Angiomat Illumena Operators Manual Rev L June 2007

ii

0-Introduction

CHANGES: 904006 Rev K to Rev L • • • •

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Update 1.7.5 Environmental (Page 1-5): Update Transport and Storage specifications; Update Operation specifications; Remove Atmospheric Pressure Specifications. Update 1.7.5 Environmental (Page 1-5): Add “Collision with other...” Warning. Update 5.1.1 Safety Instructions (Page 5-2): Add “Position of Powerhead” Warning. Add new section 7.2 Weekly Inspection/7.2.1 Suspension Arm (Page 7-1) Subsequently update all sequential numbers accordingly.

iii FOREWORD

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.

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 ___________________________________________ Angiomat ILLUMENA® is a registered trademark of the Liebel-Flarsheim Co. 904006-L June 2007

0-Introduction

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.

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0-Introduction

MEANINGS OF SYMBOLS USED IN THIS MANUAL Please regard any message that follows the word Danger, Warning or Caution!

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). Direction indicator for the fill-control bar. 904006-L June 2007

v

Powerhead connection identifier or Powerhead software version identifier. ANG IOM AT 900 0

Powerpack connection identifier or Powerpack software version identifier. Handswitch connection identifier. ECG connection identifier. Universal Interface connection identifier.

RS 422/232

RS 422

Serial Port connection identifier. Auxiliary Port connection identifier. Printer connection identifier. Heater connection identifier. Air Detector connection identifier. OFF/ON (only for the Console and Powerhead). ON/OFF. Shown on powerhead display to indicate air detected in syringe.

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Console connection identifier or Console software version identifier.

vi

Type of protection against electric shock Class I equipment Degree of protection against electric shock Type CF applied part. Degree of Protection against ingress of water

SSIFIE

Angiomat ILLUMENA

LA

SSIFIE D

D

LA

C

Ordinary Equipment

C

0-Introduction

CLASSIFICATION IN ACCORDANCE WITH EN 60601-1

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 Angiomat ILLUMENA CLASSIFIED WITH RESPECT TO ELECTRIC SHOCK, FIRE MECHANICAL AND OTHER SPECIFIED HAZARDS ONLY IN ACCORDANCE WITH CAN/ CSA C22.2 NO. 601.1, 33SL

0123 Authorized EC Representative TYCO HEALTHCARE UK LTD 154 FAREHAM ROAD GOSPORT PO13 OAS UK This manual originally written in English.

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vii

Foreword ... iii Recording Serial Numbers and Software Versions ... iii Meanings of Symbols used in this Manual ... iv Meanings of Symbols used on the Injector ... iv Classification in accordance with EN 60601-1 ... vi Type of protection against electric shock ... vi Degree of protection against electric shock ... vi Degree of Protection against ingress of water ... vi

OVERVIEW OF THE ANGIOMAT ILLUMENA ...1-1 1.1 Indications for Use ...1-1 1.2 Configuration of Unit ...1-1 1.3 User Qualifications ...1-1 1.4 System Features ...1-2 1.4.1 Standard Modes of Use ...1-2 Angio-Peripheral and Angio-Cardiac Modes ...1-2 CT Mode ...1-2 1.4.2 Console...1-2 1.4.3 Powerhead ...1-2 1.4.4 Languages ...1-2 1.4.5 Injection Library ...1-2 1.5 Safety Features ...1-3 1.5.1 Self-testing Design...1-3 1.5.2 Electrically Isolated Syringe ...1-3 1.5.3 Syringe Clarity ...1-3 1.5.4 Positive Positioning of the Powerhead ...1-3 1.5.5 Remote Control Operation ...1-3 1.5.6 Physical Stability ...1-3 1.6 System Options ...1-4 1.6.1 Air Detection Aid and Warning System-ADAWS ...1-4 1.6.2 Syringe Heater ...1-4 1.6.3 Printer ...1-4 1.6.4 Second Console ...1-4 1.7 Specifications ...1-4 1.7.1 Dimensions ...1-4 1.7.2 Weight ...1-4 1.7.3 Power Requirements ...1-4 1.7.4 Electrical Leakage ...1-5 1.7.5 Environmental ...1-5 1.7.6 Syringe Sizes ...1-6 1.7.7 Fill Rate...1-6 1.7.8 Syringe Heater (optional) ...1-6

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Table of Contents

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0-Introduction

1.7.9 Flow Rate...1-6 Angio-Cardiac and Angio-Peripheral Modes ...1-6 CT Mode ...1-6 1.7.10 Volume ...1-6 1.7.11 Duration (Angio Mode only) ...1-6 1.7.12 Pressure Limit ...1-6 Angio-Cardiac and Angio-Peripheral Modes ...1-6 CT Mode ...1-6 1.7.13 Inject Delay ...1-7 1.7.14 X-ray Delay ...1-7 1.7.15 Rate Rise ...1-7 1.7.16 Phase Delay ...1-7 1.7.17 ECG Input (Optional) ...1-7 1.7.18 Scan Delay (CT mode) ...1-7 1.7.19 Stored Protocols ...1-7 1.8 Consumables ...1-8 Syringes ...1-8 Low Pressure Tubing ...1-8 High Pressure Tubing...1-8 1.9 Accessories ...1-9

SYSTEM CONTROLS ...2-1 2.1 Powerpack ...2-1 2.2 Console ...2-2 2.2.1 ON/OFF Control/Power ON LED ...2-2 2.2.2 Touch Screen Display ...2-2 2.3 Powerhead ...2-3 2.3.1 Display ...2-4 2.3.2 Enabled/Injecting Indicator ...2-4 2.3.3 Syringe Lever ...2-4 2.3.4 Heater Connection (Optional) ...2-5 2.3.5 Air Detection Aid and Warning System (ADAWS) (optional) ...2-5 2.3.6 Manual Fill Knob ...2-5 2.3.7 Fill-Control Bar ...2-5 Use...2-5 Speed of the Plunger ...2-6 2.4 Pedestal Unit ...2-8 2.4.1 Console Rotation ...2-8 2.4.2 Powerhead Range ...2-9 2.4.3 Reversible Powerhead ...2-10 2.4.4 Bottle Holder, Shelf and Locking Casters ...2-12

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ix SYSTEM SCREENS ...3-1

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3.1 Power-up ...3-1 3.2 Main Screen ...3-2 3.2.1 Angio-Cardiac and Angio-Peripheral Main Screens ...3-2 3.2.2 CT Mode Main Screen ...3-4 3.2.3 Description of Parameters used on the Main Screen ...3-5 Parameters used in the Angio and CT Modes ...3-5 Parameter used only in the CT Mode ...3-6 3.2.4 Using the Injection Parameter Keys/Keypad ...3-6 3.2.5 Enabling a Protocol ...3-7 3.2.6 Recalling the Achieved Values Screen ...3-7 3.3 Configure System Screen ...3-8 3.3.1 Use of Display Function On Screen ...3-9 3.3.2 Changing the Mode of Use ...3-10 3.3.3 Changing the Pressure Unit of Measure...3-10 3.3.4 Changing the Flow Rate Unit of Measure ...3-10 3.3.5 Selecting Number of Phases ...3-10 3.3.6 Inject Via Volume or Duration ...3-12 3.3.7 Setting the Sync Feature ...3-13 Sync Conditions ...3-13 3.3.8 System Information ...3-14 Injector Status Information ...3-14 Setting the Date and Time ...3-14 3.3.9 Returning to Main Screen/Saving the Configuration...3-15 3.4 Protocol Screen ...3-16 3.4.1 Saving Protocols ...3-16 Establishing the First Protocol ...3-16 Establishing Additional Protocols/Saving Modifications to Existing Protocols ...3-17 Protocol Memory Full ...3-18 3.4.2 Retrieving a Protocol ...3-19 3.4.3 Deleting Protocols...3-19 3.4.4 Organizing the Protocol Order ...3-20

x INSTALLING, FILLING AND REMOVING SYRINGES ...4-1 0-Introduction

4.1 Installing the Syringe Assembly ...4-2 4.2 Installing the Syringe ...4-3 4.2.1 Installing the 150 ml, 200 ml disposable and 125 ml Prefill Syringe ...4-3 4.2.2 Installing the 150 ml Reusable Syringe ...4-4 4.3 Filling the 150 ml and 200 ml Syringes ...4-5 4.3.1 “Fill Sequence” Requirements ...4-5 4.3.2 Instructions for Filling the 150 ml and 200 ml Syringes .4-5 4.4 Removing Air from the Syringe ...4-6 4.4.1 125 ml Prefill Syringe ...4-6 4.4.2 150 ml Reusable or 150 ml and 200 ml Disposable Syringe ...4-6 4.5 Attaching the Catheter or Tubing ...4-7 4.5.1 150 ml Disposable Syringe ...4-7 4.5.2 125 ml Prefill Syringe and 200 ml syringe ...4-7 4.6 Removing the Syringe ...4-8 4.6.1 Removing the 150 ml and 200 ml Disposable and 125 Prefill Syringes ...4-8 4.6.2 Removing the 150 ml Reusable Syringe ...4-8

DELIVERING AN INJECTION ...5-1 5.1 Delivering an Angiographic Injection ...5-2 5.1.1 Safety Instructions ...5-2 5.1.2 Delivering a Complete Angiographic Injection ...5-3 5.1.3 Delivering a Test Angiographic Injection ...5-8 5.2 Delivering a CT Injection ...5-9 5.2.1 Safety Instructions ...5-9 5.2.2 Delivering a CT Injection...5-11 5.2.3 Pausing/Stopping a CT Injection (5 Methods) ...5-15 Console ...5-15 Handswitch ...5-15 Powerhead ...5-15 [Disable] Key ...5-15 Console’s ON/OFF Switch ...5-15 5.2.4 Restarting or Terminating a Stopped Injection ...5-16 Restarting a Paused Injection ...5-16 Terminating a Paused Injection ...5-16 5.2.5 Injection Complete ...5-17

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xi SYSTEM GENERATED MESSAGES ...6-1

CARE OF UNIT ...7-1 7.1 Daily Inspection ...7-1 7.2 Weekly Inspection ...7-1 7.2.1 Suspension Arm ...7-1 7.3 Cleaning ...7-2 7.3.1 Pressure Sleeve and Plate ...7-2 7.3.2 Reusable 150 ml Syringe...7-2 Cleaning ...7-3 Lubrication ...7-3 Sterilization ...7-3 Reassembly ...7-3 7.3.3 Powerhead Fill-Control Bar and Syringe Lever ...7-4 7.3.4 Console...7-4 7.3.5 Powerpack ...7-4 7.4 Replacing the Pressure Sleeve ...7-5 7.4.1 Removing/Replacing the 150 ml or 200 ml Pressure Sleeve ...7-5 7.4.2 Removing/Replacing the 125 ml Pressure Sleeve ...7-5

AIR DETECTION AID AND WARNING SYSTEM (ADAWS) OPTION ...8-1 8.1 ADAWS Messages...8-2 8.1.1 ADAWS Detected Air or Blood before the Injector is Enabled...8-2 [Blood Only] key is pressed...8-3 The [No Blood] key is pressed ...8-3 8.1.2 ADAWS Detected Air or Blood after the Injector is Enabled...8-4 8.1.3 ADAWS Detected Air During an Injection ...8-5 8.2 Discontinue Use of ADAWS ...8-6 8.3 ADAWS Not Working Messages ...8-6 8.3.1 Connector Unplugged ...8-6 8.3.2 ADAWS Malfunction Messages ...8-7

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6.1 Operator Messages ...6-1 6.1.1 Entering Parameters ...6-1 6.1.2 Enable Process Messages ...6-4 6.1.3 Injector Disabled Messages ...6-8 6.1.4 Achieved Values Messages ...6-11 6.2 Fault Messages ...6-12

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SYRINGE HEATER OPTION ...9-1 9.1 Syringe Heater ...9-1 9.1.1 Installation of Heater ...9-1 9.1.2 Removal of Heater ...9-2

ECG OPTION ...10-1 10.1 Entering the ECG Mode...10-1 10.2 Description of the ECG Screen...10-2 10.2.1 ECG Trace ...10-2 10.2.2 Bars (R-Delay and Injection) ...10-2 10.2.3 R-Delay ...10-2 10.2.4 Injection ...10-2 10.2.5 [Single/Multiple] Switch ...10-2 10.2.6 R-Term ...10-3 R-Term ON ...10-3 R-Term OFF ...10-3 10.2.7 EOI-R ...10-3 10.2.8 R-Wave Indicator ...10-3 10.2.9 R-R ...10-3 10.2.10 [Total Volume ml] Key ...10-3 10.2.11 [Flow ml/s] Key (Flow Rate) ...10-3 10.2.12 ml/INJ (Volume per Injection) ...10-3 10.2.13 # INJ (Number of Injections) ...10-3 10.2.14 Syringe ml ...10-4 10.2.15 Injected ml ...10-4 10.2.16 Pressure Limit ...10-4 10.2.17 Keypad ...10-4 10.2.18 Prefill Size ...10-4 10.2.19 [Help] Key ...10-4 10.3 Automatic Diastolic Calculation (ADC) Feature ...10-5 10.3.1 Calculation of R-Delay ...10-5 10.3.2 Calculation of Injection...10-6 10.4 Entering Parameters for an ECG Injection ...10-7 10.4.1 Single Injection ...10-7 10.4.2 Multiple Injections ...10-7 10.5 Saving an ECG Protocol ...10-9 10.6 Retrieving an ECG Protocol ...10-10 10.7 Delivering an ECG Injection ...10-10

SECOND CONSOLE AND PRINTER OPTION ...11-1 11.1 Second Console ...11-1 11.2 Printer ...11-2

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1-1

OVERVIEW OF THE Angiomat ILLUMENA The purpose of this manual is to provide instructions for using the Angiomat ILLUMENA in order to ensure patient safety. For safe operation, it is important that this manual be read carefully and its recommended procedures followed.

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 USER QUALIFICATIONS The Angiomat ILLUMENA Injector should be operated ONLY by qualified health care professionals who are completely familiar with the unit, have read and understood this Operator’s Manual, and are otherwise trained in the use of equipment and procedures of this type.

WARNING! Federal (USA) law restricts this device to sale by or on the order of a physician. (21CFR 801.109(6)(1):)

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1-Overview of the Angiomat ILLUMENA

1

1-2

1-Overview of the Angiomat ILLUMENA

1.4 SYSTEM FEATURES 1.4.1 STANDARD MODES OF USE The injector can be configured for use in an Angio-Peripheral, Angio-Cardiac or a CT mode using injection by volume. Angio-Peripheral and Angio-Cardiac Modes Angio-Peripheral and Angio-Cardiac modes are for use in angiographic injections. When in this mode, the injector performs injections utilizing the following variable parameters: • Flow Rate • Rate Rise • Volume or Duration • Injection/X-ray Delay • Pressure Limit CT Mode The CT mode is for use in injections utilizing Computed Tomography (CT). The CT mode sets up the display with the typical programmable functions for CT procedures and limits the flow rate and pressure limit to ranges that are typical for CT injectors. When in this mode, the injector performs injections utilizing the following variable parameters: • Flow Rate • Pressure Limit • Volume • Scan Delay 1.4.2 CONSOLE The Console contains a Touch Screen display. When mounted as a Pedestal unit, the Console can be rotated to improve ease of viewing. 1.4.3 POWERHEAD The Powerhead’s fill-control bar allows for easy filling or expelling of contrast in the syringe. The Powerhead’s display shows the numeric value of volume available in the syringe, programmed flow rate and programmed volume. To enable the operator to read the display at all times, the display image electronically inverts when the powerhead is rotated through 180° of motion. 1.4.4 LANGUAGES The Angiomat ILLUMENA has the capability of displaying several different languages. The language is selected by the operator. 1.4.5 INJECTION LIBRARY The Angiomat Illumena can store up to 90 protocols in memory. This information will remain in the library even after the unit has been turned off. The Angiographic and CT modes each store up to 45 protocols. The injector will call up protocols from the appropriate library as a function of the mode selected. For example, if the injector is in one of the Angio modes, selecting protocol manager will display only protocols in the Angio library. 904006-L June 2007

1-3 1.5 SAFETY FEATURES

1.5.1 SELF-TESTING DESIGN When the Angiomat ILLUMENA is switched ON, it automatically performs a series of power-up tests to monitor the status of all systems. If a problem is detected, an appropriate message will appear in the system display. Also, during the enable process and during an injection, all necessary functions are constantly checked. If a fault is detected, the system will automatically shut down and an appropriate message will be displayed. 1.5.2 ELECTRICALLY ISOLATED SYRINGE All syringes are isolated from any electrical contact with the injector. 1.5.3 SYRINGE CLARITY Transparent and semitransparent syringes are used on the Angiomat ILLUMENA. Small air bubbles can be visualized with careful observation. 1.5.4 POSITIVE POSITIONING OF THE POWERHEAD A preset friction device in the powerhead holds the syringe in the desired position during injection. 1.5.5 REMOTE CONTROL OPERATION Use of the remote handswitch or footswitch allows the operator to perform injections from outside the area of direct radiation. 1.5.6 PHYSICAL STABILITY The wide stand base of the pedestal assembly with large casters reduces the possibility of tipping and increases its ability to roll over small cords. Looping the cables over one of the cable hangars helps keep the cables away from the wheels. The casters may be locked to prevent rolling and turning. Locking the caster will lock rotation and swivel.

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1-Overview of the Angiomat ILLUMENA

The Angiomat ILLUMENA has been designed to enhance the safety of both patient and operator. Specific safety features include:

1-4

1-Overview of the Angiomat ILLUMENA

1.6 SYSTEM OPTIONS 1.6.1 AIR DETECTION AID AND WARNING SYSTEM-ADAWS This system looks for air in the neck before, during the Enable process and while enabled. It does not effectively detect air during an injection. For more information, refer to Chapter 8. 1.6.2 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 9. 1.6.3 PRINTER An optional printer allows the operator to maintain a hard copy of the programmed and achieved values of an injection. For more information about the use of the printer, refer to Chapter 11. 1.6.4 SECOND CONSOLE For operator convenience, a second Console is available to program the injector from a second location. For more information about the use of two consoles, refer to Chapter 11.

1.7 SPECIFICATIONS 1.7.1 DIMENSIONS • Console 12” W X 8.5” H X 2.25” D (304.8mm X 209.5mm X 57.2mm) • Powerpack 17” 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) • Powerhead 18” W X 6.6” H X 5” D (457.2mm X 167.6mm X 127mm) 1.7.2 WEIGHT • Control Console 5.8 lb. (2.6 kg) • Powerpack 41.8 lb. (19.0 kg) • Powerhead 15.5 lb. (6.9 kg) • Pedestal 161 lb. (73.03 kg) -with console, powerhead, arm and powerpack 1.7.3 POWER REQUIREMENTS • Voltage 100-120 VAC/220-240 VAC • Frequency 50/60 Hz • Power 1500 W Maximum, 100 W Standby

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1-5 1.7.4 ELECTRICAL LEAKAGE Chassis - less than 300 microamps

DANGER! Possible explosion hazard if used in the presence of flammable anesthetics.

WARNING! The injector may only be operated in an area that is located beyond the 5 gauss limit. Operating the unit within magnetic fields that are higher than this limit may cause the unit to malfunction, resulting in operator or patient injury.

WARNING! Collision with other equipment can cause structural failure of suspension arm, resulting in operator or patient injury. Visually inspect the J-Bow Arm, be sure all fasteners are secure. Observe system for cracks or defects. Check the suspension arm for movement. If defects are observed or adjustment is required, immediately contact your authorized service personnel.

CAUTION! Only the powerhead is considered spill proof. If fluid is spilled on the console or powerpack, remove the unit from operation and contact your authorized service personnel.

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1.7.5 ENVIRONMENTAL • Transport and Storage: -40° to +158° F (-40° to +70° C) 10% to 95% relative humidity • Operation: +50° to +104° F (10° to +40°C); 30% to 75% relative humidity • Biohazard Disposal: Dispose of biohazards 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.

1-Overview of the Angiomat ILLUMENA

1-6 1.7.6 SYRINGE SIZES • 150 ml • 200 ml • 125, 100, 75, 65, 50 ml Prefilled 1.7.7 FILL RATE • Forward or Reverse- 0.2-25 ml/sec • Accelerates from zero to maximum in less than 0.5 seconds by rotating the fillcontrol bar to the fast position. 1.7.8 SYRINGE HEATER (OPTIONAL) 37°C (98°F) nominal. Minimizes the loss of heat from preheated contrast. 1.7.9 FLOW RATE Angio-Cardiac and Angio-Peripheral Modes • 0.1 to 40.0 ml/s in 0.1 ml/s increments up to 9.9 ml/s, 1.0 ml/s increments thereafter • 0.1 to 999 ml/M in 0.1 ml/M increments up to 9.9 ml/M, 1.0 ml/M increments thereafter CT Mode • 0.1 to 10 ml/s in 0.1 ml/s increments • 0.1 to 600 ml/M in 0.1 ml/M increments up to 9.9 ml/M, 1.0 ml/M increments thereafter 1.7.10 VOLUME 0.1 to volume in syringe in 0.1 ml increments up to 9.9 ml, 1.0 ml increments thereafter 1.7.11 DURATION (ANGIO MODE ONLY) 1 to 999s in 1 s increments 1.7.12 PRESSURE LIMIT Angio-Cardiac and Angio-Peripheral Modes • 75 to 1200 PSI in 1 PSI increments • 517 to 8273 kPa in 1 kPa increments • 200 ml syringe 75 to 900 PSI in 1 PSI increments CT Mode • 75 PSI to 300 PSI • 517 kPa to 2068 kPa

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1-7

1.7.14 X-RAY DELAY 0 to 300 seconds: if delay is less then 10 seconds the programmable increment is 0.1 seconds. if delay is greater than or equal to 10 seconds the programmable increment is 1 second. 1.7.15 RATE RISE 0 to 10 seconds in 0.1 second increments 1.7.16 PHASE DELAY 0 to 300 seconds: if delay is less then 10 seconds the programmable increment is 0.1 seconds. if delay is greater than or equal to 10 seconds the programmable increment is 1 second. 1.7.17 ECG INPUT (OPTIONAL) 30-120 beats/minute 1.7.18 SCAN DELAY (CT MODE) 0 to 300 seconds: if delay is less then 10 seconds the programmable increment is 0.1 seconds. if delay is greater than or equal to 10 seconds the programmable increment is 1 second. 1.7.19 STORED PROTOCOLS Angiographic mode can store 45 protocols CT mode can store 45 protocols

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1-Overview of the Angiomat ILLUMENA

1.7.13 INJECT DELAY 0 to 300 seconds: if delay is less then 10 seconds the programmable increment is 0.1 seconds. if delay is greater than or equal to 10 seconds the programmable increment is 1 second.

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1-Overview of the Angiomat ILLUMENA

1.8 CONSUMABLES NOTE: The use of consumables not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include evidence that the safety certification of the consumables has been performed in accordance to the appropriate EN 60601-1 and/or EN 60601-1-1 harmonized national standard. SYRINGES • P/N 900105

200 ml Angiomat ILLUMENA Syringe w/Handi-Fil available from Mallinckrodt.

• P/N 900101

150 ml Angiomat ILLUMENA Syringe w/Handi-Fil available from Mallinckrodt.

• P/N 900102

150 ml Angiomat ILLUMENA CT Multipak Syringe available from Mallinckrodt.

• P/N 900411

150 ml Angiomat ILLUMENA Reusable Syringe Kit available from Mallinckrodt.

Prefilled Syringes available from Mallinckrodt. LOW PRESSURE TUBING • P/N 601195

60” Coiled Tube available from Mallinckrodt.

• P/N 601277

48” Extension Tube available from Mallinckrodt.

HIGH PRESSURE TUBING • P/N 601278 10” Extension Tube w/Rotating Adaptor available from Mallinckrodt. • P/N 601279

20” Extension Tube w/Rotating Adaptor available from Mallinckrodt.

• P/N 601280

30” Extension Tube w/Rotating Adaptor available from Mallinckrodt.

• P/N 601281

48” Extension Tube w/Rotating Adaptor available from Mallinckrodt.

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