Operation Manual
78 Pages
Preview
Page 1
Operation Manual
TABLE OF CONTENTS 1 - Introduction...1-1 Important Safety Notice ... 1-1 Certifications ... 1-1 Indications for Use ... 1-1 Contraindications ... 1-1 Restricted Sale... 1-1 Required Training ... 1-1 Disclaimers ... 1-1 The Equipotential Connector (EPC)... 1-1 Understanding Symbols... 1-2 Warnings... 1-5 Cautions... 1-7
2 - System Basics ...2-9 About the Injection System ... 2-9 Pressure Safety Limit... 2-10 Response to Occlusions ... 2-10 Volume and Rate Protection ... 2-10 Control Room Unit ... 2-11 Scan Room Unit... 2-12 Injector Head... 2-13 Battery Charger... 2-14 Optional Control Room Unit Accessories... 2-15 Touch Screen Calibration ... 2-16 Help Mode... 2-16 Setup Mode... 2-17
3 - Preparing to Inject ...3-19 Applying Power ... 3-19 Main Screen... 3-20 Battery Maintenance ... 3-21 Storing a Protocol ... 3-33 Recalling a Stored Protocol ... 3-34
4 - Arming and Injecting ...4-35 Arming... 4-35 Single and Multi-Arm... 4-35 Insufficient Volume... 4-36 Injecting... 4-36 Disarming... 4-37 Injection History ... 4-39 Clean Up ... 4-40
Appendix A: System Messages... A-43 Type 1 Messages...A-43 Type 2 Messages...A-44 Type 3 Messages...A-44 i
MEDRAD® Spectris Solaris EP MR Injection System
Appendix B: Maintenance and Checkout ... B-45 Recommended Maintenance Schedule ...B-45
Appendix C: Specifications ... C-51 Scan Room Unit... C-51 Control Room Unit ... C-52 Battery Dimensions... C-52 Battery Charger... C-53 Power Cords ... C-53 System Capabilities ... C-54 Executable Flow Rates ... C-54 System Performance ... C-55 Forward and Reverse Controls ... C-55 EMI/RFI... C-56 Electrical Requirements ... C-56 Power Supply DC Output Voltage... C-56 Electrical Leakage... C-56 Ground Continuity ... C-56 Environmental Specifications... C-56 Classifications ... C-57
Appendix D: Options and Accessories... D-59 Appendix E: System Installation ... E-61 Unpacking the Injection System...E-62 Installation Considerations...E-63 Fiber Optic Cable Installation...E-65 Strain Relief Location...E-66 Recommended Routing ...E-66 Cable Routing: ...E-66 Control Room Unit Setup ...E-66 Handswitch Mounting...E-67
Appendix F – Compliance to IEC 60601-1-2 / 2001 2nd Edition...F-69
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1 - Introduction
1 - Introduction This manual applies to the MEDRAD® Spectris Solaris EP MR Injection System, Catalog Number 3012011. Read all of the information contained in this section. Understanding the information will assist you in operating the device in a safe manner.
Important Safety Notice
This device is intended to be used by medical professionals with adequate training and experience in magnetic resonance imaging (MRI) studies.
Certifications
This device is equipped to operate at 100-240 VAC, 50/60 Hz, 180 VA (Single), and is designed to comply with EN 60601-1/IEC 60601-1 Second/ Third Edition, and EN 60601-1-2 Second Edition and IEC 60601-1-2 Second/ Third Edition Standards.
Indications for Use
This system is intended for the purposes of injecting intravenous MR contrast media and common flushing solutions into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) procedures.
Contraindications
This device is not to be used in the arterial side of the vascular system, for drug infusion, chemotherapy, or any other use for which the device is not indicated. The system should not be used with a magnetic resonance imaging scanner having a magnetic field strength greater than 3.0 Tesla.
Restricted Sale
Federal (USA) law restricts this device to sale by or on the order of a physician.
Required Training
This device is intended to be used by individuals with adequate training and experience in diagnostic image studies.
Disclaimers
External wiring and modifications disclaimers: Bayer disclaims liability for any modifications or interfaces with other equipment which are not in conformity with the specifications and information contained within this manual. Accessory equipment connected to the device must be certified according to IEC 60601-1 Second/Third Edition standard. Furthermore, all configurations shall comply with system standard EN 60601-1/IEC 60601-1-1. Anyone who connects additional equipment to the signal input or output part configures a medical system and is therefore responsible that the system complies with the requirements of the standard IEC 60601-1-1. To obtain on-site consulting or consulting references, contact Bayer HealthCare Services. The MEDRAD Spectris Solaris EP MR Injection System is not intended for portable use.
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.
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MEDRAD® Spectris Solaris EP MR Injection System
Understanding Symbols
The following symbols are used on the MEDRAD Spectris Solaris EP MR Injection System and components: Warning: Refer to warnings and cautions on Instructions for Use packaged in each carton. Attention: Refer to warnings and cautions on Instructions for Use packaged in each carton.
Indicates that this device conforms to the requirements of the European Medical Device Directive 93/42/EEC. Indicates on/off switch for the Control Room Unit. Indicates hazardous voltages.
Indicates alternating current. Identifies a type BF applied part complying with EN 60601-1 standards.
CLASS 1 IPX1
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 for the Spectris Solaris EP Injection system. Identifies connection of the handswitch.
Identifies injector head forward and reverse piston control keys. Identifies the direction of manual knob rotation relative to plunger movement. Identifies the ENABLE key. Identifies polarity of the battery pack terminals. Indicates DC power supply. Indicates the current charge level of the system battery.
Identifies Integrated Continuous Battery Charger system activity on Graphical User Interface. When illuminated yellow this indicates that the Continuous Battery Charger system is present and functioning.
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1 - Introduction
Indicates the AIR EXPELLED button on the injector head. When illuminated yellow on the touch screen, also indicates that the operator has acknowledged inspecting the fluid path for air. Identifies the Equipotential connection. Identifies the Earth Ground point.
IOIO
Identifies the Service Connection Port. Identifies the Locking Bracket. Indicates which direction to turn Locking Bracket knob to “lock” and “unlock” the bracket.
TX
Identifies the Communication Cable Transmit connection.
RX
Identifies the Communication Cable Receive connection. Indicates design for indoor use only. Identifies the Integrated Continuous Battery Charger System power supply connection. Indicates the presence of no serviceable parts.
I
Indicates the presence of AC power at the battery charger. Identifies the Control Room Unit brightness controls.
P109
Reserved for future use. Indicates the status of the battery charger. When a battery is properly inserted, the LED will illuminate while charging, and extinguish when the battery is fully charged.
Pushing Prohibited. Do not push at or above this point on the Injector.
Manufacturer.
Date of Manufacture / Sterilization
Authorized representative in the European community.
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MEDRAD® Spectris Solaris EP MR Injection System
Temperature range.
Humidity range.
Atmospheric pressure range.
This side up.
Keep dry.
Fragile.
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1 - Introduction This manual contains important information about use of the MEDRAD Spectris Solaris EP MR Injection System. Bayer urges you to read this manual carefully, become familiar with the procedures and system functions that it describes, and follow its recommendations to assure proper use of the system. Labels on the system or statements in this manual preceeded by any of the following words and/or symbols are of special significance, intended to help you to operate the system in a safe and successful manner: 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:
Warnings
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.
Patient injury may result from a system malfunction. If a system malfunction occurs, immediately remove unit power (by pulling the battery from the Scan Room Unit), 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 Bayer 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 catheters and connectors with pressure ratings compatible with this system. Explosion hazard. The MEDRAD Spectris Solaris EP MR Injection System is not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. Fire hazard. To avoid an electrical fire, assure the correct type of fuse is used for replacement. The fuse must be replaced with Type F, 250 V, 2.5 A fuse by qualified personnel only. Electrical shock hazard. Hazardous voltages exist within system components. Do not remove or open any enclosure. Electrical shock hazard. Avoid fluid entry into system components. Do not immerse any components in water or cleaning solutions. Use a damp cloth when cleaning on or around the battery and the Integrated Continuous Battery Charger system power supply. Electrical shock hazard. Serious injury or death may result from exposure to hazardous voltages existing within the system. Disconnect the Battery Charging System from line power and remove the battery from the Scan Room Unit before cleaning.
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MEDRAD® Spectris Solaris EP MR Injection System Electrical shock hazard. Equipment must only be connected to a supply mains with protective earth. Ventilation hazard. To avoid a build up of hydrogen gas from the battery, assure the room is well ventilated while battery is charging. Improper disposal of the battery pack may result in explosion, leakage, or personal injury. Do not open, or dispose of in a fire! Follow all local regulations concerning the disposal of spent lead-acid based batteries, or contact Bayer for assistance. System electronic assemblies contain potentially hazardous materials. Dispose of system components or accessories properly. Follow local regulations for proper disposal or contact Bayer HealthCare Services for assistance. Unsafe operation may result from using improper accessories. Use only accessories and options provided by Bayer designed for this system. Chemical burn hazard. Always carry the battery pack firmly by the battery pack hand grips. Damage to the housing may result in a chemical burn hazard. Do not use if the housing is severely cracked or damaged. Voltage hazard 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 voltage hazards. If any worn or damaged cables are detected, do not use the injection system. Contact Bayer for service or replacement. The MEDRAD Spectris Solaris EP MR Injection System is a dual syringe system. Always ensure that the proper syringes are loaded with contrast media and flush solution prior to the injection. Failure to properly load and install the syringes may require the procedure to be repeated. Syringe A is designated for contrast agent use only. Syringe B is designated for flush solutions only. Injury or equipment damage may result from use of tools containing ferrous materials. Use only non-magnetic tools to install any scanner/ magnet room components. Patient injury and/or catheter damage may result from using connector tubing (LPCT) that is too short. Operator must consider tubing length and stretch limitations when moving the injector or the patient. Serious injury or death may result from syringe failure. Do not retract pistons with connector tubing installed. Retracting the pistons with the connector tubing installed on syringes will create a vacuum in the syringe due to the check valve in the connector tubing. This vacuum may accelerate the plunger rapidly toward the tip of the syringe when it is removed from the injector causing the syringe to break.
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1 - Introduction For devices labeled for single use, please note: This product is intended for single use only. Do not resterilize, reprocess or reuse. The disposable devices have been designed and validated for single use only. Re-use of the single use disposable devices pose risks of device failure and risks to the patient. Potential device failure includes significant component deterioration with extended use, component malfunction, 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 cleaned or re-sterilized. Do not use if sterile package is opened or damaged. Patient or operator injury may result if package is opened or damaged, or if damaged components are used. Visually inspect contents and package before each use.
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. 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. This injection system is in compliance to IEC-60601-1-2 / Second and Third Edition Standards. Special precautions regarding ElectroMagnetic Compatibility (EMC), are required for installation and use of this injection system. Detailed EMC information can be found in Appendix C of this manual. Damage can occur as a result of incorrect voltage. Before plugging in the system, check the following: •
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.
•
Verify that the Control Room Unit and the Battery Charger power supply have the appropriate power cord plugs for the power outlet.
Additional warnings, cautions, and notes are located throughout this manual, where applicable.
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MEDRAD® Spectris Solaris EP MR Injection System
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2 - System Basics
2 - System Basics About the Injection System
The MEDRAD® Spectris Solaris EP MR Injection System is a programmable, dual syringe system, designed to accurately administer controlled doses of intra-venous MR contrast agents and common flushing solutions to patients undergoing a contrast enhanced MR scan. The system consists of two basic components that communicate by a direct connection of fiber optic lines. •
The Control Room Unit houses the Touch Screen and electronic components used to program the injection system.
•
The Scan Room Unit, positioned near the magnet bore, contains the Injector Head, system battery pack, and the mechanical assemblies required for fluid delivery.
A battery charger is also supplied with the system, used to charge the Scan Room Unit battery pack. For convenience, the charger can be used in the control room, but should never be installed or operated in the scan room.
Note:
Follow all institutional, local, or national safety regulations related to routing cabling on the floor.
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MEDRAD® Spectris Solaris EP MR Injection System
Pressure Safety Limit
The MEDRAD Spectris Solaris EP MR Injection System is designed to allow varied flow rates for contrast injections. By automatically reducing the flow rate, the system can limit the pressure produced during an injection to prevent damage or failure of any connecting devices or tubing. This feature is called Pressure Safety Limit. Inability to maintain the desired flow rate while remaining below the Pressure Safety Limit can be caused by various conditions including contrast viscosity, catheter sizing, connector tube sizing, and stopcock restrictions. If the system is unable, for a period of three seconds, to maintain a flow rate of at least 10% of the programmed rate, the system will disarm due to a stall condition. If unable to automatically achieve the required level of flow rate reduction, thus reaching the Pressure Safety Limit, the system will terminate the injection and move to a disarm state.
Response to Occlusions
When injecting into an occlusion, a stall condition (flow rate less than 10% of programmed rate) will result. A stall condition lasting more than 3 seconds (3 minutes for programmed rates less than 0.1 ml/sec) will result in the injection being automatically terminated. If an occlusion occurs during KVO (Keep Vein Open) the system will detect the condition after 4 or less KVO boluses fail to be delivered. This will correspond to from 1 minute with a KVO interval of 15 seconds configured, to 5 minutes with a KVO interval of 75 seconds. Refer to the Setup screen to determine the current KVO setting. If a stall occurs due to an occlusion, and the blockage is subsequently removed, less than 10 ml will be delivered as the pressure in the administration set dissipates.
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 and during the arming sequence remind the operator to check the programmed injection parameters prior to the system being armed.
•
An onscreen 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 before an additional 10 ml of fluid above programmed volume is delivered.
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2 - System Basics
Control Room Unit 1
3
2
1. Handswitch 2. System Power Switch 3. Touch Screen At rear of Touch Screen Assembly - Display Contrast Controls
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MEDRAD® Spectris Solaris EP MR Injection System
Scan Room Unit
5
2 1
3
4
1. Injector Head 2. Handswitch 3. Lower Console 4. System Battery Pack 5. Middle Pivot Clamp Not shown - Contrast Holder (optional)
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2 - System Basics
Injector Head
1. Manual piston movement knobs 2. Armed indicator lights 3. ENABLE button - Used to activate the forward/reverse controls - the appropriate direction must be selected within 5 seconds. 4. Syringe A forward/reverse controls 5. AIR EXPELLED button/indicator 6. Syringe B forward/reverse controls 7. Syringe A: Contrast agent 8. Syringe B: Flush solution
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MEDRAD® Spectris Solaris EP MR Injection System
Battery Charger
1
2
3
4 5
1. Battery Pack 2. Battery Charging Unit 3. Charging Indicator - Amber 4. Power Indicator - Green 5. Battery Charger Head
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2 - System Basics
Optional Control Room Unit Accessories
Adjustable Height Pedestal WARNING: Injury or equipment damage may result if the adjustable height pedestal is taken into the scanner room. Do not take the adjustable height pedestal in the scanner room. It contains ferrous material that could be attracted toward the magnet.
Wall Mounting Bracket Note:
These accessories contain ferrous material and are designed to be used in the Control Room only. Do not install or operate in the Scan Room.
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MEDRAD® Spectris Solaris EP MR Injection System
Touch Screen Calibration
To enter Touch Screen Calibration mode, simultaneously press both the Contrast UP and DOWN keys on the rear of the touch screen housing. A series of screens with instructions to press the appropriate calibration circles will appear. CAUTION: Do not touch the screen with a sharp object in order to perform the calibration.
Help Mode
The Help screen can be accessed by pressing the HELP button on the lower right corner of the Main screen. Besides safety information, the Help screen displays a variety of topics as displayed below.
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2 - System Basics
Setup Mode
The Setup screen can be accessed by pressing the SETUP button at the lower right corner of the Main screen. The Setup screen allows user configurable options and preferences to be selected, along with setting of date and time parameters. Select the appropriate option, then choose from the available selections in the display window. Select the DEFAULT key to return all options to original factory settings.
The system provides a calibration and maintenance reminder. This reminder will be displayed on the System Logo screen at each startup, beginning 30 days before the system is due to be recalibrated. The duration of time from one calibration to the next is programmed during system installation or by selecting the Calibration Reminder key and entering the correct due date.
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