MN150001

Operation Manual
2 MEDRAD Vistron Plus Operation Manual: MN150001-11.3

MEDRAD Vistron Plus Operation Manual: MN150001-11.3 3
Contents
1. Quick Start ..............................................................................................................................10
2. Introduction ............................................................................................................................11
2.1. Important Safety Notice .................................................................................................11
2.2. How To Read This Manual ..............................................................................................11
2.3. Certifications...................................................................................................................11
2.4. Intended Use ..................................................................................................................11
2.5. Contraindications ...........................................................................................................11
2.6. Trademarks .....................................................................................................................11
2.7. Disclaimers......................................................................................................................12
2.8. Imaxeon Contact Information ........................................................................................12
2.8.1. Manufacturer..........................................................................................................12
2.8.2. EC Representative...................................................................................................12
2.9. SYRINGE - Warnings and Cautions..................................................................................13
2.10. INJECTOR - Warnings and Cautions ............................................................................15
2.10.1. Glomerular filtration rate (GFR) Calculator Warnings ............................................18
3. Getting Started .......................................................................................................................19
3.1. Installation ......................................................................................................................19
3.2. Injector Features ............................................................................................................20
3.2.1. Injector Head Description.......................................................................................20
3.3. Symbols...........................................................................................................................21
3.3.1. Symbols used in this manual ..................................................................................21
3.3.2. Symbols used on labelling ......................................................................................21
3.3.3. Handswitch and Footswitch ...................................................................................22
3.3.4. Icons and Buttons used on the Injector Touch Screen Graphical Interface ...........23
3.3.5. Injector Buttons ......................................................................................................26
3.3.6. Remote Control Symbols and Buttons ...................................................................26
3.3.7. Injector Visual Indicators ........................................................................................27
3.3.8. Icons and Buttons used on the RCU Touch Screen Graphical Interface .................28
4. Clinical Information ................................................................................................................31
4.1. Cannula and Needle Selection ........................................................................................31
4.2. Understanding pressure and flow, pressure limiting & adaptive flow ..........................32
4.2.1. Pressure Basics .......................................................................................................32
4.2.2. Summary.................................................................................................................32
4.3. Adaptive Flow, Pressure Limit and Over Pressure..........................................................33
4.3.1. What to do in the event of adaptive flow reducing image quality.........................33
4.4. Warming the Contrast: Heat Maintainer........................................................................34
5. Operation Description ............................................................................................................35
5.1. Turning the System On for the First Time ......................................................................35
5.2. Syringe, Quick Fill Tube, Fill Spike, and Connector Tubes ..............................................37
5.2.1. Description and Part Number .................................................................................37
5.2.2. Syringe FluiDots™ ...................................................................................................37
5.2.3. Mounting the Syringe .............................................................................................38
5.2.4. Select Syringe..........................................................................................................38
5.3. Filling a Syringe Using a Quick Fill Tube (QFT) or Fill Spike on the Injector....................39
5.3.1. Manual and Auto Filling Procedure ........................................................................40
5.3.2. [Optional] IV Holder................................................................................................40
5.4. [Optional] Off-line Filling ................................................................................................41
5.5. Connector Tube Installation ...........................................................................................43
5.6. Dismounting a Syringe ....................................................................................................43
5.7. Performing an injection ..................................................................................................44
5.7.1. Routine Protocol Setup...........................................................................................44
5.7.2. Arming ....................................................................................................................45
5.7.3. Pressure Graph Display...........................................................................................46
5.7.4. Starting the Injection ..............................................................................................47
5.7.5. Halting the Injection ...............................................................................................47
5.7.6. Post-Injection Review .............................................................................................48
5.7.7. Common Injecting Alarms ......................................................................................49
5.8. Programming ..................................................................................................................50
5.8.1. Multi-phase protocol setup ....................................................................................50
5.8.2. Phase Type Selection ..............................................................................................50
5.8.3. Protocol Selection – Loading ..................................................................................50
5.8.4. Protocol Selection – Saving ....................................................................................52
5.9. Options Menu .................................................................................................................53
5.9.1. RCU Connection Setup............................................................................................54
5.9.2. Autofill Default Options ..........................................................................................55
5.9.3. Routine Protocol Default Options ..........................................................................55

5.10. [RCU models] Operation Description with Remote Control Unit ...............................56
5.10.1. RCU Features– ........................................................................................................56
5.10.2. The Injector and the RCU........................................................................................56
5.10.3. Turning the System On / Off ...................................................................................57
5.10.4. Injector Controller Application ...............................................................................58
5.10.5. Filling State .............................................................................................................61
5.10.6. Routine Protocol .....................................................................................................62
5.10.7. Arming ....................................................................................................................62
5.10.8. Check for Air ...........................................................................................................62
5.10.9. Starting the Injection ..............................................................................................62
5.10.10. Injection in Progress ..............................................................................................63
5.10.11. Injection Control Buttons.......................................................................................64
5.10.12. Injection Review.....................................................................................................65
5.10.13. Protocol Edit ..........................................................................................................66
5.10.14. Edit Lock .................................................................................................................67
5.10.15. Parameter Value Edit .............................................................................................67
5.10.16. Injecting remaining volume ...................................................................................67
5.10.17. Edit Phase Type ......................................................................................................68
5.10.18. Open Protocol ........................................................................................................68
5.10.19. Protocol Save .........................................................................................................68
5.10.20. Common Injecting Alarms / Warnings ...................................................................69
5.10.21. RCU Manager .........................................................................................................70
5.10.22. RCU Setup ..............................................................................................................71
5.10.23. History Viewer .......................................................................................................73
5.10.24. Protocol Manager ..................................................................................................74
5.10.25. eGFR (glomerular filtration rate) Calculator ..........................................................75
5.11. [Optional] Protocol Assistance Tool (PAT)..................................................................76
6. Cleaning and Maintenance .....................................................................................................78
6.1. General Cleaning Procedures .........................................................................................78
6.1.1. Cleaning the RCU ....................................................................................................78
6.2. Battery Maintenance ......................................................................................................79
6.2.1. Injector Batteries ....................................................................................................79
6.2.2. Remote Control Batteries .......................................................................................79

6.3. Recommended Regular Check Procedure ......................................................................80
6.3.1. Monthly ..................................................................................................................80
6.3.2. Annual Check ..........................................................................................................80
6.3.3. Operator Checkout Procedure ...............................................................................81
6.4. Disposing of the Injector and RCU ..................................................................................82
7. Trouble-shooting ....................................................................................................................83
7.1. Fault Finding Guide .........................................................................................................83
7.1.1. Trouble-Shooting ....................................................................................................84
7.2. Alarms and Error Messages ............................................................................................84
8. Specifications ..........................................................................................................................85
8.1. Dimensions .....................................................................................................................85
8.2. Mechanical .....................................................................................................................86
8.2.1. [RCU Tablet] Mechanical ........................................................................................86
8.3. Functional .......................................................................................................................86
8.4. Controls ..........................................................................................................................87
8.5. Environmental ................................................................................................................87
8.5.1. [RCU Tablet] Environmental ...................................................................................87
8.6. Electrical .........................................................................................................................88
8.6.1. [RCU Tablet] Electrical ............................................................................................88
8.7. Connectors......................................................................................................................89
8.8. IEC 60601-1 Classifications .............................................................................................89
8.9. Ground Continuity ..........................................................................................................89
8.10. RoHS ...........................................................................................................................90
8.10.1 China RoHS Statement ...........................................................................................90
8.10.2 EU RoHS Statement................................................................................................91
8.11. IEC60601-1-2:2007 (3rd Ed) Compliance .....................................................................92
8.11.1. Electromagnetic Emissions .....................................................................................92
8.11.2. Electromagnetic Immunity .....................................................................................92
8.11.3. Recommended separation distances from portable and mobile RF
communications equipment and the injector ........................................................................94
8.12. Models ........................................................................................................................95
8.13. Accessories .................................................................................................................95
9. Index .......................................................................................................................................96
1. Quick Start
§3 Getting Started
• Unpacking and installation
• System features
• Symbols and buttons
§4 Clinical Information
• Selecting cannulas and needles
• Understanding pressure and flow rates
• Adaptive flow
§5 Operation Description
• Filling
• Performing an injection
• Programming injection protocols
§6 Cleaning and Maintenance

• Cleaning
• Battery maintenance
• Regular checks
§7 Troubleshooting
• Error messages
• Injection failed
2. Introduction
Thank you for purchasing the Bayer MEDRAD® Vistron Plus® 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:

www.imaxeon.com
Record the model number in the table below, together with the serial number of your system and your
IMAXEON representative’s telephone number.
VP001
Model No Serial No: IMAXEON Service Representative Tel No:
2.1. Important Safety Notice

The information in this manual is intended for medical personnel with adequate training and experience
in X-ray imaging 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.
2.2. 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.
2.3. Certifications
This injector is equipped to operate at 100 – 230 V~, 50/60 Hz, and is designed to comply with EN 60601-
1 2nd edition (safety) and EN 60601-1-2 3rd edition (EMC/Emissions) standards.
Imaxeon Pty Ltd is EN ISO 13485:2012 certified.
0086
2.4. Intended Use

The injector is intended to be used specifically for the purposes of venous injections of contrast agents
into human patients during x-ray imaging procedures. DO NOT attempt to use the injector for any other
purpose.
2.5. Contraindications
This device is not to be used for drug infusion, chemotherapy, or any other use for which the device is not
indicated.
2.6. Trademarks
Imaxeon Pty Ltd is a subsidiary of Bayer Medical Care Inc. MEDRAD® is a federally registered trademark of
Bayer Medical Care Inc. USA. Vistron Plus™ and FluiDot™ are trademarks of Bayer Medical Care Inc. Used
by permission of Bayer Medical Care, Inc.
2.7. Disclaimers
This manual describes the use, operation and preventive maintenance needs of the MEDRAD Vistron Plus
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 disclaims liability for any modifications or interfaces with other equipment, which are not in
conformity with the specifications and information contained within this manual. Such unauthorised
action could jeopardize injector operation, safety, or reliability.
Accessory equipment connected to the injector through the interface connections must also be certified
according to the requirements of EN 60601-1. Furthermore, the combined configuration of the injector
with attached accessory equipment must comply with system standard EN 60601-1-1. To obtain on-site
consulting or consulting references, contact Imaxeon Service, or your local service representative.
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.
2.8. Imaxeon Contact Information
2.8.1. Manufacturer
Imaxeon Pty. Ltd.

Unit 1, 38-46 South St,
Rydalmere, NSW, 2116
Australia
T: +61 2 8845 4999
F: +61 2 8845 4936
www.imaxeon.com
info@imaxeon.com
0086
2.8.2. EC Representative
EC REP
Medical Device Safety Service (MDSS) GmbH

Schiffgraben 41
30175 Hannover
Germany
T: +49-511-6262 8630
F: +49-511-6262 8633
2.9. SYRINGE - Warnings and Cautions
WARNING: A biological hazard may occur if syringes are reused.
Do not reuse the used syringe and fill tube with another patient. Properly dispose of the disposable in
accordance with your facility’s contaminated blood product disposable protocols.
WARNINGS
♦ Correctly load the syringe. Improper loading may cause an under volume delivery, air
embolization or personal injury.
♦ 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.
♦ 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 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 heat
maintainer is faulty and the built-in safety circuitry has disabled the heating mechanism.
2.10. INJECTOR - Warnings and Cautions
WARNINGS
♦ Patient injury could occur if the on-screen manual fill controls 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 with air or oxygen or nitrous oxide.
♦ 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 EN 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.
♦ US/Canada Installations only. Grounding reliability can only be achieved when this equipment
is connected to an equivalent receptacle marked "Hospital Only" or "Hospital Grade".
♦ 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 IEC 60601-1 standard.
Furthermore, all configurations of injectors with attached accessory equipment must comply
with system standard EN IEC 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.
♦ Accessible parts. The operator should not contact the heat maintainer connector and the
patient at the same time.
♦ Use only the specified Imaxeon heat maintainer (DC022) with the Vistron Plus injector. Do
not connect any other device to the injector heat maintainer connector.
♦ Cease use of faulty components – if a component appears to be faulty, e.g. RCU screen or heat
maintainer, cease use until further investigation can be carried out.
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, and 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.
♦ 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 injector 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 replacement. The injector batteries should be replaced only by suitably qualified service
technicians. Replacement should not be attempted by users or their (untrained) service
personnel. See Section 6.2 for more details. The battery in the remote control can be changed by
users. See Section 6.2.2.
♦ 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.
♦ BATTERY STORAGE If the remote control will not be used for an extended period of time (more
than two weeks), the battery should be removed from the remote control.
♦ 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.
♦ 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.
♦ Trapping hazard. Be wary of retracting the piston of the injector head with syringes
removed. Fingers can be trapped by the mechanism causing minor injuries.
♦ Damage to the optional heat maintainer (DC022) can occur if it is connected to any device
other than the injector heat maintainer connector.
♦ Pushing the injector at the top of the head bracket may cause the injector to tip. Move the
injector by holding and pushing by the injector handle only
♦ Safe distance from medical equipment. The injector has an output wireless power rating of less
than 0.01W. Consult the documentation of your X-ray scanner for the recommended separation
distance for equipment of this power rating. Imaxeon recommends maintaining at least 0.5m
between the injector and scanner electronics.
♦ Keep the RCU unit including the power supply away from liquids. The RCU is not designed to
have liquids splashed on it or to be immersed.
♦ [Wi-Fi Enabled models] Keep the RCU plugged into mains power at all times. The tablet does
have a backup battery for emergency situations but this should only be used for short periods of
time. The RCU is intended to be used on mains power during operation.
2.10.1. Glomerular filtration rate (GFR) Calculator Warnings

♦ Calculation of the risk factor for contrast media dose using the RCU eGFR calculator are
estimates, and should be used by trained personnel only. The calculator assesses the risk
based on patient parameters entered by the operator and the isotope dilution mass spectrometry
(IDMS)-traceable Modification of Diet in Renal Disease (MDRD) Study equation. The clinician
should use the result, in combination with clinical experience to decide on the dose and
separately program the volume into the injection protocol.
♦ No injection parameters are modified by the injector automatically as a result of the GFR
calculation. The injection protocols should be adjusted by the operator.
♦ The eGFR calculation is not recommended for paediatric patients. The MDRD is only
recommended for adult patients.
3. Getting Started
3.1. Installation
1. 2.
A B C
3. 4.
5. 6.
4Hr
3.2. Injector Features
Arm Button
Touch Screen
Standby
Button
Syringe Bayonet
Fitting
Bottle Holder
Handle
Power Input Panel Power cord storage hooks

(see §5.1)
Injector Base
Lockable Castors
3.2.1. Injector Head Description

The injector is a modern, microprocessor-controlled Syringe
Touchscreen
powered injector system. Bayonet
Syringes are loaded into the injector with a simple

bayonet locking system.
Filling the syringes is accomplished with both
manual and automatic (preset volume) powered
Arm
options on the injector itself.
Standby button Button
After loading the syringes, the user interacts with
the injector primarily via a colour touch screen
interface.
The injector is powered on by pressing the “Standby
Button” shown in the figure above. The unit can
always power on, whether connected to mains
supply or by using the internal batteries. Whenever
the mains supply is connected and switched on
with the switch on the base unit, the batteries will
be charged.
The initial screen shown here will be displayed
every time you power on the injector. Options Next
Menu (Fill screen)
3.3. Symbols
3.3.1. Symbols used in 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
Pinch Hazard
Cautions advise of circumstances that could result in damage to the injector. Read and
understand all cautions before operating the injector.
3.3.2. Symbols used on labelling

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 on
the power switch on the base power panel.
I Identifies switch position for connection to line power. The symbol is located on the
power switch on the base power panel.
Identifies type BF medical equipment complying with EN 60601-1 standards. The

symbol is located on the base power panel.
CLASS 1 Indicates the system is Class 1 medical equipment as defined by EN 60601-1

standards. The symbol is located on the base power panel.
CB Identifies circuit breaker. The symbol is located on the base power panel.
Identifies protective earth. The symbol is located within the base unit.
Identifies location for connection of the START switch - either a hand-switch or

footswitch can be connected.
The symbol is located on the base power panel
Name and address of the manufacturer
Manufacturing Date (YYYY-MM)
Consult instructions for use.
Circuit breaker is out or tripped and requires resetting
Circuit breaker is in-circuit; unit is ready for use on battery or mains
Fuse
Standby switch: on the injector head, this switch turns the injector head on and off.
Mains power applied; batteries charging: on the injector base, the LED marked with
this symbol indicates that mains power is on and the batteries are charging
(regardless of whether the injector head is on or off).
If the LED is lit then mains is available and the battery is charging.
3.3.3. Handswitch and Footswitch

Pressing the green button on the hand-switch or pressing the footswitch will start an injection if the
injector is currently armed. They have no effect if the injector is not armed.
When the injector is injecting, pressing the green button or pressing the footswitch again stops the
current injection immediately. They have no effect if the injector is not injecting.
3.3.4. Icons and Buttons used on the Injector Touch Screen Graphical Interface
Note: The touchscreen does not have multi-touch functionality. To avoid incorrect input,
please touch one control at a time
Identifies that line power is connected to the injector
Identifies that system is running on batteries. Animates during charging, and

shows empty/full status
Back or Previous - navigation. Also halts paused or held injections and cancels
editing operations.
Forward or Next - navigation
Retract Button: Used to disengage plunger and release syringe
Engage Button: Used to move the piston forward to engage the syringe
Auto-Fill Button
Prime forward fully for a wet connection using
Load saved protocol
Routine Protocol: The routine protocol is a simple injection protocol which delivers
one phase.
Save As – used in Protocols
Press to arm injector in preparation for injection. If the injector is in Hold mode, this
button aborts the injection
Hold Phase
Indicates Pause phase of the injection
Manual Fill Mode
Syringe indicator.
The location of the black symbol indicates the current position of the plunger, with
the remaining volume indicated.
If the syringe is not engaged, the black symbol turns grey, and indicates the last
known position of the plunger.
Manual Fill Controls for manual fill/purge. Larger gradations indicate higher
fill/purge speed, and the arrows indicate the direction of the piston
(On-screen) Start Injection button
(On-screen) Stop Injection button
Display Pressure Graph (toggle button). During injection, the screen can be
switched between showing the syringe indicators to a real-time pressure graph of
the current injection phase. When the pressure graph is active, the button is shown
in yellow.
Pressure indicator
Duration/Elapsed Time indicator
Average flow
Injection entered adaptive flow
Space – used as a space-bar when typing with the alphanumeric keypad
Go to the Options menu
Finger jam warning. While moving, if any obstruction is encountered by the piston,
the piston will halt and the warning displayed.
Press to move forward, remove obstruction then toggle to continue
retraction
3.3.5. Injector Buttons

Identifies the ARM button - located on the injector power head
When indicated by the software, the user must press this button to ready the injector for
the programmed injection.
Identifies the INJECTOR on/off button - located on the power head
When the LED is unlit, the unit may be powered on by pressing the button and the
injector will start up either from battery or mains. The LED displays red during self-
testing and then green when the injector is powered up.
3.3.6. Remote Control Symbols and Buttons

Transmitting LED - When Battery Low LED - If the
lit, this LED indicates that battery is low this light will
the remote is shine continuously and the
remote will emit a beep. If this
transmitting to the
occurs the batteries should be
injector. replaced. See Section 6.2.2.
The light may also come on
when the red or green button
is pressed, but this is not an
indication of a low battery.
Start button – Starts or Stop button - When the

continues an injection. injector is injecting, pressing
The button has no effect this button stops the current
if the injector is not injection immediately. The
armed button has no effect if the
injector is not injecting.
3.3.7. Injector Visual Indicators

Event LEDs at rear of injector head LCD Display
Injector Error Condition 1 Flash Red Red Status Bar

• Overpressure
• Dead Battery
• Power-On-Start
Test Error
Warning Flash Orange Orange Status Bar
ARMED State Flash Green Flashing ARM symbol
INJECTING State Rotate Green Flashing Syringe
INJECT COMPLETE State Stop rotating (orange if Nothing

adaptive flow occurred,
green otherwise)
Touch screen Button press Nothing Nothing
Motor movement Rotate green Animated Syringe
Adaptive Flow Rotate orange Orange Status Bar

(Pressure Limiting)
1
Notes: There are no alarm presets in the injector.
All error conditions indicate a fault with the injector and the injection has stopped. Warnings and
other indicators indicate continued but changed operation of the injector.
3.3.8. Icons and Buttons used on the RCU Touch Screen Graphical Interface
Injector Controller Action Menu
RCU Manager – return to RCU manager screen
GFR Calculator: Uses the Modification of Diet in Renal Disease (MDRD) Study equation to
estimate an appropriate contrast dose based on patient parameters.
Saved Protocols: View and select saved injection protocols stored on the RCU.
Save As Protocol: Save the current protocol under another protocol name. This button is
disabled when grey.
ARM injector
Start inject
Resume inject
Pause inject
Abort inject
Skip Phase
Aborting inject
Injection Review Table Mode
Injection Review Plot Mode
Injection completed
Injection terminated with over pressure
Injection aborted from user
Injection terminated with timeout
Injection terminated with an alarm event

Power Status
Battery dead
Battery flat
Battery half
Battery full
Mains power
Filling/Injection Status
<Animation>
Injector is in filling status
<Animation>
Injection in progress
RCU Manager
Injector Controller: This is the application used to control the

paired injector.
History Viewer: Stored injections performed while the RCU was

interfaced with the injector is stored in the RCU memory and can
be reviewed from this application
Protocol Manager: Protocols can be saved or restored from a

removable USB memory drive.
Media Player: The RCU stores a number of training videos that

can be used to familiarise new users with the features of the
injection system.
Setup
Service Options menu [locked, accessible by authorised service

personnel only]
RCU Information – information on RCU software version.
Standby button
RCU Reset button

4. Clinical Information
4.1. Cannula and Needle Selection

Cannulas or I.V. catheters are the preferred choice for injecting contrast agents with powered injectors.
The following chart shows the maximum flow rate that is possible with typical gauge cannulas. However,
operating the injector at or close to maximum flow rate may lead to adapted (reduced) flow, which may
result in sub-optimum images.
Cannula Selection
Contrast: Ultravist 300 and 370 warmed to 37ºC
12
10
Max. Flow Rate ml/s
0
18 19 20 21 22
Cannula Gauge
Ultravist 370 Ultravist 300

4.2. Understanding pressure and flow, pressure limiting & adaptive flow
4.2.1. Pressure Basics

In all hydraulic systems, pressure is required to cause fluid to flow through the conduit. The pressure in
the reservoir (syringe) must exceed the resistance of the conduit (tubing and catheter) and fluid. The
conduit offers resistance by its diameter and length. The fluid offers resistance by its thickness, or
viscosity.
All hydraulic systems require pressure to cause the fluid to flow through the conduit. But here is an often
misunderstood basic fact of pressure: pressure will be dissipated in the conduit. Pressure serves only to
propel the fluid through the conduit. Because there is no opposition (resistance) to the fluid at the open
end of the conduit, the fluid will be at zero pressure at the open end. The pressure is highest at the
connection between the reservoir and the conduit (syringe and connector tubing). At the open end of the
conduit (catheter distal end within the patient), the fluid will be at zero pressure (or rather the patient’s
systemic pressure), because there is no opposition to the fluid at the open end. The illustration below
shows how pressure varies in a conduit. To simplify the following discussion, neglect the patient’s
systemic pressure and assume that there is zero pressure at the open end of the conduit. Pressure is
greatest in the fluid reservoir and at the connection of the conduit to the reservoir. Halfway down the
conduit, the pressure will be half of the reservoir pressure. And at the end of the conduit, pressure will be
zero.
Highest pressure at Median pressure Zero pressure at

output of reservoir half-way down open end of pipe
(syringe) pipe
200psi 100psi 0psi
Fluid
Force
Pressurised reservoir – Pipe (catheter) Fluid scatters

piston and barrel of (no restrictions)
syringe
4.2.2. Summary
1. The reservoir (syringe) pressure must exceed resistance in the conduit (tubing and catheter) if
fluid is to flow through the conduit
2. Higher pressure is required the smaller the diameter of the conduit (tubing, catheter), the longer
the conduit, and the more viscous the media.
3. The diameter of the conduit is the factor with the highest impact on pressure (and achievable
flow rates)
4. Pressure will dissipated (decrease) in the conduit so that the pressure at the open end will be zero
as long as there is no obstruction at the outflow end.
5. If the pressure limit is set lower than the pressure required to propel media at the desired flow
rate, the flow rate through the catheter will be reduced.
6. If the pressure limit is set higher than the pressure required to propel media at the desired flow
rate, the flow rate through the catheter will not be affected. This pressure limit will protect the
catheter only if the catheter becomes blocked.
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.
♦ The injector beep will lengthen 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 100 to 300 psi in 1 psi increments. If the gradual reduction of flow does not
sufficiently reduce the pressure, a motor stall will result, halting the injection.
If the syringe pressure exceeds the pressure limit by 20%, the injection will halt immediately. This is
known as overpressure. 2.
The injector is designed to be a regulated fluid delivery device, which monitors pressure 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.
2
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.
4.4. Warming the Contrast: Heat Maintainer

For improved patient comfort and lower viscosity, contrast manufacturers recommend warming contrast
to body temperature before use (i.e. 37°C). It is also recommended that the contrast be warmed for at
least 2 hours prior to use, because heat permeates contrast very slowly.
Heat Maintainer Connector
Imaxeon provides a syringe Heat Maintainer part number DC022, which can be used to maintain the heat
of the fluid in the syringe. The warmer is powered from a port located on the underside of the injector
head unit.
WARNING
Use only the specified

Imaxeon heat maintainer
(DC022) with the Vistron Plus
injector. Do not connect any
other device to the injector heat
maintainer connector.
WARNING
Use only the specified Imaxeon heat maintainer (DC022) with the Vistron Plus injector. Do not
connect any other device to the injector heat maintainer connector.
5. Operation Description
5.1. Turning the System On for the First Time

Plug in a power cable to the IEC socket and connect the cable to your mains supply.
Ensure that the power switch in the pedestal base is in the On position, and that the circuit breaker is in-
circuit (pushed in).
Manufacturing Date Mains On/Off

Switch
Mains on / Battery
Charging Indicator
Hand/Foot Switch
Connector
IEC Mains
Model Connector
Serial Number
Equipotential Circuit Breaker

Point
When the mains supply is connected and turned on at the switch, LED marked will light indicating
the presence of mains power and the fact that the batteries are being charged.
Leave the system plugged in for at least four hours before attempting to use with battery power alone.
The system is generally operated from battery power. If the batteries are low, or have been removed for
servicing, the injector can operate from line power directly.
Once charged, press the on/off button.
The Start screen will be displayed. Press the button.

If the injector is started for the first time since factory delivery, or has had a
service performance maintenance procedure since the last power, a clinical
efficacy screen will be displayed for information purposes.
5.2. Syringe, Quick Fill Tube, Fill Spike, and Connector Tubes
5.2.1. Description and Part Number

The syringe is available in a 190 ml size, suitable for use with contrast and saline flushing agents.
Syringe 190 ml and quick fill tube Syringe 190 ml and fill spike
ZY6320: (tray package) ZY6321: (tray package)
ZY5151: 150 cm 300 psi coiled tube set single
5.2.2. Syringe FluiDots™

A fluid-filled syringe is easily checked by noting the shape of
the FluiDots™ on the side of the syringe. When viewed
through fluid, FluiDot™ indicators will appear larger and
rounded. Viewed through an empty syringe, the indicators
will appear small and narrow.
EMPTY SYRINGE - FULLY FILLED

elongated shape SYRINGE - circular
shape
5.2.3. Mounting the Syringe

Remove the syringe from its packaging. Mount the syringe into
the injector bayonet fitting as shown and twist a quarter of a
turn to lock it into place.
If the injector is on, the syringe will automatically be detected.
See Section 5.2.4.
5.2.4. Select Syringe

New, unfilled syringe Syringe filled on offline loader (Section 5.4)
The injector will detect this and automatically The injector will detect this and be ready to proceed
purge the syringe of air. with the injection.
To manually select a syringe:
Press on the touchscreen to tell the injector that a new

contrast-filled syringe has been installed.
5.3. Filling a Syringe Using a Quick Fill Tube (QFT) or Fill Spike on the Injector
Syringes may be filled to a preset volume using the injector AutoFill functionality or to any arbitrary
volume using the Manual fill controls. See Section 0 for details on connecting the tubing.
If the syringe is removed after filing, the piston will auto-retract.
[Using ZY6320] The syringe can be filled using a quick fill tube.
Insert the tube onto the syringe and fill from the saline/contrast
bottle.
[Using ZY6321] Alternatively, the syringe may be filled using a

fill spike and a saline/contrast bottle or bag. Do not over-tighten
the spike when mounting it on the syringe.
Alter Auto Fill volume
Manual Fill speed control
Start Auto Fill
Retract piston
(to remove syringe)
5.3.1. Manual and Auto Filling Procedure

Manual filling Integral AutoFill with a QFT
1. Mount a new syringe on the injector
2. Select on the touch screen
3. The plunger will automatically purge the air from the syringe.
4. Push the QFT onto the end of the syringe. Do not install with excessive force
5. Insert the QFT into the fluid source and
6. Fill the syringe with fluid using the manual

fill control. Press the button on the tab.
7. Expel air
8. Remove QFT. Connect the disposable tubing set.
9. Follow the instructions in Section 0
10. Press button to set the injection parameters
5.3.2. [Optional] IV Holder

An IV holder (part number: DC039) can be supplied as an
optional accessory. This allows IV bags and other items to be
hung near the injector.
5.4. [Optional] Off-line Filling

Contrast can be filled off-line
using the optional manually-
operated Off-line Loader
(MDL001). This can improve the
workflow by freeing the injector
to continue with other
procedures.
With the loader lever in the
down position, mount a new
syringe into the loader and
twist a ¼ of a turn to lock it
into place.
Place the quick fill tube on the

tip of the syringe, being careful
not to touch the ends of the
tube or the syringe to avoid
contamination
Lift the lever to move the piston up the syringe
Insert fill tube into the contrast bottle and slowly draw down the
lever to fill the syringe to the desired level, avoiding introducing
bubbles into the syringe. Remove and discard the quick fill tube.
To dismount the filled syringe from the Loader, the piston should be
moved upwards slightly and then down to disengage from the syringe
plunger. 3
Twist the disengaged syringe ¼ turn and gently pull out of the
Loader.
Mount the filled syringe into the injector. Press the button on
the injector. The injector will automatically detect the filled syringe
and will be ready to perform an injection (see section 5.7)
3
If the syringe is completely full, moving the piston upwards may eject some contrast. In this situation, turn the syringe a ¼
turn and lift up with the piston engaged. The syringe can then be disengaged without moving the syringe plunger.
5.5. Connector Tube Installation

1. Ensure all air is purged from the syringe.
2. Remove the connector tube from the package. Remove the proximal-end (orange) dust cover.
3. Attach the connector tube to the syringe, ¼ turn to ½ turn maximum.
4. Once secured, verify that the tubing is not kinked or obstructed.
5. Ensure all air is purged from the connector tube using

6. Rotate the injector head downward.
7. Remove the distal-end (clear) dust cover.
8. Prime forward fully for a wet connection using

9. Connect to the patient.
10. Press
11. The injector will then display a check for air notification.
Note: Patency check through aspiration using the injector is not possible when using a check valve
on the end of the connector tube. If aspiration is important, remove the check valve from the
connector tube and directly connect the connector tube to the catheter.
5.6. Dismounting a Syringe

1. After the procedure has been completed, disconnect the disposable tubing set from the vascular
entry device. The disposable tubing set does not need to be disconnected from the syringe.
2. Press to retract
3. Rotate the syringe approximately ¼ turn counter-clockwise and gently pull the syringe out of
the injector head, discarding the syringe with disposable tubing set.
Note: In order to remove the syringe, the last piston motion must be in the forward direction, which
is typical. If you cannot remove the syringe, press to retract, then repeat Step 3.
5.7. Performing an injection

Pressing , when on the filling screen displays the current protocol screen. The routine protocol
screen is described in Section 5.7.1. More complicated multi-phase protocols may also be entered; see
Section 5.8.
5.7.1. Routine Protocol Setup

The routine protocol is a simple injection protocol which delivers one phase. The volumes and injection
rates entered on this screen are not remembered by the injector when it is powered off.
To alter the default volume and flow rate values of the routine protocol, the use the Options menu from
the start screen (see Section 5.9).
Alter injection volume
Prime forward (0.5ml/s)

Alter injection flow rate
“Arm injector” prompt (press

orange Arm button)
Back (to manual fill screen)
Load protocol (including multi- Alter pressure limit

phase protocols)
5.7.2. Arming
Press the on the injector head to ARM
To disable the ARM state, press

The injector will time out of the ARM state if the injection is
not started within 10 minutes and will return to the protocol
screen.
Check for air.

Press the OK button on the touch screen.
The injector is now ready to begin injecting, and the LEDs in
the rear of the head module will flash green to reflect this
fact.
Tilt the head down before starting the injection to minimise
risk of air injection.
5.7.3. Pressure Graph Display

Prior to starting the injection, the user can chose
to either display the syringe status or a real-time
pressure graph.
The pressure graph button is a toggle button.
- Plot not highlighted. Syringe status will

be displayed during the injection.
- Plot highlighted. Pressure graph will be

displayed during the injection.
The selected display will remain throughout the
injection.
The pressure graph of the current active phase is

always displayed if a multi-phase injection is in
progress. Volume
Pressure Limit remainin
Pressure graph Current

pressure
5.7.4. Starting the Injection

Injections may be started using the optional hand-switch or footswitch or by pressing the green button on
the supplied remote control, or the green start button on the touch screen.
Start Button
Stop Button
The start button does not need to be held down during the injection.
5.7.5. Halting the Injection

While an injection is in progress, the following screen is shown:
If the red “Stop” button is pressed, the injection will stop and display the review screen (See
Section 4.3).
If the injector screen is touched at any location away from the red “Stop” button or the red button on the
supplied remote control is pressed the injection will halt in Hold mode. The optional hand-switch or
footswitch will also halt the injection when pressed during an injection.
The injector will stay in Hold mode, as indicated by the hand symbol until the injection is resumed
using the Start button on the remote or optional hand-switch or footswitch, or pressing the .on the
screen
To abort the injection completely while the injector is in Hold mode, press and then on the
injector display screen
5.7.6. Post-Injection Review

When the injection has completed a summary of the injection details is displayed. The average flow rate,
peak pressure and duration are calculated based on the combined contrast/saline injection (including all
phases in a multi-phase injection). If the syringe is manually removed at this stage, the piston will
automatically retract.
Delivered contrast volume
Average flow rate

(press to display flow graph)
Peak measured pressure Retract piston for syringe

removal
Actual duration
Back to protocol screen Scroll through Injection

History
Flow graph
If the injection reduces the set flow rate by entering into adaptive mode, the indication will be shown as
below. See Section 4.3
Indicates injection entered

adaptive flow mode
5.7.7. Common Injecting Alarms

During an injection, the most likely alarms to occur which result in the injection halting are caused by
high pressure or the adaptive flow algorithm slowing the injection speed down to 2/3 of the programmed
speed (known as a stall alarm). When these alarms occur, the top part of the screen (the status bar) will
flash red and the LEDs at the back of the injector head will illuminate red. Press on the status bar to
display the actual error message.
Status Bar is red indicating

an alarm is active
Either of these alarms may be due to obstruction of injection pathway such as a kink in the tubing or the
patient moving and compressing the blood vessel where the injecting site is. Please examine the tubing
and injection site to clear any obstructions before attempting to resume the injection.
5.8. Programming
The injector can be programmed to deliver up to 4 sequential phases of contrast injections, hold phases or
delays.
The multi-phase programming mode is entered by pressing the load protocol button on the routine
protocol screen and loading any protocol except the routine protocol.
5.8.1. Multi-phase protocol setup
Phase 1
Phase 2 etc.
Alter phase type) Alter pause time
Add new phase Alter phase volume
Alter pressure limit Alter phase flow rate
Prime forward (3 ml/s) “Arm injector” prompt (press

orange Arm button)
Back (to manual fill screen)
Load protocol (including routine Save As

protocol)
5.8.2. Phase Type Selection
Contrast injection
Pause phase for a set time
Hold (press >> to continue)
Delete this phase
Cancel (do not save changes)
5.8.3. Protocol Selection – Loading
Pressing on either of the routine protocol or multi-phase protocol screens will cause the injector to
display a list of the stored protocols. Select a protocol name you wish to load.
Press protocol Current protocol

name to load
Back to previous screen

(cancels load operation)
“Loading” icon
Sort protocols – toggles

between alphabetically and
numerically
The protocols are saved in numerical slots. The protocols can be sorted alphabetically by pressing the
button. The list will appear as below.
The protocols can be sorted in their numerical order by pressing .
Caution: The injector is pre-loaded with some basic contrast injection protocols to assist
the user in getting started. The protocols are a guide only, and should be adjusted to meet the
clinical needs of the examination as determined by the user. The risk is minimal, but if the user
solely relies on these protocols, optimal contrast enhancement may not always be achieved.
5.8.4. Protocol Selection – Saving
Pressing on the multi-phase protocol screen will cause the injector to display a list of the stored
protocols. Select a protocol name where you want the current protocol to be stored and the injector will
then prompt you to enter a new name for the stored protocol.
Current protocol: Pressing it

saves over it
Press a protocol name to “Saving” icon

save over it
Back to previous screen Sort protocols – toggles

(cancels save operation) between alphabetically and
numerically
If you do not wish to alter the name, press the OK button and the protocol will be
saved with the current name.
Cancel (do not save changes)

5.9. Options Menu

AutoFill Default: Alter the default AutoFill volume, shuffle and
fill speed for the syringe.
Routine Protocol Defaults: Alter the default injection volume

and speed for the routine protocol. See 5.9.3 below.
Pressure Units: Display in psi or kPa
Injection History: Display details of the previous injections
Next Options screen
Back to Start screen

Fault History: Display details of the previous warnings and
alarms
Sound Volume: Adjusts sounds and alarm volumes on a scale of

1 to 10 (default 7)
Power off time: Time for system to power off automatically when
unused. 120min is max and default.0min = always on
Brightness: Set screen brightness
Next Options screen
Previous Options screen
Time: Set injector time
Date: Set injector date
Efficacy Data: Display number of injections, over-pressures and

user aborted injections
Protocol Lock: Lock protocols and auto fill parameters so they

cannot be overwritten
RCU Connection Setup: Enable or disable the connection to the

RCU. See Section 5.9.1
Service menu: Enter service menu (requires password)
Previous Options screen

5.9.1. RCU Connection Setup

Pressing the RCU Connection Setup displays the configuration for
the wi-fi connection.
The Wi-Fi connection can be enabled/disabled as required.
(The Type setting cannot be changed).
The NetID should be set to match that selected on the RCU (see
Section 5.9.12).
5.9.2. Autofill Default Options

These options govern the behaviour of the autofill feature on the fill screen. Note that only the autofill
volume can be changed on the fill screen. The shuffle volume and the fill speed will always be set to the
values entered here.
If the autofill volume is changed on the fill screen, the new value will remain in effect until the injector is
powered off and on again, when the default value on this options screen will be reloaded.
Autofill Volume: The default

volume to appear on the Autofill
Autofill Speed
screen
Autofill Shuffle Volume: The

plunger will shuffle back and
forward by this amount at the
start of Auto-filling in order to Enter new values by pressing
help reduce the number of on the numbers
bubbles created during filling
Backspace: Delete last character
Accept changes; Return to

Discard Changes; Return to Option Menu
Options menu
5.9.3. Routine Protocol Default Options

These options govern the default behaviour of the routine protocol as follows. Note that all three injection
parameters may be over-ridden by entering a new value on the protocol screen prior to performing the
injection. When the injection completes, the default option values set here will be reloaded.
Routine Protocol Contrast Routine Protocol Pressure Limit:

Volume: The default injection The default pressure limit to
volume to appear on the Routine appear on the Routine Protocol
Protocol screen. The setting screen.
shown indicates that All Volume
has been selected
Routine Protocol Contrast Flow

Enter new values by pressing on
Rate: The default injection speed
to appear on the Routine Protocol the numbers
screen.
All Volume; The injector will

Backspace: Delete last character simply inject all of the volume in
the syringe
Discard Changes; Return to Accept changes; Return to Option

Options menu Menu
5.10. [RCU models] Operation Description with Remote Control Unit

The function of the injector can be controlled by a tablet PC,
remotely-connected to the injector via peer-to-peer Wi-Fi
connection.
5.10.1. RCU Features–

USB ports Capacitive touchscreen
Power On Button& LED
Power Input Stand bracket
Note: The touch screen does not have multi-touch functionality. To avoid incorrect input,
please touch one control at a time
5.10.2. The Injector and the RCU

The RCU is designed to provide continuous status information on the injector, and full control of the
injector 4.
4
With one exception, during filling. See Section 5.10.5.
5.10.3. Turning the System On / Off

The RCU is powered on by pressing the “Power Button” shown in Section 5.10.1.
Although RCU is a mobile device, it is

recommended to be operated while
connected to power
Plug in a power cable to RCU and press and
hold the on/off button until the RCU starts.
Check that power LED is flashing.
Keep the RCU connected to power when
operating.
The first screen displayed is the Injector
Controller screen, where the injection
parameters can be set, and the injection
initiated.
To turn off the RCU, if in the Injector
Controller screen (as above), press the Exit
injector controller button.This returns to the
RCU Manager screen.
Press the Standby button on the RCU

Manager screen.
Confirm this by pressing the button

indicated
5.10.3.1. Injector Link Status
RCU Manager updates the link status in real time. It is important to ensure the link is connected before
start controlling injector.
Disconnected. RCU will attempt to connect to the injector if no

connection is found.
Connected. Number of segments reflects the strength of signal.
Communication Issue. The selected channel is already being

used, or the wrong protocol version is used.
5.10.3.2. Establishing/Re-establishing Injector Link

It the link to the injector is lost, a warning is

indicated on the RCU screen.
Ensure the injector is turned on and set to the
correct Wireless ID as the RCU (see Sections
5.9.1 and 5.10.22).
Restart both the injector and RCU to restore the
link.
5.10.4. Injector Controller Application
Routine Protocol Date and Time

Injection elapsed time
Injector Link Status
RCU Manager
Power Status
Injector Status
Syringe status
Injector S/N
LED / Alarm
Injector Frame
Action Menu Arm Injector
Injector Controller Action Menu
GFR Calculator: Uses the Modification of Diet in Renal Disease (MDRD) Study equation
to estimate an appropriate contrast dose based on patient parameters.
Saved Protocols: View and select saved injection protocols stored on the RCU.
Save As Protocol: Save the current protocol under another protocol name. This button
is disabled when grey.
5.10.4.1. Date and Time

Date and time is displayed in <YYYY/MM/DD HH:MM> format.

These values are synchronised from the injector and updated in real time.
5.10.4.2. Injector and Syringe Status, Alarms and Indicators
RCU displays current injector and syringe status in real time in 500ms
intervals. For Single injector models, only one syringe icon will be displayed
Syringe Status parameters are:
♦ Filled volume
♦ Flow rate
♦ Pressure
♦ Injection volume indicator: displayed while in ‘Protocol Edit

Screen’
Around the injector status screen, the Injector Frame displays the current status of the injector
Event LEDs at rear of injector head LCD Display
Injector Error Condition 5 Flash Red Red Status Bar
• Overpressure
• Dead Battery
• Power-On-Start Test
Error
Warning Flash Orange Orange Status Bar
ARMED State Flash Green Flashing ARM symbol
INJECTING State Rotate Green Flashing Syringe
INJECT COMPLETE State Stop rotating (orange if Nothing

adaptive flow occurred, green
otherwise)
Touch screen Button press Nothing Nothing
Motor movement Rotate green Animated Syringe
5
Notes: There are no alarm presets in the injector.
All error conditions indicate a fault with the injector and the injection has stopped. Warnings and other indicators indicate
continued but changed operation of the injector.
Adaptive Flow Rotate orange Orange Status Bar

(Pressure Limiting)
Power Status
Battery flat
Battery half
Battery full
Mains power
Filling/Injection Status
<Animation>
Injector is in filling status
<Animation>
Injection in progress
5.10.4.3. Elapsed Time
RCU displays the elapsed time since the last injection start.
Format is <HH:MM:SS> and updated every 1 second.
The time value is reset when new syringe is engaged or by pressing the timer display and holding for 2
seconds.
The time value does not wrap; max time displayed is “99:59:59”.
5.10.5. Filling State

The RCU does not support filling the syringe. The filling should be performed at the injector, or using the
optional off-line loader.
While the injector is in ‘Filling State’, ‘ARM’ is disabled in RCU.
5.10.6. Routine Protocol

Change the flow rate, volume and pressure limit of
the routine protocol, if required, by pressing the
buttons and entering the desired values.
The injection duration is automatically calculated. Flow Rate
Volume
Pressure limit
5.10.7. Arming
When the protocol has been programmed, press the
button to arm the injector. A confirmation of

arming from the fill screen is displayed.
Select the button to continue.

NOTE: Arm can also be triggered from injector.
5.10.8. Check for Air

The injector and RCU will show ‘Check for Air’
screen simultaneously.
Select the button to continue.
5.10.9. Starting the Injection

Review the protocol displayed.
Select the button on ‘Start Injection’ Screen.

5.10.10. Injection in Progress

The injection can be monitored in progress from the RCU. While an injection is in progress, the RCU will:
Update the plot display (flow rate and pressure) in real time
Display the injection progress information in real time
Play LED animation
Play injection sound
If the button is pressed, the injection is paused. When paused:
Pressing the button will stop injection
Pressing the button will resume injection

When injection is completed, all injection control buttons will disappear. The user can then proceed to
other screens (e.g. view history, edit protocol).
Injection Information
Current Phase information
Injection Plot
(Pressure & Flow Rate)
Injection Control button

(changes depending on
injection state)
5.10.11. Injection Control Buttons

If for any reason, the injection needs to be paused or aborted, select the RCU injection control button on
the Injection in Progress screen.
Resume inject
Pause inject
Skip phase – for dual routine injections, or multi-phase injections,

allows the user to skip to the next phase
Abort inject
<Blink>
Aborting inject
5.10.12. Injection Review

At the end of the injection, the details of the injection can be reviewed, either in plot format or table
format. These formats can be toggled using the or buttons.
Plot format
Table format
5.10.12.1. Injection Review Control Buttons
5.10.12.2. Injection Complete Status Icons
Injection completed
Injection terminated with over pressure
Injection aborted from user
Injection terminated with timeout
Injection terminated with an alarm event

5.10.13. Protocol Edit

Multiphase injections can be programmed and saved Edit protocol type
Protocol name
Edit phase parameters
Edit max pressure
Summary
Arm
Protocol Save
Protocol Open
Protocol Summary View shows:

♦ Overall phase information in terms of time.
♦ Overall phase information in terms of volume.

5.10.14. Edit Lock

The injector and RCU do not allow the user to edit protocol parameters simultaneously; only one device is
allowed to enter ‘edit mode’. The other device is locked while editing is performed.
When RCU is locked ‘Edit Lock’ icon is displayed in Injector Status frame and will not respond to any
button press events that are related to editing protocol parameters.
Edit Lock
Protocol being edited on the RCU – Injector is locked. Protocol is being edited on the Injector – RCU is
locked.
5.10.15. Parameter Value Edit

Current value
Number buttons
Slider control
Parameter values can be modified by:

♦ Pressing number button,
♦ Move slider bar control, or
♦ Tap top/bottom area of slider bar to increment/decrement a single step.
5.10.16. Injecting remaining volume
Remaining volume
The remaining volume of the syringe can be injected by pressing the button showing the remaining
volume.
5.10.17. Edit Phase Type

Each phase can be programmed to be one of four phase types.
Phase: Contrast
Phase: Pause
Phase: Hold
Phase: Delete
5.10.18. Open Protocol
A previously saved protocol can be loaded by selecting the button. Scroll through the saved
protocols and tap on the protocol desired.
5.10.19. Protocol Save
The current programmed protocol can be saved to a new protocol slot by pressing the button.
Scroll through the list to select the protocol slot desired.
Change protocol name
Select Protocol
5.10.20. Common Injecting Alarms / Warnings
During an injection, the most likely alarms to occur

which result in the injection halting are caused by high
pressure or the adaptive flow algorithm slowing the
injection speed down to zero (known as a stall alarm).
When these alarms occur, RCU will:
♦ Display ‘Alarm’ screen or ‘Warning’ screen
♦ Play LED flashing, alarm (red), warning (orange)
5.10.21. RCU Manager

RCU Manager provides interface to:
♦ Launch RCU Application
♦ Manages wireless/wire connection to
injector
♦ Setup / Configuration
♦ Provide service menus
♦ View videos and software information
Injector Controller: This is the application used to control the paired injector.
This application is set to run as default at start-up. This can be changed in the
RCU Setup – Injector Controller screen (see Section 5.10.22)
History Viewer: Stored injections performed while the RCU was interfaced with
the injector is stored in the RCU memory and can be reviewed from this
application
Protocol Manager: Protocols can be saved or restored from a removable USB

memory drive.
Media Player: The RCU stores a number of training videos that can be used to
familiarise new users with the features of the injection system.
RCU Setup – Section 5.10.22
Service Options menu [locked, accessible by authorised service personnel only]
RCU Information – information on RCU software and hardware version.
Standby Button
Reset RCU Button

5.10.22. RCU Setup
Press the button on the Action bar to access the setup options
Configure the wireless link to the injector. The Wireless

ID should match that set on the injector (see Section
5.9.1).
[Optional]
Enable or disable the interface between the RCU and

the scanner
Set the screen brightness.
Set the volume of the RCU sounds.
Select from the available languages.

Injection history can be downloaded to any formatted

USB stick.
(Reminder screen). Change the date and time of the

system on the injector.
Additional software features, if enabled, can be turned

on or off. Premium Features can only be enabled by an
Imaxeon service or sales representative.
5.10.23. History Viewer
From the RCU Manager, press the to view the details of recent injections.
Delete injection record
Note: Only injections recorded while the RCU is connected to the injector and controlled from the
Injector Controller screen are stored in the RCU. Injections performed by the injector while
disconnected from the RCU are not stored on the RCU.
5.10.24. Protocol Manager

Injection protocols can be saved to and from USB memory devices.
5.10.24.1. Saving Protocols
♦ Plug in the formatted USB device into an available USB port on the RCU.
♦ From the RCU Manager, press the button
♦ Select the Injector-to-USB download as shown below and press
5.10.24.2. Loading Protocols
♦ Plug in the USB device containing the saved protocols into an available USB port on the RCU.
♦ From the RCU Manager, press the button.
♦ Select the USB-to-Injector upload as shown below and press

5.10.25. eGFR (glomerular filtration rate) Calculator

The RCU includes a calculator to assist the clinician in estimating the safe volume of contrast dose.
In adults, the best equation for estimating glomerular filtration rate (GFR) from serum creatinine is the
isotope dilution mass spectrometry (IDMS)-traceable Modification of Diet in Renal Disease (MDRD) Study
equation. 6
All laboratories should be using creatinine methods calibrated to be IDMS traceable.
This IDMS-traceable MDRD study equation calculator is for use with Scr reported in mg/dL.
GFR (mL/min/1.73 m2) = 175 x (Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.212 if African descent).
Warning: The recommended contrast volume calculated by the eGFR calculator does not
alter the programmed volume in the current injection protocol. The clinician should use the
result, in combination with clinical experience to decide on the dose and separately program the
volume into the injection protocol.
Warning: The model for the calculation is applicable for adults only. The MDRD
calculation is not recommended for paediatric patients.
From the Injector Controller screen, press
Enter the patient data and assess the appropriate contrast dose accordingly.
6
Reference: Levey AS, Coresh J, Greene T, Stevens LA, Zhang YL, Hendriksen S, Kusek JW, Van Lente F; Chronic Kidney Disease
Epidemiology Collaboration. Using standardized serum creatinine values in the modification of diet in renal disease study
equation for estimating glomerular filtration rate. Ann Intern Med. 2006 Aug 15;145(4):247-54.
5.11. [Optional] Protocol Assistance Tool (PAT)

This option can only be enabled by an Imaxeon service or sales representative.
The PAT application provides the user with suggested weight based injection protocols for a range of
common CT examinations. It is available only with the optional Remote Control Unit RCU.
The PAT is intended to be used as a guide. It is not intended to replace clinical experience and judgment.
The underlying parameters are based on current, published clinical dosage rates and techniques. It is the
responsibility of the User to assess the patient’s clinical presentation before proceeding with any contrast
media injection protocol.
To access PAT, select the wand icon from the

Action menu
Select the Type of examination:
♦ Routine for chest, parenchymal and portal

venous applications.
♦ CTA for arterial imaging.
♦ [Single Only] There will not be a

saline flush if CTA is selected.
Next select the Area for examination.
PAT lists a number of common scanning regions

depending upon the Type selection.
Toggle through the selection to find the most
appropriate Area.
The Patient icon graphically represents the Area
selected. The patient body icon can also be pressed
directly to select the area.
Select Weight and enter the patient’s weight in kg

using the numeric key pad.
Select Contrast Concentration and enter the

contrast media concentration in mg/I/ml.
A specific concentration can be added by selecting
Other and entering the value via the keyboard.
For CTA Type protocols, select MDCT Number and

select the scanner multi detector slice number
from the available options: 4, 16 & 64 MDCT.
Note, this parameter is not available for Routine

type protocols as it is not required to calculate
contrast media dosing.
Once all of the parameters are entered, select the
green tick to generate a suggested protocol .
Or select the back arrow to exit .
The generated protocol is displayed with the PAT

icon to alert the user this is a suggested PAT
protocol.
Any parameter of PAT generated protocol can be
adjusted if required. If a parameter is adjusted, the
PAT icon will disappear to indicate the protocol has
changed from the original PAT suggestion.
Once the protocol is set, follow the normal safety
check and arming procedure to complete the
normal injection process.
6. Cleaning and Maintenance
6.1. General Cleaning Procedures

The injector should be switched off and disconnected from the mains supply before cleaning. The covers
and external parts of the injector should be cleaned using warm soapy water and a soft cloth. Do not use
abrasive cleaning aids, solvents or alcohol wipes.
X-Ray contrast tends to dry quite hard and hence should be wiped off as soon as possible.
Should the syringe piston engaging mechanism may become coated in dried and hardened contrast agent
over time, clean as follows:
Press with no syringe mounted in the bayonet fitting. The piston will
extend fully and stop.
With a clean, warm, damp (not wet) cloth, wipe off dried contrast in and
around the piston head.
6.1.1. Cleaning the RCU

Clean the RCU tablet with a dry cloth. Do not allow water or cleaning fluid to enter the RCU tablet
enclosure.
6.2. Battery Maintenance
6.2.1. Injector Batteries
Warning: The injector batteries should be replaced only by suitably qualified service
technicians. Replacement should not be attempted by users or their (untrained) service personnel.
The batteries should be checked at each annual preventive maintenance event for signs of enclosure
warping or content leakage.
Expected useful battery life is 2-4 years. If performance noticeably decreases, please contact your service
representative for a replacement battery. Do not use substitute batteries.
The reorder code for injector batteries is HB0013.
6.2.2. Remote Control Batteries

The battery in the remote control can be changed by users. When the battery in the remote control is
running low, the red LED will illuminate to warn the user that the battery should be changed. If the
remote does not work and no LEDs illuminate when either button is pressed, then the battery is fully
discharged and should be replaced immediately.
The battery is replaced by loosening the four screws on the bottom of the unit and removing the bottom
half of the remote control enclosure. Disconnect the old battery and fit the replacement battery into the
same location. Do not over-tighten the screws when re-assembling the remote control. Depending on
usage, the expected useful battery life is 12 months.
If the remote control will not be used for more than two weeks, the battery should be removed from the
remote control.
The reorder code for the battery in the remote control is HB0001.
6.3. Recommended Regular Check Procedure
6.3.1. Monthly
Once a month, the entire injector should be thoroughly inspected and cleaned and an operational
checkout procedure should be performed. Refer to Section 6.3.3 for the checkout procedure.
6.3.2. Annual Check
WARNING
A complete injector calibration and performance checkout should be carried out once a year
by an 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 2.8 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.
6.3.3. Operator Checkout Procedure

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.
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.
Checkout Procedure
1. Examine the injector for signs of damage or wear.

2. Disconnect the injector from the mains supply by removing the IEC mains connector from the
base of the unit.
3. With the injector off, disengage the circuit breaker marked CB on the base of the unit. Reengage
the circuit breaker noting the physical movement of the lever. Feel for any sign of difficulty in
moving the CB lever.
4. Connect an IEC power cord and connect to the mains supply.
5. Turn the mains rocker switch on the base to the ON position
6. The adjacent LED on the base of the unit will display green.
7. Press the ON switch on the injector head. The display should now turn on and the LED on the
head will turn green.
8. The screen display should be bright and clear when viewed front on.
9. Fit a new syringe.
10. Select the “?” button and allow the injector to find the syringe plunger
11. The injector should purge the air from the syringe automatically.
12. Using the manual fill control, touch the screen in the arrowed areas and observe movement of
the piston in or out depending on chosen directions.
13. Fill a syringe with an amount of water, say 120mL.
14. Press .
15. Program a routine protocol:
Volume = 100mL
Flow = 5mL/s
Pressure = 300 psi
16. Use a measuring cylinder or similar known volume container marked to 100mL (±2mL) volume.
17. Inject 100mL volume and observe the inject time to be 20 seconds (± 1 second) and the
measured volume is 100mL (±2mL).
18. Check the injection review screen displays an inject time of 20 seconds (± 1 second) and a
delivered volume of 100mL (±2mL).
19. Perform the 100mL injection again, but occlude the tubing by kinking or blocking the tube.
Ensure that the injection halts with an over-pressure or stall alarm.
20. Switch off the mains rocker switch on the base of the unit. Ensure that the battery symbol is
displayed at the top of the injector display screen.
6.4. Disposing of the Injector and RCU

The symbol shown below indicates the product must not be disposed of with other waste.
Instead, it is the user’s responsibility to dispose of the product by handing it over to a
designated collection point for the recycling of waste electrical and electronic equipment.
Contact your Imaxeon service representative for further details.
WARNING
The battery contains no mercury or mercury compounds. However, it does contain the following
hazardous materials:
• Lead 48~53 wt%
• Lead Oxide 23~26%
• Lead Sulphate < 1. wt%
• Electrolyte – Sulphuric Acid 7~10 wt%
Please dispose of this pack within environmental pollution guidelines depending on your local
regulations.
7. Trouble-shooting
7.1. Fault Finding Guide

Symptoms Actions
Injector does not power up 1. Check that circuit breaker is pressed in

2. Connect AC mains cable
3. Replace batteries
4. Contact Imaxeon Service
Injection stops mid-way 1. Check for kink in giving set tubing

through an injection 2. Check for cannula placement and possible arterial occlusion
from patient arm position
3. Check battery health
4. Contact Imaxeon Service
Piston does not disengage 1. Remove syringe manually

from syringe plunger 2. Sensor does not work if used in bright sunlight or if foreign
properly when retracting object (such as sticky tape) is affixed to syringe near plunger
after injection
Spurious over-pressures and Check for dried contrast around piston on injector head particularly
washed out images (due to where the piston passes through the O-ring. Clean all dried contrast
reduced contrast flow). from this location.
Red battery indicator - Connect injector to mains power supply and

recharge battery.
Insufficient Volume There is insufficient volume in the syringe to deliver the requested
protocol. Refill the syringe.
Syringe Plunger Not Found Remove the syringe and re-engage as shown in Section 5.2.3 of this
manual
Adaptive Flow Active Assess the patient injection site and tubing for partial occlusions and
adjust tubing or patient to reduce any occlusion.
Battery failure (not Order a replacement battery from your authorised service agent. You
charging) may continue to use the injector on mains supply until a replacement
battery is installed.
Over Pressure Check tubing and cannula for kinks or occlusions.
Stalled (Adaptive flow

reached zero flow)
Syringe Lost error Syringe removed or not detected while in Inject mode. Press the Back
button to go to the Review screen
7.1.1. Trouble-Shooting
Symptoms Actions
Unit will not connect to injector Select a different Wireless ID on both the RCU and injector system
and try to connect again.
RCU will not turn on Check the power supply is connected to the RCU.
Loading/Saving Protocols Fails Check that a formatted USB memory device is inserted into the
RCU.
Wireless connection is Ensure that there are no otherVistron Plus RCU devices within
Intermittent range using the same Wireless ID
“System Clock Error” on RCU The rechargeable backup battery for the system clock is flat.
bootup. Charge the RCU for several hours before rebooting.
In general, the RCU should be operated while on charger.
7.2. Alarms and Error Messages

Alarms and error messages are indicated by the status bar at the top of the screen changing colour to red
or yellow. Press on the status bar to view the current alarm condition.
If the error is any other than that described in Section 7.1, remove injector from use and call your
authorised service agent.
8. Specifications
8.1. Dimensions
Model: VP001
8.2. Mechanical
Weight 21.7 kg
Height 1230 mm
Floor Area 500mm x 500mm
No of Wheels 4, locking
Type of Wheel Rubber Castor, ball bearing race
Construction Materials Flame retardant ABS panels, Aluminium, Steel
Operating Noise Level < 95 dBA
8.2.1. [RCU Tablet] Mechanical

Weight 1kg
Dimensions 307mm W x 200 mm H x 35mm D (tablet without stand)
8.3. Functional
Max Pressure Limit 300 psi
(User Selectable) Set Pressure Limit 100 to 300 psi in 1 psi increments
Display pressure accuracy +/- 50psi
Max Flow Rate 10 ml/s
Injected flow rate accuracy +/- 5%
Programmable Flow Rate User-settable in 0.1 ml/s increments from 0.1 to 10ml/s
Maximum Deliverable Volume 190 ml

Programmable Volume User-settable in 1ml increments from 1 to 190ml
Displayed volume accuracy +/- 1% or 0.5ml, whichever is greater
Manual Fill rate 0.1 to 10 ml/s
Auto Fill rate 0.1 to 10 ml/s
Multistage Injection Up to 4 phases
Pause Phase Range 1 to 900 seconds in 1 s increments

8.4. Controls
Pedestal Line power ON/OFF, double pole switch
IEC power inlet, double fused
Circuit Breaker 3A max
Injector Head Touchscreen Fill control
Protocol Programming
Injector buttons Power on/off
Arm
Remote control Start/stop injection
Hand-switch or footswitch Start/stop injection
8.5. Environmental
Temperature – transport/storage -20°C to +60°C
Temperature – operation +10°C to +40°C
Humidity – transport/storage 10% to 95% RH, non-condensing
Humidity – operation 20% to 80% RH, non-condensing
Barometric Pressure – transport/storage 48kPa to 110kPa
Barometric Pressure - operation 70kPa to 106kPa
8.5.1. [RCU Tablet] Environmental

Temperature – storage and transportation -20°C to 50°C
Relative humidity – storage and transportation 20% to 93% (40°C)
Atmospheric pressure 86kPa to 106kPa
Temperature - operation 10°C to 35°C
Relative humidity – operation 35% to 80%
8.6. Electrical
Line Voltage 100-230 V~ ±10%
Line frequency 50/60 Hz
Phase Single
Charging AC only
Operating Batteries or AC
Max Current Consumption, Operating 2.0A peak
Max Current Consumption, Standby 0.5A or less
Consumption, Charging from mains 1A maximum
Current Surge (inlet fuse) Rating 2A maximum
Battery Voltage 12VDC
Battery type Imaxeon 12 V7.2Ah Lead Acid
Battery Hazardous Material Content • Lead: 48~53 wt%

• Lead Oxide: 23~26%
• Lead Sulphate: < 1. wt%
• Electrolyte – Sulphuric Acid: 7~10 wt%
Contains no mercury or mercury compounds.
No. of Batteries 2
Recharge time (for 25 injections) 8 hours
Battery Service Life 2 years
Contrast Heat Maintainer operation Auto detects heat maintainer plugged in.
Contrast Heat Maintainer – rating 5W
Contrast Heat Maintainer – temperature range 37±4°C
Category AP/APG Not Applicable
8.6.1. [RCU Tablet] Electrical

AC Adapter Wide mode AC power supply
100 – 240VAC 1.5A 50 – 60 Hz
19V 40W DC to tablet
Battery Lithium-Ion Battery
Wireless IEEE 802.11 b/g/n
Injector module
Frequency Range: 2412.0 – 2462.0 MHz
Output Power: 0.00865 W
RCU Tablet
Frequency Range: 2412.0 – 2462.0 MHz
8.7. Connectors
Head Cable 26-way D sub-miniature
Hand/Foot Switch Circular, locking. 3 pin XLR
Line Power IEC 60320-C14
Equipotential Point MC POAG-S6 SERIES
Syringe Heater 4 pin Mini-DIN
8.8. IEC 60601-1 Classifications

The Injector is classified as follows:
♦ Class 1 equipment with Type BF applied parts.
♦ Internally Powered Equipment
♦ IPX0 (Injector, RCU, and hand-switch) Clause 6.3 of IEC60601-1: 1998 (Injector head)
♦ VP021 Continuous Operation
♦ Not suitable for use in the presence of flammable anaesthetic mixtures with air or oxygen or
nitrous oxide
8.9. 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.
8.10. RoHS
8.10.1 China RoHS Statement

以下说明根据电子信息产品污染控制标识要求（标准号：SJ/T11364-2006）制定。
The following product pollution control information is provided according to SJ/T11364-2006 Marking for
Control of Pollution caused by Electronic Information Products.
电子信息产品污染控制标志说明Explanation of Pollution Control Label
该标志表明本产品含有超过中国标准SJ/T11363-2006《电子信息产品中有毒有害物质的限量要求》中限
量的有毒有害物质。标志中的数字为本产品的环保使用期，表明本产品在正常使用的条件下，有毒有害
物质不会发生外泄或突变，用户使用本产品不会对环境造成严重污染或对其人身、财产造成严重损害的
期限，单位为年。
为保证所申明的环保使用期限，应按产品手册中所规定的环境条件和方法进行正常使用，并严格遵守产
品维修手册中规定的定期维修和保养要求。
产品中的消耗件和某些零部件可能有其单独的环保使用期限标志，并且其环保使用期限有可能比整个产
品本身的环保使用期限短。应到期按产品维修程序更换那些消耗件和零部件，以保证所申明的整个产品
的环保使用期限。
本产品在使用寿命结束时不可作为普通生活垃圾处理，应被单独收集妥善处理。
This symbol indicates the product contains hazardous materials in excess of the limits established by the
Chinese standard SJ/T11363-2006 Requirements for Concentration Limits for Certain Hazardous
Substances in Electronic Information Products. The number in the symbol is the Environment-friendly Use
Period (EFUP), which indicates the period during which the toxic or hazardous substances or
elementscontained in electronic information products will not leak or mutate under normaloperating
conditions so that the use of such electronic information products will not resultin any severe
environmental pollution, any bodily injury or damage to any assets, the unit of the period is “Year”.
In order to maintain the declared EFUP, the product shall be operated normally according to the
instructions and environmental conditions as defined in the product manual, and periodic maintenance
schedules specified in Product Maintenance Procedures shall be followed strictly.
Consumables or certain parts may have their own label with an EFUP value less than the product. Periodic
replacement of those consumables or parts to maintain the declared EFUP shall be done in accordance
with the Product Maintenance Procedures.
This product must not be disposed of as unsorted municipal waste, and must be collected separately and
handled properly after decommissioning.
产品中有毒有害物质或元素的名称及含量
Table of hazardous substances’ name and concentrations
有毒有害物质或元素
部件名称 Hazardous substances’ name
Component Name
铅汞镉六价铬多溴联苯多溴二苯醚
(Pb) (Hg) (Cd) (Cr(VI)) (PBB) (PBDE)
高压注射器 X O O O O O
Single Head Injector
平板电脑 X O O O O O
RCU
O:表示该有毒有害物质在该部件所有均质材料中的含量均在 SJ/T11363-2006 标准规定的限量要求以下
X:表示该有毒有害物质至少在该部件的某一均质材料中的含量超出 SJ/T11363-2006 标准规定的限量要求
• 此表所列数据为发布时所能获得的最佳信息.
• 由于缺少经济上或技术上合理可行的替代物质或方案，此医疗设备运用以上一些有毒有害物质来实现设备的预
期临床功能，或给人员或环境提供更好的保护效果。
O: Indicates that this toxic or hazardous substance contained in all of the homogeneous materials for this part is
below the limit requirement in SJ/T11363-2006.
X: Indicates that this toxic or hazardous substance contained in at least one of the homogeneous materials used for
this part is above the limit requirement in SJ/T11363-2006
• Data listed in the table represents best information available at the time of publication.
• Applications of hazardous substances in this medical device are required to achieve its intended clinical uses,
and/or to provide better protection to human beings and/or to environment, due to lack of reasonably
(economically or technically) available substitutes.
8.10.2 EU RoHS Statement

This injector meets the Directive 2011/65/EU restriction of the use of certain hazardous substances in
electrical and electronic equipment recast (RoHS2). The injector, with the exception of the battery, does
not contain any of the following banned substances.
• Mercury
• Hexavalent Chromium
• Cadmium
• Polybrominated Biphenyls
• Polybrominated Diphenyl Ether
• Pentabromodiphenyl ether (PentaBDE)
• Octabromodiphenyl ether (OctaBDE)
• Decabromodiphenyl ether (DecaBDE)
Refer to Section 6.4 for details of the hazardous material contained in the battery.
8.11. IEC60601-1-2:2007 (3rd Ed) Compliance
8.11.1. Electromagnetic Emissions

Guidance and manufacturer’s declaration – electromagnetic emissions
The injector is suitable for use in the electromagnetic environment specified below. The customer or the user of the injector
must ensure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions Group 1 The injector uses RF energy only for its internal function.
CISPR 11 Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF emissions Class B The injector is suitable for use in all establishments, including
CISPR 11 domestic establishments and those directly connected to the
public low-voltage power supply network that supplies buildings
Harmonic emissions Class A used for domestic purposes.
IEC 61000-3-2
Voltage fluctuations Complies
IEC 61000-3-3
8.11.2. Electromagnetic Immunity

Guidance and manufacturer’s declaration – electromagnetic immunity
The injector is suitable for use in the electromagnetic environment specified below. The customer or the user of the injector
must ensure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment –
guidance
Electrostatic ± 6 kV contact ± 6 kV contact Floors should be wood, concrete or

discharge (ESD) ceramic tile. If floors are covered with
± 8 kV air ± 8 kV air
IEC61000-4-2 synthetic material, the relative
humidity should be at least 30%.
Electrical fast ± 2 kV for power supply ± 2 kV for power supply Mains power quality should be that of a
transient/burst lines lines typical commercial or hospital
IEC 61000-4-4 environment.
± 1 kV for input/output ± 1 kV for input/output
lines lines
Surge ± 1 kV line(s) to line(s) ± 1 kV line(s) to line(s) Mains power quality should be that of a
IEC 61000-4-5 typical commercial or hospital
± 2 kV line(s) to earth ± 2 kV line(s) to earth
environment.
Voltage dips, short < 5% UT < 5% UT Mains power quality should be that of a
interruptions and (> 95% dip in UT) (> 95% dip in UT) typical commercial or hospital
voltage variations on environment. If the user of the injector
for 0.5 cycle for 0.5 cycle
power supply input requires continued operation during
lines 40% UT 40% UT power mains interruptions, it is
(60% dip in UT) (60% dip in UT) recommended that the injector be
IEC 61000-4-11 for 5 cycles for 5 cycles powered from an uninterruptible power
supply or a battery.
70% UT 70% UT
(30% dip in UT) (30% dip in UT)
for 25 cycles for 25 cycles
< 5% UT < 5% UT
(> 95% dip in UT) (> 95% dip in UT)
for 5 sec for 5 sec
Power frequency 3 A/m 3 A/m Power frequency magnetic fields should
(50/60 Hz) magnetic be at levels characteristic of a typical
field location in a typical commercial or
IEC 61000-4-8 hospital environment.
Note: UT is the AC mains voltage prior to application of the test level.

Guidance and manufacturer’s declaration – electromagnetic immunity
The injector is suitable for use in the electromagnetic environment specified below. The customer or the user of the Vistron
Plus contrast injector must ensure that it is used in such an environment.
Immunity test IEC 60601 test Compliance Electromagnetic environment guidance
level level
Portable and mobile RF communication equipment should be

used no closer to any part of the Vistron Plus contrast injector
than the recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance:
Conducted RF 3 Vrms 3 Vrms d = 1.2√P

IEC 61000-4-6 150 kHz to 80
MHz
Radiated RF 3 V/m 3 V/m d = 1.2√P 80 MHz to 800 MHz
IEC 61000-4-3 80 MHz to 2.5
d = 2.3√P 800 MHz to 2.5 GHz
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 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast 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 injector is used
exceeds the applicable RF compliance level above, the injector should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating
the injector.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
8.11.3. Recommended separation distances from portable and mobile RF

communications equipment and the injector
Recommended separation distances from portable and mobile RF communications equipment and the injector
The injector is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of the injector can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the injector as recommended below,
according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
Rated maximum output m
power of transmitter
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
W
d = 1.2√P d = 1.2√P 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.
8.12. Models
Model Number Description
VP001 MEDRAD Vistron Plus Contrast Injector
8.13. Accessories
Accessory (shaded options are included standard with each injector) Part number
1. Power Cord WP0023 (AU)

WP0020 (BR)
WP0021 (JP)
WP0016 (EU)
WP0015 (CH)
WP0019 (CN)
WP0022 (IT)
WP0024 (KR & EU)
WP0009 (US)
WP0025 (UK)
2. 190 ml Syringe and Quick Fill Tube – tray (box of 50) ZY6320
3. 190 ml Syringe and Fill Spike – tray (box of 50) ZY6321
4. 150cm 300 psi coiled tube set single (box of 50) ZY5151
5. Heat Maintainer DC022
6. Hand-switch (Optional) SF0005
7. Footswitch (Optional) SF0004
8. Remote Control VP021
9. Battery (2 required) HB0013
10. Off-line syringe loader (Optional) MDL001
11. IV holder (Optional) DC039
9. Index
A
G
Accessories, 89
Adaptive flow, 19, 21, 26, 27, 40 GFR, 66
Air embolization, 9 Glomerular Filtration Rate, 66
Alarms, 21, 51, 60 Ground Continuity, 84
Anaethetics, 10 H
Arm injector, 18, 20, 37
Auto Start, 62 Handswitch, 16, 89
AutoFill, 33 Hand-switch, 17
Hazards, 11
B
Heat Maintainer, 9, 12, 28
Battery, 12, 18, 89 Hold, 18, 39
Low, 77 I
Maintenance, 74
BF, Type, 16, 84 Imaxeon, 8
Biological Hazard, 16 Immunity, 87
Indicators, 21
C
Injecting, 36
Cannula, 25 Injector Frame, 51
Castors, 12 Injector Head, 15
Cautions, 10 Injector LEDs, 51
Certifications, 7 Injector-Initiated Scanning, 69
Chemotherapy, 7 Intended Use, 7
Circuit breaker, 16 L
Cleaning, 73
Clinical, 25 LCD, 21
Connection to other equipment, 10 LED, 21
Connectors, 84 Line power, 18
Contact Information, 8
M
Contrast Warmer, 28
Controls, 81 Magnetic Fields, 12
Creatinine, 66 Maintenance, 73
D Manual Fill, 18
Mechanical, 80
Disclaimers, 8 MEDRAD Inc, 7
Disposing Multi-phase, 42
Injector, 76
N
Drug infusion, 7
Dual Injector, 81 Next, 18
Duration, 19
O
E
On/off button, 20
EC Representative, 8 Options, 19, 45
Electrical Shock, 16 Over Pressure, 27, 77
Electrical Specifications, 83
EMC, 7, 10 P
Emissions, 7, 87
Pause, 18
EN 60601-1, 7, 8
Post-Injection, 40
EN 60601-1-2, 7
Power Cord, 89
Environmental Specifications, 82
Pressure, 19, 26
Equipotential Connection, 16
Pressure limiting, 26
Error Messages, 79
Previous, 18
F Programming, 42
Protection Against Electric Shock, 84
Filling, 32 Protective Earth, 10, 16
Auto, 33 Protocol
Manual, 10 Download, 65
Flammable Anaesthetics, 10 Upload, 65
Flow rate, 19, 26, 36 Protocols, 42
High, 9 Load, 18
FluiDots, 7, 30 Multi-phase, 42
Footswitch, 16, 89 Routine, 36
Functional, 81
Fuse, 17 Q
QFT, 30 Stall, 11, 77

Quick Fill Tube, 30 Standby Button, 15
Symbols, 16
R
Syringe, 9, 30, 89
RCU, 48 Disposal, 9
RCU Edit Phase Type, 59 Filled, 9
RCU History FluiDots, 30
Control, 56 Heat Maintainer, 9, 28, 89
Icons, 56 Indicator, 18
Review, 64 Loading, 9
RCU Injection Removing, 35
Arming, 53 Reuse, 9
Check for Air, 53 T
Control, 55
Progress, 54 Time, 19
Start, 53 Touchscreen, 48
RCU Protocol Trademarks, 7
Edit, 57 Trouble-shooting, 77
Remote control, 20, 39, 74 Tube, 30, 35
Remote Control Unit, 48
U
Retract, 18
Review, 40 Under flow rates, 9
RoHS, 86 Under volume, 9
Routine Protocol, 36 USB Device, 65
S W
Save As, 18 Warnings, 10, 16

Scanner Interface, 67 WEEE, 12, 16
Serial number, 7 Wheels, 12
Specifications, 80 Wi-Fi, 48
Environmental, 82 Wireless Link, 49
© January 2017. Imaxeon Pty Ltd All rights reserved.

Reproduction of this manual is strictly prohibited without
express written consent of Imaxeon Pty Ltd.
Bayer, the Bayer Cross and MEDRAD Vistron Plus may be
registered trademarks of Bayer in the US and other
countries.
MEDRAD Vistron Plus may be a registered trademark of its
respective owner and is used herein solely for informative
purposes. No relationship or endorsement should be
inferred or implied.
In accordance with data privacy and protection laws in
Australia and other countries, all patient data that appear
in this document are fictitious. No actual patient
information is shown.
For a full list of Bayer offices and authorized dealers, go

to:
http://www.radiology.bayer.com
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Operation Manual

2 MEDRAD Vistron Plus Operation Manual: MN150001-11.3

5.9.3. Routine Protocol Default Options ..........................................................................55

6.2.2. Remote Control Batteries .......................................................................................79

§6 Cleaning and Maintenance

For the latest support information, visit our website:

Model No Serial No: IMAXEON Service Representative Tel No:

2.1. Important Safety Notice

2.2. How To Read This Manual

Imaxeon Pty Ltd is EN ISO 13485:2012 certified.

2.4. Intended Use

2.8. Imaxeon Contact Information

Imaxeon Pty. Ltd.

Medical Device Safety Service (MDSS) GmbH

2.9. SYRINGE - Warnings and Cautions

WARNING: A biological hazard may occur if syringes are reused.

2.10. INJECTOR - Warnings and Cautions

2.10.1. Glomerular filtration rate (GFR) Calculator Warnings

3.2. Injector Features

Power Input Panel Power cord storage hooks

3.2.1. Injector Head Description

Syringes are loaded into the injector with a simple

3.3.1. Symbols used in this manual

Warning, biological hazard

Electrical Shock Hazard

3.3.2. Symbols used on labelling

Identifies type BF medical equipment complying with EN 60601-1 standards. The

CLASS 1 Indicates the system is Class 1 medical equipment as defined by EN 60601-1

Identifies location for connection of the START switch - either a hand-switch or

Name and address of the manufacturer

Manufacturing Date (YYYY-MM)

Consult instructions for use.

Circuit breaker is out or tripped and requires resetting

Circuit breaker is in-circuit; unit is ready for use on battery or mains

3.3.3. Handswitch and Footswitch

Identifies that line power is connected to the injector

Identifies that system is running on batteries. Animates during charging, and

Forward or Next - navigation

Retract Button: Used to disengage plunger and release syringe

Prime forward fully for a wet connection using

Load saved protocol

Save As – used in Protocols

Indicates Pause phase of the injection

Manual Fill Mode

known position of the plunger.

(On-screen) Start Injection button

(On-screen) Stop Injection button

Duration/Elapsed Time indicator

Injection entered adaptive flow

Space – used as a space-bar when typing with the alphanumeric keypad

Go to the Options menu

3.3.5. Injector Buttons

Identifies the INJECTOR on/off button - located on the power head

3.3.6. Remote Control Symbols and Buttons

Start button – Starts or Stop button - When the

3.3.7. Injector Visual Indicators

Injector Error Condition 1 Flash Red Red Status Bar

Warning Flash Orange Orange Status Bar

ARMED State Flash Green Flashing ARM symbol