ............................................................................ 3-28Cautions for Draw Back .................................................................................................... 3-29Using Auto Load to Load a Syringe (SX and D Models) ................................................... 3-29

Select an Auto Load Purge Volume ............................................................................ 3-30Using Auto Load With a Spike or QFT ........................................................................ 3-30

Removing a 200 ml Syringe ............................................................................................... 3-31Programming Protocols .................................................................................................... 3-31

Programming Multiple Phases .................................................................................... 3-32Storing a Protocol ............................................................................................................. 3-32Locking a Protocol ............................................................................................................ 3-33Recalling a Protocol .......................................................................................................... 3-33Deleting a Protocol ............................................................................................................ 3-33Programming a Delay ....................................................................................................... 3-34

4 - Arming and Injecting ....................................................................................................... 4-35Arming ............................................................................................................................... 4-35

Before Beginning the Arming Process ........................................................................ 4-35Beginning the Arming and Injecting Process .............................................................. 4-35

Test Injection ..................................................................................................................... 4-36Configuring Test Inject Parameters ............................................................................. 4-36Performing a Test Injection ......................................................................................... 4-37

Injecting ............................................................................................................................. 4-37Performing a Injection ................................................................................................. 4-37

Injecting Views .................................................................................................................. 4-38Pressure Graph ................................................................................................................. 4-39

Pressure Graph Helpful Hints ..................................................................................... 4-40Injection Complete ............................................................................................................ 4-42

Appendix A - System Messages ..........................................................................................A-43Error Screen ......................................................................................................................A-43System Tones ...................................................................................................................A-43

General Tones ............................................................................................................A-43Notification Tones .......................................................................................................A-43

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Table of Contents

Appendix B - Cleaning and Maintenance ...........................................................................B-45Cleaning Guidelines ..........................................................................................................B-45

Cleaning the Injector Head, Piston and Syringe Interface ..........................................B-45Cleaning the Display Control Unit ...............................................................................B-46Cleaning the Pedestal .................................................................................................B-46Cleaning the Base .......................................................................................................B-46

Recommended Maintenance Schedule ............................................................................B-46Daily ............................................................................................................................B-46Monthly ........................................................................................................................B-46Annually ......................................................................................................................B-46

Inspection Procedures ......................................................................................................B-47Injector Head (Single and Dual) ..................................................................................B-47Display Control Unit ....................................................................................................B-47Wall Bracket ................................................................................................................B-47Pedestal ......................................................................................................................B-48

Operational Checkout .......................................................................................................B-48System Labels .............................................................................................................B-48Power Up ....................................................................................................................B-48Programming ...............................................................................................................B-48

Touch Screen Calibration .................................................................................................B-49

Appendix C - Specifications ................................................................................................C-51DCU and Base Unit ...........................................................................................................C-51

DCU and Base Unit Dimensions .................................................................................C-51Rear of Display ............................................................................................................C-51Rear of Base Unit ........................................................................................................C-52Bottom of Base Unit ....................................................................................................C-52

Scan Room Unit ................................................................................................................C-53Scan Room Unit Dimensions - Single .........................................................................C-53Scan Room Unit Dimensions - Dual ............................................................................C-53

Environmental Specifications ............................................................................................C-54Non-Operating: (Transportation and Storage) ............................................................C-54Operating ....................................................................................................................C-54AC Adapters for Informatics and VirtualCARE Systems) ............................................C-54Protection Against Electrical Shock ............................................................................C-54EMI/RFI .......................................................................................................................C-54Electrical Leakage .......................................................................................................C-54Ground Continuity: ......................................................................................................C-54Protection Against the Ingress of Fluids ......................................................................C-55Mode of Operation ......................................................................................................C-55Fluid Delivery Performance .........................................................................................C-55System Response to Occlusions ................................................................................C-55Over and Under Infusion Protection ............................................................................C-55System Fluid Performance ..........................................................................................C-56

Appendix D - Options and Accessories ..............................................................................D-57Catalog Numbers and Descriptions ..................................................................................D-57Overhead IV Track System ...............................................................................................D-58

Appendix E - System Installation ........................................................................................E-59

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Unpacking the Injection System ........................................................................................E-59Installation Considerations ................................................................................................E-60Injector Installation ............................................................................................................E-60Reinstalling the System in Another Room ........................................................................E-61

Appendix F – Compliance to IEC 60601-1-2 / 2001 2nd Edition ........................................F-63

Index ........................................................................................................................................ I-67

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1 - Introduction

1 - Introduction

This manual applies to the MEDRAD® Stellant® CT Injection System, also referred to as the System, Catalog Numbers: SCT 110, 111, SCT 112, SCT 120, SCT 121, SCT 122, SCT 210, SCT 211, SCT 212.

Read all the information contained in this manual. Understanding this information will assist the user in operating the the System in a safe manner.

NOTE: Operating specifications and feature availability may vary by country. Check with local product representative and country-specific operating instructions.

Certifications This device is equipped to operate at 100-240 VAC, 50/60 Hz, 180 VA (Single), 300 VA (Dual), and is designed to comply with EN 60601-1/IEC 60601-1 Second/Third Edition, and EN 60601-1-2 Second Edition and IEC 60601-1-2 Second/Third Edition Standards. Special precautions regarding ElectroMagnetic Compatibility (EMC), are required for installation and use of this injector system. Detailed EMC information can be found in “Appendix F – Compliance to IEC 60601-1-2 / 2001 2nd Edition” on page 63.

Intended Use The Stellant CT Injection System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications.

Contraindications These devices are not to be used for drug infusion, chemotherapy, or any other use for which the devices are not indicated. The Stellant CT Injection System is not intended for portable use.

Restricted Sale Federal (USA) law restricts these devices to sale by or on the order of a physician.

Required Training This device is intended to be used by individuals with adequate training and experience in diagnostic image studies.

Trademarks MEDRAD, FluiDots, and Stellant are trademarks of MEDRAD, INC. Other trademarks which appear in this manual are the property of their respective companies.

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Disclaimers External wiring and modifications disclaimers: MEDRAD disclaims liability for any modifications or interfaces with other equipment that are not in conformity with the specifications and information contained within this manual.

Accessory equipment connected to the device must be certified according to IEC 60601-1 Second/Third Edition. Furthermore, all configurations shall comply with system standard EN 60601-1/IEC 60601-1-1. Anyone who connects additional equipment to the signal input or output part configures a medical system and is therefore responsible that the system complies with the requirements of the standard IEC 60601-1-1. To obtain on-site consulting

or consulting references, contact MEDRAD Service®.

The Equipotential Connector (EPC)

The Equipotential Connector (EPC) is an electrically bonded terminal on the injector that is used as a connection point between other medical electrical equipment. The EPC’s function is to minimize any voltage potentials differences between all connected equipment. The EPC is not designed to be an electrical safety ground.

MEDRAD Contact Information

Symbols The following symbols are used on the System and components.:

MEDRAD, INC. USAOne Medrad DriveIndianola, Pa 15051-0780 U.S.A.Phone: 412 767-2400Fax: 412-767-4120

MEDRAD Europe B.V.P.O. Box 2056190 AE BeekThe NetherlandsPhone: +31(0)43-3585600FAX: +31(0)43-3656598

Nihon MEDRAD KK2-4-9, Umeda, Kita-ku,Osaka, 530-0001JapanPhone: +81(0)66-133-6250Fax: +81(0)66-344-2395

Indicates that this device conforms to the requirements of the European Medical DeviceDirective 93/42/EEC.

Protocol is locked indicator.

Protocol is unlocked or unengaged.

Attention, consult accompanying instructions.

Indicates on/off switch.

Indicates hazardous voltages.

Indicates alternating current.

Identifies a type BF applied part complying with IEC 60601-1 standards.

Indicates the injection system is Class 1 medical equipment as defined by IEC 60601-1 standards.CLASS 1

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1 - Introduction

Display Buttons and Icons

Identifies the degree of protection against fluid as drip proof.

Identifies the Equipotential connection.

Identifies the Earth Ground point.

Indicates design for indoor use only.

Indicates the presence of no serviceable parts.

Pressure Graph View.

Phase View.

Electrostatic.

Indicates separate collection for Electrical and Electronic Equipment per Directive 2002/96/EC. Refer to the following website for additional information:http://www.medrad.com/en-us/resources/Pages/WEEE.aspx

The Overhead IV Track System is only intended for hanging IV fluids. Do not hang more than 50lbs / 23 kg of weight on the hooks.

Pushing Prohibited. Do not push at or above this point on the Injector.

>23kg>50lbs.

Terminates the injection and disarms the System.

Initiates the injection.Holds the injection for a maximum of 20 minutes.

Launches the help system.Resets the protocol to the factory default values.

Accesses the system settings. Indicates on/off switch.

Increases or decreases display brightness Hand switch connection.

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Injector Head Icons

1 Activates the Fill buttons. 2Fill Buttons.

• Syringe A (green)• Syringe B (blue)

3Adjusts Auto fill volume to the desired amount in small increments/decrements.

4 Activates Auto Prime.

5Activates the forward and reverse piston controls. Illuminates when pressed.

6 Forward and Reverse Piston Controls.

7The Check for Air icon; illuminates after the operator has confirmed inspecting the fluid path for air.

8Indicates the protocol is locked; illuminates after the operator has locked the protocol.

9Arms the injector; illuminates after the operator has armed the injector.

10 Terminates and disarms injection.

11Initiates the injection.Holds the injection for a maximum of 20 minutes.

Manual knob indicators:• Syringe A (green)• Syringe B (blue)

Heat Maintainer connection on underside of Injector Head.

Hand switch connection on underside of Injector Head.

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1 - Introduction

Pressure Limit The System is designed to allow varied flow rates for contrast injections. In order to understand this section on Pressure and Pressure Limiting, it is important to clarify the terminology that will be used in this section.

Pressure

Pressure is related to the amount of force which the injector head must develop in the syringe in order to move fluid at the selected Flow Rate.

Pressure developed by the System is measured relative to the atmosphere pressure outside of the syringe or connector tubing. The pressure developed by the injector is expressed in terms of “Gauge Pressure” or “PSIG” which is the “Absolute Pressure” or “PSIA” minus the atmospheric pressure. Hereafter, pressure displayed as PSI refers to gauge pressure.

NOTE: To convert kPa to Bar, move the decimal point two places to the left (100 PSI = 6.9 Bar).

Flow RateFlow Rate is selected on the Display Control Unit in units of ml/sec.

Injector DurationInjection Duration is the length of time that the injector will require to perform the programmed protocol from the moment the start switch is depressed until the unit stops injecting. Duration is calculated by dividing the selected Volume by the selected Flow Rate (50 ml Volume divided by 2 ml/sec Flow Rate = Duration of 25 seconds). The duration of a multi-phasic injection will be calculated by the injector and displayed on the screen. Pause time is not included in this duration time.

The BasicsIn order for contrast media to flow through the CT disposable system (connector tubing, stopcock, catheter-over-needle), the pressure in the syringe must exceed the resistance of the disposable system. Pressure in the syringe is generated by the force driving the syringe plunger. This pressure decreases over the entire length of the disposable system. As the fluid flows out the end of the catheter, there will be virtually no pressure. Pressure will be essentially zero at the open (unrestricted) end of the catheter-over-needle, because there is no resistance to fluid flow.

To achieve a selected Flow Rate, the pressure exerted by the plunger must be great enough to overcome the resistance of the disposable system. To do this, the force behind a fluid must be great enough to push it through a tube.

200 ml syringe

Programmable Pressure Limit(Selectable Range: 50 psi - 325 psi (325 kPa - 2241 kPa)

Factory preset to 325 PSI (2241 kPa)

Hazard/failure limit (injector shut-down pressure in the event of a failure).

Factory preset to 375 PSI (2586 kPa)

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How the Injector is Designed

The System is a flow-controlled system. This means that the flow that is selected on the display control console is the flow rate at which the injector will deliver contrast for the duration of the injection. The only time the actual flow rate will differ from the programmed flow rate is when the flow rate cannot be delivered through the selected disposables with the amount of pressure available. When this occurs, the injector will automatically limit the maximum pressure and the resultant (lower) flow rate will be delivered. The injector still injects and delivers the total volume. However, the delivered flow rate will be lower, and thus, the injection duration will be longer.

How to Recognize if a Pressure Limit Condition Occurs

If a pressure limit condition occurs, it will first be evidenced by injection durations that are greater than what would normally be expected, and also by low-contrast films. A pressure limit condition can also be seen by observing the Pressure Graph.

Therefore, if the enhancement on the images is not as desired, this could mean a lower flow rate was delivered than selected, and pressure limiting may be occurring. Check for a pressure limit condition by comparing the actual injection duration with a calculated value (volume divided by flow rate). If the actual duration exceeds the calculated value, pressure limiting may have occurred.

To achieve the selected flow rate (avoid a pressure limit condition), consider increasing the catheter size or use a less viscous or heated contrast media.

Response to Occlusions

When injecting into an occlusion, a stall condition (flow rate less than 10% of programmed rate) or a very high pressure, a disarm will result. A stall condition lasting more than five seconds will result in the injection being automatically terminated. If a stall or high pressure disarm occurs, check the fluid path for blockage and inspect the disposable set for damage. If no blockage is found consider increasing the catheter size or decreasing the flow rate. Re-check the fluid path for air before arming.

Volume and Rate Protection

The following means are provided to protect against over and under volume or rate conditions:

• Warnings displayed on the Safety screen remind the operator to check the programmed injection parameters prior to the system being armed.

• An on-screen indication of insufficient volume is provided whenever the total volume programmed to be delivered is greater than the amount of fluid in the syringe.

• Injection monitoring is performed to detect over rate or over volume conditions due to system faults. If either of these conditions is detected, the injection will be stopped.

Definition of Terms WARNING: Indicates that the information is a warning. Warnings advise of circumstances that could result in injury or death to the patient or operator. Read and understand the warnings before operating the System.

CAUTION: Indicates that the information is a caution. Cautions advise of circumstances that could result in damage to the device. Read and understand the cautions before operating the System.

NOTE: Indicates that the information that follows is additional important information or a tip that will help the user to recover from an error or point to related information within the manual.

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1 - Introduction

Warnings

WARNING: Only use the power cord supplied with the system. Do not plug the System power cord into an extension cord or multi-outlet power strip.

WARNING: Patient injury could result from a system malfunction. If a system malfunction occurs, immediately remove unit power by pressing the power switch and disconnect the unit from the patient. If a fault message is displayed that cannot be corrected, and/or the system is not operating correctly, do not use the injection system. Call MEDRAD or a local dealer for assistance.

WARNING: Patient injury could result from leaks or ruptures during an injection. To prevent leaks or ruptures in the event of a blockage, use only MEDRAD disposable products, or use catheters and connectors with pressure ratings compatible with this system.

WARNING: Explosion hazard: Patient injury could result from using the injection system in the presence of flammables (such as anesthetics). Do not use the system when flammables are present. Do not use in the presence of oxygen or in oxygen enriched atmospheres.

WARNING: Fire hazard: Patient injury could result from using incorrect fuses. To avoid an electrical fire, assure the correct type of fuse is used for replacement. The fuse must be replaced with Type T, 250 V, 3.15 A fuse by qualified personnel only.

WARNING: Equipment must only be connected to a supply mains with protective earth.

WARNING: Shock hazard: Patient injury could result from worn cabling or unit disassembly. To avoid exposure to potentially hazardous voltages, do not disassemble the injection system in any way. Worn cabling also creates hazards. If any worn or damaged cables are detected, do not use the injection system. Contact MEDRAD or a local dealer for service or replacement.

WARNING: Patient injury could result from potentially hazardous system electronic assembly material. Dispose of system components or accessories properly. Follow local regulations for proper disposal or contact MEDRAD Service for assistance.

WARNING: Patient injury could result from using improper accessories. Use only accessories and options provided by MEDRAD designed for this system.

WARNING: Patient injury could result if the syringe is not properly engaged. Ensure the syringe is properly snapped into the front of the injector head before injecting. Improper engagement may cause the syringe to leak, become damaged, or to come off during the injection and result in an under-volume delivery.

WARNING: Biological contamination could result from reusing disposable items or failure to follow aseptic technique. Properly discard disposable items after use, or if there is any possibility that contamination may have occurred.

WARNING: Syringe sterility will be compromised, and patient infection may result, if the plunger is removed from the syringe. Do not remove the plunger to fill the syringe.

WARNING: Bacterial contamination could occur if syringes are used as storage containers. Do not use syringes to store fluids.

WARNING: Patient or operator injury could result if the sterile disposable package is opened or damaged, or if damaged components are used. Visually inspect contents and package before each use.

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Cautions

WARNING: Patient injury could result from high flow rate venous injections. Use extreme care when selecting the flow rate. Before arming the injector, verify that high flow rate injection parameters are correct.

WARNING: Patient injury or death could result from an air embolism. • Expel all trapped air from the syringe(s), connectors, tubing, and catheter-over-needle

before connecting the system to the patient. Carefully read the instructions for loading

and the use of FluiDot® indicators (where applicable) to reduce the chance of air embolism.

• The presence of rounded FluiDots indicators do not indicate the total absence of air bubbles in the syringe tip. FluiDots indicators must be viewed in a properly illuminated environment, with a light source behind the operator providing enough light to permit easy viewing.

• To minimize air embolization risks, ensure that one operator is designated the responsibility of filling the syringe(s). Do not change operators during the procedure. If an operator change must occur, ensure that the new operator verifies that the fluid path is purged of air.

• To minimize the possibility of inadvertent aspiration and injection, ensure the patient is disconnected from the injector when utilizing the forward and reverse piston controls.

WARNING: Patient or operator injury may result if damaged components are used. Do not use damaged components. Visually inspect all components before use.

WARNING: Failure to use the proper start switches and syringe heaters could result in Electro Magnetic Emissions not meeting specification.

CAUTION: Condensation may cause electrical damage to the injection system. Do not use the system immediately after it has been brought indoors from extreme outside temperatures. Allow the system to stabilize at room temperature before use.

CAUTION: Damage can occur as a result of incorrect voltage. Verify that the voltage and frequency marked on the serial tag on the back of the unit matches the voltage and frequency of the electrical outlet.

CAUTION: Do not touch the screen with a sharp object in order to perform the calibration.

CAUTION: System malfunction may be caused by failure to perform regular maintenance. Regular preventive maintenance is recommended to ensure that the system stays calibrated and functions properly. Refer to this manual or contact MEDRAD for additional information.

CAUTION: Do not expose system components to excessive amounts of water or cleaning solutions. Wipe components with a soft cloth or paper towel dampened with cleaning solution.

CAUTION: Do not use strong cleaning agents and solvents. Warm water and a mild disinfectant are all that are required to clean the injector. Do not use strong industrial cleaning solvents such as acetone.

CAUTION: Do not spray cleaning solutions directly onto the touch screen. To prevent damage, wipe the touch screen with a soft non-abrasive cloth or paper towel dampened with water soluble cleaning solution.

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1 - Introduction

Additional warnings, cautions and notes are located throughout this manual, where applicable.

CAUTION: Improper or careless cleaning methods may result in equipment damage. Do not soak or immerse any part of the injection system in water. While cleaning any outside portion of the system, avoid allowing any water to leak inside system components.

CAUTION: Component damage may occur if not installed properly. Ensure all connections are secure; do not overtighten. This will help minimize leaks, disconnection, and component damage.

CAUTION: Injector may disarm or fail to operate upon exposure to high electromagnetic fields that may be generated by radio transmitters or cellular phones, or upon exposure to high levels of electrostatic discharge.

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2 - System Basics

2 - System Basics

About the Injection System

The Stellant CT Injection System is comprised of the injector head located in the scanning room and a touch screen Display Control Unit (DCU) and Base unit, which is typically located in the control room. The three components are connected by a communications link.

Moving the System Within the Room

When moving the System, hold the pedestal below the point indicated by the label on the pedestal arm. If the pedestal does not contain this label, hold the pedestal no higher than 36 inches above the floor.

Stellant Models

Basic Features The basic foundation features of all Models include:

Model Description Catalog Number

S Single Syringe System without Auto Load and Prime

• SCT 110 (no injector head mount)• SCT 111 (includes a floor-mounted injector head

mount)• SCT 112 (includes an overhead counterpoise ceiling

head mount)

SX Single Syringe System Full featured

• SCT 120 (no injector head mount)• SCT 121 (includes a floor-mounted injector head


head mount)

D Dual Syringe System Full featured

• SCT 210 (no injector head mount)• SCT 211(includes a floor-mounted injector head


head mount)

DualFlow • SCT 220 (no injector head mount)• SCT 221 (includes a floor-mounted injector head


head mount)

• Stellant 200 ml syringe • Pressure graph (not in S model)

• Auto dock, Auto advance, and Auto retract (not in S model)

• Choice of Pedestal or Overhead Counterpoise System (OCS)

• Prime (not in S model) • Elapsed injection time indicator

• Configuration Screen • Remote Check For Air

• Protocol Lock • Remote Start

• Scan delay • Test Inject

• Store and recall of protocols • Selectable Pressure Limit

• Remote arming • Duration by phase

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Display Control Unit (DCU)

The Display Control Unit (DCU) and Base Unit:

The DCU interface is designed as a color touch screen display.

Name Description

Start/Hold Toggles between starting and holding the execution of an injection protocol.

Abort Stops injector head motion.

Reset Resets the injection protocol to default values.

Setup Switches screen to Setup screen.

Help Switches screen to Help screen.

Brightness Up Increases the display brightness.

Brightness Down Decreases the display brightness.

Power Button Turns unit on and off.

Start/HoldResetHelpSetupAbort

Base Unit

Handswitch

Brightness Controls

Power Button

Display Control Unit

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2 - System Basics

Single Stellant Injector (S and SX)

Single Stellant Injectors Models:

Single Stellant Injector Head Overlays

“S” MODEL OVERLAY “SX” MODEL OVERLAY

2 - 13


Dual Stellant Injector (D)

D model Injector head overlay

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2 - System Basics

Injector Head Control

NOTE: The single syringe model includes only the controls and connections for a single syringe.

Name Description

A Syringe A (All Models) Contrast Syringe

B Syringe B (DX Model) Saline Syringe

1 Heat Maintainer (Side A or B)

See “Heat Maintainer” on page 17 for more information.

2 Volume(Side A or B)

Syringe Installed - Indicates the volume loaded in the syringe.Auto Load Active - Indicates the volume to be loaded into the syringe.Syringe not Present - No indicator.

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Manual Knob

An operator can use the manual knob to purge air, check backflow of blood, and to assist in ensuring correct catheter placement.

NOTE: For all non-automatic movements, it is critical for volume accuracy to ensure that the manual knob is turned one full turn clockwise after every reverse movement.

An operator can adjust the amount of resistance on the manual knob from the Fluid Control option. This feature minimizes the draw-back of air or fluid after automatic piston movement, such as during Autoprime or at end of an injection. A setting of Low or Off increases the likelihood of draw-back during these conditions.

The amount of resistance felt as the manual knobs are turned increases as the setting for Manual Knob Fluid Control is increased from LOW to HIGH. The incidence of air or fluid drawback decreases as the setting for Manual Knob Fluid Control is increased from LOW to HIGH. MEDRAD recommends that the HIGH setting be used only if the manual knobs are not typically used.

NOTE: The actual resistance on the manual knob at any setting is injector-specific and can vary between injectors based on age and condition.

3 Auto Load (Not Available in S Model)

Activates the Fill A, Fill B, and the +/- buttons.

4 Fill A (all Models) Fills Syringe A to the displayed volume.

5 Fill B (D Model) Fills Syringe B to the displayed volume.

6 +/- (Side A or Side B)

Adjusts the Auto-fill volume to the nearest multiple of 5 ml, and then in increments/decrements of 5 ml.

7 Prime (Not Available in S Model)

Activates the tube priming function.

8 Move Piston Activates the forward and reverse piston controls. Times out after ten seconds of inactivity.

9 Piston Control (Side A or B)

Advances and retracts the piston (variable speed).

10 Check for Air Reminds user to verify that air is purged from the syringe and tubing. (Must be lit to enable arming.)

11 Protocol Lock Indicates the protocol lock on Display is enabled. (Must be lit to enable arming.)

12 Arm Arms the System.

13 Abort Terminates and disarms the injection.

14 Start/Hold Initiates injection.Holds injection for a maximum of 20 minutes.

15 Arm Lights See “Arm Lights” on page 17 for more information.

16 Manual Knob(Side A or B)

Permits an operator to manually move the piston when the injector is not armed. See “Manual Knob” on page 16 for more information.

Name Description

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2 - System Basics

Arm Lights

The injector head has two arm lights that illuminate or flash depending on the following conditions:T

Hand Switch

The hand switch enables an operator to start, hold, and stop an injection. The switch contains a light that identifies the state of the injector.

NOTE: Hand switch light functions the same if it is connected to the Injector Head or the Pod.

The hand switch has a light that illuminates or flash depending on the following conditions:

Heat Maintainer

The System includes one heat maintainer for each syringe. It is recommended that contrast is stored in a contrast heater at 35 degrees celsius prior to loading it into the syringe. Once it is loaded, the heat maintainer should be snapped over the syringe to maintain the contrast temperature at body temperature.

WARNING: Patient injury could result from high contrast temperature. Do not use the syringe heat maintainer if the fault indicator light is illuminated. This may indicate a condition that could result in syringe overheating.

Applying Power To apply power to the System, press the switch located on the right lower side of the display control unit (refer to the Display Control Unit section). During powering up a tone will sound at the DCU and head with all indicator lights on the head illuminating.

NOTE: Unless otherwise stated, all screens, controls and explanations described in this section represent the Dual Syringe configuration, with all operator configurable features activated.

Condition Arm Light Description

Armed The light corresponding to the syringe to be used for the protocol flashes.

Injecting The light corresponding the syringe that is moving remains solid. Syringe A illuminates Green, and Syringe B illuminates Blue.

Hold The light corresponding to the syringe to be used for the protocol flashes.

Condition Arm Light Description

Armed The light flashes.

Injecting The light illuminates.

Hold The light flashes.

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System Logo When power is applied to the system, the System Logo screen appears on the display, and a series of self-diagnostic tests are performed.

Safety Screen The Safety screen provides information about safe operation of the injector and potential hazards associated with an injection procedure.

Main Screen The Main screen appears after the Safety screen. All other screens used during normal injector operation are accessed from the Main screen. The Main screen is used during injection protocol programming, arming, and injecting. Different screen controls are visible based on the operation currently being performed, the operator-selected screen configuration, and the factory set configuration. See “Setup” on page 22 for a list of operator configurable screen elements.

NOTE: The Main screen that appears at start-up is the most recently programmed screen.

Dual Injector Main screen, Single Injector Main screen,

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2 - System Basics

Procedure Data The Procedure Data feature enhances the functionality of the Stellant injector by allowing the operator to optionally enter and display additional procedure-related information for each injection.

This feature displays a panel titled Procedure Data on the Main screen with information regarding Patient Identification number (Patient ID), Contrast Concentration, Iodine Summary, Pressure Limit, and Delay settings for the procedure. The EDIT button is used to enter or modify information displayed in the Procedure Data panel

NOTE: If P3T® (Personalized Patient Protocol Technology) applications are activated on the injector, the P3T button will appear on the Procedure Data panel.

Patient IDA patient identification number may be entered for each procedure by selecting PATIENT ID in the Procedure Data screen. An alpha-numeric keypad allows the operator to enter a value up to 20 characters to uniquely identify the procedure.

Contrast Concentration

The concentration of iodinated contrast used for each procedure is entered by selecting CONCENTRATION in the Procedure Data screen and then selecting a value from the pick list. The CLEAR option resets the contrast concentration to a null value. The OTHER option allows the operator to enter a concentration value that is not available in the pick list.

Procedure Data Feature

Selecting Patient ID Entering Patient ID

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If the OTHER option is selected, a numeric keypad appears indicating that a contrast value between 200-450 mg/ml can be entered. This range is provided to allow entry of new contrast drug products that may be available in the future. The operator can enter a concentration value and save the value using the ENTER button.

Pressure Limit

Pressure Limit programming is performed by selecting PRESSURE LIMIT in the Procedure Data screen and then selecting a value from the pick list. The pressure limit can be programmed between 50 and 325 PSI. The pressure limit values available depend on the type of syringes being used and may be different when a Stellant Pre-Filled Adapter is used.

If a pressure limit condition occurs, it will first be evidenced by injection durations that are greater than what would normally be expected, and also by low-contrast films. A pressure limit condition can also be seen by observing the pressure monitor.

Selecting Concentration Concentration Entry Using OTHER Button

Main Screen with Procedure Data Feature

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2 - System Basics

Delay

Delay programming is performed by selecting DELAY in the Procedure Data screen and then selecting a delay type from the pick list. If either a SCAN DELAY or INJECTOR DELAY is selected, the operator can enter a value for the delay using the numeric keypad and save the value using the ENTER button.

Pressing the OK and CANCEL buttons at the upper right of the Procedure Data screen returns the operator to the Main screen. The OK button accepts the changes made by the operator and the CANCEL button rejects any changes made by the operator. The Procedure Data panel is updated to reflect the changes made in the Procedure Data screen

Iodine Summary

The Iodine Summary feature provides key clinical information related to the iodine delivered and associated iodine flux for contrast injection protocols.

If the operator enters the concentration of the iodinated contrast used in a procedure via the injector display, the Iodine Summary feature displays the total grams of iodine delivered based on the contrast volumes programmed for that procedure. The iodine flux or the rate at which iodine is delivered for a procedure is also displayed. Iodine flux is calculated as the total grams of iodine delivered at the flow rate used for the contrast phases of the protocol and is displayed in g/s (grams of iodine per second).

• Iodine (g) = Contrast Concentration (mg/ml) * Contrast Volume (ml) / 1000• Iodine Flux (g/s) = Contrast Concentration (mg/ml) * Flow Rate (ml/s) / 1000

NOTE: If a contrast injection protocol uses different flow rates for the contrast phases of an injection, then the iodine flux displays a null value.

NOTE: In the case of injection protocols using DualFlow (contrast-saline mix), the iodine delivered is calculated from the volume of contrast in all phases (contrast and DualFlow phases). With DualFlow, iodine flux is calculated from contrast phases only.

Selecting Delay Type Selecting Delay Value

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Setup The Setup screen may be accessed by pressing the Setup button located on the Display Control Unit.

The Setup screen allows the selection of operator configurable options and preferences.

SETUP

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2 - System Basics

The following table identifies the configurable items and their selectable values.

Date/Time To set time and date, touch the desired programmable block, then the appropriate number.

Configurable Item Selectable Value

Language English, Dutch, Japanese, French, Italian, German, Spanish, Swedish, Russian

Display Audio Level Soft, Medium, Loud

Priming Mode Simultaneous or Sequential

Priming Source Syringe A or Syringe B

LPCT (Low Pressure Connector Tube) Type

Standard or Expanded

Calibration Reminder Year and month

Test Inject Source Syringe A or Syringe B

Test Inject Rate 1 - 7 ml/s

Test Inject Volume 10, 15, or 20 ml

Injection Display Mode Profile or Protocol

Pressure Units PSI or kPa

Date / Time Calendar date and time of day

Date Format mm/dd/yyyy, dd/mm/yyyy, or yyyy/mm/dd

Time Format hh:mm:ss, hh:mm:ss AM/PM, or hh:mm:ss A/P

Total Volume Display Syringe A or Syringe A and B combined.

Auto Retract On or Off

Auto Advance On or Off

Auto Load Purge Volume Sets the volume to be purged when using Auto Load.

Scan Delay Audio On or Off

Fluid Control Off, Low, Medium, or High

ISI On or Off.

XDS On or Off.

Informatics On or Off.

Date/Time Setup

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Help Help may be accessed by pressing the Help button located on the Display Control Unit.

Help topics include information about:

• Injection system safety• Screen functions• Programming• Injector head control keys• Service contact information• Customer Service contact information

Reset The Reset button is located on the Display Control Unit. Pressing the Reset button removes all currently programmed phases to factory default settings.

The following values are the factory default parameters:

• Flow Rate: 1.0 ml/s• Volume: 1 ml• Durations 1 s• Delay Type: none

HELP

Help screen Help topic selected

RESET

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3 - Preparing to Inject


Minimizing Air Embolization Risks

Operator vigilance and care, coupled with a set procedure, is essential to minimizing the possibility of an air embolism.

WARNING: Patient injury or death could result from an air embolism.

• Expel all trapped air from the syringe(s), connectors, tubing, and catheter-over-needle before connecting the system to the patient. Carefully read the

instructions for loading and the use of FluiDots® indicators (where applicable) to reduce the chance of air embolism.

• The presence of rounded FluiDots indicators do not indicate the total absence of air bubbles in the syringe tip. FluiDots indicators must be viewed in a properly illuminated environment, with a light source behind the operator providing enough light to permit easy viewing.

• To minimize air embolization risks, ensure that one operator is designated the responsibility of filling the syringe(s). Do not change operators during the procedure. If an operator change must occur, ensure that the new operator verifies that the fluid path is purged of air.

• To minimize the possibility of inadvertent aspiration and injection, ensure the patient is disconnected from the injector when utilizing the forward and reverse piston controls.

WARNING: Patient or operator injury may result if damaged components are used. Do not use damaged components. Visually inspect all components before use.

The following are suggested techniques for minimizing air embolization risks during a CT enhancement procedure.

• Using a MEDRAD Fluid Dispensing Device (FDD), such as a spike is recommended.

NOTE: Air removal from the syringe will be much more difficult if a small diameter tube, such as a catheter-over-needle, needle, or a tube longer than ten inches (25 cm) is used for loading.

• Point the Stellant injector head up during loading, enabling any air to accumulate at the syringe tip, then expel the air.

• Point the Stellant injector head down during an injection, enabling any small air bubbles that could still be in the fluid to float to the rear of the syringe.

• Ensure that one operator is designated the responsibility of filling the syringes. Do not change operators during the procedure. If an operator change must occur, ensure that the new operator verifies that the fluid path is purged of air.

• Use MEDRAD syringes equipped with FluiDots indicators. FluiDots indicators should be observed as part of an arming procedure. When the FluiDots is viewed through an empty syringe, the dots appear as small narrow ellipses as illustrated below. When viewed through a full syringe, the dots become larger, almost round.

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Warning: To minimize the possibility of inadvertent aspiration and injection, ensure the patient is disconnected from the injector when utilizing the forward and reverse piston controls.

FluiDots indicators must be viewed in a properly illuminated environment, with a light source behind the operator, providing enough light to permit easy viewing.

Using the Stellant Pedestal with Integrated IV Pole

The Stellant Pedestal is intended to support the a Stellant injector Head in a CT Scanner room. DO NOT attempt to use the Pedestal for any other purposes.

WARNING: Tighten all screws, clamps and knobs during assembly and as needed during use. Loose components may cause the pedestal to collapse resulting in personal injury and/or equipment damage.

WARNING: Do not move or manipulate the injector mount by pulling or pushing the integrated IV pole. Using the pole to maneuver the injector could bend the pole or cause an imbalance of the system resulting in property damage and/or serious injury. Maneuver the injector as recommended by the injector Operator Manual.

WARNING: Do not adjust the integrated IV pole or move the injector when anything is hung from the pole. Any item hung from the pole could fall, causing patient injury and/or property damage.

WARNING: To avoid pinch points and personal injury, use care and diligence in folding and unfolding the hooks, raising and lowering the pole, and tightening the adjustment knob. Keep hands and fingers clear of all pinch point areas.

WARNING: The folding hooks are designed to hold a maximum weight of 5 lbs / 2,265 grams each. Do not exceed the weight limits. Adding additional weight to the hooks may lead to instability, premature device failure and the potential for personal injury and/or property damage.

CAUTION: Use extreme care in raising and lowering the integrated IV pole. The pole should raise and lower easily without force. If raising and lowering becomes difficult, clean the pole as described in “Cleaning the Pedestal” on page 46.

Operating Instructions

• To extend Integrated IV Pole: Turn adjustment knob counter-clockwise to loosen, then raise the top of the Integrated IV Pole to the desired height.

• To lock the Integrated IV Pole: Turn the adjustment knob clockwise until tight. Do not over-tighten.

• To store: Turn the adjustment knob counter-clockwise and retract the Integrated IV Pole.

Empty Syringe Filled Syringe

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Stellant Connector Tubing

The connector tubing is equipped with a priming tube. Attach the priming tube to the end of the Low Pressure Connector Tube (LPCT). The purpose of the priming tube is to act as a small reservoir to catch excess contrast media while priming. The tube is vented so that air may escape but fluid will not. This prevents the dripping of fluid prior to the connection to the catheter.

1. Remove the connector tube from the package.

2. Remove the dust covers to expose male and female luer fittings.

3. Ensure all air is purged from the syringe.

4. Attach the connector tube to the syringe containing the desired volume of fluid, making sure that the tubing luer fitting is secured to the tip of the syringe

NOTE: If using a connector tube with a T-connector, attach the straight portion to the contrast (A) syringe and the extension to the saline (B) syringe.

NOTE: If the T-connector is connected to the (B) syringe, priming will not completely fill the connector tubing.

5. Verify that the tubing is not kinked or obstructed.

6. Connect the Prime Tube to the patient end of the tubing set.

7. Prime the tubing with fluid by pressing Prime on the injector head, turning the manual knob, or using the forward and reverse piston controls. While priming, hold the Prime Tube above the patient’s elevation, and ensure that the filter is pointing upward. Leave the Prime Tube attached until immediately prior to patient connection.

8. Ensure all air is purged.

9. Rotate the injector head downward.

10. Remove the Prime Tube.

11. Connect to the patient.

12. Press Check For Air on the injector head. The Check For Air indicator will then illuminate on the touch screen and injector head.

Loading and Priming a Syringe

The System is specifically designed to decrease the amount of time and steps to load disposable syringes with either contrast media or saline. Using the System features and recommended filling techniques will reduce the frequency of contrast spills.

WARNING: Patient injury could result if the syringe is not properly engaged. Ensure the syringe is properly snapped into the front of the injector head before injecting. Improper engagement may cause the syringe to leak, become damaged, or to come off during the injection and result in an under-volume delivery.

The System has four features that decrease the time and steps to install the syringe onto the injector:

1. Non-rotational orientation: To install a disposable Stellant syringe onto the injector, snap the syringe onto the front of the injector head (no alignment necessary).

2. Auto-docking (excluding S model): Once a disposable MEDRAD syringe is installed, the Stellant Piston will automatically advance and find the syringe plunger, dock with it, and stop. If the syringe was previously filled with contrast, no further action is initiated at this time.

AB

Prime Tube

Filter

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3. Auto-advance (excluding S model): When an empty syringe is removed from its packaging and installed on the injector, the piston automatically docks with the plunger and then advances it to the full forward position. If a prefilled syringe is installed on the injector, the piston will automatically dock with the plunger and then stop.

• When Auto Advance is configured ON through the configuration screen, it enables both Auto Dock and Auto Advance. The injector senses whether a syringe was on the unit or not by the position of the syringe plunger.

• If the syringe was not on the unit before (the syringe plunger was not advanced), and Auto Advance is ON, then the plunger automatically advances when the syringe is installed.

4. Automatic retraction: When the syringe is removed, the piston rod will automatically retract (unless configured off).

NOTE: Do not rotate the syringe after installation.

Priming Mode Selection

When priming a dual syringe LPCT with a union connector (T or Y), Priming Mode provides the flexibility of choosing one of two options:

• Simultaneous priming mode - moves saline and contrast through the union connector, simultaneously some times during the priming process.

• Sequential priming mode - moves saline and contrast through the union separately, one after the other during the priming process.

NOTE: The factory pre-set for the Priming Mode feature is Simultaneous.

Priming Volume - LPCT Type

The priming volume can be changed to support standard Low Pressure Connector Tubes sets or Expanded Low Pressure Connector Tubing sets. It is important that the correct LPCT Type is chosen to prevent under-priming of the connector tubing (may not eliminate air from the injection fluid path) or over-priming the connector tubing (may cause excessive dripping).

NOTE: The factory pre-set for the LPCT Type option is Standard LPCT.

Manual Loading and Priming a Syringe

A syringe can be loaded manually or automatically on the Stellant CT Injection System.

1. Install a new syringe on the injector head by inserting it quickly and firmly in one motion to enable it to seat properly. The piston will automatically advance to the front of the syringe (unless configured off, or the plunger previously moved forward). Installing the syringe slowly can result in an error message on the DCU screen, and the piston plunger may not automatically advance to the front of the syringe.

NOTE: The System automatically senses different syringe sizes and configures the unit to match the syringe.

2. Install the spike or Quick Fill Tube (QFT) onto the end of the syringe. Do not install with excessive force.

Warning: Contamination may occur if the end of the spike is touched.

3. Insert the spike or QFT into a fluid source.

NOTE: Refer to fluid manufacturer's instructions for use and/or package insert.

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4. Press MOVE PISTON and fill with the desired amount of fluid, using the forward and reverse piston controls on the injector head. Pressing the larger arrows (outer end) will move the piston rapidly. Pressing on the smaller arrows will move it slowly.

NOTE: MOVE PISTON only stays enabled for 10 seconds of inactivity, until it times out.

5. Expel air from syringe.

6. Remove spike or QFT.

7. Connect the disposable tubing set onto the end of the syringe.

8. Follow the instructions in the section “To use a connector tube.”

NOTE: Carefully inspect all tubing and syringes, and verify that all air has been expelled from the fluid path before pressing Check For Air.

NOTE: Any reverse movement of the pistons after Check For Air is pressed will cancel Check For Air status. If the piston is moved in reverse, re-check the fluid path for air, advance the piston, then press Check For Air again to continue.

NOTE: If bubbles appear in the syringe DO NOT hit the syringe to remove them. Reverse the plunger 3 - 5 ml, then rock the injector head on the pivot to gather and accumulate the small bubbles. Expel the remaining air.

Cautions for Draw Back

If the procedure is to draw back on the syringe plunger after the system is connected to the patient to insure a return fluid flow is received, note the following:

• Once fluid flow is seen in the tubing, the manual knob must then be advanced until the piston rod firmly mates with the syringe plunger. Failure to do this will result in the injector not arming.

Using Auto Load to Load a Syringe (SX and D Models)

The System also has an Integral Auto load function. This feature saves time and steps by automatically loading the syringe with the prescribed volume of fluid, (the operator is still responsible for confirming that all air is expelled).

As part of the Integral Auto Load capability, it is possible to program different Auto Load Purge Volumes through the Setup screen. Purging is the automatic forward movement of the piston during autoloading that expels air which may enter the syringe at the beginning of the filling cycle.

Prime Button

3 - 29


Select an Auto Load Purge Volume

1. Press the Setup button .

2. Using the arrow key at the bottom-right corner of the Setup screen, go to the second page.

3. Select Auto Load Purge Volume.

NOTE: When using MEDRAD filling devices, choose one of the four volume selections based on the following guidelines:

• 30 mL for QFT• 20 mL for short transfer sets (23” / 58 cm)• 10 mL when loading through a spike only• 0 mL (OFF) when loading through a filling device that has a check

valve – not available in the U.S.

NOTE: For other filling devices, consult the manufacturer's instructions for use.

4. Select OK.

Using Auto Load With a Spike or QFT

1. Set and lock the protocol on the DCU.

2. Install a new Stellant syringe on the injector head by inserting it quickly and firmly in one motion to enable it to seat properly. The piston will automatically advance to the front of the syringe (unless configured off, or the plunger previously moved forward). Installing the syringe slowly can result in an error message on the DCU screen, and the piston plunger may not automatically advance to the front of the syringe.

3. Install the spike or QFT onto the end of the syringe. Do not install with excessive force.

Warning: Contamination may occur if the end of the spike is touched.

4. Insert the spike or QFT into the fluid source.

NOTE: Refer to fluid manufacturer's instructions for use and/or package insert.

5. Press Auto Load on the Injector Head. The Volume indicators on the injector head will indicate how much fluid needs to be loaded to support the protocol set on the DCU (including the amount of fluid necessary to prime the patient tubing with fluid). Increase or decrease (optional) the amount of volume loaded in increments of 5 ml, by pressing the +/- keys next to Auto Load. When Auto Load is pressed, Fill will flash.

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6. Press Fill, and the syringe will automatically load the prescribed protocol volume.

NOTE: If FILL is not pressed within ten seconds, Auto Load will automatically reset. Press Auto Load again to activate it for loading of the syringes.

NOTE: When Fill is pressed, the injector automatically retracts to the selected Auto Load Purge Volume and draws in fluid. The piston stops and then advances to expel any air that was drawn into the syringe. The piston then automatically retracts again until the Volume required to perform the injection is loaded into the syringe, plus approximately 10 ml. The piston pauses for about five seconds, to ensure all fluid is drawn into the syringe, then advances to the final Volume.

7. Expel air from syringe.

8. Remove spike or QFT.

9. Connect the disposable tubing set onto the end of the syringe.

10. Follow the instructions in “Stellant Connector Tubing” on page 27.”

Removing a 200 ml Syringe

1. Disconnect the disposable tubing set from the vascular entry device. The disposable tubing set does not need to be disconnected from the syringe.

2. Rotate the syringe approximately ¼ turn counter-clockwise and gently pull the syringe out of the injector head.

NOTE: In order to remove the syringe, the last piston motion must be in the forward motion (which is typical). If the syringe cannot be removed, rotate the injector head manual knob approximately two revolutions in the forward direction, then repeat Step 2 above.

3. Properly discard the syringe and the disposable tubing set.

NOTE: Once the syringe is removed from the injector, the piston will automatically retract (if configured to do so).

Programming Protocols

Programming a protocol is initiated at the Main screen.

NOTE: The following instructions relate to either a single or dual system.

1. Touch any programmable block,(such as Flow Rate or Volume). The selected block will be black. A numeric keypad and parameter range window appears.

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2. Enter the desired Flow Rate or Volume.

3. Press Enter to lock in the value, press (<<) to edit the value, or Cancel to restore the original value if an error is made.

NOTE: Lock in a selected value by touching another parameter.

Programming Multiple Phases

If two or more phases are required, touch the triangle below the first phase of the injection. The Phase Type window will appear, allowing selection of functions for the new phase. Select one type of flow from the displayed list.

Storing a Protocol The System can store up to 32 commonly used protocols.

1. Enter the desired parameters on the main screen.

2. Touch Store located in the upper right corner of the Main screen. An alpha-numeric keypad appears with a flashing cursor in the title block.

3. Enter the desired name for the protocol. The name can be up to 20 characters long, including spaces. Use the arrow key to backspace and erase individual characters, or the clear key to erase a string of text.

4. Touch Enter when the entry is completed.

NOTE: To exit the Store screen without keeping changes press Cancel in the upper right corner of the screen to return to the main menu.

Store screen, English keyboard Store screen, delete confirmation

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Locking a Protocol When protocol programming is complete, press Lock Protocol located on the DCU touch screen. This allows arming from the injector head. Any subsequent changes to the protocol will automatically unlock it and prevent arming from the injector head.

Recalling a Protocol 1. Touch Recall on the upper right corner of the Main Screen.

2. Select a previously stored injection protocol by touching one of the protocol titles on either side of the screen. Upon selection, key parameters of the injection protocol will be displayed in the center of the screen.

NOTE: If a protocol is recalled and then changed, an asterisk appears after the protocol name in the upper left of the screen, and is no longer the stored protocol.

3. Touch OK to return to the main screen.

NOTE: Protocols are ordered starting with the oldest protocol at the top left and continuing with subsequent protocols to the bottom.

Deleting a Protocol 1. Touch Recall on the upper right corner of the Main Screen.

2. Select a previously stored injection protocol by touching one of the protocol titles on either side of the screen. Upon selection, key parameters of the injection protocol will be displayed in the center of the screen.

3. Touch Delete to permanently erase the protocol from memory.

Lock Protocol

Recall screen Protocol selected

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Programming a Delay

1. Enter desired Flow Rate and Volume parameters.

2. Touch “?” and press Pause key.

3. Enter desired pause in seconds then press Enter.

4. To program a hold, touch “?” and press Hold to program a hold.

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4 - Arming and Injecting


Arming Before Beginning the Arming Process

1. Ensure all air has been expelled from the fluid path and the programmed parameters are correct.

2. Carefully inspect all tubing and syringes, then acknowledge the inspection has occurred by pressing Check For Air on the injector head. A yellow illuminated Check For Air indicator on the DCU touch screen confirms Check For Air was pressed.

NOTE: If the fluid path was not checked, and Check For Air was not pressed, the system will request the operator for confirmation at the DCU that air was expelled as part of the arming procedure.

NOTE: Once fluid flow is seen in the tubing, the manual knob must then be advanced until the piston rod firmly mates with the syringe plunger. Failure to do this will result in the injector not arming.

3. Press Protocol Lock.

Beginning the Arming and Injecting Process

Press Arm on either the Main screen or the injector head.

If the System will not Arm:

• Ensure that the syringe(s) are docked.

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• Ensure that the Protocol Lock control on the touch screen is engaged. When engaged the Protocol Lock indicator on the injector head illuminates.

• Ensure that there is not an insufficient volume condition. Insufficient volume is defined as the total programmed injection volume of a protocol (per syringe) exceeding the corresponding displayed volume remaining value. The injector indicates an insufficient volume condition to the operator before the injector can be armed.

• An on-screen indication of insufficient volume is provided on the DCU whenever the total volume programmed to be delivered is greater than the amount of fluid in the syringe. The message indicates the amount of insufficient volume in one or both syringes, the programmed protocol, as well as the modified protocol that will be used if the operator continues to arm the injector. The operator can choose to either accept the modified protocol changes or stop the arming process

• The injector head indicates an insufficient volume condition by a flashing LED.

• Press Arm on the injector head two times to allow the arming process to continue with the remaining volume.

NOTE: The system will return to the idle state if any of the following conditions occur while the system is armed:

• Pressing Abort• Activating any injector head controls other than Start/Hold.

NOTE: Pressing Abort will always stop the piston and fluid movement.

Test Injection A test injection is programmed like a normal phase injection. Test Inject Source, Test Inject Rate, and Test Inject Volume are selectable through the setup screen.

Configuring Test Inject Parameters

1. Press right arrow to edit the first step of the protocol.

2. Select Test Inject.

3. Edit the Flow Rate and Volume parameters.

4. Touch Enter.

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Performing a Test Injection

1. Press Start/Hold to perform Test Injection.

2. After the Test Injection is complete, the injector goes into a HOLD phase. Press Start/Hold to initiate the selected protocol.

Injecting Performing a Injection

NOTE: MEDRAD recommends that the operator stay by the patient’s side at the beginning of the injection to ensure that the catheter is placed correctly (minimizing extravasation.)

1. Enter a protocol and verify parameters on protocol screen.

2. Touch Protocol Lock control on the Main Screen.

NOTE: Protocol Lock must be engaged and the Protocol Lock light on the injector head illuminated, before the System can be armed from the injector head.

3. Load syringe and verify that all air is expelled from the fluid path.

4. Press Remote Check For Air on the injector head.

5. Press Arm on the Main Screen OR Press Arm on the injector head.

• Armed indicator light flashes when armed.

• If Check for Air is not depressed on the injector head, the system requests confirmation at the DCU that the fluid path was checked for air (Yes/No).

Test injection programmedProgramming a Test Injection

Injecting screen, performing test injection

4 - 37


6. Initiate injection from the Start/Hold switch on either the injector head or Display.

• Additional presses of Start/Hold will alternately Hold and resume the injection. If the maximum hold time (20 minutes) is exceeded, the protocol in process will stop automatically.

• Armed indicator light will be lit solidly during the injection

• If an Inject Delay is programmed:

• Pressing Start/Hold activates the countdown timer. When the timer counts down to zero the programmed injection will automatically begin. If Start/Hold is pressed during an injection delay, the stopwatch timer stops counting until Start/Hold is either pressed again, or the Hold time is exceeded, (in which case the protocol ceases).

• If a Scan Delay is programmed:

• Pressing Start/Hold activates the Scan Delay countdown and the injection will start simultaneously if a scan delay is programmed. During the injection, additional presses of the Start/Hold will alternately Hold and resume the injection and the scan delay time.

• When a Scan Delay is programmed for an injection protocol, the injector counts down the delay on an on-screen timer as well as with audio beeps. I

NOTE: The default value for this setup option is On.

• If a Test Injection is programmed, the delay will occur on the first phase after the Test Injection has executed.

7. View injection status by selecting either Phase View or the Graphical View

• As each phase is activated, phase parameters are highlighted.

• A dashed red line appears on the graphical view during a Scan or Inject delay. For a Scan Delay, it appears on the graph. For an Inject Delay, it appears in the 1st phase, with the fluid section moved to the right of the dashed line.

NOTE: To DISARM, touch any button on the injector head or DCU to abort the injection, except Start/Hold.

Injecting Views • As each phase is activated, the phase parameters and the syringe in use will be highlighted with a black outline to display injection progress.

• Elapsed time and the current phase will be shown in the injector status window.

• The Delivered Volume window will increment as the injection proceeds to display Volume delivery.

• The Volume Remaining (syringe icon) display will decrement.

A dashed red line appearing during a Scan Delay

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• The operator can select either phase view or flow profile (graphical) view.

Pressure Graph The pressure graph is presented when the operator touches the pressure graph view key.

The Pressure Graph is an additional indicator of the progress of an injection. It displays the pressure being developed in the syringe during an injection. Since the pressure profile is a direct correlation to the fluid being injected, additional information about the status of the injection is provided to the operator. The pressure graph view displays the force that the injector is applying to the syringe in the following manner:

• Pressure (PSI) will be displayed on the Y-axis (vertical) and elapsed time (mm:ss) will be displayed on the X-axis (horizontal).

• During the first 60 seconds of the injection, time will be indicated from 00:00 to 60 seconds. After 60 seconds has elapsed, and thereafter until the end of the injection, the graph will display a 60 second window which will shift every 15 seconds to indicate the current range. For example, if 61 seconds has elapsed since the beginning of the injection, the time axis will display a “window” from 00:15 to 01:15; at the 76 second mark (after having shifted when reaching the 75 second mark), the time axis will display a “window” from 00:30 to 01:30.

• If a test injection is programmed, the elapsed time will count up when the actual injection begins after the test injection.

Injecting - Protocol View Injecting - Profile View

Graphical view, Injecting screen, contrast phase.

Graphical view, Injecting screen, entering a pause.

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Pressure Graph Helpful Hints

The Pressure Graph provides a visual representation of the pressure generated at the tip of the syringe during an injection. This pressure value correlates to the flow of fluid out of the tip of the syringe and to the patient.

The Pressure Graph is intended to provide a graphic display to assist the technologist in identifying a “normal” versus an “abnormal” injection. Using the Pressure Graph, the technologist can easily compare the current injection profile against the typical profile. If the graph displays a different profile than what is expected for this protocol, the technologist can take any necessary corrective action based on the guidelines below.

The following table lists eight possible conditions the graph might show, along with helpful suggestions to assist the technologist in taking any appropriate corrective action:

Condition Description Possible Causes Possible Actions

1 The graph is the typical shape, but the pressure is higher than normal.

The pressure required to push the contrast media through the disposable system is higher than normal, which means there is a greater restriction to fluid flow. Greater restrictions can be caused by any of the following:

• Higher viscosity of the contrast media (more grams of iodine/higher concentration, or lower temperature of the contrast media/not heated)·

• A smaller gauge catheter is being used·• An additional disposable is in the fluid path causing a greater

restriction to the flow of fluid (extension tube, stopcock, check valve, IV extension set)·

• Defective syringe (under lubricated).

Check to insure the syringe heater is functioning normally.As long as the “Possible Causes” listed are of no concern, then no action is necessary.

2 The graph is the typical shape, but the pressure is lower than normal.

The pressure required to push the contrast media through the disposable system is lower than normal, meaning there is less restriction to fluid flow. Lower restrictions can be caused by any of the following:

• A lower viscosity contrast media (less grams of iodine/lower concentration, or higher temperature of contrast media/heated)

• A larger gauge catheter is being used• Fewer disposables in the fluid path (lack of extension tube, stopcock,

checkvalve, IV extension set).

As long as the “Possible Causes” listed are of no concern, then no action is necessary.

3 The graph and injection start out normal, but level off to a less than expected peak pressure.

An inappropriate pressure limit may be selected. If a lower pressure is selected than what is required to deliver the flow rate, the injection will start out normally for the first few seconds. However, as soon as the pressure limit value is achieved, the flow rate will automatically decrease to keep the system from exceeding the selected pressure limit.

Check to see if the Pressure Graph is approaching the dotted horizontal line (pressure limit setting). If it is, the injector is pressure limiting and causing this condition. See “Pressure Limiting” in the Operation Manual for a thorough discussion of causes and resolution.

4 At the start of the injection, the Pressure Graph signal immediately rises straight up and hits the pressure limit setting (dotted horizontal line).

The fluid path may be occluded (after reaching a “High Pressure Disarm”, Stellant will automatically terminate the injection). Total occlusions may be caused by one of the following:

• A closed stopcock• An IV extension set with the clamp closed off• A defective disposable (fluid will not flow through it).

Consider putting the injector on hold and investigating. There is a high probability that no contrast media is being injected into the patient.

4 - 40


NOTE: MEDRAD makes no claims about the information on the Pressure Graph, other than it is a graphic representation of the force required to move the plunger of the syringe, which closely approximates the pressure developed in the syringe.

5 The injection is proceeding perfectly normal, but during the injection, with no programmed decrease in flow rate, the Pressure Graph sharply drops to baseline, but no error messages appear on the screen. Note: If a multi-level injection is programmed, and the flow rate is programmed to decrease, then the pressure will also drop at that time.

If the injector is still armed and injecting at a constant flow rate, but the Pressure Graph drops sharply to baseline: Stop the injector immediately and investigate. The pressure in the syringe has sharply dropped even though the piston is moving forward and should be developing pressure. Possible causes:

• The Low Pressure Connector Tubing, extension set, or catheter has burst or disconnected from the fluid path (fluid is running on the floor)

• The syringe may have failed. Fluid is being forced around the syringe plunger instead of out the end of the syringe (fluid is running on the floor).

If the injector is still injecting (arm light solid and manual knob on the back of the head turning), consider aborting the injection. There is a high probability that fluid is running on the floor.

6 The pressure buildup to the expected peak is taking longer than typical, even though the injector is injecting normally.

Due to operator error, the syringe may contain a large amount of air (example: half air, half fluid). It is easier to compress air, than to push fluid through a CT disposable system, so the injector is initially developing less pressure as it compresses the air.

Stop the injector immediately and investigate.

Check the fluid path for air.

7 When the injection starts, almost no pressure buildup is witnessed, when a buildup was expected.

Due to operator error, there may be no fluid in the syringe (the system could be injecting air). The injector will experience almost no resistance to moving the syringe plunger forward with an empty syringe. Note: Very slow injections through large disposable sets will require and display very little pressure. This is normal. What is being described above is a condition where a buildup of pressure was expected, and none was witnessed. OR: There may be two syringes on the injector, only performing a single syringe injection, and the LPCT may be connected to the wrong syringe.

Stop the injector immediately and investigate.

Check the fluid path for air.

8 At the end of a normal injection, the pressure graph does not immediately drop to zero.

Stellant is designed to inject all of the contrast in the syringe to help minimize contrast waste. Sometimes in the process of doing this, the piston pushes against the front of the syringe as it squeezes out the last drops of fluid. This in turn generates pressure, which is displayed by the Pressure Graph. This pressure reading should drop to baseline after about 50 seconds.

No action. This is normal operation.

4 - 41


Injection Complete The injector indicates the completion of an injection by displaying an Injection Complete screen on the DCU, and also by an audible tone at the DCU and the injector head. The DCU window displays a screen summary of injection parameters selected, and actual parameters delivered. Elapsed time continues to count up until OK is touched.

Indicator lamps on the rear of the top of the injector head will be illuminated during an injection. The appropriate lamps flash when armed but not injecting, and are lit solid while injecting. A digital read-out indicates the position of the plunger and volume loaded in the syringe.

When the System has initially delivered the programmed bolus, the injector status window on the main screen will change from “Injecting” screen to the “Complete Volume delivered Holding position” screen. The injector will hold position for approximately ten to fifteen seconds to insure syringe recoil does not occur, and then change to the “Injection Complete” screen.

NOTE: The elapsed time will continue to count up until OK is touched.

• The operator can exit the pressure graph view by pressing Phase View in the bottom right corner of the screen.

• Pressing Pressure Graph View will return the user to the pressure graph screen.

Injection Complete - Protocol View

Injection Aborted

Injection Complete - Profile View

4 - 42

Appendix A - System Messages

Appendix A - System Messages

Error Screen An Error screen displays a unique error code or keywords for a MEDRAD Service Representative to categorize the problem and error text for the operator.

System Tones Both the DCU and the Injector Head are capable of emitting tones. These tones fall into two categories, General Tones and Notification Tones. The following is an identification of several interactions and events that may generate tones

General Tones

Both the DCU and the Injector Head produce General Tones as a result of key presses and soft button interaction. In many cases these tones have system settings that can control the volume, and in some cases these General Tones may be turned off. General Tones are used as indicators of an action being taken by the user and do not denote a Notification.

Notification Tones

Notification Tones are also generated by both the DCU as well as the Injector Head. As these tones are intended to notify the user of items requiring attention or an action to be taken, with few exceptions, these tones cannot be turned off or reduced in volume.

Notification Tones take many forms, including multi-pitch tones, multiple tones and tones of differing duration. Notification Tones are distinctly different from General Tones and are designed to capture and direct the User’s attention to either the DCU or the Injector Head as needed.

NOTE: Notification Tones are intended to draw the attention of the User to the Injector Head and/or the DCU as indicated. Upon hearing a Notification Tone, users should direct their attention to the area of interest as important safety or system information may be displayed

NOTE: The provision of Notification Tones should not take the place of active attention by the User to the systems in use or the condition of the patient.

Tone Name Where Encountered

Armed DCU and Injector HeadAutoFill Complete Injector HeadCountdown to Scanner use Injector HeadCritical Error DCU and Injector HeadDelay Expired DCU and Injector HeadDelay Warn DCU and Injector HeadDisarm DCU and Injector HeadInjection Complete DCU and Injector HeadPower Up DCU and Injector HeadWarning DCU and Injector Head

A - 43


A - 44

Appendix B - Cleaning and Maintenance


Cleaning Guidelines Follow these guidelines when cleaning the Stellant CT Injection System and accessories.

WARNING: Serious injury or death may result from exposure to hazardous voltages existing within the system.

• Disconnect the System from the patient prior to cleaning.• Remove the syringe and disposable set from the System prior to cleaning.

NOTE: It is not necessary to disconnect the LPCT from the syringe prior to removal from the System.

• Disconnect the system from line power when cleaning.• Avoid fluid entry into system components. Do not immerse any components in

water or cleaning solution.• Do not remove any covers or disassemble the injector. Periodically inspect for

loose or frayed cables, loose covers, cracks, dents, or loose hardware. Contact MEDRAD Service for repairs.

• Do not expose system components to excessive amounts of water or cleaning solutions. Wipe components with a soft cloth or paper towel dampened with cleaning solution.

• Do not use strong cleaning agents and solvents. Warm water and a mild disinfectant are all that is required. Do not use strong industrial cleaning solvents such as acetone.

NOTE: For all body fluid spills, follow institutional decontamination procedures. If contrast medium has leaked inside any component of the system, the affected subassembly should be disassembled and cleaned by MEDRAD Service personnel or returned to MEDRAD Factory Service.

NOTE: If utilizing a pre-filled syringe adaptor, refer to the associated operations manual for cleaning instructions.

Cleaning the Injector Head, Piston and Syringe Interface

Using a soft non-abrasive cloth, warm water, and a mild disinfectant, carefully clean the assembly, paying particular attention to the following:

• Injector Head• Syringe Piston Plunger• Syringe Interface

1. Fully advance the piston using the forward piston controls.

2. Place the injector head in a vertical position.

3. Disconnect the Display Control Unit from line power.

4. Clean the piston with a soft cloth or paper towel dampened with cleaning solution.

5. Thoroughly dry the piston with a paper towel.

B - 45


6. Clean the inner area of the syringe interface with a soft cloth, paper towel or cotton-tipped applicator dampened with cleaning solution or warm water.

7. Wipe the injector head case and control panel with a soft cloth or paper towel dampened with cleaning solution or warm water.

8. Thoroughly dry the injector head case and control panel with a paper towel.

Cleaning the Display Control Unit

Wipe the touch screen with a soft non-abrasive cloth or paper towel dampened with cleaning solution.

Cleaning the Pedestal

Clean the pedestal and Integrated IV pole with warm water and mild detergent (such as dishwashing liquid) as needed. Chemicals typically used in a medical environment may be too harsh causing material degradation.

Cleaning the Base

Wipe the Base with a soft cloth or paper towel dampened with cleaning solution or warm water.

Recommended Maintenance Schedule

This section contains recommended procedures for maintenance, and an operational checkout of the System. Routine maintenance and inspection will:

• Ensure continued performance of the injection system.• Reduce the possibility of equipment malfunction.

The System must be properly maintained to ensure that it is in peak operating condition. Individual system maintenance and schedule depends upon how a particular injection system is used, the type of procedures performed, and frequency of use. Follow institutional guidelines when determining an appropriate maintenance schedule. The following maintenance schedule is recommended for the system:

Daily

Before use each day, clean and inspect the system using the procedures outlined in this section. Thoroughly clean the piston rod(s) after each use or each day. Ensure that all system safety and warning labels are in place and are legible.

Monthly

Once a month, inspect, clean and perform an operational checkout on the entire system.

Annually

As part of an annual maintenance program performed by a qualified MEDRAD Service Representative or authorized dealer, both Electrical Leakage and Ground Continuity checks should be performed.

NOTE: Local regulations or hospital protocol may require electrical leakage checks at more frequent intervals. If this applies, local regulations for leakage must be followed.

MEDRAD also recommends that a complete system calibration and performance checkout be performed annually. Contact MEDRAD Factory Service, or the local MEDRAD office for complete details.

B - 46


In the United States, Canada, Japan, and Europe, the MEDRAD Service Department offers Preventive Maintenance Programs. These annual programs greatly assist in maintaining accuracy and reliability, and can also extend the life of the system. Contact MEDRAD for details. In Europe, contact local MEDRAD office or local authorized dealer for further information. Refer to the back of the title page of this manual for address, telephone and FAX information.

NOTE: Failures which occur due to lack of proper maintenance will not be covered under warranty.

NOTE: MEDRAD Service will make available upon request:

• Circuit diagrams, components part lists, or other information that will assist qualified technicians to repair components classified as repairable.

• On-site consulting or consulting references upon request.

Inspection Procedures

The following procedures are recommended for daily inspection of all System components. If any defects are detected, either repair the system, or call MEDRAD for service. Do not use the System until the problem is corrected.

Injector Head (Single and Dual)

• Inspect the housing for any damage or cracks that could allow fluid to leak inside, or weaken the structural integrity of the unit.

• Inspect all cables connected to the unit: Look for cuts, cracks, worn spots or other obvious damage to the cables. Ensure that all connectors are properly seated.

• Inspect for contrast media build-up in the syringe interface area. Follow the cleaning guidelines outlined in this section.

• Inspect the stand, base, overhead counterpoise, and support arm for cracks and other defects that could weaken the structure.

• Ensure that all mounting bolts and screws are secure.• Ensure that all locking mechanisms on the casters are functional.• Inspect the pivot points. The head and support arm must pivot freely. The injector head

should rotate on the support arm no more than 270o. The support arm should not rotate

on the center post more than 350o.

NOTE: All relevant guidelines for institutional, local, or national safety recommendations related to cable routing and installation should be followed.

Display Control Unit

• Inspect all cables connected to the unit: Look for cuts, cracks, or worn spots, or other obvious damage. Ensure that all connectors are properly seated.

• Inspect the housing for any damage or cracks that could allow fluid to leak inside, or weaken the structural integrity of the unit.

Wall Bracket

• Inspect all parts of the bracket for cracks and other defects that would weaken the assembly.

• Ensure that the bracket is securely attached to the wall.• Ensure that all cables are secured to the display control unit and do not interfere with

the movement of the mounting bracket.

B - 47


Pedestal

• Inspect the stand, base and support arm for cracks and other defects that could weaken the structure.

• Ensure all mounting bolts and screws are secure.• Ensure that the casters roll smoothly with no binding or scraping.• Ensure all locking mechanisms on the casters are functional.

Operational Checkout

A basic functional checkout of the System should be included as part of regular maintenance. Verifying proper operation of the System will help in detection of any problems that may not be noticed in day to day operation. The following procedure represents a suggested series of activities which encompass typical operation of the system. Read the following procedure carefully before beginning the checkout. If problems are detected, call a MEDRAD Service Representative.

NOTE: Any problems detected during this or any other procedure should be corrected before using the injection system in patient procedures.

System Labels

Ensure that all system safety and warning labels are in place and legible.

Power Up

1. Apply power to the system.

2. Verify that the Safety screen is displayed after system diagnostics occur.

3. Press CONTINUE to acknowledge the messages on the Safety screen.

4. Verify that proper audible tones are functioning on the DCU and injector head.

5. Verify that all displays and indicators are functioning properly.

6. Verify that the arm lights on the injector head are functioning.

Programming

1. After the Main screen is displayed, verify that the following controls are functioning properly.

2. At the rear of the Display Control Unit, press the DCU Brightness UP key until the screen is lightened to its fullest extent. Press the DCU Brightness DOWN key until the screen is darkened to its fullest extent. Adjust the screen appearance to return to a desirable contrast level.

3. Fully advance and reverse the pistons or piston by using the MOVE PISTON key and the forward/reverse controls.

4. Ensure the Auto Dock, Auto Advance, and Auto Retract are enabled, if desired.

5. Enter the one of the following protocols:

• Dual Syringe System: Enter the following protocol:Flow Rate Volume

Phase 1: Syringe A: 10 ml/s 70 mlPhase 2: Syringe B: 2.5 ml/s 29 mlPhase 3: Syringe A: 5.0 ml/s 100 mlPhase 4: Syringe B: 0.1 ml/s 1 ml

B - 48


• Single Syringe System: Enter the following protocol:

1. Install disposable syringe(s) and ensure the piston automatically docks with syringe plunger. The plunger(s) should advance to full forward position.

2. Fully reverse the plunger(s).

3. Arm in single mode and inject. In one of the phases, activate the HOLD feature for at least 10 seconds.

4. Press Start/Hold again and verify the injection completes normally, and the Injection Complete screen is close to the protocol values.

5. Advance plunger(s) to the full forward position, remove syringe(s) and ensure the piston(s) automatically retracts.

6. Inspect the heat maintainer. Make sure it is warm and that the fault indicator is not illuminated.

7. Per section 3 and 4 of this manual, ensure that all of the injector functions (such as filling, priming, stop, reset, etc.) are working correctly.

Touch Screen Calibration

The touch screen Calibration Screen is accessed from the Safety screen by simultaneously pressing both the DCU Brightness Up and DCU Brightness Down keys on the rear of the touch screen housing. A screen will appear with instructions to press the appropriate target.

Flow Rate VolumePhase 1: Syringe A: 10 ml/s 70 mlPhase 2: Syringe A: 2.5 ml/s 29 mlPhase 3: Syringe A: 5.0 ml/s 100 mlPhase 4: Syringe A: 0.1 ml/s 1 ml

The touch screen target shows the operator where to touch the screen for calibrating.

B - 49


B - 50

Appendix C - Specifications


DCU and Base Unit DCU and Base Unit Dimensions

Base Weight: 13.6 lbs. (+/- 1 lb.) / 6.17 kgDisplay and Stand Weight: 8.2 lbs. (+/- 0.77 lbs) / 3.71 kg

Rear of Display

DCU BASE UNIT

31.9 cm12.5"

34.3 cm13.5"

8.6 cm3.4"

29.2 cm11.5"

22.5 cm8.9"

27.9 cm11.0"

HAND SWITCH CONNECTION

BASE INTERFACE CABLE CONNECTOR

BRIGHTNESS KEYS

C - 51


Rear of Base Unit

Bottom of Base Unit

CLAMP FORHEAD CABLE

EQUIPOTENTIAL CONNECTOR

POWER CONNECTOR

SERVICE CONNECTOR

FUTURE USE

DISPLAY CONNECTOR

HEAD CONNECTOR

C - 52


Scan Room Unit Scan Room Unit Dimensions - Single

Weight: 57.7 lbs / 26.17 kg

Scan Room Unit Dimensions - Dual

Weight: 57.7 lbs / 26.17 kg

C - 53


Environmental Specifications

Non-Operating: (Transportation and Storage)

Operating

(The system may not meet all performance specifications if operated outside of the following conditions.)

AC Adapters for Informatics and VirtualCARE Systems)

Protection Against Electrical Shock

Per IEC 60601-1, the MEDRAD Stellant CT Injection System is designed as a Class 1 Medical Device with a type BF applied part.

Type BF corresponds to the degree of protection against electrical shock by the applied part of the Medical Device. Class 1 Equipment requires a protective earth connection (electrical grounding) to ensure protection against electrical shock in the event of a failure of the basic insulation system. The following are requirements for a Class 1 type BF Medical Device.

EMI/RFI

The injector system is classified as Group 1, Class B equipment per the requirements of EN 60601-1-2.

Electrical Leakage

Complies with EN, UL, CSA and IEC requirements for safe Electrical Leakage Current limits for Medical Equipment:)

Ground Continuity:

< 0.2 ohms from power cord ground pin to base, DCU, or head enclosure.

Temperature -25° C to 70° C (-40° F to +158° F)

Humidity 5% to 100% R.H., non-condensing

Air Pressure 48 kPa to 110 kPa

Temperature +10° C to + 40° C (+50° F to +104° F)

Humidity 20% to 90% R.H.

Air Pressure 69 kPa to 110 kPa

ARK-3382: Input: 100-240 VAC, 1.5A, 50-60 Hz

Output: 19.0 Vdc, 3.42A

AEC-6420: Input: 100-240 VAC, 1.5A, 50-60 Hz

Output: 12.0 Vdc, 5.0A Max

Earth Leakage Current: < 300 microamps (NC)

Chassis (Touch) Leakage Current: < 100 microamps (NC)

Patient Connection Leakage Current: < 100 microamps (NC)

C - 54


Protection Against the Ingress of Fluids

Per IEC 60601-1, the injector head and display control unit have been classified as drip proof equipment. These components of the System are provided with an enclosure that prevents the entry of such an amount of falling liquid as might interfere with the safe operation of the injector. This is indicated by the IPX1 designation on the injector head, and DCU.

Mode of Operation

Per EN 60601-1 the mode of operation for the Base and the Display Control Unit is continuous operation. They are capable of operation under normal load for an unlimited period, without excessive temperature being developed.

The mode of operation for the injector head is continuous operation with intermittent loading. Although power is applied to the head continuously, the intermittent use of loading and injecting will result in an internal temperature less than the continuous load operating temperatures, but greater than the no load operating temperatures. Under normal operating conditions with a minimum of 10 minutes between injections, the internal temperature of the head will not raise enough to degrade safety, system performance or reliability.

Fluid Delivery Performance

System Response to Occlusions

In the event of a partial occlusion, the injection will continue at a reduced flow rate. If the occlusion is such that the flow rate must be reduced below 10%, a stall condition will result.

Over and Under Infusion Protection

The following means are provided to protect against over and under infusions:

Warnings displayed on the safety screen and arming screen remind the operator to check the programmed injection parameters prior to the injector being armed.

An on-screen indication of insufficient volume is provided whenever the total volume programmed to be delivered is greater than the amount of fluid in the syringe.

Description Specification

Volume Range: 1 ml to maximum syringe capacity in 1ml increments

Flow Rate Range: 0.1 to 10 ml/sec in 0.1 ml/sec increments

Programmable Pressure limit, 200 ml syringe (PSI / kPa):

200 ml syringe Pressure Limit selections (PSI / kPa): Choice of 50/345, 100/689, 150/1034, 200/1379, 250/1724, 300/2068, 325/2241

Pause: 1 second to 900 seconds in 1 second increments.

Scan Delay: 0 to 300 seconds (or 5 minutes) in 1 second increments

Hold: Maximum Hold time is 20 minutes

Syringes (Volume capacity) 200 ml sterile disposable syringe

Injection Capabilities: 6 phases per protocol

Storage Capacity: 32 Protocols of up to 6 phases each

Elapsed Injection Time: Minimum of 0 - 999 seconds

C - 55


Injection monitoring is performed in the injector head to detect over rate or over volume conditions due to system faults. The delivered volume is also monitored against the total programmed volume for the injection.

When a fault condition, hold or stop is detected, the injection will stop within 5 ml.

Once the system has disarmed a tone will sound and a stall message will be displayed on the Display Control Unit screen.

System Fluid Performance

An injector's ability to generate pressure is only one factor affecting maximum flow rates. Other factors are:

• Catheter diameter• Viscosity (thickness) of the fluid• Tube length• Number of tubing sections• Tube diameter• Temperature of the fluid, tube, and syringes during the injection• Maximum pressure setting on the injector

To illustrate the wide range of maximum flow rates, a number of laboratory tests were performed using a Stellant injector, ULTRAVIST® 300, ULTRAVIST® 370, different concentrations of other contrast types, two sizes of tubing, a high pressure tubing extension, three catheter sizes (18, 20, and 22 gauge), two temperatures (21 °C and 37 °C), and two maximum pressure settings (295 PSI and 325 PSI). The maximum flow rate of one injector was tested with over 100 combinations of the above items. The maximum flow rate ranged from 3.0 - 10.0 mL/second.

If the user experiences problems achieving the desired flow rate please contact the Clinical representative for suggestions that may increase it

C - 56

Appendix D - Options and Accessories

Appendix D - Options and Accessories

Catalog Numbers and Descriptions Catalog No. Description

Injector Head Extension Cables:

SHC 700 25 25ft. (7.6 m) cable

SHC 700 50 50ft. (15.2 m) cable

SHC 700 75 75ft. (22.9 m) cable

SHC 700 100 100ft. (30.5 m) cable

Mounting Options:

EOC 700 S Ceiling-mounted counterpoise system

EOW 700 Wall-Mounted Counterpoise System

OCS 155A Ceiling mount counterpoise system for use with a ceiling track system (ceiling track not supplied by MEDRAD).

CSP 115A Counterpoise support plate (mounting hardware included).

SHP 800 Pedestal. Supports the Stellant Injector Head.

Display Control Cables:

SDC 700 5 5 ft. (1.52 m) cable

SDC 700 25 25 ft. (7.6 m) cable

Dual head:SSH 200Single head:SSH 200F

Syringe heater for 200 ml syringe

Dual head: SHS 700 05Single head: SHS 700 05F

Remote coiled start switch, (5’ length). Plugs into head control unit, and/or Display Control Unit

SSM 700 1 Service Manual

D - 57


Overhead IV Track System

The Overhead IV Track System can be used with any contrast injector when it is desired to hang injection solutions above the injector.

Straight IV Track (STS 100)

“U” Shaped Track (STS 200)

IV Hanger Extensions:

6”/ 15.24 cm STS 30612" / 30.48 cm STS 31218"/ 45.72 cm STS 31824" / 60.96 cm STS 32430" / 76.2 cm STS 33036" / 91.44 cm STS 336

Item Description QTY

3.5 feet / 107 cm long track 1

End Stop with screws 2

Four wheel heavy duty trolley 1

22“/5.88 cm long Atlas IV Hanger with 2 hooks 1

Apex Swivel clip 2

Item Description QTY

7 ft. (2.13 m) long 3 ft. (.91 m) wide “U” track 1

End Stop with screws 2

Four wheel heavy duty trolley 1

22“/5.99 cm) long Atlas IV Hanger with 2 hooks 1

Apex Swivel clip 7

>23kg>50lbs.

The Overhead IV Track System is only intended for hanging IV fluids. Do not hang more than 50 lbs / 23 kg of weight on the hooks.

D - 58

Appendix E - System Installation


Unpacking the Injection System

The master shipper carton for the Stellant CT Injection System contains three cartons. The illustration below displays the contents of each carton in the master shipper box.

NOTE: Open the Master Shipper Box first. Inspect and verify the contents. Call MEDRAD if there is a problem.

NOTE: The OCS, Pedestal, and Ceiling Track are shipped in a separate carton.

Accessories

Operation Manual

Disposables Kit

Head Extension Cable

Display Base Cable

Heat Maintainer(s)

Hand Switch

Power Cord

Optional Accessories

Service Manual

Schematic Manual

Language Kit

Syringe Adapter (Japan only)

Accessories Box(Open second)

Head Box (open third)

DCU Box (Open fourth)

E - 59


Installation Considerations

Below is a typical installation of the System in a CT suite.

Injector Installation Follow the illustration below to install the cables that connect System components. Be certain to tighten the screws that hold the cable connectors in place.

NOTE: Follow all relevant guidelines for institutional, local, or national safety recommendations related to cable routing and installation.

injector head side view

connector

back of DCUback of base

power cord display base cable

J234

hand switch

J244/J246

E - 60


NOTE: Ensure that the cable tie for the head extension cable is secured to the cable at the base, prior to attaching the D-Sub and thumb screws.

NOTE: After installation, power-up the System, set the date/time (see section 2), and perform the system check-out as in section B prior to use.

WARNING: Only use the power cord supplied with the system. Do not plug the System power cord into an extension cord or multi-outlet power strip.

Reinstalling the System in Another Room

If re-installing the System in another room, disconnect the cable, lower the IV pole and fold in the hooks. Position the injector head vertically. When moving the injector, hold the pedestal below the point indicated by the label on the pedestal arm. If the pedestal does not contain this label, hold the pedestal no higher than 36 inches above the floor. Maintain a grip on the injector when moving it across a threshold or over other obstacles in the path of travel.

E - 61


E - 62

Appendix FEnglish

Appendix F – Compliance to IEC 60601-1-2 / 2001 2nd Edition

This system is in compliance to IEC-60601-1-2 / 2nd edition Standards. Special precautions regarding ElectroMagnetic Compatibility (EMC), are required for installation and use of this system. Detailed EMC information contained in this addendum

is intended to reflect conformance to IEC-60601-1-2 / 2001 2nd edition standards.

The following statements are cautions. Cautions advise of circumstances that could result in damage to the device. Read and understand these cautions before operating the system.

Caution: System may disarm or fail to operate when exposed to high magnetic fields. Portable and mobile RF communications equipment can affect the system.

Caution: FOR PROPER OPERATION, use only accessories and options provided by MEDRAD that are designed specifically for the system. Other non-MEDRAD approved accessories or options may cause equipment damage or may result in increased emissions or decreased immunity of the system. System accessories listed in the operation manual comply with the requirements of electromagnetic emissions and immunity standards IEC-60601-1-2 / 2001

2nd edition.

Caution: DO NOT USE SYSTEM ADJACENT TO OR STACKED WITH OTHER EQUIPMENT. If adjacent or stacked use is necessary, the system should be observed to verify normal operation in the configuration in which it will be used.

Recommended separation distances between portable and mobile RF communications equipment and the system

The System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the system as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitterW

Separation distance according to frequency of transmitterm

150 KHz to 80 MHzd = [3.5/V1]

80 MHz to 800 MHzd = [3.5/E1]

800 MHz to 2.5 GHzd = [7/E1]

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 2.33

10 3.69 3.69 7.38

100 11.67 11.67 23.33

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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THE SYSTEM REQUIRES SPECIAL PRECAUTIONS REGARDING EMC. Install and put into service according to the EMC information provided below:

Guidance and manufacturer's declaration - electromagnetic emissionsThe System is intended for use in the electromagnetic environment specified below. The customer or user of the system should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissionsCISPR 11

Group 1 The System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissionsCISPR 11

Class B The System is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissionsIEC 61000-3-2

Class B

Voltage fluctuations / flicker emissionsIEC 61000-3-3

Complies

Guidance and manufacturer's declaration - electromagnetic immunityThe System is intended for use in the electromagnetic environment specified below. The customer or user of the system should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance

Electrostatic discharge (ESD)IEC 61000-4-2

+6 kV contact+8 kV air

+6 kV contact+8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with a synthetic material, the relative humidity should be at least 30%.

Electrical/fast transient/burstIEC 61000-4-4

+2 kV for power supply lines+1 kV for input/output lines

+2 kV for power supply lines+1 kV for input/output lines

Mains power quality should be that of a typical commercial or hospital environment.

SurgeIEC 61000-4-5

+1 kV differential mode+2 kV common mode

+1 kV differential mode+2 kV common mode

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input linesIEC 61000-4-11

<5% UT(>95% dip in UT)for 0.5 cycle

40% UT(60% dip in UT)for 5 cycles


<5% UT(>95% dip in UT)for 5 sec

<5% UT(>95% dip in UT)for 0.5 cycle



<5% UT(>95% dip in UT)for 5 sec

Mains power quality should be that of a typical commercial or hospital environment. If the user of the system requires continuous operation during power mains interruptions, it is recommended the system be powered from an uninterruptible power supply or battery.

Power frequency(50/60 Hz) magnetic fieldIEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE UT is the a.c. mains voltage prior to application of the test level.

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Appendix F

Guidance and manufacturer's declaration - electromagnetic immunityThe System is intended for use in the electromagnetic environment specified below. The customer or user of tthe System should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance

Portable and mobile RF communications equipment should be used no closer to any part of the system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

Conducted RFIEC-61000-4-6

3 V rms150 kHz to 80 MHz

3 V rms d = 1.17

Radiated RFIEC 61000-4-3

3 V/m80 MHz to 2.5 GHz

3 V/m d = 1.17 80 MHz to 800 MHz

d = 2.33 800 MHz to 2.5 GHz

Where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b

Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the system is used exceeds the applicable RF compliance level above, the system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the system.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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INDEX

IndexAAbort, 2-12About the Injection System, 2-11Alternating Current, 1-2Applying Power, 2-17Arming, 4-35Audio Level, 2-23Auto Advance, 2-23, 3-28Auto Retract, 2-23Auto-docking, 3-27Automatic retraction, 3-28

BBase Unit, 2-12Basic Features, 2-11Brightness Controls, 2-12

CCalibration, 2-23Cautions, 1-8Certifications, 1-1, A-43Class One, 1-2Cleaning, B-45Contraindications, 1-1

DDate / Time, 2-23Date/Time, 2-23Disclaimers, 1-2Display Control Unit, 2-12Dual Syringe System, 2-11Dual, 2-14

EEarth Ground, 1-3Elapsed time, 4-38, 4-42Equipotential, 1-3Error Screen, A-43

FFlow profile, 4-39Flow Rate, 1-5Fluid Dispensing Device, 3-25FluiDots, 3-25

HHandswitch, 2-12Hazardous Voltage, 1-2

Heat Maintainer, 2-17Help, 1-3, 2-12, 2-24Hold, 2-12

IInjecting, 4-37Injection Complete, 4-42Injection Display Mode, 2-23Injection monitoring, 1-6Injector Duration, 1-5Insufficient volume, 1-6Integral Autoload, 3-29Intended Use, 1-1IPX1, 1-3

LLanguage, 2-23Loading and Priming a Syringe, 3-27Locking a protocol, 3-33

MMain Screen, 2-18Maintenance, B-46Manual Loading a syringe, 3-28Minimizing Air Embolization Risks, 3-25Moving the System 2-11, E-61

NNon-rotational orientation, 3-27

OOn/Off switch, 1-2Operational Checkout, B-48Over and under volume, 1-6Overhead IV Track System, 1-3

PPause, 1-5, C-55Power Button, 2-12Pressure graph, 4-39, 4-42Pressure Limit Condition, 1-6Pressure Safety Limit, 1-5Pressure Units, 2-23Pressure, 1-5Priming Tube, 3-27Programming, 3-31PSI, 4-39

RRecalling a protocol, 3-33

Removing a Syringe, 3-31Reset, 1-3, 2-12, 2-24Response to Occlusions, 1-6Restricted Sale, 1-1

SSafety Screen, 2-18Scan Delay, 4-38Setup, 2-12, 2-22Signals and Descriptions, 4-40Single Syringe System, 2-11Start/Hold, 2-12Stellant Connector Tubing, 3-27Stellant Models, 2-11Storing a protocol, 3-32Symbols, 1-2System Logo, 2-18

TTest Inject Rate, 2-23Test Inject Source, 2-23Test Injection, 4-36Total Volume Display, 2-23Touch Screen Calibration, 2-22Trademarks, 1-1Type BF, 1-2

VVolume and Rate Protection, 1-6

WWarnings, 1-7

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