Spectrics MR Injection System Operation Manual Rev H

TABLE OF CONTENTS SECTION 0 - PREFACE ... 0 - 1 Copyright, Trademarks & Disclaimers ... 0 - 1 Applicability ... 0 - 2 Service/Phone & Fax ... 0 - 2 About This Manual ... 0 - 2 Spectris MR Injector Acronyms ... 0 - 3 Injector Symbols and Descriptions ... 0 - 4 SECTION 1 - WARNINGS, CAUTIONS & PRESSURE LIMITING ... 1 - 1 Warnings ... 1 - 1 Cautions ... .. 1 - 4 Pressure Limiting ... 1 - 6 SECTION 2 - BASIC OPERATIONS ... 2 - 1 Power Up ... 2 - 2 Safety Screen ... 2 - 3 Battery Status ... 2 - 3 Battery Maintenance ... 2 - 4 DCU Overview. ... 2 - 5 Injector Head Overview ... 2 - 6 Syringe Selection ... 2 - 7 Phase Selection ... 2 - 8 Information Blocks ... 2 - 9 Introduction to Programming ... 2 - 10 Keep Vein Open (KVO) ... 2 - 12 Programmed Delays ... 2 - 14 Title Entry ... 2 - 15 Store ... 2 - 16 Recall ... 2 - 18 SECTION 3 - SYRINGES/LOADING ... 3 - 1 Syringe Installation ... 3 - 2 FluiDot Indicators. ... 3 - 3 Loading ... 3 - 4 SECTION 4 - ARMING & INJECTING ... 4 - 1 Arming ... 4 - 1 Single & Multi Arm ... 4 - 1 Injecting ... 4 - 2 Status ... 4 - 5 Clean Up ... 4 - 7

SECTION 5 - MESSAGES & TROUBLESHOOTING ... 5 - 1 System Reset ... 5 - 1 Message List. ... 5 - 3 Troubleshooting ... 5 - 16 SECTION 6 - HELP & CONFIGURATION ... 6 - 1 Main Menu Help ... 6 - 1 Safety Information ... 6 - 2 Control Panel Keys... 6 - 2 Injector Head Control Keys ... 6 - 3 Configuration Screen ... 6 - 4 Date/Time; Language ... 6 - 5 DCU Audio Level ... 6 - 5 Load Speeds ... 6 - 5 Configuration Screen Softkeys. ... 6 - 6 Calibration Screens ... 6 - 7 Screen Functions ... 6 - 8 How to Set Up a Protocol ... 6 - 9 Service Information ... 6 - 10 Customer Service Information ... 6 - 10 SECTION 7 - SPECIFICATIONS ... 7 - 1 Dimensions & Weights: DCU ... 7 - 1 MCU ... 7 - 1 Injector Head/Stand ... 7 - 2 HCU ... 7 - 2 Battery Pack ... 7 - 3 OTR ... 7 - 3 Electrical Requirements ... 7 - 3 Electrical Leakage ... 7 - 3 System Capabilities... 7 - 4 Environmental Specifications ... 7 - 4 Protection Against Electrical Shock ... 7 - 5 Protection Against Ingress of Fluids ... 7 - 5 Mode of Operation ... 7 - 5 Fluid Delivery Performance ... 7 - 6 Over and Under Infusion Protection ... 7 - 8 Mobile Configuration & Retrofit Configuration ... 7 - 9 SECTION 8 - MAINTENANCE & CHECKOUT PROCEDURE ... 8 - 1 APPENDIX A - IMAGING SYSTEM INTERFACE OPTION ... A - 1

PREFACE

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Copyright

Copyright Notice Copyright 2001 by Medrad, Inc. All rights reserved. No part of this manual may be reproduced in any form without the prior written consent of MEDRAD. Printed in USA.

Trademark

Spectris, Qwik-Fit Syringe and FluiDot are trademarks of MEDRAD, Inc. MEDRAD and Technology for People are registered trademarks for MEDRAD, Inc.

Disclaimers

Disclaimers This manual describes the use, operation and maintenance needs of the SpectrisTM MR Injector. The Spectris MR Injector should only be used by qualified and trained personnel. Use by unqualified and untrained personnel may result in patient or personal injury and property damage. MEDRAD reserves the right to modify the specifications and features described herein, or discontinue manufacture of the product described at any time without prior notice or obligation. Please contact your authorized MEDRAD representative for the most current information. MEDRAD is not responsible for any interpretation of information in this manual, nor do they assume any liability in connection with its use. 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 analog and digital interfaces must be certified according to IEC 601-1 standard. Furthermore, all configurations shall comply with system standard IEC 601-1-1. 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 requirements of the system standard IEC 601-1-1. To obtain on-site consulting or consult-ing references, contact MEDRAD Service. This device complies with the requirements of the European Medical Device Directive 93/42/EEC. The Spectris MR Injector is not for portable use.

PREFACE, Con’t.

0-2 Applicability

Applicability: This manual applies to MEDRAD’s Spectris MR Injector System, catalog # SMR 200.

If technical problems are encountered with any Spectris MR Injector unit, call your local dealer or: Service

Phone & Fax

North American Headquarters:

European Headquarters:

MEDRAD Service Department One MEDRAD Drive Indianola, PA 15051- 0780 (412) 767-2400

MEDRAD Europe Postbus 205 6190 AE Beek The Netherlands

Inside continental U.S. 1-800-MEDRAD-S (1-800-633-7237) FAX: (412) 767-4126

The Netherlands Phone: (31) (0) 43 3585600 FAX: (31) (0) 43 3656598

Outside continental U.S. 1-412-767-2400

ABOUT THIS MANUAL PURPOSE This manual is a user’s reference guide for Spectris MR Injector operations. Important Safety Notice: The information in this manual is intended for personnel with adequate expertise and experience in MRI studies. Any attempt to operate or repair a medical device such as the injector without adequate training may result in personal injury, property damage or patient injury. HOW TO USE THIS MANUAL

Please Read Carefully READ this manual before operating the injector and keep the manual available in the MRI suite. This manual contains important information about the safe operation of the Spectris MR injector. MEDRAD urges the operators of the Spectris MR injector to read this

PREFACE, Con’t.

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manual carefully, become familiar with the injector functions it describes, and follow its recommended procedures. 1. Read the warnings and cautions in Section 1. 2. Become familiar with the injector programming controls and indicators in Section 2. 3. Observe syringe installation and loading procedure in Section 3. 4. Read arming and injecting instructions in Section 4. 5. Become familiar with operational messages and problems, including suggestions for trouble shooting located in Section 5. 6. Perform the checkout procedure located in Section 8.

Acronyms used in this manual: LLPCT FDD QFT IR KVO VAC Hz VDC ml bar psi RAM IEC EMC

= Long Low Pressure Connector Tubing = Fluid Dispensing Device = Quick Fill Tube = Infrared = Keep Vein Open = Volts of Alternating Current = Hertz = Volts Direct Current = Milliliters = Unit of pressure measurement (Barometric gage) = Pounds Per Square Inch (gage) = Random Access Memory = International Electrotechnical Commission = Electro-Magnetic Compatibility

SYMBOLS & DESCRIPTIONS

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The following international symbols are used on the Spectris MR Injector and throughout this manual.

!

Attention, consult accompanying documents/text.

Identifies the terminal which provides a connection between the injector and the equi-potential busbar of the electrical installation.

Identifies the switch on the Display Control Unit (DCU) which switches the system from an “ON” state to a partially energized “STANDBY” state.

Identifies connection to the mains.

Identifies disconnection from the mains.

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

Identifies the display contrast control

Identifies the key which toggles the touch screen video from a light to dark background.

Identifies the control for application assistance.

SYMBOLS & DESCRIPTIONS, Con’t. Indicates hazardous voltages.

Indicates Alternating Current

IPX1

Identifies the degree of protection against fluid entry (drip proof.)

ISI

On the rear of the Master Control Unit - Identifies connection of the Imaging System Interface. (Not available)

OTR

On the rear of the Master Control Unit - Identifies the connection of the OTR.

Identifies this injection system as medical equipment with type BF applied parts complying with EN60601-1 standards.

CLASS 1

Indicates this injection system is Class 1 medical equipment as defined by EN60601-1 standards.

On DCU - Identifies connection of the Master Control Unit (MCU).

On MCU - Identifies connection of the optional printer. (Not available)

On MCU - Identifies connection of the primary and secondary Display Control Unit (DCU). (Secondary DCU is not available on a Spectris MR Injector System.)

On DCU - Identifies connection of the handswitch.

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SYMBOLS & DESCRIPTIONS, Con’t. Indicates a battery charging state.

Indicates a battery or battery holder.

Indicators of polarity on the system battery pack terminals.

Identifies the direction of plunger movement on the buttons for the load controls

Identifies start action related to loading (enable switch).

Identifies the communicator connector.

Identifies that the Communicator interface is ON and operational.

Identifies that the Communicator interface is ON, but not operational.

THE SPECTRIS MR INJECTOR SYSTEM 6

The following Spectris MR Injector component names and acronyms are used interchangeably in this manual: 1. HSU (Injector Head/Stand Unit) 2. HCU (Head Control Unit) 3. OTR (Optical Transmitter/Receiver) 4. DCU (Display Control Unit) 5. MCU (Master Control Unit) in tower configuration 6. HSU (Head/Stand Unit) in mobile configuration NOTE:

Position the HCU in the scanner room so that the HCU is placed in a location where the magnetic field does not exceed 800 gauss within 1 meter of the magnet. To ensure proper placement and operation of the HCU, follow the guidelines in the Spectris MR Installation Manual and refer to the site copy of the magnetic fringe field plot provided by the scanner manufacturer. The HCU must be located on the floor.

NOTE:

Follow all institutional, local or national safety regulations related to running cables across the floor.

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THE SPECTRIS MR INJECTOR SYSTEM

Spectris MR Injector System in an MRI suite

The DCU may be configured for table top use. Pedestal, or wall mounting options are also available.

The MCU may be placed in a tower configuration as displayed above, or may be placed horizontally on a table top (not shown).

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WARNINGS

WARNINGS & CAUTIONS

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INTENDED USE OF THE SPECTRIS MR INJECTOR: This device is intended to be used specifically for performing intravenous injections of MR contrast medium and common flushing solutions via the peripheral venous system with a Magnetic Resonance Imaging scanner of up to 1.5 Tesla field strength magnet. DO NOT attempt to use the injector for any other purpose. CONTRAINDICATIONS: This device is not to be used for drug infusion, chemotherapy or with a magnetic resonance imaging scanner with a magnetic field strength greater than 1.5 Tesla, or any other use for which the device is not indicated. RESTRICTED SALE: Federal (USA) law restricts the sale of this device only to or on the order of a physician. DISCONNECT THE PATIENT IMMEDIATELY FROM THE INJECTOR IF A “SYSTEM MALFUNCTION” occurs: Turn the injector off by pulling out the battery pack in the HCU and immediately disconnect the injector from the patient. DO NOT reconnect the patient until the system has been powered up, armed, and a test injection has been performed to verify that the system malfunction has been resolved. If a fault message is repeatedly displayed, DO NOT use the injector until the condition causing the message to appear can be identified and corrected. Call MEDRAD Service for assistance (See page 0-2). TOUCH THE DCU SCREEN IN ONE PLACE ONLYwhen programming. If the touch screen is touched in two places simultaneously, a selection that is located at a midpoint between them may be inadvertently activated or selected. DO NOT OPERATE OTHER IR REMOTE CONTROLLED EQUIPMENT in the vicinity of the Spectris MR injector system. Use of Infrared VCR, television, computer, stereo system or other remote controls may result in a malfunction of the injector system or other IR remote controlled equipment. DO NOT CONNECT A PATIENT TO THE INJECTOR UNTIL ALL TRAPPED AIR HAS BEEN CLEARED FROM THE SYRINGE, CONNECTOR TUBING AND CATHETER-OVERNEEDLE. Air embolization can cause patient injury or death. Operator vigilance and care, coupled with a set procedure is essential to the avoidance of air embolism. See Section 3 for loading procedures and use of FluiDot indicators.

1-2 Flow Rate/Volume

WARNINGS & CAUTIONS, Con’t. HIGH FLOW RATE VENOUS INJECTIONS MAY CAUSE PATIENT INJURY. Use extreme caution when setting the Flow Rate on the DCU to avoid the unintentional programming of a high Flow Rate injection. Check settings before arming and injecting. After all injection parameters have been entered, verify program values and equipment status before arming and injecting. OVER FLOW RATE when injecting may cause an indwelling catheter to burst, possible rupture of blood vessel, associated tissue injury, and local toxicity due to contrast media infiltration. OVER VOLUME, UNDER VOLUME OR, UNDER FLOW RATE injections of contrast (including pressure limiting), may result in poor images, possibly require the procedure to be repeated, and may result in injury to the patient. INADVERTENT ASPIRATION can cause the contamination of contrast or flushing solution with blood which may necessitate reload and delay of a procedure. UNCONTROLLED INJECTION: Do not use the forward/reverse plunger controls when a patient is connected to the injector. This could cause injury to the patient or require the procedure to be repeated. DO NOT DISCONNECT PATIENT UNTIL THE INJECTOR HAS DISARMED. Fluids may continue to inject and spill onto the floor causing a slippery surface which could cause operator or patient injury.

Shock/Explosion

HIGH VOLTAGE HAZARD: To avoid lethal voltages, do not remove any covers or disassemble the injector system in any way. Refer all injector servicing to MEDRAD. Call MEDRAD for assistance. Worn cables can also create a high voltage hazard. If the injector has any worn or damaged cables, do not use the injector. Contact MEDRAD for service or replacement. SHOCK HAZARD: Always carry the Spectris injector battery pack firmly by the battery pack hand grip. Damage to the case may result in a shock hazard. Do not use if the case is severely cracked or damaged. Replace only with MEDRAD specified parts. DO NOT USE A POWER ADAPTER. Insert the injector plug into a properly grounded AC power outlet. CHEMICAL BURN HAZARD. Always carry the Spectris injector battery pack firmly by the battery pack hand grip. Damage to the case may

WARNINGS & CAUTIONS, Con’t. result in a chemical burn hazard. Do not use if the case is severely cracked or damaged. Replace only with MEDRAD specified parts. DO NOT IMMERSE THE BATTERY PACKS OR ANY INJECTOR COMPONENTS in water or any type of cleaning solution. Fluid entry into the injector may result in a shock hazard. DISCONNECT THE SPECTRIS MR INJECTOR FROM THE AC WALL OUTLET and remove the HCU battery pack prior to performing extensive clean up or preventive maintenance. Use of the DCU and/or MCU power switches WILL NOT remove power from the entire injector system and electrical shock may occur. Refer to page 2-4 for battery maintenance information. DO NOT USE AN EXTENSION CORD. Plug the injector directly into properly grounded AC power outlet. Since the injector power cord supplies a safety ground to the unit, using an extension cord will compromise the ground quality and the injector could become unsafe. POSSIBLE EXPLOSION HAZARD. Do not use the injector in the presence of flammable anesthetics. DISPOSE OF SPECTRIS BATTERY PACKS PROPERLY. DO NOT OPEN. DO NOT dispose of in a fire! If not disposed of properly, batteries may explode, leak or cause personnel injury. Follow all local regulations concerning the disposal of spent lead-acid based batteries or contact MEDRAD for assistance (See page 0-2). Physical

USE CARE WHEN MOVING ANY COMPONENT IN THE SYSTEM TO AVOID OPERATOR INJURY or equipment damage. DO NOT STAND ON THE HCU, THE INJECTOR HEAD STAND, THE MOBILE CONFIGURATION BASE, OR THE DCU PEDESTAL. Unit may move without warning causing possible injury to the operator or equipment damage. Do not lean on the injector head stand. TRIP HAZARD: Use care when moving in the vicinity of system cables to avoid operator or patient injury. ENSURE THAT THE LATCH ON THE MOBILE CONFIGURATION TRANSPORT CLAMP IS COMPLETELY ENGAGED PRIOR TO VEHICULAR MOVEMENT TO AVOID INJURY or equipment damage. PINCH HAZARD: Use care when opening and closing the mobile configuration transport clamp to avoid operator injury.

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WARNINGS & CAUTIONS, Con’t.

1-4 Cables/Options

DO NOT CUT, CRUSH OR EXCESSIVELY BEND THE HCU TO INJECTOR HEAD/STAND CABLE. Damage to the injector head cable may result in improper operation of the injector system. As the HCU pivots when moving the injector head stand and connecting cable, do not allow the cable to bend or wrap around objects in the room. Curvature of the cable should not exceed a gentle arc; do not subject the cable to a severe arc or kink when positioning the injector head and stand. Do not move objects across the injec-tor head cable. Do not use the injector system if the cable is damaged. Contact MEDRAD for replacement cables. FOR PROPER OPERATION, do not use an accessory or option designed for another system on the Spectris Injector. Use only accessories and options provided by MEDRAD which are designed specifically for the Spectris Injector System.

Disposables

USE ONLY CATHETER AND CONNECTORS WITH RATINGS THAT ARE COMPATIBLE WITH THE MEDRAD SPECTRIS MR INJECTOR. If a blockage occurs, disposable components with a lower pressure rating may leak or rupture. DO NOT CONNECT ADDITIONAL INFUSION SYSTEMS/ ACCESSORIES TO THE CENTRAL FLUID PATH FROM THE INJECTOR TO THE PATIENT. This could cause underflow rates, undervolumes, or stall conditions which could possibly cause the procedure to be repeated MAINTAIN STERILE TECHNIQUE when loading syringes and making patient connections. DO NOT REUSE DISPOSABLE ITEMS. Discard disposable items after use. Do not use them on more than one patient, as the health and safety of the patient can be compromised. STORAGE OF LOADED SYRINGES. Loaded syringes which are stored can promote bacterial growth. MEDRAD syringes are designed to be filled just prior to the procedure. Discard unused loaded syringes. THE SPECTRIS INJECTOR 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 use only. Syringe B is designated for flush solutions.

WARNINGS & CAUTIONS, Con’t. CAUTIONS

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PERFORM REGULAR PREVENTIVE MAINTENANCE. Maintain a battery replacement routine. One battery should always be in the battery charging unit (MCU) while the other battery in the HCU is in use. Battery recharge time is approximately 8 hours. 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. ELECTRICAL DAMAGE COULD OCCUR DUE TO CONDENSATION if the injector is brought indoors from extreme outside temperatures and immediately used. Allow the injector to stabilize at room temperature before use. NOTE: The touch screen on the DCU will not be visible/legible if it is cold. Allow warm up time to ensure screen clarity. CONNECT TO PROPER VOLTAGE AND FREQUENCY. Before inserting the power plug of the injector into an outlet, check the voltage and frequency marked on the serial number tag on the back of the injector. Insert the injector power plug into an outlet that supplies the voltage and frequency within the range specified on the back of the injector. The injector may be damaged if power outside this range is applied. Verify that the unit has the proper cord set for the plug style. DO NOT PLACE THE HCU IN A MAGNETIC FIELD GREATER THAN 800 GAUSS WITHIN 1 METER OF THE MAGNET. The HCU will pressure limit prematurely which may terminate injections. DO NOT BLOCK FAN OR VENTS on the main MCU. This may cause the unit to overheat and shut down. Installation clearance should be minimum of 3 to 5 inches (7.62 to 12.7 cm). ENSURE PROPER ENGAGEMENT OF THE SYRINGE IN THE INJECTOR HEAD. Improperly engaged syringes may leak or be damaged. Syringe and injector head engagement points must align.

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PRESSURE LIMITING Pressure Limiting In order to understand this section on pressure and pressure limiting, it is important to clarify the terminology that will be used in this section. TERMINOLOGY Pressure Pressure is related to the amount of force which the injector head must develop in the syringe in order to move fluid in the syringe at the selected flow rate. Pressure developed by the Spectris MR injector is measured relative to the atmospheric pressure outside of the syringe or connector tubing. The pressure developed by the injector is expressed in terms of “Gauge Pressure” or “PSIG” which is the “Absolute Pressure” or “PSIA” minus the atmospheric pressure. Hereafter, pressure displayed as psi refers to gauge pressure. Pressure Limit Pressure Limit is the maximum pressure which the injector will develop. For the Spectris MR injector, the amount of force which the injector head develops will not exceed the factory set pressure limit of 300 + 50; -100 psi or 20.7 + 3.4; -6.8 bar. Flow Rate Flow Rate is the value selected in units of ml/sec and determines the constant rate at which the fluid will be delivered. Injection Duration Injection duration is the length of time the injector requires to perform the programmed protocol from the moment the startswitch is depressed until the unit stops injecting. Duration is calculated by dividing the selected Volume by the selected Flow Rate (50 ml Volume divided by 2 ml/sec Flow Rate = Duration of 25 seconds). To calculate the Duration of a multi-phase or dual syringe injection, calculate the duration of each phase for each syringe and add them together. Actual duration may differ from calculated duration due to rounding. KVO (Keep Vein Open) time and Hold time are not included in this duration.

PRESSURE LIMITING, Con’t. THE BASICS In order for contrast media to flow through the Spectris disposable system, which includes Long Low Pressure Connector Tubing (LLPCT), T-connector, and catheter, the pressure in the syringe must exceed the resistance of the disposable system. Pressure in the syringe is created by the force driving the syringe plunger. This pressure decreases over the entire length of the disposable system. As the fluid flows out the end of the catheter, there will be virtually no pressure. Pressure will be essentially zero at the open (unrestricted) end of the catheter because there is no resistance to fluid flow. To achieve a selected flow rate, the pressure exerted by the plunger must be great enough to overcome the resistance of the disposable system. To do this, the force behind a fluid must be great enough to push it through a tube. The Purpose of Pressure Limiting The primary purpose of pressure limiting is to protect the disposable system. It is possible to select a flow rate that is high enough to generate more pressure than the disposable system is capable of handling. The Spectris disposable system (syringes, T-connector, and LLPCT) is rated for a maximum pressure limit of 350 psi (24.1 bar). To minimize the potential of pressure limiting and the resultant problems, use only MEDRAD disposable products and kits. These disposable systems are designed specifically to maximize the performanceof the total injection system and give consistent and reliable results. How the Spectris MR Injector is Designed The Spectris MR Injection System is a flow-controlled system. This means that the flow rate that is selected on the DCU is the flow rate at which the injector will deliver contrast for the duration of the injection. The only time that actual flow rates will differ from programmed flow rate is when the flow rate cannot be delivered through the selected disposables. If a pressure limit condition occurs, the injector will continue to inject and will deliver the total volume. However, the delivered flow rate will be lower than the programmed flow rate. Therefore, the actual injection duration will be longer than the calculated value. This extended duration is the first indication that pressure limiting may be occurring. The results may include poor images.

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PRESSURE LIMITING, Con’t. If a pressure limit condition occurs, a message indicating this will be displayed on the status screen. If a pressure limit condition occurs and the flow rate is reduced to less that 10% of the programmed rate for at least 3 seconds, the injector will terminate the injection and post a message stating that a stall condition has occurred. How to Rectify a Pressure Limit or Stall Condition Once a pressure limit condition is confirmed, the following steps should be addressed to rectify the problem. 1. Confirm that the selected flow rate is correct. 2. Check the arc of the flex shaft to verify that it is not kinked or excessively bent. 3. If the selected flow rate is correct, the operator must then address one or more of the following to lower the pressure requirements of the disposable system: If using a stopcock, ensure that it is fully open to the patient or eliminate the stopcock. If using a catheter, switch to one with a larger inside diameter. Select a shorter connector tube Select a connector tube with a larger inside diameter. If using a butterfly needle, switch to an equivalent size catheter. If pressure limiting problems continue, call MEDRAD Service for assistance.

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BASIC OPERATIONS

Power Up

System power up of the MCU and the DCU are discussed first. Battery pack maintenance is included.

Overview of Injector Head & DCU

Injector head and DCU functions are described in overview fashion to acquaint you with the components of the system before programming.

Programming

Touch Screen instructions for basic operations such as programming, arming, and injecting are given. This section also includes Status, Store and Recall instructions.

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