Operation Manual
78 Pages
Preview
Page 1
operation manual
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CONTENTS
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 REF MN010001-07.1
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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
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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 REF MN010001-07.1
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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
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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
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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
1.1
Serial No:
IMAXEON Service Representative Telephone No:
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 REF MN010001-07.1
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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.
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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
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About This Manual
2.5 2.5.1
Symbols, Labels and Controls 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
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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
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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.
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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.
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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.
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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 lowpressure 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.
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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.
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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
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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.
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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 20mL/s flow rate
=
2.5s duration
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.
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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 1 immediately. This is known as overpressure. . 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. REF MN010001-07.1
Avidia Operation Manual
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