Operation Manual
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Operation Manual
Operation Manual
MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation Operation Manual The MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation has an expected service life* of 7 years from the date of product installation when operated according to the instructions provided with this device. These 7 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 the symbols used on the MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation can be found in Section 2 of this manual.
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MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation
Operation Manual
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1 Introduction ... 1 1.1 Certifications... 1 1.2 Intended Patient Population ... 1 1.3 Indications For Use ... 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 2.2 Injection System Buttons and Icons ... 7 2.2.1 Injector Head Icons... 7 2.2.2 Display Buttons and Icons... 8 2.2.3 Base Unit Icons ... 9 2.2.4 Overhead IV Track System... 9
3 Warnings, Precautions, and Notices ... 11 3.1 Warnings...11 3.2 Cautions...12 3.3 Notices...13
4 System Overview... 15 4.1 System Diagram...15 4.1.1 Moving the System Within the Room ...15 4.2 Fluid Delivery Basics ...15 4.2.1 Protocol...16 4.2.2 Protocol Manager...16 4.2.3 Fluid Delivery System Design ...16 4.2.4 Fluid Pressure and Pressure Limiting...16 4.2.5 Response to Occlusions ...17 4.2.6 Volume and Flow Rate Protection ...17 4.3 Syringe Installation Features ...17 4.4 Programming Mode...18 4.5 Basic Informatics ...18 4.6 Using the Pedestal with Integrated IV Pole ...18 4.6.1 Pedestal Operating Instructions...18
5 Understanding the Display and Workstation ... 19 5.1 Home Screen ...19 5.2 Workstation Descriptions ...22 5.2.1 Workstation Buttons and Icons...22 5.2.2 Workstation with Pod Buttons and Icons ...24
6 Understanding the Injector Head and Handswitch ... 25
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MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation
6.1 Injector Head Control ...25 6.2 Injector Head Components ...26 6.2.1 Syringe Heat Maintainer ...26 6.2.2 Manual Knob...27 6.2.3 Arm Lights...27 6.3 Handswitch ...27
7 Powering Up and Shutting Down the System... 29 7.1 Power Up the System...29 7.2 Shut Down the System ...29 7.2.1 Hard Shutdown...29 7.3 Restore from Injector Shutdown...29
8 Protocol Management ... 31 8.1 Create or Edit a Protocol...31 8.2 Save a Protocol...34 8.3 Recall a Saved Protocol...34 8.4 DualFlow...35 8.4.1 Essential Claims ...35 8.4.2 Programming a DualFlow Phase ...36
9 Preparing for Injection... 39 9.1 Control Room Preparation ...39 9.1.1 Informatics Panel...39 9.1.2 Prepare Injection Protocol...39 9.2 Scan Room Preparation ...41 9.2.1 Fluid Detection Methods ...42 9.2.2 Install and Fill a Syringe ...43 9.2.3 Attach and Prime the Tubing...45 9.2.4 Connect the Tubing to Patient...46
10 Arming and Injecting ... 47 10.1 Add Volume Indicator ...47 10.2 Arm the Injector...47 10.2.1 Arm from the Control Room ...47 10.2.2 Arm from the Scan Room ...49 10.3 Initiating an Injection ...49 10.4 Operator-Initiated Hold...50 10.5 Injection Aborted...50 10.6 Viewing Injection Progress...50 10.7 Viewing Reminders ...51
11 Completing an Injection ... 53 11.1 Injection Complete...53 11.2 Injection Aborted...54 11.3 Exiting Injection Complete ...55 11.3.1 Conducting Another Injection ...55
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12 Removing Disposables ... 57 13 Advanced Operations ... 59 13.1 System Setup ...59 13.1.1 System Setup Configurable Items ...60 13.2 Setup of P3T Software Functionality...61 13.2.1 P3T Setup Configurable Items...61 13.3 Protocol Manager Setup...62 13.3.1 Delete a Protocol...62 13.3.2 Rearrange Protocol List ...63 13.3.3 Hide/Show a Region ...63 13.3.4 Rename a Region...64 13.4 Fluid Delivery Setup...64 13.4.1 Fluid Delivery Setup Configurable Items ...65 13.5 Informatics Setup...66 13.6 Help ...66 13.6.1 Accessing the Help System...66 13.7 Fluid A ...67
14 Troubleshooting... 69 14.1 Injector Head Error Indication ...69 14.2 Error Screen...69 14.2.1 Error Recovery and Error Screen Messages ...69 14.3 Other Troubleshooting Tips...72 14.4 System Tones...72 14.4.1 General Tones ...73 14.4.2 Notification Tones ...73
15 Cleaning and Maintenance ... 75 15.1 In the Case of Saline or Contrast Media Spills...76 15.1.1 Cleaning the Injector Head ...76 15.2 Daily and In the Case of Visible Contamination...77 15.2.1 Cleaning the Injector Head ...77 15.2.2 Disinfecting the Injector Head ...78 15.3 Daily ...79 15.3.1 Inspecting the Injection System...79 15.3.2 Cleaning and Disinfecting the injector Head ...79 15.3.3 Cleaning the Pistons, Syringe Interface, and Light Pipe ...80 15.3.4 Cleaning the Pedestal With Integrated IV Pole, Overhead Counterpoise System (OCS), and Base. 82 15.3.5 Cleaning the Workstation Screen ...82 15.4 Monthly ...83 15.4.1 Operational Checkout...83 15.5 Annually ...84 15.5.1 Injection System Calibration ...84 15.5.2 Checking Leakage...84 15.6 Reinstalling the System in Another Room...84
16 Options and Accessories ... 85
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16.1 Mounting Options...85 16.2 Injector Head Extension Cables...85 16.3 Workstation Extension Cables ...85 16.4 Accessories ...86 16.5 Manuals...86 16.6 Sterile Disposables ...86
17 Specifications ... 87 17.1 Workstation Specifications ...87 17.1.1 Workstation Dimensions and Weight...87 17.1.2 Workstation Connections ...88 17.1.3 Workstation Input Power Requirements ...88 17.2 Workstation with Pod Specifications ...89 17.2.1 Workstation with Pod Dimensions and Weight...89 17.2.2 Workstation with Pod, Pod Connections ...89 17.2.3 Workstation with Pod, Display Connections ...90 17.2.4 Workstation with Pod, Display Input Power Requirements...90 17.3 Base Unit Specifications ...91 17.3.1 Base Unit Dimensions and Weight...91 17.3.2 Base Unit Connections ...92 17.3.3 Base Unit Input Power Requirements ...92 17.4 Injector Head Specifications...93 17.4.1 Injector Head Dimensions and Weight ...93 17.5 Environmental Specifications ...93 17.5.1 Non-Operating (Transportation and Storage)...93 17.5.2 Operating ...93 17.5.3 Protection Against Electrical Shock ...94 17.5.4 EMI/RFI ...94 17.5.5 Protection Against the Ingress of Fluids...94 17.5.6 Mode of Operation...94 17.5.7 Fluid Delivery Performance ...94 17.6 Over and Under Infusion Protection ...95 17.7 System Fluid Performance ...95 17.7.1 Factors Affecting Flow Rates...96 17.7.2 Maximum Flow Rate Performance...96 17.7.3 Programmable Pressure System Performance...96 17.8 Power Cable Specifications ...97 17.9 Cybersecurity and IT Network Connection ...97 17.9.1 System Cybersecurity Protection ...97 17.9.2 Certegra® Workstation Cybersecurity ...97 17.9.3 IT Network Connection...97 17.10 Fuse Specification ...98
18 Addendum – Compliance to IEC 60601-1-2: 3rd and 4th Editions... 99
Operation Manual
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Introduction
This manual applies to the MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation (Stellant FLEX with Certegra Workstation), also referred to as the system throughout this document, Catalog Numbers: FLEX. Read all the information contained in this manual. Understanding this information will assist users in operating the Stellant FLEX with Certegra Workstation in a safe manner. NOTE: Operating specifications, options, accessories, and feature availability may vary by country. Check with a local product representative for Bayer and country-specific operating instructions.
1.1 Certifications This device is equipped to operate at 100-240 VAC, 50/60 Hz, 300 VA and is designed to comply with IEC 60601-1 (3rd Edition Amendment 1) and IEC 60601-1-2 (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 18 - Addendum – Compliance to IEC 60601-1-2: 3rd and 4th Editions.
1.2 Intended Patient Population This device is intended for use on the general patient population. Patient physiology and institutional guidelines should be considered when selecting catheter sizes and injection protocol parameters.
1.3 Indications For Use The MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation, including Stellant FLEX CT Syringe Kits and Connector Tubing, is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications.
1.4 Contraindications None known.
1.5 Restricted Sales Federal (USA) law restricts these devices to sale by or on the order of a physician.
1.6 Required Training The device is intended to be used by trained personnel with experience in diagnostic imaging studies.
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 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.
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MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation
1.8 The Equipotential Connector (EPC) The Equipotential Connector (EPC) is an electrically bonded terminal on the injector that is used as a connection point between other medical electrical equipment. The EPC’s function is to minimize any voltage potentials differences between all connected equipment. The EPC is not designed to be an electrical safety ground.
1.9 Installation Contact Bayer for installation information.
Operation Manual
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Symbols Q
2.1 - General Symbols
Q
2.2 - Injection System Buttons and Icons
2.1 General Symbols
Warning: Refer to warnings and cautions on instructions for use packaged in each carton. (ISO 7010, W001) Attention: Refer to warnings and cautions on instructions for use packaged in each carton. (ISO 15223-1, 5.4.4)
Warning: Indicates hazardous voltages. (ISO 7010, W012)
Pushing Prohibited. Do not push at or above this point on the Injector. (ISO 7010, P017)
Indicates electrostatic sensitive device. (IEC TR 60878, 5134)
MR
MR Unsafe: Known threat or poses a hazard in all MR environments as defined by the ASTM International Standards for MRI Device Marking. (IEC 62570, 7.3.3)
Indicates alternating current. (IEC 60417, 5032)
Consult instructions for use. (ISO 15223-1, 5.4.3)
41 KG 90 LB
Maximum weight of the injection system and accessories during normal use. (ISO 7000, 1321Bl; ISO 15223-1, 5.4.3)
Maximum stacking load which may be stacked on the distribution packages
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MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation
WARNING
Indicates that the information is a warning. Warnings advise you of circumstances that could result in injury or death to the patient or operator. Read and understand the warnings before operating the injection system.
CAUTION
Indicates that the information is a caution. Cautions advise you of circumstances that could result in minor or moderate injury to the patient or operator. Read and understand the cautions before operating the injection system.
NOTICE:
Indicates that the information is a notice. Notices advise you of circumstances that could result in damage to the device. Read and understand the notices before operating the injection system.
Note
Indicates that the information that follows is additional important information or a tip that will help you recover from an error or reference to related information within the manual. 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)
PN
Part Number
Catalog Number (ISO 15223-1, 5.1.6)
This Side Up (ISO 7000, 0623)
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Keep Dry (ISO 15223-1, 5.3.4)
Fragile, Handle With Care (ISO 15223-1, 5.3.1)
Indicates that this device conforms to the requirements of the European Medical Device Directive 93/42/EEC. Identifies a type BF applied part complying with IEC 60601-1 standards. (IEC 60417, 5333) Medical - General Medical Equipment As To Electrical Shock, Fire, and Mechanical Hazards Only In accordance with ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012) CAN/CSA-C22.2 No. 60601-1 (2014) See accompanying documentation. This symbol indicates the user shall refer to the instructions-for-use to ensure safe operation. (ISO 7010, M002)
CLASS 1
Indicates the injection system is Class 1 medical equipment as defined by IEC 606011 standards.
Class II Equipment, Double Insulated (IEC 60417, 5172)
IPX1 Code that specifies the degree of protection provided by the enclosure against vertically falling water drops (IEC 60529)
Indicates separate collection for Electrical and Electronic Equipment per Directive 2002/96/EC. Refer to the following website for additional information: www.weee.bayer.com (EN 50419, Fig. 1) Indicates that 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 center of the logo. This product should be recycled immediately after its environmental protection use period has expired.
Identifies an on/off switch for equipment. (IEC TR 60878, 5009)
Identifies a computer network. (IEC TR 60878, 5988)
Identifies a power supply. (IEC TR 60878, 5534)
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MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation
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)
Net Weight (ISO 7000, 1321B)
Operation Manual
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2.2 Injection System Buttons and Icons 2.2.1 Injector Head Icons
1 2
ml
Fill
Auto Load
Fill
2 3
3 Prime
5
4 Move Piston
6
6
I Checked For Air
7 Arm
#
Button/Icon
9
8
10
11
Description
#
Button/Icon
Description Fill buttons:
1
Activates the Fill buttons.
2
Q
Syringe A (green)
Q
Syringe B (blue)
3
Adjusts volume to the desired amount in small increments/ decrements.
4
Prime button
5
Activates the forward and reverse piston controls. Illuminates when pressed.
6
Forward and reverse piston controls
7
I Checked for Air confirmation button. Illuminates after the operator has confirmed inspection of the fluid path for air.
8
Indicates the protocol is locked. Illuminates after the protocol has been locked.
9
Arms the injector. Illuminates after the injector has been armed.
10
Terminates the injection and disarms the system.
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MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation
#
Button/Icon
Description
#
Button/Icon
Manual knob indicators (not shown):
Initiates the injection. Holds the injection for a maximum of 20 minutes.
11
Description
Identifies heat maintainer connection on underside of injector head (not shown).
Q
Syringe A (green)
Q
Syringe B (blue)
Identifies handswitch connection on underside of injector head (not shown).
2.2.2 Display Buttons and Icons
4 7
5 6
1 #
Button/Icon
1
2
3
Description
#
Button/Icon
Description Displays most recent Fluid A values entered. Press OK to select again or cancel to choose new values.
Accesses the system settings.
2
Resets the protocol to the factory default values.
4
4
Displays that no Reminders are set.
5
Indicates status of communication with injector head.
5
If ISI is available, indicates status of communication with ISI.
5
I Checked for Air confirmation icon. Displays prior to the operator confirming inspection of the fluid path for air.
3
R
1
Displays the remaining number of set Reminders.
Operation Manual
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Button/Icon
5
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Description
#
Button/Icon
I Checked for Air confirmation icon. Illuminates yellow after the operator has confirmed inspection of the fluid path for air.
5
If XDS is available, indicates the status of the XDS accessory.
7
Indicates that the Informatics Panel and Modality Worklist accessories are enabled. Refer to the Certegra® Applications and Workstation Accessories operation manual for more information.
The Injector icon identifies various states of the injector: Q
6
Illuminates yellow and flashes when the system is armed.
Q
Illuminates solid yellow when the system is injecting.
Q
Not illuminated when system is idle.
Informatics Panel and Modality Worklist
Description
2.2.3 Base Unit Icons
Identifies the Equipotential connection. (IEC TR 60417, 5021)
Identifies the Protective Earth Ground point (IEC TR 60878, 5019)
2.2.4 Overhead IV Track System
>23 kg >50lbs.
The Overhead IV Track System is only intended for hanging IV fluids. Do not hang more than 50lbs/23kg of weight on the hooks.
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MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation
Operation Manual
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Warnings, Precautions, and Notices Q
3.1 - Warnings
Q
3.2 - Cautions
Q
3.3 - Notices
3.1 Warnings WARNINGS Air Embolism Hazard - Serious patient injury or death may result. Q
Use only disposables or accessories supplied by Bayer. Refer to 16.6 - Sterile Disposables.
Q
Use catheters and connectors with pressure ratings compatible with this system. Refer to 17.7.2 Maximum Flow Rate Performance and 17.7.3 - Programmable Pressure System Performance.
Environmental Contamination Hazard - Serious patient or worker injury or death may result. Q
Visually inspect all components before use.
Q
Do not use damaged components.
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.
Fire hazard - Serious patient and/or worker injury or death may result. Q
Use the correct fuse type replaced by Bayer or personnel trained by Bayer.
Applicable Restrictions - Serious patient injury or death may result. Q
Do not use this system to deliver any fluid other than intravenous contrast media and common flushing solutions.
Q
This device is not intended for drug infusions, chemotherapy, or any other use for which the device is not indicated.
Q
Handle and use contrast media and saline per the manufacturers’ instructions.
Hazard Q
Do not service or perform maintenance on the injection system while in use with a patient.
Reuse of single-use fluid sources may result in biological contamination. Q
Refer to the fluid source manufacturers' Instructions for Use.
Mechanical Hazard – Serious patient injury could result from leaks or ruptures during an injection. Q
Use only disposables supplied by Bayer. Refer to 16.6 - Sterile Disposables.
Q
Use only syringes and connector tubing with a pressure rating greater than the maximum programmable pressure limit of the injection system, which is 325 psi (2241 kPa).
Q
Use catheters with pressure ratings compatible with this system. Refer to 17.7.2 - Maximum Flow Rate Performance and 17.7.3 - Programmable Pressure System Performance.
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MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation
WARNINGS Hot surface Q
Do not touch.
Hazard Q
Do not lean against the injection system when installed on any type of mounted configuration.
3.2 Cautions
CAUTIONS Mechanical Hazard - Minor or moderate patient and/or worker injury may result. Q
Only use the system as defined in this manual. Follow the system communication if a system fault is communicated or in the event of a system malfunction. Follow the fault message.
Q
Do not use the system in the presence of flammable (such as anesthetics) or combustible gases or other agents.
Electric Shock Hazard - Minor or moderate patient and/or worker injury may result. Q
Only plug the system into a direct mains access point. Do not plug the system power cord into an extension cord or multi-outlet power strip.
Procedure Delay Hazard - Serious patient and/or worker injury or death may result. Q
Turn off any equipment that could generate a high level electrostatic discharge.
Hazard Q
Do not connect or disconnect an accessory to the system while in use with the patient.
Operation Manual
3.3 Notices NOTICE: Electro-Mechanical Hazard - Equipment damage may result. Q
Allow the system to stabilize at room temperature before use due to condensation that may cause electrical damage.
Mechanical Hazard - Equipment damage may result. Q
Do not touch the display screen with a sharp object in order to perform the calibration.
Q
Component damage may occur if not installed properly. Ensure all connections are secure; do not overtighten. This will help minimize leaks, disconnection, and component damage.
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