Spectris Solaris EP Operation & Installation Manual Rev A June 2014

MEDRAD® Spectris Solaris EP  Mobile MR Injection System Operation & Installation Manual

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MEDRAD® Spectris Solaris EP Mobile MR Injection System

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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

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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

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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

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MEDRAD® Spectris Solaris EP Mobile MR Injection System

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1 - Introduction

1 - Introduction 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.

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, 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.

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

CLASS 1

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

IPX1

Identifies the degree of protection against fluid as drip proof for the Spectris Solaris EP Injector 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. Indicates DC power supply.

IOIO

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 RX

Identifies the Communication Cable Transmit connection. Identifies the Communication Cable Receive connection. Indicates design for indoor use only. Indicates the presence of no serviceable parts. Identifies the Control Room Unit brightness controls. MR Conditional symbol. • •

1

3

5

2

4

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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

Warnings

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

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 or improper functioning of the device. Read and understand the cautions before operating the injection system.

NOTE

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

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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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.

Cautions

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.

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MEDRAD® Spectris Solaris EP Mobile MR Injection System Additional warnings, cautions, and notes are located throughout this manual, where applicable.

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2 - System Basics

2 - System Basics About the Injection System

The 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.

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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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2 - System Basics

Control Room Unit (CRU) 1

3

2

1.

Handswitch

2.

CRU Power Switch

3.

Touch Screen

At rear of Touch Screen Assembly - Display Contrast Controls

Scan Room Unit

5

3

2

4 1

1.

Injector Head

2.

Lower Console

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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

Injector Head

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2 - System Basics

SRU Power Supply

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.

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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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