Stellant with Certegra Workstation Operation Manual Rev F
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Stellant® with Certegra® Workstation Operation Manual 3033823 Rev. F
MEDRAD Stellant® with Certegra® Workstation Operation Manual i
Stellant with Certegra Workstation
MEDRAD Contact Information
MEDRAD, INC. One Medrad Drive Indianola, PA 15051-0780 U.S.A. Phone: +1 (412) 767-2400 +1 (800) MEDRAD1 +1 (800) 633-7231 Fax: +1 (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 Breeze Tower 2-4-9, Umeda, Kita-ku, Osaka 530-0001, Japan Phone: +81(0)66-133-6250 Fax: +81(0)66-344-2395 MEDRAD Medical Equipment Trading Company - Beijing Air China Plaza Xiao Yun Lu #36, 401-402 Chao Yang District, Beijing Phone: 400-810-7070 Fax: +86(10)8447-5292
©2012-2013 MEDRAD, INC. All rights reserved. Reproduction of this manual is strictly prohibited without express written consent of MEDRAD, INC. For more information about MEDRAD products and services, please visit WWW.MEDRAD.COM
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Table of Contents
Table of Contents
1 Introduction ................................................................................................................................................ 1 - 1 1.1 Certifications ...................................................................................................................................... 1 - 1 1.2 Intended Use ...................................................................................................................................... 1 - 1 1.3 Contraindications................................................................................................................................ 1 - 1 1.4 Restricted Sales ................................................................................................................................. 1 - 1 1.5 Required Training ............................................................................................................................... 1 - 1 1.6 Trademarks........................................................................................................................................ 1 - 1 1.7 Disclaimers ........................................................................................................................................ 1 - 1 1.8 The Equipotential Connector (EPC)...................................................................................................... 1 - 1 2 Symbols ..................................................................................................................................................... 2 - 3 2.1 Notified Body...................................................................................................................................... 2 - 3 2.2 Regulatory Classifications................................................................................................................... 2 - 3 2.3 Warning Symbols ............................................................................................................................... 2 - 3 2.4 Injection System Buttons and Icons .................................................................................................... 2 - 4 2.4.1 Display Buttons and Icons ......................................................................................................... 2 - 4 2.4.2 POD Buttons and Icons.............................................................................................................. 2 - 5 2.4.3 Injector Head Icons.................................................................................................................... 2 - 5 2.4.4 Base Unit Icons ......................................................................................................................... 2 - 6 2.4.5 Overhead IV Track System......................................................................................................... 2 - 6 3 Warnings, Precautions, and Notices ............................................................................................................ 3 - 7 3.1 Warnings............................................................................................................................................ 3 - 7 3.2 Cautions ............................................................................................................................................. 3 - 7 3.3 Notices............................................................................................................................................... 3 - 7 4 System Overview ........................................................................................................................................ 4 - 9 4.1 System Diagram................................................................................................................................. 4 - 9 4.1.1 Moving the System Within the Room ......................................................................................... 4 - 9 4.2 Fluid Delivery Basics........................................................................................................................... 4 - 9 4.2.1 Protocol..................................................................................................................................... 4 - 9 4.2.2 Protocol Manager .................................................................................................................... 4 - 10 4.2.3 Fluid Delivery System Design .................................................................................................. 4 - 10 4.2.4 Fluid Pressure and Pressure Limiting....................................................................................... 4 - 10 4.2.5 Response to Occlusions .......................................................................................................... 4 - 11 4.2.6 Volume and Flow Rate Protection ............................................................................................ 4 - 11 4.3 Syringe Installation Features............................................................................................................. 4 - 11 4.4 Programming Mode.......................................................................................................................... 4 - 11 4.5 Basic Informatics.............................................................................................................................. 4 - 12 4.6 Using the Pedestal with Integrated IV Pole ........................................................................................ 4 - 12 4.6.1 Pedestal Operating Instructions ............................................................................................... 4 - 12 5 Understanding the Display and Pod........................................................................................................... 5 - 13 5.1 Home Screen.................................................................................................................................... 5 - 13 5.2 Pod Description ................................................................................................................................ 5 - 16 6 Understanding the Injector Head and Hand Switch .................................................................................... 6 - 17 6.1 Injector Head Control ........................................................................................................................ 6 - 17 6.2 Injector Head Components................................................................................................................ 6 - 18 iii
Stellant with Certegra Workstation 6.2.1 Syringe Heat Maintainer .......................................................................................................... 6 - 18 6.2.2 Manual Knob........................................................................................................................... 6 - 19 6.2.3 Arm Lights .............................................................................................................................. 6 - 19 6.3 Hand Switch ..................................................................................................................................... 6 - 19 7 Power Up and Shut Down the System ....................................................................................................... 7 - 21 7.1 Powering Up the System................................................................................................................... 7 - 21 7.2 Power Down the System................................................................................................................... 7 - 21 7.2.1 Hard Shutdown ....................................................................................................................... 7 - 21 7.3 Restore from Injector Standby .......................................................................................................... 7 - 21 8 Protocol Management............................................................................................................................... 8 - 23 8.1 Create or Edit a Protocol ................................................................................................................... 8 - 23 8.2 Save a Protocol ................................................................................................................................ 8 - 25 8.3 Recall a Saved Protocol .................................................................................................................... 8 - 26 9 Preparing for Injection............................................................................................................................... 9 - 27 9.1 Control Room Preparation................................................................................................................. 9 - 27 9.1.1 Informatics Panel .................................................................................................................... 9 - 27 9.1.2 Prepare Injection Protocol ....................................................................................................... 9 - 27 9.2 Scan Room Preparation .................................................................................................................... 9 - 27 9.2.1 Install and Fill a Syringe .......................................................................................................... 9 - 28 9.2.2 Attach and Prime the Tubing ................................................................................................... 9 - 29 9.2.3 Connect the Tubing to Patient.................................................................................................. 9 - 30 10 Arming and Injecting............................................................................................................................. 10 - 31 10.1 Add Volume Indicator.................................................................................................................... 10 - 31 10.2 Arm the Injector............................................................................................................................ 10 - 31 10.2.1 Arm from the Control Room................................................................................................. 10 - 31 10.2.2 Arm from the Scan Room .................................................................................................... 10 - 33 10.3 Initiating an Injection .................................................................................................................... 10 - 33 10.4 Operator Initiated Hold.................................................................................................................. 10 - 33 10.5 Injection Aborted .......................................................................................................................... 10 - 34 10.6 Viewing Injection Progress............................................................................................................ 10 - 34 10.7 Viewing Reminders....................................................................................................................... 10 - 35 11 Completing an Injection ........................................................................................................................ 11 - 37 11.1 Injection Complete........................................................................................................................ 11 - 37 11.2 Injection Aborted .......................................................................................................................... 11 - 38 11.3 Exiting Injection Complete ............................................................................................................ 11 - 38 11.3.1 Conducting Another Injection............................................................................................... 11 - 38 12 Remove Disposables............................................................................................................................. 12 - 41 13 Advanced Operations............................................................................................................................ 13 - 43 13.1 System Setup ............................................................................................................................... 13 - 43 13.1.1 System Setup Configurable Items........................................................................................ 13 - 44 13.2 Setup of P3T® Software Functionality .......................................................................................... 13 - 45 13.2.1 P3T Setup Configurable Items ............................................................................................. 13 - 45 13.3 Protocol Manager Setup ............................................................................................................... 13 - 46 13.3.1 Delete a Protocol................................................................................................................. 13 - 46 13.3.2 Rearrange Protocol List ....................................................................................................... 13 - 47 13.3.3 Hide/Show a Region ............................................................................................................ 13 - 47 13.3.4 Rename a Region ................................................................................................................ 13 - 47 13.4 Fluid Delivery Setup...................................................................................................................... 13 - 48 13.4.1 Fluid Delivery Setup Configurable Items .............................................................................. 13 - 49 13.5 Informatics Setup ......................................................................................................................... 13 - 50 iv
Table of Contents 13.6 Help ............................................................................................................................................. 13 - 50 13.6.1 Accessing the Help System ................................................................................................. 13 - 50 13.7 Status........................................................................................................................................... 13 - 51 14 System Messages................................................................................................................................. 14 - 53 14.1 Error Screen ................................................................................................................................. 14 - 53 14.2 System Tones............................................................................................................................... 14 - 53 14.2.1 General Tones ..................................................................................................................... 14 - 53 14.2.2 Notification Tones ............................................................................................................... 14 - 53 15 Cleaning and Maintenance ................................................................................................................... 15 - 55 15.1 Daily ............................................................................................................................................ 15 - 55 15.1.1 Cleaning the Injector Head, Unit Syringe Piston, and Syringe Interface................................. 15 - 56 15.1.2 Cleaning the Pedestal.......................................................................................................... 15 - 56 15.1.3 Inspecting the Injector Head and Mounting .......................................................................... 15 - 56 15.1.4 Cleaning the Display ........................................................................................................... 15 - 57 15.1.5 Inspecting the Display ......................................................................................................... 15 - 57 15.2 Monthly ........................................................................................................................................ 15 - 57 15.2.1 Operational Checkout .......................................................................................................... 15 - 57 15.3 Annually ....................................................................................................................................... 15 - 58 15.3.1 Injection System Calibration ................................................................................................ 15 - 58 15.3.2 Checking Leakage............................................................................................................... 15 - 58 15.4 Reinstalling the System in Another Room...................................................................................... 15 - 58 16 Options and Accessories....................................................................................................................... 16 - 59 16.1 Mounting Options ......................................................................................................................... 16 - 59 16.2 Injector Head Extension Cables..................................................................................................... 16 - 59 16.3 Display Extension Cables .............................................................................................................. 16 - 59 16.4 Accessories .................................................................................................................................. 16 - 59 16.5 Manuals ....................................................................................................................................... 16 - 60 17 Specifications ....................................................................................................................................... 17 - 61 17.1 Display Specifications................................................................................................................... 17 - 61 17.1.1 Display Dimensions and Weights......................................................................................... 17 - 61 17.1.2 Display Connections ............................................................................................................ 17 - 61 17.2 Base Unit Specifications ............................................................................................................... 17 - 62 17.2.1 Base Unit Dimensions and Weight ....................................................................................... 17 - 62 17.2.2 Base Unit Connections......................................................................................................... 17 - 62 17.3 Injector Head Specifications.......................................................................................................... 17 - 63 17.3.1 Injector Head Dimensions and Weight ................................................................................. 17 - 63 17.4 Certifications ................................................................................................................................ 17 - 63 17.5 Environmental Specifications........................................................................................................ 17 - 63 17.5.1 Non-Operating (Transportation and Storage)........................................................................ 17 - 63 17.5.2 Operating ............................................................................................................................ 17 - 64 17.5.3 Protection Against Electrical Shock...................................................................................... 17 - 64 17.5.4 EMI/RFI ............................................................................................................................... 17 - 64 17.5.5 Protection Against the Ingress of Fluids ............................................................................... 17 - 64 17.5.6 Mode of Operation............................................................................................................... 17 - 64 17.5.7 Fluid Delivery Performance.................................................................................................. 17 - 65 17.6 Over and Under Infusion Protection............................................................................................... 17 - 65 17.7 System Fluid Performance............................................................................................................ 17 - 65 18 Addendum – Compliance to IEC 60601-1-2 / 2001 2nd Edition............................................................. 18 - 67 v
Stellant with Certegra Workstation vi
1 Introduction This manual applies to the MEDRAD® Stellant® with Certegra® Workstation, also referred to as the System throughout this document. Read all the information contained in this manual. Understanding this information will assist users in operating the Stellant with Certegra Workstation in a safe manner. NOTE: Operating specifications and feature availability may vary by country. Check with local product representative and country-specific operating instructions. 1.1 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. 1.2 Intended Use The System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications. 1.3 Contraindications None Known. 1.4 Restricted Sales Federal (USA) law restricts these devices to sale by or on the order of a physician. 1.5 Required Training This device is intended to be used by individuals with adequate training and experience in diagnostic image studies. 1.6 Trademarks Unless otherwise indicated, all trademarks are owned by MEDRAD, INC. or licensed for its use. 1.7 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®. 1.8 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. 1 - 1
Stellant with Certegra Workstation 1 - 2
2 Symbols This section includes the symbols and icons for the following: • "Notified Body" • "Regulatory Classifications" • "Warning Symbols" • "Injection System Buttons and Icons" 2.1 Notified Body Indicates that this device conforms to the requirements of the European Medical Device Directive 93/42/EEC. 2.2 Regulatory Classifications
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.
2.3 Warning Symbols
Indicates separate collection for Electrical and Electronic Equipment per Directive 2002/96/EC. Refer to the following website for additional information: http://www.medrad.com/en-us/resources/Pages/WEEE.aspx. This product contains certain toxic or hazardous substances or elements, and can be used safely during its environmental protection use period (indicated by the number in the middle of the logo). This product should be recycled immediately after its environmental protection use period has expired.
Attention, consult accompanying instructions.
Indicates hazardous voltages.
Indicates that the information is a warning. Warnings advise you of WARNING 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 minor or moderate injury to the patient or operator. Read and understand the cautions before operating the injection system.
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Stellant with Certegra Workstation
NOTICE Note
Indicates that the information is a notice. Notices advise you of circumstances that could result in damage to the device. Read and understand the notices before operating the injection system. Indicates that the information that follows is additional important information or a tip that will help you recover from an error or reference to related information within the manual.
2.4 Injection System Buttons and Icons 2.4.1 Display Buttons and Icons
1 3 4 5 5 2 - 4
Accesses the system settings.
2
Resets the protocol to the factory default values.
4
Displays that no Reminders are set.
5
Indicates status of communication with ISI if ISI is available.
5
The Check for Air icon illuminates
yellow when the operator has confirmed inspecting the fluid
5
path for air.
Access to status communication of Certegra and Service products. Reference associated Operations Manuals for specific details. Displays the remaining number of set Reminders. Indicates status of communication with Injector Head. The Check for Air icon prior to an operator confirming inspecting the fluid path for air. Indicates the status of the XDS accessory, if XDS is available.
Symbols
The Injector icon identifies various
states of the injector:
• illuminates yellow and
flashes when the Sys-
Informatics
6
tem is armed. • illuminates solid yellow
7
Panel and Modality
when the System is
Worklist
injecting.
• Not illuminated when
system is idle.
2.4.2 POD Buttons and Icons
Indicates that the Informatics Panel and Modality Worklist accessories are enabled. Refer to the Stellant with Certegra Workstation Informatics Panel and Modality Worklist Operation Manual for more information.
Terminates the injection and disarms the System. Launches the help system. Hand switch connection.
Indicates on/off switch. Initiates the injection. Holds the injection for a maximum of 20 minutes.
2.4.3 Injector Head Icons
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Stellant with Certegra Workstation
1
Activates the Fill buttons.
2
Adjusts Auto fill volume to the
3
desired amount in small
4
increments/decrements.
Activates the forward and reverse
5
piston controls. Illuminates when 6
pressed.
The Check for Air icon; illuminates
7
after the operator has confirmed 8
inspecting the fluid path for air.
Arms the injector; illuminates after
9
the operator has armed the
10
injector.
Initiates the injection.
11
Holds the injection for a maximum
of 20 minutes.
Heat Maintainer connection on underside of Injector Head.
2.4.4 Base Unit Icons
Fill Buttons. • Syringe A (green) • Syringe B (blue) Activates Auto Prime. Forward and Reverse Piston Controls. Indicates the protocol is locked; illuminates after the operator has locked the protocol. Terminates and disarms injection. Manual knob indicators: • Syringe A (green) • Syringe B (blue) Hand switch connection on underside of Injector Head.
Identifies the Equipotential connection. 2.4.5 Overhead IV Track System The Overhead IV Track System is only intended for hanging IV fluids. Do not hang more than 50lbs/23kg of weight on the hooks. >23 kg >50 lbs.
2 - 6
3 Warnings, Precautions, and Notices
3.1 Warnings
WARNING Air Embolism Hazard - Serious patient injury or death may result. • Use only MEDRAD approved disposable products. • Use catheters and connectors with pressure ratings compatible with this system. • Use only accessories and options approved by MEDRAD. Environmental Contamination Hazard - Serious patient or worker injury or death may result. • Visually inspect all components before use. • Do not use damaged components. Electric Shock Hazard - Serious patient and/or worker injury or death may result. • Only use the power cord supplied with the System. • Equipment must only be connected to a supply mains with protective earth. Fire hazard - Serious patient and/or worker injury or death may result. • Use the correct fuse type replaced by MEDRAD or MEDRAD trained personnel. Compromised Efficacy Hazard - Serious patient injury or death may result. • Do not use this system to deliver any fluid other than intravenous contrast media and common flushing solutions.
3.2 Cautions
3.3 Notices
CAUTION Mechanical Hazard - Minor or moderate patient and/or worker injury may result. • Only use the System as defined in this manual. Follow the System communication if a system fault is communicated or in the event of a system malfunction. Follow the fault message. • Do not use the System in the presence of flammable (such as anesthetics) or combustible gases or other agents. Electric Shock Hazard - Minor or moderate patient and/or worker injury may result. • Only plug the System into a direct mains access point. Do not plug the System power cord into an extension cord or multi-outlet power strip. Procedure Delay Hazard - Serious patient and/or worker injury or death may result. • Turn off any equipment that could generate a high level electrostatic discharge.
NOTICE Electro-Mechanical Hazard - Equipment Damage may result. • Allow the System to stabilize at room temperature before use due to condensation that may cause electrical damage. Mechanical Hazard - Equipment Damage may result. • Do not touch the Display screen with a sharp object in order to perform the calibration. • 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.
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Stellant with Certegra Workstation 3 - 8
4 System Overview This section describes: • "System Diagram" • "Fluid Delivery Basics" • "Syringe Installation Features" • "Programming Mode" • "Basic Informatics" • "Using the Pedestal with Integrated IV Pole" 4.1 System Diagram The System is comprised of the Injector Head, a touch screen Display, and Base unit. The three components are connected by a communications link.
Figure 4 - 1: Stellant with Certegra Workstation
1 Display
2 Base Unit
3 Injector Head
4.1.1 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.
4.2 Fluid Delivery Basics The system is a programmable power injector that enables an operator to generate a defined fluid delivery protocol and execute a fluid injection.
4.2.1 Protocol
A protocol defines how the fluid injection procedure will proceed and is comprised of three elements: phases, a pressure limit, and an optional number of reminders. Phases are steps that define the actual movement of fluid. The pressure limit is a setting that governs the fluid pressure generated within the system during the injection sequence. Reminders are user-determined timing notifications to be generated during the injection sequence.
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Stellant with Certegra Workstation
4.2.1.1 Phase
There are three types of phases: • Fluid Delivery Phase: Defines the flow rate, volume, and duration of a fluid to be injected. • Programmable Pause Phase: Defines a set amount of time fluid injection will be paused. The next phase will execute once the set time has elapsed. • Hold Phase: Places the fluid delivery in Hold. The user must actively re-engage the system to advance to the next phase.
4.2.1.2 Pressure Limit Defines the maximum fluid pressure the system is permitted to generate during the execution of the protocol. The maximum pressure limit is 325psi (2,241 kPa) when utilizing MEDRAD disposable syringes. If utilizing a pre-filled syringe adaptor, reference the associated operations manual for use for the associated maximum pressure limit. The operator may choose to reduce this limit based on the conditions for use of the protocol.
4.2.1.3 Reminder An operator defined request for the system to provide a notification to the user after a defined time has elapsed during the protocol execution.
4.2.2 Protocol Manager Once a user configures the phases, pressure limit, and optional reminders, the protocol is complete and can be saved and recalled for later use. Through the Protocol Manager, the operator can save and sort protocols with unique operator defined names. These protocols can then be recalled at a future point for repetitive utilization.
4.2.3 Fluid Delivery System Design The system is flow-controlled. The flow rate specified in a phase is the value the system targets to deliver during the injection until the defined phase volume is delivered. The duration is the defined time the phase will take to perform the volume injection at the stated flow rate. The System permits the operator to define any two of these three parameters with the third calculated.
4.2.4 Fluid Pressure and Pressure Limiting The fluid pressure is measured by the system during the execution of a phase and ensures the protocol Pressure Limit is not exceeded. Fluid pressure is generated by delivering fluid through the attached disposable system at the desired flow rate. The resulting measured fluid pressure is dependent on the following: • Flow Rate • Fluid Properties • Fluid Temperatures • Attached Disposables • Catheter Type/Size Pressure Limiting occurs when the above conditions result in the measured fluid pressure exceeds the protocol Pressure Limit setting. If this occurs, the system informs the operator of the condition and initiates Flow Rate Reduction for the phase to reduce the fluid pressure.
4.2.4.1 Flow Rate Reduction As flow rate is reduced the resulting measured fluid pressure is decreased. The system continues to deliver the phase volume at this reduced flow rate resulting in a phase duration exceeding the targeted duration.
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System Overview 4.2.5 Response to Occlusions When injecting into an occlusion, a stall condition or high pressure disarm results. If a stall or high pressure disarm occurs, check the fluid path for blockage and inspect the disposable set for damage. If no issue is found consider increasing the catheter size or decreasing the flow rate. NOTE: A stall condition occurs when the actual flow rate is less than 10% of the defined rate. 4.2.6 Volume and Flow Rate Protection The System provides the following protection against over and under volume or flow rate conditions: • Warnings display on the Safety screen to remind the operator to check the programmed injection parameters prior to the System being armed. • On-screen indications of insufficient volume 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 is stopped. 4.3 Syringe Installation Features CAUTION Mechanical Hazard - Minor or moderate patient and/or worker injury may result. • Ensure the syringe is properly snapped into the front of the injector head before injecting. Improper engagement or rotating syringe may cause the syringe to leak, become damaged, or to come off during the injection and result in an under-volume delivery and become a flying projectile. The injection system is designed with four features to decrease the amount of time and steps to load disposable syringes. 1. Non-rotational orientation: To install a syringe onto the injector, snap the syringe onto the front of the injector head (no alignment necessary). 2. Auto-docking: Once a syringe is installed, the injector piston advances, finds the syringe plunger, and docks with it. If the syringe was previously filled with fluid, no further action is initiated at this time. 3. Auto advance: 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 pre-filled 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. Auto retract: When the syringe is removed, the piston rod will automatically retract (if enabled). 4.4 Programming Mode The System allows an operator to enter values for any two parameters and calculates the value for the third. By default, an operator can enter values for flow rate and volume and the System calculates the duration. An operator can toggle the value calculated by the System using Programming Mode. The System can calculate the flow rate, volume, or duration. To enable Programming Mode, see "Advanced Operations" for more information. 4 - 11
Stellant with Certegra Workstation 4.5 Basic Informatics If an optional Informatics platform is included with the System, please refer to the Stellant with Certegra Workstation Informatics Panel and Modality Worklist Operations Manual for overview and functionality. 4.6 Using the 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. CAUTION Mechanical Hazard - Minor or moderate patient and/or worker injury may result. • Tighten all screws, clamps and knobs during assembly and as needed during use. Loose components may cause the pedestal to collapse. • 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. Maneuver the injector as recommended by the injector Operator Manual. • Do not adjust the integrated IV pole or move the injector when anything is hung from the pole. • 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 designed to hold a maximum weight of 5 lbs / 2,265 grams each. Do not exceed the weight limits. • 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 15 - 56. Electric Shock Hazard - Minor or moderate patient and/or worker injury may result. • Only plug the System into a direct mains access point. Do not plug the System power cord into an extension cord or multi-outlet power strip. Procedure Delay Hazard - Serious patient and/or worker injury or death may result. • Turn off any equipment that could generate a high level electrostatic discharge. 4.6.1 Pedestal 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 overtighten. • To store: Turn the adjustment knob counter-clockwise and retract the Integrated IV Pole. 4 - 12
5 Understanding the Display and Pod • "Home Screen" • "Pod Description" 5.1 Home Screen
Figure 5 - 1: Home Screen
Name 1 Volume Remaining
2
Add Volume Indicators (if applicable)
3
Phase button (edit phase)
4
Phase button (new phase)
5 Flow Rate
6 Volume
7 Duration
8 Total Volume
9 Reset 10 Date and Time
Description Shows the volume in the syringes. An outline of the syringe displays, if no syringe is present. A dotted line displays on the Syringe graphic to indicate that there is not enough volume in the syringe to complete the current protocol. An Add box displays the volume that needs to be added to complete the current protocol. Select to edit a phase type. Select to enter a new phase type. Displays the programmed flow rate. Select to modify (if enabled). Displays the programmed volume. Select to modify (if enabled). Displays the programmed duration. Select to modify (if enabled). Displays the total programmed volume per syringe or the total combined volume in both syringes. See "Advanced Operations" for more information. Resets the protocol to the default factory values. Shows the current date and time.
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Stellant with Certegra Workstation
Name 11 Protocol Name 12 Pressure Limit 13 Reminders 14 Lock/Arm/Disarm 15 Status 16 Informatics Panel 17 Protocol Manager 18 System Information 19 Launch Menu
Description Displays the name of the protocol. Displays the current pressure limit. Select to modify. Displays the number of set reminders. Select to add or modify. Select to lock a protocol, arm the injector, and disarm the injector. Displays system status or alerts. Displays Informatics panel. Reference manual for details. For more information, see Figure 5 - 3: Protocol Manager. For more information, see Figure 5 - 2: System Information. For more information, see Figure 5 - 4: Launch Menu.
Figure 5 - 2: System Information
Name
Description
20 Injector icon
The Injector icon identifies various states of the injector: • not illuminated when the System is in the idle state. • illuminates yellow and flashes when the System is armed. • illuminates solid yellow when the System is injecting.
21
Injector Communicator
Illuminated yellow when in active communication with Injector Head.
22 ISI Communicator
Indicates active communication with ISI if ISI is available. See reference manual.
23 XDS Communicator
Indicates status of XDS accessory if XDS is available. See reference manual.
24 Check for Air icon
Illuminates yellow when the operator has confirmed inspecting the fluid path for air.
5 - 14
Understanding the Display and Pod
Name 25 Region of Interest 26 Protocol List 27 Protocol Preview 28 View All 29 P3T 30 Current Protocol 31 Exit
Figure 5 - 3: Protocol Manager Description Shows list of folders in which protocols are stored. List of protocols stored in the highlighted Region of Interest. Displays details of selected protocol. Displays all stored protocols. Displays only P3T stored presets. Shows details for current protocol in use. Returns to the Home screen with no protocol selected.
Name 32 Setup 33 Virtual Care 34 Help 35 Shutdown
Figure 5 - 4: Launch Menu Description Accesses the Setup options. See "Advanced Operations" for more information. Displays the contact information for Bayer Service. Launches the Help system. See "Advanced Operations" for more information. Accesses the Shutdown options.
5 - 15
Stellant with Certegra Workstation 5.2 Pod Description
Name 1 Abort 2 Power 3 Help 4 Start/Hold
Figure 5 - 5: Pod Description Terminates and disarms the injection. Turns the System on and off. Launches the Help system. See "Advanced Operations" for more information. Initiates injection. Holds injection for a maximum 20 minutes.
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6 Understanding the Injector Head and Hand Switch • "Injector Head Control" • "Injector Head Components" • "Hand Switch" 6.1 Injector Head Control
Name A Syringe A
Figure 6 - 1: Injector Head Control
Contrast Syringe
Description
6 - 17
Stellant with Certegra Workstation
Name
B Syringe B
1
Heat Maintainer (Side A or B)
2
Volume (Side A or B)
3 Auto Load
4 Fill A
5 Fill B
6
+/(Side A or Side B)
7 Prime
8 Move Piston
9
Piston Control (Side A or B)
10 Check for Air
11 Protocol Lock 12 Arm 13 Abort 14 Start/Hold 15 Arm Lights Manual Knob 16 (Side A or B)
Saline Syringe
Description
See "Syringe Heat Maintainer" for more information.
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. Activates the Fill A, Fill B, and the +/- buttons. Fills Syringe A to the displayed volume. Fills Syringe B to the displayed volume. 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. Activates the forward and reverse piston controls. Times out after ten seconds of inactivity.
Advances and retracts the piston (variable speed).
Reminds user to verify that air is purged from the syringe and tubing. (Must be lit to enable arming.) Indicates the protocol lock on Display is enabled. (Must be lit to enable arming.) Arms the System. Terminates and disarms the injection. Initiates injection. Holds injection for a maximum of 20 minutes. See "Arm Lights" for more information. Permits an operator to manually move the piston when the injector is not armed.
6.2 Injector Head Components 6.2.1 Syringe Heat Maintainer
CAUTION Mechanical Hazard - Minor or moderate patient and/or worker injury may result. Do not use the syringe heat maintainer if the fault indicator light is illuminated. It is recommended that contrast be at 35 degrees Celsius prior to loading it into the syringe. Once the syringe is loaded, use the syringe heat maintainer to maintain the contrast temperature.
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Understanding the Injector Head and Hand Switch
6.2.2 Manual Knob
WARNING Air Embolism Hazard - Serious patient injury or death may result. • Ensure that patient is not connected while purging air from syringe, or engaging or advancing plunger. An operator can use the manual knob to purge air, check backflow of blood, and to assist in ensuring correct catheter placement. NOTE: For all non-automatic movements, it is critical for volume accuracy to ensure that the manual knob is turned one full turn clockwise after every reverse movement. An operator can adjust the amount of resistance on the manual knob from the Fluid Control option. This feature minimizes the draw-back of air or fluid after automatic piston movement, such as during Autoprime or at end of an injection. A setting of Low or Off increases the likelihood of draw-back during these conditions. See Fluid Control in "Advanced Operations" for more information.
6.2.3 Arm Lights The injector head has two arm lights that illuminate or flash depending on the conditions listed below:
Table 6 - 1: Arm Light Functionality
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.
6.3 Hand Switch The hand switch enables an operator to start, hold, and stop an injection. The hand switch contains a light that identifies the state of the injector. This light illuminates or flashes depending on the conditions listed below:
Table 6 - 2: Hand Switch Light Functionality
Condition
Hand Switch Light Description
Armed
The light flashes.
Injecting
The light illuminates.
Hold
The light flashes.
NOTE: Hand switch light functions the same whether it is connected to the Injector Head or the Pod.
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Stellant with Certegra Workstation 6 - 20
7 Power Up and Shut Down the System 7.1 Powering Up the System CAUTION Electric Shock Hazard - Minor or moderate patient and/or worker injury may result. • Verify that the voltage and frequency as labeled matches the voltage and frequency of the electrical outlet. 1. Press the Power button on the Pod. The Injector and the Display power up. 2. Read the warnings, and press Continue. The Home screen displays. 7.2 Power Down the System The System provides three options for powering down the System: Full System Shutdown, Injector Shutdown, and System Restart. 1. From the Launch menu, select a Shutdown option or press Power button on Pod. Figure 7 - 1: Power Down Options 2. Select from the following: • System Shutdown: Both the Display and Injector shut down. • Injector Shutdown: The Injector shuts down, the Display screen is blank, and Informatics operations remain running on the Display. 7.2.1 Hard Shutdown To perform a hard shutdown, press and hold the Power button on the Pod. NOTE: In the event that the graphical display is unresponsive, turn the power switch to off on the display or unplug the power cord. 7.3 Restore from Injector Standby When the System is in Injector Shutdown mode, the Injector is shutdown, the Display screen is blank, and the Informatics operations remain running in the background. 1. Press the Power button on the Display. The injector powers up and the Display screen becomes active. 2. Read the warning and press Continue. The Home screen displays. 7 - 21
Stellant with Certegra Workstation 7 - 22
8 Protocol Management WARNING Vessel Hazard - Serious patient injury or death may result. • Ensure that the programmed flow rate meets facility guidelines. • "Create or Edit a Protocol" • "Save a Protocol" • "Recall a Saved Protocol" 8.1 Create or Edit a Protocol Operators create and edit protocols from the Home screen. 1. Select an arrow (1) to create or edit a protocol.
Figure 8 - 1: Select Phase Type a. Define the phase type from the pick list (2) on the right of the display.
Table 8 - 1: Phase Types
Phase Type Test Inject A Test Inject B Contrast Saline Hold Pause
Description Injects a programmed phase from Syringe A followed by a hold phase. Injects a programmed phase from Syringe B followed by a hold phase. Injects a programmed phase from Syringe A. Injects a programmed phase from Syringe B. Phase where the injection is stopped until it is restarted by operator. Phase where the injection is stopped for a programmed amount of time. The injection resumes when the pause time elapses.
8 - 23
Stellant with Certegra Workstation NOTE: A test injection can only be the first phase in a protocol. NOTE: A user may delete phases from a protocol. The Delete functionality is only available when editing a protocol with more than one phase. NOTE: A test injection can be used to see if the catheter is properly placed. NOTE: A hold phase cannot be the first phase in a protocol. b. Select a parameter (3) and enter the values (4). Figure 8 - 2: Enter Parameters c. Select Enter to confirm the parameter or select Cancel to disregard. 2. Repeat step 1 to add additional phases. NOTE: If the programmed volume exceeds the amount of volume in the syringe(s), the System provides an on-screen indication, and displays how much fluid needs to be added in each syringe. NOTE: When modifications have been made to a protocol an Asterisk displays to the right of the protocol name. 3. Optionally, modify the default pressure limit. a. Select Pressure Limit. b. Select a pressure limit from the pick list. NOTE: Ensure that the pressure is set for the patient per facility guidelines NOTE: Ensure the proper pressure is set for the catheter and other disposables connected to the System. 4. Optionally, set or modify a reminder. Reminders are alerts that display after an operator-programmed amount of time. The System stores reminders as part of the protocol. NOTE: A reminder dialog displays when the reminder is initiated. NOTE: If an operator does not acknowledge the reminder dialog, the dialog will remain open. a. Select Reminders (1). 8 - 24
Protocol Management
Figure 8 - 3: Enter Reminders b. Select an empty reminder slot (2) to enter additional reminders, or select an existing reminder (2) to modify the parameter. c. Select Enter (3) when all reminders are entered. d. Enter the time (4) for the reminder in minutes and seconds. e. Optionally, select Remove (5) to delete a reminder. The protocol can be saved (see "Save a Protocol") or it can be used for an injection (see "Arming and Injecting"). 8.2 Save a Protocol Operators can save protocols that have been created or edited on the Home screen. NOTE: Unique protocol names are required within the same region. 1. Select Protocol Manager. 2. Under Region, select the folder in which to store the protocol. 3. Under Preview, select Store in <Region>.
Figure 8 - 4: Protocol Manager 4. Enter a Name for the protocol and select Enter.
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Stellant with Certegra Workstation 8.3 Recall a Saved Protocol 1. Select Protocol Manager. 2. Select the desired region or select View All (1). 3. Select the protocol name (2). 4. Select OK (3). The Home screen displays the selected protocol. Figure 8 - 5: Recall Protocol To edit the protocol, see "Create or Edit a Protocol". To use the protocol for an injection, see "Arming and Injecting". NOTE: P3T presets will be indicated with the P3T logo. For more information regarding P3T Presets, see the following Stellant with Certegra Workstation P3T reference manuals: P3T Cardiac, P3T Abdomen, and P3T PA. 8 - 26
9 Preparing for Injection • "Control Room Preparation" • "Scan Room Preparation" 9.1 Control Room Preparation WARNING Vessel Hazard - Serious patient injury or death may result. • Ensure that the programmed flow rate meets facility guidelines. 9.1.1 Informatics Panel See Stellant with Certegra Workstation Informatics Panel and Modality Worklist Operation Manual. 9.1.2 Prepare Injection Protocol 1. Set protocol. a. To recall a protocol, see "Recall a Saved Protocol". b. To create or edit a protocol, see "Create or Edit a Protocol". 2. Select Lock on the Display. NOTE: The icon on the Display changes to Arm, and the Injector Head Protocol Lock indicator illuminates. 9.2 Scan Room Preparation WARNING Air Embolism Hazard - Serious patient injury or death may result. • 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 the FluiDots® 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. Biological Contamination Hazard - Serious patient and/or worker injury or death may result. • Properly discard disposable items after use (refer to disposable label for specifics), or if there is any possibility that contamination may have occurred. Environmental Contamination Hazard - Serious patient or worker injury or death may result. • Follow aseptic technique, when handling disposable components. Specifically, maintain sterility of all disposable components. • Do not disassemble any disposable components. • Visually inspect contents and package before each use. Bacterial Contamination Hazard - Serious patient and/or worker injury or death may result. • Syringes are not intended to be used as storage containers. Do not use syringes to store fluids. 9 - 27
Stellant with Certegra Workstation WARNING Mechanical Hazard - Patient injury could result from leaks or ruptures during an injection. • Use only MEDRAD approved disposable products. • Use catheters and connectors with pressure ratings compatible with this system. CAUTION Mechanical Hazard - 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 or rotating syringe may cause the syringe to leak, become damaged, or to come off during the injection and result in an under-volume delivery and become a flying projectile. 9.2.1 Install and Fill a Syringe NOTICE Mechanical Hazard - Equipment damage may result. • Do not install disposables with excessive force. 1. Install a new syringe on the injector head by inserting it quickly and firmly in one motion. NOTE: Syringe can be inserted without consideration of alignment. 2. If Auto Advance is enabled, the piston automatically advances and engages the syringe plunger and then advances it to the full forward position. • Advance plunger to the end of the syringe using the piston controls on the injector head or manual knobs. 3. Install the filling device (e.g. spike, Quick Fill Tube) onto the end of the syringe. 4. Insert the filling device into the fluid source. NOTE: Refer to fluid manufacturer's instructions for use and/or package insert. 5. Fill Syringe via Auto Load or Manually. NOTE: Syringe A is the Contrast syringe and Syringe B is the Saline syringe. a. Auto Load: i. Press Auto Load on the Injector Head. The volume indicators on the injector head indicate how much fluid needs to be loaded to support the displayed protocol including the amount necessary to prime the patient tubing. • Optionally, press the +/- keys to increase or decrease the amount of volume loaded. ii. Press Fill. NOTE: Auto Load disables after 10 seconds of inactivity. NOTE: The System draws in the configured Auto Load Purge Volume and then expels this volume. The Auto Load Purge volume should be set to 30, 20, 10, or 0 mL, depending on the filling device. Instructions for selecting the correct volume are contained in“Fluid Delivery Setup” on page 13 - 48. b. Manually: i. Press MOVE PISTON and use the reverse piston control to fill the syringe with the desired amount of fluid. NOTE: MOVE PISTON disables after 10 seconds of inactivity. NOTE: If protocol volume is greater than fill volume, an insufficient volume communication will display prior to ability to inject. 6. Expel any remaining air from syringe. 9 - 28
Preparing for Injection 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 with the syringe pointed up to gather and accumulate the small bubbles. Expel the remaining air. 7. Remove filling device. 8. Connect the disposable tubing as outlined in "Attach and Prime the Tubing". 9.2.2 Attach and Prime the Tubing NOTICE Mechanical Hazard - Equipment damage may result. • Do not install disposables with excessive force. 1. Remove the connector tube from the package. 2. Remove the dust covers. 3. Ensure all air is purged from the syringe. 4. Securely attach the connector tube luer fitting to the syringe tip. NOTE: If using a connector tube with a T-connector, first attach the straight portion to the Contrast (A) syringe and then the extension to the Saline (B) syringe.
B
A
Figure 9 - 1: T-connector
5. Verify that the tubing is not kinked or obstructed. 6. Connect the Prime Tube (1) to the patient end of the tubing set.
Figure 9 - 2: Prime Tube 7. Hold the Prime Tube higher than the patient’s position, and ensure that the filter (2) is pointing upward. 8. Prime the tubing with fluid: a. Prime Function i. Press Prime on the injector head. b. Manual Prime i. Turning the manual knob to advance the piston to prime the tubing. NOTE: Use the appropriate fluid to prime the tubing (Syringe A is the Contrast syringe and Syringe B is the Saline syringe.) c. Move Piston Prime (not recommended) i. Press Move Piston and use the piston controls to prime the tubing. NOTE: Leave the Prime Tube attached until immediately prior to patient connection.
9 - 29
Stellant with Certegra Workstation 9.2.3 Connect the Tubing to Patient 1. Ensure all air is purged from syringe and tubing. NOTE: If required, turn the manual knobs to remove any remaining air. 2. Rotate the injector head downward. 3. Remove the Prime Tube. 4. Connect the tubing to the patient. 9 - 30
10 Arming and Injecting • "Add Volume Indicator" • "Arm the Injector" • "Initiating an Injection" • "Operator Initiated Hold" • "Injection Aborted" • "Viewing Injection Progress" • "Viewing Reminders" 10.1 Add Volume Indicator Whenever the Total Volume is greater than the Volume Remaining, the Home Screen provides on-screen Add Volume indicators to communicate how much fluid should be added to perform the protocol. Figure 10 - 1: Add Volume Indicators NOTE: It is recommended that the operator resolve this condition prior to Arming the injector by either adding more fluid to the syringe or modifying the protocol. 10.2 Arm the Injector The System can be armed from either the Control Room or the Scan Room. 10.2.1 Arm from the Control Room 1. Select Arm on the Display. NOTE: If the last piston movement was a reverse movement or a syringe required by the protocol is not present, the System does not permit arming and communicates this to the operator. 2. Perform the Check for Air Confirmation: 10 - 31
Stellant with Certegra Workstation Figure 10 - 2: Check for Air Confirmation a. Select Yes to acknowledge that the user has confirmed that all air has been expelled from the syringe and tubing. NOTE: On the Display, the Check for Air icon illuminates, and on the Injector Head, Check for Air button illuminates. b. Select No if the user has not checked that all air has been expelled from the syringe and tubing. The System does not Arm. NOTE: The System monitors the syringe presence and piston movement after the Check for Air has been confirmed. If the syringe is removed or the piston is reversed, the System resets the Check for Air confirmation. 3. If the operator did not correct the Add Volume Indicator prior to Arming, the Insufficient Volume message is displayed.
10 - 32
Figure 10 - 3: Insufficient Volume - Accept Modified Protocol The System generates a modified protocol based on the available Volume Remaining. a. Select Yes to accept the System modified protocol. The System continues with the arm- ing process. Go to "Initiating an Injection". b. Select No to reject the System modified protocol. The System does not Arm. The System remains armed until one of the following conditions are met: • An operator selects Disarm on the Display. • An operator presses Abort. • An operator activates any injector head controls other than Start/Hold. • A 20 minute time-out occurs. • An injection has completed. NOTE: When armed, the Injector Head Arm button illuminates, the Injector Head Arm Lights blink, and the Display shows a Disarm icon.
Arming and Injecting 10.2.2 Arm from the Scan Room 1. Press the Check for Air button on the Injector Head to acknowledge that the user has confirmed that all air has been expelled from the syringe and tubing. NOTE: If the last piston movement was a reverse movement, or if a syringe required by the protocol is not present, the System does not permit arming and communicates this to the operator. NOTE: On the Display, the Check for Air icon illuminates, and on the Injector Head, Check for Air button illuminates. 2. Press the Arm button on the injector head. a. If a protocol has not been locked, the Lock icon blinks and the System does not arm. See "Control Room Preparation" for more information. b. If the Check for Air has not been confirmed, the Check for Air button blinks and an audible tone sounds. c. If an insufficient volume condition exists, injector head LED flashes. See "Arm from the Control Room" for more information on insufficient volume. i. Press Arm on the injector head to accept the System modified protocol, or ii. Wait until Volume indicator stops flashing and address insufficient volume. The System remains armed until one of the following conditions are met: • An operator selects Disarm on the Display. • An operator presses Abort. • An operator activates any injector head controls other than Start/Hold. • A 20 minute time-out occurs. • An injection has completed. NOTE: The Icon changes to indicate Disarm, the Injector Head Arm button illuminates, and the Injector Head Arm Lights blink. 10.3 Initiating an Injection NOTE: It is recommended that the operator stay by the patient’s side at the beginning of the injection. 1. Press Start/Hold on the Injector Head, on the Pod, or Hand Switch. NOTE: See Table 6 - 1 for description on how the Arm Lights function while armed, injecting, and/or during a hold. NOTE: If a Reminder is set, the operator is provided a communication once the Reminder elapsed time equals the setting. If a test inject phase is programmed, the Reminder elapsed time begins with the start of the first phase after the test inject. NOTE: The Reminder communication is removed when either the operator acknowledges the communication or another communication is activated. NOTE: Test Injection - an injection phase followed by a hold phase. After the injection phase, the System holds the injection until the operator presses Start/Hold on the Injector Head, Pod, or Hand Switch to resume the protocol. NOTE: Hold Phase - If the protocol contains a Hold Phase, the System holds the injection until the operator presses Start/Hold on the Injector Head, Pod, or Hand Switch to resume the protocol. 10.4 Operator Initiated Hold If the operator presses Start/Hold during an injection phase, the System holds the injection until the operator presses Start/Hold on the Injector Head, Pod, or Hand Switch to resume the protocol. NOTE: If an operator initiates a hold, the Reminder elapsed time is halted. The Reminder elapsed time starts when the operator re-initiates the protocol. 10 - 33
Stellant with Certegra Workstation NOTE: If the System remains in a hold condition for (20) minutes, the System aborts the injection automatically. 10.5 Injection Aborted At any time, press the Abort button or any other button on the Injector Head (other than Start/Hold) to abort the injection. 10.6 Viewing Injection Progress During an injection, the System displays the following: NOTE: If the injection is aborted, all remaining reminders are ignored.
10 - 34
Figure 10 - 4: Injection Views
1
Pressure Graph
The graph shows the pressure sensed by the System during an injection.
2 Phase View
The System highlights each phase as it starts.
3 Elapsed Time
Shows the duration of the injection. • If a test injection is programmed, the elapsed time begins after the test injection.
4 Pressure Limit Shows the programmed pressure limit.
5 Reminders
Indicates the number of set reminders.
6
Pressure Limit Line
Displays the programmed pressure limit on the pressure graph.
7
Injection Information
Displays the injection.
8
Indicators of Start of Phase
Shows the start of each phase.
NOTE: Elapsed time continues during an Operator Initiated Hold.
Arming and Injecting NOTE: The Pause symbol and Injector icon will blink during either an Operator Initiated Hold or a Programmed Hold. 10.7 Viewing Reminders A Reminder alert will display after the programmed time for the Reminder has elapsed. 1. Press OK to dismiss a Reminder. Figure 10 - 5: Reminder Communication 10 - 35
Stellant with Certegra Workstation 10 - 36
11 Completing an Injection • "Injection Complete" • "Injection Aborted" • "Exiting Injection Complete" 11.1 Injection Complete When an injection completes, • the Display and the injector head emit an audible tone, • the Injection Completed screen displays a summary of injection parameters and the actual parameters delivered, • the elapsed time of the injection continues to increment until an operator exits the Injection Completed screen. NOTE: Any remaining Reminders will display as they are triggered. Figure 11 - 1: Injection Complete - Summary 1. Procedure Data: Displays operator defined parameters at the procedural level. 2. Protocol Summary: Displays details of the completed protocol. 3. Allows the operator to toggle between Summary view and Graphical view. 4. Allows the operator to select if the next injection will be for the same patient or a different patient. NOTE: Elapsed time continues while this screen is displayed. Select Graph (3) to view a graphical representations of the injection. 11 - 37
Stellant with Certegra Workstation Figure 11 - 2: Injection Complete - Graph 1. Select the left or right arrow to scroll through the injection history. 2. Displays a graphical representation of the phases and pressure limits of the completed injec- tion. NOTE: Elapsed time continues while this screen is displayed. 11.2 Injection Aborted If the injection was halted, the Injection Aborted screen displays. 1. The System displays a reason why the injection aborted at the top of the screen. 2. Displays the procedure data for the aborted injection. 3. Displays information for how much of the protocol was completed. Figure 11 - 3: Injection Complete - Injection Aborted 11.3 Exiting Injection Complete 11.3.1 Conducting Another Injection NOTE: The System resets the Reminders to zero when an operator leaves the Injection Completed screen. 11 - 38
Completing an Injection NOTE: Depending on how Fluid Delivery Setup is configured, the protocol may reset after the injection. By default, the System keeps the previous protocol for the next injection. 1. Select Same Patient. a. The operator is returned to the Home screen. b. Reference "Protocol Management" to create or edit a protocol, or repeat the steps for "Arming and Injecting". 2. Select New Patient. a. The operator is returned to the Home screen. b. Reference "Preparing for Injection" of this document for further instructions. 11 - 39
Stellant with Certegra Workstation 11 - 40
12 Remove Disposables WARNING Biological Contamination Hazard - Serious patient and/or worker injury or death may result. • Properly discard disposables after use or if contamination may have occurred during setup or use. 1. Disconnect the disposable tubing set from the catheter. NOTE: The disposable tubing set does not need to be disconnected from the syringe. 2. Remove the syringe by twisting counterclockwise ¼ turn and pulling out. NOTE: If the syringe cannot be removed, rotate the injector head manual knob approximately two revolutions in the forward direction, then repeat Step 2 above. NOTE: Once syringe has been removed, the piston automatically retracts to the start position (if enabled). 3. Discard all used disposable items per facility regulations. 12 - 41
Stellant with Certegra Workstation 12 - 42
13 Advanced Operations • "System Setup" • "Setup of P3T® Software Functionality" • "Protocol Manager Setup" • "Fluid Delivery Setup" • "Informatics Setup" • "Help" • "Status" 13.1 System Setup System Setup enables the operator to configure settings that affect operation of the overall system. 1. From the launch menu, select Setup. 2. Select System Setup. Figure 13 - 1: Setup Categories (System Setup) 3. Select a System Setup Option. Figure 13 - 2: Setup Screen (System Setup Screen Shown) 13 - 43