Stellant CT Injection System Operation Manual Rev D

Stellant CT Injection System Operation Manual

Stellant CT Injection System

2004, Medrad Inc. All rights reserved. Reproduction of this manual is strictly prohibited without express written consent of Medrad, Inc. For more information about Medrad products and services, please visit WWW.MEDRAD.COM

Table of Contents 1 - Introduction ... 1-1 Certifications ... 1-1 Intended Use ... 1-1 Contraindications ... 1-1 Restricted Sale ... 1-1 Trademarks ... 1-1 Disclaimers ... 1-1 Medrad Contact Information ... 1-2 Symbols ... 1-3 Pressure Limit ... 1-5 Pressure ... 1-5 Flow Rate ... 1-5 Injector Duration ... 1-5 The Basics ... 1-5 How the Injector is Designed ... 1-6 How to Recognize if a Pressure Limit Condition Occurs ... 1-6 Response to Occlusions ... 1-7 Volume and Rate Protection ... 1-7 Warnings ... 1-8 Cautions ... 1-10 2 - System Basics ... 2-11 About the Injection System ... 2-11 Stellant Models ... 2-11 Basic Features ... 2-11 Display Control Unit (DCU) ... 2-12 Stellant Injector (Single) ... 2-14 Stellant Injector (Dual) ... 2-16 Injector Head Functions ... 2-18 Heat Maintainer ... 2-20 Applying Power ... 2-20 System Logo ... 2-20 Safety Screen ... 2-20 Main Screen ... 2-21 Touch Screen Calibration ... 2-22 Setup ... 2-23 Date/Time ... 2-24 Help ... 2-25 Reset ... 2-25 3 - Preparing to Inject ... 3-27 Minimizing Air Embolization Risks ... 3-27 Minimizing Extravasation ... 3-29 Stellant Connector Tubing ... 3-30 Loading and Priming a Syringe ... 3-31 Manual Loading a Syringe ... 3-32

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Stellant CT Injection System

Cautions for draw back ... 3-33 Using Auto Load to Load a Syringe ... 3-34 Pre-loading a 200 ml Syringe on the Injector Head ... 3-36 Removing a 200 ml Syringe ... 3-36 Programming Protocols ... 3-37 Storing a Protocol ... 3-38 Locking a Protocol ... 3-38 Recalling a Protocol ... 3-39 Deleting a Protocol ... 3-39 Programming a Delay ... 3-40 Pressure Limit Programming ... 3-41 4 - Arming and Injecting ... 4-43 Arming ... 4-43 Injecting ... 4-45 Injecting Views ... 4-47 Injection Complete ... 4-48 Pressure Graph ... 4-50 Helpful Hints ... 4-51 Test Injection ... 4-53 5 - Simultaneous Injection ... 5-55 Introduction ... 5-55 Warnings ... 5-55 Upgrading the Injector ... 5-55 Protocol Programming ... 5-57 Calculating Contrast ... 5-59 Appendix A - System Messages ...A-61 Error Screen ... A-61 Tone Table ... A-61 Appendix B - Cleaning and Maintenance ...B-63 Cleaning Guidelines ... B-63 Recommended Maintenance Schedule ... B-65 Inspection Procedures ... B-66 Operational Checkout ... B-67 Dual Syringe System ... B-68 Single Syringe System ... B-68 Appendix C - Specifications ...C-71 DCU and Base Unit ...C-71 Base Unit Dimensions ...C-71 DCU Weights ...C-71 Back of Monitor ...C-71 Rear of Base Unit ...C-72 Bottom of Base Unit ...C-72 Injector Head Dimensions ...C-73 Environmental Specifications ...C-76

ii

Appendix D - Options and Accessories ...D-79 Catalog Numbers and Descriptions ...D-79 Overhead IV Track System ...D-80 Stellant Adjustable Height Pedestal (SHP 700) ...D-81 Pedestal Cleaning ...D-82 Pedestal Inspection ...D-82 Pedestal Operation Instructions ...D-82 Appendix E - System Installation ... E-83 Unpacking the Injection System ... E-83 Installation Considerations ... E-84 Injector Installation ... E-85 Wall Mount Installation ... E-86 Index ... I-89

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Stellant CT Injection System

iv

1 - Introduction

1 - Introduction This manual applies to the Medrad Stellant CT Injection System, Catalog Numbers: SCT 110, 111, SCT 112, SCT 120, SCT 121, SCT 122, SCT 210, SCT 211, SCT 212. Read all the information contained in this manual. Understanding this information will assist you in operating the Stellant CT Injection System in a safe manner. Certifications

This device is equipped to operate at 100-240 VAC, 50/60 Hz, 180 VA (Single), 300 VA (Dual), and is designed to comply with EN 60601-1 (safety), and IEC-60601-1-2 / 2nd edition Standards. Special precautions regarding ElectroMagnetic Compatibility (EMC), are required for installation and use of this injector system. Detailed EMC information can be found in the Medrad Injector Service Manual, or it’s Addendum. Certifications: Medrad, Inc. is EN ISO 9001/EN ISO 13485 certified. Medrad Europe B.V. is EN ISO 9002 EN 13488 certified. Nihon Medrad KK (NMKK) is ISO 9001/ISO 13485 certified.

Intended Use

The Stellant CT Injection System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications.

Contraindications

These devices are not to be used for drug infusion, chemotherapy, or any other use for which the devices are not indicated. The Stellant CT Injection System is not intended for portable use.

Restricted Sale

Federal (USA) law restricts these devices to sale by or on the order of a physician.

Trademarks

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

Disclaimers

External wiring and modifications disclaimers: Medrad disclaims liability for any modifications or interfaces with other equipment that are not in conformity with the specifications and information contained within this manual. Accessory equipment connected to the Stellant CT Injection System must be certified according to IEC 60601-1 standard. Furthermore, all configurations shall comply with system standard IEC 60601-1-1. Anyone who connects additional equipment to the signal input or output part configures a medical system and is therefore responsible that the system complies with the requirements of the standard IEC 60601-1-1. To obtain on-site consulting or consulting references, contact Medrad Service.

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Stellant CT Injection System

Medrad Contact Information

Medrad, Inc. USA One Medrad Drive Indianola, Pa 15051-0780 U.S.A. Phone: 412 767-2400 Fax: 412-767-4128 Medrad Europe B.V. Postbus 205 6190 AE Beek The Netherlands Phone: +31(0)43-3585601 Fax: +31(0)43-3656598 Nihon Medrad KK 9F Central Shin-Osaka Building 4-5-36, Miyahara Yodogawa-ku Osaka, 532-0003 Japan Phone: +81-6-6350-0680 Fax: +81-6-6398-0670

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1 - Introduction The following symbols are used on the Stellant CT Injection System and components:

Symbols

Indicates that this device conforms to the requirements of the European Medical Device Directive 93/42/EEC. Forward and Reverse Piston Controls. Check For Air Indicator on the injector head. Also indicates that the operator has acknowledged inspecting the fluid path for air when illuminated yellow on the touch screen, Contrast indicator (green), Saline indicator (blue). Protocol is locked indicator. Attention, consult accompanying instructions. Indicates on/off switch.

Indicates hazardous voltages. Indicates alternating current. Identifies a type BF applied part complying with EN 60601-1 standards.

CLASS 1

Indicates the injection system is Class 1 medical equipment as defined by EN 60601-1 standards. Identifies the degree of protection against fluid as drip proof. Identifies connection of the handswitch. Identifies the Equipotential connection.

Identifies the Earth Ground point.

Indicates design for indoor use only. Indicates the presence of no serviceable parts.

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Stellant CT Injection System

Identifies the DCU brightness controls.

Start / Hold. Abort. Reset. Help. Setup. Protocol is unlocked or unengaged. Pressure Graph View. Phase View. Electrostatic. Heat Maintainer(s) connection

>23 kg >50lbs.

The Overhead IV Track System is only intended for hanging IV fluids. Do not hang more than 50lbs / 23 kg of weight on the hooks.

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1 - Introduction

Pressure Limit

The Stellant CT Injection System is designed to allow varied flow rates for contrast injections. In order to understand this section on Pressure and Pressure Limiting, it is important to clarify the terminology that will be used in this section.

Pressure Pressure is related to the amount of force which the injector head must develop in the syringe in order to move fluid at the selected Flow Rate. Pressure developed by the Stellant CT Injection System is measured relative to the atmosphere pressure outside of the syringe or connector tubing. The pressure developed by the injector is expressed in terms of “Gauge Pressure” or “PSIG” which is the “Absolute Pressure” or “PSIA” minus the atmospheric pressure. Hereafter, pressure displayed as PSI refers to gauge pressure.

200 ml syringe Programmable Pressure Limit (Selectable Range: 325 kPa - 2241 kPa)

Factory preset to 325 PSI (2241 kPa)

Hazard/failure limit (injector shut-down pressure in the event of a failure).

Factory preset to 375 PSI (2586 kPa)

NOTE:

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

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

Injector Duration Injection Duration is the length of time that the injector will require to perform the programmed protocol from the moment the start switch is depressed until the unit stops injecting. Duration is calculated by dividing the selected Volume by the selected Flow Rate (50 ml Volume divided by 2 ml/sec Flow Rate = Duration of 25 seconds). The duration of a multi-phasic injection will be calculated by the injector and displayed on the screen. Pause time is not included in this duration time.

The Basics In order for contrast media to flow through the CT disposable system (connector tubing, stopcock, catheter-over-needle), the pressure in the syringe must exceed the resistance of the disposable system. Pressure in the syringe is generated by the force driving the syringe plunger. This pressure decreases over the entire length of the disposable system. As the fluid flows out the end of the catheter, there will be virtually no pressure. Pressure will be essentially zero at the open (unrestricted) end of the catheter-over-needle, because there is no resistance to fluid flow.

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Stellant CT Injection System

To achieve a selected Flow Rate, the pressure exerted by the plunger must be great enough to overcome the resistance of the disposable system. To do this, the force behind a fluid must be great enough to push it through a tube.

How the Injector is Designed The Stellant CT Injection System is a flow-controlled system. This means that the flow that is selected on the display control console is the flow rate at which the injector will deliver contrast for the duration of the injection. The only time the actual flow rate will differ from the programmed flow rate is when the flow rate cannot be delivered through the selected disposables with the amount of pressure available. When this occurs, the injector will automatically limit the maximum pressure and the resultant (lower) flow rate will be delivered. The injector still injects and delivers the total volume. However, the delivered flow rate will be lower, and thus, the injection duration will be longer.

How to Recognize if a Pressure Limit Condition Occurs If a pressure limit condition occurs, it will first be evidenced by injection durations that are greater than what would normally be expected, and also by low-contrast films. A pressure limit condition can also be seen by observing the Pressure Graph. Therefore, if the enhancement on the images is not as desired, this could mean a lower flow rate was delivered than selected, and pressure limiting may be occurring. Check for a pressure limit condition by comparing the actual injection duration with a calculated value (volume divided by flow rate). If the actual duration exceeds the calculated value, pressure limiting may have occurred. To achieve the selected flow rate (avoid a pressure limit condition), consider increasing the catheter size or use a less viscous or heated contrast media.

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1 - Introduction

Response to Occlusions

When injecting into an occlusion, a stall condition (flow rate less than 10% of programmed rate) or a very high pressure, a disarm will result. A stall condition lasting more than five seconds will result in the injection being automatically terminated. If a stall or high pressure disarm occurs, check the fluid path for blockage and inspect the disposable set for damage. If no blockage is found consider increasing the catheter size or decreasing the flow rate. Re-check the fluid path for air before arming.

Volume and Rate Protection

The following means are provided to protect against over and under volume or rate conditions: •

Warnings displayed on the Safety screen remind the operator to check the programmed injection parameters prior to the system being armed.

•

An on-screen indication of insufficient volume is provided whenever the total volume programmed to be delivered is greater than the amount of fluid in the syringe.

•

Injection monitoring is performed to detect over rate or over volume conditions due to system faults. If either of these conditions is detected, the injection will be stopped.

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

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

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Stellant CT Injection System

Warnings

Patient injury could result from a system malfunction. If a system malfunction occurs, immediately remove unit power by pressing the power switch and disconnect the unit from the patient. If a fault message is displayed that cannot be corrected, and/or the system is not operating correctly, do not use the injection system. Call Medrad or your local dealer for assistance. Patient injury could result from leaks or ruptures during an injection. To prevent leaks or ruptures in the event of a blockage, use only Medrad disposable products, or use catheters and connectors with pressure ratings compatible with this system. Explosion hazard: Patient injury could result from using the injection system in the presence of flammables (such as anesthetics). Do not use the system when flammables are present. Fire hazard: Patient injury could result from using incorrect fuses. To avoid an electrical fire, assure the correct type of fuse is used for replacement. The fuse must be replaced with Type T, 250 V, 3.15 A fuse by qualified personnel only. Shock hazard: Patient injury could result from worn cabling or unit disassembly. To avoid exposure to potentially hazardous voltages, do not disassemble the injection system in any way. Worn cabling also creates hazards. If any worn or damaged cables are detected, do not use the injection system. Contact MEDRAD or your local dealer for service or replacement. Patient injury could result from potentially hazardous system electronic assembly material. Dispose of system components or accessories properly. Follow local regulations for proper disposal or contact Medrad Service for assistance. Patient injury could result from using improper accessories. Use only accessories and options provided by Medrad designed for this system. Patient injury could result if the syringe is not properly engaged. Ensure the syringe is properly snapped into the front of the injector head before injecting. Improper engagement may cause the syringe to leak, become damaged, or to come off during the injection and result in an under-volume delivery. Patient injury or death could result from an air embolism. •

Expel all trapped air from the syringe(s), connectors, tubing, and catheter-over-needle before connecting the system to the patient. Carefully read the instructions for loading and the use of FluiDot™ indicators (where applicable) to reduce the chance of air embolism.

•

The presence of rounded FluiDot indicators do not indicate the total absence of air bubbles in the syringe tip. FluiDot indicators must be viewed in a properly illuminated environment, with a light source behind the operator providing enough light to permit easy viewing.

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1 - Introduction •

To minimize air embolization risks, ensure that one operator is designated the responsibility of filling the syringe(s). Do not change operators during the procedure. If an operator change must occur, ensure that the new operator verifies that the fluid path is purged of air.

•

To minimize the possibility of inadvertent aspiration and injection, ensure the patient is disconnected from the injector when utilizing the forward and reverse piston controls.

Biological contamination could result from reusing disposable items or failure to follow aseptic technique. Properly discard disposable items after use, or if there is any possibility that contamination may have occurred. Syringe sterility will be compromised, and patient infection may result, if the plunger is removed from the syringe. Do not remove the plunger to fill the syringe. Bacterial contamination could occur if syringes are used to store contrast media. Use loaded syringes immediately. Discard unused loaded syringes. Patient or operator injury could result if the sterile disposable package is opened or damaged, or if damaged components are used. Visually inspect contents and package before each use. Patient injury could result from high flow rate venous injections. Use extreme care when selecting the flow rate. Before arming the injector, verify that high flow rate injection parameters are correct. Only use the power cord supplied with the system. Do not plug the Stellant power cord into an extension cord or multi-outlet power strip. Patient or operator injury may result if damaged components are used. Do not use damaged components. Visually inspect all components before use. Failure to use the proper start switches and syringe heaters could result in Electro Magnetic Emissions not meeting specification.

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Stellant CT Injection System

Cautions

Condensation may cause electrical damage to the injection system. Do not use the system immediately after it has been brought indoors from extreme outside temperatures. Allow the system to stabilize at room temperature before use. Damage can occur as a result of incorrect voltage. Verify that the voltage and frequency marked on the serial tag on the back of the unit matches the voltage and frequency of the electrical outlet. Do not touch the screen with a sharp object in order to perform the calibration. System malfunction may be caused by failure to perform regular maintenance. Regular preventive maintenance is recommended to ensure that the system stays calibrated and functions properly. Refer to this manual or contact Medrad for additional information. Do not expose system components to excessive amounts of water or cleaning solutions. Wipe components with a soft cloth or paper towel dampened with cleaning solution. Do not use strong cleaning agents and solvents. Warm water and a mild disinfectant are all that are required to clean the injector. Do not use strong industrial cleaning solvents such as acetone. Do not spray cleaning solutions directly onto the touch screen. To prevent damage, wipe the touch screen with a soft non-abrasive cloth or paper towel dampened with water soluble cleaning solution. Improper or careless cleaning methods may result in equipment damage. Do not soak or immerse any part of the injection system in water. While cleaning any outside portion of the system, avoid allowing any water to leak inside system components. Component damage may occur if not installed properly. Ensure all connections are secure; do not overtighten. This will help minimize leaks, disconnection, and component damage. Injector may disarm or fail to operate upon exposure to high electromagnetic fields that may be generated by radio transmitters or cellular phones, or upon exposure to high levels of electrostatic discharge. Additional warnings, cautions and notes are located throughout this manual, where applicable.

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2 - System Basics

2 - System Basics About the Injection System

The Stellant CT Injection System is comprised of the injector head located in the scanning room and a touch screen Display Control Unit (DCU) and Base unit, which is typically located in the control room. The three components are connected by a communications link.

Stellant Models Model

Description

Catalog Number

S

Single Syringe System without Auto Load and Prime

SCT 110 (no injector head mount) SCT 111 (includes a floor-mounted injector head mount) SCT 112 (includes an overhead counterpoise ceiling head mount)

SX

Single Syringe System - Full featured

SCT 120 (no injector head mount) SCT 121 (includes a floor-mounted injector head mount) SCT 122 (includes an overhead counterpoise ceiling head mount)

D

Dual Syringe System - Full SCT 210 (no injector head mount) featured SCT 211(includes a floor-mounted injector head mount) SCT 212 (includes an overhead counterpoise ceiling head mount) Dual Flow

SCT 220 (no injector head mount) SCT 221 (includes a floor-mounted injector head mount) SCT 222 (includes an overhead counterpoise ceiling head mount)

Basic Features

The basic foundation features of all Models include: •

Stellant 200 ml syringe

•

Pressure graph (not in S model)

•

Auto dock, Auto advance, and Auto retract (not in S model)

•

Duration by phase

•

Prime (not in S model)

•

Elapsed injection time indicator

•

Configuration Screen

•

Remote Check For Air

•

Protocol Lock

•

Remote Start

•

Scan delay

•

Test Inject

•

Store and recall of protocols

•

Selectable Pressure Limit

•

Remote arming

•

Choice of floor-mounted pedestal head mount with bulk contrast holder or Overhead Counterpoise System (OCS)

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Stellant CT Injection System

Display Control Unit (DCU)

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

Display Control Unit

Power Button

Brightness Controls

Setup Help

Abort

Reset

Start/Hold

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

Control

Function

Start/Hold

Toggles between starting and holding the execution of an injection protocol.

Abort

Stops injector head motion.

Reset

Resets the injection protocol to default values.

Setup

Switches screen to Setup screen.

Help

Switches screen to Help screen.

Brightness Up

Increases the display brightness.

Brightness Down

Decreases the display brightness.

Power Button

Turns unit on and off.

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2 - System Basics S model Injector head overlay

VOLUME

FORWARD PISTON MOVE PISTON

REVERSE PISTON

CHECK FOR AIR PROTOCOL LOCK ARM

START / HOLD

ABORT

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