Spectris Solaris series Service Manual Rev D

MEDRAD Spectris Solaris and Spectris Solaris EP Injection Systems Section 4 Disassembly and Reassembly Procedures...4 - 1 DCU Touch Screen...4 - 2 Power Switch Light...4 - 4 Power Switch...4 - 5 LCD...4 - 6 DCU Interface Card...4 - 7 Single Board Computer...4 - 8 Inverter Card...4 - 9 Fuses...4 - 10 Expansion Base Cable...4 - 11 Expansion Base Interface Card...4 - 13 Power Supply...4 - 14 Hub...4 - 15 Line Power Module...4 - 16 Scan Room Unit Power Box... 4 - 17 Covers...4 - 18 Servo/CPU Card...4 - 19 Power Drive Card...4 - 20 Stand Base Interface Card...4 - 21 Motors... 4 - 22 Wheels...4 - 24 Sensor Card...4 - 25 Head Switch Card... 4 - 26 Head Cable... 4 - 27 Flex Shafts...4 - 29 Flex Shafts Casings...4 - 30 Arm Lights... 4 - 32 Motor Knobs...4 - 33 Mechanical Assembly...4 - 34 Syringe Interface/Size Sensing Assembly...4 - 35 Potentiometers...4 - 36 Load and Check for Air Switch Boots...4 - 38 Top Head Cover...4 - 39 Bottom Head Cover...4 - 40 Potentiometer Alignment...4 - 42

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Table of Contents Section 5 Theory of Operation...5 - 1 Table of Contents...5 - 1 DCU Top Block Diagram...5 - 2 PCMCIA Card Block Diagram...5 - 3 DCU Top Description...5 - 4 DCU Expansion Base Block Diagram...5 - 6 Ethernet Hub Description...5 - 7 Three Phase Motor Function Description...5 - 8 Power Drive Card Block Diagram...5 - 10 Description...5 - 11 Stand Base Interface Card Block Diagram...5 - 14 Description...5 - 15 CPU/Servo Card Block Diagram...5 - 17 Description...5 - 17 Head Block Diagram...5 - 18 Switch Card and Sensor Card Description...5 - 19 Control Room Block Diagram...5 - 22 Scanner Room block Diagram...5 - 23 Section 6 Replacement Parts...6 - 1 Parts List Component Descriptions...6 - 1 Control Room Monitor Top Front...6 - 2 Diagram...6 - 3 Top Back...6 - 4 Diagram...6 - 5 Expansion Base...6 - 6 Diagram...6 - 7 Head Stand Power Box...6 - 8 Diagram...6 - 9 Power Box...6 - 10 Diagram...6 - 11 HSU Stand Assembly...6 - 12 Diagram...6 - 13 Stand/Head...6 - 14 Diagram...6 - 15 Head...6 - 16 Diagram...6 - 17 Miscellaneous Accessory Parts...6 - 18

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MEDRAD Spectris Solaris and Spectris Solaris EP Injection Systems

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Introduction

1 Introduction Copyright Notice

Copyright 2002 - 2005 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

MEDRAD Spectris Solaris ®, Spectris Solaris ® EP, Qwik-Fit Syringe ®, FluiDot ®, Quality for Life ®, and MEDRAD ® are registered trademarks of MEDRAD Incorporated.

Restricted Sale

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

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. External wiring modification 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.S Accessory equipment connected to the MEDRAD Spectris Solaris or Spectris Solaris EP MR Injector must be certified according to IEC 60601-1 standards. Furthermore, all configurations shall comply with the system standard IEC 60601-1-1. 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 60601-1-1. To obtain on-site consulting or consulting references, contact MEDRAD 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 effected by the level of reduction required. Call MEDRAD Service if assistance in drawing interpretation is required. The Spectris Solaris or Spectris Solaris EP Injector is not for portable use.

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MEDRAD Spectris Solaris and Spectris Solaris EP Injection Systems Problems or Questions

If you experience problems with the MEDRAD Spectris Solaris or Spectris Solaris EP MR System, contact your MEDRAD authorized dealer or: MEDRAD Service One Medrad Drive Indianola, PA 15051-0780 USA Phone: 1-412-767-2400 1-800-MEDRAD-S 1-800-633-7237 FAX: 1-412-767-4126

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: 81-6-6350-0680 Fax: 81-6-6398-0670

Applicability

This manual applies to the MEDRAD Spectris Solaris or Spectris Solaris EP MR Injection System.

Purpose

The purpose of this manual is intended to provide instructions for servicing the MEDRAD Spectris Solaris or Spectris Solaris EP MR Injection System safely and accurately. It is intended for those qualified to service the injection system, whether they be MEDRAD Service Personnel, Certified Laboratory Service Technicians or MEDRAD authorized international 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.

Intended 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.

Certifications

MEDRAD Spectris Solaris or Spectris Solaris EP MR Injection Systems are equipped to operate at 100 - 240 VAC, 50/60 Hz, and designed to be in compliance with EN 60601 -1 (Safety), and EN 60601-1-2 (EMC/Emissions). MEDRAD, Inc. is EN-ISO 9001/EN 13485 certified. MEDRAD Europe B.V. is EN-ISO 9002/EN 13488 certified. (European Medical Device Directive 93/42/EEC). Nihon MEDRAD KK is ISO 9001/ISO 13485 certified.

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Introduction Additional Information Regarding Compliance to IEC 60601-1-2 / 2001 2nd Edition This section is intended to reflect conformance to IEC-60601-1-2 / 2001 2nd edition Standards.

Cautions The following statements are cautions. Cautions advise of circumstances that could result in damage to the device. Read and understand these cautions before operating the injector system. Injector may disarm or fail to operate when exposed to high magnetic fields. Portable and mobile RF communications equipment can affect the injector. FOR PROPER OPERATION, use only accessories and options provided by MEDRAD that are designed specifically for the injector system. Other non-MEDRAD approved accessories or options may cause equipment damage or may result in increased emissions or decreased immunity of the injector system. Injector system accessories listed in it’s operation manual comply with the requirements of electromagnetic emissions and immunity standards IEC-60601-1-2 / 2001 2nd edition. DO NOT USE INJECTOR ADJACENT TO OR STACKED WITH OTHER EQUIPMENT. If adjacent or stacked use is necessary, the injector should be observed to verify normal operation in the configuration in which it will be used. Recommended separation distances between portable and mobile RF communications equipment and the injector The injector is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the injector can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the injector as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W

Separation distance according to frequency of transmitter m 150 KHz to 80 MHz d = [3.5/V1] p

80 MHz to 800 MHz d = [3.5/E1] p

800 MHz to 2.5 GHz d = [7/E1] p

0.01

0.12

0.12

0.23

0.1

0.37

0.37

0.74

1

1.17

1.17

2.33

10

3.69

3.69

7.38

100

11.67

11.67

23.33

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1

At 80 MHz and 800 MHz, the separation distance for the higher frequency applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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MEDRAD Spectris Solaris and Spectris Solaris EP Injection Systems INJECTOR REQUIRES SPECIAL PRECAUTIONS REGARDING EMC. Install and put into service according to the EMC information provided below: Guidance and manufacturer's declaration - electromagnetic emissions The injector is intended for use in the electromagnetic environment specified below. The customer or user of the injector should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions Group 1 The injector uses RF energy only for its internal function. Therefore, CISPR 11 its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions Class B The injector is suitable for use in all establishments, including CISPR 11 Spectris Solaris or Spectris Solaris domestic establishments and those directly connected to the public EP low-voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions Class B IEC 61000-3-2 Spectris Solaris or Spectris Solaris EP Voltage fluctuations/flicker Complies emissions IEC 61000-3-3

Guidance and manufacturer's declaration - electromagnetic immunity The injector is intended for use in the electromagnetic environment specified below. The customer or user of the injector should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance +6 kV contact Floors should be wood, concrete or ceramic tile. If Electrostatic discharge +6 kV contact floors are covered with a synthetic material, the +8 kV air +8 kV air (ESD) relative humidity should be at least 30%. IEC 61000-4-2 Electrical/fast transient/ +2 kV for power supply lines +2 kV for power supply lines Mains power quality should be that of a typical commercial or hospital environment. +1 kV for input/output lines +1 kV for input/output lines burst IEC 61000-4-4 Surge +1 kV differential mode +1 kV differential mode Mains power quality should be that of a typical +2 kV common mode +2 kV common mode commercial or hospital environment. IEC 61000-4-5 Voltage dips, short <5% UT <5% UT Mains power quality should be that of a typical interruptions and voltage (>95% dip in UT) commercial or hospital environment. If the user of (>95% dip in UT) variations on power the injector requires continuous operation during for 0.5 cycle for 0.5 cycle supply input lines power mains interruptions, it is recommended the IEC 61000-4-11 injector be powered from an uninterruptible power 40% UT 40% UT supply or battery. (60% dip in UT) (60% dip in UT) for 5 cycles for 5 cycles

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

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70% UT (30% dip in UT) for 25 cycles

70% UT (30% dip in UT) for 25 cycles

<5% UT (>95% dip in UT) for 5 sec 3 A/m

<5% UT (>95% dip in UT) for 5 sec 3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Introduction Guidance and manufacturer's declaration - electromagnetic immunity NOTE

UT is the a.c. mains voltage prior to application of the test level.

Guidance and manufacturer's declaration - electromagnetic immunity The injector is intended for use in the electromagnetic environment specified below. The customer or user of the injector should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the injector, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance 3 V rms Conducted RF 3 V rms d = 1.17 p IEC-61000-4-6 150 kHz to 80 MHz Radiated RF 3 V/m 3 V/m d = 1.17 p 80 MHz to 800 MHz IEC 61000-4-3 80 MHz to 2.5 GHz d = 2.33

p

800 MHz to 2.5 GHz

Where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1

At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the injector is used exceeds the applicable RF compliance level above, the injector should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the injector. b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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MEDRAD Spectris Solaris and Spectris Solaris EP Injection Systems Symbols and Descriptions

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

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 606011 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.

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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.

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.

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.

Identifies the distance that the injector must be placed in relation to the magnet bore with a field strength greater than 2T.

Identifies Integrated Continuous Battery Charger system activity on Graphical User Interface. When illuminated yellow this indicates that the Continuous Battery Charger system is present and functioning.

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MEDRAD Spectris Solaris and Spectris Solaris EP Injection Systems

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Introduction

INTRODUCTION TO

WARNINGS / CAUTIONS This manual contains important information about safe servicing of the MEDRAD Spectris Solaris or Spectris Solaris EP MR Injection System. 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 MEDRAD Spectris Solaris or Spectris Solaris EP MR 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.

WARNING: Indicates electrical hazards which 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.

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MEDRAD Spectris Solaris and Spectris Solaris EP Injection Systems

WARNINGS

Injury may result from exposure to hazardous voltages existing within the system. 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. Explosion hazard in the presence of flammables. Do not use the system in the presence of anesthetic gases and equipment.

Patient or operator injury can occur from use of worn power cords or control cables. 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. Unsafe operation may result from using improper accessories and replacement parts. Use only accessories, options, and parts designed for this system, and provided by MEDRAD, 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, 250V, 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. Improper disposal of the battery pack may result in explosion, leakage, or personal injury. Do not open, or dispose, in a fire! Follow all local regulations concerning the disposal of spent lead-acid based batteries, or contact MEDRAD for assistance.

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Introduction

CAUTIONS

Damage may occur as a result of failure to follow electrostatic discharge (ESD) protection practices. ESD protection practices must be followed when servicing any component of this system. Damage can occur as a result of incorrect voltages. Check the voltage and frequency marked on the back of the Power Supply. Ensure that the outlet providing power to the injector supplies a voltage, frequency, and volt-ampere rating within the range specified on the unit. Environmental damage may result from improper disposal of system components or accessories. Electronic assemblies contain potentially hazardous materials. Follow all local regulations for the recycling or disposal of electronic assemblies, or contact MEDRAD Service for assistance. Damage can occur as a result of abrupt interruption or application of supplies. To avoid damage to sensitive circuits on the boards, disconnect the power cord before removing or replacing PC boards. Allow system temperature to stabilize before use. To avoid damage to sensitive electronic circuits, allow the system to stabilize to room temperature before servicing when exposed to extreme temperature changes. Perform regular preventive maintenance. To ensure that your MEDRAD Spectris Solaris or Spectris Solaris EP System remains properly calibrated, and that all primary and backup circuits are functioning properly, regular preventive maintenance is recommended. An annual preventive maintenance package is not included in the new machine warranty. Contact your local MEDRAD Service Representative for details. Damage may result from improper or careless cleaning methods. While cleaning any outside portion of the system, avoid allowing any water to seep inside system components.

NOTE: All relevant guidelines for institutional, local, or national safety recommendations related to cable routing and installation should be followed.

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MEDRAD Spectris Solaris and Spectris Solaris EP Injection Systems

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Maintenance and Checkout

2

Maintenance and Checkout This section contains recommended procedures for maintenance, and an operational checkout of the MEDRAD Spectris Solaris or Spectris Solaris EP MR Injection System. Routine maintenance and inspection will:

Recommended Maintenance Schedule

•

Ensure continued performance of the injection system

•

Reduce the possibility of equipment malfunction

Your MEDRAD Spectris Solaris or Spectris Solaris EP MR Injection System must be properly maintained to ensure that it is in peak operating condition. Your individual maintenance system and schedule depends upon how your injection system is used, the type of procedures performed, and frequency of use. The following maintenance schedule is recommended for the system: Daily: The piston rod should be thoroughly cleaned after each use. Before use each day, the system should be cleaned and inspected, using the procedures outlined in this section. Ensure that all system safety and warning labels are in place and are legible. Monthly: Once a month, the entire system should be thoroughly inspected and cleaned, and an Operational Checkout should be performed. Annually: As part of an annual maintenance program performed by a qualified MEDRAD Service Representative or authorized dealer, both 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.

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MEDRAD Spectris Solaris and Spectris Solaris EP Injection Systems

MEDRAD also recommends that a complete system calibration and performance checkout be performed annually. Contact MEDRAD Factory Service, or your local MEDRAD office for complete details. In the United States, Canada, Japan, and Europe, the MEDRAD Service Department offers Preventive Maintenance Programs. These annual programs greatly assist in maintaining accuracy and reliability, and can also extend the life of the system. Contact MEDRAD for details. In Europe, contact your local MEDRAD office or your local authorized dealer for further information. Refer to the back of the title page of this manual for address, telephone and FAX information. NOTE:

MEDRAD Service

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Failures which occur due to lack of proper maintenance will not be covered under warranty.

MEDRAD Service will make available upon request: •

Circuit diagrams, component parts lists, or other information that will assist qualified technicians to repair components classified as repairable.

•

On-site consulting or consulting references.

Maintenance and Checkout Inspection Procedures The following procedures are recommended for daily inspection of all components in the MEDRAD Spectris Solaris or Spectris Solaris EP MR Injection System. If any defects are detected, either repair the system, or call MEDRAD for service. Do not use the system until the problem is corrected. Scan Room Unit 1. Inspect the housing for any damage or cracks that could allow fluid to leak inside, or weaken the structural integrity of the unit. 2. Inspect all cables connected to the unit: Look for cuts, cracks, worn spots or other obvious damage to the cables. Ensure that all connectors are properly seated. 3. Inspect for contrast media build-up in the syringe interface area. Follow the cleaning guidelines outlined in this section. 4. Inspect the stand, base, and support arm for cracks and other defects that could weaken the structure. 5. Ensure that all mounting bolts and screws are secure. 6. Ensure that all locking mechanisms on the casters are functional. 7. Inspect the pivot points. The head and support arm must pivot freely. The injector head should rotate on the support arm no more than 330o. The support arm should not rotate on the center post more than 350o. NOTE:

All relevant guidelines for institutional, local, or national safety recommendations related to cable routing and installation should be followed.

Control Room Unit 1. Inspect all cables connected to the unit: Look for cuts, cracks, or worn spots, or other obvious damage. Ensure that all connectors are properly seated. 2. Inspect the housing for any damage or cracks that could allow fluid to leak inside, or weaken the structural integrity of the unit.

Wall Bracket 1. Inspect all parts of the bracket for cracks and other defects that would weaken the assembly. 2. Ensure that the bracket is securely attached to the wall. 3. Ensure that all cables are secured to the display control unit and do not interfere with the movement of the mounting bracket.

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MEDRAD Spectris Solaris and Spectris Solaris EP Injection Systems Control Room Pedestal 1. Inspect the stand, base and support arm for cracks and other defects that could weaken the structure. 2. Ensure all mounting bolts and screws are secure. 3. Ensure that the casters roll smoothly with no binding or scraping. 4. Ensure all locking mechanisms on the casters are functional. 5. Verify that the vertical height adjustment of the column shaft moves freely without binding or scraping.

Battery Charger 1. Inspect all cables connected to the unit: Look for cuts, cracks, or worn spots, or other obvious damage. Ensure that all connectors are properly seated. 2. Inspect the housing for any damage or cracks that could allow fluid to leak inside, or weaken the structural integrity of the unit.

Mobile Mount

3. Inspect all parts of the wall mounting bracket for cracks or other defects that would weaken the assembly. If applicable, ensure that the bracket remains firmly attached to the wall.

1. Inspect the bracket for cracks and other defects that would weaken the structure. 2. Insure all mounting bolts and screws are secure. 3. Ensure locking mechanism on bracket is functional.

Continuous Battery Charger

4. Ensure head pad is secured to wall and straps are present and functional.

1. Inspect all cable connected to the unit: Look for cuts, cracks, worn spots, or obvious damage. Ensure that all connectors are properly sealed. 2. Ensure ferrite clamps are present and secured to cable with cable tie. 3. Inspect the housing of the charger and battery for damage or cracks that would allow fluid to leak inside or weaken the structural integrity of the unit.

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