Stellant CT Injection System

Transcription

1 Stellant CT Injection System Rev. J

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3 Stellant CT Injection System Operation Manual 2009, 2012, 2013 MEDRAD, INC. All rights reserved. Reproduction of this manual is strictly prohibited without express written consent of MEDRAD, INC. For more information about MEDRAD products and services, please visit 3

4 Stellant CT Injection System 4

5 Table of Contents Table of Contents 1 - Introduction Certifications Intended Use Contraindications Restricted Sale Required Training Trademarks Disclaimers The Equipotential Connector (EPC) MEDRAD Contact Information Symbols Display Buttons and Icons Injector Head Icons Pressure Limit Pressure Flow Rate Injector Duration The Basics How the Injector is Designed How to Recognize if a Pressure Limit Condition Occurs Response to Occlusions Volume and Rate Protection Definition of Terms Warnings Cautions System Basics About the Injection System Moving the System Within the Room Stellant Models Basic Features Display Control Unit (DCU) Single Stellant Injector (S and SX) Single Stellant Injector Head Overlays Dual Stellant Injector (D) D model Injector head overlay Injector Head Control Manual Knob Arm Lights Hand Switch Heat Maintainer Applying Power System Logo Safety Screen Main Screen Procedure Data i

6 Stellant CT Injection System Patient ID Contrast Concentration Pressure Limit Delay Iodine Summary Setup Date/Time Help Reset Preparing to Inject Minimizing Air Embolization Risks Using the Stellant Pedestal with Integrated IV Pole Stellant Connector Tubing Loading and Priming a Syringe Priming Mode Selection Priming Volume - LPCT Type Manual Loading and Priming a Syringe Cautions for Draw Back Using Auto Load to Load a Syringe (SX and D Models) Select an Auto Load Purge Volume Using Auto Load With a Spike or QFT Removing a 200 ml Syringe Programming Protocols Programming Multiple Phases Storing a Protocol Locking a Protocol Recalling a Protocol Deleting a Protocol Programming a Delay Arming and Injecting Arming Before Beginning the Arming Process Beginning the Arming and Injecting Process Test Injection Configuring Test Inject Parameters Performing a Test Injection Injecting Performing a Injection Injecting Views Pressure Graph Pressure Graph Helpful Hints Injection Complete Appendix A - System Messages...A-43 Error Screen...A-43 System Tones...A-43 General Tones...A-43 Notification Tones...A-43 ii

7 Table of Contents Appendix B - Cleaning and Maintenance...B-45 Cleaning Guidelines...B-45 Cleaning the Injector Head, Piston and Syringe Interface...B-45 Cleaning the Display Control Unit...B-46 Cleaning the Pedestal...B-46 Cleaning the Base...B-46 Recommended Maintenance Schedule...B-46 Daily...B-46 Monthly...B-46 Annually...B-46 Inspection Procedures...B-47 Injector Head (Single and Dual)...B-47 Display Control Unit...B-47 Wall Bracket...B-47 Pedestal...B-48 Operational Checkout...B-48 System Labels...B-48 Power Up...B-48 Programming...B-48 Touch Screen Calibration...B-49 Appendix C - Specifications...C-51 DCU and Base Unit...C-51 DCU and Base Unit Dimensions...C-51 Rear of Display...C-51 Rear of Base Unit...C-52 Bottom of Base Unit...C-52 Scan Room Unit...C-53 Scan Room Unit Dimensions - Single...C-53 Scan Room Unit Dimensions - Dual...C-53 Environmental Specifications...C-54 Non-Operating: (Transportation and Storage)...C-54 Operating...C-54 AC Adapters for Informatics and VirtualCARE Systems)...C-54 Protection Against Electrical Shock...C-54 EMI/RFI...C-54 Electrical Leakage...C-54 Ground Continuity:...C-54 Protection Against the Ingress of Fluids...C-55 Mode of Operation...C-55 Fluid Delivery Performance...C-55 System Response to Occlusions...C-55 Over and Under Infusion Protection...C-55 System Fluid Performance...C-56 Appendix D - Options and Accessories...D-57 Catalog Numbers and Descriptions...D-57 Overhead IV Track System...D-58 Appendix E - System Installation...E-59 iii

8 Stellant CT Injection System Unpacking the Injection System...E-59 Installation Considerations...E-60 Injector Installation...E-60 Reinstalling the System in Another Room...E-61 Appendix F Compliance to IEC / nd Edition...F-63 Index... I-67 iv

9 1 - Introduction 1 - Introduction This manual applies to the MEDRAD Stellant CT Injection System, also referred to as the System, Catalog Numbers: SCT 110, 111, SCT 112, SCT 120, SCT 121, SCT 122, SCT 210, SCT 211, SCT 212. Read all the information contained in this manual. Understanding this information will assist the user in operating the the System in a safe manner. Operating specifications and feature availability may vary by country. Check with local product representative and country-specific operating instructions. Certifications This device is equipped to operate at VAC, 50/60 Hz, 180 VA (Single), 300 VA (Dual), and is designed to comply with EN /IEC Second/Third Edition, and EN Second Edition and IEC Second/Third Edition Standards. Special precautions regarding ElectroMagnetic Compatibility (EMC), are required for installation and use of this injector system. Detailed EMC information can be found in Appendix F Compliance to IEC / nd Edition on page 63. Intended Use The Stellant CT Injection System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications. Contraindications These devices are not to be used for drug infusion, chemotherapy, or any other use for which the devices are not indicated. The Stellant CT Injection System is not intended for portable use. Restricted Sale Federal (USA) law restricts these devices to sale by or on the order of a physician. Required Training This device is intended to be used by individuals with adequate training and experience in diagnostic image studies. Trademarks MEDRAD, FluiDots, and Stellant are trademarks of MEDRAD, INC. Other trademarks which appear in this manual are the property of their respective companies. 1-1

10 Stellant CT Injection System 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 Second/Third Edition. Furthermore, all configurations shall comply with system standard EN /IEC 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 To obtain on-site consulting or consulting references, contact MEDRAD Service. The Equipotential Connector (EPC) The Equipotential Connector (EPC) is an electrically bonded terminal on the injector that is used as a connection point between other medical electrical equipment. The EPC s function is to minimize any voltage potentials differences between all connected equipment. The EPC is not designed to be an electrical safety ground. MEDRAD Contact Information MEDRAD, INC. USA One Medrad Drive Indianola, Pa U.S.A. Phone: Fax: MEDRAD Europe B.V. P.O. Box AE Beek The Netherlands Phone: +31(0) FAX: +31(0) Nihon MEDRAD KK 2-4-9, Umeda, Kita-ku, Osaka, Japan Phone: +81(0) Fax: +81(0) Symbols The following symbols are used on the System and components.: Indicates that this device conforms to the requirements of the European Medical Device Directive 93/42/EEC. Protocol is locked indicator. Protocol is unlocked or unengaged. Attention, consult accompanying instructions. Indicates on/off switch. Indicates hazardous voltages. Indicates alternating current. Identifies a type BF applied part complying with IEC standards. CLASS 1 Indicates the injection system is Class 1 medical equipment as defined by IEC standards. 1-2

11 1 - Introduction Identifies the degree of protection against fluid as drip proof. Identifies the Equipotential connection. Identifies the Earth Ground point. Indicates design for indoor use only. Indicates the presence of no serviceable parts. Pressure Graph View. Phase View. Electrostatic. Indicates separate collection for Electrical and Electronic Equipment per Directive 2002/96/ EC. Refer to the following website for additional information: 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. Display Buttons and Icons Terminates the injection and disarms the System. Launches the help system. Initiates the injection. Holds the injection for a maximum of 20 minutes. Resets the protocol to the factory default values. Accesses the system settings. Indicates on/off switch. Increases or decreases display brightness Hand switch connection. 1-3

12 Stellant CT Injection System Injector Head Icons 1 Activates the Fill buttons. 2 Fill Buttons. Syringe A (green) Syringe B (blue) 3 Adjusts Auto fill volume to the desired amount in small increments/ decrements. 4 Activates Auto Prime. 5 Activates the forward and reverse piston controls. Illuminates when pressed. 6 Forward and Reverse Piston Controls. 7 The Check for Air icon; illuminates after the operator has confirmed inspecting the fluid path for air. 8 Indicates the protocol is locked; illuminates after the operator has locked the protocol. 9 Arms the injector; illuminates after the 10 Terminates and disarms injection. operator has armed the injector. 11 Initiates the injection. Holds the injection for a maximum of 20 minutes. Heat Maintainer connection on underside of Injector Head. Manual knob indicators: Syringe A (green) Syringe B (blue) Hand switch connection on underside of Injector Head. 1-4

13 1 - Introduction Pressure Limit The System is designed to allow varied flow rates for contrast injections. In order to understand this section on Pressure and Pressure Limiting, it is important to clarify the terminology that will be used in this section. Pressure Pressure is related to the amount of force which the injector head must develop in the syringe in order to move fluid at the selected Flow Rate. Pressure developed by the System is measured relative to the atmosphere pressure outside of the syringe or connector tubing. The pressure developed by the injector is expressed in terms of Gauge Pressure or PSIG which is the Absolute Pressure or PSIA minus the atmospheric pressure. Hereafter, pressure displayed as PSI refers to gauge pressure. 200 ml syringe Programmable Pressure Limit (Selectable Range: 50 psi psi (325 kpa kpa) Hazard/failure limit (injector shut-down pressure in the event of a failure). Factory preset to 325 PSI (2241 kpa) Factory preset to 375 PSI (2586 kpa) 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. 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. 1-5

14 Stellant CT Injection System How the Injector is Designed The System is a flow-controlled system. This means that the flow that is selected on the display control console is the flow rate at which the injector will deliver contrast for the duration of the injection. The only time the actual flow rate will differ from the programmed flow rate is when the flow rate cannot be delivered through the selected disposables with the amount of pressure available. When this occurs, the injector will automatically limit the maximum pressure and the resultant (lower) flow rate will be delivered. The injector still injects and delivers the total volume. However, the delivered flow rate will be lower, and thus, the injection duration will be longer. How to Recognize if a Pressure Limit Condition Occurs If a pressure limit condition occurs, it will first be evidenced by injection durations that are greater than what would normally be expected, and also by low-contrast films. A pressure limit condition can also be seen by observing the Pressure Graph. Therefore, if the enhancement on the images is not as desired, this could mean a lower flow rate was delivered than selected, and pressure limiting may be occurring. Check for a pressure limit condition by comparing the actual injection duration with a calculated value (volume divided by flow rate). If the actual duration exceeds the calculated value, pressure limiting may have occurred. To achieve the selected flow rate (avoid a pressure limit condition), consider increasing the catheter size or use a less viscous or heated contrast media. Response to Occlusions When injecting into an occlusion, a stall condition (flow rate less than 10% of programmed rate) or a very high pressure, a disarm will result. A stall condition lasting more than five seconds will result in the injection being automatically terminated. If a stall or high pressure disarm occurs, check the fluid path for blockage and inspect the disposable set for damage. If no blockage is found consider increasing the catheter size or decreasing the flow rate. Recheck the fluid path for air before arming. Volume and Rate Protection The following means are provided to protect against over and under volume or rate conditions: Warnings displayed on the Safety screen remind the operator to check the programmed injection parameters prior to the system being armed. An on-screen indication of insufficient volume is provided whenever the total volume programmed to be delivered is greater than the amount of fluid in the syringe. Injection monitoring is performed to detect over rate or over volume conditions due to system faults. If either of these conditions is detected, the injection will be stopped. Definition of Terms WARNING: Indicates that the information is a warning. Warnings advise of circumstances that could result in injury or death to the patient or operator. Read and understand the warnings before operating the System. CAUTION: Indicates that the information is a caution. Cautions advise of circumstances that could result in damage to the device. Read and understand the cautions before operating the System. Indicates that the information that follows is additional important information or a tip that will help the user to recover from an error or point to related information within the manual. 1-6

15 1 - Introduction Warnings WARNING: Only use the power cord supplied with the system. Do not plug the System power cord into an extension cord or multi-outlet power strip. WARNING: Patient injury could result from a system malfunction. If a system malfunction occurs, immediately remove unit power by pressing the power switch and disconnect the unit from the patient. If a fault message is displayed that cannot be corrected, and/or the system is not operating correctly, do not use the injection system. Call MEDRAD or a local dealer for assistance. WARNING: Patient injury could result from leaks or ruptures during an injection. To prevent leaks or ruptures in the event of a blockage, use only MEDRAD disposable products, or use catheters and connectors with pressure ratings compatible with this system. WARNING: Explosion hazard: Patient injury could result from using the injection system in the presence of flammables (such as anesthetics). Do not use the system when flammables are present. Do not use in the presence of oxygen or in oxygen enriched atmospheres. WARNING: Fire hazard: Patient injury could result from using incorrect fuses. To avoid an electrical fire, assure the correct type of fuse is used for replacement. The fuse must be replaced with Type T, 250 V, 3.15 A fuse by qualified personnel only. WARNING: Equipment must only be connected to a supply mains with protective earth. WARNING: Shock hazard: Patient injury could result from worn cabling or unit disassembly. To avoid exposure to potentially hazardous voltages, do not disassemble the injection system in any way. Worn cabling also creates hazards. If any worn or damaged cables are detected, do not use the injection system. Contact MEDRAD or a local dealer for service or replacement. WARNING: Patient injury could result from potentially hazardous system electronic assembly material. Dispose of system components or accessories properly. Follow local regulations for proper disposal or contact MEDRAD Service for assistance. WARNING: Patient injury could result from using improper accessories. Use only accessories and options provided by MEDRAD designed for this system. WARNING: Patient injury could result if the syringe is not properly engaged. Ensure the syringe is properly snapped into the front of the injector head before injecting. Improper engagement may cause the syringe to leak, become damaged, or to come off during the injection and result in an under-volume delivery. WARNING: Biological contamination could result from reusing disposable items or failure to follow aseptic technique. Properly discard disposable items after use, or if there is any possibility that contamination may have occurred. WARNING: Syringe sterility will be compromised, and patient infection may result, if the plunger is removed from the syringe. Do not remove the plunger to fill the syringe. WARNING: Bacterial contamination could occur if syringes are used as storage containers. Do not use syringes to store fluids. WARNING: Patient or operator injury could result if the sterile disposable package is opened or damaged, or if damaged components are used. Visually inspect contents and package before each use. 1-7

16 Stellant CT Injection System WARNING: Patient injury could result from high flow rate venous injections. Use extreme care when selecting the flow rate. Before arming the injector, verify that high flow rate injection parameters are correct. WARNING: Patient injury or death could result from an air embolism. Expel all trapped air from the syringe(s), connectors, tubing, and catheter-over-needle before connecting the system to the patient. Carefully read the instructions for loading and the use of FluiDot indicators (where applicable) to reduce the chance of air embolism. The presence of rounded FluiDots indicators do not indicate the total absence of air bubbles in the syringe tip. FluiDots indicators must be viewed in a properly illuminated environment, with a light source behind the operator providing enough light to permit easy viewing. To minimize air embolization risks, ensure that one operator is designated the responsibility of filling the syringe(s). Do not change operators during the procedure. If an operator change must occur, ensure that the new operator verifies that the fluid path is purged of air. To minimize the possibility of inadvertent aspiration and injection, ensure the patient is disconnected from the injector when utilizing the forward and reverse piston controls. WARNING: Patient or operator injury may result if damaged components are used. Do not use damaged components. Visually inspect all components before use. WARNING: Failure to use the proper start switches and syringe heaters could result in Electro Magnetic Emissions not meeting specification. Cautions CAUTION: Condensation may cause electrical damage to the injection system. Do not use the system immediately after it has been brought indoors from extreme outside temperatures. Allow the system to stabilize at room temperature before use. CAUTION: Damage can occur as a result of incorrect voltage. Verify that the voltage and frequency marked on the serial tag on the back of the unit matches the voltage and frequency of the electrical outlet. CAUTION: Do not touch the screen with a sharp object in order to perform the calibration. CAUTION: System malfunction may be caused by failure to perform regular maintenance. Regular preventive maintenance is recommended to ensure that the system stays calibrated and functions properly. Refer to this manual or contact MEDRAD for additional information. CAUTION: Do not expose system components to excessive amounts of water or cleaning solutions. Wipe components with a soft cloth or paper towel dampened with cleaning solution. CAUTION: Do not use strong cleaning agents and solvents. Warm water and a mild disinfectant are all that are required to clean the injector. Do not use strong industrial cleaning solvents such as acetone. CAUTION: Do not spray cleaning solutions directly onto the touch screen. To prevent damage, wipe the touch screen with a soft non-abrasive cloth or paper towel dampened with water soluble cleaning solution. 1-8

17 1 - Introduction CAUTION: Improper or careless cleaning methods may result in equipment damage. Do not soak or immerse any part of the injection system in water. While cleaning any outside portion of the system, avoid allowing any water to leak inside system components. CAUTION: Component damage may occur if not installed properly. Ensure all connections are secure; do not overtighten. This will help minimize leaks, disconnection, and component damage. CAUTION: Injector may disarm or fail to operate upon exposure to high electromagnetic fields that may be generated by radio transmitters or cellular phones, or upon exposure to high levels of electrostatic discharge. Additional warnings, cautions and notes are located throughout this manual, where applicable. 1-9

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19 2 - System Basics 2 - System Basics About the Injection System The Stellant CT Injection System is comprised of the injector head located in the scanning room and a touch screen Display Control Unit (DCU) and Base unit, which is typically located in the control room. The three components are connected by a communications link. Moving the System Within the Room When moving the System, hold the pedestal below the point indicated by the label on the pedestal arm. If the pedestal does not contain this label, hold the pedestal no higher than 36 inches above the floor. Stellant Models Basic Features Model Description S SX D Single Syringe System without Auto Load and Prime Single Syringe System Full featured Dual Syringe System Full featured Catalog Number The basic foundation features of all Models include: SCT 110 (no injector head mount) SCT 111 (includes a floor-mounted injector head mount) SCT 112 (includes an overhead counterpoise ceiling head mount) SCT 120 (no injector head mount) SCT 121 (includes a floor-mounted injector head mount) SCT 122 (includes an overhead counterpoise ceiling head mount) SCT 210 (no injector head mount) SCT 211(includes a floor-mounted injector head mount) SCT 212 (includes an overhead counterpoise ceiling head mount) DualFlow SCT 220 (no injector head mount) SCT 221 (includes a floor-mounted injector head mount) SCT 222 (includes an overhead counterpoise ceiling head mount) Stellant 200 ml syringe Pressure graph (not in S model) Auto dock, Auto advance, and Auto retract (not in S model) Choice of Pedestal or Overhead Counterpoise System (OCS) Prime (not in S model) Elapsed injection time indicator Configuration Screen Remote Check For Air Protocol Lock Remote Start Scan delay Test Inject Store and recall of protocols Selectable Pressure Limit Remote arming Duration by phase 2-11

20 Stellant CT Injection System Display Control Unit (DCU) The Display Control Unit (DCU) and Base Unit: Handswitch Display Control Unit Base Unit Power Button Brightness Controls Abort Setup Help Reset Start/Hold The DCU interface is designed as a color touch screen display. Name Start/Hold Abort Reset Setup Help Brightness Up Brightness Down Power Button Description Toggles between starting and holding the execution of an injection protocol. Stops injector head motion. Resets the injection protocol to default values. Switches screen to Setup screen. Switches screen to Help screen. Increases the display brightness. Decreases the display brightness. Turns unit on and off. 2-12

21 2 - System Basics Single Stellant Injector (S and SX) Single Stellant Injectors Models: Single Stellant Injector Head Overlays S MODEL OVERLAY SX MODEL OVERLAY 2-13

22 Stellant CT Injection System Dual Stellant Injector (D) D model Injector head overlay 2-14

23 2 - System Basics Injector Head Control The single syringe model includes only the controls and connections for a single syringe. Name Description A Syringe A (All Models) Contrast Syringe B Syringe B (DX Model) Saline Syringe 1 Heat Maintainer (Side A or B) See Heat Maintainer on page 17 for more information. 2 Volume (Side A or B) Syringe Installed - Indicates the volume loaded in the syringe. Auto Load Active - Indicates the volume to be loaded into the syringe. Syringe not Present - No indicator. 2-15

24 Stellant CT Injection System 3 Auto Load (Not Activates the Fill A, Fill B, and the +/- buttons. Available in S Model) 4 Fill A (all Models) Fills Syringe A to the displayed volume. 5 Fill B (D Model) Fills Syringe B to the displayed volume. 6 +/- (Side A or Side B) 7 Prime (Not Available in S Model) Manual Knob Name Adjusts the Auto-fill volume to the nearest multiple of 5 ml, and then in increments/decrements of 5 ml. Activates the tube priming function. 8 Move Piston Activates the forward and reverse piston controls. Times out after ten seconds of inactivity. 9 Piston Control Advances and retracts the piston (variable speed). (Side A or B) 10 Check for Air Reminds user to verify that air is purged from the syringe and tubing. (Must be lit to enable arming.) 11 Protocol Lock Indicates the protocol lock on Display is enabled. (Must be lit to enable arming.) 12 Arm Arms the System. 13 Abort Terminates and disarms the injection. 14 Start/Hold Initiates injection. Holds injection for a maximum of 20 minutes. 15 Arm Lights See Arm Lights on page 17 for more information. 16 Manual Knob (Side A or B) Description Permits an operator to manually move the piston when the injector is not armed. See Manual Knob on page 16 for more information. An operator can use the manual knob to purge air, check backflow of blood, and to assist in ensuring correct catheter placement. For all non-automatic movements, it is critical for volume accuracy to ensure that the manual knob is turned one full turn clockwise after every reverse movement. An operator can adjust the amount of resistance on the manual knob from the Fluid Control option. This feature minimizes the draw-back of air or fluid after automatic piston movement, such as during Autoprime or at end of an injection. A setting of Low or Off increases the likelihood of draw-back during these conditions. The amount of resistance felt as the manual knobs are turned increases as the setting for Manual Knob Fluid Control is increased from LOW to HIGH. The incidence of air or fluid drawback decreases as the setting for Manual Knob Fluid Control is increased from LOW to HIGH. MEDRAD recommends that the HIGH setting be used only if the manual knobs are not typically used. The actual resistance on the manual knob at any setting is injectorspecific and can vary between injectors based on age and condition. 2-16

25 2 - System Basics Arm Lights The injector head has two arm lights that illuminate or flash depending on the following conditions:t Condition Armed Injecting Hold Arm Light Description The light corresponding to the syringe to be used for the protocol flashes. The light corresponding the syringe that is moving remains solid. Syringe A illuminates Green, and Syringe B illuminates Blue. The light corresponding to the syringe to be used for the protocol flashes. Hand Switch The hand switch enables an operator to start, hold, and stop an injection. The switch contains a light that identifies the state of the injector. Hand switch light functions the same if it is connected to the Injector Head or the Pod. The hand switch has a light that illuminates or flash depending on the following conditions: Condition Armed Injecting Hold Arm Light Description The light flashes. The light illuminates. The light flashes. Heat Maintainer The System includes one heat maintainer for each syringe. It is recommended that contrast is stored in a contrast heater at 35 degrees celsius prior to loading it into the syringe. Once it is loaded, the heat maintainer should be snapped over the syringe to maintain the contrast temperature at body temperature. WARNING: Patient injury could result from high contrast temperature. Do not use the syringe heat maintainer if the fault indicator light is illuminated. This may indicate a condition that could result in syringe overheating. Applying Power To apply power to the System, press the switch located on the right lower side of the display control unit (refer to the Display Control Unit section). During powering up a tone will sound at the DCU and head with all indicator lights on the head illuminating. Unless otherwise stated, all screens, controls and explanations described in this section represent the Dual Syringe configuration, with all operator configurable features activated. 2-17

26 Stellant CT Injection System System Logo When power is applied to the system, the System Logo screen appears on the display, and a series of self-diagnostic tests are performed. Safety Screen The Safety screen provides information about safe operation of the injector and potential hazards associated with an injection procedure. Main Screen The Main screen appears after the Safety screen. All other screens used during normal injector operation are accessed from the Main screen. The Main screen is used during injection protocol programming, arming, and injecting. Different screen controls are visible based on the operation currently being performed, the operator-selected screen configuration, and the factory set configuration. See Setup on page 22 for a list of operator configurable screen elements. Dual Injector Main screen, Single Injector Main screen, The Main screen that appears at start-up is the most recently programmed screen. 2-18

27 2 - System Basics Procedure Data The Procedure Data feature enhances the functionality of the Stellant injector by allowing the operator to optionally enter and display additional procedure-related information for each injection. This feature displays a panel titled Procedure Data on the Main screen with information regarding Patient Identification number (Patient ID), Contrast Concentration, Iodine Summary, Pressure Limit, and Delay settings for the procedure. The EDIT button is used to enter or modify information displayed in the Procedure Data panel Procedure Data Feature If P3T (Personalized Patient Protocol Technology) applications are activated on the injector, the P3T button will appear on the Procedure Data panel. Patient ID A patient identification number may be entered for each procedure by selecting PATIENT ID in the Procedure Data screen. An alpha-numeric keypad allows the operator to enter a value up to 20 characters to uniquely identify the procedure. Selecting Patient ID Entering Patient ID Contrast Concentration The concentration of iodinated contrast used for each procedure is entered by selecting CONCENTRATION in the Procedure Data screen and then selecting a value from the pick list. The CLEAR option resets the contrast concentration to a null value. The OTHER option allows the operator to enter a concentration value that is not available in the pick list. 2-19

28 Stellant CT Injection System If the OTHER option is selected, a numeric keypad appears indicating that a contrast value between mg/ml can be entered. This range is provided to allow entry of new contrast drug products that may be available in the future. The operator can enter a concentration value and save the value using the ENTER button. Selecting Concentration Concentration Entry Using OTHER Button Pressure Limit Pressure Limit programming is performed by selecting PRESSURE LIMIT in the Procedure Data screen and then selecting a value from the pick list. The pressure limit can be programmed between 50 and 325 PSI. The pressure limit values available depend on the type of syringes being used and may be different when a Stellant Pre-Filled Adapter is used. Main Screen with Procedure Data Feature 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. 2-20

29 2 - System Basics Delay Delay programming is performed by selecting DELAY in the Procedure Data screen and then selecting a delay type from the pick list. If either a SCAN DELAY or INJECTOR DELAY is selected, the operator can enter a value for the delay using the numeric keypad and save the value using the ENTER button. Selecting Delay Type Pressing the OK and CANCEL buttons at the upper right of the Procedure Data screen returns the operator to the Main screen. The OK button accepts the changes made by the operator and the CANCEL button rejects any changes made by the operator. The Procedure Data panel is updated to reflect the changes made in the Procedure Data screen Iodine Summary Selecting Delay Value The Iodine Summary feature provides key clinical information related to the iodine delivered and associated iodine flux for contrast injection protocols. If the operator enters the concentration of the iodinated contrast used in a procedure via the injector display, the Iodine Summary feature displays the total grams of iodine delivered based on the contrast volumes programmed for that procedure. The iodine flux or the rate at which iodine is delivered for a procedure is also displayed. Iodine flux is calculated as the total grams of iodine delivered at the flow rate used for the contrast phases of the protocol and is displayed in g/s (grams of iodine per second). Iodine (g) = Contrast Concentration (mg/ml) * Contrast Volume (ml) / 1000 Iodine Flux (g/s) = Contrast Concentration (mg/ml) * Flow Rate (ml/s) / 1000 If a contrast injection protocol uses different flow rates for the contrast phases of an injection, then the iodine flux displays a null value. In the case of injection protocols using DualFlow (contrast-saline mix), the iodine delivered is calculated from the volume of contrast in all phases (contrast and DualFlow phases). With DualFlow, iodine flux is calculated from contrast phases only. 2-21

30 Stellant CT Injection System 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. 2-22

31 2 - System Basics The following table identifies the configurable items and their selectable values. Configurable Item Language Display Audio Level Priming Mode Priming Source LPCT (Low Pressure Connector Tube) Type Calibration Reminder Test Inject Source Test Inject Rate Test Inject Volume Injection Display Mode Pressure Units Date / Time Date Format Time Format Total Volume Display Auto Retract Auto Advance Auto Load Purge Volume Scan Delay Audio Fluid Control ISI XDS Informatics Selectable Value English, Dutch, Japanese, French, Italian, German, Spanish, Swedish, Russian Soft, Medium, Loud Simultaneous or Sequential Syringe A or Syringe B Standard or Expanded Year and month Syringe A or Syringe B 1-7 ml/s 10, 15, or 20 ml Profile or Protocol PSI or kpa Calendar date and time of day mm/dd/yyyy, dd/mm/yyyy, or yyyy/mm/dd hh:mm:ss, hh:mm:ss AM/PM, or hh:mm:ss A/P Syringe A or Syringe A and B combined. On or Off On or Off Sets the volume to be purged when using Auto Load. On or Off Off, Low, Medium, or High On or Off. On or Off. On or Off. Date/Time To set time and date, touch the desired programmable block, then the appropriate number. Date/Time Setup 2-23

32 Stellant CT Injection System 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 2-24

33 3 - Preparing to Inject 3 - Preparing to Inject Minimizing Air Embolization Risks Operator vigilance and care, coupled with a set procedure, is essential to minimizing the possibility of an air embolism. WARNING: Patient injury or death could result from an air embolism. Expel all trapped air from the syringe(s), connectors, tubing, and catheterover-needle before connecting the system to the patient. Carefully read the instructions for loading and the use of FluiDots indicators (where applicable) to reduce the chance of air embolism. The presence of rounded FluiDots indicators do not indicate the total absence of air bubbles in the syringe tip. FluiDots indicators must be viewed in a properly illuminated environment, with a light source behind the operator providing enough light to permit easy viewing. To minimize air embolization risks, ensure that one operator is designated the responsibility of filling the syringe(s). Do not change operators during the procedure. If an operator change must occur, ensure that the new operator verifies that the fluid path is purged of air. To minimize the possibility of inadvertent aspiration and injection, ensure the patient is disconnected from the injector when utilizing the forward and reverse piston controls. WARNING: Patient or operator injury may result if damaged components are used. Do not use damaged components. Visually inspect all components before use. The following are suggested techniques for minimizing air embolization risks during a CT enhancement procedure. Using a MEDRAD Fluid Dispensing Device (FDD), such as a spike is recommended. Air removal from the syringe will be much more difficult if a small diameter tube, such as a catheter-over-needle, needle, or a tube longer than ten inches (25 cm) is used for loading. Point the Stellant injector head up during loading, enabling any air to accumulate at the syringe tip, then expel the air. Point the Stellant injector head down during an injection, enabling any small air bubbles that could still be in the fluid to float to the rear of the syringe. Ensure that one operator is designated the responsibility of filling the syringes. Do not change operators during the procedure. If an operator change must occur, ensure that the new operator verifies that the fluid path is purged of air. Use MEDRAD syringes equipped with FluiDots indicators. FluiDots indicators should be observed as part of an arming procedure. When the FluiDots is viewed through an empty syringe, the dots appear as small narrow ellipses as illustrated below. When viewed through a full syringe, the dots become larger, almost round. 3-25

34 Stellant CT Injection System Warning: To minimize the possibility of inadvertent aspiration and injection, ensure the patient is disconnected from the injector when utilizing the forward and reverse piston controls. FluiDots indicators must be viewed in a properly illuminated environment, with a light source behind the operator, providing enough light to permit easy viewing. Empty Syringe Filled Syringe Using the Stellant Pedestal with Integrated IV Pole The Stellant Pedestal is intended to support the a Stellant injector Head in a CT Scanner room. DO NOT attempt to use the Pedestal for any other purposes. WARNING: Tighten all screws, clamps and knobs during assembly and as needed during use. Loose components may cause the pedestal to collapse resulting in personal injury and/or equipment damage. WARNING: Do not move or manipulate the injector mount by pulling or pushing the integrated IV pole. Using the pole to maneuver the injector could bend the pole or cause an imbalance of the system resulting in property damage and/or serious injury. Maneuver the injector as recommended by the injector Operator Manual. WARNING: Do not adjust the integrated IV pole or move the injector when anything is hung from the pole. Any item hung from the pole could fall, causing patient injury and/or property damage. WARNING: To avoid pinch points and personal injury, use care and diligence in folding and unfolding the hooks, raising and lowering the pole, and tightening the adjustment knob. Keep hands and fingers clear of all pinch point areas. WARNING: The folding hooks are designed to hold a maximum weight of 5 lbs / 2,265 grams each. Do not exceed the weight limits. Adding additional weight to the hooks may lead to instability, premature device failure and the potential for personal injury and/or property damage. CAUTION: Use extreme care in raising and lowering the integrated IV pole. The pole should raise and lower easily without force. If raising and lowering becomes difficult, clean the pole as described in Cleaning the Pedestal on page 46. Operating Instructions To extend Integrated IV Pole: Turn adjustment knob counter-clockwise to loosen, then raise the top of the Integrated IV Pole to the desired height. To lock the Integrated IV Pole: Turn the adjustment knob clockwise until tight. Do not over-tighten. To store: Turn the adjustment knob counter-clockwise and retract the Integrated IV Pole. 3-26

35 3 - Preparing to Inject Stellant Connector Tubing The connector tubing is equipped with a priming tube. Attach the priming tube to the end of the Low Pressure Connector Tube (LPCT). The purpose of the priming tube is to act as a small reservoir to catch excess contrast media while priming. The tube is vented so that air may escape but fluid will not. This prevents the dripping of fluid prior to the connection to the catheter. 1. Remove the connector tube from the package. 2. Remove the dust covers to expose male and female luer fittings. 3. Ensure all air is purged from the syringe. 4. Attach the connector tube to the syringe containing the desired volume of fluid, making sure that the tubing luer fitting is secured to the tip of the syringe If using a connector tube with a T-connector, attach the straight portion to the contrast (A) syringe and the extension to the saline (B) syringe. 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. 6. Connect the Prime Tube to the patient end of the tubing set. 7. Prime the tubing with fluid by pressing Prime on the injector head, turning the manual knob, or using the forward and reverse piston controls. While priming, hold the Prime Tube above the patient s elevation, and ensure that the filter is pointing upward. Leave the Prime Tube attached until immediately prior to patient connection. 8. Ensure all air is purged. 9. Rotate the injector head downward. 10. Remove the Prime Tube. 11. Connect to the patient. Filter 12. Press Check For Air on the injector head. The Check For Air indicator will then illuminate on the touch screen and injector head. Prime Tube Loading and Priming a Syringe The System is specifically designed to decrease the amount of time and steps to load disposable syringes with either contrast media or saline. Using the System features and recommended filling techniques will reduce the frequency of contrast spills. WARNING: Patient injury could result if the syringe is not properly engaged. Ensure the syringe is properly snapped into the front of the injector head before injecting. Improper engagement may cause the syringe to leak, become damaged, or to come off during the injection and result in an under-volume delivery. The System has four features that decrease the time and steps to install the syringe onto the injector: 1. Non-rotational orientation: To install a disposable Stellant syringe onto the injector, snap the syringe onto the front of the injector head (no alignment necessary). 2. Auto-docking (excluding S model): Once a disposable MEDRAD syringe is installed, the Stellant Piston will automatically advance and find the syringe plunger, dock with it, and stop. If the syringe was previously filled with contrast, no further action is initiated at this time. 3-27

36 Stellant CT Injection System 3. Auto-advance (excluding S model): When an empty syringe is removed from its packaging and installed on the injector, the piston automatically docks with the plunger and then advances it to the full forward position. If a prefilled syringe is installed on the injector, the piston will automatically dock with the plunger and then stop. When Auto Advance is configured ON through the configuration screen, it enables both Auto Dock and Auto Advance. The injector senses whether a syringe was on the unit or not by the position of the syringe plunger. If the syringe was not on the unit before (the syringe plunger was not advanced), and Auto Advance is ON, then the plunger automatically advances when the syringe is installed. 4. Automatic retraction: When the syringe is removed, the piston rod will automatically retract (unless configured off). Do not rotate the syringe after installation. Priming Mode Selection When priming a dual syringe LPCT with a union connector (T or Y), Priming Mode provides the flexibility of choosing one of two options: Simultaneous priming mode - moves saline and contrast through the union connector, simultaneously some times during the priming process. Sequential priming mode - moves saline and contrast through the union separately, one after the other during the priming process. The factory pre-set for the Priming Mode feature is Simultaneous. Priming Volume - LPCT Type The priming volume can be changed to support standard Low Pressure Connector Tubes sets or Expanded Low Pressure Connector Tubing sets. It is important that the correct LPCT Type is chosen to prevent under-priming of the connector tubing (may not eliminate air from the injection fluid path) or over-priming the connector tubing (may cause excessive dripping). The factory pre-set for the LPCT Type option is Standard LPCT. Manual Loading and Priming a Syringe A syringe can be loaded manually or automatically on the Stellant CT Injection System. 1. Install a new syringe on the injector head by inserting it quickly and firmly in one motion to enable it to seat properly. The piston will automatically advance to the front of the syringe (unless configured off, or the plunger previously moved forward). Installing the syringe slowly can result in an error message on the DCU screen, and the piston plunger may not automatically advance to the front of the syringe. The System automatically senses different syringe sizes and configures the unit to match the syringe. 2. Install the spike or Quick Fill Tube (QFT) onto the end of the syringe. Do not install with excessive force. Warning: Contamination may occur if the end of the spike is touched. 3. Insert the spike or QFT into a fluid source. Refer to fluid manufacturer's instructions for use and/or package insert. 3-28

37 3 - Preparing to Inject 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. 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. Carefully inspect all tubing and syringes, and verify that all air has been expelled from the fluid path before pressing Check For Air. 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. 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 Back If the procedure is to draw back on the syringe plunger after the system is connected to the patient to insure a return fluid flow is received, note the following: Once fluid flow is seen in the tubing, the manual knob must then be advanced until the piston rod firmly mates with the syringe plunger. Failure to do this will result in the injector not arming. Using Auto Load to Load a Syringe (SX and D Models) The System also has an Integral Auto load function. This feature saves time and steps by automatically loading the syringe with the prescribed volume of fluid, (the operator is still responsible for confirming that all air is expelled). As part of the Integral Auto Load capability, it is possible to program different Auto Load Purge Volumes through the Setup screen. Purging is the automatic forward movement of the piston during autoloading that expels air which may enter the syringe at the beginning of the filling cycle. 3-29

38 Stellant CT Injection System 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. When using MEDRAD filling devices, choose one of the four volume selections based on the following guidelines: 30 ml for QFT 20 ml for short transfer sets (23 / 58 cm) 10 ml when loading through a spike only 0 ml (OFF) when loading through a filling device that has a check valve not available in the U.S. For other filling devices, consult the manufacturer's instructions for use. 4. Select OK. Using Auto Load With a Spike or QFT 1. Set and lock the protocol on the DCU. 2. Install a new Stellant syringe on the injector head by inserting it quickly and firmly in one motion to enable it to seat properly. The piston will automatically advance to the front of the syringe (unless configured off, or the plunger previously moved forward). Installing the syringe slowly can result in an error message on the DCU screen, and the piston plunger may not automatically advance to the front of the syringe. 3. Install the spike or QFT onto the end of the syringe. Do not install with excessive force. Warning: Contamination may occur if the end of the spike is touched. 4. Insert the spike or QFT into the fluid source. Refer to fluid manufacturer's instructions for use and/or package insert. 5. Press Auto Load on the Injector Head. The Volume indicators on the injector head will indicate how much fluid needs to be loaded to support the protocol set on the DCU (including the amount of fluid necessary to prime the patient tubing with fluid). Increase or decrease (optional) the amount of volume loaded in increments of 5 ml, by pressing the +/- keys next to Auto Load. When Auto Load is pressed, Fill will flash. 3-30

39 3 - Preparing to Inject 6. Press Fill, and the syringe will automatically load the prescribed protocol volume. If FILL is not pressed within ten seconds, Auto Load will automatically reset. Press Auto Load again to activate it for loading of the syringes. When Fill is pressed, the injector automatically retracts to the selected Auto Load Purge Volume and draws in fluid. The piston stops and then advances to expel any air that was drawn into the syringe. The piston then automatically retracts again until the Volume required to perform the injection is loaded into the syringe, plus approximately 10 ml. The piston pauses for about five seconds, to ensure all fluid is drawn into the syringe, then advances to the final Volume. 7. Expel air from syringe. 8. Remove spike or QFT. 9. Connect the disposable tubing set onto the end of the syringe. 10. Follow the instructions in Stellant Connector Tubing on page 27. Removing a 200 ml Syringe 1. Disconnect the disposable tubing set from the vascular entry device. The disposable tubing set does not need to be disconnected from the syringe. 2. Rotate the syringe approximately ¼ turn counter-clockwise and gently pull the syringe out of the injector head. In order to remove the syringe, the last piston motion must be in the forward motion (which is typical). If the syringe cannot be removed, rotate the injector head manual knob approximately two revolutions in the forward direction, then repeat Step 2 above. 3. Properly discard the syringe and the disposable tubing set. Once the syringe is removed from the injector, the piston will automatically retract (if configured to do so). Programming Protocols Programming a protocol is initiated at the Main screen. 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. 3-31

40 Stellant CT Injection System 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. Lock in a selected value by touching another parameter. Programming Multiple Phases If two or more phases are required, touch the triangle below the first phase of the injection. The Phase Type window will appear, allowing selection of functions for the new phase. Select one type of flow from the displayed list. Storing a Protocol The System can store up to 32 commonly used protocols. 1. Enter the desired parameters on the main screen. 2. Touch Store located in the upper right corner of the Main screen. An alpha-numeric keypad appears with a flashing cursor in the title block. 3. Enter the desired name for the protocol. The name can be up to 20 characters long, including spaces. Use the arrow key to backspace and erase individual characters, or the clear key to erase a string of text. 4. Touch Enter when the entry is completed. Store screen, English keyboard Store screen, delete confirmation To exit the Store screen without keeping changes press Cancel in the upper right corner of the screen to return to the main menu. 3-32

41 3 - Preparing to Inject 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. Lock Protocol Recalling a Protocol 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. 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. Protocols are ordered starting with the oldest protocol at the top left and continuing with subsequent protocols to the bottom. Deleting a Protocol 1. Touch Recall on the upper right corner of the Main Screen. 2. Select a previously stored injection protocol by touching one of the protocol titles on either side of the screen. Upon selection, key parameters of the injection protocol will be displayed in the center of the screen. 3. Touch Delete to permanently erase the protocol from memory. 3-33

42 Stellant CT Injection System Programming a Delay 1. Enter desired Flow Rate and Volume parameters. 2. Touch? and press Pause key. 3. Enter desired pause in seconds then press Enter. 4. To program a hold, touch? and press Hold to program a hold. 3-34

43 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. 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. Once fluid flow is seen in the tubing, the manual knob must then be advanced until the piston rod firmly mates with the syringe plunger. Failure to do this will result in the injector not arming. 3. Press Protocol Lock. Beginning the Arming and Injecting Process Press Arm on either the Main screen or the injector head. If the System will not Arm: Ensure that the syringe(s) are docked. 4-35

44 Stellant CT Injection System Ensure that the Protocol Lock control on the touch screen is engaged. When engaged the Protocol Lock indicator on the injector head illuminates. Ensure that there is not an insufficient volume condition. Insufficient volume is defined as the total programmed injection volume of a protocol (per syringe) exceeding the corresponding displayed volume remaining value. The injector indicates an insufficient volume condition to the operator before the injector can be armed. An on-screen indication of insufficient volume is provided on the DCU whenever the total volume programmed to be delivered is greater than the amount of fluid in the syringe. The message indicates the amount of insufficient volume in one or both syringes, the programmed protocol, as well as the modified protocol that will be used if the operator continues to arm the injector. The operator can choose to either accept the modified protocol changes or stop the arming process The injector head indicates an insufficient volume condition by a flashing LED. Press Arm on the injector head two times to allow the arming process to continue with the remaining volume. 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. Pressing Abort will always stop the piston and fluid movement. Test Injection A test injection is programmed like a normal phase injection. Test Inject Source, Test Inject Rate, and Test Inject Volume are selectable through the setup screen. Configuring Test Inject Parameters 1. Press right arrow to edit the first step of the protocol. 2. Select Test Inject. 3. Edit the Flow Rate and Volume parameters. 4. Touch Enter. 4-36

45 4 - Arming and Injecting Performing a Test Injection 1. Press Start/Hold to perform Test Injection. 2. After the Test Injection is complete, the injector goes into a HOLD phase. Press Start/ Hold to initiate the selected protocol. Programming a Test Injection Test injection programmed Injecting screen, performing test injection Injecting Performing a Injection MEDRAD recommends that the operator stay by the patient s side at the beginning of the injection to ensure that the catheter is placed correctly (minimizing extravasation.) 1. Enter a protocol and verify parameters on protocol screen. 2. Touch Protocol Lock control on the Main Screen. Protocol Lock must be engaged and the Protocol Lock light on the injector head illuminated, before the System can be armed from the injector head. 3. Load syringe and verify that all air is expelled from the fluid path. 4. Press Remote Check For Air on the injector head. 5. Press Arm on the Main Screen OR Press Arm on the injector head. Armed indicator light flashes when armed. If Check for Air is not depressed on the injector head, the system requests confirmation at the DCU that the fluid path was checked for air (Yes/No). 4-37

46 Stellant CT Injection System 6. Initiate injection from the Start/Hold switch on either the injector head or Display. Additional presses of Start/Hold will alternately Hold and resume the injection. If the maximum hold time (20 minutes) is exceeded, the protocol in process will stop automatically. Armed indicator light will be lit solidly during the injection If an Inject Delay is programmed: Pressing Start/Hold activates the countdown timer. When the timer counts down to zero the programmed injection will automatically begin. If Start/Hold is pressed during an injection delay, the stopwatch timer stops counting until Start/Hold is either pressed again, or the Hold time is exceeded, (in which case the protocol ceases). If a Scan Delay is programmed: Pressing Start/Hold activates the Scan Delay countdown and the injection will start simultaneously if a scan delay is programmed. During the injection, additional presses of the Start/Hold will alternately Hold and resume the injection and the scan delay time. When a Scan Delay is programmed for an injection protocol, the injector counts down the delay on an on-screen timer as well as with audio beeps. I The default value for this setup option is On. If a Test Injection is programmed, the delay will occur on the first phase after the Test Injection has executed. 7. View injection status by selecting either Phase View or the Graphical View As each phase is activated, phase parameters are highlighted. A dashed red line 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. To DISARM, touch any button on the injector head or DCU to abort the injection, except Start/Hold. Injecting Views As each phase is activated, the phase parameters and the syringe in use will be highlighted with a black outline to display injection progress. Elapsed time and the current phase will be shown in the injector status window. The Delivered Volume window will increment as the injection proceeds to display Volume delivery. The Volume Remaining (syringe icon) display will decrement. 4-38

47 4 - Arming and Injecting The operator can select either phase view or flow profile (graphical) view. Injecting - Protocol View Injecting - Profile View Pressure Graph The pressure graph is presented when the operator touches the pressure graph view key. The Pressure Graph is an additional indicator of the progress of an injection. It displays the pressure being developed in the syringe during an injection. Since the pressure profile is a direct correlation to the fluid being injected, additional information about the status of the injection is provided to the operator. The pressure graph view displays the force that the injector is applying to the syringe in the following manner: Pressure (PSI) will be displayed on the Y-axis (vertical) and elapsed time (mm:ss) will be displayed on the X-axis (horizontal). During the first 60 seconds of the injection, time will be indicated from 00:00 to 60 seconds. After 60 seconds has elapsed, and thereafter until the end of the injection, the graph will display a 60 second window which will shift every 15 seconds to indicate the current range. For example, if 61 seconds has elapsed since the beginning of the injection, the time axis will display a window from 00:15 to 01:15; at the 76 second mark (after having shifted when reaching the 75 second mark), the time axis will display a window from 00:30 to 01:30. If a test injection is programmed, the elapsed time will count up when the actual injection begins after the test injection. Graphical view, Injecting screen, contrast phase. Graphical view, Injecting screen, entering a pause. 4-39

48 Stellant CT Injection System Pressure Graph Helpful Hints The Pressure Graph provides a visual representation of the pressure generated at the tip of the syringe during an injection. This pressure value correlates to the flow of fluid out of the tip of the syringe and to the patient. The Pressure Graph is intended to provide a graphic display to assist the technologist in identifying a normal versus an abnormal injection. Using the Pressure Graph, the technologist can easily compare the current injection profile against the typical profile. If the graph displays a different profile than what is expected for this protocol, the technologist can take any necessary corrective action based on the guidelines below. The following table lists eight possible conditions the graph might show, along with helpful suggestions to assist the technologist in taking any appropriate corrective action: Condition Description Possible Causes Possible Actions 1 The graph is the typical shape, but the pressure is higher than normal. 2 The graph is the typical shape, but the pressure is lower than normal. 3 The graph and injection start out normal, but level off to a less than expected peak pressure. 4 At the start of the injection, the Pressure Graph signal immediately rises straight up and hits the pressure limit setting (dotted horizontal line). The pressure required to push the contrast media through the disposable system is higher than normal, which means there is a greater restriction to fluid flow. Greater restrictions can be caused by any of the following: Higher viscosity of the contrast media (more grams of iodine/higher concentration, or lower temperature of the contrast media/not heated) A smaller gauge catheter is being used An additional disposable is in the fluid path causing a greater restriction to the flow of fluid (extension tube, stopcock, check valve, IV extension set) Defective syringe (under lubricated). The pressure required to push the contrast media through the disposable system is lower than normal, meaning there is less restriction to fluid flow. Lower restrictions can be caused by any of the following: A lower viscosity contrast media (less grams of iodine/lower concentration, or higher temperature of contrast media/heated) A larger gauge catheter is being used Fewer disposables in the fluid path (lack of extension tube, stopcock, checkvalve, IV extension set). An inappropriate pressure limit may be selected. If a lower pressure is selected than what is required to deliver the flow rate, the injection will start out normally for the first few seconds. However, as soon as the pressure limit value is achieved, the flow rate will automatically decrease to keep the system from exceeding the selected pressure limit. The fluid path may be occluded (after reaching a High Pressure Disarm, Stellant will automatically terminate the injection). Total occlusions may be caused by one of the following: A closed stopcock An IV extension set with the clamp closed off A defective disposable (fluid will not flow through it). Check to insure the syringe heater is functioning normally.as long as the Possible Causes listed are of no concern, then no action is necessary. As long as the Possible Causes listed are of no concern, then no action is necessary. Check to see if the Pressure Graph is approaching the dotted horizontal line (pressure limit setting). If it is, the injector is pressure limiting and causing this condition. See Pressure Limiting in the Operation Manual for a thorough discussion of causes and resolution. Consider putting the injector on hold and investigating. There is a high probability that no contrast media is being injected into the patient. 4-40

49 4 - Arming and Injecting 5 The injection is proceeding perfectly normal, but during the injection, with no programmed decrease in flow rate, the Pressure Graph sharply drops to baseline, but no error messages appear on the screen. Note: If a multi-level injection is programmed, and the flow rate is programmed to decrease, then the pressure will also drop at that time. 6 The pressure buildup to the expected peak is taking longer than typical, even though the injector is injecting normally. 7 When the injection starts, almost no pressure buildup is witnessed, when a buildup was expected. 8 At the end of a normal injection, the pressure graph does not immediately drop to zero. If the injector is still armed and injecting at a constant flow rate, but the Pressure Graph drops sharply to baseline: Stop the injector immediately and investigate. The pressure in the syringe has sharply dropped even though the piston is moving forward and should be developing pressure. Possible causes: The Low Pressure Connector Tubing, extension set, or catheter has burst or disconnected from the fluid path (fluid is running on the floor) The syringe may have failed. Fluid is being forced around the syringe plunger instead of out the end of the syringe (fluid is running on the floor). Due to operator error, the syringe may contain a large amount of air (example: half air, half fluid). It is easier to compress air, than to push fluid through a CT disposable system, so the injector is initially developing less pressure as it compresses the air. Due to operator error, there may be no fluid in the syringe (the system could be injecting air). The injector will experience almost no resistance to moving the syringe plunger forward with an empty syringe. Note: Very slow injections through large disposable sets will require and display very little pressure. This is normal. What is being described above is a condition where a buildup of pressure was expected, and none was witnessed. OR: There may be two syringes on the injector, only performing a single syringe injection, and the LPCT may be connected to the wrong syringe. Stellant is designed to inject all of the contrast in the syringe to help minimize contrast waste. Sometimes in the process of doing this, the piston pushes against the front of the syringe as it squeezes out the last drops of fluid. This in turn generates pressure, which is displayed by the Pressure Graph. This pressure reading should drop to baseline after about 50 seconds. If the injector is still injecting (arm light solid and manual knob on the back of the head turning), consider aborting the injection. There is a high probability that fluid is running on the floor. Stop the injector immediately and investigate. Check the fluid path for air. Stop the injector immediately and investigate. Check the fluid path for air. No action. This is normal operation. 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. 4-41

50 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 System has initially delivered the programmed bolus, the injector status window on the main screen will change from Injecting screen to the Complete Volume delivered Holding position screen. The injector will hold position for approximately ten to fifteen seconds to insure syringe recoil does not occur, and then change to the Injection Complete screen. Injection Complete - Protocol View Injection Complete - Profile View Injection Aborted The elapsed time will continue to count up until OK is touched. The operator can exit the pressure graph view by pressing Phase View in the bottom right corner of the screen. Pressing Pressure Graph View will return the user to the pressure graph screen. 4-42