Elite Operator's (English) LF Branded-A

MR CONTRAST DELIVERY SYSTEM
A 60
10/15 30 ml ml
/20 ml
B 60 ml50 ml
125 ml
Operator’s Manual 818509-A

for Serial Numbered injectors ending in ‘G’.
ii
I—INTRODUCTION
CONTACT INFORMATION
Liebel-Flarsheim Company LLC
1034 S Brentwood Blvd.
Suite 800
Richmond Heights, MO 63117
1-314-376-4901
1-855-266-4944
LF.PMQuality@guerbet.com
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
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FOREWORD
Congratulations on the purchase of your OptiStar® Elite MR Contrast Delivery
I—INTRODUCTION
System. The OptiStar Elite MR Contrast Delivery System represents our effort to
provide a quality product to support better health care throughout the world.
Regardless of how well equipment is designed, misuse or abuse will deny
its owner the expected quality of service. Misuse or abuse may occur
unintentionally because the proper method of operating the equipment is
unknown. Read this manual carefully before operating the OptiStar Elite MR
Contrast Delivery System. Retain this manual for future reference.
RECORDING SERIAL NUMBERS AND SOFTWARE VERSIONS

The reference number (Ref. No.) and serial numbers (S/N) must be supplied
when requesting replacement parts or optional accessories. For convenience,
record the requested information below:
Ref. No. ________________________________(located on Power control)

Power Control S/N ___________________________
Powerhead S/N ___________________________
Console S/N ___________________________
Power Supply S/N ___________________________
Date of Installation / /
Installing Company___________________________________________
Address_____________________________________________________
Phone No. ___________________________________________________
Software version numbers may be accessed via the System Info key on the
Results screen
Console_____________________________________________________
Powerpack___________________________________________________
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PATENT INFORMATION
U.S. patents protecting this product are listed at this website:
I—INTRODUCTION
www.guerbet.com/patents
MEANINGS OF SYMBOLS USED IN THIS MANUAL

Please regard any message that follows the word Danger, Warning or
Caution!
DANGER!
Hazards which could result in severe personal injury or death.
WARNING!
Hazards which could result in personal injury.
CAUTION!
Hazards which could result in equipment or property damage.
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MEANINGS OF SYMBOLS USED ON THE INJECTOR
I—INTRODUCTION
Symbol Definition
Console Connection identifier
Powerhead Connection identifier
Power Control identifier
Power Supply identifier
Hand start switch connection identifier
System OFF/ON (only for the Console)
Power OFF/ON
Ram movement/injector status identifier:

A-side Light and B-side Light OFF = Injector Disabled
A-side Light and B-side Light ON = Injector Enabled
A-side Light ON ; B-side Light Flashing = Patency Check Ready
A-side Light Flashing ; B-side Light OFF = A-side Ram moving
A-side Light OFF ; B-side Light Flashing = B-side Ram moving
Check to ensure air is removed from syringe and tubing

before injecting.
Start Injection
P Start Patency Check Injection
Stop Injection
Fluid Detect
Pinch Point possible. Keep fingers away from this area.
Refer to instruction manual / booklet
(01) 1074619000XXXX
(21) 123ABCdefG
UDI (Unique Device Identification) located on rating label
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Symbol Definition
I—INTRODUCTION
Equipment sensitive to Electrostatic Discharge.

DO NOT TOUCH exposed connectors.
MR Unsafe--an item that is known to pose hazards in all

MR MR environments.
MR Conditional--an item that has been demonstrated to pose

no know hazards in a specified MR environment with specified
MR conditions of use.
MR Safe--an item that poses no known hazards in all

MR MR environments.
<300G Locate in an area with magneticfields less than or

equal to 300 Gauss.
! ATTENTION! Consult User's/Service Manual.
European Union’s Waste Electrical and

Electric Equipment (WEEE).
CAUTION! Risk of electrical shock. Do not remove cover.

Refer servicing to qualified personnel.
T 4AH , 250 V Fuse Rating (Voltage, Amperage, Type)
REF Reference
S/N Serial Number
P/N Part Number
V/A Volts Amps
[Reverse] key. Retracts the Powerhead Ram.
[Accelerator] key. Increases the speed of the ram when held

down with [Forward] or [Reverse] key.
[Forward] key. Advances the Powerhead Ram.
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CLASSIFICATION IN ACCORDANCE WITH EN60601

TYPE OF PROTECTION AGAINST ELECTRIC SHOCK
I—INTRODUCTION
Class I equipment
DEGREE OF PROTECTION AGAINST ELECTRIC SHOCK

Type CF applied part (Syringes and Tubing)
DEGREE OF PROTECTION AGAINST INGRESS OF WATER

Ordinary equipment
DEGREE OF SAFETY OF APPLICATION IN THE PRESENCE OF A FLAMMABLE

ANAESTHETIC MIXTURE WITH AIR OR WITH OXYGEN OR NITROUS OXIDE
Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air
or with oxygen or nitrous oxide.
EMISSION STANDARD
The OptiStar Elite MR Contrast Delivery System meets emission standard EN60601-1-2
Class B
UL/CSA CLASSIFICATION
OPTISTAR® ELITE MR CONTRAST DELIVERY SYSTEM
(MEDICAL EQUIPMENT)
WITH RESPECT TO ELECTRIC SHOCK,
FIRE AND MECHANICAL HAZARDS ONLY
33SL IN ACCORDANCE WITH ANSI/AAMI ES 60601-1:2005,
CAN/CSA-C22.2 No. 60601-1 (2008), IEC 60601-1:2005,
UL 60601-1, IEC 60601-1:1998, A1:1991, A2:1995
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CE MARK INFORMATION
I—INTRODUCTION
0123
GUERBET
BP 57400
95943 Roissy CdG Cedex
France
(located at : 15 rue des Vanesses,
93420 Villepinte, France)
Liebel-Flarsheim Company LLC, 2111 E. Galbraith Road, Cincinnati, OH 45237
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TABLE OF CONTENTS
I—INTRODUCTION
Contact Information..........................................................................................................................................ii
Foreword..............................................................................................................................................................iii
Recording Serial Numbers and Software Versions................................................................................iii
Patent Information...........................................................................................................................................iv
Meanings of Symbols used in this Manual..............................................................................................iv
Meanings of Symbols used on the Injector..............................................................................................v
Classification in accordance with EN60601............................................................................................vii
Type of protection against electric shock.....................................................................................vii
Degree of protection against electric shock................................................................................vii
Degree of Protection against ingress of water............................................................................vii
Degree of Safety of Application in the presence of a Flammable anaesthetic Mixture
with Air or with Oxygen or Nitrous Oxide.......................................................................vii
Emission Standard.................................................................................................................................vii
UL/CSA Classification......................................................................................................................................vii
CE Mark Information..................................................................................................................................... viii
OVERVIEW OF THE
OPTISTAR ELITE MR CONTRAST DELIVERY SYSTEM................................ 1-1-1
1.1 Indications for Use.............................................................................................................................1-1-1
1.1.1 Contraindications................................................................................................................. 1-1-1
1.2 User Qualifications.............................................................................................................................1-2-1
1.3 Configuration of Unit........................................................................................................................1-3-1
1.4 Safety Features....................................................................................................................................1-4-1
1.4.1 Self-testing Design............................................................................................................... 1-4-1
1.4.2 Patency CheckTM Feature ................................................................................................. 1-4-1
1.4.3 Timing BolusTM Feature....................................................................................................... 1-4-1
1.4.4 Drip Mode Feature............................................................................................................... 1-4-1
1.4.5 Electrically Isolated Syringe.............................................................................................. 1-4-1
1.4.6 Syringe Clarity........................................................................................................................ 1-4-1
1.4.7 Positive Positioning of the Powerhead......................................................................... 1-4-1
1.4.8 Hand Start switch Operation............................................................................................ 1-4-1
1.4.9 Physical Stability of Remote Stand................................................................................. 1-4-2
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1.5 Specifications......................................................................................................................................1-5-1
1.5.1 Dimensions............................................................................................................................. 1-5-1
I—INTRODUCTION
1.5.2 Weight....................................................................................................................................... 1-5-1

1.5.3 Power Requirements........................................................................................................... 1-5-1
1.5.4 Electrical Leakage................................................................................................................. 1-5-1
1.5.5 Environmental....................................................................................................................... 1-5-2
1.5.6 Compatible Syringe Sizes.................................................................................................. 1-5-4
1.5.7 Programmable Flow Rate (A-side).................................................................................. 1-5-4
1.5.8 Programmable Flow Rate (B-side).................................................................................. 1-5-4
1.5.9 Programmable Volume (A-side)...................................................................................... 1-5-4
1.5.10 Programmable Volume (B-side).................................................................................... 1-5-4
1.5.11 Programmable Pressure Limit ...................................................................................... 1-5-5
1.5.12 Programmable Scan Delay............................................................................................. 1-5-5
1.5.13 Programmable Inject Delay............................................................................................ 1-5-5
1.5.14 Programmable Phase Delay........................................................................................... 1-5-5
1.5.15 Programmable Drip Injection Parameters (B-Side)................................................ 1-5-6
1.5.16 Protocol Memory............................................................................................................... 1-5-6
1.5.17 Inject Results........................................................................................................................ 1-5-6
1.6 Consumables.......................................................................................................................................1-6-1
1.6.1 Compatible Syringe............................................................................................................. 1-6-3
1.6.2 Low Pressure Tubing............................................................................................................ 1-6-3
1.6.3 Multipack Disposables........................................................................................................ 1-6-3
1.6.4 OptiMARK (gadoversetamide injection) Prefilled Syringes................................... 1-6-3
1.6.5 Dotarem (gadoterate meglumine) Prefilled Syringes.............................................. 1-6-4
1.6.6 Prefilled Saline Syringe....................................................................................................... 1-6-4
1.7 Accessories AND cOMPONENTS...................................................................................................1-7-1
Accessories......................................................................................................................................... 1-7-1
Components...................................................................................................................................... 1-7-1
POWER ON / POWER OFF............................................................................ 2-1-1

2.1 Turning System Power ON..............................................................................................................2-1-1
2.2 Turning System Power OFF.............................................................................................................2-2-1
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CONSOLE....................................................................................................... 3-1-1
3.1 Turning the System ON....................................................................................................................3-1-1
I—INTRODUCTION
3.2 Console Display Modes of Operation.........................................................................................3-2-1
3.2.1 Main Screen............................................................................................................................ 3-2-1
3.2.2 Memory Screen, System Info Screen, Results Screen and [Enable] Key............ 3-2-1
3.3 Description of Screens.....................................................................................................................3-3-1
3.3.1 Main Screen............................................................................................................................ 3-3-1
3.3.2 Memory Screen .................................................................................................................... 3-3-5
Retrieving a Protocol from Memory...............................................................................3-3-6
Deleting a Protocol from Memory..................................................................................3-3-7
Storing a Protocol in Memory...........................................................................................3-3-9
Editing a Protocol Name.................................................................................................. 3-3-11
3.3.3 System Information Screen.............................................................................................3-3-13
Selectable Features............................................................................................................ 3-3-13
Information Displayed...................................................................................................... 3-3-14
3.3.4 Injection Results Screen...................................................................................................3-3-16
3.3.5 Enabled Screen.....................................................................................................................3-3-18
3.3.6 Drip Mode Screen...............................................................................................................3-3-19
3.3.7 Accessing the Drip Infusion Progress Screen...........................................................3-3-22
3.3.8 Drip Infusion Completed Screen...................................................................................3-3-24
POWERHEAD................................................................................................ 4-1-1
4.1 Description of Powerhead..............................................................................................................4-1-1
4.1.1 Powerhead Features............................................................................................................ 4-1-1
4.1.2 Description of Powerhead Keys...................................................................................... 4-1-4
4.2 Filling Syringes....................................................................................................................................4-2-1
4.3 Purge Air from Syringe and Tubing/Install Syringe(s)...........................................................4-3-1
4.3.1 Contrast Only Injection...................................................................................................... 4-3-1
4.3.2 Begin injecting contrast followed with a saline flush.............................................. 4-3-4
Using 50 ml / 60 ml Saline Syringe..................................................................................4-3-4
Using 125 ml Saline Syringe..............................................................................................4-3-8
4.3.3 Begin injection with Drip Mode, Patency Check, or Timing Bolus ...................4-3-11
Using 125 ml Saline Syringe........................................................................................... 4-3-13
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DELIVERING
AN INJECTION.............................................................................................. 5-1-1
I—INTRODUCTION
5.1 Safety Instructions.............................................................................................................................5-1-1

5.2 Load Syringe(s) / Enter Parameters / Connect Patient..........................................................5-2-1
5.3 Check Patency of I.V. Site.................................................................................................................5-3-1
5.4 Delivering a Drip Mode Injection.................................................................................................5-4-1
5.5 Delivering the Main Protocol..........................................................................................................5-5-1
5.6 Prematurely Stopping an Injection.............................................................................................5-6-1
5.7 Restarting a Prematurely Stopped Injection.............................................................................5-7-1
SYSTEM GENERATED MESSAGES AND ALARMS...................................... 6-1-1

6.1 System Generated Messages/Indications..................................................................................6-1-1
6.1.1 * Asterisk: Protocol Retrieved from Memory has been Modified........................ 6-1-1
6.1.2 Volume Key Flashing a Magenta Color......................................................................... 6-1-1
6.1.3 Pressure Limited Injection................................................................................................. 6-1-2
6.2 System Generated Alarms................................................................................................................6-2-1
CARE OF UNIT............................................................................................... 7-1-1

7.1 Preventive Maintenance and Service.........................................................................................7-1-1
7.2 Daily Inspection..................................................................................................................................7-2-1
7.3 Cleaning ...............................................................................................................................................7-3-1
7.3.1 Syringe Holder....................................................................................................................... 7-3-1
7.3.2 Powerhead ............................................................................................................................. 7-3-2
7.3.3 Console..................................................................................................................................... 7-3-2
7.3.4 Power Control........................................................................................................................ 7-3-2
7.3.5 Power supply.......................................................................................................................... 7-3-2
ELECTROMAGNETIC COMPATIBILITY GUIDANCE....................................... A-1

INDEX I-1-1
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1
OVERVIEW OF THE
OPTISTAR ELITE MR
CONTRAST DELIVERY
1—OVERVIEW OF THE
CONTRAST DELIVERY
OPTISTAR ELITE MR
SYSTEM
SYSTEM
The purpose of this manual is to provide instructions for using the OptiStar
Elite MR Contrast Delivery System in order to ensure patient safety. For
safe operation, it is important that this manual be read carefully and its
recommended procedures followed.
1.1 INDICATIONS FOR USE

The OptiStar Elite MR Contrast Delivery System is a contrast delivery system and
is designed to inject MR contrast media and flushing solutions into a patient’s
vascular system to obtain diagnostic images when used with Magnetic
Resonance Imaging equipment.
1.1.1 CONTRAINDICATIONS
Contraindications for the use of this device are determined by the prescribing
physician at the time of use based upon the contrast media package inserts.
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1—OVERVIEW OF THE
CONTRAST DELIVERY
OPTISTAR ELITE MR
SYSTEM
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1.2 USER QUALIFICATIONS

The OptiStar Elite MR Contrast Delivery System Injection System should ONLY
be operated by qualified health care professionals who have been trained in
1—OVERVIEW OF THE
the use of this equipment and have read and understand this manual.
CONTRAST DELIVERY
OPTISTAR ELITE MR
Training made available upon installation by the manufacturer and repeat of
SYSTEM
training available upon request.
CAUTION! .
Federal (USA) law restricts this device to sale by or on the order of a physician.
(21CFR 801.109(6)(1).
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1-2-2
1—OVERVIEW OF THE
CONTRAST DELIVERY
OPTISTAR ELITE MR
SYSTEM
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1-3-1
1.3 CONFIGURATION OF UNIT

The OptiStar Elite MR Contrast Delivery System is specially designed to be
used in conjunction with MRI equipment. The unit consists of the components
1—OVERVIEW OF THE
shown in Figure 1-3-1.
CONTRAST DELIVERY
OPTISTAR ELITE MR
The console, filter, and the power supply are not designed to be placed in the
SYSTEM
MRI area and must be set up in a separate viewing room. The power control,
powerhead and remote stand have been specifically designed so that they may
remain in the MRI area throughout the procedure without interference.
NOTE: Refer to section 1.5.5 Environmental for further information concerning
component location.
WARNING!
No modification of this equipment is allowed.
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1-3-2
The console A contains a touch-sensitive display screen which provides

the ability to change the injection parameters, store protocols and retrieve
protocols. Information about the console is found in Chapter 3—Console
Screens.
1—OVERVIEW OF THE
CONTRAST DELIVERY
OPTISTAR ELITE MR
A hand start switch B , a remote control device which attaches to the rear
SYSTEM
of the console, is included so that the injection process may be started and
stopped from outside the MRI area.
The powerhead C is specifically designed from materials which will not

affect nor be affected by the magnetic fields of the MR scanner. Note,
however, the Powerhead Cable Connector (connects into the Power Control)
is MR conditional. Information about the Powerhead is found in Chapter 4—
Description of the Powerhead.
The remote stand D allows easy placement of the powerhead for operator and
patient convenience.
The power system consists of one Power Control E 1 , one Power Supply (with
mounting bracket) E 2 and one EFI/RFI Filter E 3 . Both the Power Control
and the Communication Cable (from the filter to the Power Control) are MR
Conditional. More information about the power system is found in Chapter 2—
Power ON / Power OFF.
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1-3-3
MR MR
MR
E3
1—OVERVIEW OF THE
CONTRAST DELIVERY
OPTISTAR ELITE MR
C
SYSTEM
A 60 ml
10/15/2 30 ml
0 ml
B 60 ml50 ml
125 ml
E1
D
Dividing
B E2 Wall
Control and
Equipment Rooms Magnet Room
AC Outlet
Figure 1-3-1 Overview of System
NOTE: Refer to section 1.5.5 Environmental for further information concerning

component location and safety conditions.
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1-3-4
1—OVERVIEW OF THE
CONTRAST DELIVERY
OPTISTAR ELITE MR
SYSTEM
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1-4-1
1.4 SAFETY FEATURES

The OptiStar Elite MR Contrast Delivery System has been designed to ensure
the safety of both patient and operator. Specific safety features include:
1—OVERVIEW OF THE
CONTRAST DELIVERY
OPTISTAR ELITE MR
1.4.1 SELF-TESTING DESIGN
When the OptiStar Elite MR Contrast Delivery System is switched ON, it
SYSTEM
automatically performs a series of power-up tests to monitor the system
status. If a problem is detected, an error code message will appear in the
system display. Also, during the enable process and during an injection, system
functions are constantly checked. If a fault is detected, the system will display
an error code message. Refer to Chapter 6—System Generated Messages and
Alarms for error code messages.
1.4.2 PATENCY CHECKTM FEATURE
Prior to the delivery of the main injection, a Patency Check — an injection of a
small volume of saline — can be performed to determine the integrity of the
I.V. site.
1.4.3 TIMING BOLUSTM FEATURE
Prior to the delivery of the main injection, a Timing Bolus injection — an
injection of a small volume of contrast typically followed by an injection of a
small volume of saline — can be delivered to the patient to determine the
optimal scan delay needed to capture the contrast agent in the area of interest.
1.4.4 DRIP MODE FEATURE
Prior to the delivery of the main injection, a Drip Mode injection — multiple
injections of a small volume of saline — can be delivered to the patient to keep
the fluid path open during patient set up and between injections of contrast.
1.4.5 ELECTRICALLY ISOLATED SYRINGE
All syringes are electrically isolated from any electrical contact with the injector.
1.4.6 SYRINGE CLARITY
Semitransparent syringes are used on the OptiStar Elite MR Contrast Delivery
System. If small air bubbles are present, they can be seen by visual inspection.
1.4.7 POSITIVE POSITIONING OF THE POWERHEAD
A preset friction device in the powerhead holds the syringe in the desired
position during injection.
1.4.8 HAND START SWITCH OPERATION
Use of the hand start switch allows the operator to start and stop injections
from within the view/control room.
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1.4.9 PHYSICAL STABILITY OF REMOTE STAND

The weighted base of the remote stand along with large casters reduces the
possibility of tipping and increases its ability to roll over small cords. Looping
1—OVERVIEW OF THE
the cables over the cable hanger helps keep the cables away from the wheels.
CONTRAST DELIVERY
OPTISTAR ELITE MR
WARNING!
SYSTEM
To prevent operator injury, note that injector cables laying on the floor could
possibly cause a trip hazard.
WARNING!
Maintain a constant hold on the remote stand when moving over door
thresholds, injector cables or other obstacles on the floor to help prevent the
injector from tipping over.
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1.5 SPECIFICATIONS
1.5.1 DIMENSIONS
• Console 12.25” W X 8.5” H X 2.5” D
1—OVERVIEW OF THE
CONTRAST DELIVERY
OPTISTAR ELITE MR
(311.15 mm W X 215.9 mm H X 63.5 mm D)
• Console Base 9.5” W X 2.5” H X 7” D
SYSTEM
(241.3 mm W X 63.5 mm H X 177.8 mm D)
• Powerhead 7” W X 21.5” H X 5.5” D
(177.8 mm W X 546.1 mm H X 139.7 mm D)
• Remote Stand 27” Diameter (base) X 47.5” H
(685.8 mm diameter X 1206 mm H)
• Power Control 10” W X 4.25” H X 15.25” D
(254 mm W X 107.95 mm H X 387.35 mm D)
• Power Supply 10” W X 4.25” H X 9.5” D
(254 mm W X 107.95 mm H X 241.3 mm D)
• Filter 4” W X 10.0” H X 3” D
(101.6 mm x 254.0 mm x 76.2 mm)
1.5.2 WEIGHT
• Console 5.8 lb. (2.6 kg)
• Power Control 16 lb. (7.26 kg)
• Powerhead (w/arm and cable) 14.5 lb. (6.57 kg)
• Remote Stand 29 lb. (13.00 kg)
• Power Supply 11.5 lb. (5.21 kg)
• Filter 10 lb. (4.54 kg)
1.5.3 POWER REQUIREMENTS
• Power Supply
Voltage 100-127 / 220-240 V~, 0.48 kW
Frequency 50/60 Hz
Current 4 Amp
Mode of Operation Continuous Operation
1.5.4 ELECTRICAL LEAKAGE
Chassis less than 300 microamps @ 115 VAC
less than 500 microamps @ 230 VAC
WARNING!
To avoid risk of electric shock, this equipment must only be connected to a

supply mains with protective earth.
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1.5.5 ENVIRONMENTAL
• Transport and Storage: -40° to +158° F (-40° to +70° C)
10% to 95% relative humidity
1—OVERVIEW OF THE
CONTRAST DELIVERY
• Operation: 50° to +104° F (10° to +40°C)

OPTISTAR ELITE MR
30% to 75% relative humidity

SYSTEM
• Biohazard Disposal: Dispose of biohazards in accordance with the

requirements of your hospital, facility or local regulations.
• Disposal of the OptiStar Elite MR Contrast Delivery System at the end of its
useful life: To minimize the risk to the environment associated with the disposal
of this equipment, its disposal should be performed in compliance with
local, state and federal regulations. Disposal of accessories and consumables
associated with this equipment should also be performed in compliance with
local, state and federal regulations.
• Degree of Safety of Application in the presence of a Flammable anaesthetic
Mixture with Air or with Oxygen or Nitrous Oxide: Equipment not suitable for
use in the presence of a flammable anaesthetic mixture with air or with oxygen
or nitrous oxide.
• Electromagnetic Compatibility (EMC) Guidance can be found in Appendix A.
DANGER!
Possible explosion hazard if used in the presence of flammable anesthetics.
WARNING!
Collision with other equipment can cause structural failure of suspension

arm, resulting in operator or patient injury. Visually inspect the J-Bow Arm,
be sure all fasteners are secure. Observe system for cracks or defects. Check
the suspension arm for movement. If defects are observed or adjustment is
required, immediately contact your authorized service personnel.
WARNING!
Safety in Magnetic Resonance Environment: Refer to Figure 1-3-1.

OptiStar Elite MR Contrast Delivery System Injector: The OptiStar Elite MR
Contrast Delivery System Injector is to be used with magnet strengths of up to
3.0T.
Remote Stand with Powerhead (NOT including Powerhead Cable Connector):
The Powerhead and Remote Stand are specifically designed from materials
MR
which will not affect nor be affected by the magnetic fields of the MR scanner.
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1-5-3
Note, however, the Powerhead Cable Connector (connects into the Power
Control) is MR conditional.
Powerhead Cable Connector: The Powerhead Cable Connector is MR
1—OVERVIEW OF THE
Conditional. During installation and removal, the Powerhead Cable Connector
CONTRAST DELIVERY
OPTISTAR ELITE MR
should be carried with caution when within fields between 1,125 G and 2000G.
MR
The Powerhead Cable Connector should not be carried into fields higher than
SYSTEM
2000G. NOTE: During operation the Powerhead Cable Connector is securely
connected to the Power Control and is in an area less than or equal to 300G.
Power Control: The Power Control is MR Conditional. During installation and
removal, the Power Control should not be carried into fields higher than 2000G.
MR During injector operation, the Power Control must be located in an area with a
field less than or equal to 300G.
Communication Cable Connectors: The Communication Cable Connectors are
MR Conditional. During installation and removal, the communication cable
connectors should be carried with caution when within fields between 470G
MR
and 3,200 G. The Communication Cable Connectors should not be carried into
fields greater than 3,200 G. NOTE: During operation the Communication Cable
Connectors are securely connected to the Power Control and Filter.
Console, Power Supply and Mounting Bracket, Hand Start Switch, and Filter:
The console, Power Supply and mounting bracket, hand start switch, and the
MR Filter are not designed to be placed in the MRI area and must be set up in a
separate viewing room.
CAUTION!
If fluid is spilled on the console or power control, remove the unit from
operation and contact your authorized service personnel.
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1-5-4
1.5.6 COMPATIBLE SYRINGE SIZES

Refer to Section 1.6 Consumables for more information.
• 10 ml, 15 ml, 20 ml OptiMARK prefills (used with the optional OptiMARK
1—OVERVIEW OF THE
CONTRAST DELIVERY
OPTISTAR ELITE MR
adapter 802730)
• 15 ml, 20 ml Dotarem prefills (used with supplied DOTAclip adapter 802930)
SYSTEM
• 30 ml
• 60 ml single-use, disposable syringe
• 50 and 125 ml
1.5.7 PROGRAMMABLE FLOW RATE (A-SIDE)
• 60 ml syringe: 0.1 - 10.0 ml/sec
• 10 ml, 15 ml, 20 ml, and 30 ml syringe: 0.1 - 8.0 ml/sec
1.5.8 PROGRAMMABLE FLOW RATE (B-SIDE)
• 50 ml and 125 ml syringe: 0.1 - 8.0 ml/sec
• 60 ml single-use, disposable syringe: 0.1 - 8.0 ml/sec
1.5.9 PROGRAMMABLE VOLUME (A-SIDE)
• 10 ml, 15 ml, and 20 ml syringe: 1 ml to 20 ml
• 30 ml and 60 ml syringe: 1 ml to installed syringe size
1.5.10 PROGRAMMABLE VOLUME (B-SIDE)
• 50 ml, 60 ml and 125 ml syringe: 1 ml to installed syringe size
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1-5-5
1.5.11 PROGRAMMABLE PRESSURE LIMIT

A-Side B-Side PSI kPa
10,15,20 ml 50 ml 20 - 200 PSI 138 - 1380 kPa
1—OVERVIEW OF THE
CONTRAST DELIVERY
OPTISTAR ELITE MR
10,15,20 ml 60 ml 20 - 150 PSI 138 - 1035 kPa
SYSTEM
10,15,20 ml 125 ml 20 - 200 PSI 138 - 1380 kPa
30 ml 50 ml 20 - 200 PSI 138 - 1380 kPa
30 ml 60 ml 20 - 150 PSI 138 - 1035 kPa
30 ml 125 ml 20 - 200 PSI 138 - 1380 kPa
60 ml 50 ml 20 - 150 PSI 138 - 1035 kPa
60 ml 60 ml 20 - 150 PSI 138 - 1035 kPa
60 ml 125 ml 20 - 150 PSI 138 - 1035 kPa
NOTE: When a 60 ml syringe is installed into the B side, the maximum pressure
limit for both sides will be 150 PSI (1035 kPa).
NOTE: When a 125 ml syringe is installed into the B side, the maximum
pressure for the B side (only) will be 100 PSI (690 kPa).
1.5.12 PROGRAMMABLE SCAN DELAY
0 - 1:00 (1 minute: 0 seconds) in increments of 1 second
1.5.13 PROGRAMMABLE INJECT DELAY
0 - 5:00 (5 minutes: 0 seconds) in increments of 1 second
1.5.14 PROGRAMMABLE PHASE DELAY
• 0 - 600 seconds in increments of 1 second
• Pause
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1.5.15 PROGRAMMABLE DRIP INJECTION PARAMETERS (B-SIDE)

• Flow Rate: 0.5 - 1.0 ml/sec in increments of 0.1 ml/sec
• Volume: 0.1 - 3.0 ml in increments of 0.1 ml
1—OVERVIEW OF THE
CONTRAST DELIVERY
OPTISTAR ELITE MR
• Interval: 1 - 60 seconds in increments of 1 sec

1.5.16 PROTOCOL MEMORY
SYSTEM
The OptiStar Elite MR Contrast Delivery System can store up to 40 protocols in

memory.
1.5.17 INJECT RESULTS
The OptiStar Elite MR Contrast Delivery System stores the results of the last 48
injected protocols.
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1.6 CONSUMABLES
WARNING!
1—OVERVIEW OF THE
CONTRAST DELIVERY
OPTISTAR ELITE MR
This device has been approved for use with only the consumables listed. Use
of other consumables could result in patient injury, operator injury, equipment
SYSTEM
damage, and/or injector performance issues (i.e. incorrect volume delivery,
incorrect flow rate delivery, incorrect pressure, etc.).
OptiMARK TM (GADOVERSETAMIDE) Injection

See OptiMARK Package Insert for full prescribing information.
Package Insert enclosed with drug.
WARNING
NEPHROGENIC SYSTEMIC FIBROSIS (NSF) RISK INCREASE--Gadolinium-
based contrast agents (GBCAs) increase the risk for NSF among patients
with impaired elimination of the drugs. Avoid use of GBCAs in these patients
unless the diagnostic information is essential and not available with non-
contrasted MRI or other modalities. NSF may result in fatal or debilitating
fibrosis affecting the skin, muscle and internal organs.
• Do not administer OptiMARK™ to patients with:

• chronic, severe kidney disease (GFR < 30 mL/min/1.73 m2), or
• acute kidney injury (see CONTRAINDICATIONS in OptiMARK Package Insert).
• Screen patients for acute kidney injury and other conditions that may
reduce renal function. For patients at risk for chronically reduced renal
function (e.g. age > 60 years, hypertension or diabetes), estimate the
glomerular filtration rate (GFR) through laboratory testing.
• Do not exceed the recommended OptiMARK™ dose and allow a sufficient

period of time for elimination of the drug from the body prior to any re-
administration (see WARNINGS in OptiMARK Package Insert).
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DOTAREM (Gadoterate Meglumine) Injection

See DOTAREM Package Insert for full prescribing information.
Package Insert enclosed with drug.
1—OVERVIEW OF THE
CONTRAST DELIVERY
WARNING
OPTISTAR ELITE MR
NEPHROGENIC SYSTEMIC FIBROSIS (NSF) RISK INCREASE--Gadolinium-

SYSTEM
based contrast agents (GBCAs) increase the risk for NSF among patients
with impaired elimination of the drugs. Avoid use of GBCAs in these patients
unless the diagnostic information is essential and not available with non-
contrasted MRI or other modalities.
NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and
internal organs.
• The risk for NSF appears highest among patients with:
o Chronic, severe kidney disease (GFR < 30 mL/min/1.73m2), or
o Acute kidney injury.
• Screen patients for acute kidney injury and other conditions that may
reduce renal function.
For patients at risk for chronically reduced renal function (for example,
age > 60 years, hypertension or diabetes), estimate the glomerular filtration
rate (GFR) through laboratory testing [see Warnings and Precautions in
Dotarem Package Insert].
• For patients at highest risk for NSF, do not exceed the recommended
DOTAREM dose and allow a sufficient period of time for elimination of
the drug from the body prior to any re- administration [see Warnings and
Precautions in Dotarem Package Insert].
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1.6.1 COMPATIBLE SYRINGE

801801: 60 mL MR Syringe with Lateral Flow Needle
1.6.2 LOW PRESSURE TUBING
1—OVERVIEW OF THE
CONTRAST DELIVERY
OPTISTAR ELITE MR
It is recommended that catheters, connectors and tubing used with the
OptiStar Elite MR Contrast Delivery System be rated to accommodate pressure
SYSTEM
specification of the installed syringe(s). If such products are rated at a pressure
below specified (as indicated in section 1.5.11), it is the responsibility of the
user to select a pressure limit that is appropriate for the product. Setting of the
pressure limit ([PSI/KPA] key) is performed on the Main screen.
801106: Y-Tubing with Single Check Valve; 152 cm (60”),
(200 psi / 1379 kPa maximum pressure)
601195: Coiled Tubing; 152 cm (60”),
844010: Y-Tubing; 152 cm (60”),
1.6.3 MULTIPACK DISPOSABLES
801800: 60 mL MR Syringe (2) with Single Check Valve Y-Tubing and Filling
Spikes (200 psi / 1379 kPa maximum pressure)
1.6.4 OPTIMARK (GADOVERSETAMIDE INJECTION) PREFILLED SYRINGES
• 10 ml OptiMARK (gadoversetamide injection) Prefilled Syringe
See warning for OptiMARK on page 1-6-1 and OptiMARK Package Insert for full
prescribing information. Package Insert enclosed with drug.
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1.6.5 DOTAREM (GADOTERATE MEGLUMINE) PREFILLED SYRINGES

• 15 ml Dotarem (gadoterate meglumine) Prefilled Syringe
See warning for Dotarem on page 1-6-2 and Dotarem Package Insert for full
1—OVERVIEW OF THE
prescribing information. Package insert enclosed with drug.

CONTRAST DELIVERY
OPTISTAR ELITE MR
• 20 ml Dotarem (gadoterate meglumine) Prefilled Syringe

SYSTEM
See warning for Dotarem on page 1-6-2 and Dotarem Package Insert for full
prescribing information. Package insert enclosed with drug.
1.6.6 PREFILLED SALINE SYRINGE
• 50 ml Prefilled Sodium Chloride Injection, USP 0.9% Syringe (availability
dependent upon region)
• 125 ml Prefilled Sodium Chloride Injection, USP 0.9% Syringe (availability
dependent upon region)
To order, contact your local Guerbet Distributor.
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1.7 ACCESSORIES AND COMPONENTS

A list of the accessories and components for use with the OptiStar Elite MR
Contrast Delivery System is below.
1—OVERVIEW OF THE
CONTRAST DELIVERY
OPTISTAR ELITE MR
NOTE: The use of accessories and components not complying with the
equivalent safety requirements of this equipment may lead to a reduced level
SYSTEM
of safety of the resulting system. Consideration relating to the choice shall
include:
• use of the accessory and components in the patient vicinity
• evidence that the safety certification of the accessory and
component has been performed in accordance to the appropriate
EN60601-1 and/or EN60601-1-1 harmonized national standard.
ACCESSORIES
P/N 802545 OptiStar Mobile Mount Kit
P/N 802617 Kit, Power Supple Wall Mount
P/N 802620 Start Switch Assembly, 1.8 m
P/N 802622 Start Switch Assembly, 6 m
P/N 802725 Kit, CPU Stand
P/N 802850 Remote Stand Assembly
COMPONENTS
P/N 802614 Kit, Filter
P/N 802930 DOTAclip Syringe Adapter, 15/20 mL
P/N 802730 OptiMARK Syringe Adapter, 10/15/20 mL (optional)
See Section 1-6 for the list of approved Consumables.
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1—OVERVIEW OF THE
CONTRAST DELIVERY
OPTISTAR ELITE MR
SYSTEM
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2 POWER ON / POWER OFF
2—POWER ON/
2.1 TURNING SYSTEM POWER ON
POWER OFF
Refer to Figure 2-1-1
1. At the rear of the Power Supply, place the switch to the ON position 1A .
The green LED will illuminate to indicate power is ON 1 B .
2. At the rear of the Power Control, place the DC Power Switch to the
ON position 2 . The switch illuminates to indicate DC power is supplied to
the system.
3. At the Console, push the System ON/OFF button 3 . The button illumi-
nates to indicate power to the console and powerhead is ON. The injector
will enable a power-up check sequence indicated by flashing the syringe
size indicators located on the powerhead.
WARNING!
To avoid risk of electric shock, this equipment must only be connected to a

supply mains with protective earth.
WARNING!
Unplug power cord to disconnect the powerpack from supply mains.
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1A
J2 J1
O I
1B
2—POWER ON/
POWER OFF
O I
Figure 2-1-1 Switching the System Power ON
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2.2 TURNING SYSTEM POWER OFF

Refer to Figure 2-1-1.
At the Console, push System ON/OFF button to switch the system OFF 3
Both the Power Supply and Power Control can be left ON. This allows for
quicker and easier restarts from the Console.
NOTE: If the Power Control is switched off while the console is still powered
2—POWER ON/
POWER OFF
on, an alarm message will be generated at the Console. Cycle Console power to
clear any alarm message.
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2—POWER ON/
POWER OFF
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3 CONSOLE
Operating the OptiStar Elite MR Contrast Delivery System requires knowledge

of the operator interfaces located on both the console and the powerhead. The
console contains a touch screen display in order to interact with the operator.
Through use of the console’s touch screen display, the operator can:
3—CONSOLE
• enter protocol parameters
• save protocols
• delete protocols
• recall protocols
• review achieved parameters of delivered protocols
• review alarm history
CAUTION!
Do not press on the touch screen with sharp or pointed items such as
fingernails, pens or pencils. Using items of this type may cause damage to your
screen, resulting in a nonworking unit. Do not allow objects, such as pens and
pencils to lay on the touch screen.
3.1 TURNING THE SYSTEM ON

At the Console, push System ON/OFF key A to turn the Console ON.
NOTE: If no response from the console, refer to Chapter 2—Power ON/Power
OFF.
On power-up, the unit displays the ‘Initializing... Screen’ as shown in
Figure 3-1-2.
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3-1-2
A
3—CONSOLE
Figure 3-1-1 Location of the System ON/OFF key
Initializing . . .
Console: DV.04 Power Control: DV.04

c 2002, 2007
Figure 3-1-2 Initializing... Screen
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3.2 CONSOLE DISPLAY MODES OF OPERATION

3.2.1 MAIN SCREEN
Upon power-up, the Main screen, as shown in Figure 3-2-1, is automatically
displayed after initialization . All protocol information needed by the injector is
contained within the Main screen. To access the Main screen when displaying
the Results screen, System Info screen or Memory screen, press the [Main] key
located in the lower portion of the screen.
3.2.2 MEMORY SCREEN, SYSTEM INFO SCREEN, RESULTS SCREEN AND
[ENABLE] KEY
3—CONSOLE
Located along the lower portion of the Main screen are the following
4 keys: [Memory], [System Info] [Results] and [Enable]. These keys allow access
to their respective screens.
Memory Screen — All stored protocols are located within the Memory screen.
Accessing this screen allows the operator to recall, store, rename and delete
protocols. To access the Memory screen, press the [Memory] key A located
on the lower portion of the Main screen. More information about the Memory
screen is contained within this chapter.
System Info Screen — Adjust the Display Brightness and Beeper Volume;
change the Pressure Units, Language, Date and Time; access Alarm History and
the ability to display [Patency Check], [Phase Delay], [Inject Delay] and [Scan
Delay] keys on the Main screen via the System Info screen. Also, additional
access to the Memory screen and the Results screen is located on the System
Info screen. To access the System Info screen, press the [System Info] key B
located on the lower portion of the Main screen. More information about the
System Info screen is contained within this chapter.
Results Screen — All information pertaining to the results of delivered
injections is located within the Results screen. Also, additional access to the
System Info screen is located on the Results screen. To access the Results
screen, press the [Results] key C located on the lower portion of the Main
screen. More information about the Results screen is contained within this
chapter.
Enable D — Pressing the [Enable] key “enables” the injector (displays the
[Start] key) for delivery of a protocol after pressing the [Yes] key to the prompt
“Have you checked for air and patency?”. More information about Delivering
Injections is contained in Chapter 5.
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CHECK FOR AIR IN SYRINGE AND TUBING!

A: 60 60ml AB1
B: 60 60ml Duration 00:12
Phase Side Flow Volume Phase Delay
ml/sec ml sec
1 A 0.1 1 Max Vol

0 Inject Delay
2 B 0.1 1 Max Vol 00:00

Scan Delay
3 - 00:00
3—CONSOLE
4 Peak PSI
20
Timing Bolus
A B C D
Memory System Info Results Enable
Figure 3-2-1 Location of Keys on the Main Screen
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3.3 DESCRIPTION OF SCREENS

3.3.1 MAIN SCREEN
Refer to Figure 3-3-1 and Figure 3-3-2.
Operator Message Line A — This area displays important information to the
operator to ensure operator and patient safety.
A: Syringe Size B — This information indicates the size of the syringe currently
installed in the A-side of the powerhead. Note that A-side parameters are
indicated by the color blue.
3—CONSOLE
B: Syringe Size C — This information indicates the size of the syringe currently
installed in the B-side of the powerhead. Note that B-side parameters are
indicated by the color purple.
Protocol Name D — The name of the protocol currently displayed on the Main
screen is located in this area of the screen. An asterisk, “*” , located at the end of
the name indicates that the displayed parameters have been modified and no
longer match the originally stored parameters.
Phase E — Within a protocol, up to four phases can be input.
Side F — The letters in this column indicate the side from which the injector
will be delivering. The side for Phase 1 is always set as [A]. Sides for Phase 2
through Phase 4 can toggle among the following symbols: [A], [B], [-]. Pressing
an [A] key will toggle the key to a [B] key, indicating injecting from the B-side.
Pressing a [B] key will toggle the key to a [-] key, indicating no injecting for and
past that phase. Pressing a [-] key will toggle the key to an [A] key, indicating
injecting from the A-side.
Flow G — The values entered in this column indicate rate of delivery of the contrast
medium and saline during each respective phase. Flow is expressed in ml/sec.
Volume H — The values entered in this column indicate the volume of
contrast medium and saline to be delivered during each respective phase.
If the volume value highlights magenta intermittently, this indicates that
the programmed volume exceeds syringe volume. Use the [Max Vol] key to
automatically reset the volume of the corresponding phase to the amount
currently available in the syringe or, manually lower the value until it ceases to
highlight magenta. Volume is expressed in ml.
Max Volume I — Pressing this key inputs the Maximum Volume available in
the syringe into its corresponding volume column.
Duration J — The value in this area indicates the duration of all protocol
phases based on the entered volume and flow rate values and includes
Phase Delay. Duration does not include Timing Bolus. Duration is displayed in
minutes:seconds (00:00).
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Phase Delay K — This key is displayed only if turned ON at the System

Information screen. Phase Delay is a countdown timer that delays the start of
the next phase. The next phase will start when the phase delay counter reaches
0 (zero). Phase Delay is expressed in seconds. Phase Delay can also be set to
pause the injection. Access the Pause feature by scrolling past either
the 600 (six-hundred) upper limit or by pressing the [Pause] key .
Inject Delay L — This key is displayed only if turned ON at the System Information
screen. Inject Delay is a countdown timer that begins counting down when
the Start command is activated. The injection is started when the Inject
Delay counter reaches 00:00 (zero). If Inject Delay is greater than 00:00 (zero),
3—CONSOLE
Scan Delay is automatically set to 00:00 (zero). Inject Delay is expressed in

minutes:seconds (00:00). NOTE: Starting the injection from the powerhead will
prevent the use of the Inject Delay feature.
Scan Delay M — This key is displayed only if turned ON at the System Information
screen. Scan Delay is a countdown timer that begins counting down when the
Start command is activated. Ten seconds before expiration (00:10), 3 audible
beeps will be emitted by the injector; 5 seconds before expiration (00:05), 2
audible beeps; at expiration (00:00), one long tone will be emitted. If Scan Delay
is greater than 00:00 (zero), Inject Delay is automatically set to 00:00 (zero). Scan
Delay is expressed in minutes:seconds (00:00).
PSI / KPA N — The value set in this key indicates the maximum allowable
pressure that can occur during an injection. Pressure is expressed in either PSI
or KPA. Refer to section 3.3.3 System Information Screen for more information
about changing the unit of measure and refer to section 1.5.11 Programmable
Pressure Limit for pressure ranges.
Timing Bolus O — Pressing this key allows the operator to program a Timing
Bolus injection. A Timing Bolus injection — an injection of a small volume of
contrast, typically followed by a small volume of saline — can be delivered to
the patient to determine the optimal scan delay needed to capture the contrast
agent in the area of interest. Once the [Timing Bolus] key is pressed, the screen
shown in Figure 3-3-3 is displayed. Note the addition of “Test” R to the left of
the first and second phase. Upon completion of the Timing Bolus injection, the
injector will update to the ‘INJECTOR IS READY!’ screen in order to deliver the
Main Protocol. NOTE: The default Timing Bolus flow rates will be equal to the
protocol’s first flow rates for the A and B sides. The default volumes will be 2
ml for the A side, 10 ml for the B side, and are user changeable. However, after
completion of the Timing Bolus injection, the values are not changeable. Refer
to Figure 3-3-3, R1 .
Change Parameter Values via the Slide Bar P — To change the value of a
parameter, select the desired parameter by touching its key. The key will highlight
Q to indicate it is active and the slide bar will display at the bottom of the screen
as shown in Figure 3-3-2. Touch the slide bar at the value required, or use the left
and right double arrows to decrease or increase the value. Use the left and right
single arrows to decrease or increase the value in smaller increments.
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3-3-3
A
B A: 60 60ml D AB1
C B: 60 60ml J Duration 00:12
E F G ml/sec H ml K sec
1 A 0.1 1 Max Vol

I 0 L Inject Delay
2 B 0.1 1 Max Vol 00:00

Scan Delay
3 - M
3—CONSOLE
00:00
4 PSI
N
20
O
Timing Bolus
Figure 3-3-1 Console Main Screen

A: 60 60ml AB1
ml/sec ml sec
1 A 0.1 1 Max Vol

0 Inject Delay
2 B
Q
0.1 1 Max Vol 00:00
Scan Delay
3 - 00:00
4 PSI
20
Timing Bolus
P
P P
.1 4.0 8.0
Figure 3-3-2 Console Main Screen with Active Slide Bar
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A: 60 60ml AAB1
B:125 103ml Duration 00:15
ml/sec ml sec
1 A 8.0 13 0 Inject Delay
2 B 1.6 21 Max Vol 00:00

Scan Delay
3 - 00:00
4 Peak PSI
20
Timing Bolus
O

3—CONSOLE

A: 60 60ml AAB1
B:125 103ml Duration 00:15
ml/sec ml sec
R Test A 8.0 2 Inject Delay
Test B 1.6 10 Pause 00:00

Scan Delay
1 A 8.0 13 Max Vol
0 00:00
2 B 1.6 21 Max Vol
Peak PSI
3 - 20
4 Timing Bolus
INJECTOR IS READY!
A: 60 58ml AAB1
Start Protocol
ml/sec ml sec
R1 Test A 8.0 2 Inject Delay
Test B 1.6 10 Pause 00:00
1 A 8.0 13 Max Vol 0 Scan Delay

00:00
2 B 1.6 21 Max Vol
Peak PSI
3 - 20
4 Timing Bolus
Drip Disable
Figure 3-3-3 Console Main screen with Active Timing Bolus
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3-3-5
3.3.2 MEMORY SCREEN
The [Memory] key A allows access to the Memory screen as shown in

Figure 3-3-4. The OptiStar Elite MR Contrast Delivery System can store up to
40 (forty) protocols with a name length of up to 20 (twenty) characters. Press
the [Main] key B at any time to exit the Memory screen and display the Main
screen.
3—CONSOLE
A: 60 60ml AAB1
ml/sec ml sec
1 A 8.0 13 Max Vol 0 Inject Delay
2 A 1.6 8 Max Vol

0 00:00
1.6 8
Scan Delay
3 B Max Vol
00:00
4 - Peak PSI
20
Timing Bolus
Delete Edit Name Store
Phase Side ml/sec ml sec Phase Side ml/sec ml sec

1 A 2.1 4 0 2 B 0.1 1 Inject 00:00
AB1 3 4 Scan 00:00
PSI 20
1 A 2.1 4 0 2 B 2.0 18 Inject 00:00
AB2 3 4 Scan 00:00
PSI 20
1 A 1.6 14 0 2 B 2.0 18 Inject 00:00
AB3 3 4 Scan 00:00
PSI 20
1 A 1.6 14 0 2 B 2.0 18 Inject 00:00
AB4 3 4 Scan 00:00
PSI 20
1 A 1.6 5 0 2 A 2.0 18 0 Inject 00:00
AB5 3 B 1.2 6 4 Scan 00:00
PSI 20
1 A 1.6 5 2 Inject 00:00
AB6 3 4 Scan 00:00
PSI 20
1 A 2.6 10 2 Inject 00:00
AB7 3 4 Scan 00:00
PSI 20
1 A 2.6 10 0 2 A 1.6 3 0 Inject 00:00
AB8 3 A 1.3 2 0 4 B 1.6 9 Scan 00:00
PSI 20
Memory Current 1
3
A
B
8.0
1.6
13
8
0 2
4
A 1.6 8 0 Inject
Scan
00:00
00:00
Page Value
B PSI 20
Main
1 2 3 4 5
Figure 3-3-4 Memory List Screen
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Retrieving a Protocol from Memory

1. Press the [Memory] key 1 to access the Memory screen.

2. Press on the desired protocol’s name key 2 . If the desired protocol name
A
is not displayed on Page 1, press the Page Number [2-5] 2 to display the
B
page on which the desired protocol is stored. Once the appropriate page is
displayed, press on protocol’s name key.
3. The protocol is immediately displayed on the screen 3 .
3—CONSOLE

3
A: 60 60ml AAB1
Phase Side Flow Volume Phase Delay A: 60 60ml A1
ml/sec ml sec
B: 60 60ml
1 A 8.0 13 0 Inject Delay
Phase Side Flow
Duration 00:03
Volume Phase Delay
2 A 1.6 8 Max Vol 00:00 ml/sec ml sec
3 B 1.6 8 Max Vol

Scan Delay 1 A 1.6 5 0 Inject Delay
00:00 2 00:00
4 - Peak PSI Scan Delay
3
20 00:00
4 Peak PSI
Timing Bolus
20
Timing Bolus
1 Memory System Info Results Enable

1 A 2.1 4 0 2 B 0.1 1 0 Inject 00:00
AB1 3 4 Scan 00:00
PSI 20
1 A 2.1 4 0 2 B 2.0 18 0 Inject 00:00
AB2 3 4 Scan 00:00
PSI 20
1 A 1.6 14 0 2 B 2.0 18 0 Inject 00:00
AB3 3 4 Scan 00:00
PSI 20
1 A 1.6 14 0 2 B 2.0 18 0 Inject 00:00
AB4 3 4 Scan 00:00
2A AAB1
1 A
B
1.6
1.2
5
6
0
0
2
4
A 2.0 18 0
PSI
Inject
Scan
20
00:00
00:00
3
PSI 20
1 A 1.6 5 0 2 Inject 00:00
A1 3 4 Scan 00:00
PSI 20
1 A 2.6 10 0 2 Inject 00:00
A2 3 4 Scan 00:00
PSI 20
1 A 2.6 10 0 2 A 1.6 3 0 Inject 00:00
AAAB1 3 A 1.3 2 0 4 B 1.6 9 0 Scan 00:00
PSI 20
Memory Current 1
3
A
B
8
1.6
13
8
0 2
4
A 1.6 8 0 Inject
Scan
00:00
00:00
Page Value PSI 20
Main
1 2 3 4 5
2B
Figure 3-3-5 Retrieving a Protocol from Memory
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3-3-7
Deleting a Protocol from Memory


2. If needed, press the appropriate Page Number [2-5] 2 to locate the desired
protocol.
3. Press the [Delete] key 3A then the Protocol’s name key 3 B .
4. Press the [Yes] key 4 located under “The selected Protocol will be deleted!
Do you want to continue?” prompt.
3—CONSOLE
5. The protocol is deleted 5 .
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A: 60 60ml AAB1
ml/sec ml sec
1 A 8.0 13 Max Vol

0 Inject Delay
2 A 1.6 8 Max Vol 00:00

Scan Delay
3 B 1.6 8 Max Vol
00:00
4 - Peak PSI
20
Timing Bolus
A 5
A 6
1
3—CONSOLE
3A 1
Phase Side ml/sec ml sec Phase Side ml/sec ml
A 2.1 4 0 2 B 0.1 1
sec
0 Inject 00:00
AB1 3 4 Scan 00:00
Select the protocol to delete. PSI 20
1 A 2.1 4 0 2 B 2.0 18 0 Inject 00:00
AB2 3 4 Scan 00:00
PSI 20
1 A 1.6 14 0 2 B 2.0 18 0 Inject 00:00
AB3 3 4 Scan 00:00
PSI 20
1 A 1.6 14 0 2 B 2.0 18 0 Inject 00:00
AB4 3 4 Scan 00:00
3B PSI 20
1 A 1.6 5 0 2 A 2.0 18 0 Inject 00:00
AAB1 3 B 1.2 6 0 4 Scan 00:00
PSI 20
1 A 1.6 5 0 2 Inject 00:00
A1 3 4 Scan 00:00
PSI 20
1 A 2.6 10 0 2 Inject 00:00
A2 3 4 Scan 00:00
PSI 20
1 A 2.6 10 0 2 A 1.6 3 0 Inject 00:00
AAAB1 3 A 1.3 2 0 4 B 1.6 9 0 Scan 00:00
PSI 20
Memory Current 1
3
A
B
8.0
1.6
13
8
0 2
4
A 1.6 8 0 Inject
Scan
00:00
00:00
Page Value PSI 20
Main
1 2 3 4 5
2
5
Delete Edit Name Store Cancel Delete Edit Name Store Cancel
Phase Side ml/sec ml sec Phase Side ml/sec ml sec Phase Side ml/sec ml sec Phase Side ml/sec ml sec
1 A 2.1 4 0 2 B 0.1 1 0 Inject 00:00 1 A 2.1 4 0 2 B 0.1 1 0 Inject 00:00
AB1 3 4 Scan 00:00 AB1 3 4 Scan 00:00
PSI 20 PSI 20
AB2 3 4 Scan 00:00 AB2 3 4 Scan 00:00
PSI 20 PSI 20
AB3 3 4 Scan 00:00 AB3 3 4 Scan 00:00
The selected protocol will be PSI 20 PSI 20
2 18 0 Inject 00:00 2 18 0 Inject 00:00
AB4
1
3
A deleted!
1.6 14 0
4
B 2.0
Scan 00:00 AB4
1
3
A 1.6 14 0
4
B 2.0
Scan 00:00
PSI 20 PSI 20
1 A 1.6 5 0 2 A 2.0 18 0 Inject 00:00 1 A 1.6 5 0 2 A 2.0 18 0 Inject 00:00
AAB1 3Do you
B want
1.2 6to continue?
0 4 Scan 00:00 AAB1 3 B 1.2 6 0 4 Scan 00:00
PSI 20 PSI 20
4
1 A 1.6 5 0 2 Inject 00:00 1 A 1.6 5 0 2 Inject 00:00
A1 3 Yes 4 No Scan 00:00 A1 3 4 Scan 00:00
PSI 20 PSI 20
1 A 2.6 10 0 2 Inject 00:00 1 A 2.6 10 0 2 Inject 00:00
A2 3 4 Scan 00:00 A2 3 4 Scan 00:00
PSI 20 PSI 20
1 A 2.6 10 0 2 A 1.6 3 0 Inject 00:00 1 2 Inject

AAAB1 3 A 1.3 0 4 B 1.6 9 0 Scan 00:00 3 4 Scan
PSI 20 PSI
Memory Current 1
3
A
B
8.0
1.6
13
8
0 2
4
A 1.6 8 0 Inject
Scan
00:00
00:00
Memory Current 1
3
A
B
8.0
1.6
13
8
0 2
4
A 1.6 8 0 Inject
Scan
00:00
00:00
Page Value PSI 20 Page Value PSI 20
Main Main
1 2 3 4 5 1 2 3 4 5
Figure 3-3-6 Deleting a Protocol from Memory
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3-3-9
Storing a Protocol in Memory

1. Enter desired parameters on the Main screen. Press the [Memory] key 1 to
access the Memory screen.
2. Note the parameters entered in Step 1 are shown at the bottom of the
Memory screen next to the words ‘Current Value’. Press the desired Page
Number [2-5] onto which to store the protocol 2 .
3. Press the [Store] key 3 .
3—CONSOLE
4. Locate an empty key 4A . Note: If a non-empty key 4 B is selected, the key’s
stored protocol parameters will be overwritten with the parameters entered
in step 1.
5. Press the desired key onto which to store the protocol. The keyboard is dis-
played 5 to allow naming of the protocol.
6. After entering the desired protocol name, press the [Enter] key 6 on the
keyboard. Note that the injector will display the protocol in the next avail-
able empty slot.
7. The protocol parameters and name are stored 7 .
818509-A 2017-05-16
3-3-10
CHECK FOR AIR IN SYRINGE AND TUBING! 3

A: 60 60ml AAB1

Phase Side Flow Volume Phase Delay 1 A 2.1 4 0 2 B 0.1 1 0 Inject 00:00
ml/sec ml sec AB1 3 4 Scan 0
PSI 200:00
1 A 8.0 13 Max Vol
0 Inject Delay
AB2
1
3
A 2.1 4
Select memory location.
0 2
4
B 2.0 18 0 Inject
Scan
00:00
00:00
1.6 8
PSI
2 A Max Vol 00:00 1 A 1.6 14 0 2 B 2.0 18 0 Inject
20
00:00
AB3 3 4 Scan 00:00
Scan Delay
B 1.6 8
PSI 20
3 Max Vol
1 2 2.0 18 0 Inject 00:00
00:00 AB4 3
A 1.6 14 0
4
B
Scan 00:00
4 - PSI 20
4B
Peak PSI 1 A 1.6 5 0 2 A 2.0 18 0 Inject 00:00
AAB1 3 B 1.2 6 0 4 Scan 00:00
20 2
PSI
Inject
20
1 A 1.6 5 0 00:00
A1 3 4 Scan 00:00
Timing Bolus PSI 20
4A
1 2 Inject 00:00
3 4 Scan 00:00
PSI 20
.1 4.0 8.0 1 2 Inject 00:00
3 4 Scan 00:00
PSI 20
Memory Current 1
3
A
B
8.0
1.6
13
8
0
0
2
4
A 1.6 8 0 Inject
Scan
00:00
00:00
Page Value PSI 20
3—CONSOLE
1 2 1 2 3 4 5 Main
Delete Edit Name Store Cancel

1 A 2.1 4 0 2 B 0.1 1 0 Inject 00:00
AB1 3 4 Scan 00:00
PSI 20
1 A 2.1 4 0 2 B 2.0 18 0 Inject 00:00
AB2 3 4 Scan
PSI
00:00
20 5
1 A 1.6 14 AAAB1
0 2 B 2.0 18 0 Inject 00:00
AB3 3 4 Scan 00:00
PSI 20
2
AB4
1
3
0 A 1 1.6 214 30 44
B 5 2.0
6 18 0
7 8Inject
Scan 900:00
00:00
PSI 20
1 A 1.6 5 0 2 A 2.0 18 0 Inject 00:00
AAB1 3 Q B W 1.2 E6 0R 4T Y U I O Scan P00:00
PSI 20
1 A 1.6 5 0 2 Inject 00:00
A1 3 A S D F 4G H J K LScan - 00:00
PSI 20
1 A 2.6 10 0 2 Inject 00:00
3 Z X C V 4 B N M . Scan\ 00:00
PSI 20
1 A 2.6 10 0 2 A 1.6 3 0 Inject 00:00
3Caps AOn 1.3 Cancel
0 4 Space
B 1.6 9<- 0 Enter
Scan 00:00
PSI 20
Memory Current 1
3
A
B
8.0
1.6
13
8.0
0 2
4
A 1.6 8 0 Inject
Scan
00:00
00:00 6
Page Value PSI 20
Main
1 2 3 4 5

1 A 2.1 4 0 2 B 0.1 1 0 Inject 00:00
AB1 3 4 Scan 00:00
PSI 20
1 A 2.1 4 0 2 B 2.0 18 0 Inject 00:00
AB2 3 4 Scan 00:00
PSI 20
1 A 1.6 14 0 2 B 2.0 18 0 Inject 00:00
AB3 3 4 Scan 00:00
PSI 20
1 A 1.6 14 0 2 B 2.0 18 0 Inject 00:00
AB4 3 4 Scan 00:00
PSI 20
1 A 1.6 5 0 2 A 2.0 18 0 Inject 00:00
AAB1 3 B 1.2 6 0 4 Scan 00:00
PSI 20
1 A 1.6 5 0 2 Inject 00:00
A1 3 4 Scan 00:00
PSI 20
7 1 A 8.0 13 0 2 A 1.6 8.0 0 Inject 00:00

AAAB1 3 B 1.6 8.0 0 4 Scan 00:00
PSI 20
1 2 Inject 00:00
3 4 Scan 00:00
PSI 20
Memory Current 1
3
A
B
8.0
1.6
13
8
0
0
2
4
A 1.6 8 0 Inject
Scan
00:00
00:00
Page Value PSI 20
Main
1 2 3 4 5
Figure 3-3-7 Storing a Protocol in Memory
818509-A 2017-05-16
3-3-11
Editing a Protocol Name


2. If needed, press the appropriate Page Number [2-5] 2 to locate the desired
protocol name to edit.
3. Press the [Edit Name] key 3A , then the [Protocol’s name] key 3 B . The key-
board with the protocol’s name appears 4 .
4. Using the keyboard, enter the new name. The [< -] key 5 can be used to
3—CONSOLE
clear the displayed name.
5. Press the [Enter] key 6 .
6. The Memory screen, along with the renamed protocol, is displayed 7 .
818509-A 2017-05-16
3-3-12

A: 60 60ml AAB1
ml/sec ml sec
1 A 8.0 13 Max Vol

0 Inject Delay
2 A 1.6 8 Max Vol 00:00

Scan Delay
3 B 1.6 8 Max Vol
00:00
4 - Peak PSI
20
Timing Bolus
.1 4.0 8.0
1
3—CONSOLE
3A Delete Edit Name Store

1 A 2.1 4 0 2 B 0.1 1 0 Inject 00:00
AB1 3 4 Scan 00:00
Select the protocol to rename. PSI 20
1 A 2.1 4 0 2 B 2.0 18 0 Inject 00:00
AB2 3 4 Scan 00:00
PSI 20
1 A 1.6 14 0 2 B 2.0 18 0 Inject 00:00
AB3 3 4 Scan 00:00
PSI 20
1 A 1.6 14 0 2 B 2.0 18 0 Inject 00:00
AB4 3 4 Scan 00:00
3B AAB1
1 A
B
1.6
1.2
5
6
0
0
2
4
A 2.0 18 0
PSI
Inject
Scan
20
00:00
00:00
3
PSI 20
1 A 1.6 5 0 2 Inject 00:00
A1 3 4 Scan 00:00
PSI 20
1 A 2.6 10 0 2 Inject 00:00
A2 3 4 Scan 00:00
PSI 20
1 A 2.6 10 0 2 A 1.6 3 0 Inject 00:00
AAAB1 3 A 1.3 0 4 B 1.6 9 0 Scan 00:00
PSI 20
Memory Current 1
3
A
B
8.0
1.6
13
8
0 2
4
A 1.6 8 0 Inject
Scan
00:00
00:00
Page Value PSI 20
Main
1 2 3 4 5
2
4 7
Delete Edit Name Store Cancel Delete Edit Name Store Cancel
Phase Side ml/sec ml sec Phase Side ml/sec ml sec Phase Side ml/sec ml sec Phase Side ml/sec ml sec
AB1 3 4 Scan 00:00 AB1 3 4 Scan 00:00
PSI 20 PSI 20
1 A 2.1 4 Select
0 protocol
2 B to rename.
2.0 18 0 Inject 00:00 1 A 2.1 4 0 2 B 2.0 18 0 Inject 00:00
AB2 3 4 Scan 00:00 AB2 3 4 Scan 00:00
PSI 20 PSI 20
1 A 1.6 14 CCCD1
0 2 B 2.0 18 0 Inject 00:00 1 A 1.6 14 0 2 B 2.0 18 0 Inject 00:00
AB3 3 4 Scan 00:00 AB3 3 4 Scan 00:00
PSI 20 PSI 20
2 2
AB4
10
3
A 1 1.6 214 30 44
B 5 2.0
6 18 70 Inject
8Scan 900:00
00:00 AB4
1
3
A 1.6 14 0
4
B 2.0 18 0 Inject
Scan
00:00
00:00
PSI 20 PSI 20
AAB1 3Q B W 1.2 E6 0R 4T Y U I OScan P00:00 AAB1 3 B 1.2 6 0 4 Scan 00:00
PSI 20 PSI 20
1 A 1.6 5 0 2 Inject 00:00 1 A 1.6 5 0 2 Inject 00:00
A1 3A S D F 4G H J K LScan - 00:00 A1 3 4 Scan 00:00
PSI 20 PSI 20
1 A 2.6 10 0 2 Inject 00:00 1 A 2.6 10 0 2 Inject 00:00
A2 3 Z X C V 4 B N M . Scan
\ 00:00 A2 3 4 Scan 00:00
PSI 20 PSI 20
AAAB1 3 CapsAOn 1.3 Cancel0 4 Space 9<- Enter CCCD1
6
B 1.6 Scan 00:00 3 A 1.3 0 4 B 1.6 9 0 Scan 00:00
5
PSI 20 PSI 20
Memory Current 1
3
A
B
8.0
1.6
13
8.0
0 2
4
A 1.6 8 0 Inject
Scan
00:00
00:00
Memory Current 1
3
A
B
8.0
1.6
13
8.0
0 2
4
A 1.6 8 0 Inject
Scan
00:00
00:00
Page Value PSI 20 Page Value PSI 20
Main 5 Main
1 2 3 4 5 1 2 3 4
Figure 3-3-8 Editing a Protocol Name
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3-3-13
3.3.3 SYSTEM INFORMATION SCREEN

The System Information screen is accessed by pressing the [System Info] key A
located on the Main screen.
Selectable Features
Display Brightness B — Select Low or High
Pressure Units C — Select PSI or KPA
3—CONSOLE
Beeper Volume D — Selectable among Off, Low, Medium or High
Language E — Selectable languages include: English, German, Spanish,

French, Italian, Portuguese.
Date and Time F — Press the [Change Date] key F1 and/or the [Change Time]
key F2 to access the change arrows F3 (Refer to Figure 3-3-10). Modify the date
and time as desired. Press [Set Date] key F4 and/or the [Set Time] key F5 to set.
Patency Check G — Prior to the delivery of the main injection, a Patency

Check—an injection of a small volume of saline—can be performed to
determine the integrity of the I.V. site. Toggle its key to ON to allow delivery of a
Patency Check injection.
Phase Delay H — Phase Delay is a countdown timer that delays the start of
the next phase. Toggle its key to ON to display the [Phase Delay] key on the
Main screen.
Inject Delay I — Inject Delay is a countdown timer that begins counting

when the Start command is activated. The injection is started when the inject
delay counter reaches 0 (zero). Toggle its key to ON to display the [Inject Delay]
key on the Main screen. NOTE: Starting the injection from the powerhead will
prevent the use of the Inject Delay feature
Scan Delay J — Scan Delay is a countdown timer that begins counting when
the Start command is activated and stops when the counter reaches 0 (zero).
The scan start signal will initiate once the timer reaches 0 (zero). Toggle its key
to ON to display the [Scan Delay] key on the Main screen.
818509-A 2017-05-16
3-3-14
Information Displayed
Software Versions K — of the Console and Powerhead.
Service Mode L — Accessible to Service Personnel. Refer to Service Manual.
Alarm History M — A listing of the last 80 Alarms in descending order.

(NOTE: Factory set alarms created during testing may still be present in the
unit’s alarm history.) Use the [< >] keys M1 to display the 8 pages (Refer to
Figure 3-3-11).
3—CONSOLE

A: 60 60ml A1
ml/sec ml sec
1 A 0.1 1 Max Vol

0 Inject Delay
2 - 00:00
Scan Delay
00:00
Peak PSI
20
Timing Bolus
.1 4.0 8.0
System Information
B Display Brightness Low High
C Pressure Units PSI
D Beeper Volume Off Low Med High
K Software Versions Console: V1.03 Power Control: V1.02
E Language English German Spanish French
Italian Portuguese
G Patency Check On
F1 F2 L
Change Date Change Time H Phase Delay On
Service Mode
I Inject Delay On
NOV 04 2004 10:07 M
Alarm History J Scan Delay On
Memory Main Results
Figure 3-3-9 Accessing the System Information Screen
818509-A 2017-05-16
3-3-15
System Information
Display Brightness Low High Pressure Units PSI
Beeper Volume Off Low Med High
Software Versions Console: V1.03 Power Control: V1.02
Language English German Spanish French
3—CONSOLE
Italian Portuguese
Patency Check On
F4 F5
Set Date Set Time Phase Delay On
Service Mode
F3 Inject Delay On
NOV 04 2004 10:07
Alarm History Scan Delay On
Memory Main Result
Figure 3-3-10 Setting the Date and Time
Alarm History
31 OCT 14:29 Alarm 01-B004

11 OCT 09:40 Alarm 06-B001
10 OCT 13:52 Alarm 50-0001
08 OCT 15:45 Alarm 15-B002
08 OCT 15:34 Alarm 15-B001
08 OCT 15:30 Alarm 17-A002
08 OCT 15:25 Alarm 15-B001
08 OCT 15:23 Alarm 30-0001
08 OCT 15:21 Alarm 15-A004
08 OCT 14:20 Alarm 15-B001
M1 Page 1
< >
System Info
Figure 3-3-11 Alarm History Screen
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3-3-16
3.3.4 INJECTION RESULTS SCREEN

The Injection Results screen is accessed by pressing the [Results] key A

located on the Main screen.
The Injection Results screen lists the results of the last 48 injections.
Each page B lists 8 injections C completed by date and time in descending
order D . Press the Page Previous [<] E 1 or Page Next [>] E 2 to list the
injections contained on the previous or next page respectively. The results
3—CONSOLE
include the following information for each phase F :
Side G — side in use during the delivery of the phase
Flow Rate H — the achieved flow rate
Volume I — the achieved volume
Sec J — phase delay, in seconds, before the delivery of the next phase
PSI / KPA K — the achieved pressure. Note: An asterisk (*) located on the right
of the pressure results indicates that the injection was pressure limited. The
affected pressure value is also indicated by a yellow color.
818509-A 2017-05-16
3-3-17

A: 60 60ml A1
ml/sec ml sec
1 A 0.1 1 Max Vol

0 Inject Delay
2 - 00:00
Scan Delay
00:00
Peak PSI
20
Timing Bolus
.1 4.0 8.0
3—CONSOLE
B Page 1
Injection Results
C D F G H I J K
No. Date - Time Phase Side ml/sec ml sec Phase Side ml/sec ml sec PSI
1 A 2.6 10 2 Press A 7
1 02 NOV 06 10:17 3 4 Press B 20*
1 A 3.5 5 0 2 B 1.4 8 Press A 0

2 02 NOV 06 10:27 3 4 Press B 1
1 A 3.5 5 0 2 A 3.3 4 0 Press A 0

3 02 NOV 06 10:35 3 B 1.4 8 4 Press B 2
1 A 1.6 5 0 2 A 3.4 4 0 Press A 0

4 02 NOV 06 10:42 3 B 1.4 8 4 Press B 3
1 A 3.9 12 0 2 B 2.5 8 Press A 0

5 02 NOV 06 10:50 3 4 Press B 4
1 A 1.6 4 0 2 B 2.4 8 Press A 0

6 02 NOV 06 11:03 3 4 Press B 0
1 A 2.1 7 2 Press A 0
7 02 NOV 06 11:17 3 4 Press B 0
1 A 1.9 7 2 Press A 0
8 02 NOV 06 11:28 3 4 Press B 0
E1 E2
< >
System Info Main
Figure 3-3-12 Injection Results Screen
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3-3-18
3.3.5 ENABLED SCREEN

The Enabled screen is displayed after pressing the [Air Check] key
located on the powerhead or by pressing the [Enable] key on the console, then
pressing the [Yes] key* for the prompt “Have you checked for air and patency?”
WARNING!
*The [Air Check] key { } on the powerhead and the [Yes] key on
3—CONSOLE
the console are not to be used in lieu of a visual check by the health care
professional administering the contrast media. It is meant as a reminder to the
operator to perform a visual check of the syringe(s) and connection tubing
prior to the delivery of an injection.
While the Enabled screen is displayed, [Side], [Flow] and [Volume] values can be
changed by the operator. The [Timing Bolus] key is active to allow the operator
to program a Timing Bolus injection.
PATENCY ON ... 10ml VOLUME

A: 60 60ml
Start Protocol
ml/sec ml sec
2 B 0.1 1 Max Vol 00:00

Scan Delay
3 - 00:00
4 PSI
20
Timing Bolus
Drip Disable
Figure 3-3-13 Enabled Screen
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3-3-19
3.3.6 DRIP MODE SCREEN

The [Drip] key A , available to the operator only after the injector has been
enabled, allows access to the Drip Mode. This mode allows the injector to
deliver a “drip” injection to keep the fluid path open during patient set up and
between injections of contrast.
3—CONSOLE
PATENCY ON ... 10ml VOLUME
A: 60 59ml
Start Protocol
ml/sec ml sec
1 A 3.0 12 Max Vol

0 Inject Delay
2 B 3.0 8 Max Vol 00:00

Scan Delay
3 - 00:00
4 PSI
20
Timing Bolus
Drip Disable
Drip Mode B Drip Volume Drip Time

40 ml 0:20:50
Hr:Min:Sec
49 Cancel
Start Drip
Flow Volume Interval

ml/sec ml sec
0.5 1.0 30
Figure 3-3-14 Drip Mode Screen.
818509-A 2017-05-16
3-3-20
Description of Parameter Keys/Information

Flow A — This value indicates the rate of delivery of the saline solution (B-side
syringe). Flow rate is expressed in ml/s and can be set from 0.5 to 1.0 ml/s.
Volume B — This value indicates the amount of saline delivered during each
drip injection. Volume is expressed in ml and can be set from 0.1 to 3.0 ml.
Interval C — This value indicates the amount of time the injector pauses
between each delivery of drip injections. Interval is expressed in seconds and
3—CONSOLE
can be set from 1 to 60 sec.
[Start Drip] key D — Pressing this key will begin the drip injection and display
the Drip Infusion screen. Refer to Figure 3-3-11.
[Cancel] key E — Pressing this key will exit the Drip Mode screen and return to
the Main screen.
Change Parameter Values via the Slide Bar F — To change the value of a
parameter, select the desired parameter by touching its key. The key will
highlight to indicate it is active and the slide bar will display at the bottom of
the screen. Touch the slide bar at the value required, or use the left and right
single arrows to decrease or increase the value.
Drip Time G — This value is calculated automatically by the injector by using

the Flow, Volume, Interval and Drip Volume values. Drip Time is a countdown
timer with an audible tone sounding at its expiration. Drip Time is expressed in
hours:minutes:seconds (Hr:Min:Sec).
Drip Volume H — This value is calculated automatically by rounding the

difference between Remaining Volume and B-side programmed volume. A
graphic representation of the volume remaining in the syringe is displayed I .
818509-A 2017-05-16
3-3-21
H G
Drip Mode B I Drip Volume Drip Time
40 ml 0:20:50
Hr:Min:Sec
49 Cancel E
Start Drip D
3—CONSOLE
A ml/sec ml
B sec
C
0.5 1.0 30
F F F
.5 0.7 1.0
Figure 3-3-15 Description of Parameter Keys

and Information on the Drip Mode Screen
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3-3-22
3.3.7 ACCESSING THE DRIP INFUSION PROGRESS SCREEN

Pressing the [Start Drip] key A on the Drip Mode screen begins the drip
injection and displays the Drip Infusion screen. The Powerhead ram of syringe
B delivers a drip injection using the operator programmed flow rate and
volume. Once the volume is delivered, the ram will pause until the operator
programmed interval has expired, and then deliver another drip injection. This
cycle will continue until the Drip Volume is delivered.
3—CONSOLE

40 ml 0:20:50
Hr:Min:Sec
49 Cancel
Start Drip
A
ml/sec ml sec
0.5 1.0 30
.5 0.7 1.0
Drip Infusion B Drip Volume Drip Time

38 ml 0:19:07
Hr:Min:Sec
Drip End 47 Stop and

return to:
Drip
Main
0.5 ml/sec 1.0 ml 30 sec
Figure 3-3-16 Drip Infusion Screen
818509-A 2017-05-16
3-3-23
Description of Keys/Information
[Drip] key B — Pressing this key will stop the drip infusion, exit the Drip
Infusion screen and return to the Drip Mode screen.
[Main] key C — Pressing this key will stop the drip infusion, exit the Drip
Infusion screen and display the Enabled Main screen. NOTE: Also, pressing the
[Stop] key on the powerhead will exit the Drip Infusion screen and display
the Main screen. Pressing once on the hand start switch will exit the Drip
3—CONSOLE
Infusion screen and display the Drip Mode screen.
Programmed Flow, programmed Volume and programmed Interval D —

These operator programmed values are displayed at the bottom of the screen.
Calculated Drip Volume and Drip Time E — These injector calculated values
are displayed in the upper right-hand corner.
Graphic representation of the volume remaining in the syringe and the end
of the drip injection F — This indicates the volume remaining in the syringe.
Also, the saline drop (located under the syringe symbol) flashes to indicate
delivery of the drip injection.
E
Drip Infusion
B Drip Volume
54 ml
Drip Time
0:19:31
Hr:Min:Sec
Drip End Stop and

F 35 return to:
B
Drip
Main
C
D Flow Volume Interval
Figure 3-3-17 Description of Keys and Information on the Drip Infusion Screen
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3-3-24
3.3.8 DRIP INFUSION COMPLETED SCREEN

The Drip Infusion Completed Screen is displayed upon delivery of the Drip
Volume. The [Main] key is available to immediately display the Main screen.
E
Drip Infusion
B Drip Volume Drip Time
3—CONSOLE
0 ml 0:00:00
Hr:Min:Sec
Drip End
9 Stop and
return to:
Main A
COMPLETED
D Flow Volume Interval
Figure 3-3-18 Drip Infusion Completed Screen
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4-1-1
4 POWERHEAD
4.1 DESCRIPTION OF POWERHEAD

This chapter describes powerhead features, filling instructions, removing air,
and syringe installation. Please read this chapter carefully to ensure patient
safety while using this injector.
4—POWERHEAD
4.1.1 POWERHEAD FEATURES
Syringe Holder A-side A — The syringe is placed here. Side A is used for
contrast media and can accommodate a 60 ml and a 30 ml syringe or, with the
OptiMARK adapter, a 10 ml, 15 ml, or 20 ml OptiMARK prefilled syringe. Using
a DOTAclip adapter, Side A can accommodate a 15 or 20 ml Dotarem prefilled
syringe
Syringe Holder B-side B — The 2nd syringe is placed here. Side-B is used for
saline flushing or drip solution and can accommodate a 50 ml, 60 ml or 125 ml
syringe.
Powerhead Rams C — Moveable rams which extend and retract. The ram only
pushes the syringe pushrod. It does not retract the syringe pushrod.
Syringe Size Indicators D — The syringe size indicator (A-side and B-side) is
illuminated dependent upon the installed syringe. Both indicators flash during
start up and when patency blockage occurs.
OptiMARK syringe Adapter (P/N 802730) E 1 — Syringe Holder Side A is

designed for a 60 ml or 30 ml syringe. A 10 ml, 15 ml or 20 ml OptiMARK
contrast prefilled syringe may be used by installing the OptiMARK syringe
adapter into the A-side of the powerhead, ensuring that the adapter snaps
into place. To remove the syringe adapter, push the flange upward from the
bottom of the powerhead. The OptiMARK syringe adapter is only for use with
OptiMARK prefilled syringes. The adapter is easily stored in the compartment
located in the underside of the powerhead (see inset).
Dotarem Syringe Adapter (P/N 802930) E 2 - Syringe Holder Side A may use a
15 ml or 20 ml Dotarem contrast prefilled syringe by installing the Dotarem
818509-A 2017-05-16
4-1-2
two part syringe adapter, also known as the DOTAclip. Install the DOTAclip
offset wedge into place over the side A ram face by holding the offset wedge
tab and the powerhead and sliding the wedge over the ram face as shown,
ensuring that it snaps into place. Next install the syringe holder into the A-side
of the powerhead, as shown, ensuring that it snaps into place. To remove the
DOTAclip offset wedge, hold the powerhead and hold the offset wedge by the
tab, lift up on the offset wedge and slide it off of the ram face, as shown.
To remove the DOTAclip syringe adapter hold the syringe holder and lift up, as
shown.
The DOTAclip two part syringe adapter is only for use with Dotarem prefilled
syringes.
4—POWERHEAD
Injection Indicators F — The following chart describes the status of the A-side
F1 and B-side F2 indicator lights.
Status of A-side Status of B-side

Status of Injector Indicator Light-F1 Indicator Light-F2
Disabled OFF OFF
Enabled ON ON
Patency Check OFF (solid) (solid)
Enabled ON ON 0.25 sec
Patency Check ON (solid) OFF 0.25 sec
Patency Check ON 0.5 sec
OFF
B-side Ram moving OFF 0.5 sec
Enabled or Disabled ON 0.5 sec

OFF
A-side Ram moving OFF 0.5 sec
Enabled or Disabled ON 0.5 sec

OFF
B-side Ram moving OFF 0.5 sec
Pivot Adjustment Knob G — The force of the pivot rotation is factory preset.
Adjustment of the knob allows operator to increase the force.
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4-1-3
F1
F2
A-SIDE
G
C
4—POWERHEAD
B-SIDE
A D
C A 60 ml
30 ml
B
50 ml
10/15/20 ml B 60 ml
125 ml
E1 E2
Figure 4-1-1 Powerhead
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4-1-4
4.1.2 DESCRIPTION OF POWERHEAD KEYS

[Forward] key (A-side and B-side) H — The [Forward] key moves the
powerhead ram to push against the pushrod of the syringe on its respective
side. The powerhead ram advances only while the key is pressed.
[Accelerator] key (A-side and B-side) I — Found between the [Forward] key
and [Reverse] key, the [Accelerator] key increases the speed of the ram when
held down in conjunction with either the [Forward] or [Reverse] key.
Another feature of the [Accelerator] keys is Auto-Retract. Pressing both A-side
and B-side [Accelerator] keys simultaneously for greater than 1 second will
4—POWERHEAD
activate Auto-Retract. When the B-side ram retraction is completed, the A-side
ram will repeat the same retract movement. To stop Auto-Retract, simply press
any key on the powerhead.
WARNING!
Keep fingers out of the syringe holder when using Auto-Retract. Fingers placed
in this area while using Auto-Retract may result in operator injury.
[Reverse] key (A-side and B-side) J — Retracts the powerhead ram to the
home position on its respective side.
[Air Check] key { } K — The [Air Check] key or the [Enable] key on the
console must be pressed to enable the injector. Pressing the [Air Check] key
signals to the OptiStar Elite MR Contrast Delivery System that the operator
has checked and removed all air from the syringe(s) and connection
tubing. Once the [Air Check] key is pressed, the [Start] key is active.
WARNING!
The [Air Check] key { } is not to be used in lieu of a visual check by

the health care professional administering the contrast media. It is meant as
a reminder to the operator to perform a visual check of the syringe(s) and
connection tubing prior to the delivery of an injection.
[Patency Check Start] key { P } L — The [Patency Check Start] key is only
active once the [Air Check] key has been pressed. Pressing the [Patency Check
Start] key begins a Patency Check injection by moving the ram forward.
[Start] key { } M — The [Start] key is only active once the [Air Check] key has
been pressed. Pressing the [Start] key begins the injection. NOTE: Starting the
injection from the powerhead will prevent the use of the Inject Delay feature.
[Stop] key { } N — During an injection, pressing the [Stop] key will

immediately stop the injection.
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4-1-5
I J
A-SIDE H P
N
L
K
4—POWERHEAD
B-SIDE
Figure 4-1-2 Powerhead
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4—POWERHEAD
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4-2-1
4.2 FILLING SYRINGES

1. Review the instructions that accompany the contrast. Properly cleanse the
rubber stopper of the contrast bottle prior to use.
2. Using aseptic technique and the best practices of your facility, remove the
spike cover by pulling the cover straight off. 1 NOTE: Pull, do not twist!
Retain the spike cover for later removal of the spike.
WARNING!
4—PPOWERHEAD
Whenever the spike cover is removed, take proper precaution not to
contaminate the spike!
3. Retract the pushrod (fill the syringe with air) to the desired fill volume. 2
4. Insert the spike into the bottle of contrast until ONLY the first shoulder of
the spike butts up to the stopper. 3
5. Pressurize the bottle by injecting the air into the bottle through advancing
the pushrod. 4
6. Invert bottle and syringe. Advance or retract the pushrod until all air is
removed from the syringe and replaced by fluid. Retract the pushrod until
bottle is empty or desired fill volume is achieved. 5
7. Re-invert bottle and syringe to allow fluid to settle to the bottom of the
bottle. 6
8. Relieve pressure by inserting spike to second shoulder (venting position) to
allow air to escape. 7
9. Remove filled syringe from bottle.
10. Proceed to section 4.3 Purge Air from Syringe and Tubing.
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4-2-2
LY
ON
USE
GLE
SIN
4—POWERHEAD
2 3 4
1/2
1
oz
11/2
oz
MONOJECT
2
oz
cc
First Shoulder
Second Shoulder
Venting Position
5 6 7
Expel
Air
Figure 4-2-1 Filling Syringes
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4.3 PURGE AIR FROM SYRINGE AND TUBING/INSTALL SYRINGE(S)

DANGER!
AIR EMBOLISM HAZARD!
Air entrapped in the syringe or tubing can cause patient injury or death. Always
verify that the syringe and tubing has been properly cleared of air before
connecting tubing to patient! Patient must not be connected to tubing when
purging air from the syringe and tubing.
4.3.1 CONTRAST ONLY INJECTION

WARNING!
4—POWERHEAD
The following instructions advise purging the air from the syringe by hand. If
the injector rams are to be used in lieu of hand purging, ensure the injector
is NOT ENABLED before proceeding! If the injector is enabled with Patency
Check ON, the B-side [Forward] key P is the start key for the Patency Check
injection.
1. Purge the air from the syringe by hand by advancing the pushrod until all
air is removed.
2. Reinstall the cover onto the spike. Rotate the spike counterclockwise as
shown in Figure 4-3-1 and remove from the end of the syringe. Properly
dispose of spike.
GLE
SIN
.
Figure 4-3-1 Remove the Spike
3. When performing a contrast only injection (A-side only), use straight tub-
ing. Twist off the blue end cap 3 A and insert the tube connection into the
syringe Luer thread and rotate clockwise 3 B . Refer to Figure 4-3-2. NOTE:
Do not use Y-tubing when performing a contrast only injection.
4. To remove air from the tubing, hold the syringe upright, push the syringe
pushrod and observe the contrast advancing through the tubing and out
the end of the tubing. Observe syringe and tubing to ensure all air bub-
bles have been purged.
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4-3-2
5. When all air bubbles have been purged from the syringe and tubing, place
the syringe in side A of the powerhead. Ensure syringe flanges 5A remain
square with the syringe holder as shown in Figure 4-3-3 and insert the
syringe firmly into side A . NOTE: 5 B When using a 10 ml, 15 ml, or 20 ml
OptiMARK prefilled syringe, the OptiMARK syringe adapter must be used.
Install the OptiMARK syringe adapter into the A-side of the powerhead, en-
suring that the adapter snaps into place. Then install the syringe firmly into
the adapter. Refer to inset of Figure 4-3-3. NOTE: 5 C When using a 15 ml or
20 ml Dotarem prefilled syringe, the DOTAclip adapter must be used. Install
the DOTAclip offset wedge onto the A-side ram face of the powerhead, en-
suring that it snaps into place. Then install the DOTAclip syringe holder into
the A-side of the powerhead, ensuring that it snaps into place. Next, install
4—POWERHEAD
the Dotarem prefilled syringe firmly into the DOTAclip syringe holder. Refer
to Figure 4-3-3 inset.
Ensure the syringe size indicator on the powerhead and the installed sy-
ringe size match. If a discrepancy occurs, refer to Section 7-2-1 Syringe
Holder, for cleaning instructions regarding the switches.
6. Using the A-side [Forward] key, advance the powerhead ram to come into
contact with the base of the syringe pushrod. NOTE: Failure to advance the
A side ram so that it is in contact with syringe pushrod before starting the
injection protocol may cause the injector to stop and display “No Pressure
Detected! Verify Syringe Installation” message soon after beginning the
injection protocol.
CAUTION!
Ensure the base of the pushrod is positioned concentric to the ram 6 . Failure
to align the pushrod to the powerhead ram could cause damage to both the
syringe and to the powerhead. Refer to Figure 4-3-3.
7. Leave the powerhead in the vertical position (syringe pointed upward) and
the patient end of the connection tubing at same elevation or higher as
the syringe until ready for connection to patient. NOTE: Failure to keep the
patient end of tubing at same elevation or higher as syringe may cause fluid
to leak out end of tubing.
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3A
NLY
EO
US
E
GL
SIN
3B
Figure 4-3-2 Attaching the Tubing to A-side Syringe
4—POWERHEAD
6
5A
LY
ON
USE
GLE
SIN
5B 5C
Figure 4-3-3 Installing the A-side Syringe
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4.3.2 BEGIN INJECTING CONTRAST FOLLOWED WITH A SALINE FLUSH

This method primes the tubing past the Y-intersection with contrast. If the
Patency Check, Drip Mode, or Timing Bolus feature is to be used, follow method
4.3.3 Begin injection with Drip Mode, Patency Check, or Timing Bolus.
WARNING!
injection.
4—POWERHEAD
Using 50 ml / 60 ml Saline Syringe

1. Purge the air from the syringes by hand by advancing the pushrods until all
air is removed.
2. Reinstall the cover onto the spikes. Rotate the spike counterclockwise as
shown in Figure 4-3-1 and remove from the end of each syringe. Properly
dispose of spikes.
3. To attach the Y-tubing 3 A , twist off the blue end caps 3 B and insert each
tube connection into its respective syringe Luer thread. Ensure the blue
check valve 3 C is located on the A-side syringe (contrast). Rotate the tube
endings clockwise as shown in Figure 4-3-4.
4. To remove air from the tubing, hold both syringes upright, push the B-side
syringe (saline) pushrod first and observe the saline advance through the
short tubing 4 A to the Y-intersection 4 . Then, push the A-side syringe
B
(contrast) pushrod to advance the contrast through the short tubing, past
the Y-intersection, through the long tubing 4 and out the unconnected
C
end. Observe both syringes and all tubing to ensure all air bubbles have been
purged. Refer to Figure 4-3-5.
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5. When all air bubbles have been purged from the syringes and tubing, place the
A-side syringe (contrast) in slot A and the B-side syringe (saline) in slot B.
Ensure syringe flanges 5A remain square with the syringe holders as shown
in Figure 4-3-6. NOTE: 5 B When using a 10 ml, 15 ml, or 20 ml OptiMARK
prefilled syringe, the OptiMARK syringe adapter must be used. Install the
OptiMARK syringe adapter into the A-side of the powerhead, ensuring
that the adapter snaps into place. Then install the syringe into the adapter.
Refer to Figure 4-3-6 inset. NOTE: 5 C When using a 15 ml or 20 ml Dotarem
prefilled syringe the DOTAclip adapter must be used. Install the DOTAclip
offset wedge onto the A-side ram face of the powerhead, ensuring that it
snaps into place. Then install the DOTAclip syringe holder into the A-side of
the powerhead, ensuring that it snaps into place. Next, install the Dotarem
4—POWERHEAD
prefilled syringe firmly into the DOTAclip syringe holder. Refer to Figure
4-3-6 inset.
contact with the base of the A-side syringe pushrod. Using the B-side [For-
ward] key, advance the powerhead ram to come into contact with the base
of the B-side syringe pushrod. NOTE: Failure to advance the A side ram so
that it is in contact with syringe pushrod before starting the injection proto-
col may cause the injector to stop and display “No Pressure Detected! Verify
Syringe Installation” message soon after beginning the injection protocol.
CAUTION!
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3B
3C
3A
A-SIDE
NLY
EO
US
E
GL
SIN
3C
4—POWERHEAD
3A B-SIDE
Figure 4-3-4 Attaching the Y-Tubing to the A-side Syringe and B-side Syringe
4C
4B
4A
B-SIDE A-SIDE
SINGLE
USE ONLY
SINGLE
USE ONLY
.
Figure 4-3-5 Purging Air from the Tubing
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5A
4—POWERHEAD
NLY
EO
US
E
GL
SIN
5B 5C
Figure 4-3-6 Installing 50 ml / 60 ml Syringes
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4-3-8
Using 125 ml Saline Syringe

WARNING!
Ensure injector is NOT ENABLED before proceeding! If the injector is enabled

with Patency Check ON, the B-side [Forward] key P used in step 5 is the start
key for the Patency Check injection.
1. Purge the air from the A-side syringe by hand by advancing the pushrod
until all air is removed.
shown in Figure 4-3-1 and remove from the end of the A-side syringe. Prop-
erly dispose of spike.
4—POWERHEAD
4. Place the A-side syringe (contrast) in slot A and the B-side syringe (125 ml
saline) in slot B. Ensure the flanges of the A-side syringe 4 A remain square
with the syringe holders as shown in Figure 4-3-8. NOTE: 4 When using
B
a 10 ml, 15 ml, or 20 ml OptiMARK prefilled syringe, the OptiMARK syringe

adapter must be used. Install the OptiMARK syringe adapter into the A-side
of the powerhead, ensuring that the adapter snaps into place. Then install
the syringe into the adapter. Refer to Figure 4-3-8 inset. NOTE: 4 d When
using a 15 ml or 20 ml Dotarem prefilled syringe the DOTAclip adapter must
be used. Install the DOTAclip offset wedge onto the A-side ram face of the
powerhead, ensuring that it snaps into place. Then install the DOTAclip
syringe holder into the A-side of the powerhead, ensuring that it snaps into
place. Next, install the Dotarem prefilled syringe firmly into the DOTAclip
syringe holder. Refer to Figure 4-3-8 inset.
To install the 125 ml syringe (saline), ensure the ram is retracted completely,
tilt the plunger end of the syringe 4 C as shown in Figure 4-3-8.
5. Rotate the powerhead vertically. Using the B-side [Forward] key, advance
the plunger to push the air pocket out of the syringe tip, through the short
tubing and just past the Y-intersection.
Remove the A-side syringe from its slot. Hold upright and manually push
the A-side syringe pushrod and observe the contrast advance through
the short tubing, past the Y-intersection, through the long tubing and out
the unconnected end. Observe both syringes and tubing to ensure all air
bubbles have been purged.
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6. Replace the A-side syringe in slot A.

contact with the base of the A-side syringe pushrod. NOTE: Failure to
advance the A side ram so that it is in contact with syringe pushrod before
starting the injection protocol may cause the injector to stop and display
“No Pressure Detected! Verify Syringe Installation” message soon after be-
ginning the injection protocol.
CAUTION!
4—POWERHEAD
3B
3C
3A
A-SIDE
NLY
EO
US
E
GL
SIN
3C
3A B-SIDE
Figure 4-3-7 Attaching the Y-Tubing to the A-side Syringe and 125 ml B-side Syringe
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4-3-10
4A
4—POWERHEAD
LY
ON
USE
GLE
SIN
4C
4B 4D
Figure 4-3-8 Installing 50 ml / 60 ml Syringe and 125 ml Syringe
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4-3-11
4.3.3 BEGIN INJECTION WITH DRIP MODE, PATENCY CHECK, OR TIMING BOLUS
This method primes the tubing past the Y-intersection with saline.
WARNING!
injection.
Using 50 ml / 60 ml Saline Syringe
4—POWERHEAD
1. Purge the air from the syringes by hand by advancing the pushrods until all
air is removed.
2. Reinstall the covers onto the spikes. Rotate the spikes counterclockwise as
shown in Figure 4-3-1 and remove from the end of the syringes. Properly
dispose of spikes.
3. To attach the Y-tubing, twist off the blue end caps and insert each tube end
into the respective syringe connector. Ensure the blue check valve is lo-
cated on the A-side syringe (contrast). Rotate the tube endings clockwise as
shown in Figure 4-3-4.
4. Holding both syringes upright, push the A-side syringe (contrast) pushrod
first and observe the contrast advance through the tubing, just past the Y-
intersection. Then, push the B-side syringe (saline) pushrod to advance the
saline through the short tubing, past the Y-intersection, through the long
tubing and out the unconnected end. Observe both syringes and tubing to
ensure all air bubbles have been purged. Refer to Figure 4-3-5.
5. When all air bubbles have been purged from the syringes and tubing, place
the A-side syringe (contrast) in slot A and the B-side syringe (saline) in
slot B. Ensure syringe flanges 5A remain square with the syringe holders
as shown in Figure 4-3-6. NOTE: 5 B When using a 10 ml, 15 ml, or 20 ml
OptiMARK prefilled syringe, the OptiMARK syringe adapter must be used.
Install the OptiMARK syringe adapter into the A-side of the powerhead,
ensuring that the adapter snaps into place. Then install the syringe into
the adapter. Refer to Figure 4-3-6. NOTE: 5 C When using a 15 ml or 20 ml
Dotarem prefilled syringe the DOTAclip adapter must be used. Install the
DOTAclip offset wedge onto the A-side ram face of the powerhead, ensur-
ing that it snaps into place. Then install the DOTAclip syringe holder into
the A-side of the powerhead, ensuring that it snaps into place. Next, install
the Dotarem prefilled syringe firmly into the DOTAclip syringe holder. Refer
to Figure 4-3-6 inset.
Holder, for cleaning instructions regarding the switches
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4-3-12
contact with the base of the A-side syringe pushrod. Using the B-side [For-
ward] key, advance the powerhead ram to come into contact with the base
of the B-side syringe pushrod. NOTE: Failure to advance the A side ram so
that it is in contact with syringe pushrod before starting the injection proto-
col may cause the injector to stop and display “No Pressure Detected! Verify
Syringe Installation” message soon after beginning the injection protocol.
CAUTION!
4—POWERHEAD
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4-3-13
Using 125 ml Saline Syringe

WARNING!
Ensure injector is NOT ENABLED before proceeding! If the injector is enabled

with Patency Check ON, the B-side [Forward] key P used in step 5 is the start
key for the Patency Check injection.
1. Purge the air from the A-side syringe by hand by advancing the pushrod
until all air is removed.
shown in Figure 4-3-1 and remove from the end of the A-side syringe. Prop-
erly dispose of spike.
4—POWERHEAD
Hold the A-side syringe upright and manually push the A-side syringe
pushrod and observe the contrast advance through the short tubing, just
past the Y-intersection,
4. Place the A-side syringe (contrast) in slot A and the B-side syringe (125 ml
saline) in slot B. Ensure the flanges of the A-side syringe 4 A remain square
with the syringe holders as shown in Figure 4-3-8. NOTE: 4 When using
B
a 10 ml, 15 ml, or 20 ml OptiMARK prefilled syringe, the OptiMARK syringe

adapter must be used. Install the OptiMARK syringe adapter into the A-side
of the powerhead, ensuring that the adapter snaps into place. Then install
the syringe into the adapter. Refer to Figure 4-3-8 inset. NOTE: 4 d When
using a 15 ml or 20 ml Dotarem prefilled syringe the DOTAclip adapter must
be used. Install the DOTAclip offset wedge onto the A-side ram face of the
powerhead, ensuring that it snaps into place. Then install the DOTAclip
syringe holder into the A-side of the powerhead, ensuring that it snaps into
place. Next, install the Dotarem prefilled syringe firmly into the DOTAclip
syringe holder. Refer to Figure 4-3-8 inset.
To install the 125 ml syringe (saline), tilt the plunger end of the syringe 4 C
as shown in Figure 4-3-8.
Holder, for cleaning instructions regarding the switches
5. Rotate the powerhead vertically. Using the B-side [Forward] key, advance
the plunger to push the air pocket out of the syringe tip, through the short
tubing, past the Y-intersection, through the long tubing and out the uncon-
nected end. Observe both syringes and tubing to ensure all air bubbles
have been purged.
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4-3-14
contact with the base of the A-side syringe pushrod. NOTE: Failure to
advance the A side ram so that it is in contact with syringe pushrod before
starting the injection protocol may cause the injector to stop and display
“No Pressure Detected! Verify Syringe Installation” message soon after be-
ginning the injection protocol.
CAUTION!
4—POWERHEAD
the patient end of the connection tubing at same elevation or higher as the
syringe until ready for connection to patient. NOTE: Failure to keep the
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5 DELIVERING
AN INJECTION
This chapter contains instructions on delivering an injection. Safety instructions
to ensure patient safety are also covered here. Please read this section carefully
prior to delivering an injection.
5.1 SAFETY INSTRUCTIONS

DANGER!
DANGER! AIR EMBOLISM HAZARD!
5—DELIVERING AN
Air entrapped in the delivery system can cause patient injury or death. Always
INJECTION
verify that the syringe and tubing have been properly cleared of air just prior to
starting an injection! The OptiStar Elite MR Contrast Delivery System does not
have the capability to check for air in the syringe and tubing. The operator is
responsible for removing all air from the system.
DANGER!
REMOVE SYRINGE AFTER COMPLETION OF INJECTION

Disposable syringes and tubing are labeled for SINGLE USE ONLY! Used syringes
should be promptly removed from the injector after a procedure is completed
to avoid accidental reuse of the empty syringe. Failure to remove the syringe
and tubing after completion of a procedure may lead to an inadvertent
injection of air. Injecting air can cause patient injury or death.
WARNING!
The OptiStar Elite MR Contrast Delivery System does not have the capability to
prevent or detect an extravasation. Extravasation can be minimized through
the following precautions:
• Use the largest vein possible.
• Use lowest flow rate practical to achieve enhancement.
• Use largest gauge teflon type catheter possible.
• Insure good backflow from catheter.
• Continue to monitor from remote location.
• Instruct patient to notify operator of any abnormal pain, pressure or swelling.
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5-1-2
WARNING!
This device has been approved for use with only the consumables listed in
section 1.6 Consumables. Use of other consumables could result in patient
injury, operator injury and/or equipment damage.
WARNING!
REVIEW PARAMETERS
Prior to enabling an injection, review all parameters thoroughly to ensure that
they are correct and appropriate for the procedure.
WARNING!
ROTATE POWERHEAD DOWN

5—DELIVERING AN
Prior to injecting, rotate the powerhead down to allow any small remaining air
bubbles to float away from the tip, reducing the possibility of injecting into the
INJECTION
patient.
WARNING!
INSPECT FOR DAMAGE PRIOR TO USE. Damaged components can cause

fluid leaks and other unsafe conditions. Visually inspect this device and all
accessories, including syringes and tubing. Do not use if sterile packaging is
open or parts are damaged.
WARNING!
Position this device and all accessories in a fashion that minimizes risk of
accidentally pulling out patient IV during injection.
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5.2 LOAD SYRINGE(S) / ENTER PARAMETERS / CONNECT PATIENT

Refer to Section 5.1 for Safety Instructions.
1. Properly fill and install the syringe and tubing according to the instructions
in Chapter 4.
2. Enter required injection parameters or retrieve a stored protocol. For more
information about entering parameters and retrieving stored protocols,
refer to Chapter 3.
3. Review all parameters thoroughly to ensure that they are correct and ap-
propriate for the procedure. Make adjustments as necessary. NOTE: If a
protocol has been retrieved from memory, and then modified, the Protocol
Name will be displayed followed by an “*” sign to indicate the stored param-
eters have been modified.
4. Confirm no air exists in the syringe(s) and tubing. If air is found in any part
5—DELIVERING AN
of the delivery system, take appropriate action to remove all air.
5. If no air is found in the syringe or tubing, connect system to patient.
INJECTION
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5—DELIVERING AN
INJECTION
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5.3 CHECK PATENCY OF I.V. SITE

Refer to Section 5.1 for Safety Instructions prior to delivering a Patency
Check Injection.
The integrity of the I.V. site can be determined through use of the Patency
Check feature. This feature is only active if turned ON at the System Information
2
screen. Refer to 1 and of top inset in Figure 5-3-1.
1. Review all parameters on the Main screen thoroughly to ensure that they
are correct and appropriate for the procedure. Make adjustments as neces-
sary. For more information about entering parameters and retrieving stored
protocols, refer to Chapter 3. NOTE: If a protocol has been retrieved from
memory, and then modified, the Protocol Name will be displayed followed
5—DELIVERING AN
by a “*” sign to indicate the stored parameters have been modified.
INJECTION
of the delivery system, take appropriate action to remove all air before
proceeding.
3. Press the [Air Check] key on the powerhead 3A or press the
[Enable] key 3 B on the console, then press the [Yes] key 4 for the prompt
“Have you checked for air and patency?”. Note the Operator Message Line
indicates “PATENCY ON...10ml VOLUME” and the powerhead’s B-side Injector
Indicator flashes 5 . Rotate the powerhead down prior to delivery of the
Patency Check injection.
4. Press the [P] key P on the powerhead 6 to start the Patency Check
injection. Monitor the site and instruct patient to notify operator of any
abnormal pain, pressure or swelling.
5. Pressing the [Stop] key , or any other key on the powerhead 7 will im-
mediately stop the Patency Check injection. NOTE: At the completion of the
Patency Check injection, pressing the [Start] key on the powerhead will
start the main injection
6. If the injector reaches the programmed pressure limit during the patency
injection, the message “Patency Pressure Limited! Check Fluid Path.” is dis-
played 8 and the syringe indicator lights flash. Check the fluid path for any
obstructions (such as a bent catheter or closed valve), then press the
[OK] key to continue.
7. Multiple Patency Check injections can be delivered only if the syringe
contains sufficient volume. The main injection can be delivered by pressing
either the [Start Protocol] key on the console or the [Start] key on the
powerhead.
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5-3-2

A: 60 60ml AB1 System Information
B: 60 60ml Duration 00:12 Display Brightness Low High Pressure Units PSI

ml/sec ml sec Off Low Med High
Beeper Volume
1 A 0.1 1 Max Vol
0 Inject Delay
Software Versions Console: V1.03 Power Control: V1.02
2 B 0.1 1 00:00
2
Max Vol
Scan Delay Language
3 - 00:00
English German Spanish French
Italian Portuguese
4 PSI
Patency Check On
20 Change Date Change Time

Service Mode
Phase Delay Off
Timing Bolus Inject Delay Off

NOV 04 2004 10:07
Alarm History Scan Delay Off
Opti
Memory System Info Results Enable star Memory Main Result
Elite
TM
TM
5 CHECK FOR AIR IN SYRINGE AND TUBING!

A: 60 60ml AB1
7 3A B: 60
Phase
60ml
Side Flow Volume
Duration 00:12
Phase Delay
ml/sec ml sec
1 A 0.1 1 Max Vol

0 Inject Delay
2 B 0.1 1 Max Vol 00:00

Scan Delay
-
5—DELIVERING AN
6 00:00
P
4 PSI
A 20
60
10/15 30 ml ml
INJECTION
/20 ml
B 50 Timing Bolus
60 ml
125 ml ml
3B
A: 60 60ml AB1
ml/sec ml sec
2 B 0.1 1 forMaxairVoland
Have you checked 00:00
patency? Scan Delay
3 - 00:00
4
4 Yes No
PSI
20
Timing Bolus
5 PATENCY ON ... 10ml VOLUME PATENCY ON ... 10ml VOLUME

A: 60 60ml AB1
Start Protocol
A: 60 60ml AB1
Start Protocol
B: 60 60ml Duration 00:12 B: 60 50ml Duration 00:12
Phase Side Flow Volume Phase Delay Phase Side Flow Volume Phase Delay
ml/sec ml sec ml/sec ml sec
1 A 0.1 1 Max Vol 0 Inject Delay 1 A 0.1 1 Max Vol 0 Inject Delay
2 B 0.1 1 Max Vol 00:00 2 B 0.1 1 Limited!

Patency Pressure Max Vol 00:00
Scan Delay Scan Delay
3 - 00:00
3 - Check Fluid Path. 00:00
4 Peak PSI 4 8 Peak PSI
20 20
OK
Timing Bolus Timing Bolus
Drip Disable Drip Disable
Figure 5-3-1 Delivering a Patency Check Injection
818509-A 2017-05-161
5-4-1
5.4 DELIVERING A DRIP MODE INJECTION

Refer to Section 5.1 for Safety Instructions prior to delivering a Drip Mode
Injection.
This mode allows the injector to deliver a “drip” injection to keep the fluid path
open during patient set up and between injections of contrast. Refer to
Figure 5-4-1.
5—DELIVERING AN
proceeding.
INJECTION
[Enable] key 1 B on the console, followed by pressing the [Yes] key 2 B for
the prompt “Have you checked for air and patency?” Note the powerhead’s
injection indicators illuminate 3 . Rotate the powerhead down.
4. Press the [Drip] key located on the displayed screen. 4
5. Adjust the Drip flow, Drip volume and Drip interval as desired using the
slide bar. 5 Drip volume can only be set to an amount that will not com-
promise the programmed protocol.
6. Press the [Start Drip] key 6A or the [Start] key on the powerhead 6 B to
start the Drip Mode injection.
7. Drip Time and Drip Volume decrements while injecting. The [Stop] key
on the powerhead 7A , the [Stop and return to: Drip] key or the [Stop and
return to: Main] key 7 B on the console are available to immediately stop the
Drip Mode injection.
8. Once the Drip Volume is delivered, the injector emits an audible tone for
two (2) seconds and the screen displays the word “COMPLETED”. Press the
[Main] key to exit the Drip Mode and display the enabled Main screen.
818509-A 2017-05-16
5-4-2
3 A: 60
60ml AB1
ml/sec ml sec
1 A 0.1 1 Max Vol

0 Inject Delay
2 B 0.1 1 Max Vol 00:00
7A 1A
Scan Delay
3 - 00:00
P 4 PSI
A
10/15
6B 60
30 ml
/20 ml ml
1B
20
Timing Bolus
B 50
60 ml
125 ml ml
1B
A: 60 60ml AB1
ml/sec ml sec
2 B 0.1 1 forMaxairVoland
Have you checked 00:00
patency? Scan Delay
3 - 00:00
4
2B Yes No
PSI
20
5—DELIVERING AN
Timing Bolus
INJECTION
PATENCY ON ... 10 ml VOLUME 5

A: 60 60ml AB1
Start Protocol
B: 60 60ml
Phase Side Flow Volume
Duration 00:12
Phase Delay Drip Mode B Drip Volume Drip Time
ml/sec ml sec 51 ml 00:19:31

Hr:Min:Sec
1 A 0.1 1 Max Vol
0 Inject Delay
2 B 0.1 1 Max Vol 00:00 54 Cancel
Scan Delay
3 - 00:00 Start Drip
4 Peak PSI
20 Flow
ml/sec
Volume
ml
Interval
sec
Timing Bolus 0.5 1.0 30
Drip Disable
.5 0.7 1.0

Drip Infusion
51 ml 00:19:31 B Drip Volume
31 ml
Drip Time
0:19:31
Hr:Min:Sec
Hr:Min:Sec
54 Cancel
Stop and
6A Drip End
35
return to:
Start Drip
Drip

7B
ml/sec ml sec Main
0.5 1.0 30
Figure 5-4-1 Delivering a Drip Mode Injection
818509-A 2017-05-16
5-5-1
5.5 DELIVERING THE MAIN PROTOCOL

Refer to Section 5.1 for Safety Instructions prior to delivering the Main
Protocol.
Refer to Figures 5-5-1 through 5-5-2.
proceeding.
5—DELIVERING AN
INJECTION
[Enable] key 1 B on the console, followed by pressing the [Yes] key 2 B for
the prompt “Have you checked for air and patency?” Note the powerhead’s
injection indicators illuminate 3 . Rotate the powerhead down.
4. Press either the [Start] key on the powerhead 4A , the
[Start Protocol] key on the console 4 or the hand start switch 4 to start
B C
the injection. NOTE: Starting the injection from the powerhead will prevent
the use of the Inject Delay feature.
5. The Progress screen will appear on the console and the injection indicators
flash when their respective ram (A-side or B-side) is moving.
NOTE: If Scan Delay is in use, 10 seconds before expiration, 3 audible beeps

will be emitted by the injector; 5 seconds before expiration, 2 audible
beeps; at expiration, one long tone will be emitted.
6. To stop an injection before it has been completed, press the [Stop] key
on the powerhead 5 , the [Stop] key on the console’s Progress screen 5
A B
or any other key on the powerhead, with the exception of the [Start] key.
Pressing the Hand Start switch 4 also stops an injection.
C
7. To continue a Paused injection, press the [Continue] key 6 . (Refer to

Figure 5-5-2.)
8. When the injection is completed, the injection indicator lights will extin-
guish and “Injection Complete” is displayed on the Progress screen. Press
the [Main] key 7 to access the Main screen or, after approximately 15 min-
utes, the Main screen will automatically appear.
818509-A 2017-05-16
5-5-2
3 A: 60
60ml AAB1
5A
ml/sec ml sec
1 A 8.0 13 Max Vol

0 Inject Delay
2 A 1.6 8 Max Vol Pause

00:00
1A 3 B 1.6 8 Max Vol

Scan Delay
00:00
P
4 -
4A
PSI
20
A 60
10/15 30 ml Timing Bolus
/20 ml ml
B 50
60 ml
125 ml ml
1B
A: 60 60ml AAB1
ml/sec ml sec
2 A 0.1 1 forMaxairVoland
Have you checked Pause
00:00
patency? Scan Delay
3 B 00:00
4 -
2B PSI
20
5—DELIVERING AN
Yes No
Timing Bolus
INJECTION
INJECTOR IS READY!
A: 60 60ml AAB1 4B Start Protocol
ml/sec ml sec
2 A 1.6 8 Max Vol 00:00
1.6 8
Scan Delay
3 B Max Vol
00:00
4 - Peak PSI
20
Timing Bolus
4C
Drip Disable
Injected Volume Total Time Injected Volume Total Time

21 39 ml A 0:08 21 39 ml A 0:14
3 51 ml B Side PSI
8 46 ml B Side PSI
0 50 100 150 200 A 12 0 50 100 150 200 A 12
Pressure B 15 Pressure B 15
PSI PSI
Injecting Injection
Programmed Side Flow Volume Delay Protocol Achieved Side Flow Volume Delay Complete
Protocol PH1 A 8.0 13 0 Results PH1 A 8.0 13 0

PH2 A 1.6 8 0 PH2 A 1.6 8 0
PH3 B 1.6 8 5B Stop
PH3 B 1.6 8 Main
7
Figure 5-5-1 Delivering the Main Protocol
818509-A 2017-05-16
5-5-3
3 A: 60
60ml AAB1
5A
ml/sec ml sec
1 A 8.0 13 Max Vol

0 Inject Delay
2 A 1.6 8 Max Vol Pause

00:00
1A 3 B 1.6 8 Max Vol

Scan Delay
00:00
P
4 -
4
PSI
A 20
A 60
10/15 30 ml Timing Bolus
/20 ml ml
B 50
60 ml
125 ml ml
1B
A: 60 60ml AAB1
ml/sec ml sec
2 A 0.1 1 forMaxairVoland
Have you checked Pause
00:00
patency? Scan Delay
3 B 00:00
4 -
2B PSI
20
5—DELIVERING AN
Yes No
Timing Bolus
INJECTION
INJECTOR IS READY!
A: 60 60ml AAB1 4B Start Protocol
ml/sec ml sec
2 A 1.6 8 Max Vol 00:00
1.6 8
Scan Delay
3 B Max Vol
00:00
4 - Peak PSI
20
Timing Bolus
4C
Drip Disable
Injected Volume Total Time Injected Volume Total Time

21 39 ml A 0:59 21 39 ml A 0:59
- 54 ml B Side PSI
8 46 ml B Side PSI
0 50 100 150 200 A 12 0 50 100 150 200 A 12
Pressure B - Pressure B 15
PSI
6Continue PSI
Injection
Programmed Side Flow Volume Delay Achieved Side Flow Volume Delay Complete
Protocol PH1 A 8.0 13 0 Results PH1 A 8.0 13 0

PH2 A 1.6 8 Pause PH2 A 1.6 8 0
PH3 B 1.6 8 PH3 B 1.6 8 Main
7
Main
Figure 5-5-2 Delivering a Paused Main Protocol
818509-A 2017-05-16
5-5-4
5—DELIVERING AN
INJECTION
818509-A 2017-05-16
5-6-1
5.6 PREMATURELY STOPPING AN INJECTION

Refer to Figures 5-6-1 and 5-6-2.
To stop an injection before it has been completed, press the [Stop] key
on the powerhead 1 , the [Stop] key on the console 1 , or any other key on
A B
the powerhead (with the exception of the [Start] key). Pressing the hand start
switch 1 C also stops an injection.
Pressing the Console System ON/OFF button 2 will not only immediately stop
the injection, but will also turn off the console and powerhead.
1A
5—DELIVERING AN
INJECTION
P
A 60
10/15 30 ml
/20 ml ml
B 50
60 ml
125 ml ml
Injected Volume Total Time

21 57 ml A 0:59
8 54 ml B Side PSI
0 50 100 150 200 A 12
Pressure B 15
PSI
Injecting
Programmed Side Flow Volume Delay Protocol
ml/sec ml sec
Protocol PH1 A 8.0 13 0

PH2 A 1.6 8 0
PH3 B 1.6 8 1B 1C
Stop
Figure 5-6-1 Stopping an Injection
818509-A 2017-05-16
5-6-2
Figure 5-6-2 Stopping an Injection by Turning the Injector OFF

5—DELIVERING AN
INJECTION
818509-A 2017-05-16
5-7-1
5.7 RESTARTING A PREMATURELY STOPPED INJECTION

The system does not restart a prematurely stopped injection. It only delivers
full volume injections.
5—DELIVERING AN
INJECTION
818509-A 2017-05-16
5-7-2
5—DELIVERING AN
INJECTION
818509-A 2017-05-16
6-1-1
6 SYSTEM GENERATED
MESSAGES AND ALARMS
6.1 SYSTEM GENERATED MESSAGES/INDICATIONS

6.1.1 * ASTERISK: PROTOCOL RETRIEVED FROM MEMORY HAS BEEN MODIFIED
An asterisk, “*” , A will be placed after the protocol name if the operator
modifies any parameter of a displayed protocol retrieved from memory.
MESSAGES AND ALARMS

6—SYSTEM GENERATED
A: 60 60ml AAB1*
ml/sec ml sec
1 A 8.0 13 Max Vol

0 Inject Delay
2 A 1.6 8 Max Vol 00:00

Scan Delay
3 B 1.6 8 Max Vol
00:00
4 - Peak PSI
20
Timing Bolus
.1 4.0 8.0
Memory Drip System Info Results
6.1.2 VOLUME KEY FLASHING A MAGENTA COLOR

The volume key(s) on the main screen will flash a magenta color to indicate that
its value(s) is greater than the volume contained in its respective syringe. Lower
the value of the applicable volume key(s) or fill the syringe(s) with an adequate
amount of fluid.
818509-A 2017-05-16
6-1-2
6.1.3 PRESSURE LIMITED INJECTION
If the injection is pressure limited, a message B may be displayed on the

progress screen. The injection will also have an asterisk to the right of the
affected pressure along with the pressure highlighted C on the Injection
Results screen. Possible causes of pressure limited message may include:
programmed flow rate too high for catheter size, bent catheter, and closed
valve.
Injected Volume Time

3 57 ml A 0:23
- 56 ml B Side PSI
A 2
Pressure limited B -
0 50 100 150 200
Stop injection? B
MESSAGES AND ALARMS
Pressure
PSI
Yes No Injecting
Side Flow Volume Timing Bolus
ml/sec ml
Programmed PH1:
Protocol
A 8.0 13
PH2: B 1.6 8
Stop
Page 1
Injection Results
No. Date - Time Phase Side ml/sec ml sec Phase Side ml/sec ml sec
1 A 2.6 10 0 2 Press A 0
1 02 NOV 06 10:17 3 4 Press B 0
1 A 3.5 5 0 2 B 1.4 8 0 Press A 0

2 02 NOV 06 10:27 3 4 Press B 1
3 02 NOV 06 10:35
1
3
A
B
3.5
1.4
5
8
0
0
2
4
A 3.3 4 0 Press A
Press B
0
2 C
1 A 1.6 5 0 2 A 3.4 4 0 Press A 0
4 02 NOV 06 10:42 3 B 1.4 8 0 4 Press B 3
1 A 3.9 12 0 2 B 2.5 8 0 Press A 0

5 02 NOV 06 10:50 3 4 Press B 4
1 A 1.6 4 0 2 B 2.4 8 0 Press A 0

6 02 NOV 06 11:03 3 4 Press B 0
1 A 2.1 7 0 2 Press A 0
7 02 NOV 06 11:17 3 4 Press B 0
1 A 1.9 7 0 2 Press A 0
8 02 NOV 06 11:28 3 4 Press B 0
< >
System Info Main
818509-A 2017-05-16
6-2-1
6.2 SYSTEM GENERATED ALARMS

If an injector error occurs, injector operation stops, an audible signal will be
produced and a message will be displayed on the console. Refer to Figure 6-2-1.
A: 60 60ml Protocol Name
B: 60 60ml Druation 00:12
Phase Side Flow
ml/sec
Volume
ml
Alarm 90
Phase
sec
! Delay
PH1: A 8.0 13 0 Inject Delay
PH2: A Communications
1.6 8 Max Vol Error 00:00
1.6 8 Max Vol

Scan Delay
PH3: B 00:00
PH4: - Peak PSI
20
MESSAGES AND ALARMS

Drip
.1 4.0 8.0
-
Memory Timing Bolus Patency Check Results
Figure 6-2-1 Location of Alarm Message on the Console

Alarm messages require the OptiStar Elite MR Contrast Delivery System to be
powered off and restarted. If the alarm message continues to be displayed, call
your service personnel. The following table lists the alarm numbers and their
description:
818509-A 2017-05-16
6-2-2
Alarm
Number Fault Message
1 Pressure Limit Alarm
2 Over Volume Alarm
3 Over Flow Rate Alarm
4 Motor Timing Alarm
6 Motor Alarm
9 Invalid Powerhead Pressure Measurement Alarm
13 Forward/Reverse Limit Sensor Alarm
14 Motor Control Watchdog Alarm
15 Syringe Size Sensing Alarm
MESSAGES AND ALARMS
16 Power Control Communication Buffer Alarm

17 Key Press Alarm
18 Power On Self Test Alarm
20 Protocol Parameter Alarm
21 Invalid Start Request Alarm
23 Power Control Firmware Checksum Alarm
24 Power Control NV Memory Checksum Alarm
30 Touchscreen Alarm
31 Remote Start Switch Connection Alarm
32 Console CPU Hardware Malfunction Alarm
33 Console Protocol Memory Checksum Alarm
34 Console Program Checksum Alarm
35 General Power Control Alarm
36 SW Watchdog Timer
50 Power Control not Detected Alarm
90 Power Control/Console Communication Alarm
818509-A 2017-05-16
7-1-1
7 CARE OF UNIT
7.1 PREVENTIVE MAINTENANCE AND SERVICE

Preventive maintenance schedule and service procedures are in the Service
Manual, P/N 818507.
Service will make available on request circuit diagrams, component part lists,
descriptions, calibration instructions, or other information which will assist
the user’s appropriately qualified technical personnel to repair those parts of
equipment which are designated by LF as repairable.
7—CARE OF UNIT
818509-A 2017-05-16
7-1-2

7—CARE OF UNIT
818509-A 2017-05-16
7-2-1
7.2 DAILY INSPECTION

Units need to be inspected prior to use. Contact your Guerbet distributor for
further information on the OptiStar Elite MR Contrast Delivery System.
• Inspect all cabling for secure connections or frayed sheathing.
• Ensure powerhead motors are functioning properly by expelling and
retracting both rams by using the [Forward] and [Reverse] keys on the
powerhead keypad. Rams should move in a smooth, steady motion.
• Check the Syringe Size Indicators.
-Install the syringe adapter in the A-side to verify the 10/15/20 ml indicator
illuminates on the keypad.
- Install a 60 ml syringe in both sides to verify the 60 ml indicator illuminates
on the keypad.
- Install a 30 ml syringe into the A-side to verify the 30 ml indicator
- Install a 50 ml syringe into the B-side to verify the 50 ml indicator
7—CARE OF UNIT
If indicators do not illuminate properly, clean the switches to ensure proper
operation. Refer to section 7.4.1 Syringe Holder.
818509-A 2017-05-16
7-2-2

7—CARE OF UNIT
818509-A 2017-05-16
7-3-1
7.3 CLEANING
CAUTION!
DO NOT use any solvents or alcohol based cleaners to clean the Powerhead,
Console, Power Control or Power Supply.
7.3.1 SYRINGE HOLDER

On a daily basis, move the ram to the retracted position and wipe out the inside
of the syringe holder with warm water and a soft cloth.
WARNING!
Clean the switches and the area around the switches thoroughly to ensure
proper switch operation. Improper switch operation may result in patient injury
or equipment malfunction. Refer to A in Figure 7-3-1 for location of switches.
7—CARE OF UNIT
Figure 7-3-1 Location of Switches
818509-A 2017-05-16
7-3-2
7.3.2 DOTACLIP SYRINGE ADAPTER

Clean the DOTAclip syringe adapter with water or alcohol only. Do not sterilize.
7.3.3 POWERHEAD
Clean the exterior of the powerhead and the optional OptiMark syringe adapter
by spraying a cloth with an all-purpose household cleaner, then gently wipe
clean.
7.3.4 CONSOLE
The console may be cleaned by using a lint-free cloth sprayed with an all-
purpose household cleaner. To clean the touch screen, use a damp nonabrasive
cloth and any commercially available non-ammonia and non-alcohol window
cleaner to regularly clean the surface. NOTE: The cleaning solution should be
applied to the cloth rather than the surface of the touch screen. The touch
screen is not water proof.
7.3.5 POWER CONTROL
Clean the exterior of the power control by spraying a cloth with an all-purpose
household cleaner, then gently wipe clean.
7—CARE OF UNIT
7.3.6 POWER SUPPLY

Clean the exterior of the power supply by spraying a cloth with an all-purpose
household cleaner, then gently wipe clean.
818509-A 2017-05-16
A-1
A ELECTROMAGNETIC
COMPATIBILITY GUIDANCE
Note: Electromagnetic Compatibility Tables can be found in the Installation,
Service and Parts Manual (Part Number 818507).
The OptiStar Elite MR Contrast Delivery System meets EN 60601-1-2 for Class B
conducted and radiated emissions and EMI immunity.
WARNING!
The OptiStar Elite MR Contrast Delivery System should not be used adjacent to
or stacked with other equipment. If adjacent or stacked use is necessary, the
system should be observed to verify normal operation in the configuration in
which it will be used.
A—ELECTROMAGNETIC
WARNING!
Use of accessories, transducers and cables other than those specified or
provided by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
WARNING!
Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30 cm
(12 inches) to any part of the OptiStar Elite MR Contrast Delivery System ,
including cables specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.
CAUTION!
Portable and mobile RF communication equipment can affect operations of the
OptiStar Elite MR Contrast Delivery System .
CAUTION!
Maintaining programmed flow rate (unless pressure limited) and delivered
volume are essential performance features of the OptiStar Elite MR Contrast
Delivery System. Interference from other equipment could cause degradation
of these functions, resulting in improper operation.
818509-A 2017-05-16
A-2
NOTE: The EMISSIONS characteristics of this equipment make it suitable for use
in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential
environment (for which CISPR 11 class B is normally required) this equipment
might not offer adequate protection to radio-frequency communication
services. The user might need to take mitigation measures, such as relocating
or re-orienting the equipment.
NOTE: If any anomalies in the injector performance are noticed, identify
devices within the immediate area that are capable of producing
electromagnetic interference and call a qualified service representative.
A—ELECTROMAGNETIC
818509-A 2017-05-16
I-1-1
Index
Symbols E
* Asterisk: Protocol Retrieved from Memory... 6-1-1 Editing a Protocol Name 3-3-11
Electrical Leakage 1-5-1
A Electrically Isolated Syringe 1-4-1
Accessories 1-7-1 Enable 3-2-1
A: Syringe Size 3-3-1 Enabled Screen 3-3-18
AutoRetract 4-1-4 Enter Parameters 5-2-1
Environmental 1-5-2
B
F
Begin injecting contrast followed with a saline flush
4-3-4 Filling Syringes 4-2-1
Begin injection with Drip Mode, Patency Check, or Tim- Flow 3-3-1
ing Bolus 4-3-11 H
B: Syringe Size 3-3-1
Hand Start Switch Operation 1-4-1
C
I
Care of Unit 7-1-1
CE Mark Information viii Indications for Use 1-1-1
Change Parameter Values via the Slide Bar 3-3-2, 3-3- Inject Delay 3-3-2
20 Injection Results Screen 3-3-16
Check Patency of I.V. Site 5-3-1 Inject Mode Screen 3-3-1
Classification in accordance with EN60601 vii Inject Results 1-5-6
I—Index
Cleaning 7-3-1
Configuration of Unit 1-3-1 K
Connect Patient 5-2-1 KPA / PSI 3-3-2
CONSOLE 3-1-1
Console Display Modes of Operation 3-2-1 L
Consumables 1-6-1
Contrast Only Injection 4-3-1 Load Syringe(s) 5-2-1
D M
Daily Inspection 7-2-1 Meanings of Symbols used in this Manual iv
Deleting a Protocol from Memory 3-3-7 Meanings of Symbols used on the Injector v
Delivering a Drip Mode Injection 5-4-1 Memory Screen 3-2-1, 3-3-5
Delivering
an Injection 5-1-1 O
Delivering the Main Protocol 5-5-1 Operator Message Line 3-3-1
Description of Powerhead 4-1-1 Overview of the OptiStar Elite 1-1-1
Description of Powerhead Keys 4-1-4
Description of Screens 3-3-1
Dimensions 1-5-1
Drip Infusion Progress Screen 3-3-22, 3-3-24
Description of Keys/Information 3-3-23
Drip Mode Screen 3-3-19
Description of Parameter Keys/Information 3-3-20
Duration 3-3-1
818509-A 2017-05-16
I-1-2
P T
Patency Check Feature 1-4-1 Timing Bolus 3-3-2
Phase 3-3-1 Timing Bolus Feature 1-4-1
Phase Delay 3-3-2 Turning System Power OFF 2-2-1
Physical Stability 1-4-2 Turning System Power ON 2-1-1
Positive Positioning of the Powerhead 1-4-1 Turning the System ON 3-1-1
Powerhead 4-1-1
Powerhead Features 4-1-1 U
Power Requirements 1-5-1 UL/CSA Classification vii
Prematurely Stopping an Injection 5-6-1 User Qualifications 1-2-1
Pressure Limited Injection 6-1-2 Using 125 ml Saline Syringe 4-3-8, 4-3-13
Preventive Maintenance & Service 7-1-1
Program. Drip Injection Parameters (B-Side) 1-5-6 V
Programmable Flow Rate (A-side) 1-5-4
Programmable Flow Rate (B-side) 1-5-4 Volume 3-3-1
Programmable Inject Delay 1-5-5 Volume Key Flashing a Magenta Color 6-1-1
Programmable Pressure Limit (A-side) 1-5-5, 3-3-2
Programmable Scan Delay 1-5-5 W
Programmable Volume (A-side) 1-5-4 Weight 1-5-1
Programmable Volume (B-side) 1-5-4
Protocol Memory 1-5-6
Protocol Name 3-3-1
PSI / KPA 3-3-2
R
Recording Serial Numbers and Software Versions iii
Removing Air from Syringe and Tubing 4-3-1
Restarting an Prematurely Stopped Injection 5-7-1
I—Index
Results Screen 3-2-1

Retrieving a Protocol from Memory 3-3-6
S
Safety Features 1-4-1
Safety Instructions 5-1-1
Scan Delay 3-3-2
Self-testing Design 1-4-1
Service 7-1-1
Side 3-3-1
Specifications 1-5-1
Storing a Protocol in Memory 3-3-9
Syringe Clarity 1-4-1
Syringe Sizes 1-5-4
System Generated Alarms 6-2-1
System Generated Messages/Indications 6-1-1
System Information Screen 3-3-13
818509-A 2017-05-16
NOTES
Liebel-Flarsheim Company LLC
2111 E. GALBRAITH ROAD CINCINNATI, OHIO 45237-1624

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MR CONTRAST DELIVERY SYSTEM

Operator’s Manual 818509-A

RECORDING SERIAL NUMBERS AND SOFTWARE VERSIONS

Ref. No. ________________________________(located on Power control)

MEANINGS OF SYMBOLS USED IN THIS MANUAL

Hazards which could result in severe personal injury or death.

Hazards which could result in personal injury.

Hazards which could result in equipment or property damage.

MEANINGS OF SYMBOLS USED ON THE INJECTOR

Console Connection identifier

Powerhead Connection identifier

Power Control identifier

Power Supply identifier

Hand start switch connection identifier

System OFF/ON (only for the Console)

Ram movement/injector status identifier:

Check to ensure air is removed from syringe and tubing

P Start Patency Check Injection

Pinch Point possible. Keep fingers away from this area.

Refer to instruction manual / booklet

Equipment sensitive to Electrostatic Discharge.

MR Unsafe--an item that is known to pose hazards in all

MR Conditional--an item that has been demonstrated to pose

MR Safe--an item that poses no known hazards in all

<300G Locate in an area with magneticfields less than or

! ATTENTION! Consult User's/Service Manual.

European Union’s Waste Electrical and

CAUTION! Risk of electrical shock. Do not remove cover.

T 4AH , 250 V Fuse Rating (Voltage, Amperage, Type)

S/N Serial Number

P/N Part Number

V/A Volts Amps

[Reverse] key. Retracts the Powerhead Ram.

[Accelerator] key. Increases the speed of the ram when held

[Forward] key. Advances the Powerhead Ram.

CLASSIFICATION IN ACCORDANCE WITH EN60601

DEGREE OF PROTECTION AGAINST ELECTRIC SHOCK

DEGREE OF PROTECTION AGAINST INGRESS OF WATER

DEGREE OF SAFETY OF APPLICATION IN THE PRESENCE OF A FLAMMABLE

1.5.2 Weight....................................................................................................................................... 1-5-1

POWER ON / POWER OFF............................................................................ 2-1-1

5.1 Safety Instructions.............................................................................................................................5-1-1

SYSTEM GENERATED MESSAGES AND ALARMS...................................... 6-1-1

CARE OF UNIT............................................................................................... 7-1-1

ELECTROMAGNETIC COMPATIBILITY GUIDANCE....................................... A-1

1.1 INDICATIONS FOR USE

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1.2 USER QUALIFICATIONS

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1.3 CONFIGURATION OF UNIT

No modification of this equipment is allowed.

The console A contains a touch-sensitive display screen which provides

The powerhead C is specifically designed from materials which will not

Figure 1-3-1 Overview of System

NOTE: Refer to section 1.5.5 Environmental for further information concerning

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1.4 SAFETY FEATURES

1.4.9 PHYSICAL STABILITY OF REMOTE STAND

To avoid risk of electric shock, this equipment must only be connected to a

• Operation: 50° to +104° F (10° to +40°C)

30% to 75% relative humidity

• Biohazard Disposal: Dispose of biohazards in accordance with the

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