Spectris Solaris EP Operation & Installation Manual Rev A June 2014
80 Pages
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Page 1
Operation & Installation Manual Mobile MR Injection System
MEDRAD® Spectris Solaris EP Mobile MR Injection System Operation & Installation Manual ii
MEDRAD® Spectris Solaris EP Mobile MR Injection System iiii
Table of Contents
Table of Contents
1 - Introduction ..................................................................................................... 1 Important Safety Notice ........................................................................................................... 1 Certifications ............................................................................................................................ 1 Indications for Use ................................................................................................................... 1 Contraindications ..................................................................................................................... 1 Restricted Sale ........................................................................................................................ 1 Required Training .................................................................................................................... 1 Disclaimers .............................................................................................................................. 1 Understanding Symbols .......................................................................................................... 2 Warnings ................................................................................................................................. 4 Cautions .................................................................................................................................. 5 2 - System Basics ................................................................................................. 7 About the Injection System ...................................................................................................... 7 Pressure Safety Limit .............................................................................................................. 8 Response to Occlusions .......................................................................................................... 8 Volume and Rate Protection .................................................................................................... 8 Control Room Unit (CRU) ........................................................................................................ 9 Scan Room Unit ................................................................................................................... 10 Injector Head ........................................................................................................................ 11 SRU Power Supply ............................................................................................................... 12 Optional Control Room Unit Accessories ............................................................................. 13 Touch Screen Calibration ..................................................................................................... 14 Help Mode ............................................................................................................................ 14 Setup Mode .......................................................................................................................... 15 Unstowing / Stowing the Spectris Solaris EP Mobile Injector ............................................... 16 Unstowing the Spectris Solaris EP Mobile Injector ......................................................... 16 3 - Preparing to Inject ......................................................................................... 19 Applying Power ..................................................................................................................... 19 Main Screen ......................................................................................................................... 20 Syringe and Disposable Accessory Installation .................................................................... 20 Retracting the Pistons ..................................................................................................... 20 Installing a Syringe ......................................................................................................... 21 Loading a Syringe ........................................................................................................... 23 Reinstalling a Syringe ..................................................................................................... 25 Programming the Injector ..................................................................................................... 26 Flow Rate and Volume ................................................................................................... 26 Pressure Limit ................................................................................................................. 26 Multiple Phases .............................................................................................................. 27 Hold and Pause Phases ................................................................................................. 27 Programmed Delay ......................................................................................................... 28 Scan Delay ..................................................................................................................... 28 Inject Delay ..................................................................................................................... 28 Stopwatch ....................................................................................................................... 29 KVO (Keep Vein Open) .................................................................................................. 29 Storing a Protocol ........................................................................................................... 31 iiiiii
MEDRAD® Spectris Solaris EP Mobile MR Injection System Recalling a Stored Protocol ............................................................................................ 32 4 - Arming and Injecting ..................................................................................... 33 Arming .................................................................................................................................. 33 Single and Multi-Arm ............................................................................................................ 33 Insufficient Volume ............................................................................................................... 34 Injecting ................................................................................................................................ 34 On the Injecting Screen: ................................................................................................. 34 On the Injector Head: ...................................................................................................... 34 Disarming ............................................................................................................................. 35 Injection History .................................................................................................................... 36 Clean Up ............................................................................................................................... 37 Scan Room Unit .............................................................................................................. 38 Control Room Unit .......................................................................................................... 38 Appendix A: System Messages ......................................................................... 39 Type 1 Messages ................................................................................................................. 39 Type 2 Messages ................................................................................................................. 40 Type 3 Messages ................................................................................................................. 40 Appendix B: Maintenance & Checkout ............................................................. 41 Recommended Maintenance Schedule ................................................................................ 41 Bayer HealthCare Services .................................................................................................. 42 Inspection Procedure ............................................................................................................ 42 Scan Room Unit .............................................................................................................. 42 Control Room Unit .......................................................................................................... 42 Power Supply .................................................................................................................. 42 Communication Link ....................................................................................................... 42 Cleaning Guidelines ............................................................................................................. 43 Operational Checkout ........................................................................................................... 43 System Labels ................................................................................................................ 43 Power Up ........................................................................................................................ 43 Programming .................................................................................................................. 44 Appendix C: Specifications ............................................................................... 45 Scan Room Unit ................................................................................................................... 45 Control Room Unit ................................................................................................................ 46 Power Supply ....................................................................................................................... 46 Power Cords ......................................................................................................................... 47 System Capabilities .............................................................................................................. 47 Executable Flow Rates ......................................................................................................... 47 System Performance ............................................................................................................ 48 Forward and Reverse Controls ............................................................................................. 48 EMI/RFI ................................................................................................................................ 48 Electrical Requirements ........................................................................................................ 48 Power Supply DC Output Voltage ........................................................................................ 48 Electrical Leakage ................................................................................................................ 48 Ground Continuity ................................................................................................................. 49 Environmental Specifications ............................................................................................... 49 Non-Operating: (Transportation and Storage) ................................................................ 49 Operating: ....................................................................................................................... 49 Classifications ........................................................................................................................ 49 iv iviv
Table of Contents Appendix D: Options & Accessories ................................................................ 51 Appendix E: System Installation ....................................................................... 53 Installation Considerations ................................................................................................... 53 Unpack the Injection System ................................................................................................ 56 Tools Needed For Installation ............................................................................................... 56 Control Room Unit Installation .............................................................................................. 57 SRU Power Supply Installation ............................................................................................. 57 Base Bracket Installation ...................................................................................................... 58 Injector Installation ................................................................................................................ 58 Cable Routing and Connections ........................................................................................... 60 Power Supply to SRU Cable ........................................................................................... 60 Fiber Optic Cable and Power Switch Installation ............................................................ 61 Cosmetic Cover Installation .................................................................................................. 64 CRU Handswitch Mounting .................................................................................................. 66 On the wall: ..................................................................................................................... 66 On Either Side of the Display and Control Unit ............................................................... 66 Head Pad Installation ........................................................................................................... 66 Appendix F: Compliance to IEC 60601-1-2:2007............................................... 67 vv
MEDRAD® Spectris Solaris EP Mobile MR Injection System vi vivi
1 - Introduction
1 - Introduction
Important Safety Notice Certifications Indications for Use Contraindications Restricted Sale Required Training Disclaimers
This manual applies to the MEDRAD® Spectris Solaris (Spectris Solaris) EP Mobile MR Injection System, Catalog Number 3015724 and contains important information about use of the MEDRAD Spectris Solaris EP Mobile 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. Understanding the information will assist you in operating the device in a safe manner. This device is intended to be used by medical professionals with adequate training and experience in magnetic resonance imaging (MRI) studies. This device is equipped to operate at 100-240 VAC, 50/60 Hz, and is designed to comply with EN 60601-1/IEC 60601-1 Second/Third Edition, EN 60601-1-2:2007 and IEC 60601-1-2:2007. 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. 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. Federal (USA) law restricts this device to sale by or on the order of a physician. This device is intended to be used by individuals with adequate training and experience in diagnostic image studies. 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 MEDRAD Spectris Solaris EP Mobile MR Injection System must be certified according to EN 60601-1/IEC 60601-1 Second/Third Edition standard. Furthermore, all configurations shall comply with system standard IEC/EN 60601-11. 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/EN 60601-1-1. To obtain on-site consulting or consulting references, contact Bayer HealthCare Services. The MEDRAD Spectris Solaris EP Mobile MR Injection System is not intended for portable use.
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MEDRAD® Spectris Solaris EP Mobile MR Injection System
Understanding Symbols
The following symbols are used on the MEDRAD Spectris Solaris EP Mobile MR Injection System and components.:
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.
CLASS 1 IPX1
Indicates hazardous voltages. Indicates alternating current. Identifies a type BF applied part complying with EN 60601-1 standards. 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 Injector system. Identifies connection of the handswitch.
IOIO
Identifies injector head forward and reverse piston control keys. Identifies the direction of manual knob rotation relative to plunger movement. Identifies the ENABLE key. Indicates DC power supply. Identifies the Service Connection Port. Legacy Symbol. Does not apply to Spectris Solaris EP Mobile injection system. Identifies SRU power supply activity on Graphical User Interface. When illuminated yellow this indicates that the SRU power supply system is present and functioning. 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.
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1 - Introduction
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.
Indicates the presence of no serviceable parts.
1
3
5
2
4
6
Identifies the Control Room Unit brightness controls. MR Conditional symbol. • Install the power supply a minimum of 6 ft (1.8 m) from the magnet bore. • Secure the injector head in place using the Middle Pivot when the system is in use. Wall placard containing instructions for stowing the Spectris Solaris EP Mobile Injection System.
P109
Reserved for future use. Manufacturer. Authorized representative in the European community.
Temperature range.
Humidity range. Atmospheric pressure range. This side up. Fragile. Keep dry.
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MEDRAD® Spectris Solaris EP Mobile MR Injection System
Definitions of WARNING, CAUTION and NOTE
The following are definitions of terms WARNING, CAUTION and NOTE found throughout this document: 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 the user to operate the system in a safe and successful manner:
WARNING CAUTION NOTE
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. Indicates that the information is a caution. Cautions advise you of circumstances that could result in damage to the device or improper functioning of the device. Read and understand the cautions before operating the injection system. Indicates that the information that follows is additional important information or a tip that will help you recover from an error or point you to related information within the manual.
Warnings
WARNING: No modification of this equipment is allowed. WARNING: Patient injury may result from a system malfunction. If a system malfunction occurs, immediately remove unit power 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. WARNING: 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. WARNING: Explosion hazard. The MEDRAD Spectris Solaris EP Mobile MR Injection System is not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. WARNING: 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. WARNING: Electrical Shock hazard. Equipment must only be connected to a supply mains with protective earth. WARNING: Electrical shock hazard. Hazardous voltages exist within system components. Do not remove or open any enclosure. WARNING: 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. WARNING: Electrical shock hazard. Serious injury or death may result from exposure to hazardous voltages existing within the system. Disconnect the Control Room Unit and the Scan Room Unit from line power before cleaning. WARNING: Ventilation hazard. To avoid a build up of hydrogen gas from the battery, assure the room is well ventilated while battery is charging.
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Cautions
1 - Introduction WARNING: 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. WARNING: Unsafe operation may result from using improper accessories. Use only accessories and options provided by Bayer designed for this system. WARNING: 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. WARNING: The MEDRAD Spectris Solaris EP Mobile 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. WARNING: 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. WARNING: 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. WARNING: Failure to install the MEDRAD Spectris Solaris EP Mobile MR Injector System correctly could result in patient or operator injury or in equipment damage. The MEDRAD Spectris Solaris EP Mobile MR Injector System must be mounted to the trailer manufacturer installed mounting plate. If the mounting plate has not been installed, stop the installation and contact Bayer HealthCare Services. DO NOT drill holes in the trailer wall. CAUTION: 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. CAUTION: 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. CAUTION: This injector system is in compliance to IEC-60601-1-2:2007 Standards. Special precautions regarding ElectroMagnetic Compatibility (EMC), are required for installation and use of this injector system. Detailed EMC information can be found in Appendix F of this manual. CAUTION: 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 Scan Room Unit have the appropriate power cord plugs for the power outlet. 5
MEDRAD® Spectris Solaris EP Mobile MR Injection System Additional warnings, cautions, and notes are located throughout this manual, where applicable. 6
About the Injection System
2 - System Basics
2 - System Basics
The MEDRAD Spectris Solaris EP Mobile 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, and the mechanical assemblies required for fluid delivery. NOTE: Follow all institutional, local, or national safety regulations related to routing cabling on the floor. 7
MEDRAD® Spectris Solaris EP Mobile MR Injection System
Pressure Safety Limit
The MEDRAD Spectris Solaris EP Mobile 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 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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Control Room Unit (CRU)
2 - System Basics 1
Scan Room Unit
3
2
1. Handswitch 2. CRU Power Switch 3. Touch Screen At rear of Touch Screen Assembly - Display Contrast Controls
5 3 2 4 1 1. Injector Head 2. Lower Console 9
Injector Head
MEDRAD® Spectris Solaris EP Mobile MR Injection System 3. Middle Pivot Clamp 4. Base Bracket 5. Beauty Ring 6. Power Switch (not shown)
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 10
SRU Power Supply
2 - System Basics
1 1. Power Supply 2. 20 ft. Power Supply to SRU Cable (not shown) 3. 50 ft Power Supply to SRU Cable (optional for out of room installation) (not shown)
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MEDRAD® Spectris Solaris EP Mobile MR Injection System Optional Control Room Unit Accessories 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. 12
2 - System Basics
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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Setup Mode
MEDRAD® Spectris Solaris EP Mobile MR Injection System 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. 14
2 - System Basics
Unstowing / Stowing the Spectris Solaris EP Mobile Injector
Unstowing the Spectris Solaris EP Mobile Injector 1. Undo the straps holding the injector head to the head pad.
2. Pull the locking pin straight down using one hand and at the same time pivot the Injector away from the wall. When the Injector is in the correct position, release the locking pin.
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MEDRAD® Spectris Solaris EP Mobile MR Injection System 3. Rotate the knob on the Middle Pivot Clamp counter clockwise and pivot the arm containing the injector head clockwise into position. 4. Once the injector head is in the correct position, rotate the knob on the Middle Pivot Clamp clockwise to lock the head into position. 16
2 - System Basics Stowing the Spectris Solaris EP Mobile Injector 1. Rotate the knob on the Middle Pivot counter clockwise and pivot the injector head counter clockwise until it stops. 2. Rotate the knob on the Middle Pivot clockwise to lock the injector head into place. 3. Pull the locking pin down and at the same time, pivot the injector in the direction towards the head pad on the wall. in either direction. Once the injector is parallel to the wall release the locking pin. 4. Secure the head to the head pad via the straps on the pad. 17
MEDRAD® Spectris Solaris EP Mobile MR Injection System 18
Applying Power
3 - Preparing to Inject
3 - Preparing to Inject
Place the power switch located on the right side of the Control Room Unit in the ON position. The System Logo screen will appear while the system performs a series of self diagnostic tests.
NOTE:
Do not touch the screen or activate any controls while self diagnostics are in progress. If this occurs, diagnostic tests will interpret this activity as a hardware failure and halt the system. The system must then be powered down/up to reset the error.
After diagnostics have successfully completed, the System Logo screen will be replaced by the Safety screen
After reading the Safety screen, press CONTINUE to view the Main screen. Apply power to the Scan Room Unit by pressing the power button (green switch located on the side of the top cosmetic cover). Upon power up of the CRU and SRU, verify that the indicators, lamps, and speaker are operational. NOTE: The Control Room Unit can be programmed for an injection without power applied at the Scan Room Unit. 19
Main Screen
MEDRAD® Spectris Solaris EP Mobile MR Injection System The Main screen is entered from the Safety screen after power-up. The Main screen is used during programming, arming, and injecting, with applicable screen controls made visible based on the task currently being performed.
Syringe and Disposable Accessory Installation
Retracting the Pistons Fully retract each piston by using the reverse switches on the injector head. NOTE: When using the reverse switches, first press the Enable switch; then within 5 seconds, press the reverse switch(es). Both pistons may be reversed simultaneously. The forward and reverse switches have dual speed capabilities: When the switches are partially depressed, the pistons will move slowly. When fully depressed, the pistons will move quickly. Forward and reverse piston speeds are fully configurable (1 to 10 ml/sec) in the Setup mode. The manual knobs may also be used to move the pistons in the forward or reverse direction. Turn the knobs clockwise to advance the piston, counterclockwise to retract.
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3 - Preparing to Inject Installing a Syringe 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. 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. WARNING: Patient infection may result from the use of non-sterile components. Maintain sterility of all disposable components. Do not store preloaded syringes. WARNING: The use of single-use disposable devices on more than one patient is a biological hazard. Do not reuse single-use disposable components. WARNING: Patient injury could result if the syringe is not properly engaged. Ensure the alignment marks on the syringe and injector head are properly aligned, and the piston and plunger are interlocked. Improper engagement may cause syringe damage or under-volume delivery. CAUTION: Improperly engaged syringes may leak or be damaged. Ensure proper engagement of syringe and injector. Syringe and injector engagement points must align. NOTE: Syringe A is intended for contrast media, and Syringe B is intended for flushing solution only. 1. Align the flanges on the syringe with the notches in the injector head. (The syringe is keyed to properly fit in only one way.) 2. Insert the syringe. 3. Twist 1/4 turn clockwise until the syringe snaps into place. (Graduations will be facing the front of the injector head.) 21
MEDRAD® Spectris Solaris EP Mobile MR Injection System WARNING: Air embolism can cause patient injury or death. Expel all trapped air from the syringe(s), connectors, tubing, and catheter-over-needle before injecting. NOTE: Do not hit or tap the syringe to remove air bubbles. To reduce the volume and size of air bubbles drawn into the syringe during loading, a Bayer Fluid Dispensing Device (FDD or “spike”) from Bayer is recommended. Air removal from the syringe(s) will be much more difficult if a small diameter tube, such as a catheter-over-needle, needle, or a tube longer than 10 inches (25 cm), is used for loading. Operator vigilance and care, coupled with a set procedure, is essential to minimizing the possibility of an air embolism. The injector head should be pointed upward during loading, enabling any air to accumulate at the syringe tip and to be expelled. The injector head should be pointed downward during an injection, enabling any small air bubbles which could still be in the fluid to float to the rear of the syringe(s). To help avoid air injection, syringes from Bayer are equipped with FluiDot indicators. These FluiDot indicators should be observed as part of an arming procedure. When the FluiDot is viewed through an empty syringe, the dots appear as small narrow ellipses as illustrated below in figure 1. However, when viewed through a full syringe, the dots become larger, almost round (or wider than round) as illustrated below in figure 2.
Fig. 1 Empty
Fig. 2 Filled
FluiDot indicators must be viewed in a properly illuminated environment, with a light source behind the operator providing enough light to permit easy viewing. To minimize air embolization risks, ensure that one operator is designated the responsibility of filling the syringe(s). Do not change operators during the procedure. If an operator change must occur, ensure that the new operator verifies that the fluid path is purged of air. WARNING: If a blockage occurs, disposable components with a lower pressure rating may leak or rupture. Use only catheter and connectors with ratings that are compatible with the MEDRAD Spectris Solaris EP Mobile MR Injection System. During installation of the low pressure connector tubing (LPCT) with T-connector to the syringe(s), and before arming, manually advance the syringe plunger(s) to provide a very slow flow of fluid at the connection. An absence of flow is an obvious indication of air or a blockage in the fluid path.
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3 - Preparing to Inject Loading a Syringe WARNING: Remove all trapped air from the syringe, connector tubing, and catheter-over-needle before connecting the patient to the injector. WARNING: 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. WARNING: Bacterial contamination can occur if syringes are used to store contrast media. Use loaded syringes immediately. Do not store loaded syringes for later use. Discard any unused syringes. NOTE: The presence of rounded FluiDot indicators does not indicate the total absence of air bubbles in the syringe tip. NOTE: FluiDot indicators must be viewed in a properly illuminated environment, with a light source behind the operator providing enough light to permit easy viewing 1. Position the injector head so that the syringes are pointing upward. 2. Fully advance each piston plunger. The plungers may be advanced simultaneously after pressing ENABLE. 3. Attach a sterile filling device (spike or Female-toFemale Adaptor - Bayer Catalog Number FFA 50) onto the tip of the syringe. If loading contrast media and/or saline from a bag or bottle, use a spike. If loading contrast media from a pre-filled syringe, use an FFA 50. A. If using a spike, open the bottle(s) of contrast and/or bag(s) of flushing solution, then draw the contents (contrast for syringe A; flush for syringe B) into the syringe(s) by depressing ENABLE, and then the reverse load button for each syringe. B. If using the FFA 50, attach it to the tip of syringe A, then attach the pre-filled syringe to the FFA 50. Draw the contents from the prefilled syringe into syringe A by pressing ENABLE, then the reverse load button. 4. With the filling device still attached, advance the plunger to expel any air that may remain in the top of the syringe; then, if necessary, draw more fluid into the syringe to replace fluid loss. 5. Remove the filling device and expel any air bubbles from the syringes. 23
MEDRAD® Spectris Solaris EP Mobile MR Injection System
6. Attach the long end of the T-connector to syringe B. 7. While the injector head is still in a vertical position, attach the short section of the T-connector to syringe A. 8. Starting with syringe A, then syringe B, prime the Tconnector, then fill the connector tubing with the appropriate fluid. Ensure that all air is expelled from the entire length of the tubing.
Saline Flush
Contrast
NOTE: An SSIT 96VLD low pressure connector tube (LPCT) holds approximately 7 ml of fluid. If syringe B is used to flush, use at least 8 ml of flush to deliver this volume to the patient.
NOTE: If the connector tube is filled with saline, contrast will be delivered to the patient with a delay dependent on the flow rate selected for syringe A.
NOTE: When the connector tube is filled with contrast the volume remaining displayed on the protocol screen is approximately 7 ml less than what was loaded into the syringe.
9. Tilt the injector head downward before attaching to the vascular entry device in the patient. After attaching the connector tube to the vascular entry device verify that the connector luer fittings are secured. The injector head must be maintained in this position during the injection.
WARNING: Patient injury could result from movement of the Scan Room Unit after the patient is connected to the fluid path. Lock the Middle Pivot Clamp to prevent unintended movement.
WARNING: 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. 10. Secure the Scan Room Unit by locking the Middle Pivot Clamp, then verify that all air has been expelled from the fluid path by carefully inspecting all tubing and syringe(s). Acknowledge that the inspection has occurred by pressing the AIR REMOVED confirmation button/indicator on the injector head. The Air Removed Indicator will then illuminate yellow on the touch screen.
NOTE: Reverse movement of the pistons after the AIR EXPELLED button has been pressed will cancel the Air Expelled status. Re-check the fluid path for air, then press the AIR EXPELLED button again to continue.
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3 - Preparing to Inject Reinstalling a Syringe WARNING: Patient injury could result if the syringe is not properly engaged. Ensure the alignment marks on the syringe and injector head are properly aligned, and the piston and plunger are interlocked. Improper engagement may cause syringe damage or under-volume delivery. To remove a syringe from the injector, and then reinstall it, perform the following steps: 1. Insert the end of the syringe in the horizontal cutouts in the injector head. 2. Advance the piston until it is past the plunger feet and the piston/ plunger interlock. 3. Rotate the syringe 1/4 turn clockwise until the syringe locks and alignment marks are positioned. 4. Proceed as normal by aspirating and dislodging any air bubbles. NOTE: If bubbles appear in the syringe DO NOT hit the syringe to remove them. Reverse the plunger 3 to 5 ml, then rock the head on the pivot to gather and accumulate the small bubbles. Expel the remaining air. 25
Programming the Injector
MEDRAD® Spectris Solaris EP Mobile MR Injection System If a program has not been previously entered or stored on the Main screen when the unit is powered up, the Main screen will display default settings; 1.0 ml/s flow rate and 1.0 ml volume, KVO off and No Delay. Flow Rate and Volume Begin programming by selecting any programmable block, such as FLOW RATE or VOLUME. When a programmable block on the screen is touched, a keypad will be displayed to permit the selection of numeric values. The numeric keypad is displayed when a Flow Rate, Volume or Delay value is selected. The keypad window will also display the appropriate programmable range for the parameter selected. To lock in values, press ENTER. Press << to edit a selection, or CANCEL to eliminate a selection if an error is made. Pressure Limit The pressure limit can be programmed by choosing a value between 100-325 PSI up to the greater of the syringes’ maximum pressure
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3 - Preparing to Inject Multiple Phases If appropriate, select a second phase for the injection protocol by pressing the triangle block below the first phase of the injection. The Phase Type selector will appear in order to select the function of the new phase. Hold and Pause Phases A Hold or Pause phase can be programmed into a multi-phase injection. A Pause phase will stop the total injection process for a preprogrammed length of time, while the Hold phase will stop the injection until input from the operator resumes the injection. A Hold phase can be maintained for up to 20 minutes, at which time the system will disarm. After selecting the phase type, continue programming by entering Flow Rate and Volume values for the new phase. 27
MEDRAD® Spectris Solaris EP Mobile MR Injection System Programmed Delay After entering Flow Rate and Volume parameters, press SET in the Delay Timer field to select the delay type (Scan Delay, Inject Delay, Stopwatch, or No Delay.) NOTE: There is no direct interface between the scanner and the injector. The scanner cannot trigger the injector, nor can the injector trigger the scanner. Scan Delay Scan Delay time will elapse in the timer block on the screen. The time remaining before the scan should be activated will decrement in one second intervals. (The scan delay countdown will continue through multiple arm injections.) When countdown is complete, the system will emit 5 beeps. Inject Delay Inject Delay will also countdown in one second intervals, commencing when the handswitch is pressed. The clock will display, in one second decrements, the time remaining before the injection will begin. When inject delay is chosen and the handswitch is pressed, the injection will automatically occur unless the injector is disarmed. When countdown is complete, the system will emit 5 beeps and the injection will automatically begin. If Hold is activated during an inject delay or a scan delay, the timer will stop during the hold interval and resume when the handswitch is pressed. For scan or inject delays that are longer than 3 minutes, the unit will beep 30 seconds before the delay is to terminate, then will beep every second from 5 seconds through 1 second before the delay is due to terminate. 28
3 - Preparing to Inject Stopwatch The Stopwatch function initiates an incremental count of elapsed time from initial fluid injection. After selecting the delay type, enter the delay duration on the numeric keypad. To lock in values, press ENTER. Press CANCEL to eliminate a selection if an error is made. KVO (Keep Vein Open) The KVO function delivers small boluses of fluid from syringe B at configurable intervals. KVO can run during: • Programming • Pre and post injection • Between multiple injections • During Pause and Hold The delivery interval can be selected in the Setup mode, which is accessed using the Setup button on the Main Screen. After an initial KVO pulse of 2 ml, KVO delivery intervals include 0.25 ml pulsed every: • 15 seconds • 20 seconds • 30 seconds (default) • 45 seconds • 60 seconds • 75 seconds The KVO field displays the time available to support KVO based on the configured interval and the volume remaining in syringe B less any volume programmed from syringe B in the protocol. 29
MEDRAD® Spectris Solaris EP Mobile MR Injection System Starting KVO: On the Main Screen, press START in the KVO field to initiate KVO. When KVO is running, “KVO” will appear, and the KVO Injecting arrows will flash in the Syringe B touch screen indicator. KVO will function during Pause, Hold and/or inject delay periods as long as sufficient fluid remains in syringe B to complete the programmed injection. KVO will run post-injection until no fluid remains in syringe B, or until STOP KVO is pressed in the Injection Complete window. NOTE: Volume displayed in the Volume Delivered window can be configured in the Setup mode to include the total KVO volume delivered in addition to volume delivered by the programmed injection. KVO may be stopped at any time by pressing STOP in the KVO field, or by pressing any injector head control button (this will also disarm the system and terminate any injection in progress). Other actions that disarm the injector, such as syringe removal, disarm button press and injection stall, will also stop KVO. KVO and Occlusions: If an occlusion occurs during KVO the system will detect the condition after 4 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. 30
3 - Preparing to Inject Storing a Protocol To store a protocol for future use, press the STORE button on the upper right corner of the Main screen. An alpha-numeric keypad will appear with a flashing cursor in the title block. Type in a title of up to 20 characters, including spaces. Use the arrow key to backspace, individually erasing characters, and the CLEAR key to clear a string of text. When title entry is completed, press ENTER. To exit the Store screen without making changes, press the CANCEL button in the upper right corner. 31
MEDRAD® Spectris Solaris EP Mobile MR Injection System Recalling a Stored Protocol To access program memory, press RECALL on the Main screen. Select a previously stored injection protocol by pressing one of the names on either side of the screen. Key parameters of the selected injection will be displayed in the center of the screen. Once selected, the protocol can be deleted by selecting DELETE at the upper right corner of the screen, or brought to the Main screen by selecting OK. 32
4 - Arming and Injecting 4 - Arming and Injecting
Arming Single and Multi-Arm
Before beginning the arming process, ensure that the middle pivot clamp on the Scan Room Unit are locked, verify that all air has been expelled from the fluid path, and that the programmed parameters are correct. Carefully inspect all tubing and syringe(s), then acknowledge that the inspection has occurred by pressing the AIR EXPELLED button/indicator on the injector head. A yellow illuminated Air Expelled Indicator on the touch screen confirms that the button has been pressed. WARNING: Air embolization can cause death or serious injury to the patient. Do not connect a patient to the injector until all trapped air has been cleared from the syringe and fluid path. WARNING: Patient injury could result from high flow rate venous injections. Use extreme care when selecting flow rate and duration. Before arming the injector, verify that high flow rate injection parameters have not been unintentionally programmed. WARNING: Patient injury could result from inadvertent aspiration. To minimize the possibility of inadvertent aspiriation and injection, ensure the patient is disconnected from the injector when utilizing the forward/reverse plunger control(s). WARNING: Extravasation can cause injury to the patient. Follow commonly accepted good clinical procedures to minimize the possibility of extravasation. To begin the arming and injecting process, press ARM on the Main screen. If necessary, changes can be made to programmed injection parameters after the arming sequence is complete. Select the required parameter, then enter the correct value with the on-screen keypad. NOTE: If the AIR EXPELLED button on the injector head has not been pressed, the system will request user confirmation that air has been expelled before proceeding. Select either a Single or Multiple arming sequence by pressing either SINGLE or MULTI. (The default is Single arm.) A single arm injection will perform the protocol once, then disarm. A multi-arm injection allows the protocol to be repeated, creating a series of injections. After the protocol is completed, the system will automatically re-arm in preparation for the protocol to be repeated. Each injection in the series must be started with the handswitch.
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Insufficient Volume Injecting
MEDRAD® Spectris Solaris EP Mobile MR Injection System If an insufficient volume condition occurs during a multi arm sequence, the system will remain armed to permit the injection of the remaining volume. However, the screen will update to display only the phases that are achievable with the volume that remains. In a single arm sequence, the screen will update when arming occurs to display only the phases that are achievable. While the system is armed, pressing DISARM or activating any injector head controls will return the system to the idle state. After the system has been armed, press the handswitch to begin the injection. Additional presses of the handswitch will alternately “hold” and resume the injection. The maximum duration for Hold is 20 minutes. If the maximum hold time is exceeded the injection will abort automatically. If an inject delay has been programmed, pressing the handswitch will activate the countdown timer. The programmed injection will automatically begin when the timer counts down to zero. If the handswitch is pressed during an inject delay, the countdown timer will stop counting until the switch is pressed again, or the Hold time is exceeded. If a scan delay is programmed, the scan delay countdown and the injection will start simultaneously. During the injection, additional presses of the hand switch will alternately “hold” and resume the injection and the scan delay timer. If KVO is running: KVO will function during Pause, Hold and/or inject delay periods as long as sufficient fluid remains in syringe B to complete the programmed injection. KVO will run postinjection until no fluid remains in syringe B, or until STOP KVO is pressed in the Injection Complete window. To stop KVO the operator can also press any injector head control buttons. If a Hold phase is entered, parameters for the remaining portion of the injection protocol can be altered. On the Injecting Screen: • As each phase is activated, the phase parameters will be highlighted to display injection progress. • The Duration window will also increment to display elapsed time. • The Delivered window will increment as the injection proceeds to display volume delivery (including KVO volume, if selected in Setup mode). • The Volume Remaining display will decrement. • If KVO is selected, the time available for KVO will decrement in the KVO Time Remaining window while KVO is active. (During an injection, KVO will stop and the time display will not count-down.) On the Injector Head: • While injecting, indicator lamps on the back of the injector head will be illuminated (white for syringe A, blue for syringe B). The appropriate lamps will be lit solid while injecting, and flash while either Armed or on Hold. • If multi-arm is selected, the indicator lamps will flash when the system rearms. • During KVO the blue indicator lamp for syringe B is illuminated. • AIR EXPELLED Indicator is illuminated.
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Disarming
4 - Arming and Injecting Pressing DISARM, activating any injector head controls, or touching any portion of the touch screen while the system is injecting, will cause the system to disarm. The Hold mode can be entered at any time during an injection by pressing the handswitch. The system will remain in this state until the handswitch is pressed a second time, or the maximum hold time of 20 minutes is exceeded. NOTE: An SSIT 96VLD low pressure connector tube (LPCT) holds approximately 7 ml of fluid. If syringe B is used to flush, use at least 8 ml of flush to deliver this volume to the patient. NOTE: If the connector tube is filled with saline, contrast will be delivered to the patient with a delay dependent on the flow rate selected for syringe A. NOTE: When the connector tube is filled with contrast, the volume remaining displayed on the screen is approximately 7 ml less than what is present in the system. When an injection (single or all multi-arm sequences) is completed, the following window, with a brief summary of the injection parameters, will be displayed.
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Injection History
MEDRAD® Spectris Solaris EP Mobile MR Injection System To review injection parameters used in a procedure, along with actual achieved values for the injection, press the HISTORY button on the Main screen. The Injection History screen displays an injection summary block containing the following data: • Time and Date Started • Programmed Flow Rate • Programmed Volume • Programmed Protocol • Total Fluid (plus KVO) • Delay Type • Delay Duration • Pressure Limit Programmed • Peak Pressure • Pressure Limit Status (YES/NO) • Premature Termination Status (YES/NO)
The system maintains status information of the 20 most recent injections, sorted by date and time. To delete any injection protocol history from the system, press DELETE while the protocol is selected. To scroll to the next page of protocols, press the ARROW key. To exit the Injection History screen, press CANCEL. 36
Clean Up
4 - Arming and Injecting NOTE: Do not resterilize or reuse any disposable items. When cleaning the injector, remove and discard all used disposable items. (Syringes should be removed without retracting the pistons.) It is not necessary to remove the connector tubing when removing and discarding syringes. WARNING: Serious injury 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. WARNING: Serious injury or death may result from exposure to hazardous voltages existing within the system. • Power down the injector system using the power switches on the Control Room Unit and Scan Room Unit before cleaning. • Avoid fluid entry into system components. Do not immerse any components in water or cleaning solution. • Do not remove any covers or disassemble the injector. Periodically inspect for loose or frayed cables, loose covers, cracks, dents, or loose hardware. Contact Bayer HealthCare Services for repairs. CAUTION: 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 Appendix B of this manual or contact Bayer for additional information. CAUTION: 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. CAUTION:Do not use strong cleaning agents and solvents. Warm water and a mild disinfectant are all that is required. Do not use strong industrial cleaning solvents such as acetone. NOTE: For all body fluid spills, follow institutional decontamination procedures. NOTE: If contrast medium has leaked inside any component of the system, the affected subassembly should be disassembled and cleaned by Services personnel or returned to Bayer HealthCare Services.
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MEDRAD® Spectris Solaris EP Mobile MR Injection System Scan Room Unit Using a soft non-abrasive cloth, warm water, and a mild disinfectant, carefully clean the assembly, paying particular attention to the following: • Injector Head • Syringe Piston Plunger • Syringe Interface • SRU Lower Console covers To clean the injector head, piston, and syringe interface: 1. Fully advance the piston. 2. Power down the Scan Room Unit using the power switch. 3. Place the injector head in a vertical position. 4. Clean the piston with a soft cloth or paper towel dampened with cleaning solution. 5. Thoroughly dry the piston with a paper towel. 6. Power up the Scan Room Unit then fully retract the piston. 7. Power down the Scan Room Unit again using the power switch. 8. Clean the inner area of the syringe interface with a soft cloth or paper towel dampened with cleaning solution. 9. Wipe the injector head case and control panel with a soft cloth or paper towel dampened with cleaning solution. 10. Thoroughly dry the injector head case and control panel with a paper towel. Control Room Unit CAUTION: 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 cleaning solution. 38
Type 1 Messages
Appendix A: System Messages Appendix A: System Messages The system will display messages on the screen as conditions or events occur. There are three basic types of messages: WARNING: Patient injury may result from a system malfunction. If a system malfunction occurs, immediately remove Scan Room Unit power (by pulling the battery from the head stand), and disconnect the system 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. Type 1 messages are messages which provide information regarding the current status of the system, and will clear automatically from the screen. These messages are typically displayed in the lower right corner of the screen.
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Type 2 Messages
MEDRAD® Spectris Solaris EP Mobile MR Injection System Type 2 messages are messages that convey information that must be explicitly acknowledged before proceeding. The message is displayed within a yellow dialog box - a button (or buttons) must be pressed to acknowledge and remove the message from the screen.
Type 3 Messages
Type 3 messages are system malfunction messages which require power to be removed from the system. Some Type 3 messages provide suggestions to prevent the condition from recurring. If the condition cannot be corrected, record the code and number from the lower left corner of the dialog box, then call Bayer HealthCare Services for assistance.
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Appendix B: Maintenance & Checkout Appendix B: Maintenance & Checkout
Recommended Maintenance Schedule
This section contains recommended procedures for maintenance, and an operational checkout of the MEDRAD Spectris Solaris EP Mobile MR Injection System. Routine maintenance and inspection will: • Ensure continued performance of the injection system • Reduce the possibility of equipment malfunction Your MEDRAD Spectris Solaris EP Mobile MR Injection System must be properly maintained to ensure that it is in peak operating condition. Your individual maintenance system and schedule depends upon how your injection system is used, the type of procedures performed, and frequency of use. The following maintenance schedule is recommended for the system: Daily: The piston rod should be thoroughly cleaned after each use. Before use each day, the system should be cleaned and inspected, using the procedures outlined in this section. Ensure that all system safety and warning labels are in place and are legible. Monthly: Once a month, the entire system should be thoroughly inspected and cleaned, and an Operational Checkout should be performed. Annually: As part of an annual maintenance program performed by a qualified Services Representative or authorized dealer, both Electrical Leakage and Ground Continuity checks should be performed. NOTE: Local regulations or hospital protocol may require electrical leakage checks at more frequent intervals. If this applies, local regulations for leakage must be followed. Bayer also recommends that a complete system calibration and performance checkout be performed annually. Contact Bayer HealthCare Services, or your local Bayer office for complete details. In the United States, Canada, and Europe, the Bayer HealthCare Services offers Preventive Maintenance Programs. These annual programs greatly assist in maintaining accuracy and reliability, and can also extend the life of the system. Contact Bayer for details. In Europe, contact your local Bayer office or your local authorized dealer for further information. Refer to the back cover of this manual for address, telephone and FAX information. NOTE: Failures which occur due to lack of proper maintenance will not be covered under warranty.
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Bayer HealthCare Services Inspection Procedure
MEDRAD® Spectris Solaris EP Mobile MR Injection System Bayer HealthCare Services will make available upon request: • Circuit diagrams, component parts lists, or other information that will assist qualified technicians to repair components classified as repairable. • On-site consulting or consulting references upon request. The following procedures are recommended for daily inspection of all components in the MEDRAD Spectris Solaris EP Mobile MR Injection System. If any defects are detected, either repair the system, or call Bayer for service. Do not use the system until the problem is corrected. Scan Room Unit 1. Inspect the housing for any damage or cracks that could allow fluid to leak inside, or weaken the structural integrity of the unit. 2. Inspect all cables connected to the unit: Look for cuts, cracks, worn spots or other obvious damage to the cables. Ensure that all connectors are properly seated. 3. Inspect for contrast media build-up in the syringe interface area. Follow the cleaning guidelines outlined in this section. 4. Inspect the main pivot and support arm for cracks and other defects that could weaken the structure. 5. Ensure that all mounting bolts and screws are secure. 6. Inspect all pivot points. Ensure that all pivot points pivot freely. 7. Ensure all pivot stops are functioning (no rotation > 360O) NOTE: All relevant guidelines for institutional, local, or national safety recommendations related to cable routing and installation should be followed. Control Room Unit 1. Inspect all cables connected to the unit: Look for cuts, cracks, or worn spots, or other obvious damage. Ensure that all connectors are properly seated. 2. Inspect the housing for any damage or cracks that could allow fluid to leak inside, or weaken the structural integrity of the unit. Power Supply 1. Inspect all cables connected to the unit: Look for cuts, cracks, or worn spots, or other obvious damage. Ensure that all connectors are properly seated. 2. Inspect the housing for any damage or cracks that could allow fluid to leak inside, or weaken the structural integrity of the unit. Communication Link 1. Inspect the cables for cuts, cracks or worn spots. Ensure that the connectors are properly seated.
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Cleaning Guidelines Operational Checkout
Appendix B: Maintenance & Checkout Deposits of contrast media can interfere with proper operation of the MEDRAD Spectris Solaris EP Mobile MR Injection System. The following guidelines should be followed when removing deposits, or cleaning any portion of the system. WARNING: Serious injury or death may result from exposure to hazardous voltages existing within the system. Disconnect the system from line power before cleaning or attempting to perform any maintenance. Ensure that the system is completely dry before connecting to the power source and applying power. CAUTION: 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. • If contrast medium has leaked inside any component of the system, the affected subassembly should be disassembled and cleaned. This cleaning procedure can be done in the field by trained Services personnel, or returned to Bayer HealthCare Services. If the cleaning will be performed in the field, do not disturb any internal wiring or components. • Care must be taken not to get water or cleaning solutions inside any system components. Do not use strong industrial cleaning agents or solvents such as acetone. Warm water and a mild disinfectant such as antibacterial hand soap are all that is required. • To clean the syringe interface area of the injector head, fully retract the piston. Using a paper towel moistened with warm water or a mild disinfectant, gently wipe the inner syringe installation area. Do not insert any sharp instruments into this area during the cleaning process. • Check all System Safety and Warning Labels for legibility. Ensure that the labels are not damaged or missing. A basic functional checkout of the MEDRAD Spectris Solaris EP Mobile MR Injection System should be included as part of regular maintenance. Verifying proper operation of the injection system will help in detection of any problems that may not be noticed in day to day operation. The following procedure represents a suggested series of activities which encompass typical operation of the system. Read the following procedure carefully before beginning the checkout. If problems are detected, contact Bayer HealthCare Services. NOTE: Any problems detected during this or any other procedure should be corrected before using the injection system in patient procedures. System Labels Ensure that all system safety and warning labels are in place and legible. Power Up Apply power to the system. Verify that the Safety screen is displayed after system diagnostics occur. Press OK to acknowledge the messages on the Safety screen. Upon power up of the CRU and SRU, verify that the indicators, lamps, and speaker are operational.
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