Mark V ProVis Operation Manual Rev F

MEDRAD MARK V PROVIS INJECTOR OPERATION MANUAL

KMP 910 E

98411-T-167 Rev. F Copyright 1999, 2000 Medrad, Inc. All rights reserved

TABLE OF CONTENTS

SECTION 1 - PREFACE...1 - 1 Copyright, Trademarks & Disclaimers...1 - 1 Applicability. ...1 - 2 Service/Telephone & Fax ...1 - 2 About This Manual ...1 - 3 International Symbols...1 - 5 SECTION 2 - WARNINGS, CAUTIONS & PRESSURE LIMITING ...2 - 1 Warnings ...2 - 1 Cautions ...2 - 4 Pressure Limiting ...2 - 6 SECTION 3 - SYRINGES/LOADING...3 - 1 Injector Head Controls & Indicators ...3 - 1 Loading ...3 - 2 Installing a Syringe...3 - 3

FluiDot Indicators ...3 - 6 Guidelines for Removing Air ...3 - 6 SECTION 4 - BASIC OPERATIONS ...4 - 1 Programming...4 - 2 Reset...4 - 3 Multi level Programming...4 - 3 Rise Fall Time ...4 - 4 Flow Rate & Flow Scale ...4 - 5 Volume ...4 - 6 Injection Duration ...4 - 6 Pressure Limit ...4 - 6 Pressure Scale Conversion Chart...4 - 8 Delays ...4 - 9 Store...4 - 10 Title Entry ...4 - 10 Recall ...4 - 11 Deleting a Stored Program...4 - 11 Clear All Programs ...4 - 12 Overwrite an Existing Program ...4 - 12 Utility Recall Functions ...4 - 12

Recall 50 (Change syringe size) ...4 - 13 Recall 51 (Change pressure scale)...4 - 13

Recall 52 (Delete stored program) ...4 - 13 Recall 53 (Clear memory) ...4 - 13 Recall 65 (Select head configuration) ...4 - 14 SECTION 5 - ARMING & INJECTING ...5 - 1 Prepare to Inject...5 - 1 Arming...5 - 3 Single & Multi Arm...5 - 3 Injecting...5 - 4 Status ...5 - 5 Clean Up ...5 - 6 SECTION 6 - SENTINEL MESSAGES...6 - 1 Message List. ...6 - 2 Service Messages...6 - 14 SECTION 7 - CONNECTING EXTERNAL EQUIPMENT...7 - 1 Injector Power Source ...7 - 1 Connector Panels/Interconnections ...7 - 2 Panel Connectors ...7 - 3 Start Connections ...7 - 3 Imaging System Interfacing (ISI) ...7 - 4 External Start Connections ...7 - 5 Imaging System Interface - Technical Details ...7 - 8 Analog Output Signal-ISI 100 Wiring Diagram ...7 - 11 J40 Pin Designations ...7 - 12 Imaging System Interface ISI 100 Wiring Diagram ...7 - 13 Imaging System Interface Cables...7 - 15 SECTION 8 - SPECIFICATIONS...8 - 1 Control Panel ...8 - 1 Control Room Console...8 - 2 Pedestal ...8 - 3 Injector Head...8 - 4 Cord Lengths...8 - 4 Power Requirements...8 - 5 Protection Against Electrical Shock ...8 - 5 Electrical Leakage...8 - 5 Automatic Safety Stop...8 - 6 System Monitor ...8 - 6 Flow Rates pre Syringe Size...8 - 6

Analog Output Signals ...8 - 8 Environmental Specifications ...8 - 8 Ground Continuity ...8 - 9 Mode of Operation ...8 - 9 Over and Under Infusion Protection...8 - 9 SECTION 9 - MAINTENANCE & CHECKOUT PROCEDURE ...9 - 1 Maintenance...9 - 1 Checkout Procedure ...9 - 4

NOTES:

PREFACE Copyright

Trademarks Patents

Disclaimers

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Copyright Notice Copyright 1999 by Medrad, Inc. All rights reserved. No part of this manual may be reproduced in any form without the prior written permission of MEDRAD. Printed in USA. Mark V ProVis Injector and FluiDot are trademarks of Medrad, Inc. Medrad is a registered trademark for Medrad, Inc. The Mark V ProVis injector is the subject of the following U.S. patent number: 4,854, 324. Disclaimers This manual describes the use, operation and preventive maintenance needs of the Mark V ProVis Injector, herein refered to as “the injector”. The 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. The Injector units are equipped to operate at 95-125, 190-250 VAC, 50/60 Hz. However, each system is shipped configured for the voltage range specified on the serial number label. CE 0123 indicates that this device conforms to the requirements of the European medical device directive 93/42/EEC. All Medrad ProVis injectors bear the CE mark and are designed to be in compliance with EN 60601-1 (safety) and EN 60601-1-2 (EMC/ Emissions). 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. External wiring and modifications disclaimer: 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. Such unauthorized action could jeopardize injector operation, safety, or reliability. Injectors bearing the CE mark and having accessory equipment connected to the interface connectors must be certified according to IEC 601-1 standard. Furthermore, all configurations of injectors with attached accessory equipment must 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 require-

PREFACE, Con’t.

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ments of the system standard IEC 601-1-1. To obtain on-site consulting or consulting references, contact MEDRAD Service. The injector is not for portable use. Applicability

Applicability: This manual applies to the injector in the following configurations: Pedestal Mounted System PPD, Control Room Console PRM, Remote Panel System RPS 615 IR. Medrad will make available on request any circuit diagrams, component parts lists, or other information which will assist appropriately qualified technicians to repair those parts of the equipment which are classified as repairable. Contact Medrad Service for further information. If technical problems are encountered with the injector call your local dealer or: Corporate Headquarters:

Medrad Europe:

Medrad, Inc. One Medrad Drive Indianola, PA 15051-0780 USA

Medrad Europe B. V. Postbus 3084 6202 NB Maastricht

Inside continental U.S. 1-800-MEDRAD-S (1-800-633-7237)

The Netherlands Phone: (31) (0) 43 3585601 FAX (31) (0) 43 3650020

Service

Outside continental U.S. 1-412-767-2400 For Service Repairs: Inside continental U.S. 1-800-MEDRAD-S (1-800-633-7237) Japanese Headquarters Nihon Medrad KK Central Shin-Osaka Building, 9F 4-5-36 Miyahara Yodogawa Ku Osaka, 532-0003 Japan Phone: 81-6-6350-0680 FAX: 81-6-6398-0670

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

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Medrad America Latina LTDA Av Republica Argentina 2403 Conj. 54 80610-260 Curitiba - PR Brazil Phone: +55 (41) 345-6885 FAX: +55 (41) 345-0449 Medrad, Inc. Asia 200 Jalkan Sultan #09-01 Textile Centre Singapore 199018 Phone: +65 292-5357 FAX: +65 292-7276

ABOUT THIS MANUAL PURPOSE This manual is a user’s reference guide for the injector operations.

Important Safety Notice: The information in this manual is intended for personnel with adequate training and experience in angiographic 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 area where the injector will be used. This manual contains important information about the safe operation of the injector. Medrad urges the operators of the injector to read this manual carefully, become familiar with the injector functions it describes, and follow its recommended procedures. 1.) Read the warnings and cautions in Section 2. 2.) Review syringe installation and loading procedures in Section 3.

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PREFACE, Con’t. 3.) Become familiar with the injector programming controls and indicators in Section 4. 4.) Follow directions for arming and injecting in Section 5. 5.) Become familiar with operational messages and problems, including suggestions for trouble shooting, located in Section 6.

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The following international symbols are used on the injector and throughout this manual.

Attention, consult accompanying documents/text.

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

Identifies connection to the mains.

Identifies disconnection from the mains.

Indicates dangerous voltages.

Indicates Alternating Current

Identifies a type CF medical equipment complying with EN 60601-1 standards.

CLASS 1

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

Identifies handswitch is not operational.

B1

Identifies circuit breaker one

B2

Identifies circuit breaker two

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Identifies the PPI reset switch which clears memory

Identifies earth ground

Identifies rotation direction on the manual knob for manually moving the piston. Clockwise is forward movement.

Identifies connection of start switch.

WARNINGS & CAUTIONS

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READ this manual carefully before operating the injector and keep the manual available in the Special Procedures Lab, Cath Lab or RF room.

WARNINGS

Indicates that the information is a warning. Warnings advise of circumstances that could result in injury or death to the patient or operator. Read and understand the warnings before operating the injector system.

CAUTIONS

Indicates that the information is a caution. Cautions advise of circumstances that could result in damage to the device. Read and understand the cautions before operating the injector system.

WARNINGS

INTENDED USE: This device is intended to be used specifically for the purposes of injecting intravenous contrast medium and common flushing solutions into humans for angiographic diagnostic studies. DO NOT attempt to use the injector for any other purpose. CONTRAINDICATIONS: This device is not to be used for drug infusion, chemotherapy, or any other use for which the device is not indicated. RESTRICTED SALE: Federal (USA) law restricts this device to sale by or on the order of a physician. DISCONNECT THE PATIENT IMMEDIATELY FROM THE INJECTOR IF A “SYSTEM MALFUNCTION” OCCURS. Turn the injector off 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, and/or the injector is not operating as customary, DO NOT use the injector until the condition causing the message display can be identified and corrected. Call MEDRAD Service for assistance. DO NOT CONNECT A PATIENT TO THE INJECTOR UNTIL ALL TRAPPED AIR HAS BEEN CLEARED FROM THE SYRINGE, CONNECTOR TUBING AND CATHETER. 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. DO NOT LOAD OR INJECT UNLESS THE SYRINGE IS PROPERLY ENGAGED. Improper engagement may cause an under volume delivery, air embolization or personal injury.

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WARNINGS & CAUTIONS, Con’t. 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.

Flow Rate/Volume

USE ONLY CATHETER AND CONNECTORS WITH RATINGS THAT ARE COMPATIBLE WITH THE MEDRAD 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 under flow rates, under volumes, or stall conditions which could possibly cause the procedure to be repeated. HIGH FLOW RATE INJECTIONS CAN CAUSE PATIENT INJURY. Use extreme care when selecting the flow rate 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. If a high flow rate injection is desired, select a catheter that can withstand high flow rates. DO NOT USE DISPOSABLE ITEMS ON MORE THAN ONE PATIENT. Refilling increases the risk of biological contamination. Discard disposable items after use. DO NOT REMOVE PLUNGER TO FILL SYRINGE Patient infection may result from the use of non-sterile components. Maintain sterility of all disposable components. OVER FLOW RATE, UNDER FLOW RATE, OVER VOLUME or UNDER VOLUME DELIVERY may create poor images, which may result in the necessity to repeat the procedure. Check settings before injecting. 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.

Shock/Explosion

DANGEROUS VOLTAGE: To avoid dangerous voltages, do not remove any covers or disassemble the injector system in any way. Inspect the injector system periodically for loose or frayed cables, loose covers, any signs of cracks, dents or loose hardware. Refer all injector servicing to Medrad. Call Medrad Service for assistance.

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SHOCK HAZARD when cleaning. In order to avoid shock and prevent damage to the injector, always disconnect the injector system from line power before cleaning. Ensure that the system is completely dry before connecting to a power source and applying power. MAINS VOLTAGE HAZARD. To avoid dangerous voltages, do not remove connector J130 while power is applied to the system. Always disconnect the system from line power before removing connector J130. LIVE VOLTAGE HAZARD. Avoid contact with J40 pins. Ensure cover is in place or cable is connected. DO NOT USE AN EXTENSION CORD OR A POWER CORD ADAPTER. 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. DO NOT USE THE INJECTOR IN THE PRESENCE OF FLAMMABLE ANESTHETICS. This presents a possible explosion hazard. DO NOT POSITION THE HEAD PEDESTAL OR COUNTER POISE SYSTEM BY PULLING ON THE INJECTOR HEAD, DISPLAY OR CABLING. Possible injury can occur if the injector head or stand falls on the patient or technician. Move the injector by grasping the handles and pulling or pushing the stand and counterpoise into place. Do not use the arm to lift the injector system. PINCH HAZARD. Do not grasp any pivot points. Position injector head by grasping arm or extension. OPERATOR OR PATIENT INJURY MAY RESULT FROM SPRINGING ACTION WHEN INJECTOR HEAD IS REMOVED FROM THE ARM. Move the arm to the maximum upright position before removing the injector head. When re-mounting the injector head assure the retention knob is tightened to prevent the injector head from falling off the arm. OPERATOR INJURY MAY RESULT IF EXCESSIVE WEIGHT IS APPLIED TO THE DEVICE. Do not place heavy objects or lean on the arm, injector head, or handles. OPERATOR INJURY MAY RESULT FROM BOTTLES FALLING FROM TRAY. Only use bottles that are less than 5 1/2 inches (140.3 mm) in height. Do not place bottles on top of the tray. Assure that the bottles are placed in the recesses provided.

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WARNINGS & CAUTIONS, Con’t. OPERATOR INJURY MAY RESULT DURING THE TRANSPORT OF THE INJECTOR SYSTEM. Care should be used when transporting the injector. Assure that the articulating arm is secured by inserting the locking pin. OPERATOR OR PATIENT INJURY MAY RESULT FROM INADERTENT MOVEMENT OF THE ARM OR INJECTOR HEAD. Periodically examine the articulating arm for signs of swaying and drooping. If any of these signs are evident, do not use the injector. Call Medrad Service for assistance.

CAUTIONS

FOR PROPER OPERATION, use only accessories and options provided by MEDRAD which are designed specifically for the injector system. Other accessories or options may cause equipment damage. DO NOT SOAK OR IMMERSE ANY PART OF THE INJECTOR SYSTEM IN WATER. Improper or careless cleaning methods may result in equipment damage. When cleaning any outside surface of the system, avoid allowing any water or cleaning solutions to seep inside system components. HITTING THE SYRINGE OR PRESSURE JACKET WITH ANY TOOLS WHILE ATTEMPTING TO ELIMINATE AIR MAY CAUSE EQUIPMENT DAMAGE. Hit the syringe or pressure jacket gently with the heel of hand to dislodge air bubbles. STALL CONDITION CAN OCCUR when a low flow rate is selected in conjunction with a low pressure limit. Check the fluid path for a blockage. If no blockage exists in the fluid path, adjustments may be made to the flow rate or pressure limit according to physician’s orders. PERFORM REGULAR MAINTENANCE. To ensure that the injector stays properly calibrated, and that all primary and backup systems are functioning properly. Yearly preventive maintenance is recommended. Contact your local MEDRAD Service Representative for further information. 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. 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 a voltage and frequency within the range marked on the

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back of the injector (such as 110 VAC, 60 Hz). The injector may be damaged when power is applied if the outlet does not match the stated voltage range. Verify that the unit has the proper cord set for the plug style. DO NOT BLOCK VENTS on the unit. This may cause the unit to overheat and shut down. Installation clearance should be a minimum of 3 to 5 inches (7.62 to 12.7 cm). DO NOT USE THE SYRINGE HEATER IF THE HEATER INDICATOR LIGHT IS LIT WHILE ON THE SYRINGE: This indicates that the syringe heater is overheating and should not be used. DISPOSE OF SYSTEM COMPONENTS OR ACCESSORIES PROPERLY. Electronic assemblies contain potentially hazardous materials. Follow all local regulations for the recycling or disposal of electronic assemblies or contact Medrad Service for assistance. REMOVE POWER WHEN DISCONNECTING OR RECONNECTING HEAD CABLES. Disconnecting the head cable from the injector pedestal or head extension cable from the rack mount or table mount unit when power is applied may cause equipment damage. INJECTOR MAY DISARM OR FAIL TO OPERATE WHEN EXPOSED TO HIGH MAGNETIC FIELDS. Do not use radio transmitters, cellular phones or devices generating electrostatic discharge in the vicinity of the injector system.

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PRESSURE LIMITING Terminology 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.

Pressure Pressure is related to the amount of force which the injector head must develop in the syringe in order to move fluid at the selected flow rate. Pressure developed by the 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. The amount of force which the injector head develops will not exceed the factory set Pressure Limit of 1100 psi for 60 ml syringe, 1200 psi for a 150 ml syringe or 1000 psi for a 200 ml syringe. Pressure limit is user programmable from 100 to 1200 psi in 1 psi increments. To change the pressure scale, use Recall 51 as described in “Recall Utility Functions” in Section 4.

Flow Rate Flow Rate is selected in units of ml/sec, ml/min or ml/hr. Injection Duration Injection duration is the length of time that the injector will require 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 20 ml/sec flow rate = duration of 2.5 seconds). The duration of a multi-phasic injection will be calculated by the injector and displayed on the screen. Injection duration is displayed on the control panel in seconds, minutes or hours depending on the selected flow scale. Selecting a rise or fall time extends the total time of the injection. The added time will be 1/2 of the rise/ fall time. For instance, a 30 ml injection at 10 ml/sec will take 3 sec-

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onds without rise time. If a rise time of 1 second is added, 1/2 second is added to the total time. Now the injection will take 3.5 seconds.

THE BASICS In order for contrast media to flow through the angio disposable system (connector tubing, stopcock, and catheter), the pressure in the syringe must exceed the resistance of the disposable system. Pressure in the syringe is generated 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. However, pressure limit can be programmed over a range of 100 to 1200 psi depending on the selected syringe size. Regardless of the parameters selected on the control panel, the catheter gauge chosen, or the choice of other disposable components, under steady state conditions the injector will not develop more pressure than the programmed pressure limit. 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 performance of the total injection system and give consistent and reliable results.

How the Injector is Designed The injection system is a flow-controlled system. This means that the flow rate(s) that is/are selected on the control panel is/are the flow rate(s) 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 rates is when the flow rate cannot be delivered

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PRESSURE LIMITING, Con’t. through the selected disposables. When this occurs, the injector will automatically limit the maximum pressure to the programmed value and the resultant (lower) flow rate will be delivered. The injector still injects and delivers the total volume. However, the delivered flow rate will be lower, and thus, the injection duration will be longer.

How to Recognize if a Pressure Limit Condition Occurs If a pressure limit condition occurs, it will first be evidenced by injection durations that are greater than what would normally be expected, then by washed out films. Therefore, if procedure images are lighter than normal (which could mean a lower flow rate was delivered than selected), pressure limiting may be occurring. Check for a pressure limit condition by comparing the actual injection duration with a calculated value (Volume/flow rate). If the actual duration exceeds the calculated value, pressure limiting may have occurred. If a stall condition occurs, the following sentinel message, “**Stall Time Exceeded” will be displayed. If this occurs, check the fluid path for a blockage. If no blockage exists in the fluid path, the operator may increase the flow rate setting or increase the pressure limit setting and re-arm the system. If the flow rate or pressure limit is to be increased, re-check physician’s orders.