Angiomat Illumena Installation and Service Manual May 2000

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0-Introduction

FOREWORD Congratulations on the purchase of your Liebel-Flarsheim Angiomat® ILLUMENA Digital Injection System. The Angiomat® ILLUMENA represents our effort to provide a quality product to support better health care throughout the world. Regardless of how well equipment is designed, misuse or abuse will deny its owner the expected quality of service. Misuse or abuse may occur unintentionally because the proper method of operating the equipment is unknown. Read this manual carefully before operating the Angiomat Illumena. Retain this manual for future reference. LIEBEL-FLARSHEIM TECHNICAL SUPPORT Phone No. 1-800-877-0791

RECORDING SERIAL NUMBERS AND SOFTWARE VERSIONS To facilitate requests for information, replacement parts or optional accessories, please record the serial numbers (S/N) located on the components along with the listed data. Unit S/N (located on powerpack and pedestal) Powerhead S/N Console S/N Date of Installation

/

/

Installing Company ___________________________________ Address _____________________________________________ Phone Number _______________________________________ Software version numbers may be accessed via the System Info key on the Configuration screen. Console ______________________________________________ Powerhead ___________________________________________ Powerpack ___________________________________________

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iii MEANINGS OF SYMBOLS USED IN THIS MANUAL

DANGER!

Hazards which will result in severe personal injury or death.

WARNING!

Hazards which could result in personal injury.

CAUTION!

Hazards which could result in equipment or property damage.

WARNING! - Electrical hazards which could result in personal injury.

Non-Anesthetic proof

!

Attention, consult accompanying documents.

A.C. (alternating current).

Protective earth (ground).

MEANINGS OF SYMBOLS USED ON THE INJECTOR Injector enabled identifier (light on=enabled).

Manual fill knob identifier (clockwise rotation=expel).

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Please regard any message that follows the word Danger, Warning or Caution!

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iv

Direction indicator for the fill-control knob.

Console connection identifier or Console software version identifier.

Powerhead connection identifier or Powerhead software version identifier.

Powerpack connection identifier or Powerpack software version identifier.

Handswitch connection identifier.

ECG connection identifier.

Universal Interface connection identifier.

Serial Port connection identifier. RS 422/232

Auxiliary Port connection identifier. RS 422

Printer connection identifier.

Heater connection identifier.

Air Detector connection identifier.

OFF/ON (only for the Console and Powerhead).

ON/OFF.

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v CLASSIFICATION IN ACCORDANCE WITH I.E.C. 601 0-Introduction

Type of protection against electric shock Class I equipment

Degree of protection against electric shock Type CF applied part.

Angiomat ILLUMENA

C

SSIFIE

LA

SSIFIE

D

LA

D

C

Degree of Protection against ingress of water Ordinary Equipment

UL 2601-1

®

33SL

C

®

Angiomat ILLUMENA CLASSIFIED BY UNDERWRITERS LABORATORIES INC. WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 2601-1 33SL

0123

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FOREWORD ... II RECORDING SERIAL NUMBERS AND SOFTWARE VERSIONS ... II MEANINGS OF SYMBOLS USED IN THIS MANUAL ... III MEANINGS OF SYMBOLS USED ON THE INJECTOR... III CLASSIFICATION IN ACCORDANCE WITH I.E.C. 601 ... V Type of protection against electric shock ... v Degree of protection against electric shock ... v Degree of Protection against ingress of water ... v

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Table of Contents

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OVERVIEW OF THE ANGIOMAT ILLUMENA ... 1-1 1.1 INDICATIONS FOR USE ... 1-1 1.2 CONFIGURATION OF UNIT ... 1-1 1.3 SERVICE TECHNICIAN QUALIFICATIONS ... 1-1 1.4 SYSTEM OPTIONS ... 1-1 1.4.1 Air Detection Aid and Warning System-ADAWS ... 1-1 1.4.2 Syringe Heater ... 1-1 1.4.3 ECG (Optional)... 1-2 1.5 SPECIFICATIONS ... 1-2 1.5.1 Dimensions ... 1-2 1.5.2 Weight ... 1-2 1.5.3 Power Requirements ... 1-2 1.5.4 Electrical Leakage ... 1-2 1.5.5 Environmental ... 1-2 1.5.6 Syringe Sizes ... 1-3 1.5.7 Fill Rate ... 1-3 1.5.8 Syringe Heater (optional) ... 1-3 1.5.9 Flow Rate ... 1-3 Angio-Cardiac and Angio-Peripheral ... 1-3 CT Mode ... 1-3 1.5.10 Volume ... 1-4 1.5.11 Pressure Limit ... 1-4 Angio-Cardiac and Angio-Peripheral ... 1-4 CT Mode ... 1-4 1.5.12 Inject Delay ... 1-4 1.5.13 X-ray Delay ... 1-4 1.5.14 Scan Delay (CT mode) ... 1-4 1.5.15 Rate Rise ... 1-5 1.5.16 Duration (Angio mode w/Duration selected) ... 1-5 1.5.17 Phase Delay ... 1-5 1.5.18 ECG Input (Optional) ... 1-5 1.5.19 Stored Protocols ... 1-5

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ix INSTALLATION ... 2-1 2.2 RECEIVING INSPECTION ... 2-2 2.2.1 Inspection for Damage ... 2-2 2.2.1.1 In-Transit Damage ... 2-2 2.2.1.2 Concealed Damage ... 2-2 2.2.1.3 Processing of Damage Claims ... 2-2 2.2.2 Inspection for Complete Shipment ... 2-3 2.2.2.1 Pedestal Injector ... 2-3 2.2.2.2 Rack-Mount Injector ... 2-3 2.2.2.3 Discrepancies ... 2-3 2.3 SITE INSTALLATION TIPS... 2-4 2.3.1 System Connector Locations ... 2-4 2.4 PEDESTAL CONFIGURATION INSTALLATION ... 2-5 2.4.1 Console installation ... 2-5 2.4.2 Console and Powerhead Cable Routing ... 2-6 2.4.3 Power Pack Installation ... 2-6 2.4.4 Articulating Arm Installation ... 2-10 2.4.5 Powerhead Installation on the Articulating Arm ... 2-10 2.4.6 Securing Cables and Cover Installation ... 2-12 2.4.7 Remote Start Handswitch and Power Cord Installation ... 2-14 2.4.8 Install the Pressure Jacket in the Front Plate ... 2-14 2.4.8.1 150 ml and 200 ml Syringe Assembly ... 2-14 2.4.8.2 125 ml Syringe Assembly ... 2-14 2.4.9 Mount the Syringe Assembly to the Powerhead... 2-15 2.5 INSTALLATION OF A RACK MOUNT INJECTOR ... 2-15 2.5.1 Extension Cables ... 2-15 2.5.2 Console Mounting ... 2-16 2.5.2.1 Console Wall Mounting Kit ... 2-16 2.5.2.2 Console Table Top Mount ... 2-16 2.5.3 Powerhead Mounting ... 2-17 2.5.3.1 Powerhead Table Mount Kits 600150 and 601347... 2-17 2.5.3.2 Mounting the Powerhead to the Table Mounts ... 2-17

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2.1 GENERAL ... 2-1

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2.5.4 Ceiling Suspension System Kits... 2-17 2.5.4.1 Cable Entrance Trim Kit, Part No. 241853 ... 2-17 2.5.5 Remote Stand Assembly 601075 ... 2-18 2.5.6 Powerpack Mounting ... 2-19 2.5.6.1 Power Pack Rack Mount ... 2-19 2.5.6.2 Power Pack Wall Mount ... 2-20 2.6 REMOTE START HANDSWITCH AND FOOTSWITCH ... 2-21 2.7 POWER ... 2-21 2.8 LANGUAGE ... 2-21 2.9 IMAGING SYSTEM ... 2-22 2.9.1 General Interfacing Details ... 2-22 2.9.1.1 Inputs ... 2-23 2.9.1.2 Outputs ... 2-24 2.9.2 Imaging System Interface Cables ... 2-25 2.9.3 Special Case Interfaces ... 2-26 2.9.3.1 High Voltage Signal Interfacing ... 2-26 2.9.4 Single Cable Universal Interface ... 2-27 2.9.4.1 Inputs ... 2-28 2.9.4.2 Outputs ... 2-29 2.9.4.3 Serial Communications ... 2-30 2.9.4.4 Mains Power ... 2-30 2.10 SYSTEM CHECKS ... 2-30 2.10.1 Items Required ... 2-31 2.10.2 Power Up Check ... 2-31 2.10.3 Powerhead Check ... 2-31 2.10.4 Console Check ... 2-33 2.10.5 Flow Rate Check ... 2-36 2.10.5.1 ml/s Check ... 2-36 2.10.5.2 ml/M Check ... 2-37 2.10.6 Injection Delay and X-Ray Delay Check ... 2-38 2.10.7 Rate Rise Check ... 2-39 2.10.8 Pressure limit check ... 2-40 2.10.9 Pre-Programmed Injection Checks ... 2-40 2.11 INSTALLATION KITS ... 2-42

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xi THEORY OF OPERATION ... 3-1 3.1.1 Description ... 3-1 3.1.2 Major Circuit Groups ... 3-1 3.1.2.1 Servo Control Loop ... 3-1 3.1.2.2 PIC (Peripheral Interface Controller) Backup Processor ... 3-1 3.1.3 Block Diagram ... 3-2 3.2 POWERPACK OVERVIEW ... 3-3 3.2.1 Power Supply ... 3-3 3.2.1.1 Functions ... 3-3 3.2.1.2 Inputs and Outputs ... 3-3 3.2.1.3 Circuit Descriptions ... 3-3 3.2.1.4 Block Diagram ... 3-4 3.2.2 Main CPU Board ... 3-5 3.2.2.1 Functions ... 3-5 3.2.2.2 Inputs and Outputs ... 3-5 3.2.2.3 Circuit Description ... 3-12 3.2.2.4 Block Diagram ... 3-15 3.2.3 Servo Interface Board ... 3-16 3.2.3.1 Functions ... 3-17 3.2.3.2 Inputs and Outputs ... 3-17 3.2.3.3 Circuit Descriptions(PCB P/N 901095, Schematic P/N 901096) ... 3-24 3.2.3.4 Block Diagram ... 3-31 3.2.4 Communication Board ... 3-33 3.2.4.1 Functions ... 3-33 3.2.4.2 Inputs and Outputs ... 3-33 3.2.4.3 Circuit Descriptions ... 3-42 3.2.4.4 System Communications ... 3-52 3.2.4.5 Block Diagram ... 3-56 3.2.5 Powerpack Diagnostics ... 3-58 3.2.5.1 Watchdog timer test. ... 3-58 3.2.5.2 NVRAM check. ... 3-58 3.2.5.3 Communications check. ... 3-58

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3.1 SYSTEM OVERVIEW ... 3-1

xii 3.2.5.4 Analog-to-Digital Converter check. ... 3-58 0-Introduction

3.2.5.5 Console +24VDC power check. ... 3-58 3.2.5.6 Powerhead +24VDC power check. ... 3-58 3.2.5.7 Pressure monitor check. ... 3-59 3.2.5.8 Servo amplifier enable check. ... 3-59 3.2.5.9 Safety Relay check. ... 3-59 3.2.5.10 Servo Digital-to-Analog Converter check. ... 3-59 3.2.5.11 Servo Power Supply check. ... 3-59 3.2.5.12 Servo Control chipset check. ... 3-59 3.3 CONSOLE OVERVIEW ... 3-60 3.3.1 Console CPU ... 3-60 3.3.1.1 Functions ... 3-60 3.3.1.2 Inputs and Outputs ... 3-60 3.3.1.3 Circuit Descriptions ... 3-64 3.3.1.4 Block Diagram ... 3-67 3.4 POWERHEAD OVERVIEW ... 3-69 3.4.1 Powerhead Control Board ... 3-69 3.4.1.1 Functions ... 3-69 3.4.1.2 Inputs and Outputs ... 3-69 3.4.1.3 Circuit Descriptions ... 3-74 3.4.1.4 Block Diagram ... 3-80

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xiii TROUBLESHOOTING ... 4-1 4.2 TOOLS AND TEST EQUIPMENT REQUIRED ... 4-2 4.3 GENERAL TROUBLESHOOTING GUIDELINES ... 4-2 4.4 FAULTS WITHOUT MESSAGES ... 4-4 4.5 FAULTS WITH MESSAGES ... 4-5 4.5.1 Console Faults ... 4-5 4.5.2 Powerhead Faults ... 4-8 4.5.2 Powerhead Faults ... 4-8 4.5.3 Powerpack Faults ... 4-11 4.5.3 Powerpack Faults ... 4-11 4.6 SERVO STATUS LED'S ... 4-17

CALIBRATION ... 5-1 5.1 OVERVIEW ... 5-1 5.1.1 Use of the Service Key ... 5-1 5.1.2 Frequency of Calibration ... 5-1 5.2 ACCESSING SERVICE MODE OF THE INJECTOR ... 5-2 5.3 CALIBRATING THE CONSOLE SCREEN ... 5-3 5.4 CALIBRATING THE POWERHEAD ... 5-4 5.5 PRESSURE CALIBRATION PROCEDURE OVERVIEW ... 5-8

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4.1 GENERAL ... 4-1

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5.6 PRESSURE CALIBRATION FOR SOFTWARE V6.04 AND LATER ... 5-9 5.6.1 Overview ... 5-9 5.6.2 Maintaining The Fixture ... 5-10 5.6.3 Pressure Gauge ... 5-11 5.6.4 Reusable Syringe Faceplate ... 5-11 5.6.5 150 mL faceplate ... 5-11 5.6.6 Activating Service Mode ... 5-12 5.6.7 First, Ready A Syringe ... 5-13 5.6.8 Calibrating the Pressure Limit ... 5-15 5.6.9 Verifying calibration ... 5-29 5.7.10 Troubleshooting ... 5-29 5.7 PRESSURE CALIBRATION FOR SOFTWARE V6.03 ... 5-31 5.7.1 Overview ... 5-31 5.7.2 Maintainge The Fixture ... 5-33 5.7.3 Pressure Gauge ... 5-34 5.7.4 Reusable Syringe FACEPLATE ... 5-34 5.7.5 150 mL faceplate ... 5-34 5.7.6 ACTIVATING Service Mode ... 5-34 5.7.7 First, Ready A Syringe ... 5-36 5.7.8 Calibrating the Pressure Limit ... 5-38 5.7.9 Exiting the Service Mode ... 5-52 5.7.10 Verifying calibration ... 5-52 5.7.11 Troubleshooting ... 5-52 5.8 PRESSURE CALIBRATION FOR SOFTWARE V5.07 AND EARLIER ... 5-55 5.8.1 Overview ... 5-55 5.8.2 Maintaining the fixture ... 5-55 5.8.3 Calibrating the Pressure Limit ... 5-56 5.8.4 Existing the service mode ... 5-60 5.8.5 Verifying calibration ... 5-60 5.8.6 Troubleshooting ... 5-60

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xv MAINTENANCE ... 6-1 6.2 QUALIFICATIONS... 6-1 6.3 DAILY INSPECTION ... 6-2 6.4 POWERHEAD ... 6-2 6.4.1 Visual Inspection ... 6-2 6.4.2 Operational check ... 6-3 6.5 CONSOLE ... 6-3 6.5.1 Visual Inspection ... 6-3 6.5.2 Operational Check ... 6-3 6.6 POWER PACK ... 6-4 6.6.1 Visual Inspection ... 6-4 6.7 PEDESTAL ... 6-4 6.7.1 Visual Inspection ... 6-4 6.7.2 Pedestal Arm Assembly tension Adjust ... 6-4 6.8 ELECTRICAL CHECKS ... 6-6 Ground Continuity ... 6-6 Electrical Leakage ... 6-6 Ground Impedance ... 6-7 6.9 SYSTEM ... 6-8 6.9.1 Functional Check ... 6-8 Pressure Limit Check ... 6-8 6.10 CLEANING AND LUBRICATION ... 6-9 6.10.1 Pressure Sleeve and Plate ... 6-9 6.10.2 Reusable 150 mL Syringe ... 6-9 Cleaning ... 6-10 Lubrication ... 6-10 Sterilization ... 6-10 Reassembly ... 6-10 6.10.3 Powerhead Fill-Control Bar and Syringe Lever ... 6-10 6.10.4 Console ... 6-10 6.10.5 Powerhead and Powerpack ... 6-11 6.11 REPLACING THE PRESSURE SLEEVE ... 6-11 6.11.1 Removing/Replacing the 150 mL Pressure Sleeve ... 6-11 6.11.2 Removing/Replacing the 125 mL Pressure Sleeve ... 6-12 900946-A May 2000

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SOFTWARE DOWNLOAD AND UPGRADE ... 7-1 7.1 OVERVIEW ... 7-1 7.2 DOWNLOAD AND UPGRADE PROCEDURE ... 7-1 7.2.1 Power pack ... 7-1 7.2.2 Powerhead ... 7-5 7.2.3 Console ... 7-9

OPTIONS INSTALLATION ... 8-1 8.1 ADAWS: AIR DETECTION AID AND WARNING SYSTEM ... 8-1 8.1.1 Installation ... 8-1 8.1.2 System Test ... 8-3 8.1.2.1 ADAWS Detected Air in the Vertical Position ... 8-3 8.1.2.2 ADAWS Detected Air in the Inject Position ... 8-5 8.1.2.3 ADAWS Detected Air Bubble Passed into Syringe ... 8-6 8.1.2.4 ADAWS Detected Air During an Injection, Injector Disabled... 8-7 8.1.2.5 ADAWS Malfunction Messages: Component Failure ... 8-8 8.2 SYRINGE HEATER ... 8-8 8.2.1 Installation ... 8-8 8.2.2 Removal ... 8-9

SCHEMATICS ... 9-1 POWER PACK WIRING DIAGRAM ... 9-2 POWERHEAD WIRING DIAGRAM ... 9-3 CONSOLE WIRING DIAGRAM ... 9-4 MAIN CONTROL, SCHEMATIC ... 9-5 COMMUNICATION BOARD... 9-9 SERVO INTERFACE ... 9-13 CONSOLE SCHEMATIC ... 9-17 POWERHEAD SCHEMATIC ... 9-21 LED DISPLAY BOARD ... 9-30 FILL/EXPEL SCHEMATIC ... 9-31 ACCESSORY INPUT SCHEMATIC ... 9-32 OEM COMMUNICATION BOARD ... 9-33

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xvii ASSEMBLY AND DISASSEMBLY ... 10-1 10.1.1 POWER PACK COVER REMOVAL ... 10-2 10.1.2 MAIN CONTROL BOARD, COMMUNICATION BOARD and COMMUNICATIONS HARNESS REMOVAL. ... 10-2 10.1.3 FAN ASSEMBLY and FILTER REMOVAL ... 10-2 10.1.4 POWER HEAD HARNESS REMOVAL ... 10-3 10.1.5 TRANSFORMER ASSEMBLY ... 10-3 10.1.6 AC INLET ASSEMBLY and CLAMP ... 10-3 10.1.7 SERVO AMPLIFIER REMOVAL ... 10-3 10.1.8 DC POWER SUPPLY, SERVO INTERFACE BOARD, SERVO SIGNAL HARNESS, SERVO POWER HARNESS, ACP3 and ACP4 HARNESS and LINE FILTER REMOVAL ... 10-4 10.2 POWER PACK ASSEMBLY ... 10-5 10.2.1 Power supply sub-assembly ... 10-5 10.2.2 Power Pack assembly ... 10-6 10.3 CONSOLE DISASSEMBLY ... 10-8 10.4 CONSOLE ASSEMBLY ... 10-9 10.5 POWER HEAD DISASSEMBLY ... 10-11 10.5.1 Main Frame Disassembly ... 10-12 10.5.2 Top cover Disassembly ... 10-12 10.6 POWERHEAD ASSEMBLY ... 10-13 10.6.1 Mainframe assembly ... 10-13 10.6.2 Top cover assembly ... 10-15 10.6.3 Final Assembly ... 10-16

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10.1 POWERPACK DISASSEMBLY ... 10-2

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1-1

The purpose of this manual is to provide instructions for installation, service and calibration of the Angiomat Illumena. For further information about operation and daily maintenance of the unit, refer to the Angiomat Illumena Operator’s Manual.

1.1 INDICATIONS FOR USE The Angiomat ILLUMENA is designed to inject a radiopaque contrast medium into the vascular system for Angiographic or CT procedures as prescribed by qualified health care professionals. Contraindications for the use of this device are determined by the prescribing physician at the time of use based upon the contrast media package inserts.

1.2 CONFIGURATION OF UNIT Your particular unit may be configured as a Rack Mount, Wall Mount, Table Top or a Pedestal unit. In any configuration, the powerhead, console(s) and powerpack will operate in the same manner.

1.3 SERVICE TECHNICIAN QUALIFICATIONS The Angiomat Illumena Injector should be installed, serviced and calibrated ONLY by qualified personnel who are completely familiar with the unit, have read and understood the Installation, Service and Parts Manual, and are otherwise trained in the service of equipment and procedures of this type. Failure to follow these guidelines could result in serious injury to the service technician.

1.4 SYSTEM OPTIONS 1.4.1 AIR DETECTION AID AND WARNING SYSTEM-ADAWS This system looks for air in the neck before and during the Enable process. It does not effectively detect air during an injection. For more information, refer to Chapter 8. 1.4.2 SYRINGE HEATER The syringe heater fits snugly against the pressure sleeve. It minimizes the loss of heat from preheated contrast. For more information, refer to Chapter 8.

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OVERVIEW OF THE ANGIOMAT ILLUMENA

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1-Overview

1.4.3 ECG (OPTIONAL) The Angiomat ILLUMENA has an ECG option available for use in the Cardiac mode. For more information about the use of the ECG option, refer to Chapter 8.

1.5 SPECIFICATIONS 1.5.1 DIMENSIONS • Console 12” W x 10.5” H x 6” D (304.8mm x 266.7mm x 144mm) • Powerpack17” W x 7.25” H x 11” D (431.8mm x 184.2mm x 279.4mm) • Pedestal 21.52” W (base) x 41.94” H x 23.54” D (base) (546.6mm x 1065.3mm x 597.9mm) • Powerhead18” W x 6.6” H x 5” D (457.2mm x 167.6mm x 127mm) 1.5.2 WEIGHT • Control Console 11 lb. (4.99 kg) • Powerpack40 lb. (18.14 kg) • Powerhead17 lb. (7.71 kg) • Pedestal 160 lb. (75.57 kg)-with console, powerhead, arm and powerpack 1.5.3 POWER REQUIREMENTS • Voltage 100-120 VAC/220-240 VAC • Frequency 50/60 Hz • Power 1300 W Maximum, 150 W Standby 1.5.4 ELECTRICAL LEAKAGE Chassis less than 300 microamps 1.5.5 ENVIRONMENTAL • Transport and Storage: -4°F to 158°F (-40°C to 60°C); 10% to 100% relative humidity • Operation: +50°F to 104°F (10°C to 40°C); 30% to 75% relative humidity; 700kPA to 1060kPA atmospheric pressure • Bioharzard Disposal: Dispose of bioharzards in accordance with the requirements of your hospital, facility or local regulations. • Electromagnetic Compatibility (EMC): The Angiomat Illumena meets EN60601-1-2 for level B conducted and radiated emissions and EMI immunity. NOTE: If any anomalies in the injector performance are noticed, identify devices within the immediate area that are capable of producing electromagnetic interference and call a qualified service representative.

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