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Stellant CT Injector

Operation Manual
Catalog # SOM 700 EN

201071 Rev. H
Stellant CT Injection System

Operation Manual
Stellant CT Injection System

2009, 2012 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
Table of Contents
1 - Introduction ............................................................................................................ 1-1
Certifications ................................................................................................................. 1-1
Intended Use ................................................................................................................. 1-1
Contraindications .......................................................................................................... 1-1
Restricted Sale .............................................................................................................. 1-1
Required Training ......................................................................................................... 1-1
Trademarks ................................................................................................................... 1-1
Disclaimers ................................................................................................................... 1-1
The Equipotential Connector (EPC) .............................................................................. 1-1
MEDRAD Contact Information ...................................................................................... 1-2
Symbols ........................................................................................................................ 1-3
Pressure Limit ............................................................................................................... 1-5
Pressure ........................................................................................................................ 1-5
Flow Rate ...................................................................................................................... 1-5
Injector Duration ............................................................................................................ 1-5
The Basics .................................................................................................................... 1-5
How the Injector is Designed ........................................................................................ 1-6
How to Recognize if a Pressure Limit Condition Occurs .............................................. 1-6
Response to Occlusions ............................................................................................... 1-7
Volume and Rate Protection ......................................................................................... 1-7
Warnings ....................................................................................................................... 1-8
Cautions ...................................................................................................................... 1-10

2 - System Basics ..................................................................................................... 2-11
About the Injection System ......................................................................................... 2-11
Stellant Models ........................................................................................................... 2-11
Basic Features ............................................................................................................ 2-11
Display Control Unit (DCU) ......................................................................................... 2-12
Stellant Injector (Single) .............................................................................................. 2-14
Stellant Injector (Dual) ................................................................................................ 2-16
Injector Head Functions .............................................................................................. 2-18
Heat Maintainer ........................................................................................................... 2-20
Applying Power ........................................................................................................... 2-20
System Logo ............................................................................................................... 2-20
Safety Screen ............................................................................................................. 2-20
Main Screen ................................................................................................................ 2-21
Touch Screen Calibration ........................................................................................... 2-22
Setup ........................................................................................................................... 2-23
Date/Time ................................................................................................................... 2-24
Help ............................................................................................................................. 2-25
Reset ........................................................................................................................... 2-25

3 - Preparing to Inject ............................................................................................... 3-27
Minimizing Air Embolization Risks .............................................................................. 3-27
Minimizing Extravasation ............................................................................................ 3-29
Stellant Connector Tubing .......................................................................................... 3-30

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Stellant CT Injection System

Loading and Priming a Syringe ................................................................................... 3-31
Manual Loading a Syringe .......................................................................................... 3-32
Cautions for draw back ............................................................................................... 3-33
Using Auto Load to Load a Syringe ............................................................................ 3-34
Pre-loading a 200 ml Syringe on the Injector Head ..................................................... 3-36
Removing a 200 ml Syringe ......................................................................................... 3-36
Programming Protocols .............................................................................................. 3-37
Storing a Protocol ....................................................................................................... 3-38
Locking a Protocol ...................................................................................................... 3-38
Recalling a Protocol .................................................................................................... 3-39
Deleting a Protocol ...................................................................................................... 3-39
Programming a Delay ................................................................................................. 3-40
Pressure Limit Programming ...................................................................................... 3-41

4 - Arming and Injecting ........................................................................................... 4-43
Arming ......................................................................................................................... 4-43
Injecting ....................................................................................................................... 4-45
Injecting Views ............................................................................................................ 4-47
Injection Complete ...................................................................................................... 4-48
Pressure Graph ........................................................................................................... 4-50
Helpful Hints ................................................................................................................ 4-51
Test Injection ............................................................................................................... 4-53

5 - Simultaneous Injection ....................................................................................... 5-55
Introduction ................................................................................................................. 5-55
Warnings ..................................................................................................................... 5-55
Upgrading the Injector ................................................................................................. 5-55
Protocol Programming ................................................................................................ 5-57
Calculating Contrast .................................................................................................... 5-59

Appendix A - System Messages ..............................................................................A-61
Error Screen ................................................................................................................ A-61
Tone Table .................................................................................................................. A-61

Appendix B - Cleaning and Maintenance ...............................................................B-63
Cleaning Guidelines .................................................................................................... B-63
Recommended Maintenance Schedule ...................................................................... B-65
Inspection Procedures ................................................................................................ B-66
Operational Checkout ................................................................................................. B-67
Dual Syringe System .................................................................................................. B-68
Single Syringe System ................................................................................................ B-68

Appendix C - Specifications ....................................................................................C-71
DCU and Base Unit .....................................................................................................C-71
Base Unit Dimensions .................................................................................................C-71
DCU Weights ..............................................................................................................C-71
Back of Monitor ...........................................................................................................C-71
Rear of Base Unit ........................................................................................................C-72
Bottom of Base Unit ....................................................................................................C-72
Injector Head Dimensions ...........................................................................................C-73

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Environmental Specifications ......................................................................................C-76

Appendix D - Options and Accessories ..................................................................D-79
Catalog Numbers and Descriptions ............................................................................D-79
Overhead IV Track System .........................................................................................D-80
Stellant Adjustable Height Pedestal (SHP 700) .........................................................D-81
Pedestal Cleaning .......................................................................................................D-82
Pedestal Inspection .....................................................................................................D-82
Pedestal Operation Instructions ..................................................................................D-82

Appendix E - System Installation ............................................................................ E-83
Unpacking the Injection System .................................................................................. E-83
Installation Considerations .......................................................................................... E-84
Injector Installation ...................................................................................................... E-85
Wall Mount Installation ................................................................................................ E-86

Index ............................................................................................................................ I-89

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Stellant CT Injection System

iv
1 - Introduction

1 - Introduction

This manual applies to the MEDRAD Stellant CT Injection 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
you in operating the Stellant CT Injection System in a safe manner.

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 the MEDRAD Injector Service
Manual or its Addendum.

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

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 The Equipotential Connector (EPC) is an electrically bonded terminal on the injector that is
Connector (EPC) 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.

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Stellant CT Injection System

MEDRAD Contact MEDRAD, INC. USA
Information One Medrad Drive
Indianola, Pa 15051-0780 U.S.A.
Phone: 412 767-2400
Fax: 412-767-4120

MEDRAD Europe B.V.
P.O Box 205
6190 AE Beek
The Netherlands
Phone: +31(0)43-3585600
Fax: +31(0)43-3656598

Nihon MEDRAD KK
2-4-9, Umeda, Kita-ku,
Osaka, 530-0001
Japan
Phone: +81(0)66-133-6250
Fax: +81(0)66-344-2395

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1 - Introduction

Symbols The following symbols are used on the Stellant CT Injection System and components:

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

Forward and Reverse Piston Controls.

Check For Air Indicator on the injector head. Also indicates that the operator has
acknowledged inspecting the fluid path for air when illuminated yellow on the touch screen,

Contrast indicator (green), Saline indicator (blue).

Protocol is locked indicator.

Attention, consult accompanying instructions.

Indicates on/off switch.

Indicates hazardous voltages.

Indicates alternating current.

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

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

Identifies the degree of protection against fluid as drip proof.

Identifies connection of the handswitch.

Identifies the Equipotential connection.

Identifies the Earth Ground point.

Indicates design for indoor use only.

Indicates the presence of no serviceable parts.

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Stellant CT Injection System

Identifies the DCU brightness controls.

Start / Hold.

Abort.

Reset.

Help.

Setup.

Protocol is unlocked or unengaged.

Pressure Graph View.

Phase View.

Electrostatic.

Heat Maintainer(s) connection

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.
>23 kg
>50lbs.

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

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1 - Introduction

Pressure Limit The Stellant CT Injection 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 Stellant CT Injection 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.

200 ml syringe

Programmable Pressure Limit Factory preset to 325 PSI (2241 kPa)
(Selectable Range: 325 kPa - 2241 kPa)

Hazard/failure limit (injector shut-down Factory preset to 375 PSI (2586 kPa)
pressure in the event of a failure).

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

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

Injector Duration
Injection 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 Basics
In 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.

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Stellant CT Injection System

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.

How the Injector is Designed

The Stellant CT Injection 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.

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1 - Introduction

Response to When injecting into an occlusion, a stall condition (flow rate less than 10% of programmed rate)
Occlusions 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 The following means are provided to protect against over and under volume or rate conditions:
Protection
• 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.

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

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

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

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Stellant CT Injection System

Warnings 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 your local dealer for
assistance.

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.

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.

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.

Electrical Shock Hazard: Equipment must only be connected to a supply mains with protective
earth.

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 your local dealer for service or replacement.

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.

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

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.

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 FluiDot indicators do not indicate the total absence of air
bubbles in the syringe tip. FluiDot indicators must be viewed in a properly illuminated

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1 - Introduction

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.

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.

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.

Bacterial contamination could occur if syringes are used to store contrast media. Use loaded
syringes immediately. Discard unused loaded syringes.

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.

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.

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

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

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

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Stellant CT Injection System

Cautions 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.

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.

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

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.

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
are required to clean the injector. Do not use strong industrial cleaning solvents such as
acetone.

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.

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.

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.

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.

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

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2 - System Basics

2 - System Basics

About the Injection The Stellant CT Injection System is comprised of the injector head located in the scanning
System 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.
Stellant Models

Model Description Catalog Number
S Single Syringe System SCT 110 (no injector head mount)
without Auto Load and
Prime SCT 111 (includes a floor-mounted injector head
mount)

SCT 112 (includes an overhead counterpoise ceiling
head mount)
SX Single Syringe SCT 120 (no injector head mount)
System - Full featured
SCT 121 (includes a floor-mounted injector head
mount)

SCT 122 (includes an overhead counterpoise ceiling
head mount)
D Dual Syringe System - Full SCT 210 (no injector head mount)
featured
SCT 211(includes a floor-mounted injector head
mount)

SCT 212 (includes an overhead counterpoise ceiling
head mount)
Dual Flow SCT 220 (no injector head mount)

SCT 221 (includes a floor-mounted injector head
mount)

SCT 222 (includes an overhead counterpoise ceiling
head mount)

Basic Features The basic foundation features of all Models include:

• Stellant 200 ml syringe • Pressure graph (not in S model)
• Auto dock, Auto advance, and Auto • Duration by phase
retract (not in S model)
• 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
• Choice of floor-mounted pedestal head
mount with bulk contrast holder or
Overhead Counterpoise System (OCS)

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Stellant CT Injection System

Display Control Unit The Display Control Unit (DCU) and Base Unit:
(DCU)
Handswitch

Base Unit
Display Control Unit

Power Button

Brightness Controls

Abort Setup Help Reset Start/Hold

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

Control Function
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.

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2 - System Basics

S model Injector head overlay

VOLUME

FORWARD PISTON

MOVE PISTON

CHECK FOR AIR REVERSE PISTON

PROTOCOL LOCK

ARM

ABORT START / HOLD

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Stellant CT Injection System

Stellant Injector CT Suite with Stellant Injector (SX model).
(Single)

MANUAL KNOB

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2 - System Basics

SX model Injector head overlay

VOLUME

AUTO LOAD FILL
PLUS / MINUS

PRIME
FORWARD PISTON

MOVE PISTON

CHECK FOR AIR
REVERSE PISTON
PROTOCOL LOCK

ARM

ABORT START / HOLD

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Stellant CT Injection System

Stellant Injector (Dual) CT Suite with Stellant Injector (Dual).

MANUAL KNOB

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2 - System Basics

D model Injector head overlay

SYRINGE B SYRINGE A

VOLUME

AUTO LOAD

FILL B FILL A
PLUS / MINUS PLUS / MINUS

PRIME

FORWARD PISTON FORWARD
PISTON

MOVE PISTON

REVERSE PISTON CHECK FOR AIR

REVERSE PISTON
PROTOCOL LOCK

ARM

ABORT START/HOLD

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Stellant CT Injection System

Injector Head Manual Knob
Functions
• Permits manual movement of the syringes when the injector is not armed.
• Use to purge air, check backflow of blood and to assist in assuring correct catheter
placement.

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

Volume
• Indicates the position of the plunger and the volume loaded in the syringes.
• Insufficient volume conditions indicated on DCU and at the injector head by a flashing
LED.
• Press Arm on the injector head two times to allow the arming process to
continue with the remaining volume.

Auto Load (not available in S model)
• Press to enable the system to automatically load a 200 ml syringe with the Volume
selected for the current protocol.

Prime (not available in S model)
• Press to activate priming function which fills the low pressure tubing with fluid.

Move Piston
• Press to enable the forward and reverse piston controls for ten seconds, (then times out.)

Check For Air
• Press to verify that air is purged from the disposable system.
• Flashing indicates that the system has not been checked for air.
• Any reverse movement of the piston cancels Check For Air.

Protocol Lock
• When lit, indicates protocol lock on DCU is enabled.
• Must be lit to enable remote arming.
Arm
• Arms system if remote Check For Air and Protocol Lock indicators on DCU are enabled.

NOTE: The Armed indicator light, located at the back of the injector head:

• Illuminates when syringe is armed or injecting
• Flashes when the injector is armed and on hold.

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2 - System Basics

Abort (Red)

• Terminates and disarms injection.

Start/Hold Injection (Yellow)

• Initiates injection at patient’s side.
• Holds injection in the armed mode for 20 minutes, then disarms.

Piston Controls (Side A or Side B)

• Reverse piston control (variable speed).
• Forward piston control (variable speed).

Plus/Minus (Side A or Side B)

• Adjusts Auto-fill volume to the desired amount in small increments/decrements.
• Activate by pressing Auto Load.

Fill (not available in S model)

• Automatically fills Syringe A with displayed Volume.

Fill B (Dual head only)

• Automatically fills Syringe B with displayed Volume.

Fill A (Dual head only)

• Automatically fills Syringe A with displayed Volume.

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Stellant CT Injection System

Heat Maintainer The Stellant CT Injection 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 Stellant 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.

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.

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2 - System Basics

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. Refer to the Setup Screen section for a list of operator configurable
screen elements.
Main screen, dual mode (D),
syringes attached.

Main screen, dual
mode, no syringes
attached.

Main screen, single.

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Stellant CT Injection System

Main screen, dual mode, six-
phase protocol.

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

Touch Screen The touch screen Calibration Screen is accessed from the Safety screen by simultaneously
Calibration 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.

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

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2 - System Basics

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

SETUP

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

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Stellant CT Injection System

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

Configurable Item Selectable Value
Language English, Japanese, French, Italian, German, Spanish,
Swedish
Display Audio Level Soft, Medium, Loud
Calibration Reminder Year and month
Priming Source Syringe A or Syringe B
Test Inject Source Syringe A or Syringe B
Test Inject Rate Test injection rate
Test Inject Volume Test injection volume
Injection Display Mode Profile or Protocol
Pressure Units 50 - 325 PSI
Date / Time Calendar date and time of day
Total Volume Display Syringe A or Syringe A plus Syringe B
Auto Retract On or Off
Auto Advance On or Off

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

Date/Time Setup

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2 - System Basics

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

HELP

Help topics include information about:

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

Help screen Help topic selected

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

RESET

The following values are the factory default parameters:

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

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Stellant CT Injection System

2 - 26
3 - Preparing to Inject

3 - Preparing to Inject

Minimizing Air Operator vigilance and care, coupled with a set procedure, is essential to minimizing the
Embolization Risks 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 FluiDot™ indicators (where applicable) to
reduce the chance of air embolism.

• The presence of rounded FluiDot indicators do not indicate the total absence of
air bubbles in the syringe tip. FluiDot 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. Visusally 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.

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Stellant CT Injection System

• 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 FluiDot indicators. FluiDot indicators should be
observed as part of an arming procedure. When the FluiDot 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.

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.

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

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3 - Preparing to Inject

Minimizing MEDRAD, INC. as a manufacturer cannot recommend specific procedures for venipuncture in
Extravasation Enhanced Computed Tomography. We offer this compilation of information, obtained from the
following physicians, as suggestions relating to practices which have worked well at their
institutions.

Richard L. Baron, M.D. University of Pittsburgh Medical Center

Elliot K. Fishman, M.D. Johns Hopkins Hospital

Philip Costello, M.D. New England Deaconess Hospital

Patrick Freeny, M.D. University of Washington

Paul M. Silverman, M.D. University of Texas, M.D. Anderson Cancer Center

W. Dennis Foley, M.D. Medical College of Wisconsin

The following are suggested techniques for minimizing extravasation during a CT
enhancement procedure.

1. Use a 20 gauge or larger IV catheter over needle (a 22 gauge may be used with slower
flow rates).

2. The preferred location for venipuncture is the medially located antecubital vein.

3. Have at least 1/2 inch of the catheter positioned in a good vein with rapid backflow.

4. Tape the catheter securely to avoid catheter movement.

NOTE: A winged catheter over needle allows easy insertion into the vein and
secure taping.

5. Use a 60 inch coiled low pressure tube securely attached to the catheter. The coiled
tubing reduces motion effect during table incrementation.

6. Instruct the patient to communicate immediately any pain or change in feeling during the
injection.

7. If possible, instruct the patient to put his or her arm vertically above the shoulder with the
palm of the hand on the face of the gantry during injection. This allows for uninterrupted
passage of injected contrast through the axillary and subclavian veins at the thoracic
outlet.

8. A small volume test injection of contrast or saline may be utilized to confirm venous
access. A trained professional should remain by the patient during the initial stages of the
injection palpating the venous access site to ensure proper placement of the I.V. catheter.
If local pain, swelling or signs of extravasation are noted, the injection should be stopped
immediately.

9. Central lines and hep-locks should only be used in accordance with hospital policy
guidelines.

10. Adhere to all instructions, warnings, and cautions listed for the specific products being
used.

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Stellant CT Injection System

Stellant Connector The connector tubing is equipped with a priming tube. Attach the priming tube to the end of the
Tubing 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.

To use a connector tube:

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 you are 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. B A

5. Verify that the tubing is not kinked or obstructed.
Filter
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 Prime Tube
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.

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3 - Preparing to Inject

Loading and Priming a The Stellant CT Injection System was specifically designed to decrease the amount of time and
Syringe steps to load disposable syringes with either contrast media or saline. Using the Stellant CT
Injection 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 Stellant Injection 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.

3. Auto-advance (excluding S model): If the Stellant syringe was not pre-loaded with
contrast, the plunger is automatically advanced to the full forward position (as long as it
has not been previously filled with contrast, removed from the injector, and re-installed, or
is not configured off).

• 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.

• If a syringe is filled by squeezing contrast or saline into it from a bag (plunger is
not moved forward), and then the syringe is installed on the unit, the plunger
automatically advances to the front of the syringe if Auto Advance is configured
on. If a syringe is loaded in this manner, the syringe plunger should be manually
moved forward about 5 ml before the syringe is installed on the injector so that it
does not automatically advance.

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.

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Stellant CT Injection System

Manual Loading a A syringe can be loaded manually or automatically on the Stellant CT Injection System.
Syringe
To manually Load and Prime a syringe on the Stellant CT
Injection System:

1. 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.

NOTE: The Stellant CT Injection 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.

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."

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3 - Preparing to Inject

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.

PRIME BUTTON

Cautions for draw If the procedure is to draw back on the syringe plunger after the system is connected to the
back 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.

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Stellant CT Injection System

Using Auto Load to (SX and D models):
Load a Syringe
The Stellant CT Injection System also has an Integral Autoload function. This feature saves
time and steps by automatically loading the syringe, (the operator is still responsible for
confirming that all air is expelled). The Stellant CT Injection System is also specifically
designed to take advantage of the convenience (and typically lower cost per milliliter) of bulk
contrast containers.

As part of the Integral Auto Load capability, you can 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. Auto Load Purge Volumes of 30 ml, 20 ml, 10 ml, and OFF (zero ml) can be selected to
match the particular filling device being used.

To 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.

4. Choose one of the four volume selections based on the following guidelines:

• 30 ml for long transfer sets (46" / 117 cm tubing), LPCT with 14" "T" connector,
or if a QFT is used.
• 20 ml for short transfer sets (23" / 58 cm tubing), and with SVTS
• 10 ml when loading through a spike
• OFF when using a European-style transfer set.

5. Select OK.

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3 - Preparing to Inject

To use 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.

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). You can
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.

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

NOTE: If you do not press Fill within ten seconds, Auto Load will
automatically reset. You will then have to 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 the section "To use a connector tube."

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Stellant CT Injection System

Pre-loading a 200 ml If you wish to pre-load a 200 ml syringe and remove it from the injector, Stellant provides
Syringe on the Injector unique features to assist you in this area.
Head
NOTE: Ensure that Auto Advance and Auto Retract are configured in the
ON mode (through the Setup Screen).

To pre-load a 200 ml syringe:

1. Install a disposable 200 ml syringe onto the injector.

2. Using either the manual loading technique, or Auto Load, fill the syringe to the desired
Volume and purge of air.

3. Remove the syringe from the injector. The piston rod will automatically retract at this time.

To re-install the syringe:

1. Snap the previously filled syringe onto the front of the injector head. The Stellant piston
rod will automatically advance, find the syringe plunger, and dock.

2. At this point, continue with the normal preparation steps (install patient tubing, prime,
Check For Air, etc.)

Removing a 200 ml To remove a 200 ml syringe:
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 you cannot remove the syringe,
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).

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3 - Preparing to Inject

Programming Programming a protocol is initiated at the Main screen.
Protocols
To Program a Protocol:

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.

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: You can also lock in a selected value by touching another parameter.

To program 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.

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Stellant CT Injection System

Storing a Protocol To 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.

Store screen, English keyboard Store screen, delete confirmation

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

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. If you are arming from the
DCU, you do not need to press Protocol Lock in order to arm.

Lock Protocol

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3 - Preparing to Inject

Recalling a Protocol To recall a protocol stored in memory:

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

Recall screen Protocol selected

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 To delete a protocol stored in memory:

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.

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Stellant CT Injection System

Programming a Delay To program a Delay:

1. Enter desired Flow Rate and Volume parameters.

2. Touch Set in the Delay time block to bring up the delay types.

3. Choose the desired delay type (Scan Delay, Inject Delay, and No Delay).

4. Enter the desired delay duration.

5. Touch Enter.

NOTE: There is no direct interface between the scanner and the injector. The
scanner cannot trigger the injector, nor can the injector trigger the
scanner.

Scan Delay time will elapse in the timer block on the screen. This is the time remaining before
the scan needs to be activated by the operator. It will decrement in one-second intervals. (The
scan delay countdown will continue through multiple levels of armed injections.) When the
countdown is complete, the injector will emit 5 beeps as an indicator for the operator to initiate
the scan.

Inject Delay will also countdown in one-second intervals, commencing when the handswitch is
pressed. The clock will display, in one-second decrements, the time remaining before the
injection will begin. When Inject Delay is chosen and the handswitch is pressed, the injection
will automatically occur when the timer reaches zero unless the operator presses Start/Hold
again or the injector is disarmed. When countdown is complete, the injector will emit 5 beeps
and contrast delivery will automatically begin.

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3 - Preparing to Inject

Pressure Limit The pressure limit can be programmed by choosing a value between 50-325 PSI up to the
Programming greater of the syringes’ maximum pressure.

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.

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Stellant CT Injection System

3 - 42
4 - Arming and Injecting

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.

To begin 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.

• 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.

• Insufficient volume conditions are indicated at the injector head by a flashing
LED.

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

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Stellant CT Injection System

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.

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4 - Arming and Injecting

Injecting To complete an injection:

NOTE: It is recommended that you stay by the patient’s side at the beginning
of the injection to ensure that the Angio-cath 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 you can arm 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)

6. Initiate injection from the Start/Hold switch on the injector head (at the patient’s side) or at
the DCU.

• 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. Dur-
ing the injection, additional presses of the Start/Hold will alternately
Hold and resume the injection and the scan delay time.

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

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Stellant CT Injection System

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

• As each phase is activated, phase parameters are hightlighted.
A dashed red line
appearing during a Scan
Delay

• 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.

4 - 46
4 - Arming and Injecting

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.

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

4 - 47
Stellant CT Injection System

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 Stellant CT Injection 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, as pictured below. 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.

Injection Complete Injection Complete, showing a test
injection

Injection Complete, with premature Injection Complete displaying the
termination of injection pressure graph.

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4 - Arming and Injecting

Injection Complete, holding position for Profile view.
pressure dissipation.

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 take you back to the pressure graph screen.

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Stellant CT Injection System

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.

Graphical view, Injecting screen, contrast Graphical view, Injecting screen, entering
phase. a pause.

Graphical view, Injecting screen, Hold
phase.

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4 - Arming and Injecting

Helpful Hints The Stellant 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 The pressure required to push the contrast media Check to insure the syringe heater is
shape, but the pressure is through the disposable system is higher than functioning normally.As long as the
higher than normal. normal, which means there is a greater restriction to "Possible Causes" listed are of no
fluid flow. Greater restrictions can be caused by any concern, then no action is necessary.
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).

2 The graph is the typical The pressure required to push the contrast media As long as the "Possible Causes"
shape, but the pressure is through the disposable system is lower than listed are of no concern, then no
lower than normal. normal, meaning there is less restriction to fluid action is necessary.
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).

3 The graph and injection An inappropriate pressure limit may be selected. If Check to see if the Pressure Graph is
start out normal, but level a lower pressure is selected than what is required to approaching the dotted horizontal
off to a less than expected deliver the flow rate, the injection will start out line (pressure limit setting). If it is, the
peak pressure. normally for the first few seconds. However, as injector is pressure limiting and
soon as the pressure limit value is achieved, the causing this condition. See "Pressure
flow rate will automatically decrease to keep the Limiting" in the Operation Manual for
system from exceeding the selected pressure limit. a thorough discussion of causes and
resolution.

4 - 51
Stellant CT Injection System

4 At the start of the injection, The fluid path may be occluded (after reaching a Consider putting the injector on hold
the Pressure Graph signal "High Pressure Disarm", Stellant will automatically and investigating. There is a high
immediately rises straight terminate the injection). Total occlusions may be probability that no contrast media is
up and hits the pressure caused by one of the following: being injected into the patient.
limit setting (dotted
horizontal line). • A closed stopcock
• An IV extension set with the clamp closed off
• A defective disposable (fluid will not flow
through it).

5 The injection is proceeding If the injector is still armed and injecting at a If the injector is still injecting (arm
perfectly normal, but during constant flow rate, but the Pressure Graph drops light solid and manual knob on the
the injection, with no sharply to baseline: Stop the injector back of the head turning), consider
programmed decrease in immediately and investigate. The pressure in the aborting the injection. There is a high
flow rate, the Pressure syringe has sharply dropped even though the piston probability that fluid is running on the
Graph sharply drops to is moving forward and should be developing floor.
baseline, but no error pressure. Possible causes:
messages appear on the
screen. Note: If a multi- • The Low Pressure Connector Tubing,
level injection is extension set, or catheter has burst or
programmed, and the flow disconnected from the fluid path (fluid is
rate is programmed to running on the floor)
decrease, then the • The syringe may have failed. Fluid is being
pressure will also drop at forced around the syringe plunger instead of
that time. out the end of the syringe (fluid is running on
the floor).

6 The pressure buildup to the Due to operator error, the syringe may contain a Stop the injector immediately and
expected peak is taking large amount of air (example: half air, half fluid). It is investigate.
longer than typical, even easier to compress air, than to push fluid through a
though the injector is CT disposable system, so the injector is initially Check the fluid path for air.
injecting normally. developing less pressure as it compresses the air.

7 When the injection starts, Due to operator error, there may be no fluid in the Stop the injector immediately and
almost no pressure buildup syringe (you could be injecting air). The injector will investigate.
is witnessed, when a experience almost no resistance to moving the
buildup was expected. syringe plunger forward with an empty syringe. Check the fluid path for air.
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: You may
have two syringes on the injector, only performing a
single syringe injection, and the LPCT may be
connected to the wrong syringe.

8 At the end of a normal Stellant is designed to inject all of the contrast in the No action. This is normal operation.
injection, the pressure syringe to help minimize contrast waste.
graph does not immediately Sometimes in the process of doing this, the piston
drop to zero. 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.

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.

4 - 52
4 - Arming and Injecting

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.

To configure Test Inject parameters:

1. Press the Setup button

2. Touch Test Inject Source, Test Inject Rate, or Test Inject Volume

3. Touch any programmable block and enter the desired rate, volume, or source

4. Press Start/Hold to perform Test Injection

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

Programming a Test Injection Test injection programmed

Test Injection fluid source programming Test Inject - Armed

4 - 53
Stellant CT Injection System

Injecting screen, performing test injection During Test Injection

Pressure graph view, following test Post test inject - phase view
injection

Protocol with a test injection selected

4 - 54
5 - Simultaneous Injection

5 - Simultaneous Injection

Introduction The Simultaneous Injection feature of the Stellant CT Injection System provides the capability
to program the contrast and saline syringes to move simultaneously. The user can program
various ratios to achieve the desired volumetric delivery of the media. Always refer to the
specific contrast media manufacturer's labeling.

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

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

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

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

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

Upgrading the Injector You must first get a unique feature password key from MEDRAD to upgrade the injector. The
feature password key will only work on the injector for which it was purchased.

NOTE: If your Stellant injector was purchased with the Simultaneous Injection
feature, the unique feature password key was included in the box with
the display unit.

To enable Simultaneous Injection, do the following:

1. Turn the injector on.

2. At the Safety Screen, press "Continue."

3. Press the Setup button.

Setup

5 - 55
Stellant CT Injection System

4. At the Setup Screen, press "Upgrade."

5. At the Upgrade Screen press "Enter New Key."

6. At the Keyboard Screen enter the new password key given to you by MEDRAD.

7. Press "Enter." You will see the Upgrade Screen with your current injector password key
visible and your features will be listed as available.

8. Turn the injector off and then back on. The Simultaneous Injection feature will then be
enabled.

5 - 56
5 - Simultaneous Injection

Protocol Programming Refer to the Stellant CT Injection System Operation Manual for complete instructions on
programming protocols.

To add a phase, select a phase button.

Select phase

Select Ratio Phase from the pick list on the right of the display.

Select Ratio Phase

Select a ratio in the pick list on the right of the display. The first value is the percentage of
contrast and the second value is the percentage of saline.

Ratio pick list

Enter the total flow rate and volume for the phase. These values will be the combined total of
contrast and saline for the ratio phase.

5 - 57
Stellant CT Injection System

For example, at a flow rate of 4.0 ml/sec and a volume of 60 ml, the following would result:

Ratio selected Syringe A Syringe B
A90% B10% 54 ml @ 3.6 ml/sec 6 ml @ 0.4 ml/sec
A80% B20% 48 ml @ 3.2 ml/sec 12 ml @ 0.8 ml/sec
A70% B30% 42 ml @ 2.8 ml/sec 18 ml @ 1.2 ml/sec
A60% B40% 36 ml @ 2.4 ml/sec 24 ml @ 1.6 ml/sec
A50% B50% 30 ml @ 2.0 ml/sec 30 ml @ 2.0 ml/sec
A40% B60% 24 ml @ 1.6 ml/sec 36 ml @ 2.4 ml/sec
A30% B70% 18 ml @ 1.2 ml/sec 42 ml @ 2.8 ml/sec

Stellant calculates the total amount of contrast and saline needed for the programmed protocol.
The auto load feature loads the appropriate amount of contrast and saline. 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.

Changing the ratio once the phase has been programmed requires re-selecting the phase and
choosing the new ratio value.

5 - 58
5 - Simultaneous Injection

Calculating Contrast If you prefer to see only the Programmed Contrast Volume (Syringe A) instead of contrast +
saline in the Programmed Volume section, you must change that option in the Setup Screen.

Total Volume Display

5 - 59
Stellant CT Injection System

5 - 60
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.

Tone Table The DCU and injector head contain speakers to provide audible feedback to the operator. The
table below identifies the different types of feedback.

Tone Name Where Used Tone Type

Armed DCU, Head Long, High pitch, 1 beep

AutoFill Complete Head Short, High pitch, 2 beeps

Critical Error DCU, Head Dual tone (high then low
pitch)

Delay Expired DCU, Head Short, High pitch, 5 beeps

Delay Warn DCU, Head Long, High pitch, 1 beep

Disarm DCU, Head Short, Low pitch, 1 beep

Injection Complete DCU, Head Short, High pitch, 1 beep

Invalid Key DCU, Head Short, Low pitch 1 beep

Invalid Touch DCU Short, Low pitch, 1 beep

Key Press DCU Short, High pitch, 1 beep

Power Up Test DCU, Head Long, High pitch, 1 beep

Warning DCU, Head Short, High pitch, 1 beep

NOTE: In the Critical Error state, the system generates a tone on the head
and DCU, and will not respond to external or internal inputs.

A - 61
Stellant CT Injection System

A - 62
Appendix B - Cleaning and Maintenance

Appendix B - Cleaning and
Maintenance

Cleaning Guidelines Remove the syringe by moving the piston forward and then twisting counterclockwise ¼ turn
and pulling out. Once syringe has been removed, the piston will automatically retract to the
start position unless not configured to do this. Discard all used disposable items. (Syringes
may be removed without retracting the pistons.) It is not necessary to remove the connector
tubing from the syringes when removing and discarding syringes.

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

To clean the Injector Head Unit

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

B - 63
Stellant CT Injection System

To clean the injector head, piston, and 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.

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.

To clean the Display Control Unit:

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

B - 64
Appendix B - Cleaning and Maintenance

Recommended This section contains recommended procedures for maintenance, and an operational checkout
Maintenance Schedule of the MEDRAD Stellant CT Injection System. Routine maintenance and inspection will:

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

Your MEDRAD Stellant CT Injection System must be properly maintained to ensure that it is in
peak operating condition. Your individual maintenance system and schedule depends upon
how your injection system is used, the type of procedures performed, and frequency of use.
The following maintenance schedule is recommended for the system:

Daily:

The piston rod or rods should be thoroughly cleaned after each use or each day. Before use
each day, the system should be cleaned and inspected, using the procedures outlined in this
section. Ensure that all system safety and warning labels are in place and are legible.

Monthly:

Once a month, the entire system should be thoroughly inspected and cleaned, and an
Operational Checkout should be performed.

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 your local MEDRAD office for
complete details.

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 your local MEDRAD office or your 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 repair-
able.
• On-site consulting or consulting references upon request.

B - 65
Stellant CT Injection System

Inspection Procedures The following procedures are recommended for daily inspection of all components in the
MEDRAD Stellant CT Injection System. 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 - 66
Appendix B - Cleaning and Maintenance

Control Room 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.

• Verify that the vertical height adjustment of the column shaft moves freely without binding
or scraping.

Operational Checkout A basic functional checkout of the MEDRAD Stellant CT Injection System should be included
as part of regular maintenance. Verifying proper operation of the injection 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 your 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.

B - 67
Stellant CT Injection System

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.

Dual Syringe System Enter the following protocol:

Flow Rate Volume

Phase 1: Syringe A: 10 ml/s 70 ml

Phase 2: Syringe B: 2.5 ml/s 29 ml

Phase 3: Syringe A: 5.0 ml/s 100 ml

Phase 4: Syringe B: 0.1 ml/s 1 ml

Single Syringe System Enter the following protocol:

Flow Rate Volume

Phase 1: Syringe A: 10 ml/s 70 ml

Phase 2: Syringe A: 2.5 ml/s 29 ml

Phase 3: Syringe A: 5.0 ml/s 100 ml

Phase 4: Syringe A: 0.1 ml/s 1 ml

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.

B - 68
Appendix B - Cleaning and Maintenance

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.

B - 69
Stellant CT Injection System

B - 70
Appendix C - Specifications

Appendix C - Specifications

DCU and Base Unit
DCU BASE UNIT

31.9 CM 8.6 CM
12.5" 3.4"

34.3 CM
13.5" 29.2 CM
11.5"

27.9 CM 22.5 CM
11.0" 8.9"

Base Unit Dimensions

Height: 29.2 cm / 11.5"
Width: 27.94 cm / 11"
Depth: 22.2cm / 8.8"
Weight: 13.6 lbs. (+/- 1 lb.) / 6.17 kg

DCU Weights

Display and stand 8.2 lbs. (+/- 0.77 lbs) / 3.71 kg
Back of Monitor

HAND SWITCH
CONNECTION

BASE INTERFACE CABLE
CONNECTOR

BRIGHTNESS
KEYS

C - 71
Stellant CT Injection System

Rear of Base Unit

EQUIPOTENTIAL POWER CLAMP FOR
CONNECTOR CONNECTOR HEAD CABLE

Bottom of Base Unit

SERVICE FUTURE DISPLAY HEAD
CONNECTOR USE CONNECTOR CONNECTOR

C - 72
Appendix C - Specifications

50.5 cm
20.2" 90.2 cm
35.8 cm 35.5"
19.1"

28.6 cm
11.2"

152.4 cm
60"

68.6 cm
27"

Injector Head Dimensions

Dual Single

Weight 17.9 lbs / 8.11 kg 11.9 lbs / 5.39 kg

Length 14.5" / 36.83 cm 14.5" / 36.83 cm

Width 12.1" / 30.73 cm 8.7" / 22.09 cm

Depth (height) 6.1" / 15.49 cm 6.3" / 16.00 cm

C - 73
Stellant CT Injection System

85.1 cm
33.5"

51.3 cm
20.2"

35.9 cm
14.1"

180.3 cm 28.6 cm
71.0" 11.3

69.3 cm
27.3"

51.4 cm
20.2"
90.2 cm
36.8 cm 30.5"
14.5"

28.6 cm
11.3"

180.3 cm
71.9"

69.3 cm
27.3"

C - 74
Appendix C - Specifications

87.1 cm
34.3"

50.5 cm
20.2"

36.0 cm
14.2"

28.6 cm
180.9 cm
11.3"
71.2"

69.3 cm
27.3"

C - 75
Stellant CT Injection System

Environmental Non-Operating: (Transportation and Storage)
Specifications
Temperature: -25o C to 70o C (-40o F to +158o F)

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

Air Pressure: 48 kPa to 110 kPa

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

Temperature: +10o C to + 40o C (+50o F to +104o F)

Humidity: 20% to 90% R.H.

Air Pressure: 69 kPa to 110 kPa

AC Adapters for Informatics and VirtualCARE Systems
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

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:

Earth and Chassis Leakage Current:

< 300 microamps (NC)

Chassis (Touch) Current:

< 100 microamps (NC)

Patient Connection Leakage Current:

< 100 microamps (NC)

C - 76
Appendix C - Specifications

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

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 MEDRAD Stellant CT Injection 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:

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 200 ml syringe Pressure Limit selections (PSI /
syringe (PSI / kPa): 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 - 77
Stellant CT Injection System

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.

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 using MEDRAD Disposables
18 Gauge cather-over-needle (BD PN 381144)

• Ultravist 300 (Preheated to 35oC +/- 5oC) 8.5 ml/s
• UltraVist 370 (Preheated to 35oC +/- 5oC) 8.5 ml/s
• Saline 8.5 ml/s

20 Gauge cather-over-needle (BD PN 381134)

• Ultravist 300 (Preheated to 35oC +/- 5oC) 7 ml/s
• UltraVist 370 (Preheated to 35oC +/- 5oC 7 ml/s
• Saline 7.0 ml/s

22 Gauge cather-over-needle (BD PN 381123)

• Ultravist 300 (Preheated to 35oC +/- 5oC) 6 ml/s
• UltraVist 370 (Preheated to 35oC +/- 5oC) 5 ml/s
• Saline 6.0 ml/s

C - 78
Appendix D - Options and Accessories

Appendix D - Options and
Accessories
Catalog Numbers and
Descriptions
Catalog No. Description
EDW 700 Display Control Unit Wall Mounting System
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
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 700 Height Adjustable Pedestal
Display Control Cables:
SDC 700 5 5 ft. (1.52 m) cable
SDC 700 25 25 ft. (7.6 m) cable
Dual head: Syringe heater for 200 ml syringe
SSH 200
Single head:
SSH 200F
Dual head: SHS Remote coiled start switch, (5’ length). Plugs into head control unit,
700 05 and/or Display Control Unit
Single head: SHS
700 05F
SSM 700 1 Service Manual

D - 79
Stellant CT Injection System

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

Systems available:

Straight IV Track (STS 100)

Item Description Part Number QTY

3.5 feet / 107 cm long track 1

End Stop with screws 3008428 2

Four wheel heavy duty trolley 3008429 1

22" / 55.88 cm long Atlas IV Hanger with 2 3008430 1
hooks

Apex Swivel clip 3008725 2

"U" Shaped Track (STS 200)

Item Description Part Number QTY

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

End Stop with screws 3008428 2

Four wheel heavy duty trolley 3008429 1

22" / 55.99 cm) long Atlas IV Hanger with 3008430 1
2 hooks

Apex Swivel clip 3008725 7

IV Hanger Extensions:

6”/ 15.24 cm STS 306
12" / 30.48 cm STS 312
18"/ 45.72 cm STS 318
24" / 60.96 cm STS 324
30" / 76.2 cm STS 330
36" / 91.44 cm STS 336

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.
>23 kg
>50lbs.

D - 80
Appendix D - Options and Accessories

Stellant Adjustable The Stellant Adjustable Height Pedestal is intended to be used to support a Stellant Injector
Height Pedestal (SHP Head in a CT scanner room. DO NOT attempt to use the device for any other purposes.
700)

Warnings 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.

Do not move or manipulate the injector mount by pulling or pushing the contrast holder. Using
the holder in this manner to position or move the injector head mount may cause the holder to
bend or create an imbalance of the system resulting in property damage and/or serious injury.
Move the mount with attached contrast holder as recommended by the injector Operator
Manual.

Do not adjust or transport the contrast holder with contrast containers attached. The
containers, pedestal/holder may fall causing patient injury and/or property damage. Attach
containers only after the mount/holder are in a stationary position.

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.

The folding hooks are intended to hold a maximum volume of fluid (see the table below.) Do not
exceed this weight or volume. Adding additional weight/volume to the hooks may lead to
instability, premature device failure, and eventual container breakage leading to the potential
for personal injury and/or property damage.
Maximum Load Volumes

Hook 1 Hook 2

500 ml bottle of contrast 500 ml bottle of contrast

OR

500 ml bottle of contrast 1,000 ml bottle of saline

Cautions Use extreme care in retracing and raising the contrast holder. The pole should extend and
retract easily without force. If retraction or raising becomes difficult, clean the holder as
described below.

D - 81
Stellant CT Injection System

Pedestal Cleaning Clean the pedestal and contrast holder with warm water and mild detergent (such as
dishwashing liquid) to remove contrast media, buildup, etc. from the holder and tray.
Chemicals typically used in a medical environment may be too harsh causing material
degradation.
Pedestal Inspection Periodically inspect the pedestal for loose or damaged components. Tighten or repair as
necessary.
Pedestal Operation 1. To extend holder assembly, turn adjustment knob counter-clockwise to loosen, then raise
Instructions the top of the holder assembly to the desired height.

2. Lock the holder by turning the adjustment knob clockwise until tight. Do not over-tighten.

3. To hang contrast container, invert container and attach to hook (see warning above on
maximum load volumes).

4. To store: turn the adjustment knob counter-clockwise and retract the top assembly.

D - 82
Appendix E - System Installation

Appendix E - System Installation

Unpacking the The master shipper carton for the Stellant CT Injection System contains three cartons. The
Injection System 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.

Accessories Box
Accessories (Open second) Optional Accessories
Operation Manual Service Manual
Disposables Kit Schematic Manual
Head Extension Cable Language Kit
Display Base Cable Syringe Adapter (Japan
Heat Maintainer(s) only)
Hand Switch
Power Cord

Head Box (open third)

DCU Box (Open fourth)

NOTE: The following items are shipped in a separate carton: OCS, AHP, and
Ceiling Track.

E - 83
Stellant CT Injection System

Installation Below is a typical installation of the injection system in a CT suite.
Considerations

E - 84
Appendix E - System Installation

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

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

J244/J246
J234

CONNECTOR

BACK OF BASE BACK OF DCU HAND SWITCH

POWER CORD DISPLAY BASE CABLE

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
Stellant power cord into an extension cord or multi-outlet power strip.

E - 85
Stellant CT Injection System

Wall Mount Installation
Before attaching the bracket to the wall,
the installer must know if the wall studs in
the room are made of metal or wood. This
will determine the kind of hardware which
will be required to complete the
installation.

Caution: The bracket must be mounted to a stud to insure a secure mount.
Wallboard and wing anchors will not support the weight and movement created by
swinging the Display Control Unit into position during routine use.

NOTE: If the wallboard is thicker than 5/8 inch, longer screws must be
purchased to insure a secure mount.

1. Holding the bracket so that the friction plates are on the bottom, position the wall bracket
on the wall where it is to be installed. The bracket must be mounted to a stud to insure a
secure mount. While holding the bracket to the wall, mark the wall where the mounting
holes need to be drilled.

2. Drill a 5/32 inch by 2 inch deep hole through the wall and into the stud (3/8 inch hole if
there is a metal stud).

3. On metal studs only: place the hollow wall anchors into the holes drilled.

4. Place the wall bracket onto the wall and secure with the fasteners provided (#12 x 2"
screws for wood studs, #10-24 x 2 1/2" screws for metal studs.)

5. After the bracket is mounted, place the Display Control Unit onto the plate an secure the
'Display Control Unit to the bracket with the #8 - 32 x 3/8 screws provided.

E - 86
Appendix E - System Installation

To swing the Display Control Unit from side to side, push up on the bottom of the Display
Control Unit. While in this position, the bracket and DCU will swing from side to side.

After the Display Control Unit is positioned, allow the DCU to drop down to lock into position. A
light tap on the top of the Display Control Unit will insure a lock condition.

Caution: DO NOT hang items on the Display Control Unit or mounting bracket. The
mounting bracket is made to support the Display Control Unit. Hanging items on
either the Display Control Unit or the mounting bracket can loosen the bracket from
the wall.

Caution: DO NOT oil the friction plates on the mounting bracket. The friction plates
must remain tight so that the Display Control Unit does not move when buttons are
pushed during programming. Lubrication will deteriorate the locking ability of the
bracket.

E - 87
Stellant CT Injection System

E - 88
INDEX

Index F
Fill A, 2-19
Fill B, 2-19
A Flow profile, 4-47
Abort, 1-4, 2-12 Flow Rate, 1-5
About the Injection System, 2-11 Fluid Dispensing Device, 3-27
Alternating Current, 1-3 FluiDots, 3-28
Applying Power, 2-20
Arming, 4-43 H
Audio Level, 2-24 Handswitch connection, 1-3
Auto Advance, 2-24 Handswitch, 2-12
Auto Retract, 2-24 Hazardous Voltage, 1-3
Auto-advance, 3-31 Heat Maintainer, 2-20
Auto-docking, 3-31 Help, 1-4, 2-12, 2-25
Automatic retraction, 3-31 Hold, 1-4, 2-12

B I
Base Unit, 2-12 Inject Delay, 3-40
Basic Features, 2-11 Injecting, 4-45
Brightness Controls, 1-4, 2-12 Injection Complete, 4-48
Injection Display Mode, 2-24
C Injection monitoring, 1-7
Calculating Contrast, 5-59 Injector Duration, 1-5
Calibration, 2-24 Insufficient volume, 1-7
Cautions, 1-10 Integral Autoload, 3-34
Certifications, 1-1, A-61 Intended Use, 1-1
Check For Air, 1-3 IPX1, 1-3
Class One, 1-3
Cleaning, B-63 L
Contraindications, 1-1 Language, 2-24
Contrast Indicator, 1-3 Loading and Priming a Syringe, 3-31
Contrast indicator, 1-3 Locking a protocol, 3-38

D M
Date / Time, 2-24 Main Screen, 2-21
Date/Time, 2-24 Maintenance, B-65
Disclaimers, 1-1 Manual Knob, 2-14
Display Control Unit, 2-12 Manual Loading a syringe, 3-32
Dual Syringe System, 2-11 Minimizing Air Embolization Risks, 3-27, 5-
Dual, 2-16 55
Minimizing Extravasation, 3-29
E
Earth Ground, 1-3 N
Elapsed time, 4-47, 4-48 Non-rotational orientation, 3-31
Equipotential, 1-3
Error Screen, A-61

I - 89
Stellant CT Injection System

O T
On/Off switch, 1-3 Test Inject Rate, 2-24
Operational Checkout, B-67 Test Inject Source, 2-24
Over and under volume, 1-7 Test Injection, 4-53, 4-54
Overhead IV Track System, 1-4 Total Volume Display, 2-24
Touch Screen Calibration, 2-22
P Trademarks, 1-1
Pause, 1-5, C-77 Type BF, 1-3
Power Button, 2-12
Pressure graph, 4-49, 4-50 U
Pressure Limit Condition, 1-6 Upgrading the injector, 5-55
Pressure Limit Programming, 3-41
Pressure Safety Limit, 1-5 V
Pressure Units, 2-24 Volume and Rate Protection, 1-7
Pressure, 1-5
Priming Source, 2-24 W
Priming Tube, 3-30 Warnings, 1-8, D-81
Programming, 3-37
Protocol Lock indicator, 1-3
PSI, 4-50

R
Ratio Phase, 5-57
Recalling a protocol, 3-39
Removing a Syringe, 3-36
Reset, 1-4, 2-12, 2-25
Response to Occlusions, 1-7
Restricted Sale, 1-1
Reverse, 1-3

S
Safety Screen, 2-20
Saline, 1-3
Scan Delay, 3-40, 4-45
Setup, 1-4, 2-12, 2-23
Signals and Descriptions, 4-51
Simultaneous Injection, 5-55
Single Syringe System, 2-11
Start/Hold, 1-4, 2-12
Stellant Connector Tubing, 3-30
Stellant Models, 2-11
Storing a protocol, 3-38
Symbols, 1-3
System Logo, 2-20

I - 90