Spectris Solaris MR Injection System Operation Manual Rev D

Medrad, Inc. One Medrad Drive Indianola, Pa 15051 USA Phone: 412 767-2400 Fax: 412-767-4120 Medrad Europe B.V. Postbus 205 6190 AE Beek The Netherlands Phone: +31(0)43-3585601 Fax: +31(0)43-3656598 Nihon Medrad KK 9F Central Shin-Osaka Building 4-5-36, Miyahara Yodogawa-ku Osaka, 532-0003 Japan Phone: +81(0)66-350-0680 Fax: +81(0)66-398-0670

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

TABLE OF CONTENTS 1 - Introduction...1-1 Important Safety Notice ... 1-1 Certifications ... 1-1 Indications for Use ... 1-1 Contraindications ... 1-1 Restricted Sale... 1-1 Trademarks... 1-1 Disclaimers ... 1-1 Understanding Symbols... 1-2 Warnings... 1-4 Cautions... 1-5

2 - System Basics ...2-7 About the Injection System ... 2-7 Pressure Safety Limit... 2-8 Response to Occlusions ... 2-8 Volume and Rate Protection ... 2-8 Control Room Unit ... 2-9 Scan Room Unit... 2-10 Injector Head... 2-11 Battery Charger... 2-12 Optional Control Room Unit Accessories... 2-13 Touch Screen Calibration ... 2-14 Help Mode... 2-14 Setup Mode... 2-15

3 - Preparing to Inject ...3-17 Applying Power ... 3-17 Main Screen... 3-18 Battery Maintenance ... 3-19 Syringe and Disposable Accessory Installation ... 3-20 Retracting the Pistons... 3-20 Installing a Syringe ... 3-21 Loading a Syringe... 3-23 Reinstalling a Syringe ... 3-25 Programming ... 3-26 Flow Rate and Volume ... 3-26 Multiple Phases ... 3-27 Hold and Pause Phases ... 3-27 Programmed Delay ... 3-28 Scan Delay ... 3-28 Inject Delay ... 3-28 Stopwatch ... 3-29 KVO (Keep Vein Open) ... 3-29 Storing a Protocol ... 3-31 Recalling a Stored Protocol ... 3-32

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Medrad Spectris Solaris MR Injection System

4 - Arming and Injecting ...4-33 Arming... 4-33 Single and Multi-Arm... 4-33 Insufficient Volume... 4-34 Injecting... 4-34 Disarming... 4-35 Injection History ... 4-37 Clean Up ... 4-38

Appendix A: System Messages... A-41 Type 1 Messages...A-41 Type 2 Messages...A-42 Type 3 Messages...A-42

Appendix B: Maintenance and Checkout ... B-43 Recommended Maintenance Schedule ...B-43 Inspection Procedures ...B-44 Cleaning Guidelines...B-46 Operational Checkout ...B-46

Appendix C: Specifications ... C-49 Scan Room Unit... C-49 Control Room Unit ... C-50 Battery Pack... C-50 Battery Charger... C-50 System Capabilities ... C-51 Executable Flow Rates: ... C-52 System Performance ... C-52 Forward and Reverse Controls ... C-52 EMI/RFI... C-53 Electrical Requirements ... C-53 Electrical Leakage... C-53 Ground Continuity ... C-53 Environmental Specifications... C-53 Classifications ... C-54

Appendix D: Options and Accessories... D-55 Appendix E: System Installation ... E-57 Unpacking the Injection System...E-58 Installation Considerations...E-59 Fiber Optic Cable Installation...E-61 Control Room Unit Setup ...E-62 Handswitch Mounting...E-63

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1 - Introduction

1 - Introduction This manual applies to the Medrad Spectris Solaris® MR Injection System, Catalog Number SSMR 300 3T. Read all of the information contained in this section. Understanding the information will assist you in operating the device in a safe manner.

Important Safety Notice

This device is intended to be used by medical professionals with adequate training and experience in magnetic resonance imaging (MRI) studies.

Certifications

This device is equipped to operate at 100-240 VAC, 50/60 Hz, and is designed to comply with IEC/EN 60601-1 (safety), and IEC/EN 60601-1-2 (EMC/Emissions). MEDRAD, Inc. is ISO 9001/EN ISO 13485 certified. MEDRAD Europe B.V. is EN ISO 9002 EN 13485 certified. Nihon MEDRAD KK (NMKK) is ISO 9001/ISO 13485 certified.

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.

Trademarks

Medrad, Fluidot, Qwik-Fit, and Spectris Solaris are trademarks of Medrad, Inc. The trademarks Becton Dickinson, Daiichi, NSKK, Multihance, Gadovist, Magnevist, Optimark, Prohance, and Omniscan appear in this manual, and are the property of their respective companies.

Disclaimers

External wiring and modifications disclaimers: Medrad 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 MR Injection System must be certified according to IEC/EN 60601-1 standard. Furthermore, all configurations shall comply with system standard IEC/EN 60601-1-1. Anyone who connects additional equipment to the signal input or output part configures a medical system and is therefore responsible that the system complies with the requirements of the standard IEC/EN 60601-1-1. To obtain on-site consulting or consulting references, contact Medrad Service. The Medrad Spectris Solaris MR Injection System is not intended for portable use.

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Medrad Spectris Solaris MR Injector System The following symbols are used on the Medrad Spectris Solaris MR Injection System and components.

Understanding Symbols

!

Attention, consult accompanying instructions. 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. Indicates the injection system is Class 1 medical equipment as defined by EN 60601-1 standards. Identifies the degree of protection against fluid as drip proof.

Identifies connection of the handswitch.

Identifies injector head forward and reverse piston control keys.

Identifies the direction of manual knob rotation relative to plunger movement.

Identifies the ENABLE key.

Identifies polarity of the battery pack terminals. Identifies the distance that the injector must be placed in relation to the magnet bore for magnets with a field strength greater than 2T.

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1 - Introduction Indicates the current charge level of the system battery.

Indicates the AIR EXPELLED button on the injector head. When illuminated yellow on the touch screen, also indicates that the operator has acknowledged inspecting the fluid path for air. Identifies the Equipotential connection. Identifies the Earth Ground point.

IOIO

Identifies the Service Connection Port.

Identifies the Communication Cable Transmit connection. Identifies the Communication Cable Receive connection.

Indicates design for indoor use only.

Indicates the presence of no serviceable parts.

I

Indicates the presence of AC power at the battery charger. Identifies the Control Room Unit brightness controls. Reserved for future use.

Indicates the status of the battery charger. When a battery is properly inserted, the LED will illuminate while charging, and extinguish when the battery is fully charged.

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Medrad Spectris Solaris MR Injector System This manual contains important information about use of the Medrad Spectris Solaris MR Injection System. Medrad urges you to read this manual carefully, become familiar with the procedures and system functions that it describes, and follow its recommendations to assure proper use of the system. Labels on the system or statements in this manual preceeded by any of the following words and/or symbols are of special significance, intended to help you to operate the system in a safe and successful manner: WARNING: Indicates that the information is a warning. Warnings advise you of circumstances that could result in injury or death to the patient or operator. Read and understand the warnings before operating the injection system. CAUTION: Indicates that the information is a caution. Cautions advise you of circumstances that could result in damage to the device. Read and understand the cautions before operating the injection system. Note:

Warnings

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

Patient injury may result from a system malfunction. If a system malfunction occurs, immediately remove unit power (by pulling the battery from the Scan Room Unit), and disconnect the unit from the patient. If a fault message is displayed that cannot be corrected, and/or the system is not operating correctly, do not use the injection system. Call Medrad for assistance. Patient injury could result from leaks or ruptures during an injection. To prevent leaks or ruptures in the event of a blockage, use only catheters and connectors with pressure ratings compatible with this system. Explosion hazard: Do not use the injection system in the presence of flammables (such as anesthetics). 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. Chemical burn hazard: Always carry the battery pack firmly by the battery pack hand grip. Damage to the housing may result in a chemical burn hazard. Do not use if the housing is severely cracked or damaged. Injector performance degradation, image degradation and/or damage to the disposable set may result if the injector is placed too close to the magnet bore. The injector must be placed a minimum of four feet (1.2 meters) from the magnet bore for magnetic resonance imaging scanners having a field strength GREATER than 2.0 Tesla.

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1 - Introduction 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 Medrad for service or replacement. Improper disposal of the battery pack may result in explosion, leakage, or personal injury. Do not open or incinerate! Follow all local regulations concerning the disposal of spent lead-acid based batteries, or contact Medrad for assistance. System electronic assemblies contain potentially hazardous materials. Dispose of system components or accessories properly. Follow local regulations for proper disposal or contact Medrad Service for assistance. Unsafe operation may result from using improper accessories. Use only accessories and options provided by Medrad designed for this system. The Medrad Spectris Solaris MR Injection System is a dual syringe system. Always ensure that the proper syringes are loaded with contrast media and flush solution prior to the injection. Failure to properly load and install the syringes may require the procedure to be repeated. Syringe A is designated for contrast agent use only. Syringe B is designated for flush solutions only. Injury or equipment damage may result from use of tools containing ferrous materials. Use only non-magnetic tools to install any scanner/ magnet room components. Patient injury and/or catheter damage may result from using connector tubing (LPCT) that is too short. Operator must consider tubing length and stretch limitations when moving the injector or the patient.

Cautions

Condensation may cause electrical damage to the injection system. Do not use the system immediately after it has been brought indoors from extreme outside temperatures. Allow the system to stabilize at room temperature before use. Damage can occur as a result of incorrect voltage. Before plugging in the system, check the following: •

Verify that the voltage and frequency marked on the serial tag on the back of the unit matches the voltage and frequency of the electrical outlet.

•

Verify that the Control Room Unit and the battery charger have the appropriate power cord plugs for the power outlet.

Additional warnings, cautions, and notes are located throughout this manual, where applicable.

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Medrad Spectris Solaris MR Injector System

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2 - System Basics

2 - System Basics About the Injection System

The Medrad Spectris Solaris MR Injection System is a programmable, dual syringe system, designed to accurately administer controlled doses of intravenous MR contrast agents and common flushing solutions to patients undergoing a contrast enhanced MR scan. The system consists of two basic components that communicate by a direct connection of fiber optic lines. •

The Control Room Unit houses the Touch Screen and electronic components used to program the injection system.

•

The Scan Room Unit, positioned near the magnet bore, contains the Injector Head, system battery pack, and the mechanical assemblies required for fluid delivery.

A battery charger is also supplied with the system, used to charge the Scan Room Unit battery pack. For convenience, the charger can be used in the control room, but should never be installed or operated in the scan room.

Note:

Follow all institutional, local, or national safety regulations related to routing cabling on the floor.

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Medrad Spectris Solaris MR Injector System

Pressure Safety Limit

The Spectris Solaris 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 1

3

2

1. Handswitch 2. System Power Switch 3. Touch Screen At rear of Touch Screen Assembly - Display Contrast Controls

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Medrad Spectris Solaris MR Injector System

Scan Room Unit

1. Injector Head 2. Handswitch 3. Lower Console 4. System Battery Pack Not shown - Contrast Holder (optional)

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2 - System Basics

Injector Head

1

1. Manual piston movement knobs 2. Armed indicator lights 3. ENABLE button - Used to activate the forward/reverse controls - the appropriate direction must be selected within 5 seconds. 4. Syringe A forward/reverse controls 5. AIR EXPELLED button/indicator 6. Syringe B forward/reverse controls 7. Syringe A: Contrast agent 8. Syringe B: Flush solution

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Medrad Spectris Solaris MR Injector System

Battery Charger

1. Battery Pack 2. Battery Charging Unit 3. Charging Indicator - Amber 4. Power Indicator - Green 5. Battery Charger Head

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2 - System Basics

Optional Control Room Unit Accessories

Adjustable Height Pedestal

!

WARNING: Injury or equipment damage may result if the adjustable height pedestal is taken into the scanner room. Do not take the adjustable height pedestal in the scanner room. It contains ferrous material that could be attracted toward the magnet.

Wall Mounting Bracket These accessories contain ferrous material and are designed to be used in the Control Room only. Do not install or operate in the Scan Room.

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Medrad Spectris Solaris MR Injector System

Touch Screen Calibration

To enter Touch Screen Calibration mode, simultaneously press both the Contrast UP and DOWN keys on the rear of the touch screen housing. A series of screens with instructions to press the appropriate calibration circles will appear. CAUTION: Do not touch the screen with a sharp object in order to perform the calibration.

Help Mode

The Help screen can be accessed by pressing the HELP button on the lower right corner of the Main screen. Besides safety information, the Help screen displays a variety of topics as displayed below.

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2 - System Basics

Setup Mode

The Setup screen can be accessed by pressing the SETUP button at the lower right corner of the Main screen. The Setup screen allows user configurable options and preferences to be selected, along with setting of date and time parameters. Selectable options include: Select the appropriate option, then choose from the available selections in the display window. Select the DEFAULT key to return all options to original factory settings.

The system provides a calibration and maintenance reminder. This reminder will be displayed on the System Logo screen at each startup, beginning 30 days before the system is due to be recalibrated. The duration of time from one calibration to the next is programmed during system installation or by selecting the Calibration Reminder key and entering the correct due date.

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Medrad Spectris Solaris MR Injector System

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