Operation Manual: Centargo

Operation
Manual
Centargo
MEDRAD® Centargo CT Injection System Operation Manual
MEDRAD® Centargo CT Injection System
Operation Manual
The MEDRAD® Centargo CT Injection System has an expected service life* of 8 years from the date of product installation
when operated according to the instructions provided with this device. These 8 years include suggested or mandatory
actions of preventative maintenance and repair activities, as well as required calibration(s) that are needed. Required
reading includes the instructions for use and other materials provided with the device. This also includes any hardware
and software updates that may be required.
*EXPECTED SERVICE LIFE - The length of time that an individual unit, lot, or batch of devices is expected to remain
functional after it is placed into use.
Report any serious incident that has occurred in relation to this device to Bayer (radiology.bayer.com/contact) and to your
local European competent authority (or, where applicable, to the appropriate regulatory authority of the country in which
the incident has occurred).
A glossary of symbols can be found in Section 2 of this manual.
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1 Introduction ....................................................................................................1
1.1 Certifications ............................................................................................................................................................................ 1
1.2 Indications for Use.................................................................................................................................................................. 1
1.3 Training Information ............................................................................................................................................................. 1
1.4 Contraindications ................................................................................................................................................................... 1
1.5 Restricted Sales........................................................................................................................................................................ 1
1.6 Required Training.................................................................................................................................................................... 1
1.7 Disclaimers ............................................................................................................................................................................... 1
1.8 The Equipotential Connector (EPC) .................................................................................................................................... 2
1.9 Installation ............................................................................................................................................................................... 2
2 Symbols ...........................................................................................................3
2.1 General Symbols...................................................................................................................................................................... 3
3 Warnings, Cautions, and Notices ...................................................................7

3.1 Definitions................................................................................................................................................................................. 7
3.2 Warnings ................................................................................................................................................................................... 7
4 System Overview .............................................................................................9

4.1 Power On and Shut Down ..................................................................................................................................................... 9
4.2 Injector....................................................................................................................................................................................... 9
4.2.1 Fluid Loading Area.....................................................................................................................................................10
4.2.2 Day Set Install Area...................................................................................................................................................10
4.2.3 Heat Maintainer.........................................................................................................................................................11
4.2.4 Injector Base................................................................................................................................................................11
4.2.5 Lights ............................................................................................................................................................................12
4.2.5.1 Fluid Loading Area Lights ............................................................................................................................12
4.2.5.2 Patient Line Port Lights.................................................................................................................................12
4.2.5.3 Door Lights.......................................................................................................................................................12
4.2.5.4 Door Open Button Lights..............................................................................................................................13
4.2.5.5 Outlet Air Sensor Light..................................................................................................................................13
4.2.6 Moving the Injector...................................................................................................................................................13
4.3 Control Room Unit (CRU)....................................................................................................................................................13
4.3.1 Control Room Unit Symbols ...................................................................................................................................14
4.4 Display .....................................................................................................................................................................................15
4.4.1 Home Screen ...............................................................................................................................................................15
4.5 Day Set and Patient Line .....................................................................................................................................................16
5 Prepare Injector.............................................................................................17
5.1 Install Day Set........................................................................................................................................................................17
5.2 Load Fluids into Day Set......................................................................................................................................................18
5.3 Install, Prime, and Connect Patient Line.........................................................................................................................19
5.4 Within 24 Hours ....................................................................................................................................................................19
5.4.1 Replace Fluids As Needed ........................................................................................................................................19
5.4.2 Remove and/or Replace Spikes If Required .........................................................................................................20
5.4.3 Empty Prime Container As Needed .......................................................................................................................20
6 Perform Exam ................................................................................................21

6.1 Select Patient (Licensed Feature) ......................................................................................................................................21
6.1.1 Enter Patient and Procedure Information...........................................................................................................21
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6.1.1.1 Mandatory Fields........................................................................................................................................... 22

6.2 Select Protocol....................................................................................................................................................................... 23
6.3 Edit Protocol .......................................................................................................................................................................... 23
6.4 Arm Injector and Confirm Check for Air ......................................................................................................................... 24
6.5 Perform Injection(s) ............................................................................................................................................................. 24
6.6 Review Protocol and Perform Additional Injections.................................................................................................... 26
6.7 Finish Patient Exam ............................................................................................................................................................. 26
6.8 Remove, Discard and Replace Patient Line.................................................................................................................... 27
7 Eject Day Set ................................................................................................. 29

7.1 Empty Day Set (Optional)................................................................................................................................................... 29
7.2 Eject Day Set .......................................................................................................................................................................... 29
8 Administrative Operations........................................................................... 31
8.1 Admin Menu .......................................................................................................................................................................... 31
8.2 Protocol Management ........................................................................................................................................................ 32
8.2.1 Protocol Folders......................................................................................................................................................... 33
8.2.2 Protocols...................................................................................................................................................................... 33
8.2.2.1 Create Protocol............................................................................................................................................... 33
8.2.2.2 Edit Protocol ................................................................................................................................................... 34
8.2.2.3 Routine Protocol ............................................................................................................................................ 34
8.2.2.4 Configure Reminders .................................................................................................................................... 34
8.3 Contrast Management........................................................................................................................................................ 35
8.4 Settings ................................................................................................................................................................................... 36
8.4.1 Injector and CRU Networking ................................................................................................................................ 36
8.4.2 Scanner Suite Name ................................................................................................................................................. 36
8.4.3 Administration Passcode and Protected Tasks ................................................................................................. 36
8.5 Training................................................................................................................................................................................... 36
8.6 Import and Export................................................................................................................................................................ 36
8.7 Reports .................................................................................................................................................................................... 36
8.8 Licensing................................................................................................................................................................................. 38
8.9 Modality Worklist (MWL) Setup (Licensed Feature) ..................................................................................................... 38
8.9.1 Networking ................................................................................................................................................................. 38
8.9.2 Settings ........................................................................................................................................................................ 38
8.9.3 Anonymous................................................................................................................................................................. 39
8.9.4 DICOM Tags ................................................................................................................................................................ 39
8.10 Catheters (Licensed Feature)........................................................................................................................................... 39
8.10.1 Catheter Type........................................................................................................................................................... 39
8.10.2 Injection Sites .......................................................................................................................................................... 40
8.11 eGFR Setup (Licensed Feature) ....................................................................................................................................... 40
8.11.1 Equations and Background ................................................................................................................................. 41
8.11.2 References ................................................................................................................................................................ 41
9 Personalized Protocols (Licensed Feature).................................................. 43

9.1 Create and Edit Personalized Protocols.......................................................................................................................... 43
9.2 Using Personalized Protocols............................................................................................................................................ 44
9.3 P3T® Cardiac Software......................................................................................................................................................... 46
9.3.1 Essential Claims ........................................................................................................................................................ 46
9.3.2 Indications for Use.................................................................................................................................................... 46
9.3.3 Default Input Parameters ....................................................................................................................................... 46
9.3.4 Configuration Parameters ...................................................................................................................................... 47
9.4 P3T® Pulmonary Angiography (PA) Software ................................................................................................................ 49
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9.4.1 Essential Claims.........................................................................................................................................................49

9.4.2 Indications for Use ....................................................................................................................................................49
9.4.3 Default Input Parameters........................................................................................................................................49
9.4.4 Configuration Parameters.......................................................................................................................................50
9.5 P3T® Abdomen Software .....................................................................................................................................................53
9.5.5 Dosing Methods .........................................................................................................................................................56
9.5.6 Clinical Literature Summary...................................................................................................................................57
9.5.6.1 Individualized Dosing ...................................................................................................................................57
9.5.6.2 Delivery Method (Injection Duration or Flow Rate)...............................................................................58
9.5.6.3 Saline Flush......................................................................................................................................................58
9.5.7 References....................................................................................................................................................................58
9.6 Protocol Assistant .................................................................................................................................................................59
9.6.5 Clinical Literature Summary...................................................................................................................................60
9.6.5.1 Arterial Enhancement Procedures .............................................................................................................60
9.6.5.2 Parenchymal Enhancement Procedures ..................................................................................................61
9.6.6 References....................................................................................................................................................................61
10 Scanner Connectivity ..................................................................................63

10.1 ISI Configure Connectivity Settings................................................................................................................................63
10.2 Connect.CT............................................................................................................................................................................64
10.2.1 Indications for Use..................................................................................................................................................64
10.3 Connection Status Indicators ..........................................................................................................................................64
10.4 Troubleshooting Tips.........................................................................................................................................................65
11 Advanced Fluid Delivery Features...............................................................67

11.1 Adaptive Flow Behavior (Pressure Limiting) ...............................................................................................................67
11.2 Preloading the Protocol in the Patient Line.................................................................................................................68
11.2.1 Enabling Preload Protocol ....................................................................................................................................68
11.2.2 Configure a Protocol to be Preloaded ................................................................................................................68
11.2.3 Preloading a Protocol.............................................................................................................................................69
11.2.4 Repriming the Patient Line ...................................................................................................................................70
11.2.5 Modifying the Preloaded Protocol ......................................................................................................................70
12 Data Manager (Licensed Feature)...............................................................71

12.1 Web Based Applications....................................................................................................................................................71
12.1.1 Login ...........................................................................................................................................................................71
12.1.2 Compatibility Specifications.................................................................................................................................71
12.1.3 Navigation Bar .........................................................................................................................................................71
12.2 Accessing Injection Data...................................................................................................................................................71
12.2.1 Licensing....................................................................................................................................................................72
12.2.2 Security and Compliance Safeguards ................................................................................................................72
12.2.3 Roles and Access......................................................................................................................................................72
12.2.4 Edit Injector Details ................................................................................................................................................72
12.3 Manage Injections..............................................................................................................................................................72
12.3.1 Match .........................................................................................................................................................................73
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12.3.1.1 Match Additional Studies.......................................................................................................................... 73

12.3.2 Unmatch................................................................................................................................................................... 74
12.3.3 Edit Injection............................................................................................................................................................ 74
12.3.4 Transfer ..................................................................................................................................................................... 76
12.3.5 Hide/Unhide............................................................................................................................................................. 76
12.4 Export.................................................................................................................................................................................... 76
12.4.1 Export Injection Summary.................................................................................................................................... 77
12.4.2 Export Injection Details......................................................................................................................................... 77
12.4.3 Export Consumable Usage................................................................................................................................... 77
12.5 Site Management............................................................................................................................................................... 78
12.5.1 Backup....................................................................................................................................................................... 78
12.6 User Management ............................................................................................................................................................. 78
12.6.1 Add User.................................................................................................................................................................... 78
12.6.2 My Account .............................................................................................................................................................. 78
12.7 Data Manager Troubleshooting..................................................................................................................................... 79
13 Troubleshooting ......................................................................................... 81
13.1 Troubleshooting Tips ........................................................................................................................................................ 81
13.2 System Alerts....................................................................................................................................................................... 81
13.3 Communication Loss Between Injector and Control Room Unit........................................................................... 82
13.4 VirtualCare........................................................................................................................................................................... 82
14 Cleaning and Maintenance ........................................................................ 83

14.1 Daily Maintenance ............................................................................................................................................................ 83
14.1.1 Inspect Injector........................................................................................................................................................ 83
14.1.2 Inspect Control Room Unit .................................................................................................................................. 84
14.2 Clean Fluid Spills or Debris.............................................................................................................................................. 84
14.2.1 Clean Inlet/Outlet Air Sensor and Barcode Reader ........................................................................................ 84
14.2.2 Clean Piston Area ................................................................................................................................................... 84
14.2.3 Clean Prime Container .......................................................................................................................................... 85
14.3 Disinfect System ................................................................................................................................................................. 85
14.4 Annual Maintenance ........................................................................................................................................................ 86
14.4.1 Injection System Calibration ............................................................................................................................... 86
14.4.2 Check Electrical Leakage ...................................................................................................................................... 86
15 Options and Accessories............................................................................. 87

15.1 Ethernet Cables .................................................................................................................................................................. 87
15.2 Sterile Disposables............................................................................................................................................................. 87
15.3 Scan Room Unit Accessories ........................................................................................................................................... 87
15.4 Control Room Unit, USB Devices (Not provided by Bayer) ...................................................................................... 87
16 Specifications.............................................................................................. 89
16.1 Injector Specifications....................................................................................................................................................... 89
16.1.1 Injector Dimensions and Weight ........................................................................................................................ 89
16.1.2 Injector Power Requirements .............................................................................................................................. 89
16.2 Control Room Unit Specifications ................................................................................................................................. 90
16.2.1 Control Room Unit Dimensions and Weight................................................................................................... 90
16.2.2 Control Room Unit Connections......................................................................................................................... 90
16.2.3 Control Room Unit Power Requirements ......................................................................................................... 91
16.3 Injector Environmental Specifications ......................................................................................................................... 91
16.3.1 Non-Operating (Storage) ...................................................................................................................................... 91
16.3.2 Non-Operating (Transport) .................................................................................................................................. 91
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16.3.3 Operating ..................................................................................................................................................................91

16.3.4 Protection Against Electrical Shock....................................................................................................................91
16.3.4.1 Electrical Leakage........................................................................................................................................91
16.3.4.2 Ground Continuity.......................................................................................................................................91
16.3.5 EMI/RFI .......................................................................................................................................................................92
16.3.6 Protection Against the Ingress of Fluids ...........................................................................................................92
16.3.7 Mode of Operation ..................................................................................................................................................92
16.3.8 Fluid Delivery Performance...................................................................................................................................92
16.4 Control Room Unit Environmental Specifications.....................................................................................................93
16.4.1 Non-Operating (Transportation and Storage) .................................................................................................93
16.4.2 Operating ..................................................................................................................................................................93
16.5 Over and Under Infusion Protection..............................................................................................................................93
16.6 System Fluid Performance................................................................................................................................................94
16.6.1 Factors Affecting Flow Rates ................................................................................................................................94
16.6.2 Maximum Flow Rate Performance .....................................................................................................................94
16.7 Power Cable Specifications...............................................................................................................................................94
16.8 Cybersecurity and IT Network Connection...................................................................................................................94
16.8.1 System Cybersecurity Protection.........................................................................................................................94
16.8.2 Control Room Unit (CRU) Cybersecurity ...........................................................................................................95
16.8.3 IT Network Connection ..........................................................................................................................................95
16.9 Mains (AC) Fuse Specifications........................................................................................................................................95
16.10 Wireless Communication Specification ......................................................................................................................95
17 Compliance to IEC 60601-1-2 / 2nd, 3rd, and 4th Editions ........................97

18 Country-Specific Information ...................................................................103
18.1 Australia and New Zealand .......................................................................................................................................... 103
18.2 Canada ............................................................................................................................................................................... 103
18.3 European Union (EU)...................................................................................................................................................... 103
18.3.1 Declaration of Conformance ............................................................................................................................. 103
19 Index ..........................................................................................................105
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1 Introduction
This manual applies to the MEDRAD® Centargo CT Injection System (Centargo), also referred to as the system throughout
this document, Catalog Numbers: CENT-SYS-PED (pedestal) and CENT-SYS-BAT (pedestal with battery). Read all of the
information contained in this manual. Understanding this information will assist users in operating the system in a safe
manner.
NOTE: Operating specifications and feature availability may vary by country. Check with local product
representatives and refer to country-specific operating instructions.
1.1 Certifications
This device is equipped to operate at 100-240 VAC, 50/60 Hz, 336-377 VA and is designed to comply with IEC 60601-1 (3rd
Edition Amendment 1) and IEC 60601-1-2 (2nd, 3rd, and 4th Edition) standards, including national differences. Special
precautions regarding Electro-magnetic Compatibility (EMC) are required for installation and use of this injection system.
Detailed EMC information can be found in 17 Compliance to IEC 60601-1-2 / 2nd, 3rd, and 4th Editions.
1.2 Indications for Use

The system is indicated for the specific purpose of injecting intravenous contrast media and flushing solutions into
humans for diagnostic studies in x-ray applications.
1.3 Training Information

This manual is intended as an extension of the user interface of the Centargo to provide procedural and technical
information. Additional Centargo training information will be available in the following formats:
Q On-site initial installation and additional training as requested
Q Video training accessible on the control room unit (CRU) display
Q Instructions for use (IFU)
Please contact Bayer or your local Bayer representative if any of these resources are needed.
1.4 Contraindications
None known.
1.5 Restricted Sales

Federal (USA) Law restricts this device to sale by or on the order of a physician.
1.6 Required Training

This device is intended to be used by individuals with adequate training and experience in diagnostic studies in x-ray
applications.
1.7 Disclaimers
External wiring and modifications disclaimers: Bayer disclaims liability for any modifications or interfaces with other
equipment that are not in conformity with the specifications and information contained within this manual.
Anyone who connects additional equipment to the device or configures a medical system is responsible to ensure that the
system complies with the relevant requirements of IEC 60601-1. Any accessory or equipment connected to the device
must be certified to either IEC 60601-1 (Operator or Patient Environment Use) or, outside the patient environment, the
level of safety must be equivalent to equipment complying with their respective IEC or ISO safety standards, e.g. IEC
62368-1 or IEC 60950-1 (Operator Environment Use Only), and must comply with the relevant requirements according to
IEC 60601-1. Consult Bayer for any modifications to the equipment.
Screen images in this manual are for illustration purposes only. Actual screens may vary.
1
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 to form a medical system. 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.
Anyone who connects additional equipment to the device or configures a medical system is responsible to ensure that the
system complies with the relevant requirements of IEC 60601-1.
1.9 Installation
Contact Bayer for installation information.
2
2 Symbols
2.1 General Symbols
Warning: Refer to warnings and cautions on Instructions for Use packaged in each carton.
(ISO 7010, W001)
Warning: Indicates hazardous voltages. (ISO 7010, W012)
Warning: Indicates a pinch or crush hazard. (ISO 7000, W024)
Attention: Refer to warnings and cautions on Instructions for Use packaged in each carton.
(ISO 15223-1, 5.4.4)
MR Unsafe: Known threat or poses a hazard in all MR environments as defined by the ASTM
MR International Standards for MRI Device Marking. (IEC 62570, 7.3.3)
Pushing Prohibited. Do not push at or above this point on the Injector. (ISO 7010, P017)
Indicates alternating current. (IEC 60417, 5032)
Identifies the Equipotential connection. (IEC TR 60878, 5021)
Identifies the Earth Ground point. (IEC TR 60878, 5017)
Identifies a type BF applied part complying with IEC 60601-1 standards. (IEC 60417, 5333)
Indicates the injection system is Class 1 medical equipment as defined by EN 60601-1

CLASS 1 standards.
Class II Equipment, Double Insulated. (IEC 60417, 5172)
Indicates that this device conforms to the requirements of the European Medical
Device Directive 93/42/EEC.
Indicates separate collection for Electrical and Electronic Equipment per Directive 2012/19/
EU. Refer to the following website for additional information:
http://www.weee.bayer.com.
3
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.
10
Identifies a power switch for equipment. (IEC TR 60878, 5009)
Symbols on the Power Switch (IEC TR 60878: 5007, 5008):

O - Off
I - On
Stop button. (IEC TR 60878, 5110A)
Identifies a computer network. (IEC TR 60878, 5988)
Identifies a power supply connection. (IEC TR 60878, 5534)
Identifies a terminal suitable for direct current. (IEC TR 60878, 5031)
Identifies a transfer of displayed image to a second screen. (IEC TR 60878, 5892)
Identifies a handswitch connection. (IEC TR 60878, 5322)
Identifies an input terminal. (IEC TR 60878, 5034)
Identifies an output terminal. (IEC TR 60878, 5035)
Identifies service assistance. (IEC TR 60878, 0717)
Manufacturer (ISO 15223-1, 5.1.1)
Authorized Representative in the European Community (ISO 15223-1, 5.1.2)
4
Date of manufacture (ISO 15223-1, 5.1.3)
Temperature range (ISO 15223-1, 5.3.7)
Humidity range (ISO 15223-1, 5.3.8)
Atmospheric pressure range (ISO 15223-1, 5.3.9)
Serial number (ISO 15223-1, 5.1.7)
Part number
Catalog number (ISO 15223-1, 5.1.6)
This side up (ISO 7000, 0623)
Keep dry (ISO 15223-1, 5.3.4)
Fragile (ISO 15223-1, 5.3.1)
Quantity (IEC TR 60878, 2794)
91 KG
200 LB Maximum weight of the injection system and accessories during normal use.
(ISO 7000, 1321Bl; ISO 15223-1, 5.4.3)
5
Net Weight (ISO 7000, 1321B)
Hand wash only. (ISO 7000, 3125)
See accompanying documentation. This symbol indicates the user shall refer to the
instructions-for-use to ensure safe operation. (ISO 7010, M002)
Consult instructions for use. (ISO 15223-1, 5.4.3)
6
3 Warnings, Cautions, and Notices

3.1 Definitions
Indicates that the information is a warning. Warnings advise of circumstances that could
WARNING result in injury or death to the patient or operator. Read and understand the warnings
before operating the injection system.
Indicates that the information is a caution. Cautions advise of circumstances that could
 CAUTION result in minor or moderate injury to the patient or operator. Read and understand the
cautions before operating the injection system.
Indicates that the information is a notice. Notices advise of circumstances that could result
NOTICE: 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, a tip that
Note
helps with recovery from an error, or a reference to related information within the manual.
3.2 Warnings
WARNING
Environmental Contamination Hazard - Serious patient and/or worker injury or death may result.
Q Follow aseptic technique at all times. Improper handling can cause infection.
Q Discard disposables in case of suspected fluid path contamination.
Mechanical Hazard - Serious patient and/or worker injury may result.

Q Use only disposable products, accessories, and options compatible with this system. Use catheters and
connectors with pressure ratings compatible with this system. Patient injury could result from leaks or
ruptures during an injection.
Q Do not pull the injector with excessive force. Injector could fall and result in patient or operator injury.
Electric Shock Hazard - Serious patient and/or worker injury or death may result.
Q The system should be opened and serviced by qualified service personnel only.
Q Only use the power cord supplied with the system.
Q Equipment must only be connected to a supply mains with protective earth.
Q Only plug the system into a direct mains access point. Do not plug the system power cord into an extension
cord of multi-outlet power strip.
Q Do not touch the patient while pressing the Power, Unlock Door, or Advance Saline button.
Explosion Hazard - Serious patient and/or worker injury or death may result.
Q The system contains a lithium ion batteries. Replacement and disposal should be performed only by a
qualified service engineer. Contact Bayer for assistance.
Electro-Mechanical Hazard - Serious injury or death may result from exposure to hazardous voltages
existing within the system. Equipment damage may result or system may fail to operate.
Q Do not modify this equipment without authorization of the manufacturer. Patient or operator injury could
result from unauthorized modification to the equipment.
Q Do not service or perform maintenance on the injection system while in use with a patient.
7
8
4 System Overview
The system is comprised of the injector with a touchscreen display and the control room unit (CRU). The two components
are connected by a wired or wireless communications link.
4.1 Power On and Shut Down

Power On
Q Injector: Push power switch at the base of the injector to ON position (Figure 4 - 3: Injector Base). Press the Power
button on the side of the injector.
Q CRU: Press the power button (Figure 4 - 4: Control Room Unit).
Restart
Q Press the Restart button in the shutdown menu.
Shutdown
Q Press the Shutdown button in the shutdown menu. Alternatively, press and hold the power button on the side of
the injector.
4.2 Injector
Table 4 - 1: Injector Icons
# Icon Name
1 Advance Saline button

3
1
4 2 Unlock Door button
2 5
6 3 Power button (other side)
4 All-Stop button
5 Barcode Reader
6 Patient Line Port
7
7 Power switch (4.2.4 Injector Base)
9
4.2.1 Fluid Loading Area

The injector can support 50 mL to 500 mL of contrast bottles and 50 mL to 1000 mL of saline.
1 2
7
5
6
Figure 4 - 1: Fluid Loading Area
# Name Function
1 Saline Clamp Secure saline bottles.
2 Contrast Clamp Secure contrast bottles.
3 Clamp Hook Secure fluid bags.
4 Bottle Holder Hold fluid bottles in place and ease spiking (removable).
5 Spike & Spike Adapter Spike fluid for loading into the Day Set.
6 Inlet Air Sensor Detect air in Day Set tubing and lock spike adapter into the injector.
7 Advance Saline button Push a small amount of saline through an installed Patient Line.
4.2.2 Day Set Install Area
1 2
Figure 4 - 2: Day Set Install Area
# Name Function
1 Day Set location Store and administer saline and up to two contrast fluids.
10
# Name Function
2 Lock Levers Lock Day Set in place.
3 Outlet Air Sensor Detect air within fluids.
4 Prime Container Store discarded fluids.
4.2.3 Heat Maintainer

It is recommended that contrast be at 37 °C prior to being loaded into the Day Set. Once contrast is loaded into the Day
Set, the heat maintainer will maintain the contrast temperature.
4.2.4 Injector Base
2 4
Figure 4 - 3: Injector Base
# Icon Name
1 Power switch
2 Mains (AC power)
3 Battery circuit breakers
4 Network connection
11
4.2.5 Lights
The injector has various sets of lights that aid in providing instruction, depicting system status, and enhancing aesthetics.
4.2.5.1 Fluid Loading Area Lights

The fluid loading area lights are located within the fluid loading area and provide instruction and fluid status.
Light Display Condition
Off Day Set is not installed.
Flashing white Day Set is installed, but spike is not.
White Day Set and spike are installed, but no fluid is loaded.
Flashing fluid color Filling Day Set is in progress.
Fluid color Fluid is loaded into Day Set.
Orange Fluid supply is empty.
4.2.5.2 Patient Line Port Lights

The Patient Line Port lights surround the Patient Line Port and provide instruction and fluid status.
Flashing white System is ready for Patient line installation.
Do not connect to a patient.

Red Q Day Set is purging air.
Q Installed Patient Line is not primed.
Flashing fluid color Specified fluid is being primed or injected.
Fluid is successfully primed and/or fluid is being injected.

Fluid color NOTE: The fluid color light will display even if the injection is on hold or
paused.
Orange Patient Line is used and needs to be replaced with a new Patient Line.
4.2.5.3 Door Lights

The door lights provide injection status and aesthetic lighting.
Mood lighting Day Set is not installed.
Off Day Set is installed.
Flashing yellow Injector is armed.
Flashing fluid color Injection is in progress.
Fluid color Fluid is successfully primed and/or fluid is being injected.
12
4.2.5.4 Door Open Button Lights
Blue Door can be opened.
Off Door cannot be opened.
4.2.5.5 Outlet Air Sensor Light
Flashing orange Outlet air sensor door is open.
Green Outlet air sensor door is closed.
4.2.6 Moving the Injector

Unlock the wheels by pressing up on the brakes. Hold the handles located on the back of the injector and push in any
direction.
Re-lock the wheels by pressing down on the brakes.
NOTE: The injector power cord is the mains (AC power) disconnection device that isolates and removes AC
power from the injector. Do not place the injector in front of AC wall outlets and prevent access to the
supply mains.
4.3 Control Room Unit (CRU)

NOTE: The CRU is not for use in the scan room.
NOTE: The CRU power cord is the mains (AC power) disconnection device that isolates and removes AC power
from the CRU. Do not place the CRU in front of AC wall outlets and prevent access to the supply mains.
Figure 4 - 4: Control Room Unit
# Icon Name
1 Power On/Off
13
4.3.1 Control Room Unit Symbols
1 2 3 4 5 6 7 8
9
Figure 4 - 5: Control Room Unit, Rear and Side Port View
# Icon Function # Icon Function
Identifies computer network

Identifies power input and connection. Use to connect
1 2
supply connection. the system to the local area
network (RIS).
SS Identifies USB connections.

Identifies connection for
screen extension or transfer
3 Port 4, identified with yellow 4
to a second display. For Bayer
outline, always remains on.
use only.
Identifies a network
Identifies the fiber optic input
connection. Use for wired
5 6 and output connections. Not
CRU connection to the
for use with this system.
Injector.
Identifies injector head Identifies handswitch

7 connection. Not for use with 8 connection. Not for use with
this system. this system.
Identifies service ports. This

connection for Bayer service
9 use or for Connect.CT scanner
connectivity (refer to 10.2
Connect.CT).
14
4.4 Display
NOTE: Saline will always show as blue, Contrast 1 as green, and Contrast 2 as purple. If the same type and
concentration is loaded into both contrast reservoirs, both will show as green.
NOTE: Certain functions are available only on the injector or CRU display.
4.4.1 Home Screen
2
6
4
3
1
5
8 7
Figure 4 - 6: Home Screen
# Name Function
Load contrast and saline into Day Set and view status of Day Set and other fluid-loading
1 Injector
components. View contrast(s) loaded into the Day Set. Refer to 5 Prepare Injector.
Perform a patient's exam and injections. Depending on licensed features there are either
three or four steps: selecting a patient from the Modality Worklist (if licensed), selecting
2 Exam
a protocol from the protocol library, performing injection, and finally finishing the
patient's exam. Refer to 6 Perform Exam.
Manage the protocol library and contrast information, configure system settings, and
3 Admin
perform other administrative tasks. Refer to 8 Administrative Operations.
4 System Alerts Display a list of system alerts. Refer to 13.2 System Alerts.
5 Power button Open shutdown menu.
Press icons on user interface for more information on injector battery status, wireless
6 Status Icons
connection, and network connection status.
7 Screen Lock Press and hold to lock the screen.
8 Display Theme Switch themes.
15
4.5 Day Set and Patient Line
1
2
4 6
Figure 4 - 7: Day Set
# Name
1 Reservoir
2 Air Sensor Tube
3 Spike Adapter
4 Spike (dust cap on)
5 Patient Line Port (Day Set cap in)
6 Plunger
Figure 4 - 8: Patient Line
# Name
1 Patient end
2 Tubing
16
5 Prepare Injector
WARNING
Biological Contamination Hazard - Serious patient and/or worker injury or death may result.
Q For Patient Line and replacement spike, inspect contents and package prior to use. Do not use if sterile package is opened or
damaged. Patient or operator injury may result.
Q For Day Set, inspect components prior to use. Do not use if any dust caps are missing or displaced. Do not remove dust caps
until ready to make connections. Early removal of dust caps can result in contamination.
Q Do not reinstall, re-sterilize, or reprocess Day Set. Potential device failure includes significant component deterioration and
system failure. Potential risks to the patient include injury due to device malfunction or infection as the device has not been
validated to be reinstalled, re-sterilized, or reprocessed.
Q Do not use the Day Set for longer than 24 hours. Over-use poses risks to the patient, including contamination and injury due to
device failure.
Q Do not remove dust caps until ready to make connections. Early removal of dust caps can result in contamination.
Mechanical Hazard - Serious patient and/or worker injury or death may result.
Q Use care in handling and inserting spikes into saline and contrast. The spikes are sharp and may cause injury.
Air Embolism Hazard - Serious patient injury or death may result.

Q Do not modify or attempt to circumvent the operation of the air sensors.
5.1 Install Day Set

1. Press Unlock Door button to unlock injector door.
NOTE: Injector door will not open if Patient Line is inserted.
2. Insert new Day Set straight into the injector.
NOTE: Maximum use time for the Day Set is 24 hours.
3. Push down on lock levers. Lock levers click when Day Set is locked into place.
4. Push Air Sensor Tube into the outlet air sensor and close the outlet air sensor door.
5. Snap on spike adapters from Day Set onto assigned inlet air detectors.
NOTE: Ensure spike adapters are aligned with corresponding fluid reservoirs.
NOTE: Ensure adapters are fully inserted. Adapters click when locked into place.
6. Ensure the air detector door is closed.

7. Close the injector door.
17
5.2 Load Fluids into Day Set

Select Injector from the system Home screen to load contrast and saline into the Day Set.
1 3
8 7
Figure 5 - 1: Injector Screen
# Name Function
1 Saline Icon View saline installed or to be installed into the Day Set.
2 Contrast Fluid Icons View contrast(s) installed or to be installed into the Day Set.
Select and edit information for reservoir selected or view details of selected fluid
3 Side Panel
loading area.
Load selected and installed fluid into the corresponding fluid reservoir within the Day
Set.
4 Fill button
NOTE: Pressing Fill activates an expiration timer for each fluid loaded into
the Day Set.
When Day Set is installed, fill Day Set with fluid or empty/eject Day Set. Refer to 7.2 Eject
5 Day Set Day Set. When Day Set is not installed, activate piston moving for cleaning; refer to 14.2
Clean Fluid Spills or Debris.
Outlet Air Sensor

6 View outlet air sensor tubing status (primed, not primed).
Tubing
7 Patient Line View Patient Line status (primed, not primed).
8 Prime Container View status of fluid volume level within prime container.
1. Select one fluid icon.

a. For contrast, use the middle or far right icon.
b. For saline, use the far left icon.
2. Set fluid type and information by selecting the type on the display or scanning the barcode.
18
NOTE: Contrast barcodes must first be defined in the system for successful scanning. Refer to 8.3 Contrast
Management.
NOTE: If it is a different fluid from what is currently loaded in the reservoir, on-screen prompts will provide
instructions for emptying and re-filling the reservoir.
NOTE: Mandatory fields are identified with a red asterisk. Fluid information that is indicated as mandatory
must be entered to enable the Fill button.
3. Remove the spike dust cap (if present).

4. Spike the bottle or bag.
NOTE: Spike adapter may be removed from Inlet Air Sensor to ease spiking.
NOTE: Bottle holder may also be removed from injector to ease spiking; hold and slide bottle holder up to
remove.
a. For bottles, use clamp to secure. Pinch clamp and adjust position as needed.
b. For bags, use clamp hook to hang.
5. Press Fill.
NOTE: To set up a second contrast source if desired, repeat the steps in this section.
5.3 Install, Prime, and Connect Patient Line
WARNING

Q Do not connect the Patient Line to the patient until all trapped air has been cleared.
Q The Patient Line is intended for single use only. Do not re-sterilize, reprocess, or reuse. Potential device failure includes
significant component deterioration and system failure. Potential risks to the patient include injury due to device malfunction
or infection as the device has not been validated to be re-sterilized, reprocessed, or reused.
Q Do not reuse or reconnect the Patient Line. Cross-contamination can cause infection.
1. Remove orange Day Set cap (if present).

2. Insert Patient Line until it clicks.
NOTE: The system primes the Patient Line automatically. If lights are solid blue, the Patient Line is primed and
ready. If lights are red, the Patient Line is not primed. Refer to 13 Troubleshooting.
3. Check Patient Line for air.
NOTE: If additional prime fluid is needed, press and hold the Advance Saline button on the injector. Saline will
be pushed through the Patient Line.
4. Disconnect the patient end of the Patient Line from the injector.
5. Connect the Patient Line to the patient.
5.4 Within 24 Hours
5.4.1 Replace Fluids As Needed

For additional contrast and saline, repeat steps in 5.2 Load Fluids into Day Set.
19
5.4.2 Remove and/or Replace Spikes If Required

If the spike is accidentally touched, discard and replace with a new, sterile spike.
To replace a spike in a spike adapter:
1. Press both levers on left and right side of spike adapter.
2. While pressing, remove used spike and discard per facility guidelines.
3. Insert new spike into spike adapter.
NOTE: When installing a new spike, the circular orange vent must align with the indent on the back of the
adapter.
5.4.3 Empty Prime Container As Needed

1. Press Unlock Door button to unlock injector door.
2. Remove prime container, and dispose of fluids per facility guidelines.
3. Reinsert prime container, and close injector door.
20
6 Perform Exam
Press Exam from the system Home screen to begin an exam and deliver injections. Depending on licensed features there
are either three or four steps involved with performing a patient's exam.
Q If Modality Worklist (MWL) is licensed, select a patient’s study from the list and provide information about the
patient and procedure.
Q Select a protocol from the protocol library and modify if necessary.
Q Perform injection(s).
Q Finish a patient's exam.
6.1 Select Patient (Licensed Feature)

Modality Worklist is a licensed feature that displays a list of scheduled studies. Each entry lists the patient's name,
birthdate, sex, and identification number along with the study description and accession number. Refer to 8.9 Modality
Worklist (MWL) Setup (Licensed Feature) for instructions to configure which items are displayed.
Select the desired patient from the MWL.
NOTE: By default the first entry displayed in the worklist is an “Anonymous” patient. Select this entry if the
current patient does not appear on the worklist (e.g. the patient is unscheduled). Refer to 8.9 Modality
Worklist (MWL) Setup (Licensed Feature) to configure the values used for an Anonymous patient exam
entry or to make “Anonymous” unavailable.
Figure 6 - 1: Modality Worklist
6.1.1 Enter Patient and Procedure Information

Enter additional information about the selected patient or procedure as necessary.
NOTE: The number of available entry items depends on configured settings. This information is recorded along
with injection information and is used by other licensed features.
21
Figure 6 - 2: Patient Procedure
Table 6 - 1: Additional Patient or Procedure Information

Name Function
If the selected patient has other studies listed on the Modality Worklist, these studies
can be “linked” to the selected one. This is appropriate if multiple studies are being done
Linked Other Numbers simultaneously and the injections being performed apply to all of them.
NOTE: Refer to department/facility practices to determine applicability of

this feature.
If values for patient height or weight are available in the MWL entry, these values will
be shown. If values are missing or are incorrect, this information can be corrected.
Height, Weight Height and/or weight values may be used in the calculation of personalized protocols
(Refer to 9 Personalized Protocols (Licensed Feature)) or in an eGFR calculation (Refer to
8.11 eGFR Setup (Licensed Feature)).
If this feature is activated (Refer to 8.10 Catheters (Licensed Feature)) these values can
Catheter Type, Injection Site
be entered. If no options have been configured then these fields are not shown.
If one or more eGFR calculators were configured (Refer to 8.11 eGFR Setup (Licensed
eGFR
Feature), this is displayed. To use an eGFR calculator, enter the required values.
NOTE: Certain patient information (e.g. the patient's weight) is shared between personalized protocol
calculations, eGFR calculations and the patient procedure screen. The value displayed on the screen
across these applications may differ based on the units used (kilograms or pounds) or the precision
applied to the calculation. For personalized protocols using “Weight Bins” the midpoint of the bin is
used as the starting value.
6.1.1.1 Mandatory Fields

Specific patient or procedure information can be designated as a mandatory. Any fields that are designated as mandatory
must be populated. unpopulated mandatory fields are indicated with a red asterisk. The exam cannot be finished until all
mandatory fields are populated.
NOTE: If contrast (or saline) lot/batch or expiration date are designated as mandatory fields, then they must be
provided in order to Fill.
Mandatory Fields can be designated under Admin/Settings/Admin.

When ready to begin the exam for a patient, press Start Exam.
22
6.2 Select Protocol

Select a protocol from the protocol library, and press Select.
NOTE: If no protocol is selected from the protocol library, the system will display the Routine Protocol. For
information on configuring the Routine Protocol, refer to 8.2.2.3 Routine Protocol.
Figure 6 - 3: Select Protocol
6.3 Edit Protocol
WARNING
Extravasation Hazard - Serious patient injury or death may result.

Q Ensure the programmed flow rate meets hospital guidelines.
Hazard - Serious patient injury or death may result.

Q Patient injury or an image that is not sufficient for diagnosis could result if the protocol is not confirmed by the user. The user
is responsible for confirming that the protocol does not compromise the safety of a particular patient and will result in an
image sufficient for diagnosis, prior to injection.
Specific protocol values (e.g. flow rate or volume) can be edited by pressing the values; once selected, the system displays
a keypad. Add injections and phases using the edit panel on the right side.
NOTE: Refer to 8.2.2 Protocols for more information on injections and phases.
NOTE: Edits while performing an exam do not affect the stored protocol. Refer to 8.2.2.2 Edit Protocol to make
changes to a saved protocol.
23
Figure 6 - 4: Edit Protocol
6.4 Arm Injector and Confirm Check for Air
WARNING


The system must be armed prior to performing any injection in a protocol. Press Arm to arm the system.
For the first injection of an exam, a message displays asking for confirmation the Patient Line has been checked for air.
Q Press Yes to confirm all air has been expelled and no air is visible in the Patient Line.
Q Press No if the Patient Line has not been checked for air. The system will not arm.
If there is not enough available volume to fill the Day Set and complete the injection, an insufficient volume message
displays. Press Yes for the system to automatically adjust the volume to be delivered in the injection, or press No to load
more contrast and saline. Press Arm again after either reviewing the adjusted volumes or refilling has completed.
6.5 Perform Injection(s)

Q Start Injection: Once the system is armed, press the Start button to begin an injection.
24
Figure 6 - 5: Start Injection
Figure 6 - 6: Injection in Progress

Q Pause Injection: Press the Pause button. The system holds the injection until the Start button is pressed again
to resume to protocol.
NOTE: The system holds the injection for up to 20 minutes, after which time the injection is stopped.
NOTE: If Pause button is selected, the reminder elapsed time is halted and started again when the protocol is
resumed.
Q Skip to Next Phase: Press the Skip to Next Phase button to stop the current phase of an injection and start the
next phase. The button is disabled during the last phase of an injection.
Q Stop Injection: Press the Stop button on the display or the All-Stop button on the injector at any time to stop
the injection.
Q Adjust Flow Rate: Press the +/- buttons to adjust the flow rate in 0.1 mL/sec increments. Available only for test
injections.
25
6.6 Review Protocol and Perform Additional Injections

When an injection is completed, the injection summary panel is shown and the protocol displayed. The injection summary
panel includes further details on the last performed injection. The protocol area shows previously completed injections
and/or injections not yet started.
Figure 6 - 7: Protocol
Q Perform Additional Injections: Add additional injections to the protocol by opening the edit panel on the right
by tapping the < or sliding the panel open from the right side of the display. Select modifications to the protocol
by tapping and/or dragging and dropping the items.
Q Repeat Injection: The last performed injection can be repeated by pressing Repeat Injection on the injection
summary panel. The last performed injection is automatically duplicated in the protocol; press Arm to start the
injection.
NOTE: The pressure graph of the last performed injection can be viewed by pressing View Graph in the
injection summary panel.
6.7 Finish Patient Exam

When all injections are completed, press Finish to exit the protocol screen. The injection details are combined into a
summary and displayed.
When finished reviewing the summary, press End Exam to end the exam to prepare for the next patient exam.
Figure 6 - 8: End Exam
26
NOTE: Depending on available licensed features, the End Exam screen may have additional inputs or may have
other features shown (Refer to Figure 6 - 8: End Exam). The left image shows the screen when no
optional licensed features are in use (e.g. MWL or patient information). The right image shows the
screen when Mandatory Fields are missing. This information must be entered to enable the End Exam
button.
Name Function
Enter the ID (or initials, or name) of the person who conducted the exam. The system
Technologist ID maintains a list of the last 10 used values to be selected from or a keyboard to enter a
new one.
Enter any notes using a keyboard or select from a list of preconfigured Quick Notes that
Notes
were setup in Admin/Settings/Admin/Quick Notes.
6.8 Remove, Discard and Replace Patient Line
WARNING
Q Immediately insert a new Patient Line in order to protect the Patient Line Port. Failure to immediately insert a new Patient Line
can result in contamination.
NOTE: Patient Line is single-use only.
When an exam is completed, disconnect used Patient Line from the injector and the patient, and discard per facility
guidelines.
Immediately insert a new Patient Line in order to protect the Patient Line Port.
27
28
7 Eject Day Set

NOTE: Maximum use time for the Day Set is 24 hours.
Day Set
Reservoirs
Figure 7 - 1: Eject Day Set

Select Injector from the system Home screen, then select the Day Set reservoirs to:
7.1 Empty Day Set (Optional)

Empty the Day Set reservoirs of remaining contrast and saline in order to dispose of fluids separately from the Day Set.
Contrast and saline will remain in the inlet lines.
1. Press Empty Day Set, and follow the prompts on the user interface.
2. Once finished, disconnect and discard Patient Line.
3. Dispose of fluids per facility guidelines.
7.2 Eject Day Set

1. Press Eject Day Set.
2. A message displays asking for confirmation:
Q Press Yes to confirm the Day Set should be ejected. The pistons will begin retracting.
NOTE: Once the Day Set is ejected, it cannot be used again.
Q Press No if the Day Set should remain installed.

3. Open the injector door.
4. Lift the lock levers.
5. Open the outlet air sensor door, remove the Outlet Air Sensor tubing and close the outlet air sensor door.
6. Remove contrast, saline, and spike assemblies from spike adapters.
7. Remove the Day Set and discard per facility guidelines.
29
30
8 Administrative Operations
Select Admin from the CRU system Home screen to manage the protocol library, view training videos, configure system
settings and perform other administrative tasks.
Select Admin from the Injector system Home screen on the injector to manage contrast information.
8.1 Admin Menu

Most administrative tasks are done on the control room unit, a subset is available on the Injector Display.
NOTE: Depending on licensed features there may be more tiles than those shown in Figure 8 - 1: Admin Menu
Figure 8 - 1: Admin Menu

Table 8 - 1: Standard Tiles
Tile Function
Create, modify, and delete protocols, including personalized protocols (if licensed).
Protocols
Refer to 8.2 Protocol Management.
Manage saved contrast types. Refer to 8.3 Contrast Management.

Contrasts NOTE: This task is not available in the control room. The injector’s Barcode
Reader is required.
Settings Manage system settings. Refer to 8.4 Settings.
Logbook View exam, injector, and fluid activity.
View system information, including manufacturer, model and serial number, and
About
current software version.
Training View supplemental training material and videos. Refer to 8.5 Training.
VirtualCare Access remote service capabilities. Refer to 13.4 VirtualCare.
Date/Time Change the system’s date, time and time zone.
Import/Export Manage transfer and storage of system and exam information.
License View available programmed licenses. Refer to 8.8 Licensing.
31
Table 8 - 1: Standard Tiles
Tile Function
LAN1-RIS View and configure network connection status.
Proxy Settings Configure network settings.
Service For Bayer use only.
Reports View available reports. Refer to 8.7 Reports.
Table 8 - 2: Licensed Feature Tiles
Tile Function
Manage the settings for the Modality Worklist (MWL) feature. Refer to 8.9 Modality
MWL Setup
Worklist (MWL) Setup (Licensed Feature)
Configure the list of catheter types and injection sites. Refer to 8.10 Catheters (Licensed
Catheters
Feature)
Setup eGFR calculators to be available for use. Refer to 8.11 eGFR Setup (Licensed
eGFR Setup
Feature).
8.2 Protocol Management

Under Admin on the CRU, select Protocols to manage the organization and display of protocols stored in the system.
4 5
6 7
Figure 8 - 2: Protocol Management
# Name
1 Protocol Folder
2 Search Protocols
32
# Name
3 Add Protocol Folder
4 Protocol
5 Add Protocol
6 Delete Protocol Folder
7 Rename Protocol Folder
8 Display Summary Panel
8.2.1 Protocol Folders

Protocols are organized by and stored in folders, shown on the left side panel. View the protocols in each folder by
selecting a folder.
NOTE: A protocol must be stored in a folder. The only exception is the Routine Protocol (8.2.2.3 Routine
Protocol).
8.2.2 Protocols
A protocol is an injection or set of injections to be performed in an exam. It is comprised of three elements:
1. Phase(s): Delivery of individual volumes of fluid or duration of a pause within an injection. Phase types include:
a. Contrast: Injects a programmed volume of contrast.
b. DualFlow: Simultaneously injects a programmed volume of contrast and saline.
NOTE: The system automatically determines the individual volumes of contrast and saline and the individual
flow rates needed for the DualFlow phase.
c. Saline: Injects a programmed volume of saline.

d. Delay: Stops injection of fluids for a programmed amount of time.
2. Pressure Limit: Maximum pressure limit not to be exceeded during the injection.
NOTE: The maximum programmable pressure limit is 300 psi (2,068 kPa) when using disposables from Bayer.
This limit may be reduced based on patient condition or on the catheter type being used. Lowering the
pressure limit will reduce the maximum achievable flow rates.
3. Reminder(s) (optional): Countdown timers based on injection start (or end). These are stored as part of the
protocol and may be useful for coordinating timing of scan acquisitions. Refer to 8.2.2.4 Configure Reminders.
8.2.2.1 Create Protocol

1. Select a protocol folder.
2. Press the Add Protocol button.
3. Enter a name using the displaying keyboard, and press OK.
4. Select and/or drag and drop injection(s) to the center panel:
a. Test Injection: A test injection can be used to confirm the catheter is properly placed and the access site is
patent. Test injections can only contain Saline phases and can only be the first injection in a protocol. If
scanner connectivity is used, test injections are not associated with scan acquisitions.
b. Injection: A fixed set of phases to be injected.
c. Personalized Injection: An injection with phases based on parameters that are input at the time of a
patient's exam. Refer to 9 Personalized Protocols (Licensed Feature).
5. Select and/or drag and drop phases into the injection within the center panel. Arrange Contrast, Saline, DualFlow
or Delay phases as needed. Specify volume, rate, percentage, or duration values to be as desired.
33
6. Modify values as needed.

7. Press Save when completed.
8.2.2.2 Edit Protocol

When Display Summary is off, select a protocol. An editable protocol displays.
When Display Summary is on, select a protocol and press Edit in the right side panel. An editable protocol displays.
Figure 8 - 3: Edit Protocol
8.2.2.3 Routine Protocol

The Routine Protocol is the default protocol that displays when starting an exam.
The Routine Protocol displays when no protocol is selected. Like any other protocol, the Routine Protocol can be edited
from the Admin / Protocols section. To edit, select and edit as if any other protocol (8.2.2.2 Edit Protocol).
8.2.2.4 Configure Reminders
WARNING


Within a selected protocol, select the Reminders button next to the injection name. Select and enter parameters:
Q Time: Determine when the timer displays.
Q Begin Timer At: Determine if timer begins during the start of injection or when injection is completed.
Q Message: Determine if a message displays with reminder timer.
Press Save when completed.
34
8.3 Contrast Management
WARNING
Exposure to Unintended Contrast Hazard - Serious patient injury or death may result.
Q Do not configure contrast media with different active pharmaceutical ingredients (APIs) into the same contrast group. Small
residual amounts of contrast media within the Day Set could lead to dose-independent reactions. Refer to the contrast media
manufacturer’s package insert for specific indications and use time.
Under Admin, select Contrasts to manage the organization and display of contrasts stored in the system.
NOTE: Contrast agents of the same brand, including different concentrations, should be grouped together. The
system will not allow contrast agents from different groups to be loaded together into the Day Set.
1
5
2
6
Figure 8 - 4: Contrasts
# Name/Function
1 Contrast (by brand and concentration)
2 Contrast Group
3 Add Contrast
4 Delete Contrast
5 Define contrast barcode (separate barcodes for each package size).
6 Add another contrast package size for the same brand and concentration.
35
8.4 Settings
Under Admin, select Settings to configure system settings. Each setting has a name, short description and default value.
The following sections provide additional details for specific tasks.
8.4.1 Injector and CRU Networking

Select Admin/Settings/Networking to configure the communication between the injector and the CRU. connection, or
CENTARGO for a wireless connection. The wireless network is named BAYER_CENTARGO_SN<serial-number> and visible to
other devices but is password protected and private to the injector system.
Q On the CRU: Enter the injector serial number (visible on the injector's Admin/About screen). Select Disabled for a
wired.
Q On the Injector: Select Wireless or Wired as the connection type.
When configured the Injector will connect to the CRU and communications will be established. refer to 13
Troubleshooting.
8.4.2 Scanner Suite Name

Select Admin/Settings/General to enter the name of the scanner suite to identify the injector and CRU pairing. This name
will appear on the both injector and CRU user interface.
8.4.3 Administration Passcode and Protected Tasks

Set a passcode for certain administrative tasks to prevent any unauthorized changes.
To configure the passcode:
1. Select Admin/Settings/Admin, then Admin Passcode.
2. Enter a passcode, and select OK when finished.
To select which task(s) require passcode entry:
1. Select Admin/Settings/Admin and then Admin Protected Tasks.
2. Select the task(s), and select Done when finished.
8.5 Training
Under Admin, select Training to view available training materials.
8.6 Import and Export

Under Admin, select Import/Export to perform the following data management activities from the system:
Q Import: Import specified content from a previously exported file.
Q Export: Export specified content for use on another system.
Q Backup: Creates a system backup file, including injection history.
Q Restore: Restores a previously created backup file, preferably from the same unit; a restart is required when
restoration is complete.
Q Initial Setup: Partially restores a different system’s backup file (excluding injection data) when a new suite is
setup.
Q Stellant Import: Set up a new suite being upgraded from a MEDRAD® Stellant or MEDRAD® Stellant with
Certegra® Workstation.
Q Bayer Barcodes: View and update the saved Bayer barcodes and defined contrast information for the system.
8.7 Reports
Disposables Utilization Reports provide a monthly summary of the Day Set and Patient Line use in four charts.
36
NOTE: Patient Line reuse is estimated using pressure measurements during priming operations. This feature is
under development. Depending on disposable configuration, calibration, and system-to-system
variability, a Patient Line may be misclassified as new or used. It is intended for informational purposes
only, displaying general trends and not a definitive statement on whether the system is being used
according to the labeling.
Figure 8 - 5: Disposables Utilization Report
NOTE: This tile can be hidden using Admin/Settings/Admin and changing Reports Enabled.
Chart Name Description
Day Set Use Time Provides the length of time the Day Set was used.
Provides the number of exams performed with an expired Day Set per day of the
Exams with Expired Day Sets displayed month. The time for Day Set expiration is configured in Admin/Settings/
Admin.
Patient Line Utilization Provides the number of Patient Lines used for 1, 2 3, or more than 3 exams.
Exams with Reused Patient Provides the number of exams performed with a reused Patient Line per day of the
Lines displayed month.
The injector can be configured via Admin/Reports/Settings to automatically email a PDF copy of the reports.
NOTE: Contact facility IT networking group for required settings.
Setting Description
Disabled (default), Weekly, Monthly, Weekly & Monthly

Email Frequency NOTE: Monthly reports are sent on the first of the month. Weekly reports are
sent on Monday of each week.
Email address(es) to receive the report. Each email address must be separated by a
Email Recipient
semicolon (;)
Email Server/Host IP Address Hostname or IP Address of the email server.
Email Server/Host Port Port number of the email server.
37
Setting Description
Email Server/Host SSL

Does the email server requires use of SSL?
Authentication
Email Server/Host Account

The account name on the email server from which the email will be sent.
Name
Email Server/Host Password Password of the email server account.
8.8 Licensing
Under Admin, select License to activate or enable specific features for the injection system. A license must be obtained
and applied to the system. When the license is successfully installed, a restart is required. Contact Bayer or your local
representative from Bayer for further details.
8.9 Modality Worklist (MWL) Setup (Licensed Feature)

Modality Worklist is a licensed feature that links the injector system to the facility network and displays a list of
scheduled patient exams on the injector display.
Figure 8 - 6: Modality Worklist Setup
8.9.1 Networking
Modality Worklist must be configured before it can be utilized. Contact facility RIS or PACS administrator for help
configuring the Networking settings.
The DICOM Ping (C-Echo) button at lower right (refer to Figure 8 - 6: Modality Worklist Setup) can be used to confirm that
the provided values are correct and working.
8.9.2 Settings
Additional Modality Worklist settings that must be configured are shown in the following table:.
Setting Description
The worklist server may contain entries for multiple modalities. The injector can be set
Modality
to restrict the displayed modaility .
38
Setting Description
The worklist server may contain entries for multiple scanner suites. The injector can
Scheduled AE Title
sort and display patients scheduled to a specific suite.
Include Past X Days, By default the worklist server provides the current day’s scheduled studies. The system
Include Next X Days can be configured to provide additional days to the provided list.
Query Timeout, Determines how long the injector will wait for data from the worklist server and how
Modality Worklist Polling frequently the injector asks for updated worklist contents. Both can be adjusted as
Period required.
Procedure ID Source The values for these attributes may be Referring, Requested or Scheduled. Contact
Procedure Description Source facility RIS or PACS administrator for help selecting which to use if the default settings
Referring Physician Source do not provide the required values.
8.9.3 Anonymous
An Anonymous patient exam is available by default. If necessary, the availability of an Anonymous exam entry on the
worklist can be disabled/enabled. if different terminology or marker values are used to denote an Anonymous exam, the
name, sex, birthdate and study description can be customized.
8.9.4 DICOM Tags

Lists additional DICOM Tags that can be specified for retrieval from the worklist server, and/or displayed on the patient
and procedure screen (Refer to 6.1.1 Enter Patient and Procedure Information).
8.10 Catheters (Licensed Feature)

When the Modality Worklist feature is licensed and configured for use, catheter type and injection site used can also be
entered and recorded. Toggle between Types (catheter types) and Sites (injection sites) via the button on the lower left of
the screen. Entries can be deleted via the Delete button on the lower right corner of the screen
8.10.1 Catheter Type

The list of available catheter types must be configured before use. The list can be reordered by dragging and dropping the
catheter type.
Setting Description
User-entered name (e.g. "18g" or "18g by ER”). Allows more specific information about
Name
the catheter to be captured.
Catheter types have a common color coding conventions (e.g. 18g is green). The
Color designated color can be set for an catheter type as a visual cue to help the user select
the right value.
Displays standardized lists of values (e.g. Periperial or Indwelling) used for database
Type
queries. These do not appear on the exam screen but should be specified.
Displays standardized lists of values (e.g. 18 G or 24 G) used for database queries. This
Size
value does not appear on the exam screen but should be specified
39
8.10.2 Injection Sites

The list of available injection sites must be configured before use. The list can be reordered by dragging and dropping the
injection site. Each placement entry consists of the following:
Setting Description
Name User-entered name (e.g. "Right Antecubital", "Right Arm", or "Right AC").
Displays a standardized list of injection sites used for database queries (e.g. right wrist).
Code
This does not appear on the exam screen but should be specified.
8.11 eGFR Setup (Licensed Feature)

When the Modality Worklist is licensed, one or more eGFR (Estimated Globular Filtration Rate) calculator can be
configured for use. If more than one is configured, the individual performing the exam can select the appropriate eGFR
calculator to use.
Figure 8 - 7: eGFR Setup

The user can configure the equation type, default values and the equation name. Ranges with limits and color coding
may also be set. The first listed calculator is used as the default, drag and drop to reorder the list. Refer to Figure 8 - 7:
eGFR Setup.
In addition to a selection of pre-installed published equations, The user can manually enter an eGFR value from either the
patient's chart, or from a SCr meter device.
Name Description
Equation Name The equation used to calculate the eGFR value.
Either IDMS or Non-IDMS. The default calibration type for the SCr measuring device. Set
this based on department/facility standard practice. Default is IDMS. This option only
Calibration
appears if the Equation is set to MDRD, CKD-EPI, Bedside Schwartz, Cockcroft-Gault, or
Modified Cockcroft-Gault.
If desired, the calculated eGFR can be color-coded based on where the resulting eGFR
values land within your range determinations. Select the number of ranges that aligns
Number of Ranges with your institution's policy (e.g. <= 40: patient is not given contrast and >40: patient
is given contrast, then select 2 as your number of ranges). The default is None (no color
coding of ranges will be present).
40
Name Description
Upper Range Limits User is given the ability to select the upper limit for each range.
Range Color The color used to highlight the eGFR value when it falls in the range.
Toggle button: The default African descent setting to be used (default is No). This
African Decent
option only appears if the Equation is set to MDRD or CKD-EPI.
When performing a patient's exam, their eGFR value can be calculated by entering the values required for the configured
calculator. The required inputs vary for each equation. Serum Creatinine, gender and age are common example inputs. If
the required values were already entered on other screens or were available from the Modality Worklist those values are
pre-populated in the calculator.
8.11.1 Equations and Background
Euqtion Type Formula
MDRD eGFR=175 × S_cr^(-1.154) × Age^(-0.203) × 0.742 if Female × 1.212 if African Descent
eGFR = 141 × min(S_cr/0.7, 1)^(-0.329) × max (S_cr/0.7, 1)^(-1.209) × 0.993^Age ×

CKD-EPI
1.018 if Female × 1.159 if African Descent
Bedside Schwartz eGFR=(0.41 × Height)/S_cr
Cockcroft-Gault C_cr 24=((140 -Age) × Weight)/(72 × S_cr) × 0.85 if Female.
eGFR=(((140 -Age) × Weight)/(72 × S_cr )×0.85 if Female)×1.73/BSA

Modified Cockcroft-Gault
BSA= √((Height×Weight)/3600)
Manual Entry User-defined calculator.
NOTE: MDRD, Cockroft-Gault, Modified Cockroft-Gault, and CKD-EPI calculators are intended to be used only
for adults age 18 years or older. Bedside Schwartz is intended to be used only for children under 18
years of age. All formulas are only intended to be used with patient ages consistent with contrast
package inserts.
NOTE: eGFR formulas have known limitations. Adhere to site policy and guidelines for proper use of these
formulas.
NOTE: Known limitations regarding the Bedside Schwartz formula:
Q Above a GFR of 90 ml/min/1.73m2, the Schwartz formula may significantly overestimate eGFRs.
Q Bedside Schwartz formula is not adjusted for age or sex, which can have a significant effect on the prediction of
GFR.
Q The lower serum creatinine concentration in most children makes the influence of a measurement error
proportionally larger than the same magnitude error in an adult sample.
Q The generally lower serum total protein in very young children can alter the relative magnitude of the influence
of the nonspecific reaction of proteins in some Jaffe methods used to determine serum creatinine.
8.11.2 References
1. Levey AS, Coresh J, Greene T, Stevens LA, Zhang YL, Hendriksen S, Kusek JW, Van Lente F; Chronic Kidney Disease
Epidemiology Collaboration. Using standardized serum creatinine values in the modification of diet in renal
disease study equation for estimating glomerular filtration rate. Ann Intern Med. 2006 Aug 15;145(4):247-54.
2. Levey AS, Stevens LA, et al. A New Equation to Estimate Glomerular Filtration Rate. Ann Intern Med. 2009;
150:604-612.
3. Schwartz GJ, et al. New equations to estimate GFR in children with CKD. J Am Soc Nephrol. 2009; 20: 629-637.
41
4. Schwartz GJ and Work DF. Measurement and estimation of GFR in children and adolescents. Clin J Am Soc
Nephrol. 2009; 4 (11): 1832-43.
5. Cockroft DW, Gault MH. Prediction of Creatinine Clearance from Serum Creatinine. Nephron 1976 16: 31- 41.
6. Hahn T, Yao S, Dunford LM, Thomas J, Lohr J, Arora P, Battiwalla M, Smiley SL, McCarthy PL, Jr. A Comparison of
Measured Creatinine Clearance versus Calculated Glomerular Filtration Rate for Assessment of Renal Function
before Autologous and Allogeneic BMT. Biol Blood Marrow Transplant. 2009; 15: 574-579.
42
9 Personalized Protocols (Licensed Feature)

If the feature is licensed, Personalized Patient Protocol Technology (P3T®) or Protocol Assistant (PAT) software can be used
to generate personalized injection protocols.
NOTE: Not all algorithms are available in all markets. Check with local product representatives.
Depending on the algorithm, the personalized protocol may include the following injection types:
Q Test Injection: In order to check the patency of the vein, a small amount of saline can be injected as the first
injection in a protocol. With a personalized protocol, the test injection flow rate will be calculated to match the
diagnostic injection.
Q Transit Bolus Injection: For some algorithms, an optional transit bolus of contrast followed by saline can be
added to the protocol. This is also referred to as a timing bolus or test bolus, and is used to determine scan
timing or to make adjustments to the diagnostic injection protocol.
Q Diagnostic Injection: This is the main injection of the protocol and may be adjusted based on additional
parameters entered after a transit bolus.
Available algorithms with their claims, indications for use, and available configuration parameters are listed in 9.3 P3T®
Cardiac Software, 9.4 P3T® Pulmonary Angiography (PA) Software, 9.5 P3T® Abdomen Software and 9.6 Protocol Assistant.
9.1 Create and Edit Personalized Protocols

Under Admin / Protocols, personalized protocols can be created, edited, and organized similar to standard protocols (8.2.2
Protocols).
For each personalized protocol, configuration parameters, such as minimum and maximum flow rates or dosing factors,
are set. Default values for input parameters are set as well. When a personalized protocol is selected for an exam, those
default parameters are updated with the current patient and procedure information.
1. Select a protocol folder.
2. Press the Add Protocol button to add a new protocol.
3. Enter a name using the displaying keyboard, and press OK.
4. Select and/or drag and drop the Personalized Injection button to the center panel. This will create a diagnostic
injection.
1
4
3
5
Figure 9 - 1: Create/Edit Personalized Protocol
43
# Name Function
1 Personalized Injection Adds personalized injections to the protocol.
Defines default values for patient/procedure-specific inputs. Refer to the

2 Default Input Parameters
applicable algorithm’s Default Input Parameters section within this chapter.
Defines the P3T or PAT algorithm used for the calculation.

3 Algorithm
NOTE: Only one algorithm can be used per protocol.
4 Injection Type Defines the injection type (Test Injection, Transit Bolus, Diagnostic Injection).
Defines the configuration parameter values for the personalized protocol. Refer
5 Configuration Parameters to the applicable algorithm’s Configuration Parameters section within this
chapter.
5. To add a Test Injection and/or Transit Bolus Injection, select and/or drag and drop the Personalized Injection
button to the center panel again. Set the Injection Type accordingly.
6. Set values for Default Input Parameters and Configuration Parameters.
7. To preview the calculated protocol based on the selected values, press the Preview button.
8. Press Save when completed.
9.2 Using Personalized Protocols
WARNING


Q Patient injury could result if personalized protocols are used with patients with compromised renal function or other contrast-
adverse related health issues. Personalized protocols are not recommended if performing a procedure on a patient with
compromised renal function or some other contrast-adverse related health issues.

is responsible for confirming that the personalized protocol generated does not compromise the safety of a particular patient
and will result in an image sufficient for diagnosis, prior to injection.
NOTE: Personalized protocols can only be used when the CRU is on and connected (wired or wirelessly) to the
injector.
Personalized protocols that have been saved are available for selection in the protocol library under Exam / Protocols. In
the library, a preview displays of the calculated protocol, generated based on the Default Input Parameters.
After the personalized protocol has been selected, the Input Parameters should be updated based on the current values
for this exam. For example, if the Scan Duration differs from the stored default, the user should edit that value to
recalculate the protocol.
44
Figure 9 - 2: Edit Personalized Protocol

Prior to arming, review the calculated protocol to confirm none of the values are outside of acceptable ranges given the
condition of the patient. All flow rates and volumes are editable if necessary.
NOTE: During protocol selection, any edits made to a personalized protocol will not be saved when the exam is
completed. Refer to 9.1 Create and Edit Personalized Protocols to implement changes to a saved
personalized protocol.
When finished selecting and editing protocol (as applicable), perform exam, following steps in 6 Perform Exam.
45
9.3 P3T® Cardiac Software

P3T Cardiac is an algorithm that creates personalized protocols intended for CT angiography of cardiac structures,
coronary arteries, chambers of the heart, pulmonary vasculature, and thoracic and abdominal aorta.
9.3.1 Essential Claims

Q P3T Cardiac computes individual contrast injection protocols and scan timing for individualized dosing.
Q P3T Cardiac increases the consistency of individualized injection protocols amongst clinicians.
9.3.2 Indications for Use

P3T Cardiac is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart,
pulmonary vasculature, and thoracic and abdominal aorta. P3T Cardiac computes individual contrast injection protocols
and scan timing, based on patient characteristics, scanner parameters and contrast concentration.
9.3.3 Default Input Parameters

Table 9 - 1: P3T Cardiac Default Input Parameters
User-Selectable
Name Description Default Value
Values
300 - 450 mg/mL in

Contrast Defines the contrast concentration value used for
350 mg/mL increments of 1 mg/
Concentration the protocol.
mL
≤ 39 kg
40 - 59 kg
Sets either the exact patient weight or the weight 60 - 74 kg
Patient Weight bin, depending on the Weight Entry Method 75 - 94 kg 75 - 94 kg
parameter. Units can be in pounds or kilograms. 95 - 109 kg
110 - 125 kg
> 125 kg
Sets the maximum flow rate allowed for the

protocol. If the P3T protocol is generated such
that it exceeds the maximum flow rate value, the 5 mL/s - 10 mL/s in
Maximum Flow
protocol will automatically be adjusted so that 6.0 mL/s increments of 0.1
Rate
the maximum flow rate value is not exceeded mL/s
and the user is notified of the protocol
adjustment.
1 - 40 seconds in
Identifies the length of time for the Diagnostic
Scan Duration 10 sec increments of 1
portion of the scan acquisition.
second
Sets the maximum contrast volume allowed for

the diagnostic portion of the protocol. If the P3T
protocol is generated such that it exceeds the
Maximum 79 mL - 194 mL in
max contrast volume value, the protocol will 194 mL
Contrast Volume increments of 1mL
automatically be adjusted so that the max
volume is not exceeded and the user is notified of
the protocol adjustment.
Sets the maximum saline volume allowed for the

diagnostic portion of the protocol. If the P3T
Maximum Saline 0 mL - 194 mL in
maximum saline volume value, the protocol will 194 mL
Volume increments of 1 mL
46
9.3.4 Configuration Parameters

Table 9 - 2: P3T Cardiac Configuration Parameters
User-Selectable
Values
Test Injection Selects the way the test injection is calculated Volume, Injection
Volume
Delivery Method and delivery - by volume or duration. Duration
Test Injection Sets the volume for the test injection when the 10 mL- 50 mL in
20 mL
Volume Test Inject Delivery Method is set to Volume. increments of 1 mL
3 seconds -15
Test Injection Sets the duration of the test injection when the seconds in
5 seconds
Duration Test Inject Delivery Method is set to Duration. increments of 1
second
Sets the default volume for a contrast bolus

Transit Bolus 10 - 25 mL in
portion of the Transit Bolus if the Transit Bolus 20 mL
Contrast Volume increments of 1 mL
parameter is set to Yes.
Sets the default volume for a saline bolus portion

of the Transit Bolus if the Transit Bolus 40 mL
Saline Volume increments of 1 mL
Defines the way in which the user enters patient

weight. For Weight Bins, the system displays five
defined weight ranges for the patient. For Exact
Weight, the system displays a numeric keypad for
patient weight entry.
Weight Entry NOTE: If the user configures the Weight Entry Weight Bins, Exact
Method to use Weight Bins, a Weight Bins
Method Weight
representative weight within the
selected range will be used to
calculate the contrast dosage. As a
result, the Exact Weight weight entry
method is more accurate compared to
the Weight Bin entry method.
≤ 39 kg
40 - 59 kg
Enables a user to create seven custom weight 60 - 74 kg User defined. Each
Weight Bins bins. Units can be in pounds or kilogram 75 - 94 kg bin can be 3-31 kg
depending on system settings. 95 - 109 kg (3-71 lbs) wide
110 - 125 kg
> 125 kg
Enables the use of DualFlow for the P3T Preset.

When Yes is selected, the underlying algorithm
will consider a contrast dilution phase for the
protocol. In some cases, even through the Preset
DualFlow may include DualFlow, the algorithm may not Yes Yes, No
generate a protocol with a DualFlow phase (for
example, when scan durations are short and the
scan is completed before the time of the injection
of the DualFlow phase).
47
Table 9 - 2: P3T Cardiac Configuration Parameters
User-Selectable
Values
Used to calculate the duration for the first phase

of the diagnostic protocol. The Duration
Adjustment is added to the Scan Duration to
determine the injection duration of the first
phase. Contrast injection durations should be
sufficiently long to account for the dispersive
effects of the cardio pulmonary system. It is
therefore advisable to include additional
0 -10 seconds in
Duration injection duration to the bolus to avoid
4 seconds increments of 1
Adjustment suboptimal enhancement towards end of the
second
scan. The Duration Adjustment setup option
enables the user to configure this additional
injection duration. Since P3T computes the flow
rate of the contrast phase in the Diagnostic
Protocol based on contrast volume and injection
duration, a larger value of Duration Adjustment
results in a longer injection duration and a lower
flow rate.
Specifies the minimum injection duration of the

diagnostic contrast phase. In order to reduce
contrast volume, short minimum injection
duration value may be desired for very fast scans
(3-5 seconds) when the user is comfortable with
higher flow rates for a patient. The minimum
injection duration requirement is enforced after
Minimum
the Duration Adjustment is added to the Scan 16 seconds 6 - 16 seconds
Injection Duration
Duration. For example, in the case of a 5 second
Scan Duration, a 4 second Duration Adjustment,
and a Min Injection Duration of 10 seconds: the
calculated injection duration of the first phase of
the P3T protocol is 9 seconds, but would be
increased to 10 seconds based on the Min
Injection Duration specified.
Enables the user to edit the default weight 0.05 - 1.0 gl/kg in
0.5, 0.4, 0.375, 0.35,
Weight Factors factors, which determine the gI/kg used in the increments of
0.31, 0.30 gI/kg
first contrast phase of the diagnostic protocol. 0.001 gI
Sets the minimum volume for iodine load. If the

P3T protocol is generated such that it is less than
the Minimum Iodine Load value, the protocol's
Minimum Iodine 0 gI - 50 gI in
contrast volume will automatically be adjusted 20 gI
Load increments of 1 gI
so that the minimum iodine load value is not less
than the Minimum Iodine Load limit and the user
is notified of the protocol adjustment.
Sets the maximum volume for iodine load. If the

P3T protocol is generated such that it exceeds the
Maximum Iodine Max Iodine Load value, the protocol's contrast 20 gI - 80 gI in
38 gI
Load volume will automatically be adjusted so that increments of 1 gI
the max iodine load value is not exceeded and
the user is notified of the protocol adjustment.
Sets the volume for the saline flush phase. Set

Saline Flush 0 mL- 50 mL in
the volume to zero to eliminate the saline flush 30 mL
phase
48
9.4 P3T® Pulmonary Angiography (PA) Software

P3T PA is an algorithm that creates personalized protocols intended for CT angiography of pulmonary vasculature.

Q P3T PA computes individual contrast injection protocols and scan timing for individualized dosing.
Q P3T PA increases the consistency of individualized injection protocols amongst clinicians.

P3T PA is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart,
pulmonary vasculature, and thoracic and abdominal aorta. P3T PA computes individual contrast injection protocols and
scan timing, based on patient characteristics, scanner parameters, and contrast concentration.
NOTE: P3T PA has not been validated for anatomical regions outside of the stated Indications For Use.

Table 9 - 3: P3T PA Default Input Parameters
User-Selectable
Values
300 - 450 mg/mL in

mL
≤ 39 kg
40 - 59 kg
Sets either the exact patient weight or the weight 60 - 74 kg
Patient Weight bin, depending on the Weight Entry Method 75 - 94 kg 75 - 94 kg
parameter. Units can be in pounds or kilograms. 95 - 109 kg
110 - 125 kg
> 125 kg

that it exceeds the maximum flow rate value, the 5 mL/s - 10 mL/s in
Maximum Flow
Rate
adjustment.
1 - 40 seconds in
Identifies the length of time for the Diagnostic
Scan Duration 5 sec increments of 1
portion of the scan acquisition.
second


49

Table 9 - 4: P3T PA Configuration Parameters
User-Selectable
Values
Volume
20 mL
3 seconds -15
5 seconds
second
Sets the default volume for a contrast bolus

portion of the Transit Bolus if the Transit Bolus 20 mL
Contrast Volume increments of 1 mL
Sets the default volume for a saline bolus portion

of the Transit Bolus if the Transit Bolus 40 mL
Saline Volume increments of 1 mL

Weight Entry NOTE: If the user configures the Weight Entry Weight Bins, Exact
Method to use Weight Bins, a Weight Bins
Method Weight
≤ 39 kg
40 - 59 kg
110 - 125 kg
> 125 kg
50
User-Selectable
Values
Enables the use of DualFlow for the P3T Preset.

When Yes is selected, the underlying algorithm
will consider a contrast dilution phase for the
protocol. In some cases, even through the Preset
may include DualFlow, the algorithm may not
generate a protocol with a DualFlow phase (for
example, when scan durations are short and the
scan is completed before the time of the injection
DualFlow No Yes, On
of the DualFlow phase). Since DualFlow is
primarily beneficial for maintaining opacification
of the right heart structures, it may not be
required for pulmonary angiography studies.
Also, by configuring the Preset for P3T PA to not
include DualFlow, initial contrast volume
calculation could be lower than if it were
included.
Used to calculate the duration for the first phase

of the diagnostic protocol. The Duration
Adjustment is added to the Scan Duration to
determine the injection duration of the first
phase. Contrast injection durations should be
sufficiently long to account for the dispersive
effects of the cardio pulmonary system. It is
therefore advisable to include additional
0 -10 seconds in
Duration injection duration to the bolus to avoid
4 seconds increments of 1
Adjustment suboptimal enhancement towards end of the
second
scan. The Duration Adjustment setup option
enables the user to configure this additional
injection duration. Since P3T computes the flow
rate of the contrast phase in the Diagnostic
Protocol based on contrast volume and injection
duration, a larger value of Duration Adjustment
results in a longer injection duration and a lower
flow rate.
Specifies the minimum injection duration of the

diagnostic contrast phase. In order to reduce
contrast volume, short minimum injection
duration value may be desired for very fast scans
(3-5 seconds) when the user is comfortable with
higher flow rates for a patient. The minimum
injection duration requirement is enforced after
the Duration Adjustment is added to the Scan 6 - 16 seconds in
Minimum
Duration. 13 seconds increments of 1
Injection Duration
second
For example, in the case of a 5 second
Scan Duration, a 4 second Duration Adjustment,
and a Min Injection Duration of 10 seconds: the
calculated injection duration of the first phase of
the P3T protocol is 9 seconds, but would be
increased to 10 seconds based on the Min
Injection Duration specified.
Enables the user to edit the default weight 0.05 - 1.00 gl/kg in
0.5, 0.4, 0.375, 0.35,
Weight Factors factors, which determine the gI/kg used in the increments of
0.31, 0.30 gI/kg
first contrast phase of the diagnostic protocol. 0.001 gI
51
User-Selectable
Values


38 gI

phase
52
9.5 P3T® Abdomen Software

P3T Abdomen is an algorithm that generates personalized protocols intended to enhance the abdominal region (liver,
pancreas, kidneys, etc.). An overview of the relevant clinical literature with regards to the practice of patient-based dosing
for abdominal studies is available in 9.5.6 Clinical Literature Summary.

Q P3T Abdomen automates calculation of individualized injection protocols.
Q P3T Abdomen increases consistency of individualized protocols amongst clinicians.
Q P3T Abdomen provides multiple options for contrast dosing for CT imaging of the abdominal region.
Q P3T Abdomen makes these options available through an easy to use interface.

P3T Abdomen is indicated for use with CT imaging of abdominal organs (i.e., liver, pancreas, kidneys). P3T Abdomen
automates the calculation of individual contrast injection protocols, based on patient characteristics and contrast
concentration.

Table 9 - 5: P3T Abdomen Default Input Parameters
User-Selectable
Values
200 - 450 mg/mL in

mL
Sets either the exact patient weight or the weight

Patient Weight bin, depending on the Weight Entry Method 85 kg 20-320 kg
parameter. Units can be in pounds or kilograms.

that it exceeds the maximum flow rate value, the 4 mL/s - 7mL/s in
Maximum Flow
Rate
adjustment.


53

Table 9 - 6: P3T Abdomen Configuration Parameters
User-Selectable
Values
Defines the fluid to be used during the test

Test Injection Fluid Saline Contrast, Saline
injection.
Volume
20 mL
3 seconds -15
5 seconds
second

Weight Entry NOTE: If the user configures the Weight Entry Weight Bin, Exact
Method to use Weight Bins, a Exact Weight
Method Weight
≤ 39 kg
40 - 59 kg
110 - 125 kg
> 125 kg
Sets the minimum flow rate allowed for the

that it is less than the minimum flow rate value, 0 mL/s - 4 mL/s in
Minimum Flow
the protocol will automatically be adjusted so 0 mL/s increments of 0.1
Rate
that the minimum flow rate value is not less mL/s
than the Minimum Flow Rate limit and the user
Configures the module to generate a protocol

Injection Duration,
Delivery Method based on a fixed flow rate or fixed injection Flow Rate
Flow Rate
duration (time).
1 mL/s - 7 mL/s in
Delivery Method: Sets the flow rate for the generated P3T protocol
4 mL/s increments of 0.1
Flow Rate if the Delivery Method is set to Flow Rate.
mL
1 second - 3
Delivery Method: Sets the injection duration for the generated P3T minutes in
30 seconds
Duration protocol if the Delivery Method is set to Duration. increments of 1
second
54
Table 9 - 6: P3T Abdomen Configuration Parameters
User-Selectable
Values
Sets the Dosing Method for calculating contrast Weight, Volume,

Dosing Method Weight
volumes to Weight, Volume, or Iodine Load. Iodine Load
Configures the module to calculate the contrast

volume based on patient weight in terms of One value per bin.
Dosing Method: grams of Iodine per kilogram of patient weight 0.4 gI/kg - 0.6 gI/kg
0.5 gI/kg
Weight (gI/kg). Contrast volume is calculated by: in increments of
Contrast volume = (Dosing Factor * Patient 0.01 gI/kg
Weight) / (Iodine Concentration * 1000)

volume based on patient weight in terms of One value per bin.
Dosing Method: milliliters of contrast per kilogram of patient 1.0 mL/kg - 2.5 mL/
1.6 mL/kg
Volume weight (mL/kg). Contrast volume is calculated by: kg in increments of
Contrast volume = Dosing Factor * Patient 0.1 mL/kg
Weight

volume based on grams of iodine. Contrast
volume is calculated by: One value per bin.
Dosing Method: Contrast volume = Dosing Factor * Iodine 40 gI 18 gI - 70 gI in
Iodine Concentration * 1000. increments of 1 gI
NOTE: Patient weight is not considered when
Iodine Load dosing method is used.


60 gI

phase
55
9.5.5 Dosing Methods

P3T Abdomen offers flexibility with the choice of three dosing methods: Weight Factor, Volume Factor and Iodine Load.
The dosing methods primarily differ in the variables used for calculating the individualized contrast volume: Patient
Weight and Concentration. Weight Factor method uses both Patient Weight and Concentration for determining an
individualized contrast dose. Volume Factor takes into account Patient Weight only, and Iodine Load takes into account
Concentration only for determining an individualized contrast dose.
Table 9 - 7: Three Dosing Methods: Weight Factor, Volume Factor, and Iodine Load
Dosing Method Parameter Dependent Variables Formula
Patient Weight Concentration
Volume = Weight*Weight Factor/

Weight Factor gl/kg Yes Yes
Concentration
Volume Factor mL/kg Yes No Volume = Weight*Volume Factor
Iodine Load gl No Yes Volume = Iodine Load/Concentration
For example, when using a contrast concentration of 300 mg/mL, a Volume Factor of 1.5 mL/kg is equivalent to specifying
a Weight Factor of 0.45 gI/kg.
The following table shows the equivalent weight factor values (gI/kg) for each volume factor –contrast concentration pair.
The shaded entries are weight factors that are either smaller or larger than the minimum and maximum values found in
clinical literature and hence would not be typically used for a CT Abdomen protocol. Using these results, it is possible to
summarize the most commonly used volume factor and contrast concentration pairs.
Table 9 - 8: Weight Factors Corresponding to Volume Factor-Concentration Pairs
Volume Factor
1.0 mL/kg 1.3 mL/kg 1.6 mL/kg 2.0 mL/kg 2.5 mL/kg
Concentration
300 mg/mL 0.30 0.39 0.48 0.60 0.75
320 mg/mL 0.32 0.42 0.51 0.64 0.80
350 mg/mL 0.35 0.46 0.56 0.70 0.88
370 mg/mL 0.37 0.38 0.59 0.74 0.93
400 mg/mL 0.40 0.52 0.64 0.80 1.00
The following graph shows the variation of iodine delivered with Weight Factor for different patient weights. Iodine dose
increases linearly with large weight factors and heavy patients.
56
Figure 9 - 3: Relationship Between Iodine Load and Weight Factor
NOTE: If different contrast concentrations are routinely used for abdomen studies, the Weight Factor method is
recommended since it takes into account both varying iodine content across contrast products as well
as patient weight.
NOTE: The Volume Factor method is superior to the Weight Factor method if the clinician prefers higher dosing
factors (the maximum Weight Factor value that can be configured is 0.6 gI/kg, but it is possible to
generate weight factors of up to 0.875 gI/kg when using Volume Factor with a contrast concentration of
370 mg/mL).
NOTE: The total iodine delivered in a protocol with any of the three methods will always be limited by the
value set with the Max Iodine Load setup option. Max Iodine Load provides the clinician with the
flexibility of setting an upper limit for contrast volume in the interest of patient safety.
9.5.6 Clinical Literature Summary

P3T Abdomen is designed to provide the clinician with flexibility in contrast dosing options for abdominal imaging. These
options are intended to reflect the range of clinical care currently practiced and described in the literature. A summary of
relevant clinical literature that was used to determine the different setup options and range of values is presented below.
9.5.6.1 Individualized Dosing

Literature references support the use of the following ranges to configure the dosing factor values:
Q Weight Factor: 0.4 gI/kg – 0.6 gI/kg in 0.01 gI/kg increments
Q Volume Factor: 1.0 mL/kg – 2.5 mL/kg in 0.1 mL/kg increments
Q Iodine Load: 18 g – 60 g in 1 g increments
Arana et al. analyzed the influence of contrast dose adjusted by weight vs. fixed contrast dose in the attenuation and cost
of abdominal CT and determined that aortic attenuation was significantly superior when contrast was tailored to the
patient weight. They concluded that when dose was tailored to patient weight, the use of 1.75 mL/kg of 320 mg/mL con-
centration contrast material (or 0.56 gI/kg) with saline flushing in abdominal SDCT allowed a reduction of contrast mate-
rial dose.
Yanaga et al. prospectively compared the effect of a protocol with a fixed contrast material injection dose and one with a
dose tailored to patient body weight on pancreatic enhancement. They concluded that injection protocols with doses tai-
lored to patient weight (2.0 mL/kg; 300 mg/mL concentration or 0.6 gI/kg) and fixed injection duration may help reduce
variations in pancreatic enhancement.
57
Heiken et al. determined a relationship linking per-patient contrast dosing and hepatic enhancement. They found that
the iodine doses required for desired hepatic parenchymal enhancement levels of 40, 50, 60, and 70 HU are 0.417, 0.521,
0.625, and 0.729 gI/kg. They also recommended against using contrast material of concentration of 240 mg/mL for
dynamic incremental hepatic CT except in small patients.
Yamashita et al. studied the optimal dose of intravenous contrast material for CT of the abdomen based on patient
weight. When dose was tailored to patient weight, they determined that 2.0-2.5 mL/kg of 300 mg/mL contrast (0.6-0.75
gI/kg) produced better results than did 1.5 mL/kg or a fixed dose for both arterial and hepatic parenchymal enhancement.
Arterial enhancement did not differ among the 2.0 mL/kg, 2.5 mL/kg, or fixed-dose groups when contrast was adminis-
tered at a rate of 3 mL/s.
Megibow et al. studied the minimum optimal dose of contrast medium for helical CT that can preserve image quality
while reducing cost. In a prospective trial, they assessed the acceptability of scans for different dose categories of 1.25,
1.5, 1.75, and 2.0 mL/kg with 300 mg/mL contrast. They concluded that a weight based dose at 1.5 mL/kg of low osmolal-
ity contrast medium (0.45 gI/kg) can provide acceptable scans in most patients.
Brink et al. assessed the potential for reduction of contrast material dose in hepatic by prospectively studying maximum
hepatic enhancement and contrast enhancement index for iodine loads varying from 18 g to 44 g. They found that in
heavy patients, a dose of 38 g of iodine produced adequate enhancement whereas, doses as small as 26 g may be suffi-
cient for lighter patients.
Ichikawa et al. studied the technical factors employed in an injection protocol for multiphasic contrast enhanced MDCT of
the liver. They determined that the use of a fixed injection duration (30 s) and a body-weight adapted contrast protocol (2
mL/kg with 300 mg/mL contrast or 0.6 gI/ kg), achieves similarity of time density curves of each organ in shape and pat-
tern across different patient weights. With fixed injection duration, the peak enhancement of the aorta, portal vein, and
liver constantly appear approximately at 10, 20, and 30 s after the injection is completed.
9.5.6.2 Delivery Method (Injection Duration or Flow Rate)

Awai et al. studied the effect of contrast material injection duration and rate for weight based injection protocols and
concluded that aortic peak time and peak enhancement are closely related to injection duration.
Bae et al. investigated the effect of injection rate of contrast medium on aortic and hepatic peak enhancement using
pharmokinetic analysis. They concluded that while the use of injection rates above 2 mL/s did not substantially increase
hepatic enhancement, higher flow rates helped increase the magnitude of arterial enhancement and temporal separation
of arterial and venous phases of enhancement.
9.5.6.3 Saline Flush

The benefits of including a saline flush following the diagnostic contrast injection phase for abdomen studies has been
cited in several literature references.
Schoellnast et al. reported that a saline flush statistically significantly improved enhancement of the liver, pancreas, por-
tal vein, and abdominal aorta for contrast enhanced abdominal multidetector CT.
Dorio et al. compared hepatic tumor conspicuity on CT after injection of either 150 mL or contrast or 100 mL of contrast
followed by 50 mL of saline. They determined that the two injection protocols did not result in meaningful difference in
liver parenchyma attenuation or lesion conspicuity. They also concluded that the routine use of saline flush potentially
yields cost savings and also decreases risk of contrast nephropathy.
Murakami et al. studied CT imaging of the hepatic artery and concluded that peak enhancement and duration of the pla-
teau of enhancement were greater when a saline flush is included in the injection protocol.
9.5.7 References
1. Arana E, et al. Cost reduction in abdominal CT by weight-adjusted dose, Eur J Radiol (2008), doi:10.1016/
j.ejrad.2008.01.048
2. Awai et al. Effect of Contrast Material Injection Duration and Rate on Aortic Peak Time and Peak Enhancement at
Dynamic CT Involving Injection Protocol with Dose Tailored to Patient Weight. Radiology 2004; 230:142–150.
3. Bae K et al. Aortic and Hepatic Peak Enhancement at CT: Effect of Contrast Medium InjectionRate –
Pharmokinetic Analysis and Experimental Porcine Model. Radiology 1998; 206:455–464.
4. Brink J et al. Hepatic Spiral CT: Reduction of Dose of Intravenous Contrast Material. Radiology 1995; 197:83–88.
5. Dorio et al. Using a Saline Chaser to Decrease Contrast Media in Abdominal CT. AJR 2003; 180:929–934.
58
6. Heiken, J et al. Dynamic Incremental CT: Effect of Volume and Concentration of Contrast Material and Patient
Weight on Hepatic Enhancement. Radiology 1995; 195:353–357.
7. Ichikawa et al. Multiphasic contrast-enhanced multidetector-row CT of the liver: Contrast enhancement theory
and practical scan protocol with a combination of fixed injection duration and patients’ body-weight tailored
dose of contrast material. EJR 2006; 58:165–176.
8. Megibow et al. Quantitative and Qualitative Evaluation of Low Osmolality Contrast Medium needed for Routine
Helical Abdominal CT. AJR 2001; 176:583–589.
9. Murakami, T et al. Determining the Optimal Timing for Early Arterial Phase Hepatic CT Imaging by Measuring
Abdominal Aortic Enhancement in Variable Contrast Injection Protocols. JCAT 2006; 30:206–211.
10. Schoellnast H et al. Improvement of parenchymal and vascular enhancement using saline flush and power
injection for multiple-detector-row abdominal CT. EJR 2004; 14:659-664.
11. Yamashita, Y et al. Abdominal Helical CT: Evaluation of Optimal Doses of Intravenous Contrast Material – A
Prospective Randomized Study. Radiology 2000; 216:718–723.
12. Yanaga, Y et al. Patient Body Weight-tailored Contrast Material Injection Protocol versus Fixed Dose Protocol at
Dynamic CT. Radiology 2007; 245:475–487.
9.6 Protocol Assistant

Protocol Assistant is a set of formulas that create personalized protocols intended for routine and advanced CT
examinations. An overview of the relevant clinical literature with regards to each CT procedure is available in section 9.5.6
Clinical Literature Summary. It is the responsibility of the user to assess the patient’s clinical presentation before
proceeding with any contrast media injection protocol.

Protocol Assistant provides the user with suggested weight based injection protocols for a range of common CT
examinations, with parameters based on published clinical dosage rates and techniques. It is not intended to replace
clinical experience and judgment.

Protocol Assistant is indicated for use in the following common CT examination types: Pulmonary, Aorta, Head/Neck,
Renal, Routine Chest, Soft Tissue Neck, Liver Portal Venous, and Liver Arterial. Protocol Assistant automates calculation of
individual contrast injection protocols, based on patient characteristics, scanner parameters, and contrast concentration.
Name Description Default Value User Selectable Values
Defines the contrast concentration value 300 mg/ml 200-450 mg/ml in

Contrast Concentration
used for the protocol. increments of 1 mg/ml
Sets the weight of the patient used to

calculate contrast volume for Routine 40-150 kg in increments
Patient Weight 85 kg
Chest, Soft Tissue Neck, Liver Portal of 1 kg
Venous, Liver Arterial procedure types.
Name Description
Pulmonary, Aorta, Head/

Defines the specific parameters and
Neck, Renal, Routine
algorithms used to create the
Procedure Type Pulmonary Chest, Soft Tissue Neck,
personalized protocol for the region of
Liver Portal Venous, Liver
interest.
Arterial
59
Name Description
Selects the way the test injection is

Test Inject Delivery Volume, Injection
calculated and delivered - by volume or Volume
Method Duration
duration.
Sets the volume for the test injection

10 - 50 ml in increments
Test Injection Volume when the Test Inject Delivery Method is 20 ml
of 1 ml
set to Volume.
Sets the duration of the test injection

3 seconds - 15 seconds in
Test Injection Duration when the Test Inject Delivery Method is 5 seconds
increments of 1 second
set to Duration.
Configures the protocol to include a

Saline Flush Saline Flush phase after the contrast Yes Yes, No
phase.
Sets the Iodine Delivery Rate for the

generated personalized protocol for 1.4 - 1.8 gI/s in
Iodine Delivery Rate 1.5 gI/s
Pulmonary, Aorta, Head/Neck, or Renal increments of 0.01 gI/s
procedure types.
Sets the MDCT Slice number used for

generating the personalized protocol for 4 MDCT, 16 MDCT, 64
MDCT Slice Number 4 MDCT
Pulmonary, Aorta, Head/Neck, or Renal MDCT, 128 MDCT
procedure types.
Sets the Iodine Dose used for calculating

Liver Iodine Dosing the volume of the contrast phase for 450 mgI/kg, 500 mgI/kg,
450 mgI/kg
Factor Liver Portal Venous or Liver Arterial 600 mgI/kg
procedure types.
9.6.5 Clinical Literature Summary

Protocol Assistant is designed to provide the clinician with suggested contrast media injection protocols for both routine
and advanced CT examinations. These options are intended to reflect the range of clinical care currently practiced and
described in the literature. A summary of the relevant clinical literature that was used to determine the different setup
options and range of values is presented below.
9.6.5.1 Arterial Enhancement Procedures

Fleischmann et al, investigated the effect of injection flow rate, volume, and duration on image enhancement. They con-
cluded that arterial enhancement can be increased increasing the injection flow rate and/or increasing iodine concentra-
tion.
Bae et al, analyzed protocols used with four, 16, and 64 Detector CT scanners and proposed injection durations based on
scanner capability.
Meiling et al, investigated the clinical use of 128 slice 4D CT in the diagnosis of hepatic disease. Reliable images were
obtained with injection times as short as 10 seconds.
Sigal-Cinqualbre et al, assessed the effect of a weight based dosage using contrast media concentration of 300mg/ml
Iodine at 0.8ml/kg injected over 30 seconds which dosage equals 240mg/I/kg. They concluded that this protocol is suffi-
cient for diagnostic image quality.
Auler et al, examined the use of saline chasing techniques and their effect on the contrast bolus in CT angiography. They
proposed that the saline flush pushes the contrast media into the venous system resulting in a longer time to peak
enhancement and allowing more consistent opacification.
60
9.6.5.2 Parenchymal Enhancement Procedures

Fleishmann et al, investigated the effect of body weight on the level of enhancement for CT Image acquisition. They deter-
mined that enhancement is directly related to contrast media concentration and volume, and inversely proportional to
the patient’s body weight.
Bae et al, reviewed protocols used on the soft tissue neck region. They recommend a dose of 0.4g I/kg (400mg/l/kg) inde-
pendent of injection flow rate.
Benbow et al, investigated the effect of weight based volume of contrast to optimize enhancement during abdominal CT.
They proposed a dosage of 450mgI/kg is more sufficient for a western body weight.
Ichikawa et al, investigated the relationship of weight based contrast dosing and image enhancement. They determined
that a dosage of 600 mgI/kg is more appropriate for the leaner Japanese demographic.
9.6.6 References
1. Fleischmann, D., & Kamaya, A. (2009). Optimal Vascular and Parenchymal Contrast Enhancement: The Current
State of the Art. Radiological Clinics of North America, 47, 13-26.
2. Bae, K. T. (2010). Intravenous Contrast Medium Administration and Scan Timing at CT: Considerations and
Approaches. Radiology, 256(Number 1), 32-61.
3. Meiling, G., Yongmei, Y. Application of 128 Slice 4D CT Whole Liver Perfusion Imaging in Hepatic Tumor. Cell
Biochem Biophys, 70, 173-178.
4. Sigal-Cinqualbre, A. B., Hennequin, R., & Abada, H. (2004). Low-kilovoltage Multi-Detector Row Chest CT in
Adults: Feasibility and Effect on Image Quality and iodine Dose. Radiology, 169-174.
5. Auler, M. A., Heagy, T., Aganovic, L., Brothers, R., Costelli, P., & Schoepf, J. (2006). Saline Chasing Technique with
Dual-Syringe Injector Systema for Multi-Detector Row Computed Tomographic Angiography: Rationale,
Indications, and Protocols. Current Problems in Diagnsotic Radiology, Vol 35, Number 1.
6. Benbow, M., K., & R., B. (2011). Simple weight-based contrast dosing for standardization of portal phase CT liver
enhancement. Clinical Radiology, 66, 940-944.
7. Ichikawa, T., Erturk, S., & Araki, T. (2006). Multiphasic contrast-enhanced multidetector-row CT of liver: Contrast-
enhancement theory and practical scan protocol with a combination of fixed injection duration and patients'
body-weight-tailored dose of contrast material. European Journal of Radiology, 58, 165-176.
61
62
10 Scanner Connectivity
The MEDRAD® Centargo CT Injection System can be connected to certain brands or models of CT scanners to exchange
information and to synchronize actions. There are three different types of scanner connectivity supported by Centargo:
two use the ISI2 hardware box, and one uses a standard ethernet cable.
NOTE: The injection system does not control the imaging system via the ISI2 module or Connect.CT. The
Injector notifies the scanner of the injection status which enables the scanner to synchronize the scan
timing based upon when the injection started. The scanner controls the start of the scan sequence after
it has received the injection start status and will not start the scan unless the scanner is in the correct
state. The scanner system maintains full control of the radiation initiation.
NOTE: The scanner CANNOT override any injector operation that is considered safety critical; for example, air
check confirmation, hold during an injection or stopping an injection.
Before using the instructions contained in this section:

Q All physical connections must be made between the Injection system, the MEDRAD® Centargo CT Injection
System and the scanner. Refer to the ISI2 Module Installation and User Manual and the following sections.
Q Both the scanner and injector must be configured to work together. Scanner connectivity may require that the
option to have been separately purchased from the scanner manufacturer.
10.1 ISI Configure Connectivity Settings

Once all physical connections are made between the CRU, ISI2 box and scanner, the injection system software must be
configured to allow communication.
ISI2 configurations must be set from Admin / Settings / General to one of the following values:
Table 10 - 1: ISI Connectivity Settings
Value Scanner Manufacturer
Disabled (Default) No ISI connectivity.
Philips (Hardware SAS)

ISI 700
Hitachi
ISI 900, ID 1 GE
Siemens (older models)

ISI 900, ID 2 Canon (formerly Toshiba)
Hitachi
ISI 900, ID 3 Siemens (newer models)
NOTE: There are two USB ports on the ISI2 box. If the cable is connected via the wrong port for the selected
configuration, a popup displays; unplug and switch ports or change the configuration. If unsure of
which ISI-900 ID to use for Siemens, try each.
63
10.2 Connect.CT
This interface uses a standard Ethernet cable between the scanner and the injector's CRU to communicate. For the CRU,
use port shown.
Scan Room Control Room
Ethernet cable
Scanner gantry Scanner console CRU Injector
Figure 10 - 1: Connect.CT Scanner Connectivity)

In addition to exchanging injection information and synchronizing actions, the scanner sends the patient and exam
information directly to the injector; therefore, the Modality Worklist on the injector is disabled.
Connect.CT is enabled by applying a license to the injector (using Admin / Licensing) and requires the scanner console to
have injector integration enabled. Contact the scanner manufacturer to enable injector integration.

The Connect.CT application is indicated for the specific purpose of allowing the injector to interface with a CT scanner.
10.3 Connection Status Indicators

The top right status area on the injector screens shows an icon that reflects the current connection status.
Table 10 - 2: Connection Status Indicators
Icon Description
None Scanner Connectivity is not enabled (or licensed).
No communication with the ISI2 box.
No communication with the scanner.
Scanner is not ready.
Injector and scanner communication working.
The presence of single or double arrows beside the white scanner icon indicates the connection mode. A single arrow
means the scanner is tracking the injector's activity but not controlling it. A double arrow means the scanner is
controlling the injector.
64
10.4 Troubleshooting Tips

Table 10 - 3: Troubleshooting Tips
Problem Condition Potential Solution
Go to Admin/Settings/General and select

Injector and scanner will not work Scanner communication icon is ISI2 connection type per Table 10-1, or for
together not present. Connect.CT verify that it is licensed by
going to Admin/Licenses.
There is no communication between the

The software displays the system and ISI2 module.
following icon: Q Verify the USB cable is connected
between the CRU and the ISI2 module.
Q Reboot the injector
If the problem persists, contact Bayer.
There is no communications with the

scanner.
Q Verify the scanner is configured to con-
The software displays the trol the injector
following icon:
Q Verify the cable between the scanner
and the ISI2 module/CRU is connected
to the proper ports.
Q Consider rebooting the injector and/or
scanner
If the problem persists, contact Bayer.
The software displays the The scanner and injector are

following icon: communicating, but the scanner is not
ready.
Q Consult your scanner manual
65
66
11 Advanced Fluid Delivery Features

The MEDRAD® Centargo CT Injection System offers a selection of advanced fluid delivery features that can further refine
the system's delivery of fluids to the patient.
11.1 Adaptive Flow Behavior (Pressure Limiting)

The injector allows the user to configure injector performance when injection pressure approaches the programmed
pressure limit to help prevent over-pressurization.
To configure Adaptive Flow Behavior, under Admin, select Settings/Device. There are two injector performance
configuration options:
User-entered value from 0-50%. Sets the maximum percentage the flow rate can be
reduced by when pressure exceeds the programmed pressure limit. Configuring a lower
Maximum Flow Rate Reduction will ensure the system prioritizes maintaining flow rate
Maximum Flow Rate and will abort the injection if pressure dictates that the flow rate cannot be achieved.
Reduction
NOTE: Configuring a Maximum Flow Rate Reduction of 0% will ensure that the
injection is aborted if the pressure is ever detected to exceed the programmed
pressure limit.
Displays lists of values: High, Default, Medium and Low. Selecting a lower sensitivity will
Pressure Limit
give the system greater flexibility to maintain the desired injection flow rate while still
Sensitivity
limiting pressure near the programmed pressure limit.
Figure 11 - 1: Adaptive Flow Rate Sensitivity Graphs demonstrates the expected differences in the pressure graph for a
5mL/s contrast injection while varying the configuration for Pressure Limit Sensitivity. This figure can be used as an
example for the relative differences in expected performance with the various configurations.
High Sensitivity Default Sensitivity
A B
Medium Sensitivity Low Sensitivity
C D
Figure 11 - 1: Adaptive Flow Rate Sensitivity Graphs
67
High Sensitivity A Flow rate reduction prioritized to prevent pressure from reaching programmed limit.
Default Sensitivity B Behavior optimized to prevent pressure from exceeding programmed limit.
Pressure allowed to slightly exceed programmed limit to allow greater achievable flow
Medium Sensitivity C
rate.
Low Sensitivity D Behavior prioritizes maintaining flow rate without greatly exceeding programmed limit.
11.2 Preloading the Protocol in the Patient Line
WARNING
Hazard - Serious patient injury may result.

Q The patient must be disconnected from the Patient Line before preloading a protocol.
The system provides the ability to preload the first 10ml of the injection protocol to the end of the Patient Line. Normally,
at the start of an injection, the patient receives the saline that was used to prime the Patient Line, and then the injection
that was programmed. However, when the injection protocol is preloaded, the saline used to prime the Patient Line is
expelled to the priming container or to a waste container and the patient receives the programmed injection when the
injection is started.
NOTE:Preload Protocol button is only available on the Injector screen. Refer to Figure 11 - 3: Preloading
Injection Protocol.
NOTE:The Preload Protocol feature must be enabled before an injection protocol can be preloaded. Refer to
11.2.1 Enabling Preload Protocol.
NOTE:Each protocol must be individually configured to be Preloaded.
11.2.1 Enabling Preload Protocol

Under Admin Select Settings / Admin / Preload Protocol Enabled.
11.2.2 Configure a Protocol to be Preloaded

Under Admin select Protocols then either select an existing, or create a new protocol. Select the Preload dropdown and
select Preload On. Refer to Figure 11 - 2: Configure a Protocol to be Preloaded.
68
Figure 11 - 2: Configure a Protocol to be Preloaded
11.2.3 Preloading a Protocol
WARNING

Q Do not connect the Patient Line to the patient until all trapped air has been cleared.
Figure 11 - 3: Preloading Injection Protocol

1. Select a protocol, then select the Preload button on the injector.
NOTE: The Preload button will only be enabled if the protocol was configured to be preloadable.
69
2. The injector advances approximately 10ml of the programmed injection to the end of the Patient Line.
NOTE: This can include multiple phases if the first phase is less than volume of the Patient Line.
3. Once the injection protocol is preloaded, the Preload button on the injector changes to a Reprime. In addition,
an icon appears next to the injection name on both the injector and control room unit.
Figure 11 - 4: Protocol Preload Complete
11.2.4 Repriming the Patient Line

To undo the preload, Press the Reprime button. The injector will reprime the Patient Line with saline. Refer to Figure 11 -
4: Protocol Preload Complete.
11.2.5 Modifying the Preloaded Protocol

Once an injection protocol has been preloaded, any changes made to the protocol (e.g. adding a saline phase) will require
the protocol to be preloaded again.
Q Press Preload to perform the Preload operation again for the modified injection protocol.
Q Press Reprime to undo the Preload and prime with saline.
70
12 Data Manager (Licensed Feature)

12.1 Web Based Applications
The Injection System hosts a web server that makes available some injection data management features.
12.1.1 Login
1. Open a supported web browser on a computer that is on the same network as the Control Room Unit.
2. Open the URL http://<cru-ip-address>/DMW
NOTE: If necessary, contact Service or a local designated contact for the <cru-ip-address> address and
credentials.
3. Login using the provided credentials.
12.1.2 Compatibility Specifications

The following browsers are supported:
Q Microsoft IE11 (Internet Explorer version 11) and above
Q Mozilla Firefox version 60 and above
12.1.3 Navigation Bar

The information bar at the top of the screen displays the selected injector and modality (Figure 12 - 1: Navigation Bar.)
Drop Down Menus Information Edit
Figure 12 - 1: Navigation Bar

To navigate through the features within web applications manager, use the drop-down menus located within the
information bar.
12.2 Accessing Injection Data

Data Manager captures and stores exam information from the MEDRAD® Centargo into a local database for later data
management. When an exam is completed, injection information from the system is transferred to Data Manager, where
hospital personnel can:
Q Access: Access injection data stored in the database.
Q Matching: Create a link between an injection and study data.
Q Unmatching: Remove a link between an injection and study that was automatically matched by the injector
system.
Q Edit Injection: Edit patient, procedure, and fluid data of a selected injection.
Q Transfer: Transfer injection records to PACS or RIS/VR.
Q Hide/Unhide: Hide or unhide injection records for further processing in the system.
Q Export: Export injection information to a spreadsheet for data analysis and presentation.
Q Backup: Backup the entire Data Manager database to a database backup file.
Q User Management: Add a user and access account information.
71
12.2.1 Licensing
Data Manager is made available when PACS connectivity is licensed.
12.2.2 Security and Compliance Safeguards

The following security and compliance safeguards are built into Data Manager:
Q Authentication: User credentials (username and password) are required to access the injection records through
Data Manager.
Q Audit Control: Modification of any ancillary data through Data Manager is audited. The Audit feature tracks all
modifications to records and captures the login credentials, the date of the change, and the changes made to the
record.
12.2.3 Roles and Access

User roles and user access to certain functions in Data Manager are defined in Table 12 - 1: Data Manager User Roles and
Access.
Table 12 - 1: Data Manager User Roles and Access
Data Manager Feature Feature Function User Administration User
Manage Access Access

Injections
Export Access Access
Site Management Backup Access No Access
My Account Access Access

User Management
User Management Access No Access
12.2.4 Edit Injector Details

When logged into Data Manager, the injector type, injector name, facility name, and suite name of the selected injector
are displayed in the navigation bar. Edit injector details from any page within Data Manager.
To edit the facility name, suite name, or injector name:
1. Select the Edit button on the navigation bar and make edits.
2. Select the Confirm button or Cancel button on the navigation bar.
Confirm Select the Confirm button to save changes
Cancel Select the Cancel button to cancel the operation
3. A confirmation window displays the updated names for review.

a. Select Confirm to save changes made, or
b. Select Cancel to discard changes made.
4. If changes were successfully updated, the message "Injector/Suite details successfully updated" displays.
5. Select Close to return to Data Manager.
12.3 Manage Injections

When logged into Data Manager, the Manage Injections page displays. Manage Injections can also be accessed by
selecting Manage under the Injections drop-down menu.
72
Figure 12 - 2: Manage Injections

Under Manage Injections, perform any of the following tasks:
Q Match
Q Unmatch
Q Edit
Q Transfer
Q Hide/Unhide
12.3.1 Match
NOTE: Only one injection can be matched at a time, unless Multiple Accession Number is enabled.
To match a specific injection record with study data:

1. Under the Injections drop-down menu, select Manage.
2. Under Manage Injections, select Match (Figure 12 - 2: Manage Injections).
3. Search for a specific injection record using the provided search criteria.
NOTE: Specifying a start and end date is required.
4. Select Search.
5. Under Search Results, a list of injections based on the search criteria displays.
6. Select Match next to the appropriate injection record.
7. A window displays the selected injection record and a list of study records that can be matched to the selected
injection record.
NOTE: By default, all of the study data matching the injection start date displays. Either edit the date range or
search by accession number to retrieve relevant study records.
8. Select Match next to the appropriate injection record to match the injection with any study listed, or select
Cancel to cancel the operation.
9. If Match is selected, a confirmation message displays.
NOTE: If the incorrect injection record was matched to a study, unmatch the incorrect injection record (refer to
section 12.3.2 - Unmatch) and re-match the correct injection record.
12.3.1.1 Match Additional Studies

Multiple studies with the same MRN number can be matched to an injection record.
When Match Search Results display, select Match Add'l Studies. A window displays the selected injection record and a list
of study records with the same MRN number. Select a study record by selecting the box under the "Match" column; multi-
ple study records can be matched at once.
NOTE: Studies already matched are noted as such and cannot be selected.
Select Match to match the selected study records to the injection record.
73
12.3.2 Unmatch
To unmatch a study from a specific injection record:
2. Under Manage Injections, select Unmatch (Figure 12 - 2: Manage Injections).
4. Select Search.
NOTE: The Search Results display injection records grouped and sorted by injection start date. Each injection
record lists studies matched to that injection record.
6. Select Unmatch next to the appropriate injection record to unmatch the injection with the study listed.
7. A summary displays ().
8. Select Confirm to proceed with the unmatch, or select Cancel to cancel the operation.
9. If Confirm is selected, a confirmation message displays.
NOTE: If the incorrect injection was unmatched from a study, re-match the injection to the correct study (refer
to 12.3.1 - Match) and unmatch the incorrect injection.
NOTE: Unmatching an injection does not automatically remove it from any PACS/RIS system to which the
record may have been transferred. To update or delete, necessary adjustments within the interfaced
system(s) need to be made.
12.3.3 Edit Injection

To edit patient or procedure data for the selected injection:
2. Under Manage Injections, select Edit (Figure 12 - 2: Manage Injections).
4. Select Search.
5. Select Edit next to the appropriate injection record (Figure 12 - 3: List of Injections to Edit.
Figure 12 - 3: List of Injections to Edit
74
6. The Edit Injection Detail window displays for viewing or editing patient data (Figure 12 - 4: Patient Tab),
procedure details (Figure 12 - 5: Study Tab) and fluid details (Figure 12 - 6: Contrast Tab).
NOTE: Editing permission will vary depending upon whether matched or unmatched is selected.
List of editable fields:
Q Patient Tab (Patient Data)

• Patient ID/MRN
• Patient Name
• Date of Birth
• Gender
• Patient Height
• Patient Weight
Figure 12 - 4: Patient Tab

Q Study Tab (Procedure Details)
• Injection Site
• Catheter Gauge
• Injection Site Name
• Catheter Gauge Name
• Technologist
• Accession Number
• Study Number
• Study UID
• Study Description
• Study Date
• Study Time
• Notes
Figure 12 - 5: Study Tab

Q Contrast Tab (Fluid Details)
NOTE: These entries can not

be edited.
• Brand
• Concentration
• Vial Volume
• Expiration Date
• Lot Number / Batch
Figure 12 - 6: Contrast Tab
NOTE: All fields are editable, except when used with Connect.CT. Under Connect.CT, the Edit function would
follow the Modality Worklist rules for editable/non-editable fields.
7. Edit injection information.
NOTE: Information fields for patient and study data are editable except when used with Connect.CT. Under
Connect.CT, the Edit function would follow the Modality Worklist rules for editable/non-editable fields.
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8. Select Confirm to accept changes made, or select Cancel to discard changes made.
9. If Confirm is selected, a confirmation message displays.
12.3.4 Transfer
To transfer injection data to assigned PACS or RIS:
2. Under Manage Injections, select Transfer (Figure 12 - 2: Manage Injections).
3. Search for specific injection record(s) using the provided search criteria.
4. Select Search.
5. Under Search Results, a list of injection records displays based on the search criteria.
6. Select the check box next to the injection or injections to schedule for transfer.
NOTE: Transfer multiple injections by selecting the associated checkbox for each injection record.
7. Choose the destination for transfer by selecting To PACS and/or To RIS/VR. The Destination column highlights
PACS, RIS/VR, or both, based on the transfer status.
8. Select Transfer.
9. Select Confirm to confirm changes made, or select Cancel to discard changes made.
10. If Confirm was selected, a confirmation message displays.
12.3.5 Hide/Unhide
NOTE: Hidden injections cannot be managed or exported.
To hide or unhide a specific injection record:

2. Under Manage Injection, select Hide/Unhide (Figure 12 - 2: Manage Injections).
4. Select Search.
6. Select Hide next to the appropriate injection record to hide the injection, or select Unhide next to the appropriate
injection record to un-hide the injection.
7. A summary screen, with the selected injection details and selected operation (Hide/Unhide), displays.
8. Select Confirm to confirm changes made, or select Cancel to discard changes made.
9. If Confirm was selected, a confirmation message displays.
12.4 Export
NOTE: Exports will not contain hidden injection records.
Export injection details into a Comma Separated Value (CSV) file for use in spreadsheet and database applications and for
more detailed data analysis and presentation.
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Figure 12 - 7: Export Screen

Choose the level of detail exported:
Q Injection Summary: Consolidated summary of the injections within a specified date range.
Q Injection Details: Injection details and history records that meet specific search criteria provided.
Q Consumable Usage: Consolidated summary of the consumables used within a specified date range.
12.4.1 Export Injection Summary

To export the injection summary for a given date range:
1. Under the Injections drop-down menu, select Export.
2. Select Injection Summary (Figure 12 - 7: Export Screen).
3. Enter the appropriate date range in the Start Date and End Date fields.
4. Select Export Injections.
5. Select Download to download the exported injection summary as a CSV file.
12.4.2 Export Injection Details

To export injection details and injection history records for a given date range:
2. Select Injection Details (Figure 12 - 7: Export Screen).
4. Select Search.
5. A list of injections based on the search criteria displays ().
6. Select the check box next to the injection or injections to export.
7. Select Export Injection Details to export the file(s) selected.
8. Select Download to download the exported injection details as a CSV file.
12.4.3 Export Consumable Usage

To export the consumable usage for a given date range:
2. Select Consumable Usage (Figure 12 - 7: Export Screen).
3. Enter the appropriate date range in the Start Date and End Date fields.
4. Select Export Consumable Usage.
5. Select Download to download the consumable usage summary as a CSV file.
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12.5 Site Management
12.5.1 Backup
To back up all of the injection records to the local system:
1. Under the Site Management drop-down menu, select Backup.
2. Select Backup (Figure 12 - 8: Backup Database).
Figure 12 - 8: Backup Database

3. The Database Activity Monitor display opens and monitors the progress of the backup.
NOTE: After a backup has started, Data Manager cannot be accessed until the backup is complete.
4. When the backup is complete, a completion message displays.

5. Select Close to resume using Data Manager.
6. Select Download Backup File to download the backup database file.
NOTE: The backup database file must be saved only to the hospital network.
12.6 User Management
12.6.1 Add User

To add a new user:
1. Under the User Management drop-down menu, select Add User.
2. Enter the required user information to create the new user account.
3. When creating a password, the Password Policy explains how to create a secure password. Select Close when
finished.
NOTE: To modify the Password Policy, contact Service or a designated site contact.
4. Select Save to create the new user account, or select Cancel to cancel the operation.
12.6.2 My Account
To access account information:
1. Under the User Management drop-down menu, select My Account.
2. The account information screen displays the user name and associated account information.
3. To change the current password, fill in the fields under Change Password. The Password Policy explains how to
create a secure password. Select Close when finished.
NOTE: To modify the Password Policy, contact Service or a designated site contact.
NOTE: If the old password is lost or forgotten, contact Bayer or create a new user account.
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12.7 Data Manager Troubleshooting

Table 12 - 2: Data Manager Troubleshooting
Error Corrective Action
Q Ensure the address in the browser window is correct.

Q Ensure the Control Room Unit, including the
connected injection system, is powered on and is
Data Manager is not available from viewing station.
operational.
Q Verify Control Room Unit, is connected to the hospital
network.
Q Contact Service or a local designated site contact to

Cannot login. create a new users account or reset the password of an
existing account.
Q Ensure the parameters for the search criteria are

Data not found. correct or use alternative criteria.
Q Verify the network location for the backup is

accessible from the viewing station.
Cannot backup data.
Q Confirm sufficient storage capacity exists on the
target backup location.
Q Verify appropriate licenses are associated with the

Cannot access certain functions. users’ login.
Q Increase Maximum Attempts per Query setting.

Queries may continuously be timing out.
Q Verify configurable setting for retry wait time.
Q Verify PACS is online.

PACS Transfer failure Q Verify the injection has auto-matched and there is a
value for Study UID.
RIS/VR Transfer failure Q Verify RIS/VR is online.
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80
13 Troubleshooting
If the problem is not resolved after trying the listed potential solutions, restart the system and try again. If the problem
persists, contact Bayer.
13.1 Troubleshooting Tips

Table 13 - 1: Troubleshooting Tips
Problem Potential Solution
Q Ensure saline is loaded into the Day Set.

Advance Saline button is not priming
tubing/pushing out any saline. Q Press and hold the Advance Saline button until saline is pushed
through.
Remove Outlet Air Sensor tubing from the outlet air sensor and push back
Outlet air detector is detecting air.
in. Ensure outlet air detector door is firmly latched.
Q Ensure spike adapters are fully inserted onto inlet air sensors; spike
adapters will click when locked in place. Ensure spikes are fully
The system does not detect installed fluid inserted into fluid bottles and/or bags.
source. Q If problem persists, remove spike adapters from inlet air sensors and
restart the injector. Clean fluid loading area if necessary, and
reinstall spike adapters.
Q Ensure the saline bag neck is not twisted.

Q Ensure spike adapters are fully inserted onto inlet air sensors; spike
adapters will click when locked in place. Ensure spikes are fully
The system will not fill the Day Set from
inserted into fluid bottles and/or bags.
the installed fluid source.
Q If problem persists, remove spike adapters from inlet air sensors and
restart the injector. Clean fluid loading area if necessary, and
reinstall spike adapters.
Refer to 13.3 Communication Loss Between Injector and Control Room

Wireless connection is not working.
Unit.
Q Ensure injector is powered on.

Injector door will not open. Q Ensure Patient Line is not inserted. Insert a screwdriver into the
manual release hole located next to the Unlock Door button.
Q Ensure saline is loaded into the Day Set.

Patient Line is not primed; injector lights Q Check for occlusions.
are red. Q Press and hold the Advance Saline button until the Patient Line is
primed.
Prime container is displaying as missing Ensure prime container presence sensor is clean and clear of
when installed. obstructions. Refer to 14.2.3 Clean Prime Container.
Q Plug in injector power cord. Turn on power switch at the base of the
injector, then press the Power button. Refer to 4.1 Power On and
Shut Down.
Injector is not powering on.
Q (If applicable) Ensure battery circuit breakers are not disengaged
(Figure 4 - 3: Injector Base). If disengaged, push back in. Power on
injector.
13.2 System Alerts

The upper left corner of the injector and CRU displays will show any active system alerts (Refer to 4.4.1 Home Screen, item
4). During normal operation there should not be any system alerts visible.
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If a system alert is about a problem that prevents safe operation of the system, the Device and Exam panels on the user
interface (Refer to 4.4.1 Home Screen, items 1 and 2) become disabled until the problem is resolved.
The alert may provide details or instructions that may help resolve the problem, some alerts can be cleared by restarting
the system and trying again. If the issue persists, contact Bayer or qualified service personnel.
13.3 Communication Loss Between Injector and Control Room Unit

The injector can operate separately of the CRU should communication between the two be disrupted or lost.
NOTE: The only exceptions are: Personalized Protocols (Refer to 9 Personalized Protocols (Licensed Feature))
and Scanner Connectivity (Refer to 10 Scanner Connectivity). These features require the CRU to be
connected in order to work.
NOTE: In the event of communications loss while an injection is in progress the injector continues the injection
normally in order to not disrupt scan acquisition timing. If the injection needs to be aborted, the
operator must do so from the injector screen in the scan room.
Should communication between the injector and CRU be lost, the CRU will prevent access to Exam. If communication was
lost during an injection, the CRU will redirect to the Home screen and a notification displays to continue from the injector.
Set up a wired connection if if wireless communications has frequent problems. On the injector, go to Admin / Settings /
Networking, and select Wired. Plug in ethernet cable from the base of the injector (Figure 4 - 3: Injector Base) to the port
on the CRU (Refer to 16.2.2 Control Room Unit Connections, item 5). Contact Bayer.
13.4 VirtualCare
VirtualCare™ Remote Support allows the user to request service and provides remote service support. The CRU must be
connected to the network and able to reach the internet for VirtualCare to operate.
VirtualCare creates help reports to be copied to a USB, which can be sent to Bayer for review. There are two types of help
reports that can be created:
Q Technical Assistance Center (TAC) Report is intended for use by internal service engineers from Bayer and
contains detailed logs for debugging.
Q Fight Recorder Activity (FRA) Report contains simple human readable data in the form of English-only
Microsoft Excel files (one per day) that can be opened and reviewed; these files contain a timestamped listing of
all system activity.
NOTE: Neither a TAC nor FRA report contains patient information.
If connected to the internet, VirtualCare allows the user to request support. When support is requested, Bayer will contact
the user using the site information provided. Access can be granted to enable remote connection to the CRU for the
duration of the service session. (During normal use, remote access is disabled.) The injection system cannot be used for
patient exams during this time.
In order to connect the system to the VirtualCare server, LAN1-RIS must be configured (under Admin / LAN1-RIS), and a
network cable must be connected. If a proxy server is used for internet, configure the connection under Admin / Proxy
Server. Contact the hospital IT department for help with configuring network settings.
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14 Cleaning and Maintenance
WARNING
Electro-Mechanical Hazard - Serious injury or death may result from exposure to hazardous voltages
existing within the system.
Q The system should be opened and serviced by qualified service personnel only.
Q Do not remove any covers or disassemble the injector.
Q Do not expose system components to excessive amounts of water or cleaning solutions.
Q Disconnect the injector before cleaning near power switch (AC power); dry thoroughly before reconnecting.
Pinch Hazard - Serious injury may result from moving pistons.

Q Do not insert fingers or hands into the Day Set install area when pistons are advancing or retracting.
This section contains recommended procedures for maintenance and an operational checkout of the injection system.
Routine maintenance and inspection ensures continued performance of the injection system and reduces the possibility
of equipment malfunction.
The system must be properly maintained to ensure it is in peak operating condition. The individual maintenance schedule
depends upon how each injection system is used, the type of procedures performed, and the frequency of use.
NOTE: Dispose of system components or accessories properly. Follow local regulations for proper disposal or
contact Bayer for assistance.
NOTE: If contrast has leaked inside any component of the system, contact Bayer.
NOTE: Failures that occur due to lack of proper maintenance will not be covered under warranty.
NOTE: Bayer will make available upon request:
Q Circuit diagrams, components part lists, or other information that will assist qualified technicians
in repairing components classified as repairable.
Q Instructions and training for correct replacement of interchangeable or detachable parts Bayer
specifies as replaceable by service personnel.
Q On-site consulting or consulting references.
14.1 Daily Maintenance

Before use each day, the system should be inspected as needed using the procedures outlined in this section. Ensure all
system safety and warning labels are in place and are legible. If cleaning is required, follow procedures outlined in 14.2
Clean Fluid Spills or Debris.
The following procedures are recommended for inspection of all components in the system. If any defects are detected,
contact a qualified service representative for service. Do not use the system until the problem is corrected.
14.1.1 Inspect Injector

Q Inspect the injector body for any cracks that could allow fluid to leak inside the system or weaken the structural
integrity of the unit.
Q Inspect all connected cables. Look for cuts, cracks, worn spots, or other obvious damage. Ensure all connections
are properly seated.
Q Inspect the Day Set area for contrast media build-up. Follow the cleaning guidelines outlined in 14.2 Clean Fluid
Spills or Debris.
Q Make note of any loose exterior mounting bolts and screws, and contact Bayer for servicing.
Q Ensure the Day Set lock levers, door latch, and fluid loading mechanisms are functioning.
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Q For pedestal units, ensure the wheels roll smoothly without binding or scraping and the brakes work.
Q Confirm operation of the All-Stop button by pressing it; a tone will emit.
NOTE: All relevant guidelines for facility, local, or national safety recommendations related to cable routing
and installation should be followed.
NOTE: Contact Bayer or a local dealer for service or repairs.
14.1.2 Inspect Control Room Unit

Q Inspect all cables connected to the unit. Look for cuts, cracks, worn spots, or other obvious damage. Ensure all
connectors are properly seated.
Q Inspect the housing for any damage or cracks that could weaken the structural integrity of the unit.
14.2 Clean Fluid Spills or Debris

NOTICE:
Electro-Mechanical Hazard - Equipment damage may result.
Q The system has been tested for chemical resistance to the following cleaning agents: 96% ethanol, 70% isopropyl alcohol,
chlorine bleach diluted 1:10, 3% hydrogen peroxide, PDI Super Sani-Cloth®, and Lysol® Brand II Disinfecting wipes. Use of other
cleaning agents may cause equipment damage.
Q Do not spray cleaning solutions directly onto the display screen. Refer to cleaning instructions for details.
Q Do not pour water directly onto the system; instead, dampen wipe with water.
Refer to the following instructions when cleaning off visible contamination on the system. For these items refer to the
referenced section for specific cleaning instructions. For the remainder of the system, refer to the following instructions
for cleaning off visible contamination.
Q inlet/outlet air sensor and barcode reader (14.2.1 Clean Inlet/Outlet Air Sensor and Barcode Reader),
Q pistons (14.2.2 Clean Piston Area), and
Q prime container (14.2.3 Clean Prime Container).
1. Power off the system.

2. Clean the system:
a. In the case of contrast media spills, clean the system with a clean and soft non-linting wipe dampened with
warm water (wet but not dripping) until visibly clean. Replace wipe if it becomes visibly soiled.
b. In the case of other debris, wipe all external surfaces with cleaning agent (alcohol-based quaternary ammo-
nium cleaning agent, such as PDI Super Sani-Cloth®) for a minimum of one minute or until visibly clean.
3. Ensure all seams, recessed areas, and buttons are clean. If any visible contrast media or other debris is evident,
repeat step 2 until no visible soil is detected.
14.2.1 Clean Inlet/Outlet Air Sensor and Barcode Reader

Clean using a dry, clean, and soft non-linting wipe and warm water. Finish with isopropyl alcohol (IPA).
14.2.2 Clean Piston Area

1. Power on the system.
2. Ensure the Day Set is not installed.
3. Select Injector from the system Home screen, then select the Day Set reservoirs.
4. Press Clean Piston Area.
5. Select the Forward button once. The pistons will partially advance for access to the piston tips.
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Figure 14 - 1: Piston Area
# Name
1 Piston tip
2 Piston shaft
6. Open the injector door and clean the piston tips.

a. In the case of contrast media spills, clean the area with a clean and soft non-linting wipe dampened with
warm water (wet but not dripping) until visibly clean. Replace wipe if it becomes visibly soiled.
b. In the case of other debris, wipe all external surfaces with cleaning agent (alcohol-based quaternary ammo-
nium cleaning agent, such as PDI Super Sani-Cloth®) for a minimum of one minute or until visibly clean.
7. Press the Forward button again. The pistons will fully advance for access to the piston shafts.
8. Clean the piston shafts.
9. Press the Reverse button once. The pistons will retract to their original position.
10. Clean the Day Set area.
11. When finished, shut injector door.
14.2.3 Clean Prime Container

Discard fluids per facility guidelines. Only hand wash the prime container using warm water, a mild soap solution, and a
clean, soft non-linting wipe. When finished, place prime container back into injector. Ensure prime container presence
sensor is clean and clear of obstructions.
Figure 14 - 2: Prime Container Presence Sensor
14.3 Disinfect System

1. Ensure the system has been thoroughly cleaned. Refer to 14.2 Clean Fluid Spills or Debris.
85
2. Use an alcohol-based quaternary ammonium disinfection agent, such as PDI Super Sani-Cloth®, following the
manufacturer’s instructions to thoroughly wipe all external surfaces. Ensure all seams, recessed areas, and
buttons are clean.
3. Allow surface to remain visibly wet for the contact time specified by the manufacturer for disinfection. If needed,
use additional wipes to ensure the surfaces remain wet for the full duration.
4. Allow surfaces to thoroughly air dry.
14.4 Annual Maintenance

Once a year, a system calibration and leakage check should be performed by a qualified service representative. Bayer
offers preventative maintenance programs. These annual maintenance programs greatly assist in maintaining accuracy
and reliability and can extend the life of the system. Contact Bayer for information.
14.4.1 Injection System Calibration

Bayer recommends a complete system calibration and performance checkout be performed annually. Contact Bayer for
complete details.
14.4.2 Check Electrical Leakage

As part of an annual maintenance program performed by a qualified service representative or authorized dealer, both
electrical leakage and protective earth ground continuity checks should be performed. Refer to 16.3.4.1 Electrical Leakage
for leakage specifications.
NOTE: Local regulations or facility protocol may require electrical leakage checks at more frequent intervals. If
this applies, the local regulations for leakage must be followed.
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15 Options and Accessories
WARNING
Electro-Mechanical Hazard - Serious injury or death may result from exposure to hazardous voltages existing
within the system. Equipment damage may result or system may fail to operate.
Q Only connect items that have been specified as part of or as compatible with the system.
15.1 Ethernet Cables
Catalog Number Description
CENT-ETH-20 20 m (65.61 ft.) cable
15.2 Sterile Disposables
CENT-DS Day Set
CENT-PL Patient Line
CENT-RS Replacement Spike
15.3 Scan Room Unit Accessories
CENT-PC Prime container
15.4 Control Room Unit, USB Devices (Not provided by Bayer)

CRU is designed as a touch screen based user interface; however, USB interface devices such as keyboards, mice or
barcode readers are generally supported. A USB mouse or keyboard can be connected to the CRU and will generally work
for clicking/scrolling and data entry when alphanumeric input fields have focus. Special keystrokes (e.g. Ctrl-Alt-Del) are
disabled and there is no access to the operating system on the CRU.
USB based barcode readers often emulate a keyboard by default. A scanned barcode is entered just like it was manually
typed in followed by a carriage return. If paper charts or order forms in the control room contain a barcode with the
patient's MRN or the exam's Accession Number a barcode reader may be useful. When the Modality Worklist is displayed
and the search field selected, scanning the barcode will enter the value into the search field. If only one matching entry is
found it is automatically selected, this may be convenient if the worklist contains many entries and may help reducing
errors, resulting in the selection of the wrong patient from the worklist.
Bayer offers no specific support for USB interface devices and their usability for any specific purpose may be subject to
change when CRU software is updated.
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88
16 Specifications
16.1 Injector Specifications
16.1.1 Injector Dimensions and Weight
NOTE: Listed weight and dimensions are approximate.
167.6 cm 167.6 cm
66.0 in. 66.0 in.
68.6 cm 76.2 cm
27.0 in. 30.0 in.
Weight: 74.5 kg (164.2 lbs)
16.1.2 Injector Power Requirements

100-240 VAC
50/60 Hz
336-377 VA
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16.2 Control Room Unit Specifications
16.2.1 Control Room Unit Dimensions and Weight
NOTE: Listed weight and dimensions are approximate.
38.40 cm
15.12 in
27.33 cm
25.88 cm
10.76 in
10.19 in
17.27 cm
6.80 in 19.81 cm
29.21 cm 20.17 cm 7.80 in
11.50 in 7.94 in
Weight: 7.2 kg (15.8 lbs)
16.2.2 Control Room Unit Connections
1 2 3 4 5 6 7 8
# Description # Description
Power input and supply connection
NOTE: For the power input and supply

connection, the CRU requires use of a
Listed Class 2, LPS, or Listed Information Computer network connection. Use to connect
1 2
Technology Equipment (ITE) power the system to the local area network (RIS).
supply with output rated 12Vdc,
minimum 6A, marked LPS. Use only part
number from Bayer for power supply.
USB connections. Port 4, identified with yellow Connection for screen extension/transfer to a
3 4
outline, always remains on. second display. For Bayer use only.
Network connection. Use for wired CRU Fiber optic input and output connections. Not for
5 6
connection to the Injector. use with this system.
Injector head connection not applicable for Handswitch connection not for use with this
7 8
system system
Service ports - not shown (for Bayer use only)
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16.2.3 Control Room Unit Power Requirements

100-240 VAC
50-60 Hz
1.3A
16.3 Injector Environmental Specifications
16.3.1 Non-Operating (Storage)

0 °C to 40 °C with a mean kinetic temperature of ≤ 25 °C (32 °F to 104 °F with a mean
Temperature:
kinetic temperature of ≤ 77 °F).
Humidity: 10% to 90% R.H., non-condensing
16.3.2 Non-Operating (Transport)

Extreme Cold: -29 °C (-20 °F) at uncontrolled RH, for 72 hours.
High temperature and

38 °C (100 °F), 85% RH for 72 hours
humidity:
Extreme Heat: 60 °C (140 °F) for 16 hours
16.3.3 Operating
NOTE:The system may not meet all performance specifications if operated outside of the following conditions.
Temperature: +16 °C to + 28 °C (+61 °F to +82 °F)
Humidity: 20% to 90% R.H.
Air Pressure: 70 kPa to 106 kPa
16.3.4 Protection Against Electrical Shock

Per IEC 60601-1, the system is designed as a Class 1 Medical Device and Internally Battery Powered with a Type BF Applied
Part.
Type BF corresponds to the degree of protection against electrical shock by the applied part of the Medical Device. Class 1
Equipment requires a protective earth connection (electrical grounding) to ensure protection against electrical shock in
the event of a failure of the basic insulation system. The following are requirements for a Class 1 type BF Medical Device.
16.3.4.1 Electrical Leakage

Complies with EN, UL, CSA, and IEC requirements for safe Electrical Leakage Current limits for Medical Equipment:
Earth Leakage Current: < 500 microamps (NC)
Chassis (Touch) Leakage Current: < 100 microamps (NC)
Patient Connection Leakage Current: < 100 microamps (NC)
16.3.4.2 Ground Continuity

< 0.2 Ohms from power cord ground pin to metal components of the pedestal base.
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16.3.5 EMI/RFI
The injection system is classified as Group 1, Class A equipment per the requirements of IEC 60601-1-2. Accessories
provided by Bayer comply with this standard.
16.3.6 Protection Against the Ingress of Fluids

The injector has not been classified for protection against the ingress of fluids.
NOTE: In the event of fluid ingress or spillage on the injection system ensure all equipment and accessory
connections are removed, dried, and inspected. Follow hospital policies and procedures or contact
Service personnel for performing appropriate electrical safety and operational checks prior to use.
16.3.7 Mode of Operation

Per IEC 60601-1 the mode of operation for the base and the display is continuous operation. They are capable of
operation under normal load for an unlimited period, without excessive temperature being developed.
The mode of operation for the injector is continuous operation with intermittent loading. Although power is applied
continuously, the intermittent use of loading and injecting will result in an internal temperature less than the continuous
load operating temperatures, but greater than the no load operating temperatures. Under normal operating conditions
with a minimum of 10 minutes between injections, the internal temperature will not raise enough to degrade safety,
system performance, or reliability.
16.3.8 Fluid Delivery Performance
NOTE: Continued compliance to the fluid delivery performance accuracy specifications can only be ensured if
the system has an annual pressure calibration per the recommended maintenance schedule.
Description Specification
1 mL to 200 mL for contrast and flush phases, 1 mL to 400 mL for DualFlow phases,
in 1 mL increments
Volume Range
A total of 400 mL of contrast can be delivered in the same injection if both contrast
reservoirs contain the same type and concentration.
Flow Rate Range 0.1 to 10 mL/sec in 0.1 mL/sec increments
Pressure Limit selections (PSI / kPa / kg/cm2): Choice of 50/345/3.5, 100/689/7.0, 150/
1034/10.5, 200/1379/14.1, 225/1551/15.8, 250/1724/17.6, 300/2068/21.1
Programmable Pressure limit Q Configured for kPa: from 345 kPa to 2068 kPa in 1 kPa increments.
(PSI / kPa) Q Configured for psi: from 50 psi to 300 psi in 1 psi increments.
Q Configured for kg/cm2: from 3.5 kg/cm2 to 21.1 kg/cm2 in 0.1 kg/cm2 incre-
ments.
Programmable Delay 1 second to 900 seconds in 1 second increments
Pause Maximum pause time is 20 minutes
Reservoirs (Volume Capacity) Maximum three (200 mL)
Injection Capabilities Maximum 6 phases per injection. Maximum of 10 injections per patient exam.
NOTE: The injection system performs within the defined accuracy specifications:
- a 2 second interval for flow rates > 5 mL/s, or
Flow Rate Accuracy - a 10 mL volume for flow rates ≤ 5 mL/s
Q +/- (5% + 0.1) mL/s
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Description Specification
Contrast or Saline Phase:

Q +/- (2% + 1 mL)
Simultaneous (DualFlow) Phase:
Q For a DualFlow phase with a ratio of less than 80%, or that occurs following
a contrast phase of 20 mL or greater:
• Contrast: +/- (4% + 2 mL)
• Saline: +/- 4% + 2 mL)
Volume Delivered Accuracy • Combined fluid volume: +/- (4% + 2 mL)
Q For a DualFlow phase with a ratio of 80% or greater that occurs without a
preceding contrast phase of 20 mL or greater:
• Contrast: +/- (4% + 2 mL)
• Saline: + (4% + 7 mL) / - (4% + 2 mL)
• Combined fluid volume: + (4% + 7 mL) / - (4% + 2 mL)
Multi phase injection:
Q The total volume of fluid will be within the combined accuracy limits of the
individual phases.
16.4 Control Room Unit Environmental Specifications
16.4.1 Non-Operating (Transportation and Storage)

Temperature: -20 °C to + 60 °C (-4 °F to +140 °F)
Humidity: 5% to 100% R.H., non-condensing
16.4.2 Operating
NOTE:The system may not meet all performance specifications if operated outside of the following conditions.
Temperature: +10 °C to + 40 °C (+50 °F to +104 °F)
Humidity: 20% to 90% R.H.
16.5 Over and Under Infusion Protection

The following means are provided to protect against over and under infusions:
Q Warnings displayed on the Safety screen act as a reminder to check the programmed injection parameters prior
to the injector being armed.
Q If the required fluids are available, the injector will automatically refill the reservoirs when they do not contain
sufficient fluid to complete the next programmed injection. If the fluids are not available, the insufficient volume
condition will be indicated when arming is requested.
Q Injection monitoring is performed in the injector to detect system faults that could result in over rate or over
volume conditions. The delivered volume is also monitored against the total programmed volume for the
injection.
Q When a fault, pause, abort, or stop request is detected, the injection will stop within 10 mL.
Q Once the system has disarmed, a tone sounds, and a message displays on the display screen.
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16.6 System Fluid Performance
16.6.1 Factors Affecting Flow Rates

An injector's ability to generate pressure is only one factor affecting maximum flow rates. Other factors include:
Q Catheter diameter and length
Q Viscosity (thickness) of the fluid
Q Temperature of the fluid, Day Set, and Patient Line during the injection
Q Maximum pressure setting on the injector
Q Injection phase volume
If problems are experienced achieving the desired flow rate, please contact a Clinical representative for suggestions that
may increase it.
16.6.2 Maximum Flow Rate Performance
NOTE: Use of an extension set may compromise fluid delivery performance.
Fluid Catheter (18 Gauge)
Ultravist 370 at a temperature

8 mL/s
greater than 28°C
0.9% Saline 8 mL/s
NOTE: The injection system was designed to use the Day Set and Patient Line to operate in a safe and effective
manner. The performance of the injection system has been tested with Bayer supplied disposables, with
a maximum pressure rating of 300 psi (2068 kPa), and the following plastic catheters:
Q Inner diameter: 0.876 mm – 0.978 mm

18 Gauge Q Length: 1.16 in
Q Gravity flow rate >/= 105 ml/min
16.7 Power Cable Specifications

The specifications required by the Centargo injection system relative to the power cable (plug, receptable, and cord) are:
Q Rated temperature: 60 °C minimum
Q Receptacle type: IEC 60320 C13
Q Normal cord voltage: 300 VAC minimum
Q Wire gauge: 1.00 mm2 minimum

Q Cord type: IEC 60245-1, Annex A, Designation 53, or IEC 60227-1, Annex A, Designation 53 Certified
Q Cord length: 3 m maximum
The power cable must meet applicable plug, cord, and receptacle specifications, including type, voltage, current, and
safety approval markings for the country in which the power cable is being used.
16.8 Cybersecurity and IT Network Connection
16.8.1 System Cybersecurity Protection

System software cybersecurity controls include:
Q Internal data integrity checks
94
Q Remote access requires valid credentials and a user at the CRU to approve a remote connection
Q Service access requires valid credentials
Q Access to the Operating System is restricted
Q Firewall and Anti-Virus
Q (Configurable) Masking Protected Health Information (PHI) when sharing with external systems
Q Data Manager website access requires valid credentials
Q Data Manager database is access restricted
Q The virtual wireless access point in the CRU is protected via WPA2 Encryption
16.8.2 Control Room Unit (CRU) Cybersecurity

When Informatics is enabled, the CRU hard drive can contain PHI. The security and privacy of this information must be
safeguarded by all individuals interacting with the device. Prior to disposing of the CRU, this information must be
removed from the hard drive inside the system. Contact Bayer or a local authorized dealer for further information. Refer to
the back cover of this manual for contact information
16.8.3 IT Network Connection

Connecting the system to a network that includes other equipment could result in unidentified risks to patients,
operators, or third parties.
The organization responsible for managing the network should identify, analyze, evaluate, and control risks associated
with connecting the equipment to the network.
Subsequent changes to the network could introduce new risks and require additional analysis. For example:
Q Changes in the network configuration
Q Connecting additional items to the network
Q Disconnecting items from the network
Q Updating equipment connected to the network
Q Upgrading equipment connected to the network
16.9 Mains (AC) Fuse Specifications

FUSE, 2AH, 250V, 5X20MM, IEC TYPE T
16.10 Wireless Communication Specification

The injector can communicate with the CRU via a wireless connection. The wireless radio specifications used in Centargo
are:
IEEE 802.11 b/g/n Standard

Standard
Q Supports 2.4 GHz only
Frequency Range IEEE 802.11b/g, 802.11g/n HT20: 2412 MHZ ~ 2472 MHz
IEEE 802.11b: 17.13 dBm
Transmit Power
IEEE 802.11g: 19.22 dBm
(EIRP)
IEEE 802.11g/n HT20: 19.34 dBm
Channel Number IEEE 802.11b/g, 802.11g/n HT20: 13 channels
Security WPA2
95
96
17 Compliance to IEC 60601-1-2 / 2nd, 3rd, and 4th Editions

The MEDRAD® Centargo CT Injection System complies with the requirements of:
IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance
– Collateral standard: Electromagnetic compatibility – Requirements and tests
CISPR 11: Industrial, scientific and medical (ISM) radio-frequency equipment- Electromagnetic disturbance characteristics
– Limits and methods of measurement
IEC 61000-3-2: Electromagnetic compatibility (EMC) – Part 3-2: Limits – Limits for harmonic current emissions
(equipment input current ≤ 16 A per phase) (This does not apply to Class A equipment.)
IEC 61000-3-3: Electromagnetic compatibility (EMC)- Part 3-3: Limits - Limitation of voltage changes, voltage
fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤ 16 A per phase and not
subject to conditional connections) (This does not apply to Class A equipment.)
IEC 61000-4-2: Electromagnetic compatibility (EMC) – Part 4-2: Testing and measurement techniques –Electrostatic
discharge immunity test
IEC 61000-4-3: Electromagnetic compatibility (EMC) – Part 4-3: Testing and measurement techniques – Radiated, radio-
frequency, electromagnetic field immunity test
IEC 61000-4-4: Electromagnetic compatibility (EMC) – Part 4-4: Testing and measurement techniques – Electrical fast
transient/burst immunity test
IEC 61000-4-5: Electromagnetic compatibility (EMC) – Part 4-5: Testing and measurement techniques – Surge immunity
test
IEC 61000-4-6: Electromagnetic compatibility (EMC) – Part 4-6: Testing and measurement techniques – Immunity to
conducted disturbances, induced by radio frequency fields
IEC 61000-4-8: Electromagnetic compatibility (EMC) – Part 4-8: Testing and measurement techniques – Power frequency
magnetic field immunity tests
IEC 61000-4-11: Electromagnetic compatibility (EMC) – Part 4-11: Testing and measurement techniques – Voltage dips,
short interruptions and voltage variations immunity tests
This system is in compliance to IEC-60601-1-2 / 2nd, 3rd, and 4th edition standards. Special precautions regarding
Electromagnetic Compatibility (EMC), are required for installation and use of this system. Detailed EMC information
contained in this chapter is intended to reflect conformance to IEC- 60601-1-2 / 2nd, 3rd, and 4th edition standards.
WARNING
Electromagnetic Interference Hazard - Serious patient and/or worker injury or death may result.
Q For proper operation, use only accessories and options provided by Bayer that are designed specifically for the system. Other
non-Bayer approved accessories or options may cause equipment damage or may result in increased emissions or decreased
immunity of the system. System accessories listed in the operation manual comply with the requirements of electromagnetic
emissions and immunity standards IEC-60601-1-2 / 2nd, 3rd, and 4th edition.
Q Do not use the system adjacent to or stacked with other equipment. Use of this equipment adjacent to or stacked with other
equipment should be avoided because it could result in improper operation. If adjacent or stacked use is necessary, the system
and the other equipment should be observed to verify normal operation in the configuration in which it will be used.
Q Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used
no closer than 30 cm (12 inches) to any part of the injection system unless a greater separation distance is required as
indicated by the equation. Otherwise, degradation of the performance of this equipment could result.
 CAUTION
Electromagnetic Hazard - Equipment damage may result or system may fail to operate.
Q System may disarm or fail to operate when exposed to high magnetic fields. Portable and mobile RF communications
equipment can affect the system.
97
Recommended separation distances between

portable and mobile RF communications equipment and the system
The system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of the system can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the system as recommended below,
according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter (m)
Rated maximum output 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz
power of transmitter (W)
3.5 3.5 7
d = ------- p d = ------- p d = ------ p
V1 E1 E1
0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.69 3.69 7.38
100 11.67 11.67 23.33
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters
(m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output
power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.
98
THE SYSTEM REQUIRES SPECIAL PRECAUTIONS REGARDING EMC. Install and put into service according to the EMC
information provided below
Guidance and manufacturer’s declaration - electromagnetic emissions
The system is intended for use in the electromagnetic environment specified below. The customer or user of the system
should ensure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions Group 1 The system uses RF energy only for its internal function.
CISPR 11 Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic
equipment.
RF emissions Class A The emission characteristics of this system make it
CISPR 11 suitable for use in industrial areas and hospitals (CISPR
11 Class A). If the system is used in a residential
Harmonic emissions Not applicable environment (for which CISPR 11 Class B is normally
IEC 61000-3-2 required), this equipment might not offer adequate
Voltage fluctuations / flicker Not applicable protection to radio-frequency communication services.
emissions The user might need to take mitigation measures, such
IEC 61000-3-3 as relocating or reorienting the equipment.
Guidance and manufacturer’s declaration - electromagnetic immunity
Immunity test IEC 60601 Test Compliance Level Electromagnetic environment - guidance
Electrostatic ±8 kV contact Floors should be wood, concrete, or ceramic tile. If

discharge (ESD) ±2, ±4, ±8, ±15 kV air floors are covered with a synthetic material, the
IEC 61000-4-2 relative humidity should be at least 30%.
Electrical/fast ±2 kV for a.c. mains Mains power quality should be that of a typical
transient/burst ±1 kV for I/O ports commercial or hospital environment.
IEC 61000-4-4
Surge ± -0.5 kV, ± -1 kV, ± -2 kV line to ground Mains power quality should be that of a typical
IEC 61000-4-5 ± -0.5 kV, ± -1 kV line to line commercial or hospital environment.
Voltage dips 100% Vac for 0.5 cycles at 0°, 45°, 90°, Mains power quality should be that of a typical
IEC 61000-4-11 135°, 180°, 225°, 270°, 315 commercial or hospital environment. If the user of
the system requires continuous operation during
100% Vac for 1.0 cycles at 0° power mains interruptions, it is recommended the
30% Vac for 30 cycles at 0° system be powered from an uninterruptible power
supply or battery.
100% Vac for 250 (50Hz) cycles or 300
(60Hz) cycles at 0°
Voltage 0% a.c. 250(50 Hz) or 300(60 Hz) at 0°
interruptions
IEC 61000-4-11
Power frequency 30 A/m Power frequency magnetic fields should be at
(50/60 Hz) magnetic levels characteristic of a typical location in a
field typical commercial or hospital environment.
IEC 61000-4-8
Guidance and manufacturer's declaration - electromagnetic immunity
99
Electromagnetic environment -
Immunity test IEC 60601 Test Compliance Level
guidance
3Vrms from 150kHz to 80 MHz at 80% AM 1kHz WARNING: Portable RF
6Vrm, 80% AM 1kHz at ISM frequencies listed below: communications equipment
(including peripherals such as
antenna cables and external
Frequency Test Level
(MHz-ISM List) (Vrms) antennas) should be used no
1.8 - 2.0 6 closer than 30 cm (12 inches) to
3.5 - 4.0 6 any part of the injection system
5.3 - 5.4 6 unless a greater separation
6.765 - 6.795 6 distance is required as indicated by
7.0 - 7.3 6 the equation. Otherwise,
Conducted RF
10.1- 10.15 6 degradation of the performance of
IEC-61000-4-6
13.553 - 13.567 6 this equipment could result.
14.0 - 14.2 6
18.07 - 18.17 6 Recommended separation
21.0 - 21.4 6 distance
24.89 - 24.99 6
d = 1.17 p
26.957 - 27.283 6
28.0 - 29.7 6
40.66 - 40.70 6
50.0 - 54.0 6
Radiated RF 3Vrms from 80 MHz to 2.7 GHz at 80% AM 1kHz and

IEC 61000-4-3 specific ISM bands listed below: d = 1.17 p 80 MHz to 800 MHz
Field d = 2.33 p 800 MHz to 2.7 GHz

Frequency Modulation Modulation
(MHz) Type Frequency
Strength Where p is the maximum output
(Volts/meter) power rating of the transmitter in
385 Pulse 18 Hz 27 watts (W) according to the
450 Pulse 18 Hz 28 transmitter manufacturer and d is
710 Pulse 217 Hz 9 the recommended separation
745 Pulse 217 Hz 9 distance in meters (m).
780 Pulse 217 Hz 9
810 Pulse 18 Hz 28 Field strengths from fixed RF
870 Pulse 18 Hz 28 transmitters, as determined by an
930 Pulse 18 Hz 28
electromagnetic site surveya,
1720 Pulse 217 Hz 28
should be less than the
1845 Pulse 217 Hz 28
compliance level in each frequency
1970 Pulse 217 Hz 28
2450 Pulse 217 Hz 28 range.b
5240 Pulse 217 Hz 9
5500 Pulse 217 Hz 9 Interference may occur in the
5785 Pulse 217 Hz 9 vicinity of equipment marked with
the following symbol:
Non-ionizing Radiation
Symbol
(IEC TR 60878, 5140)
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.
100
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the system is used exceeds the applicable RF compliance level above,
the system should be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as reorienting or relocating the system.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
101
102
18 Country-Specific Information
The following information is country-specific. The information within each section pertains only to that country.
18.1 Australia and New Zealand
Australian Communications and Media Authority (ACMA) Regulatory

Compliance Marking (RCM)
18.2 Canada
This device complies with Industry Canada’s licence-exempt RSSs. Operation
is subject to the following two conditions: (1) this device may not cause
interference, and (2) this device must accept any interference, including
interference that may cause undesired operation of the device.
IC RSS(Gen, 210 (UNII-1/2/2Ext/3))
ID:4608A-SXPCEAN2 Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux
appareils radio exempts de licence. L'exploitation est autorisée aux deux
conditions suivantes : (1) l'appareil ne doit pas produire de brouillage, et (2)
l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi,
même si le brouillage est susceptible d'en compromettre le fonctionnement.
18.3 European Union (EU)
18.3.1 Declaration of Conformance

Hereby, Imaxeon Pty Ltd declares that the radio equipment type MEDRAD® Centargo CT Injection System is in compliance
with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address:
https://radiology.bayer.com/contact
103
104
19 Index
A Create ............................................................................... 33
Administration ........................................................................ 31 Edit .............................................................................23, 34
Arming ...................................................................................... 24 Manage ............................................................................ 32
Personalized Protocol ............................................43, 67
B Routine Protocol ............................................................ 34
Barcode Reader ..........................................................................9 Select ................................................................................. 23
C R
Check for Air ............................................................................ 19 Reminder .................................................................................. 33
Confirm ............................................................................ 24 Configure ......................................................................... 34
Cleaning ................................................................................... 84
Contrast S
Manage ............................................................................ 35
Control Room Unit ................................................................ 13 Scanner Connectivity ............................................................ 63
Symbols ............................................................................ 14 Connect.CT ...................................................................... 64
Settings ..................................................................................... 36
Shut Down ..................................................................................9
D Symbols .......................................................................................3
Day Set ...................................................................................... 16 System .........................................................................................9
Eject .................................................................................. 29 System Alerts
Empty ............................................................................... 29 Display .............................................................................. 15
Install ............................................................................... 17
Load Fluids ...................................................................... 18 T
Replace Fluids ................................................................ 19 Training .................................................................................... 36
Display ...................................................................................... 15 Troubleshooting ..................................................................... 81
E W
Exam ......................................................................................... 21 Warnings .....................................................................................7
I
Import and Export ................................................................. 36
Injector .........................................................................................9
Icons .....................................................................................9
Inlet Air Sensor ....................................................................... 10
L
Licensing .................................................................................. 38
M
Maintenance ........................................................................... 83
Annual .............................................................................. 86
Daily .................................................................................. 83
N
Networking
Wireless Connection ..................................................... 36
O
Outlet Air Sensor .................................................................... 11
P
Patient Line .............................................................................. 16
Install, Prime, and Connect ........................................ 19
Remove ............................................................................. 27
Power On .....................................................................................9
Prime Container ..................................................................... 11
Cleaning ........................................................................... 85
Empty ............................................................................... 20
Protocol .................................................................................... 33
105
106
( 240) 86342812 ( 10) E
December 09, 2019
Bayer reserves the right to modify the specifications and features described herein or to discontinue any product or service
identified in this publication at any time without prior notice or obligation. Please contact your authorized Bayer
representative for the most current information.
The patient data that appear in this document are fictitious protected health information (PHI) and/or actual PHI from
which all personally identifiable information (PII) have been removed or otherwise anonymized. No personally identifiable
information is shown.
Bayer, the Bayer Cross, MEDRAD, Centargo, MEDRAD Centargo, MEDRAD Stellant, Stellant, Certegra, VirtualCare,
Connect.CT, P3T, and Imaxeon are trademarks owned by and/or registered to Bayer in the U.S. and/or other countries. Other
trademarks and company names mentioned herein are properties of their respective owners and are used herein solely for
informational purposes. No relationship or endorsement should be inferred or implied.
© 2019 Bayer. This material may not be reproduced, displayed, modified, or distributed without the express prior written
consent of Bayer.
To provide feedback or Manufacturer Authorized European Authorized Japanese

request support, please use Imaxeon Pty Ltd Representative Representative
the contact form provided on Unit 1, 38-46 South Street Bayer Medical Care B.V. バイエル

radiology.bayer.com/contact Rydalmere NSW 2116 Avenue Céramique 27 〒530-0001
Australia 6221 KV Maastricht 2-4-9
Phone: +61 2 8845 4999 The Netherlands
Fax: +61 2 8845 4998 Phone: +31(0)43-3585600 :+81(0) 6-6133-6250
2797 Fax: +31(0)43-3656598 Fax: +81(0) 6-6344-2395

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Operation

MEDRAD® Centargo CT Injection System

A glossary of symbols can be found in Section 2 of this manual.

3 Warnings, Cautions, and Notices ...................................................................7

4 System Overview .............................................................................................9

6 Perform Exam ................................................................................................21

6.1.1.1 Mandatory Fields........................................................................................................................................... 22

7 Eject Day Set ................................................................................................. 29

9 Personalized Protocols (Licensed Feature).................................................. 43

9.4.1 Essential Claims.........................................................................................................................................................49

10 Scanner Connectivity ..................................................................................63

11 Advanced Fluid Delivery Features...............................................................67

12 Data Manager (Licensed Feature)...............................................................71

12.3.1.1 Match Additional Studies.......................................................................................................................... 73

14 Cleaning and Maintenance ........................................................................ 83

15 Options and Accessories............................................................................. 87

16.3.3 Operating ..................................................................................................................................................................91

17 Compliance to IEC 60601-1-2 / 2nd, 3rd, and 4th Editions ........................97

1.2 Indications for Use

1.3 Training Information

1.5 Restricted Sales

1.6 Required Training

1.8 The Equipotential Connector (EPC)

Warning: Indicates hazardous voltages. (ISO 7010, W012)

Warning: Indicates a pinch or crush hazard. (ISO 7000, W024)

Indicates alternating current. (IEC 60417, 5032)

Identifies the Equipotential connection. (IEC TR 60878, 5021)

Identifies the Earth Ground point. (IEC TR 60878, 5017)

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

Class II Equipment, Double Insulated. (IEC 60417, 5172)

Identifies a power switch for equipment. (IEC TR 60878, 5009)

Symbols on the Power Switch (IEC TR 60878: 5007, 5008):

Stop button. (IEC TR 60878, 5110A)

Identifies a computer network. (IEC TR 60878, 5988)

Identifies a power supply connection. (IEC TR 60878, 5534)

Identifies a terminal suitable for direct current. (IEC TR 60878, 5031)

Identifies a transfer of displayed image to a second screen. (IEC TR 60878, 5892)

Identifies a handswitch connection. (IEC TR 60878, 5322)

Identifies an input terminal. (IEC TR 60878, 5034)

Identifies an output terminal. (IEC TR 60878, 5035)

Identifies service assistance. (IEC TR 60878, 0717)

Manufacturer (ISO 15223-1, 5.1.1)

Authorized Representative in the European Community (ISO 15223-1, 5.1.2)

Date of manufacture (ISO 15223-1, 5.1.3)

Temperature range (ISO 15223-1, 5.3.7)

Humidity range (ISO 15223-1, 5.3.8)

Atmospheric pressure range (ISO 15223-1, 5.3.9)

Serial number (ISO 15223-1, 5.1.7)

Catalog number (ISO 15223-1, 5.1.6)

This side up (ISO 7000, 0623)

Keep dry (ISO 15223-1, 5.3.4)

Fragile (ISO 15223-1, 5.3.1)

Quantity (IEC TR 60878, 2794)

Net Weight (ISO 7000, 1321B)

Hand wash only. (ISO 7000, 3125)

Consult instructions for use. (ISO 15223-1, 5.4.3)

3 Warnings, Cautions, and Notices

Mechanical Hazard - Serious patient and/or worker injury may result.

4.1 Power On and Shut Down

Table 4 - 1: Injector Icons

1 Advance Saline button

6 Patient Line Port

4.2.1 Fluid Loading Area