Stellant Service Manual Rev B

Table of Contents 1 - Introduction ... 1-3 Copyright Notice ... 1-3 Trademarks ... 1-3 Restricted Sale ... 1-3 Disclaimer ... 1-3 Address / Telephone ... 1-4 Applicability ... 1-4 Purpose ... 1-4 Important Safety Notice ... 1-4 Intended Use ... 1-4 Certifications ... 1-4 Symbols and Descriptions ... 1-5 WARNINGS ... 1-12 CAUTIONS ... 1-13 2 - Maintenance and Checkout ... 2-15 Recommended Maintenance Schedule ... 2-15 MEDRAD Service ... 2-15 Inspection Procedures ... 2-16 Single and Dual Head ... 2-16 Syringe Heat Maintainer ... 2-16 Display and Base ... 2-16 Wall Bracket ... 2-16 Adjustable Height Pedestal ... 2-17 CS Mounting Systems ... 2-17 ISI ... 2-17 Electrical Leakage Check ... 2-18 Ground Continuity Check ... 2-18 Cleaning and Operational Checkout ... 2-18 System Labels ... 2-19 Power Up ... 2-19 Programming ... 2-19 3 - Troubleshooting ... 3-21 System Malfunction Codes ... 3-21 General Troubleshooting Guidelines ... 3-21 System Messages ... 3-22 Type 1 Messages ... 3-22 Type 2 Messages ... 3-22 Type 3 Messages ... 3-23 White Screen/System Lock Up Condition ... 3-24 Listing of Type 3 Errors ... 3-24 4 - Theory of Operation ... 4-33 Single Head Interconnect Drawing ... 4-34 Dual Head Interconnect Drawing ... 4-36

1

MEDRAD Stellant CT Injection System

Display Unit ... 4-38 Display - Block Diagram Description ... 4-38 Display Top Block Diagram ... 4-40 PCMCIA Block Diagram ... 4-41 Base Unit - Block Diagram Description ... 4-42 Three Phase Motor Function Operation ... 4-42 Base Unit Block Diagram ... 4-44 Single Head Block Diagram Description ... 4-45 Power Drive Card - Block Diagram Description ... 4-47 Single Head Block Diagram ... 4-48 Dual Head Block Diagram ... 4-49 Cable Wiring Pin Out Diagrams ... 4-50 5 - Disassembly / Assembly & Replacement Parts ... 5-51 Parts List Components ... 5-51 Symbols Guide ... 5-52 Drawings ... 5-52 Display ... 5-53 Base ... 5-65 Single Head ... 5-74 Dual Head ... 5-96 ISI 800 ... 5-119 ISI 700 ... 5-121 Pedestal ... 5-123 Miscellaneous Replacement Parts ... 5-124

2

1 - Introduction

1 - Introduction Copyright Notice

Copyright 2006 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 Stellant CT®, Qwik-Fit Syringe ®, FluiDot ®, Quality for Life ®, and MEDRAD ® are registered trademarks of MEDRAD, INC.

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.

Disclaimer

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. Accessory equipment connected to the MEDRAD Stellant CT 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 Stellant CT Injector is not for portable use.

1-3

MEDRAD Stellant CT Injection System

Address / Telephone

MEDRAD, INC. One Medrad Drive Indianola, Pa 15051-0780 U.S.A Phone: 412 767-2400 Fax: 412-767-4128

If you experience problems with the MEDRAD Stellant CT System, contact your MEDRAD authorized dealer or: MEDRAD Europe B.V. Postbus 205 6190 AE Beek The Netherlands Phone: +31(0)43-3585601 Fax: +31(0)43-3656598

Nihon MEDRAD KK 9F Central Shin-Osaka Building 4-5-36, Miyahara, Yodogawa-ku Osaka, 532-0003 Japan Phone: +81-6-6350-0680 Fax: +81-6-6398-0670

Applicability

This manual applies to the MEDRAD Stellant CT Injection System.

Purpose

The purpose of this manual is intended to provide instructions for servicing the MEDRAD Stellant CT 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

Refer to the Stellant CT Injection System operation manual.

Certifications

MEDRAD Stellant CT 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).

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1 - Introduction

Symbols and Descriptions

The following international symbols are used on the MEDRAD Stellant CT 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 60601-1 standards. Identifies the degree of protection against fluid as drip proof. Identifies connection of the handswitch. Forward and Reverse Piston Controls.

Identifies the direction of manual knob rotation relative to plunger movement. Identifies the ENABLE key. 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. Indicates design for indoor use only.

1-5

MEDRAD Stellant CT Injection System Indicates the presence of no serviceable parts.

Identifies the Control Room Unit brightness controls. Indicates the Protocol Lock is engaged. Start / Hold. Stop. Reset. Help. Setup. Labels on the system or statements in this manual preceeded by any of the following words and/or symbols are of special significance, intended to help you to operate the system in a safe and successful manner: Protocol is unlocked or unengaged. Phase View. Profile Preview. Pressure Graph View.

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1 - Introduction

ISI Symbols Indicates scanner hookup. Indicates DC power. Indicates injector hookup. Identifies the CAN Interface TRANSMIT LED. Identifies the CAN Interface RECEIVE LED. Identifies the Ethernet LINK LED. Identifies the Ethernet ACTIVITY LED. DO NOT dispose of in municipal waste. Wheeled bin symbol indicates separate collection for electrical and electronic equipment. (WEEE Directive 2002/96/EEC). Symbols on the Power Switch:

I - On O - Off

The following icons may appear on the injector screen when using ISI 700: The user is not able to arm the injector. The injector is configured for ISI, and it is communicating to the ISI module. The injector and ISI module are functional, but the scanner signals are in a state that will NOT allow arming the injector. The injector is configured for ISI and it is communicating to the ISI module. The scanner signals are in a state that will allow arming the injector. Communication is lost between the injector and the ISI module. OR The ISI module is in need of repair. Refer to the ISI System Messages section of this manual. The following icons may appear on the injector screen when using ISI 800: (No Highlight) Indicates that communication between the injector and the MEDRAD ISI 800 Module has been established. (Highlighted in Yellow) Indicates that communication between the Injector and the scanner has been established. (No Highlight) Indicates that communication has been lost between the injector and the MEDRAD ISI 800 Module. The MEDRAD ISI 800 Module may be in need of repair. Refer to the ISI 800 System Messages section of this manual. (Highlighted in Yellow) Indicates that the injector is working in conjunction with the scanner ("coupled"). This symbol will only appear on the screen when the system is in Control or Tracking modes. (No Highlight) Indicates whether or not the injection protocol has been locked. When this icon is highlighted in yellow, the protocol has been locked.

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MEDRAD Stellant CT Injection System NOTE: The configurations below are determined by the scanner manufacturer. Refer to the scanner manufacturer instructions for further information. Indicates that the injector will request the initiation of a procedure. When either or both system symbol is gray, that system is not ready and the injection will not proceed. When both symbols are highlighted in yellow, both systems are ready and the injection can proceed. Indicates that the scanner will request the initiation of a procedure. The Start Button has been locked out on the Injector. When either or both system symbol is gray, that system is not ready and the injection will not proceed. When both symbols are highlighted in yellow, both systems are ready and the injection can proceed. Indicates that the procedure request can be initiated from EITHER the scanner or the injector. When either or both system symbol is grayed out, that system is not ready and the injection will not proceed. When both symbols are highlighted in yellow, both systems are ready and the injection can proceed.

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1 - 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 Stellant CT Injection System 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 Stellant domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for Harmonic emissions Class B domestic purposes. IEC 61000-3-2 Stellant 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 +1 kV for input/output lines +1 kV for input/output lines commercial or hospital environment. burst IEC 61000-4-4 +1 kV differential mode Mains power quality should be that of a typical Surge +1 kV differential mode commercial or hospital environment. +2 kV common mode +2 kV common mode IEC 61000-4-5 Voltage dips, short <5% UT Mains power quality should be that of a typical <5% UT 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 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 (50/60 Hz) magnetic field IEC 61000-4-8 NOTE UT is the a.c. mains voltage prior to application of the test level.

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

1 - Introduction

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 Stellant CT Injection System

Introduction to Warnings and Cautions This manual contains important information about safe servicing of the MEDRAD Stellant CT 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 Stellant CT 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. 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 T, 250V, 3.15 A fuse by qualified personnel only.

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1 - 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 Stellant CT 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.

1 - 13

MEDRAD Stellant CT Injection System

1 - 14

2 - Maintenance and Checkout

2 - Maintenance and Checkout This section contains recommended procedures for maintenance, and an operational checkout of the MEDRAD Stellant CT 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 Stellant CT 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 or rods 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. 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: Failures which occur due to lack of proper maintenance will not be covered under warranty.

MEDRAD Service

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 upon request

2 - 15

MEDRAD Stellant CT Injection System

Inspection Procedures

The following procedures are recommended for daily inspection of all components in the MEDRAD Stellant CT 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.

Single and Dual Head

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.

Ensure that all mounting bolts and screws are secure.

5.

Inspect the pivot points. The head and support arm must pivot freely.

6.

Ensure that the keypad is clean and free of cracks.

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

Syringe Heat Maintainer

Display and Base

Wall Bracket

1.

Ensure that the device is warm to the touch while attached to the head.

2.

Ensure that the LED indicator is not illuminated or flashing.

3.

Inspect the cable and conncector for cracks, worn areas, or other obvious damage.

4.

Ensure the heater has extension cable attached P/N 3013737.

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.

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.

2 - 16

2 - Maintenance and Checkout

Adjustable Height Pedestal

CS Mounting Systems

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.

1.

Inspect all parts of the arm and mounting system for cracks and other defects that would weaken the system.

2.

Ensure that the mounting system is securely assembled, with no loose parts. The area should be stable with the head installed.

3.

Ensure that the arm moves smoothly in all directions, with no binding or scraping.

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.

ISI

1.

Inspect all parts of the ISI, ensure all cables are secured to the ISI.

2.

Ensure ISI cables are free of cuts, cracks or other obvious damage.

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MEDRAD Stellant CT Injection System

Electrical Leakage Check

To ensure safe operation of the MEDRAD Stellant CT Injection System, an electrical leakage check must be part of regular maintenance. Use a commercial leakage tester such as one of the following:

Ground Continuity Check

Cleaning and Operational Checkout

MANUFACTURER

MODEL

Bio-Tek Instruments, Inc. Electrical Safety Analyzer

Model 601 PRO

Bender

Unimet 1000 ST

Bapco

IEC601L

1.

With the AC ground open, power applied, and the line at normal, leakage should be less than 100 micro amps at 110V or 300 micro amps at 220 V.

2.

With the AC ground open, power applied and the line reversed, leakage should be less than 100 micro amps at 110V or 300 micro amps at 220 V.

3.

Disconnect the leakage test device.

A ground continuity check must also be part of regular maintenance of the MEDRAD Stellant CT system. 1.

Disconnect the system from the power source.

2.

Using an ohm meter, measure the resistance between the ground terminal, the power cord and the equipotential connector on the Base and the front casting of the head. The resistance measured must be less than 0.2 ohms.

Cleaning Guidelines Deposits of contrast media can interfere with proper operation of the MEDRAD Stellant CT Injection System. The following guidelines should be followed when removing deposits, or cleaning any portion of the system. WARNING: Serious injury or death may result from exposure to hazardous voltages existing within the system. Disconnect the system from line power before cleaning or attempting to perform any maintenance. Ensure that the system is completely dry before connecting to the power source and applying power. CAUTION: Improper or careless cleaning methods may result in equipment damage. Do not soak or immerse any part of the injection system in water. While cleaning any outside portion of the system, avoid allowing any water to leak inside system components. •

If contrast medium has leaked inside any component of the system, 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 Service.

•

Care must be taken not to get water or cleaning solutions inside any system components. Do not use strong industrial cleaning agents or solvents such as acetone. Warm water and a mild disinfectant such as antibacterial hand soap are all that is required.

•

To clean the syringe interface area of the injector head, fully retract the piston. Using a paper towel moistened with warm water or a mild disinfectant, gently wipe the inner syringe installation area. Do not insert any sharp instruments into this area during the cleaning process.

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2 - Maintenance and Checkout

Operational Checkout A basic functional checkout of the MEDRAD Stellant CT Injection System should be included as part of regular maintenance. Verifying proper operation of the injection system will help in detection of any problems that may not be noticed in day to day operation. The following procedure represents a suggested series of activities which encompass typical operation of the system. Read the following procedure carefully before beginning the checkout. If problems are detected, refer to the General Troubleshooting Procedure. CAUTION: Any problems detected during this or any other procedure should be corrected before using the injection system in patient procedures.

System Labels

Ensure that all system safety and warning labels are in place and legible.

Power Up

1.

Apply power to the system.

2.

Verify that the Safety screen is displayed after system diagnostics occur.

3.

Press Continue to acknowledge the messages on the Safety screen.

4.

Verify that audible tones are functioning on the Display Control Unit and injector head.

5.

Verify that the following controls are functioning properly. • • • •

Programming

Forward and Reverse Start Stop Fill

6.

Verify that the arm lights on the injector head are functioning.

7.

After the Main screen is displayed, verify that the following controls are functioning properly.

8.

At the rear of the Display, press the Display Brightness Up key until the screen is lightened to its fullest extent. Press the Display Brightness Down Key until the screen is darkened to its fullest extent. Adjust the screen appearance to return to a desirable contrast level.

9.

Fully advance and reverse the pistons by using the ENABLE key and the forward/reverse controls.

10. Ensure the Auto Dock, Auto Advance, and Auto Retract are enabled. 11. Verify that both pistons respond to the forward and reverse controls. Enter the following protocol: Dual Flow Rate Phase

Syringe

Flow Rate

Volume

Phase 1:

Syringe A:

10 ml/s

70 ml

Phase 2:

Syringe B:

2.5 ml/s

29 ml

Phase 3:

Syringe A:

5.0 ml/s

100 ml

Phase 4:

Syringe B:

0.1 ml/s

1 ml

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