Mark V ProVis Service Manual Rev C

This copy of 98411-T-205 Rev C is valid as of May-08-2003 at 15:43:00. The signed original is maintained in Documentation Systems. Prior to use, you are responsible to confirm this copy’s revision is the latest released.

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Table of Contents

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Table of Contents 2 - Preface Copyright Notice Trademarks Patents Restricted Sale Notice Applicability European Council Directive Compliance Manual Purpose Safety Notice Disclaimers Address/Telephone Introduction to Warnings and Cautions Statement of Intended Use Contraindications Warnings Cautions

2-1 2-1 2-1 2-1 2-1 2-1 2-1 2-1 2-2 2-2 2-3 2-3 2-3 2-3 2-5

3 - Condensed Operating Guide Control Panel

3-1

4 - Preventive Maintenance Recommended Preventive Maintenance Recommended Preventive Maintenance Schedule Inspection Procedures Cleaning Procedures Leakage Check Ground Continuity Check

4-1 4-2 4-3 4-5 4-6 4-6

TOC - 1

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Mark V ProVis Injection System

TOC - 2

5 - CPU Card CPU Card - Summary of Operation Block Diagram: CPU Card

5-1 5-2

6 - Input/Output Card I/O Card - Summary of Operation Block Diagram: I/O Card

6-1 6-2

7 - Servo Control Card SCC Card - Summary of Operation Block Diagram: SCC Card

7-1 7-4

8 - Pre-Programmed Injection Card PPI Card - Summary of Operation Block Diagram: PPI Card

8-1 8-2

9 - Control Panel Control Panel - Summary of Operation Controller Card Block Diagram: Controller Card DC to DC Converter Block Diagram: DC to DC Converter

9-1 9-2 9-4 9-5 9-6

10 - Power Drive Circuit Description of Power Drive Circuit PDCI Card - Summary of Operation Block Diagrams: Power Drive (PDCI) Circuit

10 - 1 10 - 2 10 - 8

11 - Mechanical Stop Drive MSD Card - Summary of Operation Block Diagram: MSD Card

11 - 1 11 - 2

12 - Power Supply Circuit PSC - Summary of Operation Block Diagram: PSC Card

12 - 1 12 - 2

Table of Contents

This copy of 98411-T-205 Rev C is valid as of May-08-2003 at 15:43:00. The signed original is maintained in Documentation Systems. Prior to use, you are responsible to confirm this copy’s revision is the latest released.

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13 - Injector Head Description of Injector Head Description of Motor and Drive System Description of Feedback Pots Description of Syringe Heat Maintainer Circuit Descriptions: Injector Head Card SIP Switch Settings Block Diagram: Head Card

14 - Imaging System Interface Description of Imaging System Interface Interfacing Cautions Imaging System Interface Circuits Block Diagram: Imaging System Interface Z5 Option Schematic: Siemens Interface Schematic: Phillips Interface

15 - Troubleshooting Guide Required Test Equipment Service Access Card (SAC) SAC Test Points Troubleshooting Guide: Introduction General Troubleshooting Guidelines Suggested Troubleshooting Sequence Message Faults: Non-Message Faults: Dead Unit No Drive Will Not Inject Garbled Message

13 - 1 13 - 2 13 - 2 13 - 2 13 - 2 13 - 6 13 - 7

14 - 1 14 - 2 14 - 4 14 - 6 14 - 7 14 - 8 14 - 9

15 - 1 15 - 2 15 - 3 15 - 6 15 - 7 15 - 9 15 - 10 15 - 32 15 - 33 15 - 34 15 - 35 15 - 35

TOC - 3

Mark V ProVis Injection System

This copy of 98411-T-205 Rev C is valid as of May-08-2003 at 15:43:00. The signed original is maintained in Documentation Systems. Prior to use, you are responsible to confirm this copy’s revision is the latest released.

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16 - System Disassembly and Reassembly Procedures Introduction Replacement Parts Replacement Circuitry How to Order Parts Required Tools Control Unit Electronics Console Access PC Cards Control Panel Removal and Replacement Display Card Controller Card Injector Head Covers Syringe Heat Maintainer Plunger Position Pot Mechanical Stop Pot Plunger Motor Drive Belt Plunger Drive Motor Mechanical Stop Motor Head Control Panel Mechanical Stop Limit Switch Injector Head Cable Oil Seal Pivot Knuckle Adjustment Power Switch Line Voltage Conversion Line Frequency Conversion Line Frequency Checkout

TOC - 4

16 - 1 16 - 2 16 - 4 16 - 6 16 - 7 16 - 8 16 - 9 16 - 10 16 - 11 16 - 12 16 - 13 16 - 14 16 - 16 16 - 19 16 - 21 16 - 23 16 - 25 16 - 27 16 - 28 16 - 29 16 - 30 16 - 31 16 - 32 16 - 33 16 - 35 16 - 36

Introduction

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Introduction Copyright Notice

Copyright 2003 by Medrad Inc. All rights reserved. No part of this manual may be reproduced in any form without prior written permission of Medrad. Printed and assembled in the U.S.A.

Trademarks

FluiDot, Medrad, and Quality for Life, are registered trademarks of Medrad Incorporated.

Patents

The Mark V ProVis Injection System is the subject of the following U.S. patent numbers: 4,677,980; 4,854,324; 5,383,858.

Restricted Sale

Federal (U.S.A.) law restricts the sale of this device to, or by the order of a physician.

Applicability

This manual applies to Mark V ProVis Injection Systems in the following configurations: PPD 100 60 XXX PPD 110 60 XXX PPD 200 50 XXX PPD 220 50/60 XXX PPD 240 50 XXX

PRM 100 60 XXX PRM 110 60 XXX PRM 200 50 XXX PRM 220 50/60 XXX PRM 240 50 XXX

All Mark V ProVis models are designed to be in compliance with EN 60601-1 (Safety) and EN 60601-1-2 (EMC/Emissions). Represents compliance to the European Council Directive concerning medical devices - 94/42/EEC. Purpose

This manual is intended to provide instructions for servicing the Mark V ProVis Injection System (herein referred to as “the injection system” safely and accurately. It is intended for those qualified to service the injection system, whether they be Medrad Service Personnel, Laboratory Service Technicians, or Medrad Authorized Dealers.

Important Safety Notice

The information in this manual is intended for people with adequate backgrounds and experience in electronics and electromechanical devices. Any attempt to repair a sophisticated medical device such as the injector may result in personal injury, property damage, or patient injury.

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Mark V ProVis Injection System Disclaimers

Medrad makes no warranties on the contents of this manual, and specifically disclaims any implied warranties of merchantability or fitness for any purpose. Medrad reserves the right to change specifications and the contents of this manual without obligation.

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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 Modification: 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. Accessory equipment connected to the system interfaces must be certified according the IEC 601-1 standards. Furthermore, all configurations with attached accessory equipment shall comply with the system standard IEC 601-1-1. Anyone who connects additional equipment to the signal input or output configures a medical system, and is therefore responsible that the system complies with the requirements of the system standard IEC 601-11. To obtain on-site consulting or consulting references, contact Medrad Factory Service. All drawings in this manual are for reference purposes only, and may not reflect the construction of units produced prior to the publication of this manual. Reproduction quality of these drawings may have been affected by the level of reduction required. Call Medrad Factory Service if assistance in drawing interpretation is required. The injection system is not intended for portable use. Problems or Questions

If you experience problems with any Medrad Injection System, contact: Medrad Factory Service MEDRAD, INC. One Medrad Drive Indianola, PA 15051-0780 Phone: (412) 767-2400 1-800-MEDRAD-S 1-800-633-7237 FAX: (412) 767-4126

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MEDRAD EUROPE, B.V. Postbus 205 6190 AE Beek The Netherlands Phone: (31) (0) 43 3585601 FAX: (31) (0) 43 3656598 Nihon MEDRAD K.K. 9F Central Shin-Osaka Building 4-5-36 Miyahara Yodogawa-ku Osaka, 532-0003 Japan Phone: (81) (06) 6350-0680 FAX: (81) (06) 6398-0670

Introduction INTRODUCTION TO

WARNINGS / CAUTIONS This manual contains important information about safe servicing of the injection system.

This copy of 98411-T-205 Rev C is valid as of May-08-2003 at 15:43:00. The signed original is maintained in Documentation Systems. Prior to use, you are responsible to confirm this copy’s revision is the latest released.

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Medrad urges the service technician to read this manual carefully, become familiar with the procedures and system functions that it describes, and follow its recommendations to assure proper servicing of the system. Warning labels on the injection system or Warning statements in this manual preceeded by any of the following words and/or symbols are of special significance:

!

WARNING: Indicates a potentially hazardous situation. If not avoided, this could result in death or serious injury.

!

CAUTION: Indicates potential hazards or unsafe practices which could cause product, system, or property damage.

NOTE: Indicates helpful information is being offered.

Intended Use

This device is intended to be used specifically for the purpose of injecting intravenous contrast medium into humans, for the purpose of 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.

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Mark V ProVis Injection System !

WARNINGS

!

Dangerous voltages exist within the injection system that can shock, burn, or cause death. To avoid injury, the system should be opened and serviced by qualified service personnel only. Disconnect the system from line power before cleaning or attempting to perform any maintenance or repairs.

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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 that the connector cover is in place or cable is connected. Possible explosion hazard in the presence of flammable anesthetic gases. The injection system is not designed for use in association with anesthetic gases and equipment. Electronic assemblies contain potentially hazardous materials. Dispose of system components or accessories properly. Follow all local regulations for the recycling or disposal of electronic assemblies, or contact Medrad Service for assistance. Worn power cords or control cables may shock, injure, or cause death. Examine power cords and cables for cuts, frays, or any other visible damage. Do not use the system if any of the cords or cables show signs of damage. Any damaged or worn connection cables or power cords should be replaced. Check for proper voltage and frequency before connecting the injector to an electrical outlet. Failure to do so may result in personal injury or equipment damage/malfunction. Check the voltage and frequency marked on the back of the unit. Ensure that the outlet providing power to the injector supplies a voltage, frequency, and volt-ampere rating within the range specified. Do not use an extension cord or power cord adaptor. Connect the injector directly into a properly grounded AC outlet. Since the power cord supplies a safety ground to the unit, using an extension cord will compromise ground quality and the injector could become unsafe. Do not immerse any injector components in water or any type of cleaning solution. Fluid entry may result in a shock hazard. Ensure that FluiDot labels are clearly visible on all pressure jackets. FluiDot labels are intended to help in the avoidance of air embolization, which could result in patient injury or death. 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, ensure that the retention knob is secured to prevent the injector head from falling from the arm. 2-4

Introduction 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. Injury may result during the transport of the injection system. Care should be taken when transporting the injector. Ensure that the articulating arm is secured by inserting the locking pin.

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Pinch Hazard. Do not grasp any pivot points. Position the injector head by grasping the arm or extension.

!

CAUTIONS

!

Electrostatic Discharge (ESD). Failure to follow ESD protection practices may result in equipment damage. To avoid damage, ESD protection practices must be followed when servicing any component of this system. If electronic components are to be shipped, place the components in conductive carriers (as supplied at Medrad).

This copy of 98411-T-205 Rev C is valid as of May-08-2003 at 15:43:00. The signed original is maintained in Documentation Systems. Prior to use, you are responsible to confirm this copy’s revision is the latest released.

Disconnect the power cord before removing or replacing PC boards. Sensitive circuits on the boards can be damaged by abrupt interruption or application of supplies. Remove power when disconnecting or reconnecting head cables. Disconnecting the head cable from the injector pedestal, or head extension cable from the rack or table mounts, when power is applied, may result in equipment damage. Allow system temperature to stabilize before use. When the system is exposed to an extreme temperature change (heat or cold), allow it to stabilize to room temperature before servicing. Use only accessories and options designed specifically for the Mark V ProVis injection system. To ensure compatibility and proper operation, do not use an accessory or option designed for another system. Perform regular preventive maintenance. To ensure that your injection system remains properly calibrated, and that all primary and backup circuits are functioning properly, regular preventive maintenance is recommended. An annual preventive maintenance package (offered in the U.S.A., Canada, and Europe) is available at an additional cost. Contact your local Medrad Factory Service Representative for details. Do not soak or immerse any part of the injection system in water. Improper or careless cleaning methods may result in equipment damage. While cleaning any outside portion of the system, avoid allowing any water to seep inside system components. Do not short the PPI Card Batteries. Do not place the card or the batteries on any conductive surface. When checking or replacing the PPI card batteries, discharge can occur with even a momentary short.

2-5

Mark V ProVis Injection System Do not apply voltage to ISI connector J40 pins 5,6,7,8 or 9. Equipment damage or malfunction may result.

This copy of 98411-T-205 Rev C is valid as of May-08-2003 at 15:43:00. The signed original is maintained in Documentation Systems. Prior to use, you are responsible to confirm this copy’s revision is the latest released.

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Do not move the injector or pedestal by pulling on the syringe heater cable. Equipment damage or malfunction may result.Do not connect injector head extension cables in parallel. Connecting the extension cables in parallel, or extending the total extension length beyond 100 feet (30.5 m), can adversely effect injector performance and specifications. NOTE: All relevant institutional, local, or national safety regulations related to cable routing and installation should be followed. Do not apply voltage to external start lines if the injector is being started by an external start connection. Provide only a switch closure. If the external circuit contains excessive line frequency noise or voltage transients, injector damage or malfunction may result. The Remote Start Signal from the film changer programmer (at pins 7 and 9 of J40), must never contain voltage or AC noise. Any voltage applied to these pins can damage the injector and void the warranty. Excess noise on these lines may cause intermittent problems of premature, or no injections. The Remote Start Signal from the film changer programmer must remain closed throughout the duration of the injection. If the start signal is removed before the injection volume limits when armed in the SINGLE mode, the injection will stop, the unit will disarm, and display “PREMATURE TERMINATION” on the Control Panel. If the start signal is removed before the injection volume limits when armed in the MULTIple mode, the injection will stop, the Mechanical Stop will reposition at the selected volume, and the unit will remain armed. If a start signal is received at this time, an additional injection will result at the selected Flow Rate and Volume. When starting the injection process from a remote location by the use of a relay closure in the film changer programmer, always install a “panic button” in series with the start signal. This function must be provided in the event that the operator must immediately terminate the injection. This button should be installed in a convenient location, properly labeled, and instructions for use provided to all users of the injection system.

2-6

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Operating Guide

3 Operating Guide

3-1

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Mark V ProVis Injection System

3-2

Preventive Maintenance

4 VIEWED/PRINTED: 02/04/2005 at 09:49:10.

This section contains recommended procedures for preventive maintenance of injection systems. Routine maintenance and inspection will:

Recommended Procedures This copy of 98411-T-205 Rev C is valid as of May-08-2003 at 15:43:00. The signed original is maintained in Documentation Systems. Prior to use, you are responsible to confirm this copy’s revision is the latest released.

Preventive Maintenance •

Ensure the continued performance of your injector.

•

Reduce the possibility of equipment malfunction.

Preventive maintenance of the injection system should consist of four procedures: Inspection, cleaning, leakage, and performance checks. This section contains guidelines, recommended methods, and expected results for each of these procedures: 1. Inspection: This first step should encompass inspection of the entire system, looking for obvious signs of damage, such as; cracks in the housing, frayed or worn cables, missing or damaged labels, and contrast spills that may have leaked into the injector. 2. Cleaning: This cleaning procedure involves thorough cleaning of the console and head to remove any deposits of contrast medium. If any substances have leaked into any part of the unit, the subassembly should be disassembled and thoroughly cleaned. 3. Electrical Leakage / Ground Continuity Checks: To ensure the safety of the patient and hospital personnel in injector operations. 4. Operational Checkout: A complete functional performance checkout of the injection system.

4-1

Mark ProVis Injection System Recommended Schedule

The injection system must be properly maintained to ensure that it is in peak operating condition. Your individual maintenance schedule depends upon how your injector is used; the type of procedures performed, and frequency of use. The following guidelines represent a suggested maintenance schedule:

This copy of 98411-T-205 Rev C is valid as of May-08-2003 at 15:43:00. The signed original is maintained in Documentation Systems. Prior to use, you are responsible to confirm this copy’s revision is the latest released.

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Daily: Before use each day, the system should be inspected, and the injector head piston rod thoroughly cleaned. Monthly: Once a month, the entire system should be thoroughly inspected and cleaned, and an operational checkout should be performed. Annually: Once per year, Electrical Leakage and Ground Continuity checks should be performed. NOTE: Local regulations or hospital protocol may require electrical leakage checks at more frequent intervals. If this applies, local regulations for leakage must be followed. Medrad also recommends that a complete system calibration and performance checkout, by a qualified Medrad Service Representative, be performed once a year. Contact Medrad Factory Service, or your local Medrad office for details. In the United States, Canada, Europe, and other select areas of the world, the Medrad Service Department offers Preventive Maintenance Programs. These annual programs greatly assist in maintaining accuracy and reliability, and can extend the life of the injection system. Contact Medrad for details. In Europe, contact Medrad Europe B.V., or your local authorized dealer, for further information. Refer to Section 2 of this manual for address and telephone numbers. NOTE: Failures which occur due to lack of proper maintenance, or abuse, will not be covered under warranty.

4-2

Preventive Maintenance

Inspection Procedures

The following procedures are recommended for all the components of the injection system. If defects are detected, either repair the system, or call Medrad for service. Do not use the unit until the problem has been corrected.

Injector Head

1. Inspect the housing for any cracks that could allow fluid to leak inside, or weaken the structural integrity of the unit.

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2. Inspect the head cable for cuts, cracks, or worn areas. 3. Inspect the head connector for cracks, loose pins, or a loose strain relief. 4. Inspect the injector head control panel for cuts or cracks that could allow fluid to leak inside.

Syringe Heat Maintainer

1. Ensure that the device is warm to the touch. 2. Ensure that the LED indicator is not illuminated or flashing when installed on the pressure jacket/syringe. The lamp may illuminate if the syringe heat maintainer is not installed on the pressure jacket/syringe. If the lamp is illuminated while installed on the pressure jacket/syringe, the heater is too hot and should be replaced. 3. Inspect the cable and connector for cracks, worn areas, loose pins, or a loose strain relief.

Control Panel

1. Inspect the control panel case for cracks that could allow fluid to leak inside, or weaken the assembly. 2. Inspect the interconnect cable for cuts, cracks, or worn spots. Inspect the plug for cracks, loose prongs, loose wires, or a loose strain relief. 3. Inspect the handswitch and cord: Look for cuts, cracks, or worn spots in the cable; look for cracks and loose parts in the switch and housing. 4. Inspect any other cables connected to the control unit: Look for cuts, cracks, or worn spots in the cables; look for cracks, loose pins, or loose strain reliefs on the connectors.

Pedestal Mount

1. Inspect the case and legs for cracks and other defects that could weaken the structure. 2. Ensure that all mounting bolts and screws are secure. 3. Inspect the connectors on the pedestal for cracks or loose pins. 4. Ensure that the wheels roll smoothly, with no binding and scraping. 5. Ensure that the locking mechanism on all locking wheels is functional.

4-3

Mark ProVis Injection System Injector Head Articulating Arm

The injector head support arm is typically associated with pedestal type injection systems and free standing injector head stands. Carefully inspect the areas shown below for any signs of damage. 1. Inspect all parts of the mounting system for cracks and other defects that would weaken the assembly.

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2. Ensure that the mounting system is securely assembled, with no loose parts. The system should be stable with the head installed. 3. Ensure that the system moves smoothly in all directions, with no binding, scraping, or drifting. 4. Verify that all cabling is tied back and does not interfere with the movement of the supporting parts or the injector head. NOTE: The injector head pivot knuckle should rest flat and rotate smoothly on the support arm. NOTE: The head cable can wrap around the support arm, causing damage to the head cable, and possibly lifting the injector head from the support arm. Contact Medrad Factory Service for support arm replacement information.

Counterpoise Systems

1. Inspect all parts of the mounting system for cracks and other defects that would weaken the assembly. 2. Ensure that the mounting system is securely assembled, with no loose parts. The system should be stable with the head installed. 3. Ensure that the system moves smoothly in all directions, with no binding, scraping, or drifting. 4. Verify that all cabling is tied back and does not interfere with the movement of the supporting parts or the injector head. NOTE: All relevant guidelines for institutional, local, or national safety recommendations related to cable routing and installation should be followed. NOTE: Rotating the counterpoise consistently in one direction can cause the head extension cable to wrap around the counterpoise, causing possible equipment damage. NOTE: The head cable can wrap around the support arm, causing damage to the head cable, and possibly lifting the injector head from the support arm. Contact Medrad Factory Service for support arm replacement information.

4-4

Preventive Maintenance

Cleaning Procedure

Deposits of contrast media can interfere with proper operation of the injection system. The following guidelines should be followed when removing deposits, or cleaning any portion of the system.

This copy of 98411-T-205 Rev C is valid as of May-08-2003 at 15:43:00. The signed original is maintained in Documentation Systems. Prior to use, you are responsible to confirm this copy’s revision is the latest released.

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!

WARNING: Shock Hazard. Remove the power cord from the power source before cleaning any part of the system. Failure to do this could result in the exposure of lethal voltages, causing injury or death.

•

Using warm water and soft cloths, clean the injector console and head thoroughly to remove contrast medium or other deposits.

•

The injector head requires particular attention. Remove the turret, then: Clean the front casting where the piston moves in and out; Clean the turret and its pivot point; Remove any contrast from the entire length of the piston rod.

!

CAUTION: Do not soak or immerse any parts of the injector in water. Improper or careless cleaning methods may result in equipment damage. While cleaning the outside of the unit, avoid letting any liquids seep inside injector components.

•

If contrast medium has leaked inside the head or console, the affected subassembly should be disassembled and cleaned. This cleaning procedure can be done in the field by trained Medrad Service personnel, or returned to Medrad Factory Service. If the cleaning will be performed in the field by a properly trained individual, ensure that any internal wiring or components are not disturbed, and that the system is completely dry before applying power.

•

Check all of the System Safety and Warning Labels for legibility. Ensure that the labels are not damaged or missing.

!

WARNING: Ensure that the system is completely dry before connecting to a power source and applying power.

4-5