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operation manual

REF MN010001-07.1

CONTENTS

REF MN010001-07.1 Avidia Operation Manual of 78

1 INTRODUCTION ................................................................................................................................. 7

1.1 Certifications .................................................................................................................................. 7

1.2 Trademarks .................................................................................................................................... 7

1.3 Disclaimers .................................................................................................................................... 7

1.4 Imaxeon Contact Information ....................................................................................................... 7

2 ABOUT THIS MANUAL ...................................................................................................................... 8

2.1 Purpose .......................................................................................................................................... 8

2.2 Important Safety Notice ................................................................................................................ 8

2.3 How to Read this Manual .............................................................................................................. 8

2.4 Quick Start ..................................................................................................................................... 9

2.5 Symbols, Labels and Controls ................................................................................................... 10 2.5.1 Symbols Used Throughout this Manual .................................................................................... 10 2.5.2 System Controls ........................................................................................................................ 10 2.5.3 System Labels ........................................................................................................................... 11

3 WARNINGS & CAUTIONS ............................................................................................................... 12

3.1 Intended Use ................................................................................................................................ 12

3.2 Contraindications ........................................................................................................................ 12

3.3 Restricted Sale ............................................................................................................................. 12

3.4 SYRINGE- Warnings and Cautions ............................................................................................ 13

3.5 INJECTOR- Warnings and Cautions .......................................................................................... 14

3.6 Operator Service Procedures ..................................................................................................... 18

4 GENERAL INFORMATION ............................................................................................................... 19

4.1 Injection Duration ........................................................................................................................ 19

4.2 Over and Under Infusion Protection .......................................................................................... 19

4.3 Adaptive Flow, Pressure Limit and Over Pressure .................................................................. 20 4.3.1 What to do in the event of adaptive flow reducing image quality .............................................. 20

5 SYSTEM BASICS .............................................................................................................................. 21

5.1 Pedestal Features ........................................................................................................................ 21 5.1.1 Optional Height Adjustable Arm ................................................................................................ 21 5.1.2 Injector Power Head Features .................................................................................................. 22 5.1.3 The Pressure Jacket ................................................................................................................. 22 5.1.4 The Syringe Package ................................................................................................................ 23

CONTENTS


5.2 Other Accessories ....................................................................................................................... 24

5.3 Common System Features ......................................................................................................... 25 5.3.1 Monitor Symbols ....................................................................................................................... 25 5.3.2 Power-On Indicator ................................................................................................................... 26 5.3.3 State Indicator ........................................................................................................................... 26

6 OPERATION DESCRIPTION ............................................................................................................ 27

6.1 Syringe Filling .............................................................................................................................. 27 6.1.1 Prepare To Fill the Syringe with Contrast ................................................................................. 27 6.1.2 Loading a Syringe ..................................................................................................................... 28 6.1.3 Locking and Unlocking the Piston ............................................................................................. 29

6.2 Setup Fill - Manual and Auto Fill ................................................................................................ 29 6.2.1 FluiDots ..................................................................................................................................... 29 6.2.2 Manual Fill ................................................................................................................................. 30 6.2.3 Auto Fill ..................................................................................................................................... 30

6.3 Purging and Manual Drawback .................................................................................................. 31

6.4 Flow Setup ................................................................................................................................... 32 6.4.1 Arm and Inject ........................................................................................................................... 34

6.4.1.1 ARM ENABLE and ARM .................................................................................................. 35 6.4.2 Arming with ISI .......................................................................................................................... 36 6.4.3 Not Enough Volume .................................................................................................................. 36 6.4.4 Paused and Puff Mode .............................................................................................................. 36

6.5 End of Injection Status................................................................................................................ 37

6.6 Refill Injection .............................................................................................................................. 38

6.7 Repeat Injection ........................................................................................................................... 38

6.8 Syringe Removal ......................................................................................................................... 39

6.9 Scan Delay ................................................................................................................................... 40

6.10 Inject Delay ................................................................................................................................... 40

6.11 Multi-ARM Flow Setup ................................................................................................................. 41

6.12 (Multi-)Phase Flow Setup ............................................................................................................ 41

6.13 Injection Protocols ...................................................................................................................... 42

6.14 Injection Occlusion (pressure stalled or Over Pressure) & Over Speed ............................... 43

7 OPTIONS ........................................................................................................................................... 44

7.1 Beep Volume ................................................................................................................................ 45

8 CONNECTIONS ................................................................................................................................ 46

8.1 External Panel Connector – PEDESTAL VERSION ONLY ....................................................... 46

8.2 Front Panel Controls – RACK VERSION ONLY ........................................................................ 47

CONTENTS


8.3 External Panel Connector- RACK VERSION ONLY .................................................................. 47 8.3.1 Circuit Breakers CB1/CB2 ......................................................................................................... 48

8.4 ISI/COMM ...................................................................................................................................... 48 8.4.1 PEDESTAL VERSION .............................................................................................................. 48 8.4.2 RACK VERSION ....................................................................................................................... 48

8.5 Power Inlet ................................................................................................................................... 49

8.6 Fuse Replacement ....................................................................................................................... 49 8.6.1 Fuse Type ................................................................................................................................. 49 8.6.2 PEDESTAL VERSION .............................................................................................................. 49 8.6.3 RACK VERSION ....................................................................................................................... 49

8.7 Start Button .................................................................................................................................. 50

8.8 Potential Equalization Connection (PEC) - PEDESTAL VERSION ......................................... 50

8.9 Potential Equalization Connection (PEC) - RACK VERSION .................................................. 50

8.10 Serial Number Locations ............................................................................................................ 51

8.11 Battery Maintenance and Replacement .................................................................................... 52 8.11.1 Battery Disposal .................................................................................................................... 52

9 MAINTENANCE AND CLEANING .................................................................................................... 53

9.1 Maintenance ................................................................................................................................. 53 9.1.1 Daily Inspection and Cleaning................................................................................................... 53 9.1.2 Monthly Cleaning and Operational check ................................................................................. 53 9.1.3 Annual Check ............................................................................................................................ 53

9.2 Daily Inspections ......................................................................................................................... 54 9.2.1 Pressure Jacket Inspection ....................................................................................................... 54 9.2.2 Pressure Jacket Replacement .................................................................................................. 55 9.2.3 Injector Head / Pedestal Inspection .......................................................................................... 56 9.2.4 Hand and Footswitch Inspection ............................................................................................... 56 9.2.5 System Labels Inspection ......................................................................................................... 56

9.3 Cleaning ....................................................................................................................................... 57 9.3.1 General cleaning instructions .................................................................................................... 57 9.3.2 Contrast spills into the front of the injector ................................................................................ 57 9.3.3 Control panel cleaning .............................................................................................................. 57 9.3.4 Injector Head Cleaning .............................................................................................................. 57 9.3.5 Pressure Jacket Cleaning ......................................................................................................... 58

9.3.5.1 Pressure Jacket Sterilization ............................................................................................ 58 9.3.6 Syringe Interface / Injector Piston Cleaning .............................................................................. 59

9.4 Operator Checkout Procedures ................................................................................................. 60 9.4.1 Introduction ............................................................................................................................... 60 9.4.2 Checkout Procedure ................................................................................................................. 60

9.5 Rack Model Configuration .......................................................................................................... 61

9.6 Avidia ISI ...................................................................................................................................... 61 9.6.1 Description ................................................................................................................................ 61

CONTENTS


9.6.2 Enabling ISI Function ................................................................................................................ 61

10 TROUBLE-SHOOTING ..................................................................................................................... 62

10.1 Fault Finding Guide ..................................................................................................................... 62

10.2 Error Messages ............................................................................................................................ 64

10.3 Calling Service ............................................................................................................................. 65

11 SPECIFICATIONS ............................................................................................................................. 66

11.1 Pedestal Dimensions .................................................................................................................. 66

11.2 Rack Dimensions ......................................................................................................................... 67

11.3 Approvals ..................................................................................................................................... 67

11.4 Functional .................................................................................................................................... 68

11.5 Controls ........................................................................................................................................ 68

11.6 Indicators ..................................................................................................................................... 68

11.7 Mechanical (Pedestal) ................................................................................................................. 69

11.8 Mechanical (Rack) ....................................................................................................................... 69

11.9 Electrical ....................................................................................................................................... 69

11.10 Environmental ......................................................................................................................... 70

11.11 External Interfaces .................................................................................................................. 70

11.12 Connectors .............................................................................................................................. 70

11.13 Protection Against Electrical Shock ..................................................................................... 70

11.14 Electrical leakage .................................................................................................................... 70

11.15 Operating ................................................................................................................................. 70

11.16 Ground Continuity .................................................................................................................. 71

11.17 IEC60601-1-2:2001 Compliance ............................................................................................. 71 11.17.1 Electromagnetic Emissions ................................................................................................... 71 11.17.2 Electromagnetic Immunity .................................................................................................... 72 11.17.3 Recommended separation distances from portable and mobile RF communications equipment and the Avidia angiographic contrast injector ...................................................................... 74 11.17.4 Magnetic Navigation Systems .............................................................................................. 74

11.18 Authorised Accessories ......................................................................................................... 75 11.18.1 General Accessories ............................................................................................................. 75 11.18.2 Pedestal Accessories ........................................................................................................... 75 11.18.3 Rack Mount Accessories ...................................................................................................... 76 11.18.4 ISI Accessories ..................................................................................................................... 76

11.19 Mode of Operation .................................................................................................................. 76

CONTENTS


12 WARRANTY CONDITIONS .............................................................................................................. 76

13 INDEX ................................................................................................................................................ 77

©2005-2009, Imaxeon Pty Ltd. All rights reserved. Reproduction of this operation manual is strictly prohibited without express

written consent of Imaxeon Pty Ltd.

For more information about Imaxeon products and services, please visit www.imaxeon.com


1 Introduction

Thank you for purchasing the IMAXEON Avidia Angiographic Contrast Injector. Read this manual and follow the safety precautions closely so you will be able to use the injector and all of its features properly and safely. For the latest support information, visit our website: http://www.imaxeon.com/ Record below the model number, serial number and your IMAXEON representative’s telephone number.

Model No Serial No: IMAXEON Service Representative Telephone No:

1.1 Certifications This injector is equipped to operate at 110 – 240 Vac, 50/60 Hz, and is designed to comply with EN 60601-1 (safety) and EN 60601-1-2 (EMC/Emissions) 2nd edition standards. IMAXEON Pty Ltd is ISO 13485:2003 certified.

1.2 Trademarks IMAXEON Pty Ltd is a subsidiary of MEDRAD Inc. MEDRAD is a federally registered trademark of MEDRAD Inc. USA. Avidia and FluiDot are trademarks of MEDRAD Inc. Used by permission of MEDRAD, Inc.

1.3 Disclaimers This manual describes the use, operation and preventive maintenance needs of the Avidia Angiographic Contrast Injector, herein referred to as “the injector”. Qualified and trained personnel should only use the injector. Use by unqualified and untrained personnel could result in patient or personal injury and property damage. IMAXEON reserves the right to modify the specifications and features described herein, or discontinue manufacture of the product described at any time without prior notice or obligation. Please contact your authorised Imaxeon representative for the most current information. IMAXEON will make available on request any circuit diagrams, component parts lists, or other information, which will assist appropriately qualified technical personnel to repair the injector to a level deemed by Imaxeon to be field repairable. Contact IMAXEON Service, or your local service representative for further information.

1.4 Imaxeon Contact Information

Imaxeon Pty. Ltd. Unit 1, 38-46 South St, Rydalmere, NSW, 2116 Australia Phone: +61 2 8845 4999 Fax: +61 2 8845 4998 www.imaxeon.com [email protected]

Medical Device Safety Service (MDSS) GmbH Schiffgraben 41 30175 Hannover Germany Phone: +49 511 6262 8630 Fax: +49 511 6262 8633

http://www.imaxeon.com/�

mailto:[email protected]�


2 About This Manual

2.1 Purpose This manual is a user’s reference operating guide for the Avidia Angiographic Contrast Injector. Please note that the injector can be supplied as a Pedestal based product or a Rack mounted product. The Pedestal incorporates all assemblies of the unit to enable the injector to be moved within the scanning room. The Rack Mount version provides a power head and small monitor connected via extension cables to a control enclosure that can be mounted within the X-Ray scanner equipment room racking.

2.2 Important Safety Notice The information in this manual is intended for medical personnel with adequate training and experience in angiographic studies. Any attempt to operate or repair a medical device such as the injector without adequate training may result in personal injury, property damage or patient injury.

2.3 How to Read this Manual READ this manual thoroughly before operating the injector and keep the manual available in the area where the injector will be used. This manual contains important information about the safe operation of the injector. IMAXEON urges the operators of the injector to read this manual carefully, become familiar with the injector functions it describes, and follow its recommended procedures. Many parts of this manual are common to both the Pedestal and the Rack versions of the product. Differences are noted where appropriate throughout the manual.

About This Manual


2.4 Quick Start

§4 Clinical Information•Understanding pressure and flow•Adaptive Flow•Over and under infusion

§5 System Basics•System Features•Controls

§6 Operation Description•Filling•Performing an injection•Programming injection protocols

§9 Cleaning and Maintenance•Cleaning•Battery maintenance•Regular checks

§10 Troubleshooting•Error messages•Troubleshooting

About This Manual


2.5 Symbols, Labels and Controls

2.5.1 Symbols Used Throughout this Manual

Warnings advise of circumstances that could result in injury or death to the patient or operator. Read and understand all warnings before operating the injector. Consult accompanying documents/text. The symbol is located throughout this manual and on the injector labelling as required.

Warning, biological hazard

Electrical Shock Hazard

Cautions advise of circumstances that could result in damage to the injector. Read and understand all cautions before operating the injector.

Caution, hot surface.

2.5.2 System Controls

Identifies the POWER on/off button - located on the injector power head

Identifies rotation direction on the manual knob for manually moving the injector piston. Anti-clockwise is forward movement. The symbol is located on the rear of the Manual Control Knob on the injector Power Head unit.

Identifies the ARM ENABLE button - located on the injector head

Identifies the START button - located on the small monitor

About This Manual


2.5.3 System Labels

Do not dispose in municipal waste, in accordance with the DIRECTIVE 2002/96/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on waste electrical and electronic equipment (WEEE).

Identifies the terminal which provides a connection between the injector and the equipotential busbar of the electrical installation. The symbol is located on the Base power panel

Identifies switch position for disconnection from line power. The symbol is located adjacent to the power switch on the Base power panel.

I Identifies switch position for connection to line power. The symbol is located adjacent to the power switch on the Base power panel.

Identifies type CF medical equipment complying with EN 60601-1 standards. The symbol is located on the Pedestal Base power panel and Rack Mount front panel..

CLASS 1 Indicates the system is Class 1 medical equipment as defined by EN60601-1 standards. The symbol is located on the Base power panel.

CB1 Identifies circuit breaker one. The symbol is located on the Pedestal Base power panel.

CB2 Identifies circuit breaker two. The symbol is located on the Pedestal Base power panel.

Identifies protective earth. The symbol is located within the Pedestal Base unit.

Identifies location for connection of the START switch - either a handswitch or footswitch can be connected. The symbol is located on the Pedestal Base power panel and Rack Mount front panel.

Pinch Hazard. Note the hazard between the injector head and the pedestal arm (Pedestal only)

Circuit breaker Open (Rack only)

Circuit breaker Closed (Rack only)

LED solid green - Normal (battery) operation (Rack only)

LED solid amber - Battery fully charged (Rack only)

LED flashing amber - Battery charging (Rack only)

LED solid red - Fault – consult manual (Rack only)

In the interests of continually improving product quality, the specifications and illustrations in this manual may change at the discretion of the manufacturer


3 Warnings & Cautions

WARNING Warnings advise of circumstances that could result in injury or death to the patient or operator. Read and understand all warnings before operating the injector.

CAUTION Cautions advise of circumstances that could result in damage to the injector. Read and understand all cautions before operating the injector.

3.1 Intended Use The injector is intended to be used specifically for the purposes of injecting contrast agents and common flushing solutions into humans for angiographic diagnostic procedures. DO NOT attempt to use the injector for any other purpose.

3.2 Contraindications This device is not to be used for drug infusion, chemotherapy, or any other use for which the device is not indicated.

3.3 Restricted Sale Imaxeon company policy restricts this device to sale to, or on the order of, a physician.

WARNING DISCONNECT THE PATIENT IMMEDIATELY FROM THE INJECTION IF A SYSTEM MALFUNCTION OCCURS: Turn the injector off and immediately disconnect the injector from the patient. DO NOT reconnect until the injector has been powered up, armed and a test injection performed to verify that the injector malfunction has been resolved. If a fault message is repeatedly displayed, and/or the injector is not operating as customary, DO NOT use the injector until the condition causing the message display can be identified and corrected. Contact IMAXEON Service, or your local service representative for assistance.

Warnings & Cautions


3.4 SYRINGE- Warnings and Cautions

WARNINGS

• CORRECTLY LOAD THE SYRINGE. Improper loading may cause an under volume delivery, air embolization or personal injury. See Section 6.1.2 for correct loading procedures

• FILLED SYRINGES, WHICH ARE STORED, CAN PROMOTE BACTERIAL GROWTH. Imaxeon syringes are intended to be filled, and then used immediately. Discard all filled syringes, in particular when removed from the injector for some period of time.

• MINIMIZE THE LENGTH OF THE FLUID PATH FROM THE SYRINGE TO THE PATIENT. The connection of additional infusion systems/ accessories to the central fluid path from the injector to the patient increases resistance to flow. This could cause under flow rates, under volumes, or stall conditions which could possibly cause the procedure to be repeated.

• USE EXTREME CARE WHEN SELECTING FLOW RATES to avoid the unintentional programming of an inappropriate high rate injection. Always check settings before arming and injecting; high flow rate injections may cause patient injury.

• AIR EMBOLIZATION CAN CAUSE PATIENT INJURY OR DEATH, DO NOT CONNECT A PATIENT TO THE INJECTOR UNTIL ALL TRAPPED AIR HAS BEEN CLEARED FROM THE SYRINGE, CONNECTOR TUBING AND CATHETER. Operator vigilance and care, coupled with a set procedure is essential to the avoidance of air embolism. See Section 6.1.2 for loading procedures and use of FluiDot indicators.

• REFILLING A SYRINGE INCREASES THE RISK OF BIOLOGICAL CONTAMINATION. Do Not Use Disposable Items On More Than One Patient. Discard disposable items after each use.

• PATIENT INFECTION MAY RESULT FROM THE USE OF NON-STERILE COMPONENTS, do not remove plunger to fill the syringe. Maintain sterility of all disposable components.

CAUTIONS

• THE SYRINGE AND PRESSURE JACKET MAY BE DAMAGED IF HIT WITH TOOLS WHILE ATTEMPTING TO ELIMINATE AIR. Only use the palm of hand to gently hit the syringe or pressure jacket to dislodge air bubbles.

• ENSURE PRESSURE SETTINGS ARE LOWER THAN CATHETER AND CONNECTOR RATINGS. Should an occlusion occur, disposable components with a lower pressure rating may be subjected to pressure beyond their capability, resulting in failure.

• THE SYRINGE HEAT MAINTAINER INCORPORATES A FAILURE INDICATOR LIGHT, IF INDICATOR LIGHT IS LIT WHILE ON THE SYRINGE, REMOVE THE HEAT MAINTAINER. This indicates that the syringe heater is overheating and should not be used.

Warnings & Cautions


3.5 INJECTOR- Warnings and Cautions

WARNINGS

• PATIENT INJURY COULD OCCUR IF THE ON SCREEN MANUAL FILL CONTROLS OR MANUAL KNOB ARE USED WHEN THE PATIENT IS CONNECTED. This could cause injury to the patient by delivery of contrast or blood extraction and may require the procedure to be repeated.

• A POSSIBLE EXPLOSION RISK EXISTS IF THE INJECTOR IS USED IN THE PRESENCE OF FLAMMABLE ANAESTHETICS.

• REGULAR MAINTENANCE SHOULD BE PERFORMED. To ensure that the injector stays properly calibrated and that all primary and backup systems are functioning properly, YEARLY SAFETY CHECKING IS RECOMMENDED. Contact your local Imaxeon Service Representative for further information.

• ELECTROMAGNETIC INTERFERENCE. The injector must be installed in a suitable EMC environment according to the following:

• Portable and mobile RF communications equipment can affect Medical Electrical Equipment.

• To maintain compliance with IEC 60601-1-2 EMC compatibility requirements, do not substitute cables or connectors not recommended by the manufacturer as emissions or decreased immunity to interference may result causing erratic operation.

• PLUG THE INJECTOR DIRECTLY INTO PROPERLY GROUNDED AC POWER OUTLET. Do not use an extension power cord or adapter. Since the injector power cord supplies a safety ground to the injector during charging, using an extension cord will compromise the ground quality and the injector could become unsafe.

• PROTECTIVE EARTH CONDUCTOR. Should the integrity of the external protective conductor in the installation or its arrangement be in doubt, the injector must be operated from the internal power source

• CONNECTION TO OTHER EQUIPMENT. Injectors bearing the CE mark and having accessory equipment connected to the interface connectors must be certified according to the EN 60601-1 standard. Furthermore, all configurations of injectors with attached accessory equipment must comply with system standard EN 60601-1-1. Anyone who connects additional equipment to the signal input or output part configures a medical system and is therefore responsible that the system complies with requirements of the system standard EN 60601-1-1. To obtain on-site consulting or consulting references, contact local Imaxeon Service Representative.

• A BIOLOGICAL HAZARD MAY RESULT IF FLUIDS, IN PARTICULAR BLOOD OR BODILY FLUIDS, TO COME INTO CONTACT WITH THE INJECTOR. Fluid ingress could also adversely affect the function of the injection. Clean the injector immediately, according to the procedure described in 9.3.

• MAGNETIC NAVIGATION SYSTEM COMPATIBILITY. The injector is compatible with Magnetic Navigation Systems up to 0.15mT. It is recommended that the injector is placed 4 feet away and with locked wheels as a precaution.

Warnings & Cautions


CAUTIONS

• REMOVAL OF COVERS MAY ALLOW ACCESS TO DANGEROUS VOLTAGES. Contact your local Imaxeon Service Representative for correct maintenance procedures, do not remove any covers or disassemble the injector in any way. Inspect the injector periodically for loose or frayed cables, loose covers, signs of cracks, dents or loose hardware. Refer all injector servicing to authorised Imaxeon Service Representatives.

• SHOCK HAZARD when cleaning. In order to avoid shock and prevent damage to the injector, always disconnect the injector from line power before cleaning. Ensure that the injector is completely dry before reconnecting to line power.

• LINE VOLTAGE HAZARD. To avoid dangerous voltages, do not remove the IEC connector (base cable) while line power is applied to the injector. Always disconnect the injector from line power before removing the IEC power connector.

• DO NOT POSITION THE INJECTOR PEDESTAL BY PULLING ON THE INJECTOR HEAD, DISPLAY OR CABLING. Possible injury can occur if the injector head or stand falls on the patient or technician. Move the injector by grasping the handle and pulling or pushing the pedestal into place. Do not use the arm to lift the injector.

• PINCH HAZARD. Do not grasp any pivot points. Position the injector head by grasping the head alone.

• OPERATOR INJURY MAY RESULT IF EXCESSIVE WEIGHT IS APPLIED TO THE DEVICE. Do not place heavy objects or lean on the arm, injector head, or handles.

• OPERATOR INJURY MAY RESULT FROM BOTTLES FALLING FROM TRAY. Do not place bottles on top of tray. Ensure that the bottles are placed in the recesses provided.

• OPERATOR INJURY MAY RESULT DURING THE TRANSPORT OF THE INJECTOR. Care should be used when transporting the injector. Ensure that the arm is properly secured in the locked position.

• OPERATOR OR PATIENT INJURY MAY RESULT FROM INADVERTENT MOVEMENT OF THE ARM OR INJECTOR HEAD. Periodically examine the articulating arm for signs of swaying and drooping. If any of these signs are evident, do not use the injector. Contact your local Imaxeon Service Representative for assistance.

• FOR CORRECT OPERATION, use only accessories and options provided by Imaxeon, which are designed specifically for the injector. Other accessories or options may cause equipment damage.

• IMPROPER OR CARELESS CLEANING METHODS MAY RESULT IN EQUIPMENT DAMAGE. When cleaning any outside surface of the injector, avoid allowing any water or cleaning solutions to leak inside system components.

• STALL CONDITIONS CAN OCCUR when a low flow rate is selected in conjunction with a low-pressure limit. Check the fluid path for a blockage. If no blockage exists in the fluid path, adjustments may be made to the flow rate or pressure limit according to physician’s orders.

• ELECTRICAL DAMAGE COULD OCCUR DUE TO CONDENSATION if the injector is brought indoors from extreme outside temperatures and immediately used. Allow the injector to stabilize at room temperature before use.

Warnings & Cautions


• CONNECT TO CORRECT LINE VOLTAGE AND FREQUENCY. Before applying line power, check the voltage and frequency range marked on the serial number tag on the base of the injector. The injector may be damaged when line power is outside the stated voltage range. Verify that the injector has the proper cord set for the plug style.

• PROVIDE SUFFICIENT CLEARANCE AROUND THE INJECTOR. This may cause the injector to overheat and shut down. Installation clearance should be a minimum of 10cm.

• THIS DEVICE CONTAINS MATERIALS THAT ARE POTENTIALLY HAZARDOUS TO THE ENVIRONMENT. In accordance with the DIRECTIVE 2002/96/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on waste electrical and electronic equipment (WEEE), the Avidia system and accessories should not be disposed as unsorted municipal waste. Contact your Imaxeon Service Representative for disposal details.

• REMOVE POWER WHEN DISCONNECTING OR RECONNECTING HEAD CABLE. Disconnecting the head cable from the injector pedestal when line power is applied may cause equipment damage.

• BATTERY PACK DISPOSAL. The injector contains lead acid batteries housed in a custom pack. Please dispose of this pack within environmental pollution guidelines depending on your local regulations.

• INJECTOR MAY DISARM OR FAIL TO OPERATE WHEN EXPOSED TO HIGH MAGNETIC FIELDS. Do not use radio transmitters, cellular phones or devices generating electrostatic discharge in the vicinity of the injector.

• CLOSE INJECTOR SYRINGE HOLDER BEFORE MOVING THE PISTON. The piston or the motor drive mechanism could be damaged if it collides with the syringe holder or any other object when in motion.

• THE SYRINGE HEAT MAINTAINER MAY BE HOT WHEN IN OPERATION. Avoid holding the heat maintainer when in operation.

• THE BASE COVER MAY BE DAMAGED BY IMPACT. This may also damage the components in the base. Avoid stepping on the base cover.

• MOVING THE INJECTOR MAY CAUSE RISK OF CATHETER PULL-OUT DURING INJECTION. When injecting, lock the wheel castors, and prevent the injector head from moving. When moving the injector again, ensure the castors are unlocked, to avoid the injector tipping over.

Warnings & Cautions


WARNING TRANSPORTATION OF THE INJECTOR – PEDESTAL ONLY The injector can topple over if moved on surfaces at angles greater than 10º to the horizontal with the power head oriented at the point of furthest extension. Always fold the injector head in-board as far as possible towards the bridge handle to assist with stability during transportation The arm incorporates a locking mechanism which automatically locks closed when the arm is rotated towards the handle. Secure the injector head in this position before transportation or changing the battery pack. See the illustration, and Lock and Unlock instructions below.

Lock the castors before moving the injector head to prevent the injector from moving. TO LOCK:

1. Position the injector head nose down as shown in the illustration

2. Locate the small knurled button under the arm pivot point on the handle assembly

3. Pull the button down and gently move the arm towards the front of the injector

4. The arm will be free to rotate and should be carefully pulled so that the injector head does not collide with the Small Monitor. As the injector head approaches the locked position, note that the button will click into place to lock the arm.

TO UNLOCK:

1. Pull down on the button whilst moving the arm away from the locked position.

2. Continue to move the arm until the button retracts into the normal use position

Warnings & Cautions


3.6 Operator Service Procedures The operator can perform the following procedures, described in this manual.

1) Maintenance Checks Section 9.1

2) Cleaning Section 9.3

3) Fuse Replacement Section 8.6

4) Pressure Jacket Inspection and Replacement Sections 9.2.1 and 9.2.2

5) Operator Checkout Procedure Section 9.4

To ensure patient and operator safety, all other service operations should be performed by an authorised IMAXEON Service Representative.


4 General Information

In order for contrast media to flow through the disposable system (connector tubing, stopcock, and catheter), the pressure in the syringe must exceed the resistance of the disposable system. Pressure in the syringe is generated by the force driving the syringe plunger. This pressure decreases over the entire length of the disposable system. As the fluid flows out the end of the catheter, there will be virtually no pressure. Pressure will be essentially zero at the open (unrestricted) end of the catheter because there is no resistance to fluid flow. Pressure is related to the amount of force, which the injector head must apply to the syringe in order for fluid to flow at the selected rate. To achieve a selected Flow Rate, the pressure exerted by the plunger must be great enough to overcome the resistance of the disposable system. Flow rates are expressed in terms of mL/s. Pressure developed by the injector is measured relative to the atmosphere pressure outside of the syringe or connector tubing. The pressure developed by the injector is expressed in terms of “Gauge Pressure” or “PSIG” which is the “Absolute Pressure” or “PSIA” minus the atmospheric pressure. Hereafter, pressure displayed as psi refers to gauge pressure. The default pressure display is psi (this can be changed to kPa in the Option settings, Section 7). See the table at the end of this section for conversion factors.

4.1 Injection Duration Injection duration is the length of time that the injector will require to perform the programmed protocol from the moment the start switch is depressed until the unit stops injecting. Duration is calculated by dividing the selected volume by the selected flow rate:

50ml volume = 2.5s duration

20mL/s flow rate

The duration of a multi-phasic injection will be calculated by the injector and displayed on the screen. Injection duration is displayed on the control panel in seconds, minutes or hours depending on the selected flow scale. Selecting a rise or fall time extends the total time of the injection. The added time will be ½ of the rise/fall time. For instance, a 30 mL injection at 10 mL/sec will take 3 seconds without rise time. If a rise time of 1 second is added, ½ second is added to the total time. Now the injection will take 3.5 seconds.

4.2 Over and Under Infusion Protection The following means are provided to protect against over and under infusions:

• Display messages remind the operator to check the programmed injection parameters prior to the injector being armed.

• An indication of insufficient volume is provided on the display whenever the total volume programmed to be delivered is greater than the amount of fluid in the syringe.

• The unit incorporates a dual volume delivered detection system. The injection could be implemented only if the two detectors work simultaneously and synchronously. Otherwise, malfunction of one of the detectors or asynchrony between the detectors will result in system shutdown so as to avoid over infusion.

General Information


4.3 Adaptive Flow, Pressure Limit and Over Pressure At normal injection pressures, the injector will maintain the programmed flow rate. The x-ray image should display good contrast and opacity. However, if the fluid path encounters a blockage, or if the connected disposables restrict the flow of contrast, the syringe pressure will rise. In order to ensure patient safety and protect the disposable system, the flow rate will be automatically reduced by the injector in order to reduce excessive pressure on the fluid line. Reduction of flow rate in this condition is known as adaptive flow.

When adaptive flow occurs: • Lower opacification may result, and the images may give an

appearance of being “washed out”. • The injection duration will increase. • A message is displayed on the screen to indicate flow rate reduction is

occurring and the LEDs at the back of the injector head flash orange.

Adaptive flow will start as the pressure approaches the pressure limit setting. This pressure limit is a user-programmable value from 2068 kPa (300 psi) to 8270 kPa (1200 psi) set in 10 kPa (1 psi) increments.

If the syringe pressure exceeds the pressure limit by 20%, the injection will halt immediately. This is known as overpressure. 1

The Avidia is designed to be a regulated fluid delivery device, which monitors pressure to an accuracy of ± 50psi for safety reasons.

.

4.3.1 What to do in the event of adaptive flow reducing image quality

WARNING Always check the pressure and flow limitations of any disposables to be used with this injector. The system will remind you of the need to check before an injection can proceed. You are urged to visually check the packaging of disposables for a pressure and flow rate limit and adjust the injector limits to be below the limits marked on the packaging. If adaptive flow occurs, and the image quality is reduced, check the fluid path for a blockage. If no blockage exists in the fluid path, the operator may decrease the flow rate setting or increase the pressure limit setting and re-arm the system. If the flow rate or pressure limit is to be changed, re-check the physician’s orders.

1 In the event of a sudden blockage during an injection, a very rapid pressure rise may occur. The injector will go into overpressure and stop without entering the flow reduction process. In this situation, the pressure can exceed the Pressure Limit for very short periods of time, insufficient to damage disposable sets. If the pressure remains 20% above the pressure limit for a substantial time, the injection will halt.


5 System Basics

5.1 Pedestal Features The injector power head is supported on a pedestal connected to the base unit, which contains the battery pack and power control system. A system view is illustrated below showing major components.

5.1.1 Optional Height Adjustable Arm

The Pedestal system is optionally available with a height-adjustable arm. This arm provides additional height extension for the injector head. To adjust height, loosen the lock knob, set at desired height, then re-tighten lock knob.

Injector power head Small monitor

Pedestal

Base

Lockable Castors

External Connector Panel

lock knob

System Basics


5.1.2 Injector Power Head Features

NOTE: Rotating the manual knob when the injector is OFF will turn the injector ON in anticipation of continued use.

5.1.3 The Pressure Jacket The pressure jacket is a very important component, which supports the syringe, and ensures that the syringe withstands the high pressures that can develop during an injection. The pressure jacket is manufactured from high impact resistant polycarbonate.

CAUTION It is critical to perform a regular check of the pressure jacket. Refer to Section 9.2.1 for details.

Syringe Pressure Jacket surrounds the syringe to allow for operating pressures up to 8270 kPa (1200 psi). Syringe Holder opens to allow the syringe to be inserted in the syringe pressure jacket. Display and Touch Screen provides the controls for the injector through the display screen and the integrated touch panel.

Arm Enable Button (ORANGE) used for preparing the injector so there is an intentional start to the injection. Power On indicator changes colour to indicate one of three conditions: power on, charging or battery failure. On/Off Button (BLUE) turns the injector on and off. Each press changes the state from ON-OFF-ON.

Manual Knob rotates to move the syringe piston forward or reverse as required for purging of air and manual syringe retraction.

State indicator lights in various colours depending on the system state.

System Basics


5.1.4 The Syringe Package

The syringe package contains a single assembled 150mL syringe and a curved Quick Fill Tube (QFT). The contents have been gas sterilised, and whilst in the unopened package, retain their sterility until the use by date on the label. CHECK SYRINGE PACKAGING AND THE FOLLOWING INFORMATION BEFORE OPENING. IF IN DOUBT, DO NOT USE. Please contact Imaxeon or your local sales Representative in case of any questions or difficulties with the syringe or filler tube.

Open the syringe package by peeling at the top left and right arrows. The 150-EF-Q syringe is a sterile single use device, which comprises:

White plunger

Black rubber seal

Barrel

Lock-nut over the Luer fitting

Dust Cover (orange)

Quick Fill Tube (QFT)

Confirm use with AVIDIA ANGIOGRAPHIC CONTRAST INJECTOR

Check the use by date for valid sterility period

You may wish to note the syringe Lot Number for your procedure records

Check the catalog number, must be 150-EF-Q

Arrows indicate the direction to peel open the package.

System Basics


5.2 Other Accessories The small monitor features are illustrated below.

The features of the small monitor are: The screen size and displays are the same on both the Injector Head and the Small Monitor. The small monitor green START button has the same function as the handswitch or footswitch, which is used to start the injection after arming. The small remote sits in a holder on the bridge above the large handle. The coiled cable allows the operator to remove the small remote and relocate the functional control of the injector away from the sterile region of the procedure if required. The cable will allow the small remote to operate approximately 1 metre from the injector. NOTE: The injector will operate normally without the small monitor being fitted (although a warning message with be displayed – this message can be disabled by your Imaxeon Service Representative).

The footswitch can be used as the START button to start the injection after arming. The footswitch is connected to the external connector panel using the designated connector. See Section 8.7 to connect and disconnect the switch. Step on the switch to START the injection.

The handswitch is connected to the external connector panel using the same designated connector as the footswitch. Press the button to START the injection.

The handswitch can be holstered in the handswitch holster when not in use.

A syringe heat maintainer can also be fitted to the pressure jacket to maintain the contrast temperature in the syringe. NOTE: The heat maintainer has a fault indicator lamp that will illuminate in case of an internal failure within the device. The lamp can be viewed through the pressure jacket.

The illustration shows the fitment to the pressure jacket. The small power connector mates with a socket located on the underside of the injector head.

CAUTION The heat maintainer may be hot during operation. Avoid holding the syringe heat maintainer.

Touch screen

START button

Power On indicator

Fault indicator

Power connector

System Basics


5.3 Common System Features

5.3.1 Monitor Symbols Functional, pressable screen buttons are shown as raised images with shadow.

BACK button allows the operator to revert to the previous screen displayed. QUIT button allows the operator to revert to the Main Start Selection screen.

The syringe image indicates relative position of the plunger and volume (in mL) remaining in syringe. An indicator next to the syringe symbol shows the heat maintainer state (1st illustration)

• White – heat maintainer is not engaged • Yellow – syringe sensed but not heating – either the syringe is up to

temperature, or the heater is not connected. • Orange – syringe sensed and heating

The grey bar in the centre of the syringe indicates the position of the injector piston (1st illustration). If the piston has retracted, the grey bar is not shown (2nd illustration). Note that when the piston has retracted, the plunger location indicated is the last-known location. This will be updated each time the piston engages the plunger.

During injection, a red bar symbol appears to the left of the syringe symbol. The solid red bar indicates the current pressure. A short horizontal bar above it indicates the peak pressure achieved during the current injection. The peak pressure indicator is reset at the beginning of each injection

Duration: This displays the cumulative injection time. Note the timer pauses while an injection is paused. When multi-arm or multi-phase injections are performed, the value is also cumulative. This value is reset when the syringe is removed.

(Volume) Used: This displays the cumulative contrast volume, in mL, delivered during the injection. Multi-arm and multi-phase volumes are cumulative. This value is reset when the syringe is removed.

This symbol shows the battery capacity as a percent of full charge, where 100% is fully charged. Below 25% the injector should be reconnected to line power to recharge the battery.

During injection process, the colour of the battery indicator will change depending on whether the set flow rate is below 20mL/s (green, requiring lower battery power), or above 20mL/s (red, requiring higher battery power).

When the battery is near-empty, an empty battery symbol is displayed, and will flash

This symbol replaces the battery symbol when line power is connected

System Basics


5.3.2 Power-On Indicator Coloured indicators show the injector status as detailed below.

Power On Indicator (located below the screen)

COLOUR FUNCTION COMMENT

GREEN solid Power On -

RED flashing Battery Low Line power needs to be connected

RED solid Battery Failure Requires immediate operator attention

-

None Power Off -

ORANGE solid Battery Charged Only when power OFF and line power is

ORANGE flashing Battery Charging Connected

5.3.3 State Indicator

State Indicator (located at the base of the power head)

COLOUR FUNCTION COMMENT

RED Solid Alarm state All alarm states are serious and require immediate operator attention. Note the error message displayed on the screen

ORANGE solid

Factory setup mode. Scan delay end Flow rate reduced

During injection, if the pressure limit is reached, the flow rate is reduced.

GREEN solid

Armed mode Inject ready

GREEN flashing

Injecting Duration of flash represents effort/pressure – longer flashes indicates higher pressure


6 Operation Description

6.1 Syringe Filling Filling syringes can be completed in several ways, depending on personal preference. This section contains guidelines and recommendations for a standard procedure that should be followed initially. An alternate procedure can be developed as familiarity is gained.

6.1.1 Prepare To Fill the Syringe with Contrast One operator should fill the syringe and arm the injector. If an operator change occurs, the second operator should not assume responsibility for a syringe filled by another operator. For patient comfort, the contrast media should be warmed to approximately 37°C prior to filling. Mount the syringe heat maintainer onto the pressure jacket (see Section 5.1.3) to maintain the contrast temperature during the procedure.

Apply power by pressing on the injector head. The screen will illuminate and system diagnostics will take place. All lighted indicators on the injector head will briefly illuminate and the start-up screen will be displayed when complete.

The start-up screen contains two button options:

The software will start from the main start screen (shown below).

When manually powering down, or automatically powering down (after approximately 2 hours continuous use), the screen state of the injector is saved. Pressing Resume starts the injector at this state.

These buttons can also be pressed on the small monitor During the start-up, the system will move the motor to perform a “jog” test for approximately 1s.

To enable syringe loading, the injector piston must be fully retracted. The injector will automatically retract the piston at the completion of the previous procedure. If the syringe holder will not open, press Unlock and this will ensure the injector piston is fully retracted. Once the injector piston has retracted, open the syringe holder to the fully open position.

Syringe holder in fully open position

Syringe holder in partially open position (do not leave partially open)

Operation Description


6.1.2 Loading a Syringe

WARNING To ensure sterility, do not touch either end of the QFT, or the tip or insides of the syringe during this procedure.

PEDESTAL VERSION ONLY. Lock the castors to prevent the injector from rolling away

Open the syringe holder. Remove the new syringe from its package. DO NOT touch the tip or the inside of the syringe as this can compromise sterility.

Inspect the rear of the pressure jacket to ensure that the hexagonal spring, which is used to firmly secure the syringe, is in place.

Slide the syringe into the pressure jacket. Ensure the syringe is fully seated into the pressure jacket. Close the syringe holder fully.

CAUTION - STORAGE OF FILLED SYRINGES: Filled syringes which are stored can promote bacterial growth. Avidia syringes are intended to be filled just prior to use. Discard all unused filled syringes. The 150-EF-Q syringe is purpose designed for the injector - do not substitute any other type of syringe or a syringe manufactured by any alternate supplier. The syringe has been tested to withstand the pressures and flow rates encountered across the full range of angiographic procedures completed by the injector.

WARNING Always use a new syringe and fill tube for each patient. Do not reuse a syringe or fill tube as patient contamination may result. Additionally, reusing syringes may result in syringe failure



6.1.3 Locking and Unlocking the Piston The following functions control the engaging and disengaging of the piston to and from the syringe:

This button locks the syringe holder, and moves the piston forward until it engages with the syringe plunger. Once the plunger is engaged, the screen changes to the manual fill screen

If the piston has halted and is already engaged to the syringe, pressing this button display the manual fill screen.

This button disengages the piston from the syringe, retracts it all the way back into the injector and unlocks the syringe holder. The syringe can then be removed.

If the piston is not engaged to the syringe, this button will move the piston forward until it does so. Once the plunger is engaged, the screen changes to the manual fill screen

While the piston is moving to engage the syringe, pressing this button will abandon the engage procedure, and proceed directly to the Setup Fill window, Section 6.2

If the injector detects that syringe has less than 147mL (by the position of the piston when the button is pressed), the Manual Fill screen will be displayed, Section 6.2.1 If the injector detects there is more than 147mL, the Setup Fill screen will be displayed, Section 6.2. This option is designed for pre-filled syringes.

6.2 Setup Fill - Manual and Auto Fill

The Setup Fill window has the following options

This selects manual filling sequence; section 6.2.1. Can only be used if a syringe is present and engaged.

selects automatic filling sequence; section 6.2.3. Can only be used if a syringe is present and engaged.

Engages the piston to the syringe plunger. Section 6. This button is only displayed when a syringe is not present or the plunger is not engaged with the piston.

Note that filling can be performed from either the injector head or the small monitor.

6.2.1 FluiDots

NOTE: a contrast-filled syringe is easily checked by noting the shape of the FluiDots on the pressure jacket. Viewed through fluid, FluiDot indicators will appear larger and rounded; viewed through air or an empty syringe, the indicators will appear small and narrow.

EMPTY - elongated shape FULLY FILLED SYRINGE - circular shape



6.2.2 Manual Fill

Point the syringe tip up by rotating the entire injector head. Remove the protective cap and attach the short leg of the QFT to the syringe. Hold the QFT at the curved portion of the tube only to avoid compromising sterility. Open the bottle of contrast and insert the long leg of the QFT into the media as per illustration.

The slider arrows control the fill rate and direction of travel of the piston. The wider gradations on the fill arrows indicate faster fill speed. Syringe piston travel will continue in the direction requested until the limits are reached.

6.2.3 Auto Fill

In the SETUP FILL screen (Section 6.2), pressing the Auto Fill button will display the automatic fill settings

Fill speed: slower creates fewer bubbles. 3-5mL/s if using a spike; 5-10mL/s if using a fill tube

Fill volume: shows presently selected volume to fill. Touching this button allows for a change to this volume using the on screen numeral key head.

Automatic movement of the syringe seal to expel air

Changing any of these parameters will turn on a button. Press this button to store the changed parameter.

Press - to commence filling.

During AutoFill, the following screen is displayed

shows the progress of filling and the volume filled

press to halt the filling operation

Once the syringe is filled, follow the Arm and Inject procedure as described in Sections 6.4.1.1.



6.3 Purging and Manual Drawback

The piston is engaged to the syringe at all times except during injection and retraction. When engaged, the system can purge air from the fluid path or draw back fluid as required.

With the catheter connected to the syringe, turn the manual knob to purge all air from the fluid path – “turn the knob away from the injector to move the piston away from the injector”.

The manual knob can also be used to draw back as well, to check the patency of the line. Turn the knob in the direction shown to draw back – “turn the knob towards the injector to move the piston towards the injector”.



6.4 Flow Setup

Flow Setup Window: Before arming can occur the operator is prompted to firstly check the maximum ratings of the catheter in use for pressure and flow. If the injection parameters need to be changed, press the Setup button (which also shows the currently-set parameters).

The injection parameters are:

Maximum allowable pressure to be achieved before controlled flow begins to operate – refer for an explanation of controlled flow operation

Rate of rise of pressure; also sets the rate of pressure fall at the end of the injection (the fall time)

This is a toggle button which sets the delay type to either Scan or Inject. Scan delay provides an audio cue to the user when the imaging system (scanner) should be started. If ISI is enabled the injector will also signal the imaging system to begin the scan. The duration of the scan delay is set in the field immediately below (set a value of zero to turn the delay feature off). Inject delay postpones the start of the injection itself by the specified amount (set a value of zero to turn the delay feature off).

This is a toggle button which indicates the current injection mode. Press the button to cycle through each of the three modes.

• Single – a single injection. Once completed, the system needs to be rearmed before a further injection can commence

• Multi-ARM – multiple injections of the same flow parameters. The injector will remain armed between each injection

• Phase - a injection containing multiple phases with different flow parameters. This option will only appear if Phase is enabled in the Options (see Section 7)

For more details on setting Multi-ARM and Phase injections, see Section 6.11.

Save all parameters to the current protocol location.

Displays a screen to edit the name of the protocol. After confirming the new name, all protocol values will be saved.

Returns to the Protocol screen, without saving



A screen will appear to confirm saving the parameters. If the protocol parameters are changed without being saved, the Protocol button will be highlighted in yellow as a reminder. More details on saving injection protocols can be found in Section 6.13

The injector will return to the Protocol screen. Press the (arm enable) button on the injector head, to ARM ENABLE the injector. When the injector is arm enabled, it can then be armed from either the injector head or the small monitor. The ARM ENABLE is cancelled whenever the injector is set to any fill mode, or is turned off.

Check the displayed ratings exceed those of the catheter, or Change as required. Confirm you have checked for air by pressing OK

Press the ARM on either the injector head or small monitor screen to arm the system, in preparation for injecting.

The system is now ARMED and ready to inject.



6.4.1 Arm and Inject Ensure the hand switch or foot switch is connected if it is intended to be used. The injection cannot be initiated without a start switch or the small monitor being connected to the injector. Connect the catheter, tubing, stopcocks and other adapters only after air has been purged from the syringe. The syringe should be pointing down for this procedure. The catheter can be connected directly to the syringe tip or a connector tube may be used between the catheter and the syringe tip. A stopcock may also be used in the fluid path with or without the connector tube. Be aware that the connector tubes and stopcocks will require the injector to develop higher pressure to deliver the selected flow rate. Make a wet-to-wet connection. The fluid path must be free of all air. Point the syringe tip down. Position the tubing hub close to the front of the syringe tip. Turn the manual knob on the back of the injector head so that contrast drips out of the syringe tip. Catch these drips with an absorbent pad.

WARNING To avoid the risk of dislodging the catheter during the injection, ensure the castors are locked and avoid moving the injector head.

The ARMED message must appear before attempting to start. If the start button is pressed before arming then a “Release Start Button” message will appear. To inject, you must operate the START switch by pressing and holding for the duration of the injection. The start switch can be: • The GREEN button on the small remote, OR • The handswitch when connected via the base power

panel connector, see Section 8.1 for location, OR • The footswitch when connected via the base power

panel connector, see Section 8.1 for location. Note: Either the footswitch or the handswitch can be connected.

The injection screen shows the current mL/s being delivered, and the volume remaining of the injection. During the injection, releasing the START switch will pause the injection immediately and return to the ARMED screen. Press the START switch to recommence the injection.

The injector can be stopped during an injection by touching anywhere on the touchscreen, powering the injector off, or touching the ARM button, i.e. any user interface control on the injector head will stop the injection, even whilst the handswitch or footswitch is activated. This is an extra safety feature allowing "blind" touches to stop an injection.



6.4.1.1 ARM ENABLE and ARM In order to minimise risk of air injection to the patient, the system can only be arm enabled at the injector head after the fluid path has been checked for air by the operator. Thereafter, the system can be armed from either the injector head, or remotely, from the small monitor. Arming can be repeated multiple times, until either an automatic or manual fill function is performed, or the injector is turned off. If REPEAT is selected, and the injector is in Multi-ARM mode, the system will remain armed and a further injection can be performed. If the injector is in Single mode, the system needs to be armed again before an injection can commence. A summary of the process flow is shown below.

System is not ARM ENABLED

Check for air

Press ARM on injector or small monitor screen

System is ARM ENABLED

System ARMED

Press Start to inject

Injecting

Press to ARM ENABLE

Injection mode is

Fill

Injection Complete



6.4.2 Arming with ISI

Refer to Section 9.6 for details on ISI installation. If the ISI function is enabled, a small text notation is added to the injection screen to indicate the type of ISI scanner selected. The notation is added below the Setup label.

Prior to attempting to use the system, please check that the scanner type shown is correct. Once the ARM button is pressed, the ARM on screen button will be displayed as shown at left. Once the ARM on screen button is pressed, the injector will be armed but not injecting, and under the control of the connected scanner. The ISI can function as an injector triggered scan or a scan triggered injection depending on the configuration selected, and the scanner setup.

6.4.3 Not Enough Volume Should insufficient volume be available to repeat the injection, the screen display will ask the user to select either Continue or Refill.

Will automatically re-adjust the volume to inject to be the actual volume available

Will advise the user to disconnect the patient, and manually fill as outlined above for the REFILL operation Refill is described in Section 6.6. Reconnect the patient

Fill the syringe manually as required and then either manually purge using the manual knob or use the forward motion arrow to expel a small amount of contrast

6.4.4 Paused and Puff Mode

You must keep pressing the inject button to continue the injection. If the inject button is released the injector goes into the ARMED mode, and the flow and volume settings return to the originally programmed values. The injection can continue by pressing and holding the inject button, or footswitch, again. This feature can be used to deliver small amounts of contrast to assist with catheter location, before commencing the full injection. Note that this mode is different from the Injection Paused mode, used in multi-phasic injections. See Section 6.11 Also note that in single-injection mode, if the volume remaining is less than the programmed volume, the injector ask whether to continue with the injection, or refill with more contrast, Section 6.2.



6.5 End of Injection Status When an injection is completed, the actual values achieved will be displayed. The actual pressure achieved should be lower than the pressure set limit. If the actual pressure achieved and the set pressure limits are the same, the injector may have pressure limited. In this case, the actual flow rate may be less than the set flow rate. At the end of the injection, disconnect the patient.

Press QUIT to return to the main screen (note the grey bar retracts, indicating the piston location) Note: From this screen, another injection process can also be started. Refer to Section 6.6 Refill Injection or Section 6.7 Repeat Injection for details. While retracting the piston, the system will display a STOP button. If you stop the plunger retraction, the system will return to the main screen, with the plunger remaining where it was stopped.

In the main screen, if the plunger is not already retracted, press Unlock. After the plunger has fully retracted, the syringe holder will now be unlocked. It can be opened, and the used syringe removed.

A biological hazard may occur if syringes are reused. Do not reuse the used syringe and fill tube with another patient. Dispose of them in accordance with your facility’s contaminated blood product disposable protocols.



6.6 Refill Injection

To increase the volume of the injection, for the same patient if more contrast is required, press Refill. Disconnect the patient from the fluid path

Reconnect the fill tube. Press Confirm to proceed to the manual fill screen. Fill the syringe manually as required and then either manually purge using the manual knob or use the forward motion arrow to expel a small amount of contrast. Reconnect the patient and press Next. The procedure to arm and inject after this is as described in Section 6.4.1

6.7 Repeat Injection

To repeat the injection with the same injection parameters, for the same patient, press Repeat Should insufficient volume be available to repeat the injection, the screen display will ask the user to select either Continue or Refill.

Will automatically re-adjust the volume to inject to be the actual volume available

Will advise the user to disconnect the patient, and manually fill as outlined above for the REFILL operation Refill is described in Section 6.6. Reconnect the patient

Fill the syringe manually as required and then either manually purge using the manual knob or use the forward motion arrow to expel a small amount of contrast Reconnect the patient

To proceed with the injection, follow the Arm and Inject procedure as described in Section 6.4.1.



6.8 Syringe Removal

WARNING ENSURE THAT THE PATIENT IS NOT CONNECTED DURING SYRINGE REMOVAL.

Disconnect the syringe from the fluid path.

Unlock the injector piston as described in Section 6.1.3. This will withdraw the injector piston from the used syringe (leaving the seal and syringe plunger at the end of the syringe barrel).

As the syringe holder unlocks, a click will be heard, indicating that the front-end lock has disengaged correctly. Rotate the front part holding the syringe pressure jacket to aid the rotation. Continue rotating until the end stop, which will lock in place. The syringe can now be removed.

Loosen the lock nut on the syringe by turning the nut fully counter clockwise 2¼ turns to 2½ turns (while the syringe is held stationery) until gentle resistance is felt. Lift the Luer lock out of the nut cut-out.

WARNING Properly dispose of the disposable in accordance with your facility’s contaminated blood product disposable protocols.



6.9 Scan Delay

A scan delay can be programmed that will trigger an audible and visual indication on the Avidia after a set time has elapsed from the beginning of the injection. In the Setup window, press the Scan button so that it toggles to “Scan”; the length of the delay can be set by entering a value in the button immediately below the delay type button. Enter a value of zero to turn the delay feature off. With the scan delay on, the sequence of indicators is:

During delay 1s before delay 0.5s before delay Delay end

Flashing Green

Solid Green

Solid Orange

Solid Orange

Pulse tone Warble tone

6.10 Inject Delay

An inject delay can be programmed that will delay the start of the Avidia injection for a set time. In the Setup window, press the Scan button so that it toggles to “Inject”; the length of this delay can be set by entering a value in the button immediately below the delay type button. Enter a value of zero to turn the delay feature off. The “Injection Paused” screen is displayed while the Inject delay counts down and no LEDs are lit during the delay.

Star

t Inj

ectio

n



6.11 Multi-ARM Flow Setup

Multi-Arm injections Setting the injection mode to Multi ARM allows multiple injections of the same flow setup shown in the single-mode screen above. At the end of each injection cycle, the system will automatically arm, ready for the injection to be repeated. Multi-arm injections are one type of multi-phase injections. More complex multi-phased injections can be set up following the steps below.

6.12 (Multi-)Phase Flow Setup

The injector can be programmed to perform a consecutive series of injection parameters in a multi-phase injection sequence. Ensure Phase is enabled in the options (see Section 7). Press Phase to enter the multi-phase screen.

Multi-Phase injections Up to four injection phases can be programmed for a multi-phase injection. Pressing one of the filled boxes [a] allows you to change or delete the action.

Inject sets the injection parameters as described in Section 6.4

Pause sets a pause time in between each stage, and restarts after this time has elapsed. If Pause is set to 0s, this action becomes Hold – the user needs to press Next to recommence the next injection stage. Pressing the switch in Pause mode will cause the timer to restart.

Multi-Arm will repeat the previous block of actions while the START button is being held or until the syringe is empty.

Delete deletes the currently selected action.

When the inject type is selected as Inject or Pause, the program will next show the keypad for the operator to enter the flow rate or pause time You can press the buttons on the right of the screen to change the value directly. Press the ARM button and begin the injection as described in Section 6.4.1. You can return to a single-mode injection by pressing Single.

[a]



6.13 Injection Protocols

Preset injection parameters can be stored in injection protocols. When injection parameters in the current protocol are changed, they are not automatically saved, and will be lost if the injector is powered off and on again. When the title of the current protocol is highlighted in yellow, this indicates that the protocol has been changed but not yet saved. To save this protocol, press the “Setup” button and then the “Save” button. The title will now change back to a white background. To recall a previously stored protocol, press the Protocol title and then select the desired protocol. To rename a protocol, press the “Setup” button and then the “Rename” button. This will rename and save the current protocol.

Press the name of the current protocol to load a previously stored protocol. A list of available protocols will be displayed.

(on the Setup screen)

Saves to the currently selected protocol name.

(on the Setup screen)

The protocol name can be renamed from the presets Protocol1, 2 etc

Alphanumeric

Telephone

Rename Protocol: The protocols can be renamed to alphanumeric titles. There are two modes of entry. These modes can be set by Imaxeon service personnel on installation of the system. Alphanumeric keypad: The keypad spans three screens – use the to select between upper and lower case, and numeric characters Telephone keypad: The keypad is similar to a telephone keypad – press the key multiple times to select the letter or number shown on the key. In both entry modes, pressing the < button erases the typed text.

Recall: A previously-saved protocol can be recalled. Select the desired protocol and press OK.



6.14 Injection Occlusion (pressure stalled or Over Pressure) & Over Speed

During the injection procedure, it is possible that the injection encounters an occlusion. The Avidia will sense whether the flow has been stopped for 2 seconds or more (Pressure Stalled), or if it has reached the pressure limit (Over Pressure). In this situation, the motor will stop, and the injection will halt. The injection piston will move back to equalise the pressure.

Additionally, if the Avidia senses the motor is moving too fast (Over Speed), the injection will halt to avoid causing an excessive flow rate.

Clear the occlusion or increase the pressure limit before proceeding.

WARNING

Disposable components with a lower pressure rating may be subjected to pressure beyond their capability, resulting in failure of the disposable and result in patient and/or user injury. ENSURE PRESSURE SETTINGS ARE LOWER THAN CATHETER AND CONNECTOR RATINGS. Only use Imaxeon disposable components.


7 Options

From the main screen, click on Options to open the Options screen.

Press the Prev or Next button to move through the Option screens.

1. Beep Volume adjusts the system beep volume, or it can be turned off completely. See Section 7.1. Note alarm will sound regardless of how the volume is set.

2. Auto Off allows the system auto timer to operate and turn power off after a preset number of minutes to save battery power. The maximum time is 120min.

3. Heater Option Turns the heat maintainer on or off.

4. System Status displays the status screen.

5. LCD Contrast sets the display contrast level ranging from light to dark. The higher number decreases the contrast level; the lower number increases the contrast level. Note that this control is independent for the injector head display and the small monitor i.e. each display has an individual contrast control.

6. Residual Volume programs the injector to leave an amount of contrast in the syringe.

7. Load Defaults reloads the original Avidia settings. A confirmation screen will appear before the defaults are loaded.

8. Help displays the IMAXEON contact information.

9. Staff shows a list of the Avidia developers

10. Units – changes the pressure units between psi and kPa. psi is default.

11. ISI Interface: If the optional ISI interface is installed, this option can select the brand of scanner to be connected to the injector.

12. Small Monitor: This option can select whether to activate or deactivate the small monitor

13. Error Log The system error log can be displayed. The log files may be useful in fault finding. 14. Data Log this displays the usage log – each action of

the injection is recorded with a time stamp.

Options


15. Language sets system language to one of the following - English, Spanish, Brazilian Portuguese, French, Italian, German, Chinese, Japanese or Dutch

16. Phase: This option turns on or off the (multi-)phase mode. By default this option is Off. See Section 6.11 on setting up parameters for this mode.

17. Clock changes the system clock.

18. Service button opens the Service Options window. NOTE: The service options are only accessible by service personnel. This option is password protected.

7.1 Beep Volume

The beep volume for the keypad/user interface and the injection warnings can be selected separately. Choose between three volume levels or silent Note alarm will sound regardless of how the volume is set.


8 Connections

This section provides information about connecting the injector to a power supply, injector accessories and other equipment in the imaging system.

WARNING

• Injectors bearing the CE mark and having accessory equipment connected to the interface connectors must be certified according to the EN 60601-1 standard. Furthermore, all configurations of injectors with attached accessory equipment must comply with system standard EN 60601-1-1. Anyone who connects additional equipment to the signal input or output part configures a medical system and is therefore responsible that the system complies with requirements of the system standard EN 60601-1-1. To obtain on-site consulting or consulting references, contact your local Imaxeon Service Representative.

CAUTION

• DO NOT USE AN EXTENSION CORD OR A POWER CORD ADAPTER. Plug the injector directly into a properly grounded AC power outlet. Since the injector power cord supplies a safety ground to the injector, using an extension cord will compromise the ground quality and the injector could become unsafe.

• CONNECT TO PROPER VOLTAGE AND FREQUENCY. Before inserting the power cord of the

injector into a power outlet, check ratings for voltage and frequency marked on the label of the power inlet panel on the base of the injector. The injector may be damaged when power is applied, which is outside the range stated.

8.1 External Panel Connector – PEDESTAL VERSION ONLY The external connector panel is located on the base between the rear castors. An illustration is shown below.

Circuit Breaker (CB1) for battery pack 1


Imaging System Interface (ISI)

IEC Power Inlet, power switch, fuse holder

Handswitch/footswitch Start connections

Potential Equalization Connection (PEC)

Connections


8.2 Front Panel Controls – RACK VERSION ONLY

8.3 External Panel Connector- RACK VERSION ONLY



Handswitch/footswitch Start connections

Charge Status LED

IEC Power Inlet, power switch, fuse holder

Imaging System Interface (ISI)

Potential Equalization Connection (PEC)

Injector head connection

Small Monitor Connection

Connections


8.3.1 Circuit Breakers CB1/CB2 The circuit breakers are a safety overload device for the battery packs fitted inside the injector.

CAUTION Whenever the injector is to be disassembled or the battery packs are to be changed, always disable the circuit breakers. Serious damage could result if the batteries are left in an active connected state during disassembly.

To DISCONNECT (disable) the circuit breakers (CB1 & CB2) Grip each CB lever – marked with the numeral 50 and pull away from the injector. The level will move and a white band around the lever will become visible. ENSURE BOTH CB1 AND CB2 ARE DISABLED

To CONNECT (enable) the circuit breakers (CB1 &CB2)

Push each CB lever towards the injector until the movement stops. The white band on the body of the lever should no longer be visible.

Circuit Breaker Actuator Positions

Connected: Unsafe to

disconnect cables Disconnected: Safe to

disconnect wires

When enabling the circuit breakers, the injector head will operate and show the start up screen. If you do not intend to use the injector, power OFF by pressing the blue injector head mounted ON/OFF button.

8.4 ISI/COMM

8.4.1 PEDESTAL VERSION The 37 way D connector serves two functions –

• ISI interface for connection to an x-ray system which can control the injector • Communications connections for a remote mounted external display.

A custom cable is required for the remote connection of the Small Monitor, please contact Imaxeon for details.

8.4.2 RACK VERSION

A 16 way circular connector is provided on the rear panel of the Rack enclosure for the ISI cable connection.

Connections


8.5 Power Inlet The power inlet assembly incorporates the following:

• ON/OFF switch – connects power to the injector for battery charging function only, I = On, O = Off.

• Fuse access drawer – this give access to the two fuses in the base. Refer to Section 8.6 for instructions on replacing the fuse.

• IEC Inlet – allows for the connection of a standard 3 pin IEC female power connector. A 3 metre power cord is provided with the injector. Use the power cord with a properly-earthed wall power outlet.

8.6 Fuse Replacement

8.6.1 Fuse Type The required fuse type is 250VAC max, 2A nominal, Time Lag (SPT) 5x20mm

8.6.2 PEDESTAL VERSION

To replace fuses, remove the main power cord and using a flat blade screwdriver, prise open the fuse access drawer by locating the slot under the drawer. The drawer will move away from the injector and can be removed for fuse inspection and replacement. Only use fuses as marked.

8.6.3 RACK VERSION

To replace fuses, remove the main power cord and using a flat blade screwdriver, prise open the fuse access drawer by locating the slot under the drawer. The drawer will move away from the injector and can be removed for fuse inspection and replacement. Only use fuses as marked.

Connections


8.7 Start Button A 3-pin XLR connector is provided for connection of a handswitch or footswitch. When connected, the injector will detect the presence of the external control and also warn the user if the start switch is not connected.

• To connect push the mating male plug into the socket until a click is heard indicating correct engagement.

• To remove locate the small lever below the connector, push-in whilst pulling on the connector body – do not pull on the cord.

NOTE: If the small monitor is connected, the GREEN button fitted to the small remote will also operate as the START button.

8.8 Potential Equalization Connection (PEC) - PEDESTAL VERSION The PEC is located on the base unit of the injector in the connector recess. The PEC allows the injector to be potentially equalised with other components used during the procedure, and provide a common earthing point. Connection to the PEC can be by mating female socket, earth clip or clamp.

8.9 Potential Equalization Connection (PEC) - RACK VERSION

The PEC is located on the Rack enclosure rear panel in the upper connector recess. The PEC allows the injector to be potentially equalised with other components used during the procedure, and provide a common earthing point. Connection to the PEC can be by mating female socket, earth clip or clamp.

Connections


8.10 Serial Number Locations

System Serial Number. Appears on the outside rim of the base tub, underneath the splash covers. The same serial number also appears on the battery tray inside the base.

Injector head serial number. Appears on the underside of the injector head. Note this number is not the serial number of the system.

Small monitor serial number. Appears on the underside of the small monitor

Battery serial number. Appears on the top corner of the battery, which resides underneath the base splash covers

(Optional) Height adjustable arm serial number. Appears on the underside of the arm

Connections


8.11 Battery Maintenance and Replacement On delivery of your new injector, and whenever a new battery is installed, the battery should be fully charged to obtain optimal performance. Leave the injector connected to line power for a minimum of 8 hours for a full charge to be reached - LED will be FLASHING ORANGE during charging. During charging, ensure that both of the circuit breakers are connected (see Section 8.3.1). If one of the circuit breakers is disconnected, one of the cells will not fully charge. Without two charged cells, the injector will not be able to perform high flow-rate injections. After 8 hours charge time, the front panel indicator should show an ORANGE colour indicating a full charge has been reached. The injector is now ready for use.

CAUTION To maintain optimal battery performance, the injector will automatically shut down after approximately 2 hours non-use, which may result in interruption to procedure 2

. If the injector is not used and recharged for an extended period, the battery will slowly self-discharge. Upon reaching a minimum charge value, a beep sound will indicate recharging is required.

Expected useful battery life is 2-4 years. If performance noticeably decreases, please contact your service representative for a replacement battery

8.11.1 Battery Disposal

WARNING The battery contains no mercury or mercury compounds. However, it does contain the following hazardous materials:

• Lead and lead alloy metals 35% • Lead inorganic compounds 40% • Electrolyte – Sulphuric Acid 15% • Separator – Glass Fibre 2%

Please dispose of this pack within environmental pollution guidelines depending on your local regulations.

2 This time is user selectable from the Options menu – Section 7


9 Maintenance and Cleaning

This section contains recommended procedures for injector maintenance, and an operational checkout. Routine maintenance and inspection will ensure continued performance and reduce the possibility of injector damage.

WARNING With the exception of the maintenance and cleaning procedures described in this section, there are no user serviceable parts in the injector.

9.1 Maintenance The injector must be properly maintained to ensure that it is in peak operating condition. Your individual maintenance system and schedule depends upon how your injector is used, the type of procedures performed and frequency of use. The following maintenance schedule is recommended for the injector.

9.1.1 Daily Inspection and Cleaning Before use each day, the entire injector should be inspected as per Section 9.2 and the injector piston thoroughly inspected for contrast fouling and if necessary cleaned as per instructions in Section 9.3.6 of this manual.

9.1.2 Monthly Cleaning and Operational check Once a month, the entire injector should be thoroughly inspected and cleaned and an operational checkout procedure should be performed. Refer to Section 9.4 for the checkout procedure.

9.1.3 Annual Check

WARNING A complete injector calibration and performance checkout should be carried out once a year by a authorised Imaxeon Service Representative. Failure to do so may result in patient or operator injury. Contact IMAXEON Service or your local Imaxeon dealer for complete details. These annual programs ensure PATIENT SAFETY by maintaining accuracy and reliability, and can also extend the life of the injector. Refer to Section 1.4 of this manual for address, fax and telephone information. Every twelve months, or more often, as required by local authorities, an electrical leakage and ground continuity check should be performed. Note: Failures which occur due to lack of proper maintenance will not be covered under warranty.

Maintenance and Cleaning


9.2 Daily Inspections The following procedures are recommended for daily inspection of all the components in the injector. If defects are detected, either repair the injector or contact your local Imaxeon Service Representative.

WARNING: DO NOT USE THE INJECTOR UNTIL THE PROBLEM IS CORRECTED.

9.2.1 Pressure Jacket Inspection

WARNING THE PRESSURE JACKET CAN DETERIORATE OVER TIME. REGULAR INSPECTION OF THE PRESSURE JACKET IS ESSENTIAL. Replace the jacket if it shows signs of deterioration (as described below). Failure to do so may result in pressure jacket failure and also result in patient or operator injury. Prior to each procedure, inspect the pressure jacket for signs of deterioration. The pressure jacket is see-through. Inspect the pressure jacket by looking through the jacket body using a strong light to highlight any of the following:

1. Cracks- inspect carefully as cracks can be hidden by the cylindrical shape of the jacket. Cracks are typically caused by dropping or other sharp impacts.

2. Stress Cracks- These are very small cracks usually in concentrated groups or patterns around the jacket circumference. Rotate the jacket under a strong light as this aids in seeing the cracks. Stress cracks usually appear after a number of pressure cycles.

3. Crazing- crazing is a form of stress mark and usually occur if non-compatible cleaning solutions have been used. Crazing also occurs as an indication that the jacket is approaching the end of useful life. The crazing will tend to interfere with the transparency of the jacket.

4. Scratches- can occur on the inside and outside of the jacket caused by objects rubbing against the surface, and may be a sign of incorrect handling. Test the depth of the scratch by pulling your fingernail across the scratch. If your nail catches the scratch then the scratch is too deep.

5. Cloudy- check that this is not caused by a contrast spill or grime. Wash the jacket as detailed below and re-inspect.

Should any of these conditions appear or if in any doubt DO NOT USE THE INJECTOR UNTIL THE PRESSURE JACKET HAS BEEN REPLACED. Contact your local Imaxeon Service Representative for replacements. Section 9.2.2 describes the replacement procedure.

WARNING Patient or operator injury, or component damage may result if an injection is performed without a pressure jacket. Ensure the pressure jacket is in place before performing an injection.



9.2.2 Pressure Jacket Replacement

Open the syringe holder.

The pressure jacket is held in place by a spring-loaded retainer. The pressure jacket is shown here in the locked position.

Turn the pressure jacket gently in a clockwise direction until it moves into the unlocked position show here.

The pressure holder will now slide out easily. Replace with a new pressure jacket if necessary.



9.2.3 Injector Head / Pedestal Inspection Inspect the housing for cracks that could allow fluid to penetrate and breakdown the structural integrity of the injector. Inspect the injector head cable for cracks, or worn sections. Inspect the injector head pivot. The injector head and arm must pivot freely between the end stops. Verify that the end stops do not allow more than 180º rotation of the injector head or a 120º rotation of the arm pivot. Ensure the injector arm moves freely with minimal force and does not drift. If drifting occurs, do not use the injector. Pedestal version only – Inspect the injector pedestal castors. Verify that all casters rotate smoothly and that all locking mechanisms function properly.

WARNING

• IF IN DOUBT ABOUT THE INJECTOR INTEGRITY, DO NOT USE. Contact your local Imaxeon Service Representative immediately. See Section 1.4 for contact details.

• SHOCK HAZARD when cleaning. In order to avoid shock and prevent damage to the injector, always disconnect the injector system from line power before cleaning. Ensure that the injector is completely dry before connecting to a power source and applying power.

• DO NOT IMMERSE ANY PART OF THE INJECTION SYSTEM IN WATER. Improper or careless cleaning methods may result in equipment damage. While cleaning any outside surface of the injector, avoid allowing any water or cleaning solutions to seep inside injector components

Carefully wipe off any liquid spills before they dry, using a paper towel moistened in warm water. A mild disinfectant is recommended after normal cleaning. If contrast medium has leaked inside any component of the injector, the affected subassembly should be dissembled and cleaned. This cleaning procedure can be done in the field by trained IMAXEON service personnel.

9.2.4 Hand and Footswitch Inspection Inspect switches and cables connected to the injector. Look for cuts, cracks or worn spots in the cable; look for cracks and loose parts in the switch and housing. Ensure that the switch operates without sticking and that all connectors are properly seated.

9.2.5 System Labels Inspection Check all of the injector safety and warning labels for legibility. Ensure labels are not damaged or missing.



9.3 Cleaning

9.3.1 General cleaning instructions

WARNING In order to avoid any biological contamination hazards, if any blood or bodily fluids come into contact with the injector, clean the injector with warm water and disinfectant immediately. Follow the instructions below to avoid shock hazards or damage to the injector. Cleaning of the injector should be limited to the external covers and user replacement components such as the pressure jacket and surrounding syringe holder. While cleaning, do not expose injector components to excessive amounts of water or cleaning solutions. Wipe components with a soft cloth or paper towel dampened with cleaning solution. Do no use strong cleaning agents and solvents such as acetone. Warm water and a disinfectant are all that is required. Wipe off contrast spills with warm water before they dry. If contrast media has leaked inside any system component, the affected subassembly should be disassembled and cleaned by Imaxeon Service personnel or returned to Imaxeon Factory Service.

9.3.2 Contrast spills into the front of the injector Inspect the front end of the injector for contrast spillage in and around the syringe holder. Look into the piston housing and observe the piston for cleanliness. If any contrast or other matter is visible, follow the procedure for cleaning in Section 9.3.

9.3.3 Control panel cleaning Wipe the control panel with a soft cloth or paper towel dampened with warm water or a cleaning solution.

CAUTION SHOCK HAZARD when cleaning: In order to avoid shock and prevent damage to the injector, always disconnect the injector from line power before cleaning. Ensure that the injector is completely dry before connecting to a power source and applying power. Improper or careless cleaning methods may result in equipment damage. When cleaning any outside surface of the injector, avoid allowing any water or cleaning solutions to seep inside injector components. Wipe off contrast spills with warm water before they dry.

9.3.4 Injector Head Cleaning Using a paper towel moistened with warm water or a mild disinfectant, gently wipe the injector head and front end components. Care must be taken not to get water or cleaning solutions inside the injector head. 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.



9.3.5 Pressure Jacket Cleaning In addition to regular cleaning, it is critical to perform a regular inspection of the pressure jacket. Refer to Section 9.2.1 for details. Pressure Jackets should be routinely cleaned to remove contrast and other contaminants. Some cleaning agents react with the plastic material and may cause structural degradation. Recommended Cleaning Procedure:

1. Wash in a solution of warm water (35°C to 45°C) and mild detergent (neutral grade low pH, enzymatic cleaner)

2. Rinse thoroughly 3. Dry with soft cloth

CAUTION

• Should a germicidal cleaning agent be preferred, please check the compatibility with polycarbonate and the dilution requirements before use. Do not leave the pressure jacket in any germicidal cleaner for extended periods.

• Pressure jackets should not be exposed to Fluorocarbons (such as Freon) or other solvents (acetone, benzol, carbon tetrachloride, MEK, MIBK, toluol, trichlor or triclene). Gases used to pressurize aerosol cans can also damage pressure jackets.

9.3.5.1 Pressure Jacket Sterilization Sterilization of the pressure jacket is not normally required as injected contrast does not contact the jacket. If sterilization is required, cold chemical sterilization is recommended. Zephiran Chloride diluted as recommended by the manufacturer can be used.

CAUTION • Do not use gas sterilization (ethylene oxide) • Do not leave the pressure jacket in any the cold chemical sterilizer for extended periods as the

life of the jacket may be reduced. • Autoclave temperatures will distort the pressure jacket. Do not Autoclave.



9.3.6 Syringe Interface / Injector Piston Cleaning

Ensure the injector piston pins and syringe sensor, are clear of contrast build up and injector performance is not degraded. The illustration shows the important parts of the injector piston and syringe plunger interface.

Front View Side View

Syringe plunger sensor

Syringe plunger actuator pin. Pins must be free to move

Remove the pressure jacket (see Section 9.2.2 for details on how to remove the pressure jacket) and close the syringe holder.

Press the Lock button on the main screen The piston will fully extend and give an error when it does not find a syringe.

WARNING Keep clear of the piston as it is moving to prevent injury.

As the piston extends out from the injector, the pins will retract into the piston. Use the manual knob to retract the piston and the pins will extend out from the piston. Ensure all pins move together during these movements. If the pins appear to be stuck, clean the pins and piston with a soft damp cloth. Mild detergents can be used. However harsh and abrasive cleaners are not to be used under any circumstances.

For stubborn build up, you may need to soak the piston in a solution of hot water and detergent solutions. Moving the piston backwards and forwards will extend and retract the actuator pins, which facilitates cleaning. Once clean, wipe the piston head dry. Retract the piston.

Inspect the rear of the pressure jacket to ensure that the hexagonal spring, which is used to firmly secure the syringe, is in place.



9.4 Operator Checkout Procedures

9.4.1 Introduction The following checkout procedures test the major functions of the injector and should be completed before using the injector for the first time or as a monthly routine preventive maintenance program. If a problem or a calibration error is suspected, use this procedure for troubleshooting before contacting IMAXEON Service. Note: After performing this procedure before using the injector for the first time, the injector warranty registration card should be completed, noting the checkout has been performed, and returned to Imaxeon. Certain steps in this procedure require that multiple observations be made during the test. Read through each step for complete understanding. Each step explains what to do and what should happen on the injector. Section 6 contains specific information about each control display. If problems arise while going through these procedures, stop and do not use the injector. Record any messages that are displayed. Contact your local Imaxeon Service Representative.

9.4.2 Checkout Procedure 1. Examine the injector for signs of damage or wear. 2. With the injector off, disengage each circuit breaker CB1 and CB2. Reengage each circuit

breaker noting the physical movement of the lever. Feel for any sign of difficulty in moving the CB lever. (Note: Once either CB is disengaged, the front panel LED will glow RED).

3. The injector will now be powered on with the front panel indicator showing green. Power OFF the injector, by pressing the blue power ON/OFF button on the injector head.

4. The green LED will extinguish. Connect an IEC power cord, and depending on the state of charge of the batteries, the LED may begin to flash ORANGE once line power is applied.

5. Turn the injector ON and the LED will display green, in colour. 6. The screen display should be bright and clear when viewed front on. 7. The piston should either be retracted or should now retract. 8. Fit a syringe. 9. Select LOCK. 10. Select MANUAL (fill). 11. Touch the screen in the arrowed areas and observe movement of the piston in or out depending

on chosen directions. A warning message will appear if the maximum volume has been reached. 12. Fill a syringe with an amount of water, say 120mL. 13. Press NEXT. 14. Check the displayed parameter as –

Volume = 100mL Flow = 10mL/s Set up Rise = 0.5 Set up Fall = 0.5 Pressure = 3500 kPa = (500 psi)

15. Use a measuring cylinder or similar known volume container marked to 100mL (±2mL) volume. 16. Inject 100mL volume and observe the inject time to be 10 seconds and the volume of 100±2mL.

The test can incorporate a pressure measurement if a measurement transducer is available (calibrated pressure gauge to 7000 kPa [1000 psi] or an electronic measurement transducer).

17. Check pressure accuracy to 3500±350kPa [500±50psi]. Use of a restrictor device will be needed to achieve consistent pressure build up.

18. Check the volume indicated on the screen as 100mL, and injection time of 10 seconds. 19. Retest at a flow rate of 40mL/sec and check results. 20. Check values on screen to confirm injection results.



9.5 Rack Model Configuration The Rack mount configuration has a number of possible installation configurations depending on the site conditions. Illustrated below are a number of possible customer configurations depending on customer preferences. These configurations are not intended to be exhaustive as each site will be different. Typically, the extension cables for the power head and small monitor would be laid in a floor well or cable harness in a ceiling space. The cable routing may be through a wall or into a ceiling space via a wall plate or bulkhead interface plate. The floor mount adapter, referred to above as Connector Kit provides a protected mounting point for the head extension cable connector. This component terminates the head extension cable within the scan room and allows for the disconnection of the Power head from the table bracket, and pedestal storage if required.

9.6 Avidia ISI

9.6.1 Description The ISI adapter provides a means of connection between the Avidia injector and X-Ray scanners from major manufacturers. The Avidia supports ISI interfaces from the following manufacturers:

• Philips • Siemens • Toshiba

The cables used to connect to the scanners listed are MEDRAD cables available from Imaxeon. The cables required may already be installed at the scanner site if ISI connectivity was ordered, or if Avidia is replacing an older MEDRAD injector. The installation of the ISI should only be carried out by an authorised Imaxeon Service Representative.

9.6.2 Enabling ISI Function

From the main screen, click on Options to open the Options screen. Press the Prev or Next button to move through the Option screens.

ISI Interface: If the optional ISI interface is installed, this option can select the brand of scanner to be connected to the injector.


10 Trouble-Shooting

10.1 Fault Finding Guide This guide is limited to suggestions for problem rectification that do not require the use of special tools or equipment not available to the majority of users. Should the following suggested procedures not solve the problem, please contact local Imaxeon Service Representative. Do not attempt to use the injector if a problem persists.

PROBLEM CORRECTIVE ACTION

REFERENCE

Unit will not turn on from Head on/off switch

Battery Packs charged? Section 8.11

Battery Packs connected? Section 8.11

Battery packs not charged Check indicator colour. Red = Battery pack failure Orange Flash = charging Orange= charged

Section 8.11

Battery pack not charging correctly

Connect mains power, turn power on, check indicator colour. Red = Battery pack failure Orange Flash = charging

Section 8.11

Charger not functional Check mains power on. Section 6.1.1

Check fuse in IEC connector. Section 8.5

No screen display Contact Service Section 1.4

Dull screen Contrast setting in OPTIONS. Section 7

Touch screen not working Contact Service Section 1.4

Error message displayed Contact Service; quote error message Section 1.4

Front of injector will not open when selecting UNLOCK

Press firmly on front of the injector to ensure it is fully closed, and select UNLOCK again. A click should be heard.

Section 6.1.3

If this does not occur, select LOCK to engage the piston, and then select UNLOCK again.

If no click is heard call Service Section 1.4

Pressure Jacket loose Open front and rotate jacket to lock into position. Section 6.1.2

Syringes fall out Open front and check hex spring is fitted to pressure jacket. Section 6.1.2

Piston doesn’t move during manual fill

Check front closed properly. Section 6.1.2

Batteries low on charge – connect mains supply and retest movement. Section 8.11

Piston will not engage with syringe correctly

Change syringe. Section 6.1.2

Piston will not engage with syringe and retract for syringe filling

Remove syringe and check build up on piston end. Section 9.3.6

Check condition of piston. Section 9.3.6

Piston will not disengage from the syringe after injection

Move the piston fully to the front of the syringe. Block off the syringe tip, and wind back the plunger using the manual knob. The vacuum created in the syringe should disengage the piston.

Section 5

Piston collides with, and pushes the syringe, and fails to stop

Syringe detector dirty. Clean and retest Section 9.3.6

Contact Service Section 1.4

Cannot inject at a rate more than 20mL/s

Battery charge required (both cells need to be charged) Section 8.11

Check both circuit breakers were connected during battery charge Section 8.3.1

Less than 10 injections per battery charge (overnight)

Battery charge required. Section 8.11

Contact Service Section 1.4

Injector noisy Contact Service Section 1.4

Repeated BEEP when unplugged from mains

Recharge battery. Section 8.11

Trouble-Shooting


PROBLEM CORRECTIVE ACTION

REFERENCE

Injection will not start Ensure injector is powered ON, and has not automatically powered down if the preparation time has exceeded the auto-power off function. Max time is 2 hours.

Section 6.1.1

Check injector is ARMED Section 6.4.1

Check cables connected securely Section 8

[If ISI installed] Check correct ISI interface for the scanner is selected as indicated by on-screen message

Section 9.6.2

[If ISI installed] Check correct interface box is in use for scanner type Section 11.18.4

[If ISI installed] Check correct cable for scanner

[If ISI installed] Check scanner is ISI enabled Section 9.6.2

Injector runs immediately after Arming

[If ISI installed] Cable fault – disconnect and call service Section 1.4

Injector will not stop [If ISI installed] Cable fault – disconnect and call service Section 1.4

Trouble-Shooting


10.2 Error Messages Diagnostic and error messages are listed below. A recommended action is listed in the table. MESSAGE SCREEN CAUSE ACTION

Battery Low

Battery pack is discharged Recharge for 8 hours

Software Error

Error detected in running software Contact service

Over Pressure

Overpressure detected during injection Check set point Check occlusion Check kink

Over Speed

A blockage in the fluid line may have occurred. If this occlusion is suddenly removed, or the connection leaks, the piston may experience over speed, and is shut down for safety

Check fluid line for leaks or occlusion

Final Drive Error

Mechanical failure in drive mechanism Call service

Motor Overheat / Over Temp

Mechanical failure in drive mechanism Call Service

No Footswitch

No footswitch or handswitch connected Connect footswitch or handswitch

End Error

The piston has been wound too far past the end of travel

Manually wind the piston back towards the injector. Section 6.3

Trouble-Shooting


Start SW Error

The piston has been wound back too far towards the injector.

Manually wind the piston forward away from the injector. Section 6.3

Pressure Stalled

Fluid line has been occluded and the flow rate has been reduced

Check set point Check occlusion Check kink

Motor Lag Error

The motor control has determined the motor position is incorrect.

Call Service

Hall Error/Motor Sensor alignment error

Motor position sensor error Call Service

10.3 Calling Service Please call Service at any time you feel that a problem has developed with the injector. If you have seen an error message, please note all operating conditions at the time of the message, along with the message details. This information will assist your service engineer in responding to the problem quickly.


11 Specifications

11.1 Pedestal Dimensions The injector’s major physical dimensions in mm are illustrated below

The injector with height-adjustable arm physical dimensions in mm are illustrated below

Specifications


11.2 Rack Dimensions

11.3 Approvals CE marked, Class IIB medical device TGA medical device inclusion for Australia only: ARTG: 127668 (Injector), 127663 (syringe) Standards : EN 60601-1 Class 1, Type CF

EN 60601-1-2

Specifications


11.4 Functional Max Pressure 1200 psi

(Displayed) Pressure Resolution 1 psi

Pressure Accuracy ±50 psi

(User Selectable) Set Pressure Limit variable, steps of 1 psi

(Internal) Control Pressure Limit Set Pressure Limit – 12.5%xSet Pressure Limit (see Section 4.3)

Max Flow Rate 50 mL/sec

Flow Rate Resolution 0.1 mL/sec

Flow Rate Accuracy ±5% of selected flow rate

Pressure Rise Time range 0-10 second

Pressure Rise Time resolution 0.1 second

Maximum Volume 150mL

(User Selectable) Volume Resolution 0.1 mL

Volume Accuracy ±1% of selected volume

Manual Fill rate 0.2 –12 mL/sec

Auto Fill rate 5 – 20 mL/sec

Automatic syringe plunger detection

Multistage Injection 4 stages

Multi stage arming (safety)

Delay Timer Range 0 - 99 seconds

Delay Timer Resolution 1 second

11.5 Controls Pedestal/Rack Line power ON/OFF, double pole switch

IEC power inlet, double fused

Dual Circuit Breakers 50A max

Injector Head 4.7”, 1/4VGA, 16 colour minimum, On screen controls via 4 wire Touch screen, Manual Purge (mechanical). Volume display, Flow Rate Display, Fill rate control– variable speed, Purge rate control– variable speed

Small Monitor 4.7”, 1/4VGA, 16 colour minimum, On screen controls via 4 wire Touch screen, Integral “START” button, Removable from Pedestal on coiled cable

Small Monitor/Hand Switch/Footswitch Inject now/Stop

11.6 Indicators Line on/off Power on Green

Battery charging charging Orange

Battery Failure/Low Red LED

Alarm/Warning Red LED in rear lens

Armed Green LED on continuously

Paused Injection Green LEDs on continuously

Injecting Green LEDs flashing

Flow Controlled 3 Orange LEDs

3 Flow Controlled Injection – reached Pressure Limit and injection continues at achievable Flow.

Specifications


11.7 Mechanical (Pedestal) Weight Injector head: 10Kg, Total: 65Kg

Height 1500 mm, injector head upright fill position

Floor Area 650W x 700D mm

Folded Area within floor plan dimensions

No of Wheels 4, two locking

Type of Wheel Rubber Castor, ball bearing race

Extension 800mm from pedestal centre

Construction Materials Kydex panels, Aluminium, Stainless Steel

Operating Noise Level <75 dBA

Centre of Gravity 200mm agl

Moisture/Dust Ingress (excluding footswitch) IPX0

Moisture/Dust Ingress (footswitch) IP68

11.8 Mechanical (Rack) Weight Injector head: 10Kg, Rack Unit: 25Kg

Construction Materials Kydex panels, Aluminium, Stainless Steel

Operating Noise Level <75 dBA

Moisture/Dust Ingress IPX0 (Injector head only)

11.9 Electrical Line Voltage 110-240 VAC ±10%

Line frequency 50/60 Hz

Phase single

Charging AC only

Operating Batteries only

Max Current Consumption, Operating 45A peak (battery only)

Max Current Consumption, Standby 0.5A or less

Consumption, Charging from mains 1A maximum

Current Surge (inlet fuse) Rating 2A maximum

Battery Voltage 24VDC

Battery type Imaxeon 12 V7.2Ah Lead Acid

Battery Hazardous Material Content • Lead and lead alloy metals 35% • Lead inorganic compounds 40% • Electrolyte – Sulphuric Acid 15% • Separator – Glass Fibre 2% Contains no mercury or mercury compounds.

No. of Batteries 2 packs of 2 cells

Recharge time (for 25 injections) 8 hours

Battery Service Life 2 years

Contrast Heater operation auto detect syringe

Contrast Heater – rating 5W

Contract Heater – temperature range 37±2°C

Category AP/APG Not Applicable

Specifications


11.10 Environmental Temperature – transport -20°C to +60°C

Temperature – operation +10°C to +40°C

Humidity – transport 10% to 95% RH, non condensing

Humidity – operation 20% to 80% RH

Barometric Pressure - transport 48kPa to 110kPa

Barometric Pressure - operation 70kPa to 100kPa

11.11 External Interfaces Remote Display/Controller RS422

ISI Inputs/Outputs:

X ray trigger input Opto-isolated input sourced by internal isolated supply

Handswitch Disable Opto-isolated input sourced by internal isolated supply

Injector Disarm Opto-isolated input sourced by internal isolated supply

Remote Injector start Opto-isolated input sourced by internal isolated supply

X ray trigger output isolated N.O contact

Armed isolated N.O contact

Injector Started isolated N.O contact

Handswitch Operated isolated N.O contact

11.12 Connectors Head Cable High power D connector, 27 Way

Small Remote 15 way D connector integrated cable in pedestal

ISI/RS422 37 way D connector (in Base)- Pedestal version 16 way circular (rear of Rack enclosure)- Rack version

Foot Switch Circular, locking. 3 pin XLR

Line Power IEC dual

Equipotential Point MC POAG-S6 SERIES

Syringe Heater 2.5mm DC power socket

11.13 Protection Against Electrical Shock Per EN 60601-1, the injector is designed as Class 1 equipment with Type CF applied parts. Type CF corresponds to the degree of protection against electrical shock via the applied parts. Class 1 applies to equipment which includes a means for the connection of the equipment to protective earth in such a way that accessible metal parts cannot become live in the event of failure of the basic insulation.

11.14 Electrical leakage Earth <100 μA at 120 VAC

<300 μA at 240 VAC

Chassis <100 μA

Patient <10 μA

11.15 Operating The system may not meet all performance specifications if operated outside of the following conditions: Temperature +10°C to + 40°C (+50°F to + 104°F)

Humidity 20% to 80% R.H. at 40°C non condensing

Air Pressure: 70 kPa to 100 kPa

Specifications


11.16 Ground Continuity The resistance from the earth ground connector at the plug-end of the AC power cord to any grounded exposed metal is less than 0.2Ω.

11.17 IEC60601-1-2:2001 Compliance

11.17.1 Electromagnetic Emissions

Guidance and manufacturer’s declaration – electromagnetic emissions

The Avidia angiographic contrast injector is suitable for use in the electromagnetic environment specified below. The customer or the user of the Avidia angiographic contrast injector must ensure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment – guidance

RF emissions CISPR 11

Group 1 The Avidia angiographic contrast injector uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class B The Avidia angiographic contrast injector is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions

IEC 61000-3-2 Class A

Voltage fluctuations IEC 61000-3-3

Complies

Specifications


11.17.2 Electromagnetic Immunity

Guidance and manufacturer’s declaration – electromagnetic immunity


Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance

Electrostatic discharge (ESD)

IEC61000-4-2

± 6 kV contact

± 8 kV air

± 6 kV contact

± 8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/burst

IEC 61000-4-4

± 2 kV for power supply lines

± 1 kV for input/output lines

± 2 kV for power supply lines

± 1 kV for input/output lines

Mains power quality should be that of a typical commercial or hospital environment.

Surge

IEC 61000-4-5

± 1 kV line(s) to line(s)

± 2 kV line(s) to earth

± 1 kV line(s) to line(s)

± 2 kV line(s) to earth

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

< 5% UT (> 95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles < 5% UT (> 95% dip in UT) for 5 sec

< 5% UT (> 95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles < 5% UT (> 95% dip in UT) for 5 sec

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Avidia angiographic contrast injector requires continued operation during power mains interruptions, it is recommended that the Avidia angiographic contrast injector be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz) magnetic field

IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Note: UT is the AC mains voltage prior to application of the test level.

Specifications


Guidance and manufacturer’s declaration – electromagnetic immunity


Immunity test IEC 60601 test level

Compliance level

Electromagnetic environment guidance

Portable and mobile RF communication equipment should be used no closer to any part of the Avidia angiographic contrast injector than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance:

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms

d = 1.2√P

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 V/m d = 1.2√P 80 MHz to 800 MHz d = 2.3√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 metres (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 this symbol:

NOTE 1 NOTE 2

At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a

b

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 and TV 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 Avidia angiographic contrast injector is used exceeds the applicable RF compliance level above, the Avidia angiographic contrast injector should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Avidia angiographic contrast injector. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Specifications


11.17.3 Recommended separation distances from portable and mobile RF communications equipment and the Avidia angiographic contrast injector

Recommended separation distances from portable and mobile RF communications equipment and the Avidia angiographic contrast injector

The Avidia angiographic contrast injector is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Avidia angiographic contrast injector can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Avidia angiographic contrast 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 = 1.2√P

80 MHz to 800 MHz d = 1.2√P

800 MHz to 2.5 GHz d = 2.3√P

0.01 0.1 0.1 0.2

0.1 0.4 0.4 0.7

1 1.3 1.3 2.3

10 3.8 3.8 7.3

100 12.0 12.0 23.0

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (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 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.

11.17.4 Magnetic Navigation Systems The injector is compatible with Magnetic Navigation Systems up to 0.15mT. As a precaution, is recommended that the Avidia is placed 4 feet away and with locked wheels.

Specifications


11.18 Authorised Accessories The use of substitute or non-original accessories may endanger the patient or operator.

11.18.1 General Accessories The following COMMON accessories are designed for use with the Pedestal or Rack version of the injector. Accessory Part number SAP No

Power Cord

1. Australia WP0004

2. South America WP0020

3. Japan WP0021

4. EU WP0016

5. China WP0019

6. UK WP0022

7. 150mL Syringe and Quick Fill Tube 150-EF-Q 3013495

8. Pressure Jacket AV020 3013642

9. Heat Maintainer AV012 3013632

10. Handswitch AV015 3013610

11. Footswitch AV014 3013643

12. Battery HB0020S 3013655

13. Operation Manual - English MN010001

14. Operation Manual - Chinese MN010002

15. Operation Manual - German MN010003

16. Operation Manual - Brazilian Portuguese MN010005

17. Operation Manual - Latin American Spanish MN010006

18. Operation Manual - Polish MN010008

19. Operation Manual - French MN010009

20. Operation Manual - Italian MN010010

21. Operation Manual - Dutch MN010011

22. Operation Manual - Iberian Spanish MN010014

23. Operation Manual - Danish MN010015

24. Operation Manual - Turkish MN010016

25. Quick Guide Avidia English MN010007

26. Quick Guide Avidia Dutch MN010012

27. Quick Guide Avidia Danish MN010018

28. Quick Guide Avidia Chinese MN010019

11.18.2 Pedestal Accessories Accessory Part number SAP No

29. Height adjustable arm AV006B 3018425

Specifications


11.18.3 Rack Mount Accessories The following additional optional components are available for particular configurations of the RACK version of the injector system: Accessory Part number SAP No

30. Small Monitor Rack Mount AV013R 3018805

31. Small Monitor Desk Mount AV203 3018806

32. Injector Head Mount Adapter AV204 3018808

33. Cable Mount Floor Assembly AV205 3018428

34. Small Monitor Rail Mount AV207 3018807

35. Head Cable, 4.5m WCAS002 - 45 3018437

36. Rack to head cable, 18.3m WCAS047 -18.3 3018429

37. Rack to head cable, 22.9m WCAS047 - 22.9 3018430

38. Rack to head cable, 30.5m WCAS047 - 30.5 3018432

39. Small Monitor Extension cable, 18.3m WCAS049 -18.3 3018433

40. Small Monitor Extension cable, 22.9m WCAS049 - 22.9 3018434

41. Small Monitor Extension cable, 30.5m WCAS049 - 30.5 3018435

42. Medrad Bed Mount MED-KMA-350

43. Front Connector Plate AFM 006

44. Overhead Counterpoise Refer to Portegra2 catalog list, available on request

11.18.4 ISI Accessories The following additional optional components are available for systems with ISI installed:

Scanner Medrad Cable ISI ADAPTER box required

Notes

Siemens XMC 977A AVISI-S Mains Present

Toshiba XMC 960R AVISI-U

Philips XMC 927A AVISI-U

Ziehm XMC 906i AVISI-U

11.19 Mode of Operation Per EN 60601-1 the mode of operation for the injector is continuous operation with intermittent loading. It is capable of operation under normal load for an unlimited period, without excessive temperature being developed. Although power is applied continuously, the intermittent use for loading, and injecting will result in an internal temperature less than the continuous load operating temperatures, but greater than the no load operating temperatures. Under normal operating conditions with minimum of 10 minutes between injections, the internal temperature will not rise enough to degrade injector performance or reliability.

12 Warranty Conditions

IMAXEON warrants the Avidia Angiographic Contrast Injector for a period of 12 months from date of installation, and covers manufacturing faults and component part defects provided the following operational conditions are observed:

1. Use by trained and qualified personnel 2. Use within the environmental conditions listed in Section 11.10 3. Adequate cleaning is undertaken to ensure smooth operation of moving components.

Please contact your service representative using the addresses and phone/fax numbers listed in Section 1.4 for warranty and service enquiries.


13 Index

Accessories, 75 Adaptive Flow, 20 Air Embolization, 13 Air Pressure, 70 Approvals, 67 ARM, 33, 35 ARM ENABLE, 10, 33, 35 Arming

ISI, 36 Auto Off, 44 Autoclave, 58 Back button, 25 Base, 21 Batteries, 16, 25

Low, 64 Battery, 75 Battery Disposal, 52 Beep, 44 Biological Hazard, 10 Blockage, 43 Bridge, 21 Castors, 21 Catalog Number, 23 Catheter, 34 CE Mark, 67 Certifications, 7 Checkout, 60 Circuit Breaker, 46, 48 Cleaning, 57 Clock, 45 Connection to other equipment, 14 Connector Tube, 34 Connectors, 70 Contact Information, 7 Contraindications, 12 Contrast

Spilled, 57 Controls, 68 Data Log, 44 Defaults, 44 Duration, 25 Electrical Leakage, 70 Electrical Shock, 10 Electrical Specifications, 69 EMC, 14 End Error, 64

Environmental Specifications, 70 Equipotential, 46, 50 Equipotential Connection, 11 Error Messages, 64 Ethylene Oxide, 58 External Connector Panel, 21 External Interfaces, 70 External Panel Connector, 46 Fault Finding, 62 FDE, 64 Fill speed, 30 Final Drive Error, 64 Flow Rate, 19

High, 13 Flow Setup, 32 FluiDots, 29 Footswitch, 11, 24, 46, 50, 75

Inspection, 56 Functional Specifications, 68 Fuse, 46, 49 Ground Continuity, 71 Handswitch, 11, 24, 46, 50, 75

Inspection, 56 Hazards, 15 Heat Maintainer, 13, 24 Height adjustable arm, 75 Height Adjustable Arm, 21 Help, 44 Humidity, 70 IEC60601-1-2, 71 Imaxeon, 7 Indicators, 68 Injecting, 34

End of, 37 Injection

Blockage, 43 multi-mode, 41

Injection Duration, 19 Injections

high rate, 62 Injector, 21

Head, Cleaning, 57 Locking and Unlocking, 17 Piston, cleaning, 59

insufficient volume, 38 Intended Use, 12

Index


ISI, 46, 76 Arming, 36

Labels, 56 Lot Number, 23 Mains Power, 46 Maintenance, 53 Manual Drawback, 31 Manual Fill, 10, 30 Mode of Operation, 76 Monitor, 21, 24 Motor Lag Error, 65 Motor Overheat, 64 Multi-ARM, 32 Multi-mode, 41 Options, 44 Over Pressure, 43, 64 Over Speed, 64 Over Temp, 64 Overspeed

Over-, 19 Paused, 36 Pedestal, 21

Mechanical Specifications, 69 Phase, 32 Phase option, 45 Potential Earth Equalization, 46 Potential Equalization Connection, 50 Power, 10 Power Cord, 75 Power Head, 21 Power Inlet, 49 Power On, 26, 46 Pressure, 19

Over, 19, 43 Stalled, 19, 43

Pressure Jacket, 13, 22 Cleaning, 58 Inspection, 54 Sterilization, 58

Pressure Jacket Replacement, 55 Pressure Limit, 20, 43 Pressure Stalled, 65 Protection Against Electric Shock, 70 Protective Earth, 11, 14 Protocols, 42

Puff, 36 Purging, 31 QFT, 30 Quit button, 25 Rack

Mechanical Specifications, 69 Rack Assembly, 61 Refill, 38 Repeat, 38 Residual Volume, 44 Run, 10 Save protocol, 33 Scan Delay, 40 Serial Number, 51 Service, 65 Service Options, 45 single injection, 32 Specification, 66 Stall, 15 Start button, 24, 50 Start SW Error, 65 State Indicator, 26 Sterility, 23 Sterilization, 58 Syringes, 75

Disposal, 39 Filled, 13, 28 Filling, 27 Heat Maintainer, 13, 24, 75 Heater, 44 Holder, 27 Loading, 28 Package, 23 Position, 25 Prefilled, 29 Removal, 39

Temperature, 70 TGA, 67 Time, 45 Trademarks, 7 Transportation, 17 Trouble-shooting, 62 Used, 25 Warnings, 10 Warranty, 76

operation manual - imaxeonomr.imaxeon.com.au/omr/.../download/om...mn010001.pdf · read this manual...

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