Medrad mark 7 arterion инструкция

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Operation Manual
READ BEFORE USING
1 Information ....................................................................................................................... 1 - 1
1.1 Important Safety Notice..................................................................................................................................... 1 - 1
1.2 Disclaimers ....................................................................................................................................................... 1 - 1
1.3 Training Information .......................................................................................................................................... 1 - 1
2 About This Manual ........................................................................................................... 2 - 3
2.1 Intended Use ..................................................................................................................................................... 2 - 3
2.2 Contraindications .............................................................................................................................................. 2 - 3
2.3 Certifications..................................................................................................................................................... 2 - 3
2.3.1 Safety Certifications................................................................................................................................ 2 - 3
2.3.2 EMC Certifications .................................................................................................................................. 2 - 3
2.4 Additional Information Regarding Compliance to IEC 60601-1-2/2007............................................................... 2 - 4
2.5 Restricted Sales ................................................................................................................................................ 2 - 7
3 Symbols and Icons .......................................................................................................... 3 - 9
3.1 Notified Body..................................................................................................................................................... 3 - 9
3.2 Regulatory Classifications ................................................................................................................................. 3 - 9
3.3 Warnings........................................................................................................................................................... 3 - 9
3.4 Buttons and Icons ........................................................................................................................................... 3 - 10
3.4.1 Display Control Unit Buttons and Icons.................................................................................................. 3 - 10
3.4.2 Injector Head Buttons and Icons............................................................................................................ 3 - 11
3.4.3 Power Unit Icons................................................................................................................................... 3 - 12
3.5 Packaging ....................................................................................................................................................... 3 - 13
4 System Warnings, Precautions, and Notices .............................................................. 4 - 17
4.1 Warnings......................................................................................................................................................... 4 - 17
4.2 Cautions.......................................................................................................................................................... 4 - 18
4.3 Notices............................................................................................................................................................ 4 - 18
5 System Overview ........................................................................................................... 5 - 19
5.1 Injection Protection.......................................................................................................................................... 5 - 19
5.2 Pressure Limiting ............................................................................................................................................ 5 - 20
5.3 System Technical Specifications ..................................................................................................................... 5 - 20
5.3.1 Input Power Requirements.................................................................................................................... 5 - 20
5.3.2 Technical Specifications ....................................................................................................................... 5 - 21
5.4 High Pressure Connector Tubing Specifications (Non-Twist & Go).................................................................... 5 - 21
5.5 Display Control Unit......................................................................................................................................... 5 - 22
5.5.1 Display Control Unit Sterile Sheath........................................................................................................ 5 - 22
5.6 Injector Head................................................................................................................................................... 5 - 22
5.7 Power Unit ...................................................................................................................................................... 5 - 23
5.8 Imaging System Interface................................................................................................................................ 5 - 23
5.9 MEDRAD® VFlow........................................................................................................................................... 5 - 23
5.10 Start Switches............................................................................................................................................... 5 - 23
5.10.1 Hand Switch and Foot Switch ............................................................................................................. 5 - 23
5.10.2 MEDRAD VFlow Hand Controller ......................................................................................................... 5 - 24
5.11 Pedestal and Stand Movement ...................................................................................................................... 5 - 25
5.11.1 Pedestal System ................................................................................................................................. 5 - 25
5.11.2 Head Stand (KMA 320 RT) and Adjustable Height Stand (KMA 330) ..................................................... 5 - 26
5.11.3 Mark 7 Arterion Stand Mounting Kit Configuration............................................................................... 5 - 27
6 Using and Understanding the Display Control Unit Screen ...................................... 6 - 29
6.1 Home Tab ....................................................................................................................................................... 6 - 29
6.1.1 Programmed Window ........................................................................................................................... 6 - 29
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MEDRAD® Mark 7 Arterion Injection System
6.1.2 Actuals Window .................................................................................................................................... 6 - 30
6.1.3 Sentinel Window................................................................................................................................... 6 - 30
6.2 Protocols Tab .................................................................................................................................................. 6 - 30
6.3 History Tab...................................................................................................................................................... 6 - 30
6.4 Options Tab..................................................................................................................................................... 6 - 30
6.4.1 Modify Options ..................................................................................................................................... 6 - 31
6.5 Help Tab ......................................................................................................................................................... 6 - 31
6.6 Display Control Unit Lock-outs ........................................................................................................................ 6 - 32
6.7 Performing Touch Screen Calibration .............................................................................................................. 6 - 32
7 Using and Understanding the Injector Head............................................................... 7 - 33
7.1 Injector Head Components .............................................................................................................................. 7 - 33
7.2 Injector Head Position...................................................................................................................................... 7 - 34
7.3 Syringe Interface............................................................................................................................................. 7 - 34
7.3.1 Piston Auto Retract ............................................................................................................................... 7 - 35
7.4 Pressure Jacket .............................................................................................................................................. 7 - 35
7.4.1 Pressure Jacket Storage ....................................................................................................................... 7 - 35
7.5 Injector Head Displays..................................................................................................................................... 7 - 36
7.5.1 Flow Rate (A) ........................................................................................................................................ 7 - 36
7.5.2 Volume (B)............................................................................................................................................ 7 - 36
7.5.3 Pressure Limit (C) ................................................................................................................................. 7 - 36
7.5.4 Volume Remaining (D) .......................................................................................................................... 7 - 36
7.6 Injector Head Controls ..................................................................................................................................... 7 - 37
7.6.1 Enable Button (F) .................................................................................................................................. 7 - 37
7.6.2 Fill Strip (H)........................................................................................................................................... 7 - 37
7.6.3 Auto-Fill Button (I)................................................................................................................................. 7 - 37
7.7 Armed Light .................................................................................................................................................... 7 - 37
7.8 Manual Knob................................................................................................................................................... 7 - 38
7.9 Syringe Heat Maintainer .................................................................................................................................. 7 - 38
7.10 Injector Head Lock-outs ................................................................................................................................ 7 - 38
8 Power Up and Shutdown the Injector.......................................................................... 8 - 39
8.1 Powering up the System.................................................................................................................................. 8 - 39
8.2 Shutdown........................................................................................................................................................ 8 - 39
8.3 Emergency Shutdown ..................................................................................................................................... 8 - 39
9 Setting and Managing Protocols.................................................................................. 9 - 41
9.1 Set Injection Parameters from the Home Tab................................................................................................... 9 - 41
9.1.1 Set Injection Parameters on Home Tab - Single .................................................................................... 9 - 41
9.1.2 Set Injection Parameters on Home Tab - Phased................................................................................... 9 - 42
9.1.3 Set Injection Parameters on Home Tab - Variable Flow Rate ................................................................. 9 - 43
9.2 Manage Protocols from the Protocols Tab........................................................................................................ 9 - 44
9.2.1 Create Protocols ................................................................................................................................... 9 - 44
9.2.2 Recall a Stored Protocol........................................................................................................................ 9 - 47
9.2.3 Edit an Existing Protocol ....................................................................................................................... 9 - 48
9.2.4 Delete a Protocol .................................................................................................................................. 9 - 49
10 Preparing for Injection .............................................................................................. 10 - 51
10.1 Installing the Mark 7 Arterion or Twist & Go Syringe .................................................................................... 10 - 51
10.2 Filling and Purging the Mark 7 Arterion or Twist & Go Syringe ..................................................................... 10 - 53
10.3 Installing and Purging Standard High Pressure Connector Tubing ............................................................... 10 - 54
10.4 Installing and Purging Twist & Go HPCT....................................................................................................... 10 - 55
10.5 Installing the MEDRAD® VFlow Hand Controller .......................................................................................... 10 - 56
ii
10.6 Connecting to and Purging the Catheter ...................................................................................................... 10 - 57
10.7 Enabling 15 mL Purge Feature and Choosing Configuration Options ............................................................ 10 - 58
10.7.1 15 mL Purge ON ............................................................................................................................... 10 - 58
10.7.2 15 mL Purge OFF.............................................................................................................................. 10 - 58
10.8 Defining a Protocol...................................................................................................................................... 10 - 59
10.9 Turning ISI On or Off.................................................................................................................................... 10 - 59
11 Arming and Injecting ................................................................................................. 11 - 61
11.1 Purged Air Confirmation .............................................................................................................................. 11 - 61
11.2 Arming the Injector...................................................................................................................................... 11 - 61
11.2.1 Arm Single Mode .............................................................................................................................. 11 - 62
11.2.2 Arm Multi Mode ................................................................................................................................ 11 - 64
11.3 Performing an Injection ............................................................................................................................... 11 - 65
11.3.1 Performing a Single mL/s Injection in Arm Single Mode .................................................................... 11 - 65
11.3.2 Performing a Single mL/m Injection in Arm Single Mode .................................................................. 11 - 65
11.3.3 Performing a Single mL/s or Variable Flow Rate Injection in Arm Multi Mode..................................... 11 - 65
11.3.4 Performing a Phased Injection ......................................................................................................... 11 - 66
11.3.5 Performing an Injection with Imaging System Interface (ISI) .............................................................. 11 - 66
11.4 Completing an Injection .............................................................................................................................. 11 - 69
11.5 Refilling Syringe During a Procedure ........................................................................................................... 11 - 70
11.5.1 Refilling Syringe with 15 mL Purge Feature Enabled ......................................................................... 11 - 71
12 Tear Down .................................................................................................................. 12 - 73
12.1 Remove Disposables ................................................................................................................................... 12 - 73
12.2 Clean up ..................................................................................................................................................... 12 - 73
12.3 Storing the Injector...................................................................................................................................... 12 - 74
13 System Messages...................................................................................................... 13 - 75
13.1 Error Messages ........................................................................................................................................... 13 - 75
13.2 Sentinel Messages ...................................................................................................................................... 13 - 75
13.3 Popup Messages......................................................................................................................................... 13 - 77
14 VirtualCare Option ..................................................................................................... 14 - 81
15 Cleaning and Maintenance ....................................................................................... 15 - 83
15.1 Daily ........................................................................................................................................................... 15 - 83
15.1.1 Cleaning the Injector Head, Syringe Heat Maintainer, Drop Front Cover, Pressure Jacket, Piston, Syringe
Interface, and Table Bracket ....................................................................................................................................... 15 - 83
15.1.2 Inspecting the Injector Head.............................................................................................................. 15 - 85
15.1.3 Inspecting the Pressure Jacket ......................................................................................................... 15 - 85
15.1.4 Inspecting the Heat Maintainer ......................................................................................................... 15 - 86
15.1.5 Inspecting the Display Control Unit.................................................................................................... 15 - 86
15.1.6 Inspecting the Table Mount Bracket.................................................................................................. 15 - 86
15.1.7 Inspecting the Pedestal..................................................................................................................... 15 - 87
15.1.8 Inspecting the Power Unit ................................................................................................................. 15 - 87
15.2 Monthly....................................................................................................................................................... 15 - 87
15.2.1 Cleaning the Display Control Unit, Pedestal, Power Unit, and Table Bracket ...................................... 15 - 87
15.2.2 Inspecting and Cleaning the Internal Air Filter ................................................................................... 15 - 87
15.2.3 Performing an Operational Checkout................................................................................................. 15 - 88
15.3 Annually...................................................................................................................................................... 15 - 90
15.3.1 Injection System Calibration.............................................................................................................. 15 - 90
15.3.2 Checking Leakage ............................................................................................................................ 15 - 90
16 Installation - System and Accessory ....................................................................... 16 - 91
16.1 Unpacking the Injection System................................................................................................................... 16 - 91
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MEDRAD® Mark 7 Arterion Injection System
16.2 Pedestal Mount Installation ......................................................................................................................... 16 - 92
16.3 Power Unit Installation................................................................................................................................. 16 - 95
16.3.1 Power Unit Connections .................................................................................................................... 16 - 96
16.3.2 Power Unit Floor Mount Bracket Assembly........................................................................................ 16 - 97
16.3.3 Relocate Power Unit Connectors ....................................................................................................... 16 - 98
16.4 Injector Head Mounting Options................................................................................................................... 16 - 99
16.4.1 Head Stand Installation (KMA 320RT)................................................................................................ 16 - 99
16.4.2 Adjustable Height Stand Installation (KMA 330) ................................................................................. 16 - 99
16.4.3 Adjustable Table Bracket Installation (KMA 350) ............................................................................... 16 - 99
16.4.4 Overhead Counterpoised System Installation..................................................................................... 16 - 99
16.5 Display Control Unit Mounting Options......................................................................................................... 16 - 99
16.5.1 Fulcrum Mount Kit Installation........................................................................................................... 16 - 99
16.5.2 Desk Stand Kit Installation .............................................................................................................. 16 - 100
16.5.3 Fixed Table Mount Installation......................................................................................................... 16 - 101
16.5.4 Wall Mount Bracket Installation....................................................................................................... 16 - 103
16.6 Accessory Installation................................................................................................................................ 16 - 105
16.6.1 Syringe Heat Maintainer Installation................................................................................................ 16 - 105
16.6.2 Syringe Pressure Jacket Installation................................................................................................ 16 - 106
16.6.3 Hand Switch and Foot Switch Installation........................................................................................ 16 - 106
16.6.4 Hand Switch Mount Kit .................................................................................................................. 16 - 107
16.6.5 Display Control Unit Sterile Sheath Installation ................................................................................ 16 - 108
16.6.6 Cable Bracket Installation ............................................................................................................... 16 - 109
16.7 Stand Mounting Kit Installation .................................................................................................................. 16 - 116
16.8 Power Unit Bracket Installation.................................................................................................................. 16 - 116
16.9 Display Control Unit (DCU) Support Assembly Installation........................................................................... 16 - 118
17 Specifications........................................................................................................... 17 - 121
17.1 System Component Weights and Dimensions ............................................................................................ 17 - 121
17.1.1 Pedestal System Weight and Dimensions........................................................................................ 17 - 121
17.1.2 Display Control Unit Weight and Dimensions ................................................................................... 17 - 122
17.1.3 Injector Head Weight and Dimensions............................................................................................. 17 - 122
17.1.4 Power Unit Weight and Dimensions ................................................................................................ 17 - 123
17.2 Mounting Components Weights and Dimensions ....................................................................................... 17 - 123
17.2.1 Pedestal Mount Weight and Dimensions ......................................................................................... 17 - 123
17.2.2 Head Stand Weight and Dimensions ............................................................................................... 17 - 124
17.2.3 Adjustable Height Stand Weight and Dimensions ............................................................................ 17 - 124
17.2.4 Stand Mounting Kit Components Weights and Dimension................................................................ 17 - 125
17.2.5 Adjustable Table Mount (KMA 350) Weight and Dimensions............................................................ 17 - 126
17.2.6 OCS Mount Weight and Dimensions................................................................................................ 17 - 126
17.2.7 Fixed Table Mount Weight and Dimensions..................................................................................... 17 - 129
17.2.8 Display Control Unit Desk Stand Mount Weight and Dimensions...................................................... 17 - 129
17.2.9 Display Control Unit Wall Mount Weight and Dimensions................................................................. 17 - 130
17.2.10 Power Unit Floor Mount Weight and Dimensions ........................................................................... 17 - 130
17.3 ISI Technical Specifications ....................................................................................................................... 17 - 131
17.3.1 ISI Output Specifications ................................................................................................................. 17 - 131
17.3.2 ISI Input Specifications.................................................................................................................... 17 - 132
17.3.3 ISI Connector Specifications............................................................................................................ 17 - 132
17.4 Environmental Specifications..................................................................................................................... 17 - 136
17.4.1 Operating........................................................................................................................................ 17 - 136
17.4.2 Non-Operating: (Transportation and Storage) .................................................................................. 17 - 136
17.4.3 EMI/RFI........................................................................................................................................... 17 - 136
17.4.4 Equipment Classification................................................................................................................. 17 - 136
17.4.5 Class I Product................................................................................................................................ 17 - 136
iv
17.4.6 Type CF Defibrillation-proof Applied Part......................................................................................... 17 - 136
17.4.7 IPX1................................................................................................................................................ 17 - 136
17.4.8 Continuous Mode of Operation........................................................................................................ 17 - 137
17.4.9 EU Directive.................................................................................................................................... 17 - 137
18 Options and Accessories ........................................................................................ 18 - 139
18.1 Mark 7 Arterion Disposables/Syringe Kits .................................................................................................. 18 - 139
18.2 Mark 7 Arterion System Mount Options ..................................................................................................... 18 - 139
18.2.1 Injector Head Mount Options........................................................................................................... 18 - 139
18.2.2 Power Unit Mount Options .............................................................................................................. 18 - 139
18.2.3 Display Control Unit Mount Options ................................................................................................. 18 - 140
18.2.4 Cable Brackets ............................................................................................................................... 18 - 140
18.3 Mark 7 Arterion Accessory Devices and Kits.............................................................................................. 18 - 140
18.3.1 Switches......................................................................................................................................... 18 - 140
18.3.2 Accessory Devices and Kits ............................................................................................................ 18 - 140
18.4 Mark 7 Arterion Cords and Cables ............................................................................................................. 18 - 141
18.4.1 Power Cords ................................................................................................................................... 18 - 141
18.4.2 Head Power and Communication Extension Cables ......................................................................... 18 - 141
18.4.3 Display Cables ................................................................................................................................ 18 - 141
18.5 OCS Mounting Systems............................................................................................................................. 18 - 142
18.5.1 Stationary Ceiling Mount................................................................................................................. 18 - 142
18.5.2 Mobile Ceiling Mount ..................................................................................................................... 18 - 142
18.5.3 Wall Mount .................................................................................................................................... 18 - 142
18.5.4 Ceiling Mount Plate......................................................................................................................... 18 - 142
18.6 OEM Imaging System Interface Cables ...................................................................................................... 18 - 142
18.6.1 General Electric .............................................................................................................................. 18 - 142
18.6.2 Philips ............................................................................................................................................ 18 - 143
18.6.3 Siemens ......................................................................................................................................... 18 - 143
18.6.4 Ziehm............................................................................................................................................. 18 - 143
18.6.5 Universal Imaging System Interface Cables..................................................................................... 18 - 143
18.6.6 Equipotential Cables ....................................................................................................................... 18 - 143
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MEDRAD® Mark 7 Arterion Injection System
vi
1
Information
1.1 Important Safety Notice
This manual and the equipment it describes are for use by qualified medical professionals with
proper training and experience in angiographic procedures and the use of the MEDRAD® Mark 7
Arterion (Mark 7 Arterion) Injection System. The manual is intended as instructions on the proper
use of the Mark 7 Arterion Injector and Syringe.
The Mark 7 Arterion injector system is designed to operate with syringes from Bayer and that use of
other, unauthorized syringes, may result in syringe rupture or leaking. Accordingly, only authentic
syringes from Bayer should be used in the operation of Arterion Injector system.
The safe and effective use of the Mark 7 Arterion Injection System to a large degree depends upon
factors solely under the control of the medical professionals using the system. There is no
substitute for a properly trained and vigilant angiographic team. It is important that the operating
instructions and the user warnings and cautions supplied with this injection system be read,
understood and followed.
Before starting any angiographic injection procedure, the angiographic team should be trained in
the particular angiographic procedures to be performed. In addition, the angiographic team should
be familiar with the medical literature related to angiographic procedures and the benefits of
performing angiographic procedures with automated injection systems versus the potential
complications and risks, including but not limited to air embolism.
Read and understand all the information contained in this manual. Understanding this information
will assist you in operating the Mark 7 Arterion Injection System in a safe and effective manner.
1.2 Disclaimers
Operating specifications and feature availability may vary by country. Check with your local product
representative and county-specific operating instructions.
External wiring and modifications disclaimers: Bayer disclaims liability for any modifications or
interfaces with other equipment that are not in conformity with the specifications and information
contained in this manual.
Accessory equipment connected to the MEDRAD Mark 7 Arterion Injection System must be certified
according to EN 60601-1 / IEC 60601-1 standard. Furthermore, all configurations shall comply with
system standard EN 60601-1-1/IEC 60601-1-1 Second Edition and EN 60601-1/IEC 60601-1 Third
Edition. Anyone who connects additional equipment to the signal input or output part configures a
medical system and is therefore responsible that the system complies with the requirements of the
standard EN 60601-1-1/IEC 60601-1-1 Second Edition and EN 60601-1/IEC 60601-1 Third Edition. To
obtain on-site consulting or consulting references, contact Bayer HealthCare Services.
1.3 Training Information
This manual is intended as an extension of the user interface of the Mark 7 Arterion Injection System to
provide procedural and technical information. Additional Mark 7 Arterion training information will be
available in the following formats:
•
•
•
•
On-site initial installation and additional training, as requested
In-service video/DVD
Syringe instruction for use (IFU)
Service Manual
Please contact Bayer HealthCare Services or local Bayer representative if any of these resources are
needed.
1-1
MEDRAD® Mark 7 Arterion Injection System
1-2
2
About This Manual
This manual applies to the MEDRAD Mark 7 Arterion Injection System.
Read all of the information contained in this manual. Understanding this information will assist you in
operation of the MEDRAD Mark 7 Arterion Injection System in a safe manner.
2.1 Intended Use
The MEDRAD Mark 7 Arterion Injection System is intended to be used specifically for the purposes of
injecting contrast medium and common flushing solutions into humans for angiographic studies.
2.2 Contraindications
This device is not intended to be used for chemotherapy and is not intended to administer fluids other
than intravascular contrast agents and common flushing solutions.
2.3 Certifications
This device is equipped to operate at 100-240 VAC, 50/60 Hz, and is designed to comply with EN
60601-1 / IEC 60601-1 Second/Third Edition and EN 60601-1-2/IEC 60601-1-2 Third Edition.
2.3.1 Safety Certifications
The MEDRAD Mark 7 Arterion Injection System complies with the requirements of CAN/CSA-C22.2 No.
0-M91 - General Requirements - Canadian Electrical Code, Part II CAN/CSA-C22.2 No. 601.1-M90 Medical Electrical Equipment Part I: General Requirements for Safety UL 60601-1 - Medical Electrical
Equipment IEC 60601-1:2005 - Medical Electrical Equipment Part 1: General Requirements for Safety,
CAN/CSA-C22.2 No. 60601-1-08 Medical Electrical Equipment - Part 1: General Requirements for
basic safety and essential performance, ANSI/AAMI ES60601-1:2005 Medical electrical equipment,
Part 1: General requirements for basic safety and essential performance.
2.3.2 EMC Certifications
The MEDRAD Mark 7 Arterion Injection System complies with the requirements of:
EN 60601-1-2:2007, (3rd Ed.). Medical Electrical Equipment-Part 1: General Requirements for Safety,
Amendment No. 2. Collateral Standard: Electromagnetic Compatibility Requirements and Tests.
2-3
MEDRAD® Mark 7 Arterion Injection System
2.4 Additional Information Regarding Compliance to IEC 60601-1-2/2007
This section is intended to reflect conformance to IEC-60601-1-2 / 2007 3rd edition.
The following statements are notices. Notices advise of circumstances that could result in damage to
the device. Read and understand these cautions before operating the injector system.
NOTICE
Electro-Mechanical Hazard - Equipment Damage may result.
• For proper operation, use only accessories and options provided by Bayer that are
designed specifically for the injector system. Other non-Bayer approved accessories or
options may cause equipment damage or may result in increased emissions or decreased
immunity of the injector system. Injector system accessories listed in it’s operation
manual comply with the requirements of electromagnetic emissions and immunity
standards IEC 60601-1-2/2007 3rd edition.
• Injector may disarm or fail to operate when exposed to high magnetic fields. Portable and
mobile RF communications equipment can affect the injector.
• Do not use injector adjacent to or stacked with other equipment. If adjacent or stacked
use is necessary, the injector should be observed to verify normal operation in the
configuration in which it will be used.
Table 2 - 1: Recommended separation distances between portable and mobile RF communications equipment and the
injector
The injector is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of the injector can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the injector as recommended below,
according to the maximum output power of the communications equipment
Separation distance according to frequency of transmitter
Rated maximum output
power of transmitter W
80 MHz to 800 MHz
150 KHz to 80 MHz
3.5
d = ------V1
3.5
d = ------E1
p
800 MHz to 2.5 GHz
7
d = -----E1
p
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74
1
1.17
1.17
2.33
10
3.69
3.69
7.38
100
11.67
11.67
23.33
p
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m)
can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power
rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1
At 80 MHz and 800 MHz, the separation distance for the higher frequency applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
2-4
About This Manual
INJECTOR REQUIRES SPECIAL PRECAUTIONS REGARDING EMC. Install and put into service according
to the EMC information provided below:
Table 2 - 2: Guidance and manufacturer's declaration - electromagnetic emissions
The injector is intended for use in the electromagnetic environment specified below. The customer or user of the injector
should assure that it is used in such an environment.
Emission Test
Compliance
Electromagnetic Environment - Guidance
RF emissions
CISPR 11
Group 1
The injector uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class A
Harmonic current emissions
IEC 61000-3-2
Class A
Voltage fluctuations/flicker
emissions
IEC 61000-3-3
Complies
Notice: This injector is intended for use by healthcare
professionals only. This injector may cause radio
interference or may disrupt the operation of nearby
equipment. It may be necessary to take mitigation
measures, such as re-orienting or relocating the injector or
shielding the location.
Table 2 - 3: Guidance and manufacturer's declaration - electromagnetic immunity
The injector is intended for use in the electromagnetic environment specified below. The customer or user of the injector
should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment - guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
6 kV contact
8 kV air
6 kV contact
8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with a
synthetic material, the relative humidity
should be at least 30%
2 kV for power supply
2 kV for power supply
lines
1 kV for input/output
lines
lines
1 kV for input/output
lines
1 kV differential
1 kV differential
mode
2 kV common mode
mode
2 kV common mode
Electrical/fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Mains power quality should be that of a
typical commercial or hospital
environment.
Mains power quality should be that of a
typical commercial or hospital environment
2-5
MEDRAD® Mark 7 Arterion Injection System
Table 2 - 3: Guidance and manufacturer's declaration - electromagnetic immunity
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE:
<5% UT
(>95% dip in UT)
for 0.5 cycle
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
<5% UT
(>95% dip in UT)
for 5 sec
3 A/m
3 A/m
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the injector
requires continuous operation during
power mains interruptions, it is
recommended the injector be powered
from an uninterruptible power supply or
battery
Power frequency magnetic fields should be
at levels characteristic of a typical location
in a typical commercial or hospital
environment.
UT is the a.c. mains voltage prior to application of the test level.
Table 2 - 4: Guidance and manufacturer's declaration - electromagnetic immunity
The injector is intended for use in the electromagnetic environment specified below. The customer or user of the injector
should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment - guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the injector, including cables, than
the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended Separation Distance
Conducted RF
IEC-61000-4-6
3 V rms
150 kHz to 80 MHz
3 V rms
d = 1.17 p
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
d = 1.17 p
2-6
80 MHz to 800 MHz
About This Manual
Table 2 - 4: Guidance and manufacturer's declaration - electromagnetic immunity
d = 2.33 p
800 MHz to 2.5 GHz
Where p is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey,a should be less than the
compliance level in each frequency range.b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the injector is used exceeds the applicable RF compliance level above, the
injector should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the injector.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
2.5 Restricted Sales
Rx Only - U.S. Federal law restricts this device to sale by or on the order of a licensed health care
practitioner.
2-7
MEDRAD® Mark 7 Arterion Injection System
2-8
3
Symbols and Icons
The symbols and icons discussed in the sections below describe the requirements to which the Mark 7
Arterion Injection System conforms, how warnings are displayed in manual, and the icons used on the
equipment and equipment packaging.
3.1 Notified Body
Indicates that this device conforms to requirements of the European Medical
Device Directive 93/42/EEC
3.2 Regulatory Classifications
.
Type Cardial Floating (CF) Defibrillation-Proof applied part as defined by IEC
60417-2.
IPX1
IPX1 Code that specifies the degree of protection against vertically falling water
drops (IEC 60529).
Indicates separate collection for Electrical and Electronic Equipment per
Directive 2002/96/EC . Refer to the following website for additional information:
http://www.medrad.com/en-us/resources/Pages/WEEE.aspx
3.3 Warnings
Indicates risk of electric shock.
Warning: Refer to warnings and cautions on Instructions for Use packaged in
each carton.
Indicates a pinch or crush hazard.
Attention: Refer to warnings and cautions on Instructions for Use packaged in
each carton.
Indicates hot surface. Item can be hot and should not be touched without taking
care.
3-9
MEDRAD® Mark 7 Arterion Injection System
Pushing Prohibited. Do not push at or above this point on the Injector.
Air Warning Label
• Air Embolism Hazard: injury or death can result.
• Read operation manual.
• Expel air from syringe/disposable before connecting or injecting to patient.
• Observe change in FluiDots Indicators, for syringes from Bayer.
Table Mount Warning
Patient or operator injury could occur if all knobs are not properly tightened.
Ensure that all knobs are securely tightened before use. Do not overtighten.
WARNING
Indicates that the information is a warning. Warnings advise you of
circumstances that could result in serious injury or death to the patient or
operator. Read and understand the warnings before operating the injection
system.
CAUTION
Indicates that the information is a caution. Cautions advise you of
circumstances that could result in minor or moderate injury to the patient or
operator. Read and understand the cautions before operating the injection
system.
NOTICE
Indicates that the information is a notice. Notices advise you of circumstances
that could result in damage to the device. Read and understand the notices
before operating the injection system.
NOTE
Indicates that the information that follows is additional important information or
a tip that will help you recover from an error or point you to related information
within the manual.
3.4 Buttons and Icons
The buttons on the Display Control Unit (DCU), Injector Head, and Power Unit allow operators to access
functions on the injector system. The icons used on the DCU, Injector Head, and Power Unit notify
operators about system processes and identify connection ports.
3.4.1 Display Control Unit Buttons and Icons
The Display Control Unit brightness controls.
Purged Air Confirmation icon - indicates that the operator has confirmed that all
air has been purged.
Indicates that Display Control Unit is locked because someone is accessing
another Display Control Unit or the Injector Head controls.
3 - 10
Symbols and Icons
The On/Off Switch.
The hand switch connection location found on the back of the Display Control
Unit.
The Power Unit cable connection location found on the back of the Display
Control Unit.
Indicates that an Imaging System Interface (ISI) is enabled and functioning
properly.
This symbol is also used throughout the manual to indicate ISI specific steps.
Operators use the End Case button to end the injection for a patient case, to
retract the syringe plunger, to clear the Total Contrast number, and to create a
record of the case.
Injection Indicator displays during an injection.
3.4.2 Injector Head Buttons and Icons
The Enable button activates the Fill Strip and Auto-Fill button.
Displays in Volume Remaining LED on the Injector Head when an operator is
accessing the Display Control Unit.
The Fill Strip allows operators to retract and advance the piston from the
Injector Head.
The Auto-Fill button fills the syringe with a user defined contrast volume and at
a user defined speed.
Identifies the Volume Remaining LED.
Identifies rotation direction on the manual knob for manually moving
the piston. Clockwise is forward movement.
The Syringe Heat Maintainer connection location.
Future expansion port.
3 - 11
MEDRAD® Mark 7 Arterion Injection System
J31
J32
Hand Controller.
Identifies the Service Port.
Pressure Jacket Syringe Alignment.
3.4.3 Power Unit Icons
Power Unit On/Off switch.
Indicates Alternating Current and identifies the Power Unit power cord
connection.
Identifies a connection for Display Control Unit1. The Power Unit has two
connection points.
Identifies a connection for Display Control Unit2. The Power Unit has two
connection points.
Identifies the hand switch or foot switch connection.
Identifies the Equipotential connection. The Equipotential Connector (EPC) is an
electrically bonded terminal on the injector, used as a connection point between
other medical electrical equipment. The EPCs function is to minimize any
voltage potentials differences between all connected equipment. The EPC is not
designed to be an electrical safety ground.
Identifies the Earth Ground point (this terminal is meant for supplementary
grounding please contact Bayer prior to using this terminal).
Identifies an Injector Head connection. The Power Unit has two connection
points.
Identifies the Imaging System Interface connection.
Identifies the CAN connection.
3 - 12
Symbols and Icons
Identifies the service port.
NOTE: Used by Bayer HealthCare Services or Bayer trained
personnel.
Future expansion port.
Future expansion port.
Future expansion port.
3.5 Packaging
Catalog Number
Do not Re-sterilize.
Do not use if package is damaged.
Do Not Reuse
Batch Code
Date of Manufacture/Sterilization
Non-Pyrogenic Fluid Path
Rx Only
Prescription Device - U.S. Federal law restricts this device to sale by or on the
order of a (licensed health care practitioner).
Serial number
Sterilized using Irradiation.
3 - 13
MEDRAD® Mark 7 Arterion Injection System
Sterilized with Ethylene Oxide.
Use By
Atmospheric Pressure Limitation
Chinese Recycling symbol for paperboard.
CB
Chinese Recycling symbol for corrugated cardboard.
Do Not Stack
Authorized Representative in the European Community.
Fragile, Handle with care
Humidity limitation
ISTA tested
Keep Dry
Manufacturer
China ROHS - Environmental Protection use Period Mark.
Temperature Limitation
3 - 14
Symbols and Icons
This Way Up
Not made with natural rubber latex.
3 - 15
MEDRAD® Mark 7 Arterion Injection System
3 - 16
4
System Warnings, Precautions, and Notices
4.1 Warnings
Air Embolism Hazard - Serious patient injury or death may result.
• Do not inject air.
• Purge all air from syringe and disposables before connecting or injecting to patient.
• Use only accessories and options provided by Bayer which are designed specifically for
the injection system.
• Inspect system and do not use when signs of damage are evident.
• Verify that the FluiDots indicators are rounded to ensure that fluid is present in the
syringe.
• No modification of equipment is allowed.
Serious patient and/or worker injury or death may result.
• Use of non-Bayer supplied disposables, including administration sets and additions to
administration sets, such as but not limited to bleed back control devices and pressure
transducers may cause patient injury if not properly connected or flushed. These devices
must be compatible with your system. Refer to manufacturer's instructions for proper use
of these devices.
Do not use if sterile package is opened or damaged.
• Patient or operator injury may result if package is opened or damaged, or if damaged
components are used. Visually inspect contents and package before each use.
Cross contamination hazard - Serious patient and/or worker injury or death may result.
• Ensure only syringes from Bayer are used on the system.
• Do not store filled syringes for later use.
• Discard previously filled unused syringes.
• Do not reuse disposables.
• For devices labeled for single use, please note: This product is intended for single
use only. Do not resterilize, reprocess or reuse. The disposable devices have been
designed and validated for single use only. Re-use of the single use disposable
devices pose risks of device failure and risks to the patient. Potential device failure
includes significant component deterioration with extended use, component malfunction,
and system failure. Potential risks to the patient include injury due to device malfunction
or infection as the device has not been validated to be cleaned or re-sterilized.
Procedure Delay Hazard - Serious patient and/or worker injury or death may result.
• Turn off any equipment that could generate an electrostatic discharge during procedure.
Electric Shock Hazard - Serious patient and/ or worker injury or death may result.
• The system should be opened and serviced by Bayer HealthCare Services or Bayer trained
service personnel.
• Use only power cord approved for use on Mark 7 Arterion.
• For U.S. installations, equipment shall only be connected to Hospital Grade or Hospital
Only outlets.
• Disconnect the system from line power before cleaning or attempting to perform any
maintenance or repairs.
• Avoid contact with pins.
• Ensure that connector covers are in place or cables are connected.
• Do not allow injector head to contact patient.
• Equipment must only be connected to supply mains with protective earth.
• Unplug system prior to servicing.
4 - 17
MEDRAD® Mark 7 Arterion Injection System
4.2 Cautions
CAUTION
Environmental Contamination Hazard - Minor or moderate patient and/ or worker injury may
result.
• Follow sterile technique specifically, maintain sterility of the syringe tip and plunger,
syringe barrel internal surface, Quick Fill Tube, high pressure connector tubing, catheter,
and Display Control Unit Sheath.
• Properly discard disposables after use, in accordance with hospital hazard waste disposal
procedures.
Mechanical Hazard - Minor or moderate patient and/ or worker injury may result.
• Do not use injector head handle to move injector system.
• Do not use the cabling or syringe to position injector system.
• Do not use system in the presence of flammable or combustible gases or other agents.
• Turn off system power and disconnect patient when system malfunction occurs.
4.3 Notices
NOTICE
Mechanical Hazard - Equipment Damage may result.
• Do not hang items on the Display Control Unit or Wall Mounting Bracket.
• Do not oil the friction plate on the Wall Mount Bracket.
Electro-Mechanical Hazard - Equipment Damage may result.
• Do not use tools to over tighten connections or to assist in the removal of disposables.
• Do not roll pedestal over cables.
• Regular preventive maintenance is recommended to ensure that the system stays
calibrated and functions properly. Refer to maintenance section of this manual or contact
Bayer for additional information.
• Allow two hours for the injector to reach room temperature before use.
• Follow Electrostatic Discharge (ESD) protection practices.
• Disconnect the power cord before removing or replacing PC boards.
• Do not apply voltage to ISI connector.
• Provide only a switch closure if the injector is being started by an external start
connection.
• Do not block Power Unit vents.
• Installation clearance should be a minimum of 3 to 5 inches (8 to 13 cm).
• Before installing the Table Mount, ensure the table rail can withstand a minimum vertical
static load of 18 kg (40 lbs.) Refer to the table manufacturer documentation for weight
load information.
• Do not over tighten Table Mount knob.
• Do not force the Table Mount onto the table rail.
• Loosen Table Mount knob prior to removal of components.
4 - 18
5
System Overview
This chapter describes:
•
•
•
•
•
•
•
•
•
•
"Injection Protection"
"Pressure Limiting"
"System Technical Specifications"
"High Pressure Connector Tubing Specifications (Non-Twist & Go)"
"Display Control Unit"
"Injector Head"
"Power Unit"
"Imaging System Interface"
"Start Switches"
"Pedestal and Stand Movement"
Figure 5 - 1: Mark 7 Arterion Injection System
A
Display Control Unit
B
Injector Head
C
Power Unit
5.1 Injection Protection
The following means are provided to protect against over and under injections:
An on-screen indication of insufficient volume is provided whenever the total volume programmed to
be delivered is greater than the amount of fluid in the syringe.
The system monitors injections to detect over rate or over volume conditions due to system faults. The
delivered volume is also monitored against the total programmed volume for the injection.
Once the system has disarmed a tone will sound and a disarm message displays on the Display Control
Unit screen.
When any fault condition is detected, the injection will stop.
5 - 19
MEDRAD® Mark 7 Arterion Injection System
5.2 Pressure Limiting
The purpose of the programmed pressure limit is to protect the patient, the catheter, and any
disposable device attached to the injector.
As a general rule, set pressure limit no higher than the max pressure rating of the weakest component
in the fluid path (tubing, stopcocks, connectors, catheters, administration sets, etc.).
Max pressure rating examples for an example scenario:
•
•
•
Tubing - 1200 psi
Stopcock - 1050 psi
Catheter - 1200 psi
In this case, set the pressure limit no higher than 1050 psi because anything higher could potentially
cause the component to fail.
Typical factors to consider and how they affect Pressure:
Effects on Pressure
Factors
Decrease
Pressure
Increase
Pressure
Fluid Viscosity
Low
High
Catheter and
Tubing Length
Short
Long
Catheter ID
Large
Small
Consider the above factors when setting pressure limit to achieve the desired injection flow rate.
Proper pressure limit setting optimizes the angiographic images.
The injector applies the minimum pressure needed to achieve the programmed flow rate. If the
pressure from the injector exceeds the programmed pressure limit, the system cannot achieve the flow
rate and a Sentinel message displays.
Pressure information can be found in the History tab.
5.3 System Technical Specifications
5.3.1 Input Power Requirements
100-240 VAC
50/60 Hz
1000 VA
5 - 20
System Overview
5.3.2 Technical Specifications
Table 5 - 1: System Technical Specs
0.1-45.0 mL/s in 0.1 mL/s
increments (single and phased)
Flow Rate:
0.1-59.9 mL/m in 0.1 mL/m
increments (single mL/m)
1.0-10.0 mL/s in 0.1mL/s
increments (variable)
Volume:
1-150 mL in 1 mL increments
Pressure Limit (150 mL
syringe):
100-1200 psi in 1 psi increments
Rise Time:
0.0-9.9 seconds in 0.1s increments
Delay Time:
0.0-99.9 seconds in 0.1s
increments
Manual Fill Speed:
1-20 mL/s in 1 mL/s increments
Auto Fill Speed:
1-10 mL/s in 1 mL/s increments
Fill Volume:
1-150 mL in 1 mL increments
Syringe Size:
150 mL
Protocol Memory:
39 Protocols (4 default, 35 storable)
Injection History Memory
Approximately 50 injections
689-8273 kPa in 1 kPa increments
5.4 High Pressure Connector Tubing Specifications (Non-Twist & Go)
The injection system was designed to use the MEDRAD Mark 7 Arterion Syringe and Twist and Go
Syringe. When using the Mark 7 Arterion Syringe, tubing should meet the following specifications to
operate in a safe and effective manner.
•
•
•
•
•
Disposable tubing shall be rated to a minimum of 1200 psi
Disposable tubing shall have a minimum internal diameter of .070" with a maximum length
of 72".
Syringe interface luer shall be a standard female luer as defined in:
• ISO 594-1:1986
• EN 20594-1:1993/AC:1996/A1:1997.
Catheter interface luer shall be a standard male luer as defined in:
• ISO 594-1:1986
• ISO 594-2: 1998
• EN 20594-1:1993/AC:1996/A1:1997.
Disposable tubing shall be made from a clear polymeric material that allows for proper
visualization of fluid path to ensure all air has been adequately purged with fluid before
connection to a patient.
5 - 21
MEDRAD® Mark 7 Arterion Injection System
5.5 Display Control Unit
The injection system Display Control Unit consists of a touch screen display. From the Display Control
Unit, an operator can manage protocols, arm and disarm the injector, review injection history, set
options, and view help topics.
Figure 5 - 2: Display Control Unit
The injection system supports the connection of a second Display Control Unit. In a two Display Control
Unit system, both Display Control Units have the same controls and functionality. Depending on
operational situations, only one of the Display Control Units may be active at a time. For example, if an
operator is entering a protocol on a Display Control Unit in the Control room, the system locks-out the
Display Control Unit in the Scan room. See "6.6 - Display Control Unit Lock-outs" for more information.
For more information about the navigating through Display Control Unit screens, see "Chapter 6 - Using
and Understanding the Display Control Unit Screen".
5.5.1 Display Control Unit Sterile Sheath
If the Display Control Unit will be used in the Sterile Field, a sheath such as the Display Control Unit
Sheath (AVA 500 DCOV) from Bayer should be used. See "16.6.5 - Display Control Unit Sterile Sheath
Installation".
5.6 Injector Head
The Injector Head has a handle that is used to rotate the head. The Injector Head position determines
what functions are active and what values display on the Injector Head. The Injector Head keypad and
Manual Knob can be used to fill and purge a syringe. A drop front allows operators to load syringes
from the front. The Syringe Heat Maintainer clamps onto the Pressure Jacket and connects to the
underside of the Injector Head and is designed to keep pre-warmed contrast in the syringe.
For more information about the Injector Head or the Syringe Heat Maintainer, see "Chapter 7 - Using
and Understanding the Injector Head".
Figure 5 - 3: Injector Head
5 - 22
System Overview
5.7 Power Unit
The injection system Power Unit supplies power to the Injector Head and the Display Control Unit. As
the main communications hub, the Power Unit provides system communications to all connected
components. A green light illuminates when the Power Unit is on.
The front plate on the Power Unit contains a serviceable air filter. For cleaning instructions, see
"Chapter 15 - Cleaning and Maintenance".
5.8 Imaging System Interface
The Imaging System Interface (ISI) allows the injection system to interface with an imaging system to
provide synchronization of an injection and an X-ray exposure. To use ISI on the injection system,
configure the system from the Display Control Unit Options tab. See "Chapter 6 - Using and
Understanding the Display Control Unit Screen". For more information on how ISI interacts with the
injection system, see "11.3.5 - Performing an Injection with Imaging System Interface (ISI)".
5.9 MEDRAD® VFlow
MEDRAD VFlow (VFlow) enables the use of Variable Flow Rate injections. In the Variable Flow Rate
injection mode, the injector automatically re-arms after each injection. A Variable Flow Rate injection
can be initiated by the Hand Controller and ranges from 1 - 10 mL/sec in increments of 0.1 mL/sec.
Variable Flow Rate is intended for use in those procedures where low volumes are injected and
Variable Flow Rate control is desired. The system has an option for receiving audible feedback when
using the Hand Controller. The feedback indicates the flow rate.
See "6.4 - Options Tab" for instructions on how to enable VFlow.
5.10 Start Switches
The injection system can be used with a hand switch, foot switch and/or hand controller. The switches
allow the operator to initiate an injection.
Hand switch
Foot switch
Hand Controller
Single mL/s
X
X
X
Phased
X
X
X
Variable Flow Rate Single mL/m
X
X
X
X
5.10.1 Hand Switch and Foot Switch
Figure 5 - 4: Hand Switch and Foot Switch
For installation instructions, see "16.6.3 - Hand Switch and Foot Switch Installation".
5 - 23
MEDRAD® Mark 7 Arterion Injection System
5.10.2 MEDRAD VFlow Hand Controller
The VFlow Hand Controller is a sterile device intended for single patient use.
The Hand Controller works in two different modes, Variable Flow Rate and Fixed Flow Rate. When in
the Variable Flow Rate injection mode, the flow rate increases incrementally as the Hand Controller
plunger (A) is depressed, and decreases as the Hand Controller is released. In the Fixed Flow Rate
injection mode, the Hand Controller acts as a start switch, and release of the device ceases all flow.
The Hand Controller button (B) is non-functional and will beep from the Injector head and DCU when
depressed.
A
B
Figure 5 - 5: Hand Controller
NOTE: The hand controller is required to perform Variable Flow Rate injections. For
installation instructions, see"10.5 - Installing the MEDRAD® VFlow Hand
Controller".
5 - 24
System Overview
5.11 Pedestal and Stand Movement
5.11.1 Pedestal System
Place pedestal system components into the approximate positions shown in Figure 5 - 6 prior to
moving the system. When necessary, lift pedestal by using the handle to move over obstacles.
Figure 5 - 6: Approximate Component Positions for System Movement
5 - 25
MEDRAD® Mark 7 Arterion Injection System
5.11.2 Head Stand (KMA 320 RT) and Adjustable Height Stand (KMA 330)
Place hands in the positions shown in Figure 5 - 7 to move an injector Head mounted on a Head Stand
and Adjustable Height Stand over obstacles.
Figure 5 - 7: Approximate Hand Positions to Move Head Stand and Adjustable Height Stand Over
Obstruction
5 - 26
System Overview
5.11.3 Mark 7 Arterion Stand Mounting Kit Configuration
Place the Mark 7 Arterion Stand Mounting Kit components into the approximate positions and place
hands in the positions shown in Figure 5 - 8 prior to moving the system.
Figure 5 - 8: Approximate Hand Positions to Move Stand Mounting Kit Configuration over
Obstruction
5 - 27
MEDRAD® Mark 7 Arterion Injection System
5 - 28
6
Using and Understanding the Display Control Unit Screen
The Display Control Unit touch screen has five tabs from which an operator can manage protocols, arm
and disarm the injector, review injection history, set options, and view help topics.
NOTE: An operator will be locked-out from a Display Control Unit if another operator is
performing functions on the Injector Head or another Display Control Unit
connected to the same system.
The chapter discusses:
•
•
•
•
•
•
•
"Home Tab"
"Protocols Tab"
"History Tab"
"Options Tab"
"Help Tab"
"Display Control Unit Lock-outs"
"Performing Touch Screen Calibration"
6.1 Home Tab
Operators can set protocols, select the Single or Phased protocol, or arm the injector on the Home tab.
This tab has a Programmed window (A), Actuals window (B), and Sentinel window (C). Each of these
windows is discussed below.
Figure 6 - 1: Home Tab
6.1.1 Programmed Window
The Programmed window displays the protocol parameters for an injection including Flow Rate,
Volume, Pressure, Rise time (Rise Time is not listed for Variable Flow Rate or mL/m protocols), and
Delay (Delay is not listed for phased and Variable Flow Rate or mL/m protocols).
Operators can set Single mL/s and mL/m, Phased, and Variable Flow Rate protocols from the
Programmed window. For more information, see "9.1 - Set Injection Parameters from the Home Tab".
6 - 29
MEDRAD® Mark 7 Arterion Injection System
6.1.2 Actuals Window
The Actuals window displays Peak (maximum Flow Rate achieved), Delivered (actual total volume
delivered), Total Contrast (total volume delivered for the current case), and the End Case button. An
operator presses the End Case button after completing a patient procedure and before removing the
disposables to retract the syringe plunger. This button also zeroes the Total Contrast and creates a new
case entry on the History tab. For more information on cases, see "6.3 - History Tab".
6.1.3 Sentinel Window
The Sentinel window displays system messages, such as “Rotate head down to arm”. The Sentinel
window also displays the status of the last injection.
The Sentinel window message flashes momentarily when the system cannot arm.
A list of messages is available in Chapter 13 “System Messages.”
6.2 Protocols Tab
Operators can store new protocols, recall stored protocols, and edit existing protocols on the Protocols
tab. For information on how to manage protocols from the Protocols tab, see "9.2 - Manage Protocols
from the Protocols Tab".
NOTE:To set protocol parameters from the Home tab, see "9.1 - Set Injection Parameters
from the Home Tab".
6.3 History Tab
The History tab shows a list of recent injections with date and time of the injection and the
programmed parameters and actuals. Injections are grouped by case. Cases are reset when an
operator selects the End Case button from the Home tab.
For example, an operator may want to group all of the injections for one patient together. The operator
performs all of the injections for a patient. The operator then selects the End Case button after the last
injection has completed. The system groups all of the injections for that patient together. This group of
injections can be retrieved from the History tab.
6.4 Options Tab
Operators can modify system settings from the Options tab. A green LED displays beside the current
setting for each option. When an operator changes a setting, the system adds an asterisk next to the
option name to identify unconfirmed setting changes. To enable the new settings, select one of the
other tabs, such as Home. A popup displays requesting confirmation for the new value. Select Yes to
confirm the setting. Select No to go to the selected tab without saving the changes; the system reverts
to the previous settings.
Table 6 - 1: Options
6 - 30
Option
Description
Language
Sets the Display Control Unit display language.
Flow Rate
Select mL/m or mL/s.
Fill Volume
Determines the volume of contrast drawn into the syringe when an
operator presses the Auto-Fill button on the Injector Head.
Fill Speed
Determines the speed at which the injector draws contrast into the
syringe when an operator presses the Auto-Fill button on the Injector
Head.
Using and Understanding the Display Control Unit Screen
Table 6 - 1: Options
Option
Description
ISI
Enables or disables Imaging System Interface (Single mL/s protocols
only).
Auto Retract
Enables or disables the piston auto retract feature. See "7.3.1 - Piston
Auto Retract" for more information.
Phased
Enables or disables Phased protocols.
Date/Time
Sets the system date and time and the calibration date.
Pressure Units
Sets the pressure measurement to PSI or kPa. PSI is set by default.
Head Audio Volume
Sets the audio volume level for the Injector Head.
DCU Audio Volume
Sets the audio volume level for the Display Control Unit.
Upgrade
Used by Bayer HealthCare Services or Bayer trained personnel to
activate features.
®
MEDRAD VFlow
Enables Variable Flow Rate injections when this feature is activated
from Upgrade. Contact Bayer to enable this feature.
Audio Feedback
When VFlow is enabled, the system provides a sound when the Hand
Controller plunger is depressed.
15 mL Purge
With this feature enabled, the system provides a choice between two
configurations (ON or OFF) of the 15 mL Purge Option. Contact Bayer
to enable this feature.
6.4.1 Modify Options
To modify an option:
1. Select the Options tab. A list of options displays. For an explanation of the options, see
Table 6 - 1.
2. Select an option. A center panel displays with setting choices or a numeric keypad based on
the option.
3. Make the appropriate changes.
4. Select another tab to save the changes. A popup displays requiring confirmation to save the
changes or revert back to previous settings. Select Yes to save changes. Select No to revert
back to previous settings.
6.5 Help Tab
The Help tab provides a list of help topics.
To view a help topic
1. Select the Help tab.
2. Select the topic name.
6 - 31
MEDRAD® Mark 7 Arterion Injection System
6.6 Display Control Unit Lock-outs
The Display Control Unit will be locked-out while an operator is interacting with the Injector Head
controls, or while an operator is accessing another Display Control Unit in a dual Display Control Unit
system.
The inactive Display Control Unit remains in lock-out until (A):
1. the operator finishes accessing the active Display Control Unit, and active Display Control
Unit displays the Home tab,
2. or, an operator has accessed the active Display Control Unit and doesn’t do anything for a
minute,
3. or, an operator has not interacted with the Injector Head controls for a period of several
seconds.
Figure 6 - 2: Display Control Unit Locked Out
6.7 Performing Touch Screen Calibration
Calibrate the Display Control Unit if the touch screen does not respond appropriately when pressing
buttons on the screen. To calibrate at the Safety Screen, simultaneously press the Brightness Up and
Brightness Down buttons on the back of the Display Control Unit. Follow the on-screen instructions
that display.
NOTE: Touch the center of the calibration targets to ensure proper touch screen
calibration.
Figure 6 - 3: Touch Screen Calibration
6 - 32
7
Using and Understanding the Injector Head
This chapter describes:
•
•
•
•
•
•
•
•
•
•
"Injector Head Components"
"Injector Head Position"
"Syringe Interface"
"Pressure Jacket"
"Injector Head Displays"
"Injector Head Controls"
"Armed Light"
"Manual Knob"
"Syringe Heat Maintainer"
"Injector Head Lock-outs"
7.1 Injector Head Components
Figure 7 - 1: Injector Head
A
Drop Front
B
Pressure Jacket - See"7.4 - Pressure
Jacket"
C
Injector Head Handle.
D
Injector Head Displays - See "7.5 - Injector Head Displays"
E
Injector Head Controls - See "7.6 - Injector Head Controls"
F
Armed Light - See "7.7 - Armed Light"
G
Manual Knob - See "7.8 - Manual Knob"
7 - 33
MEDRAD® Mark 7 Arterion Injection System
7.2 Injector Head Position
The Mark 7 Arterion Injector Head contains a sensor that monitors the head’s position: Purge (upright)
(X), Intermediate (Y), or Inject (downward) (Z). The head position determines how the data displays and
the available functions. Use the handle and the back of the Injector Head (but not the Manual Knob) to
rotate the head into position.
X
Y
Z
Figure 7 - 2: Injector Head Position
Table 7 - 1: Injector Head Position and Functionality
Injector Head Position
Functions
Purge (X)
Intermediate (Y)
Inject (Z)
Fill
Enabled
Enabled
Enabled
Inject
Disabled
Disabled
Enabled
7.3 Syringe Interface
The syringe interface supports a single 150 mL syringe. Operators can attach a syringe to the head
from the front of the injector (front loading). The syringe locks into place when the drop front is fully
7 - 34
Using and Understanding the Injector Head
closed. An operator can remove the syringe from the piston rod at any point within the normal travel of
the piston by rotating the syringe 1/4 turn clockwise, while the Injector Head is powered on or off, and
without removing the disposable set from the syringe.
7.3.1 Piston Auto Retract
The Mark 7 Arterion Injection System has an auto retract option that automatically retracts the piston
when the Injector Head is in the Purge position. Below are the two scenarios that describe how this
feature functions when the Injector Head is in the Purge Position or in the Intermediate and Inject
Positions (see "7.2 - Injector Head Position" for a description of the positions).
•
•
Purge position - The operator lowers the drop front and removes the syringe. The Injector
Head beeps three times and auto-retracts to the syringe ready position.
Intermediate and Inject Positions - The operator lowers the drop front, removes the
syringe, and rotates the Injector Head into the Purge (upright) position. The injector Head
beeps three times and auto-retracts to the syringe ready position.
NOTE: Press any key on the Injector Head to halt the auto retract.
NOTE: Enable the auto retract feature from the Options tab. See "6.4 - Options Tab" for
more information.
7.4 Pressure Jacket
The Mark 7 Arterion has a Pressure Jacket designed to hold the syringe in place and help to maintain
syringe integrity during use.
Figure 7 - 3: Pressure Jacket
The Pressure Jacket is manufactured from high impact resistant material; however, sharp impacts
such as from dropping, may cause small barely visible cracks to form, which may propagate during
subsequent pressure cycles.
7.4.1 Pressure Jacket Storage
When not in use, the Pressure Jacket should remain securely attached to the Injector Head.
Alternatively, the Pressure Jacket may be wrapped in a cloth and stored where it will not be hit or
dropped.
After each procedure, check the Pressure Jacket for contrast build up. For Pressure Jacket cleaning
and maintenance, see "Chapter 15 - Cleaning and Maintenance".
7 - 35
MEDRAD® Mark 7 Arterion Injection System
7.5 Injector Head Displays
The Injector Head has two display areas. One area shows the programmed parameters for flow rate,
volume, and pressure limit. The other area shows the volume remaining in the syringe.
A
B
D
C
G
F
H
I
E
Figure 7 - 4: Injector Head Display
A
Flow Rate
B
Volume
C
Pressure Limit
D
Volume Remaining
E
Volume Remaining Icon
F
Enable Button
G
Enable Indicator
H
Fill Strip
I
Auto-Fill Button
7.5.1 Flow Rate (A)
The flow rate displays the programmed rate. For Phased protocols, the Injector Head displays the
values of the current phase. The flow rate displays in per second or per minute mode based on the
protocol parameters. Operators can change the flow rate mode using the Options tab. See "6.4 Options Tab" for more information.
7.5.2 Volume (B)
The volume displays the programmed volume in milliliters. For Phased protocols, the Injector Head
displays the values of the current phase.
7.5.3 Pressure Limit (C)
The pressure limit indicates the maximum pressure that the system can use to inject contrast for the
programmed protocol. The limit displays in either psi or kPa. To understand more about pressure
limiting, see "5.2 - Pressure Limiting" or the Display Control Unit Help Tab.
7.5.4 Volume Remaining (D)
The volume remaining indicates the amount of contrast currently in the syringe.
7 - 36
Using and Understanding the Injector Head
7.6 Injector Head Controls
The Injector Head Controls on the injection head display contain the Enable button, Enable Indicator,
Fill Strip, and Auto-Fill button.
7.6.1 Enable Button (F)
The Enable button activates the Fill Strip and Auto-Fill button. After pressing the Enable button, the
Enable Indicator (G) illuminates and the Fill Strip and Auto-Fill button stay active while in use or for
five seconds of inactivity.
7.6.2 Fill Strip (H)
The Fill Strip allow operators to advance and retract the piston on the Injector Head. After pressing the
Enable button, press the forward arrows (closest to syringe) to advance the piston, or press the
reverse arrows (farthest from syringe) to retract the piston. The piston speed increases progressively
as an operator presses the arrows farther away from the Enable button.
7.6.3 Auto-Fill Button (I)
The Auto-Fill button fills the syringe with a user-defined contrast volume and at a user defined speed.
After pressing the Enable button, press the Auto-Fill button. Configure the volume and speed from the
Options tab. See "6.4 - Options Tab".
7.6.3.1 Auto-Fill Button with 15 mL Purge Configuration Options
Table 7 - 2: 15 mL Purge Configuration Options
15 mL Purge ON
Auto-Fill available for use in any Injector position.
15 mL Purge OFF
Auto-Fill only available for use in the Injector’s
upright position.
7.7 Armed Light
The Armed Light (J) remains illuminated when the system is armed. The light flashes once every
second when injecting
Figure 7 - 5: Armed Light
7 - 37
MEDRAD® Mark 7 Arterion Injection System
7.8 Manual Knob
Use the Manual Knob (K) to manually advance or retract the piston. Turn the knob clockwise to
advance the piston and counterclockwise to retract the piston.
Figure 7 - 6: Manual Knob
7.9 Syringe Heat Maintainer
The Syringe Heat Maintainer clamps onto the Pressure Jacket and connects to the underside of the
Injector Head and is designed to keep pre-warmed contrast in the syringe. For information on installing
the Syringe Heat Maintainer, see "16.6.1 - Syringe Heat Maintainer Installation".
7.10 Injector Head Lock-outs
The Injector Head will be locked-out while an operator is accessing a Display Control Unit. LOC displays
in the volume remaining.
The Injector Head remains in lock-out until:
1. An operator finishes accessing the active Display Control Unit, and active Display Control Unit
displays the Home tab,
2. Or, an operator has accessed the active Display Control Unit and doesn’t do anything for a
minute.
7 - 38
8
Power Up and Shutdown the Injector
This chapter describes:
•
•
"Powering up the System"
"Shutdown"
8.1 Powering up the System
CAUTION
Electric Shock Hazard - Minor or moderate patient and/ or worker injury may result.
• Verify that the voltage and frequency marked on the serial tag on the Power Unit matches
the voltage and frequency of the electrical outlet.
• Do not use extension cord or power adaptor with the system.
1. Press the Power Switch on the Power Unit.
2. Open the power switch cover on the Display Control Unit, and press the Power Switch. A
splash screen and then a safety screen displays.
3. Close the power switch cover.
4. Read the warnings and press Continue. The Home tab displays.
8.2 Shutdown
1. Open the power switch cover on the Display Control Unit, and press the Power Switch.
2. Close the power switch cover.
3. Press the Power Switch on the Power Unit.
8.3 Emergency Shutdown
CAUTION
Mechanical Hazard - Minor or moderate patient and/ or worker injury may result.
• Turn off system power and disconnect patient when system malfunction occurs.
In the event of an emergency such as a fire, explosion, or electrical shock, press the Power Switch at
either the Display Control Unit or Power Unit, or disconnect the power cord from the wall outlet to shut
down the system.
8 - 39
MEDRAD® Mark 7 Arterion Injection System
8 - 40
Setting and Managing Protocols
9
Setting and Managing Protocols
Over Volume Hazard - Serious patient injury or death may result.
• Do not program a protocol outside of the clinically accepted volume range.
• Ensure that the correct volume is programmed in the protocol for the target anatomy.
Vessel Dissection Hazard - Serious patient injury or death may result.
• Do not program a protocol outside of the clinically accepted flow rate range.
• Ensure that the correct flow rate is programmed in the protocol for the target anatomy.
• Do not program a protocol outside of the clinically accepted pressure limit.
• Ensure that the correct pressure limit is programmed in the protocol for the target
anatomy.
Foreign Body Embolism Hazard - Serious patient injury or death may result.
• Do not program a pressure greater than the lowest rated disposable’s pressure rating.
Bloodborne contamination hazard - Serious patient and/or worker injury or death may
result.
• Do not program a pressure greater than the lowest rated disposable’s pressure rating.
This chapter discusses how to:
•
•
"Set Injection Parameters from the Home Tab"
"Manage Protocols from the Protocols Tab"
9.1 Set Injection Parameters from the Home Tab
NOTE: Refer to syringe and disposable packaging to confirm lowest pressure rating prior
to programing an injection.
9.1.1 Set Injection Parameters on Home Tab - Single
A Single protocol injects a set Volume of contrast at one flow rate, pressure, rise time, and delay time
(if using ISI).
NOTE: Delay and rise time are not available for mL/m protocols.
1. Select the Single tab (A).
Figure 9 - 1: Set Single Protocol
9 - 41
MEDRAD® Mark 7 Arterion Injection System
2.
3.
4.
5.
NOTE: The displayed values are based on the last used protocol or the default values.
Select the box corresponding to a parameter to change it.
Use the numeric keypad to enter the protocol parameter.
Commit the value by selecting Enter or another parameter.
Select Delay. A numeric keypad displays with X-Ray and Inject buttons.
a. Enter the delay time. Setting delay time to zero is equivalent to having no delay.
b. Select X-Ray or Inject.
c. Select Enter to commit the value.
NOTE: A programmed delay parameter only functions when using ISI.
6. Repeat steps 2-4 to change additional parameters.
9.1.2 Set Injection Parameters on Home Tab - Phased
Phased Protocols have up to four different sets of flow rates and volumes for single continuous
injection. Operators can enter up to four phases per protocol. The pressure limit remains consistent for
each phase.
NOTE: The initial rise time is dependent on the value the operator enters. The intra-phase
rise time is fixed.
NOTE: If the Phased option is not visible, go to the Display Control Unit Options tab to
enable Phased injections. See "6.4 - Options Tab".
NOTE: ISI does not function with Phased protocols.
1. Select the Phased tab (A).
Figure 9 - 2: Set Phased Protocol
From the Programmed window, operators can modify protocol parameters and existing
phases, add phases, or delete phases.
• To modify an existing phase, go to step 2.
• To modify the pressure limit, rise time, or delay, go to step 3.
• To add a phase, go to step 4.
• To delete a phase, go to step 5.
2. To modify values for an existing Phase, select the Flow Rate or Volume to the right of the
index number (B) for that phase.
a. Select either Flow Rate or Volume.
b. Use the numeric keypad to enter the protocol parameter.
c. Commit the value by selecting Enter or another parameter.
9 - 42
Setting and Managing Protocols
d. Repeat this step to change additional parameters.
NOTE: When editing a phase, an operator cannot delete a phase.
3. Select Pressure Limit or Rise Time to change that parameter.
a. Use the numeric keypad to enter the protocol parameter.
b. Commit the value by selecting Enter or another parameter.
4. To add a phase, select the index number (C) for the phase directly below the last entered
phase. A new phase is added with flow rate and volume both equal to “1”.
a. In the new phase, select either Flow Rate or Volume.
b. Use the numeric keypad to enter the protocol parameter.
c. Commit the value by selecting Enter or another parameter.
d. Repeat this step to add additional parameters.
5. To delete a phase, select the index number for the phase. If a lower numbered phase is
deleted, the higher number remaining phases are renumbered. For example, in a three phase
protocol, if Phase 1 is deleted, Phases 2 and 3 become Phases 1 and 2.
NOTE: If values for only one phase exist, that phase cannot be deleted.
9.1.3 Set Injection Parameters on Home Tab - Variable Flow Rate
A Variable Flow Rate protocol injects a set Volume of contrast at a Flow Rate determined by the Hand
Controller. As an operator depresses the Hand Controller plunger, the system increases the Flow Rate
until it reaches the maximum Flow Rate set by the operator.
NOTE: If the Variable Flow Rate option is not visible, go to the Display Control Unit Options
tab to enable MEDRAD VFlow. See "6.4 - Options Tab".
NOTE: ISI does not function with Variable Flow Rate protocols.
1. Select the Variable tab (A).
Figure 9 - 3: Set Variable Flow Rate Protocol
2.
3.
4.
5.
NOTE: The displayed values are based on the last used protocol or the default values.
Select the box corresponding to a parameter to change it.
Use the numeric keypad to enter the protocol parameter.
Commit the value by selecting Enter or another parameter.
Repeat steps 2-4 to change additional parameters.
9 - 43
MEDRAD® Mark 7 Arterion Injection System
9.2 Manage Protocols from the Protocols Tab
NOTE: To store, view, or edit mL/m, Phased, or Variable Flow Rate protocols, enable that
protocol type from the Display Control Unit Options tab. See "6.4 - Options Tab". If
the mL/m option is enabled, only mL/m protocols display.
9.2.1 Create Protocols
The injection system can store up to 40 protocols. The number of protocols stored on the system
displays in the upper right corner of the Protocols tab. Each protocol stores the volume, flow rate,
pressure limit, rise time, and delay.
NOTE: Refer to syringe and disposable packaging to confirm lowest pressure rating prior
to programing and injection.
9.2.1.1 Create a New Single mL/s or mL/m Protocol on the Protocols tab
A Single protocol consists of a single volume, flow rate, pressure limit, rise time, and delay.
NOTE: Delay and rise time are not available for mL/m protocols.
1. Select the Protocols tab.
Figure 9 - 4: Protocols Tab - Single Protocols
2. Select the Type (B) button until Single is highlighted. A list of Single protocols displays.
3. Select the blank blue button (A).
NOTE: If a blank button is not visible, scroll through the list of protocols until one displays.
If a blank button is not available or 0 Available displays in the upper right corner,
the system cannot store any more protocols. Delete a protocol to add a new one.
4. Enter the protocol name.
5. Select a parameter and enter the values for the selected parameter.
NOTE: If an operator tries to commit a value outside of the acceptable range, an audible
beep sounds and the parameter range blinks in the keypad.
6. Select a different parameter to commit the values.
7. To enter a delay, select Delay.
a. Enter the delay time. Setting the delay time to zero is equivalent to having no delay.
b. Select X-Ray or Inject.
NOTE: A programmed delay parameter only functions when using ISI.
8. Select Save.
9 - 44
Setting and Managing Protocols
9.2.1.2 Create a New Phased mL/s Protocol on the Protocols tab
Phased protocols consist of multiple phases of Volumes and flow rates with a single pressure limit and
rise time.
NOTE: ISI does not function with Phased protocols.
1. Select the Protocols tab.
Figure 9 - 5: Protocols Tab - Phased Protocols
2. Select the Type (B) button until Phased is highlighted. A list of Phased protocols displays.
NOTE: If the Phased button on the Protocols tab is not displayed, go to the Options tab to
enable Phased Protocol. See "6.4 - Options Tab" for more information.
3. Select the blank blue button (A).
NOTE: If a blank button is not visible, scroll through the list of protocols until one displays.
If a blank button is not available or “0 Available” displays in the upper right corner,
the system cannot store any more protocols. Delete a protocol to add a new one.
4. Enter the protocol name.
5. To enter phases:
a. Select Volume or Flow Rate. Phase 1 displays with default values.
b. Select Volume or Flow Rate for Phase 1 to modify the settings.
9 - 45
MEDRAD® Mark 7 Arterion Injection System
Figure 9 - 6: Index Number
c. To enter a new phase, select an empty index number (C). A new phase is added with
default values for flow rate and volume.
d. Enter the phase values, as needed
NOTE: The currently selected values update in the top row parameters. The value in the
Phased Selection pane does not update until the value is committed.
e. To commit the values, select a different parameter.
f. Repeat this step for each phase to be added.
6. Select Pressure or Rise Time.
a. Enter the parameter values.
b. To commit the values, select a different parameter.
c. Repeat this step for each parameter to be set.
NOTE: The operator enters the initial rise time. The intra-phase rise time is fixed.
7. Select Save.
9.2.1.3 Create a New Variable Flow Rate Protocol on the Protocols tab
A Variable Flow Rate protocol injects a set Volume of contrast at a Flow Rate determined by the Hand
Controller. As an operator depresses the Hand Controller plunger, the system increases the flow rate
until it reaches the maximum Flow Rate set by the operator.
NOTE: If the Variable Flow Rate option is not visible, go to the Display Control Unit Options
tab to enable MEDRAD VFlow. See "6.4 - Options Tab".
NOTE: ISI does not function with Variable Flow Rate protocols.
1. Select the Protocols tab.
2. Select the Type button until Variable is highlighted. A list of Variable Flow Rate protocols
displays.
9 - 46
Setting and Managing Protocols
Figure 9 - 7: Protocols Tab - Variable Flow Rate Protocols
3. Select the blank blue button (A).
NOTE: If a blank button is not visible, scroll through the list of protocols until one displays.
If a blank button is not available or 0 Available displays in the upper right corner,
the system cannot store any more protocols. Delete a protocol to add a new one.
4. Enter the protocol name.
5. Select a parameter and enter the values for the selected parameter.
NOTE: If an operator tries to commit a value outside of the acceptable range, an audible
beep sounds and the parameter range blinks in the keypad.
6. Select a different parameter to commit the values.
7. Select Save.
9.2.2 Recall a Stored Protocol
An operator can recall a protocol for use, view the parameters, edit the parameters, or delete the
protocol.
1. Select the Protocols tab. The currently selected protocol (A) on the Home tab displays at the
top of the list.
Figure 9 - 8: Active Protocol
9 - 47
MEDRAD® Mark 7 Arterion Injection System
2. Select the Type button to display the type of protocol to be recalled.
3. Select the Sort button to sort the protocols. The options are:
• Sort A-Z
• Sort Z-A
• Most Frequently Used
• Most Recently Used
4. Press the up or down arrow to locate the protocol.
5. Select the protocol name to load the protocol for use. The system returns to the Home tab
with the selected protocol parameters displayed.
9.2.3 Edit an Existing Protocol
9.2.3.1 Edit Single ml/s or ml/m or Variable Flow Rate Protocol
1. If in the Armed state, select Disarm.
2. Select the Protocols tab.
3. Select the Type button to display the protocol type to be edited.
4.
5.
6.
7.
8.
NOTE: If the Variable Flow Rate type is not displayed, go to the Options tab to enable
MEDRAD® VFlow. See "6.4 - Options Tab".
Navigate to the desired protocol.
Select the Edit button.
Select a parameter to change it.
Use the keypad to enter the new values.
Commit the value by selecting Enter or another parameter.
9.2.3.2 Edit Phased mL/s Protocol
1. If in the Armed state, select Disarm.
2. Select the Protocols tab.
3. Select the Type button to display the protocol type to be edited.
NOTE: If the Phased type is not displayed, go to the Options tab to enable Phased
Protocol. See "6.4 - Options Tab".
4. Navigate to the desired protocol.
5. Select the Edit button.
6. To edit phases:
a. Select a parameter. The phased protocol displays.
b. Locate the phase to be edited.
c. Select a parameter, such as Volume or Flow Rate.
d. Use the keypad (A) to enter the values for the selected parameter.
9 - 48
Setting and Managing Protocols
Figure 9 - 9: Edit Phased Protocols
7.
8.
9.
10.
e. To commit the values, select a different parameter.
f. Repeat steps b through e for each parameter to be edited.
To add phases:
a. Select an empty index number (B) for the phase. A new phase is added with Flow Rate
and Volume both equal to “1”and Flow Rate is selected.
b. Edit Flow Rate or select another parameter.
c. Use the keypad (A) to enter the values for the selected parameter.
d. To commit the values, select a different parameter.
To delete a phase, select the index number for the phase. If a lower numbered phase is
deleted, the higher number remaining phases are renumbered. For example, in a three phase
protocol, if Phase 1 is deleted, Phases 2 and 3 become Phases 1 and 2.
To edit the Pressure Limit or Rise Time select the corresponding box.
a. Enter the values for the selected parameter.
b. To commit the values, select a different parameter.
c. Repeat this step for each parameter to be edited.
Select Save.
9.2.4 Delete a Protocol
1.
2.
3.
4.
5.
NOTE: An operator cannot delete a protocol, if it is active on the Home tab.
Select the Protocols tab.
Select the Type button to display the protocol type to be deleted.
Navigate to the desired protocol using the page arrows or sort button.
Select the Edit button for the protocol to be deleted.
Select Delete.
6. Select Yes on the confirmation popup to delete the protocol.
9 - 49
MEDRAD® Mark 7 Arterion Injection System
9 - 50
10
Preparing for Injection
Cross Contamination Hazard - Serious patient and/or worker injury or death may result.
• Do not re-use disposables
Foreign Body Embolism Hazard - Serious patient injury or death may result.
• Follow contrast manufacturer recommendations for contrast use.
• Ensure that contrast has not crystallized in the system prior to use.
Thrombus Hazard - Serious patient injury or death may result:
• Do not leave injector system attached to a static fluid system for an extended period of
time.
CAUTION
Environmental Contamination Hazard - Minor or moderate patient and/ or worker injury may
result.
• Properly discard disposables after use, in accordance with hospital hazard waste disposal
procedures.
• Do not store contrast media in syringe.
• Follow contrast manufacturer recommendations for contrast use.
This chapter describes:
•
•
•
•
•
•
•
•
•
"Installing the Mark 7 Arterion or Twist & Go Syringe"
"Filling and Purging the Mark 7 Arterion or Twist & Go Syringe"
"Installing and Purging Standard High Pressure Connector Tubing"
"Installing and Purging Twist & Go HPCT"
"Installing the MEDRAD® VFlow Hand Controller"
"Connecting to and Purging the Catheter"
"Enabling 15 mL Purge Feature and Choosing Configuration Options"
"Defining a Protocol"
"Turning ISI On or Off"
10.1 Installing the Mark 7 Arterion or Twist & Go Syringe
Air Embolism Hazard - Serious patient injury or death may result.
• Ensure that patient is not connected while purging air from syringe, or engaging or
advancing plunger.
• Inspect Pressure Jacket and replace when signs of damage are evident.
Environmental Contamination Hazard - Minor or moderate patient and/ or worker injury may
result.
• Visually inspect contents and package before use.
• Do not use if package integrity is compromised.
Cross Contamination Hazard - Serious patient and/or worker injury or death may result.
• Use caution when removing air from the syringe. Component damage may result from the
use of tools during air removal.
• Do not store filled syringes for later use.
Bloodborne Contamination Hazard- Serious patient and/or worker injury or death may result.
• Ensure only syringes from Bayer are used on the system.
10 - 51
MEDRAD® Mark 7 Arterion Injection System
CAUTION
Environmental Contamination Hazard - Minor or moderate patient and/ or worker injury may
result.
• Visually inspect contents and package before use.
• Do not use disposables past Use By date identified on the package.
• Do not use if package integrity is compromised.
• Follow sterile technique principles, specifically, maintain sterility of the syringe tip,
plunger, syringe barrel internal surface, and Quick Fill Tube.
• Do not scrape off dried, potentially contaminated contrast into the head cavity during
syringe installation.
• Do not reuse disposables.
Prior to installing a syringe, ensure that the system is on and the pressure jacket is installed.
1. Ensure the syringe piston is fully retracted. To retract the piston, press the Enable button (A),
and then press reverse arrows (B) on the Fill Strip (C).
Figure 10 - 1: Install Syringe
2.
3.
4.
5.
10 - 52
NOTE: Your finger placement on the Fill Strip determines the speed at which the syringe
retracts or advances. Move your finger farther from the Enable button to increase
the speed.
Open the syringe package and remove the syringe.
Insert the syringe in the Pressure Jacket. Install the syringe with the raised syringe alignment
key (D) aligned with the triangle (E) on the Pressure Jacket.
Maintain syringe tip sterility, and raise and completely close the drop front (F).
On the Injector Head, press the Enable button, and then press the forward arrows (G) on the
Fill Strip to fully advance the plunger in the syringe.
Preparing for Injection
10.2 Filling and Purging the Mark 7 Arterion or Twist & Go Syringe
Air Embolism Hazard - Serious Patient Injury or Death May Result.
• Ensure that one operator is designated as being responsible for filling and refilling the
syringe. Do not change operators during the procedure. If an operator change must occur,
ensure that the new operator verifies that the fluid path is purged of air.
• Ensure that patient is not connected while purging air from syringe, or engaging or
advancing plunger.
• Orient the Injector head to the Purge (upright) position during filling of syringe and purging
of air.
• Purge all air out of syringe and any and all disposables after filling.
• Tap syringe after filling to facilitate air removal.
• Verify that the FluiDots indicators are rounded to ensure that fluid is present in the
syringe.
Bloodborne Contamination Hazard - Serious patient and/or worker injury or death may
result.
• Do not grasp the drop front, pressure jacket, or syringe to rotate the Injector Head.
Cross Contamination Hazard - Serious patient and/or worker injury or death may result.
• Use caution when removing air from the syringe. Component damage may result from the
use of tools during air removal.
CAUTION
Environmental Contamination Hazard - Minor or moderate patient and/ or worker injury may
result.
• Follow sterile technique principles, specifically, maintain sterility of the syringe tip,
plunger, syringe barrel internal surface, and Quick Fill Tube.
Operators can fill a syringe using the Fill Strip or the Auto-Fill button.
1. Use the handle and the back of the Injector Head (but not the Manual Knob) to rotate the
Injector Head to the Purge (upright) position.
2. Remove the Quick Fill Tube from the syringe package.
3. Remove the dustcap from the syringe tip and set aside maintaining sterility.
4. Attach the short end of the Quick Fill Tube to the syringe tip.
NOTE: The Quick Fill Tube can be attached without repositioning the FasTurn nut (H) (Mark
7 Arterion Syringe only) attached to the syringe tip.
5. Insert the long end of the Quick Fill Tube into the fluid source (usually contrast media). Raise
the contrast bottle until the Quick Fill Tube is fully inserted into the contrast.
NOTE: Use a Quick Fill Tube or equivalent device to reduce the volume and size of air
bubbles drawn into the syringe during filling. It is more difficult to remove the air
bubbles if you use smaller diameter tubes or a tube longer than 10 in. (25 cm.)
6. On the Injector Head, press the Enable button (A), and then press and hold the reverse
arrows (B) on the Fill Strip (C) until the system fills the syringe with the desired contrast
volume.
• Alternatively, on the Injector Head, press the Enable button and then press and release
the Auto-Fill button (I). The Mark 7 Arterion fills the syringe with the preconfigured
contrast volume at the preconfigured speed. The volume and speed are configured from
the Display Control Unit Options tab.
7. If required, use your free hand to gently tap the base of the Pressure Jacket to facilitate
migration of air bubbles remaining within the syringe and on the syringe plunger to the
syringe tip.
10 - 53
MEDRAD® Mark 7 Arterion Injection System
8. Carefully observe the FluiDots indicators to ensure that fluid is present in the syringe. Verify
that the FluiDots indicators are round in the filled portion of the syringe. The rounded shape
of the FluiDots indicators varies according to the type of contrast media, but an oblong shape
indicates the presence of air. Rounded FluiDots indicators do not indicate the total absence of
air bubbles in the syringe tip.
Figure 10 - 2: FluiDots Indicators
9. Purge all air out of syringe after filling. Turn the Manual Knob (J) clockwise to remove air from
the syringe.
10. Visually confirm that all air bubbles have been removed from the syringe. Tap syringe after
filling to facilitate air removal.
11. Remove the Quick Fill Tube from the syringe tip.
12. The system is ready to accept installation of the High Pressure Connector Tubing (HPCT). If
you are not installing the HPCT at this time, replace the sterile dustcap.
NOTE: Refer to "5.4 - High Pressure Connector Tubing Specifications (Non-Twist & Go)"
for high pressure connector tubing specifications.
10.3 Installing and Purging Standard High Pressure Connector Tubing
Air Embolism Hazard - Serious patient injury or death may result.
• Securely tighten the high pressure connector tubing to syringe connection. Component
damage may result from the use of tools during tightening.
• Remove all air from the high pressure connector tubing.
• Use caution when removing air from the syringe or tubing connections. Component
damage may result from the use of tools during air removal.
• Ensure that patient is not connected while purging air from high pressure connecting
tubing, or engaging or advancing plunger.
Bloodborne Contamination Hazard - Serious patient and/or worker injury or death may
result.
• Securely tighten the high pressure connector tubing to syringe connection. Component
damage may result from the use of tools during tightening.
• Use caution when removing air from the syringe or tubing connections. Component
damage may result from the use of tools during air removal.
• Avoid contact of and damage to syringe tip, tubing, and connections when manipulating
injector position.
• Do no reuse disposables.
• Do not exceed pressure identified on the disposable packaging.
CAUTION
Environmental Contamination Hazard - Minor or moderate patient and/or worker injury may
result.
• Follow sterile technique principles, specifically, maintain sterility of the syringe tip and the
high pressure connector tubing.
• Do not reuse disposables.
10 - 54
Preparing for Injection
1.
2.
3.
4.
NOTE: Refer to "5.4 - High Pressure Connector Tubing Specifications (Non-Twist & Go)"
for high pressure connector tubing specifications.
Remove the Dust cap from the syringe tip if attached.
Insert the high pressure connector tubing into FasTurn nut (H) on the Mark 7
Arterion Syringe.
Turn the FasTurn nut clockwise to securely tighten the high pressure connector tubing to the
syringe tip.
Purge all air from the high pressure connector tubing. Turn the Manual Knob clockwise to
push contrast out until all of the air bubbles have been removed from the high pressure
connector tubing. Gentle tapping at any connection point may be needed to facilitate air
removal.
NOTE: Ensure at least 3.5mL of fluid has been purged.
5. Rotate the head to the downward position prior to arming and injecting. Do not grasp the
drop front, pressure jacket, syringe or tubing to rotate the injector head.
10.4 Installing and Purging Twist & Go HPCT
Air Embolism Hazard - Serious patient injury or death may result.
• Securely tighten the high pressure connector tubing to syringe connection. Component
damage may result from the use of tools during tightening.
• Remove all air from the high pressure connector tubing.
• Use caution when removing air from the syringe or tubing connections. Component
damage may result from the use of tools during air removal.
• Ensure that patient is not connected while purging air from high pressure connecting
tubing, or engaging or advancing plunger.
Bloodborne Contamination Hazard - Serious patient and/or worker injury or death may
result.
• Securely tighten the high pressure connector tubing to syringe connection. Component
damage may result from the use of tools during tightening.
• Use caution when removing air from the syringe or tubing connections. Component
damage may result from the use of tools during air removal.
• Avoid contact of and damage to syringe tip, tubing, and connections when manipulating
injector position.
• Do no reuse disposables.
• Do not exceed 1200 PSI.
• Use only Twist & Go High Pressure Connector Tubing with the Twist & Go Syringe.
CAUTION
Environmental Contamination Hazard - Minor or moderate patient and/or worker injury may
result.
• Follow sterile technique principles, specifically, maintain sterility of the syringe tip and the
high pressure connector tubing.
• Do not reuse disposables.
NOTE: Use Twist & Go HPCT only with Twist & Go Syringes.
1. Remove the dust cap from the syringe tip if attached.
2. Insert the Twist & Go High Pressure Connector Tube onto the Twist & Go syringe tip.
10 - 55
MEDRAD® Mark 7 Arterion Injection System
Figure 10 - 3: Twist & Go Connection
3. Turn the (A) Luer nut clockwise to securely tighten the high pressure connector tubing to the
syringe tip (B).
4. Purge all air from the high pressure connector tubing. Turn the Manual Knob clockwise to
push contrast out until all of the air bubbles have been removed from the High Pressure
Connector Tube. Gentle tapping at any connection point may be needed to facilitate air
removal.
10.5 Installing the MEDRAD® VFlow Hand Controller
1.
2.
3.
4.
Ensure that the injector is in the disarmed state.
Open the hand controller bag using sterile technique.
Using sterile technique, remove the hand controller from the bag.
Plug the hand controller into the underside of the Injector Head (see drawing below). Listen
for an audible “click” to confirm proper connection.
Figure 10 - 4: Hand Controller Connector
NOTE: If the hand controller is damaged or does not work properly, discontinue use and
discard.
10 - 56
Preparing for Injection
10.6 Connecting to and Purging the Catheter
Air Embolism Hazard - Serious patient injury or death may result.
• Advance the piston prior to connection between the high pressure connector tubing and a
catheter or other non-Bayer disposables including administration sets and additions to
administration sets, such as but not limited to bleed back control devices and pressure
transducers.
• Aspirate via the manual knob when connecting to the high pressure connector tubing and
a catheter or other non-Bayer disposables including administration sets and additions to
administration sets, such as but not limited to bleed back control devices and pressure
transducers to ensure all air has been removed from the fluid path.
• Securely tighten the catheter to high pressure connector tubing connection to the catheter
or other non-Bayer disposables including administration sets and additions to
administrations sets, such as but not limited to bleed back control devices and pressure
transducers to ensure all air has been removed from the fluid path.
• Do not inject air.
• Purge all air from syringe and disposables before connecting or injecting to patient.
Bloodborne Contamination Hazard - Serious patient and/or worker injury or death may
result.
• Securely tighten the catheter to high pressure connector tubing connection to catheter or
other non-Bayer disposables including administration sets and additions to administration
sets, such as but not limited to bleed back control devices and pressure transducers to
ensure all air has been removed from the fluid path.
• Do not grasp the drop front, pressure jacket, or syringe to rotate the Injector Head.
Thrombus Hazard - Serious patient injury or death may result:
• Do not pull excessive blood back into syringe.
CAUTION
Environmental Contamination Hazard - Minor or moderate patient and/or worker injury may
result.
• Follow sterile technique principles, specifically, maintain sterility of the high pressure
connector tubing, catheter, and other connection points.
This section assumes that the catheter has already been inserted into the patient and that air has been
removed from the high pressure connector tubing as outlined in "10.3 - Installing and Purging
Standard High Pressure Connector Tubing" or "10.4 - Installing and Purging Twist & Go HPCT".
1. Use the handle and the back of the Injector Head (but not the Manual Knob or tubing) to
rotate the Injector Head to the Inject (downward) position.
2. Secure the catheter hub in one hand and the distal rotating luer of the HPCT in the other
hand.
3. Advance the piston using the Manual Knob prior to connecting the high pressure connector
tubing to a catheter or other non-Bayer disposables including administration sets and
additions to administration sets, such as but not limited to bleed back control devices and
pressure transducers.
4. Securely tighten the high pressure connector tubing connection to the catheter or other nonBayer disposables including administration sets and additions to administration sets, such as
but not limited to bleed back control devices and pressure transducers.
5. Aspirate via the manual knob when connecting to the high pressure connector tubing and a
catheter or other non-Bayer disposables including administration sets and additions to
administration sets, such as but not limited to bleed back control devices and pressure
transducers to ensure all air has been removed from the fluid path.
10 - 57
MEDRAD® Mark 7 Arterion Injection System
6. Stop aspirating with manual knob once blood is visualized in the high pressure connector
tubing.
7. Verify that there no air is in the high pressure connector tubing.
a. If there is air in the tubing, disconnect from patient, remove air, and try fluid to fluid
connection again.
8. Once it has been established that all air has been removed, turn the Manual Knob clockwise
to clear blood from high pressure connector tubing.
The system is ready to define protocols or arm.
10.7 Enabling 15 mL Purge Feature and Choosing Configuration Options
The operator can choose between two different configurations (ON or OFF) of the 15 mL Purge Option.
NOTE: Access the 15 mL Purge Configurations (ON or OFF) from the Options menu.
NOTE: Default configuration upon power-up is 15 mL Purge ON.
10.7.1 15 mL Purge ON
•
•
•
•
The system will require a purge of 3.5 mL or more with the Injector in the upright position
with a plunger retraction of 15 mL or more, regardless of whether the Injector head is in the
upright or downward position.
The system will NOT require a purge in the upright position with a plunger retraction of less
than 15 mL, regardless of whether the Injector head is in the upright or downward position.
Auto-Fill will remain available for use with 15 mL Purge turned ON.
With 15 mL Purge turned ON, the system will require a purge in the upright position during
system power-up, syringe installation, and new case.
NOTE: The operator can still choose to purge prior to arming, if desired, with a plunger
retraction of less than 15 mL but the system will not require it.
10.7.2 15 mL Purge OFF
•
•
•
The system will require a purge of 3.5 mL or more in the Injector’s upright position ONLY with
a plunger retraction of 15 mL or more in the Injector’s upright position.
Auto-Fill will be available for use ONLY in the Injector’s upright position.
With 15 mL Purge turned OFF, the system will require a purge in the upright position during
system power-up, syringe installation, and new case.
NOTE: The operator can still choose to purge, if desired, with a plunger retraction of less
than 15 mL and/or upon plunger retraction in the Injector’s downward position.
10 - 58
Preparing for Injection
Table 10 - 1: 15 mL Purge Configuration Options (ON or OFF)
15 mL Purge ON
≥15 mL Plunger
Retraction
Arming
Requirements
MUST purge 3.5
mL or more with
Injector in upright
position
15 mL Purge OFF
<15 mL Plunger
Retraction
≥15 mL Plunger
Retraction
NOT REQUIRED
to purge
MUST purge 3.5
mL or more ONLY
when retraction
occurs in
Injector’s upright
position
Auto-Fill remains available for use
NOTE: Operator can still choose to
purge prior to arming, if desired, with
plunger retraction of < 15 mL but
system will not require it
<15 mL Plunger
Retraction
NOT REQUIRED
to purge
Auto-Fill only available in Injector’s
upright position
NOTE: Operator can still choose to
purge, if desired, with plunger
retraction of < 15 mL and/or upon
plunger retraction in Injector’s
downward position
NOTE: With 15 mL Purge turned ON or OFF, the system will require a purge in the upright
position during system power-up, syringe installation, and new case.
10.8 Defining a Protocol
Recall a protocol from the Protocols tab or set a protocol from the Home tab. For more information,
see "Chapter 9 - Setting and Managing Protocols".
The Injector is ready to be armed. For more information, refer to "Chapter 11 - Arming and Injecting".
10.9 Turning ISI On or Off
NOTE: To use ISI, ISI must be enabled from the Options tab and turned on from the Home
tab.
1. Select the Single tab.
NOTE: If the ISI On/Off buttons are not available, confirm the ISI has been enabled on the
Options tab.
NOTE: The ISI tab is not available for ml/m, Phased, or Variable Flow Rate protocols.
2. Select On or Off. The ISI symbol (A) indicates that ISI is on.
10 - 59
MEDRAD® Mark 7 Arterion Injection System
Figure 10 - 5: ISI Enabled
10 - 60
11
Arming and Injecting
Vessel Dissection Hazard - Serious patient injury or death may result.
• Do not move injector head or pedestal while catheter is connected to patient.
This chapter discusses:
•
•
•
•
•
"Purged Air Confirmation"
"Arming the Injector"
"Performing an Injection"
"Completing an Injection"
"Refilling Syringe During a Procedure"
11.1 Purged Air Confirmation
Air Embolism Hazard - Serious patient injury or death may result.
• Do not inject air.
• Purge all air from syringe and disposables before connecting or injecting to patient.
• Verify that the FluiDots indicators are rounded to ensure that fluid is present in the
syringe.
Before arming, the system prompts the operator to confirm that air has been purged from the syringe
and disposable set. Once in the armed stated, the system will not prompt the operator to check for air
unless the operator performs an action that may introduce air into the disposable set, such as opening
the drop front or a powered reverse piston movement. It is the operator’s responsibility to successfully
purge all air from the system.
The Purged Air Confirmation icon displays on the Display Control Unit after the operator confirms air is
expelled from syringe and disposable set. The icon remains active until the system requires the
operator to re-check for air.
11.2 Arming the Injector
Air Embolism Hazard - Serious patient injury or death may result.
• Do not inject air.
• Purge all air from syringe and disposables before connecting or injecting to patient.
• Use only accessories and options provided by Bayer which are designed specifically for
the injection system.
• Inspect system and do not use when signs of damage are evident.
• Verify that the FluiDots indicators are rounded to ensure that fluid is present in the
syringe.
• Use the handle and the back of the Injector Head (but not the Manual Knob or tubing) to
rotate the head to the Inject (downward) position prior to arming and injecting.
• Avoid contact of and damage to syringe tip, tubing, and connections when manipulating
injector position.
This section describes how to arm in arm single mode and arm multi mode.
11 - 61
MEDRAD® Mark 7 Arterion Injection System
Before an operator performs the arming process, the Sentinel window displays messages to indicate
any remaining tasks that need to be performed to complete the arming process:
•
•
•
•
a syringe is present.
the Injector Head is in the Inject (downward) position.
the drop front is closed.
a purge has been completed.
The system removes the messages as each task is performed.
Operators can change the protocol parameters from the Home tab or Protocols tab when in the armed
state.
11.2.1 Arm Single Mode
NOTE: The term start switch is used in this section to refer to the hand switch, foot switch
or hand controller.
The Arm Single mode is used in Single (mL/s and mL/m) protocols and Phased protocols. This mode
allows for one injection.
Single and Phased mL/s Injection: The injection starts when the operator presses and holds the start
switch.
Single mL/m Injection: The injection starts when the operator presses the start switch.
1. Select the Home tab.
2. Single mL/s protocols: select Arm Single (A).
Figure 11 - 1: Single Arm
11 - 62
Arming and Injecting
Single mL/m and Phased protocols: select Arm (B).
Figure 11 - 2: Phased protocol
3. Visually confirm that all air has been purged from the syringe and disposable set, and select
Yes.
NOTE: There is sufficient volume remaining in the syringe. For Single mL/s and mL/m
protocols with insufficient volume remaining in the syringe for the programmed
protocol, the system gives the option of overriding the programmed volume and
using the available volume remaining. If the operator selects Yes, the system arms
with the new programmed volume. If the operator selects No, the system will not
arm. Adjust the protocol volume to be equal or less than the volume remaining in
the syringe. For Phased protocols with insufficient volume remaining in the syringe
for the programmed protocol, the system will not arm.
NOTE: If the injector is set in the mL/m mode, a confirmation popup displays confirming
that the injection will be performed using mL/m.
NOTE: The system stays armed until:
• the operator presses Disarm.
• any Injector Head button is pressed.
• a reverse piston motion of greater than 2 mL occurs via the Manual Knob.
• the drop front is lowered.
• the Injector Head is rotated out of the Inject position.
• a start switch is connected or disconnected.
• a 30 minute time-out occurs.
• ISI signals a disarm.
4. The Armed Light illuminates solid and the system is ready for injection. For more information,
refer to "11.3-Performing an Injection"
11 - 63
MEDRAD® Mark 7 Arterion Injection System
11.2.2 Arm Multi Mode
NOTE: The term start switch in this section is used to refer to the hand switch, foot switch
or hand controller.
The Arm Multi mode is available only for Single mL/s and Variable Flow Rate protocols. This mode
allows for multiple injections per arming sequence. An injection starts when the operator presses and
holds the start switch. After each injection, the system re-arms if all of the system tests described in
step 3 below pass.
1. Select the Home tab.
2. Single mL/s protocols: select Arm Multi (A). Variable Flow Rate protocols: select Arm (B).
Figure 11 - 3: Arm Multi
Figure 11 - 4: Arm Variable
3. Visually confirm that all air has been purged from the syringe and disposable set, and select
Yes.
NOTE: There is sufficient volume remaining in the syringe. If there is not sufficient volume
remaining in the syringe for the programmed protocol, the system gives the option
of overriding the programmed volume and using the available volume remaining. If
the operator selects Yes, the system arms with the new programmed volume. If the
operator selects No, the system will not arm. The operator needs to adjust the
protocol Volume equal to or less than the volume remaining in the syringe.
11 - 64
Arming and Injecting
NOTE: The system will stay armed until:
• the user presses Disarm.
• any Injector Head button is pressed.
• a reverse piston motion of greater than 2 mL occurs via the manual knob.
• the drop front is lowered.
• the head is rotated out of the Inject position.
• a start switch is connected or disconnected.
• a 30 minute time-out occurs.
• ISI signals a disarm.
4. The Armed Light illuminates solid and the system is ready for injection. For more information,
refer to "11.3-Performing an Injection".
11.3 Performing an Injection
The Mark 7 Arterion Injection System can perform Fixed Flow Rate and Variable Flow Rate injections.
For Fixed Flow Rate, Arm Single mode injections, the injector disarms after the injection is complete or
an operator releases the hand switch, foot switch, or Imaging System start switch. For Fixed Flow Rate,
Arm Multi mode injections and Variable Flow Rate injections, the injector remains armed until one of
the disarm criteria are met.
NOTE: Ensure the fluid path is open before performing an injection.
11.3.1 Performing a Single mL/s Injection in Arm Single Mode
NOTE: The term start switch in this section is used to refer to the hand switch, foot switch
or hand controller.
1. Press and hold the start switch to start the injection, and continue holding until the injection
is complete.
The system stops injecting and disarms when:
• the programmed volume is delivered, or
• the operator releases the start switch, or
• the operator presses the Display Control Unit screen or Injector Head controls.
During the injection, the Injection Indicator displays below the syringe graphic and the Armed
Light flashes.
2. Go to "11.4-Completing an Injection".
11.3.2 Performing a Single mL/m Injection in Arm Single Mode
NOTE: The term start switch in this section is used to refer to the hand switch, foot switch
or hand controller.
1. Press and release the start switch to start the injection.
The system stops injecting and disarms when:
• the programmed volume is delivered, or
• the operator presses and releases the start switch again, or
• the operator presses the Display Control Unit screen or Injector Head controls.
During the injection, the Injection Indicator displays below the syringe graphic and the Armed
Light flashes.
2. Go to "11.4-Completing an Injection".
11.3.3 Performing a Single mL/s or Variable Flow Rate Injection in Arm Multi Mode
NOTE: The term start switch in this section is used to refer to the hand switch, foot switch
or hand controller.
1. Press and hold the start switch to start the injection, and continue holding until the injection
is complete.
The system stops injecting and remains armed when:
11 - 65
MEDRAD® Mark 7 Arterion Injection System
•
the programmed volume is delivered and the volume remaining in the syringe is
sufficient to perform another injection, or
• the operator release the start switch and the volume remaining in the syringe is
sufficient to perform another injection, or
• the operator presses and release another start switch connected to the system and the
volume remaining in the syringe is sufficient to perform another injection.
The system disarms when:
• the operator releases the start switch and the volume remaining in the syringe is
insufficient to perform another injection, or
• the operator presses and releases another start switch and the volume remaining in the
syringe is in-sufficient to perform another injection, or
• the operator presses the Display Control Unit screen or Injector Head controls.
During the injection, the Injection Indicator displays below the syringe graphic and the Armed
Light flashes.
2. Repeat step step 1 to perform additional injections.
3. Go to"11.4-Completing an Injection".
11.3.4 Performing a Phased Injection
NOTE: The term start switch in this section is used to refer to the hand switch, foot switch
or hand controller.
1. Press and hold the start switch to start the injection, and continue holding until the injection
is complete. The system injects the contrast per the parameters for each phase.
The system stops injecting and disarms when:
• the programmed volume is delivered, or
• the operator releases the start switch, or
• the operator presses and releases another start switch connected to the system, or
• the operator presses the Display Control Unit screen or Injector Head controls.
During the injection, the Injection Indicator displays below the syringe graphic and the Armed
Light flashes.
2. Go to "11.4-Completing an Injection".
11.3.5 Performing an Injection with Imaging System Interface (ISI)
NOTE: To use ISI, it must enabled from the Options tab and turned on from the ISI tab.
The functionality of the Injector hand switch or foot switch and the Imaging System start switch is
determined by the interconnecting cable and the configuration within the Imaging System. The order in
which the systems are initiated determines whether an injection occurs, an X-ray occurs, or neither.
The typical operating scenarios are described in the following tables. Consult with the Field Engineer
for the Imaging System to confirm its internal configuration.
The tables in the subsections below show the Imaging Systems covered in this section and how each
functions with the Mark 7 Arterion Injection System.
NOTE: Call Bayer HealthCare Services to determine compatibility of other Imaging
Systems.
NOTE: The Bayer catalog numbers, for the Imaging Systems listed below, is located on the
cable near the Mark 7 Arterion Power Unit.
11 - 66
Arming and Injecting
11.3.5.1 Injection System Initiates Injection
Table 11 - 1 shows the results of pressing the Mark 7 Arterion Injection System hand switch or foot
switch to initiate the protocol.
Table 11 - 1: Injection System Initiates Injection
OEM
GE
Bayer Catalog Number
Action
XMC 915R
No Injection/No X-ray
XMC 917A
No Injection/No X-ray
GE/OEC
XMC 990R
Injection Only
Philips
XMC 925A
No Injection/No X-ray
XMC 927A
1 knob operation
Injection Only
XMC 927A
2 knob operation
XMC 928A
1 knob operation
No injection/No X-ray
Injection Only
XMC 928A
2 knob operation
No injection/No X-ray
XMC 945 40
No Injection/No X-ray
XMC 947R
1 knob operation
Injection Only
XMC 947R
2 knob operation
No Injection/No X-ray
XMC 970A
No Injection/No X-ray
XMC 977A
No Injection/No X-ray
Toshiba
XMC 906i
Injection Only
Shimadzu
XMC 906i
Injection Only
Hitachi
XMC 906i
Injection Only
Ziehm
XMC 951A
Injection Only
Siemens
11.3.5.2 Imaging System Initiates Protocol
Table 11 - 2 shows the results of pressing the Imaging System start switch to initiate the protocol.
Table 11 - 2: Imaging System Initiates Injection
OEM
GE
Bayer Catalog Number
Action
XMC 915R
Injection and X-ray
XMC 917A
Injection and X-ray
11 - 67
MEDRAD® Mark 7 Arterion Injection System
Table 11 - 2: Imaging System Initiates Injection
OEM
Bayer Catalog Number
Action
GE/OEC
XMC 990R
Injection and X-ray
Philips
XMC 925A
No Injection/No X-ray
XMC 927A
1 knob operation
Injection and X-ray
XMC 927A
2 knob operation
No Injection/No X-ray
XMC 928A
1 knob operation
Injection and X-ray
XMC 928A
2 knob operation
No Injection/No X-ray
XMC 945 40
No Injection/No X-ray
XMC 947R
1 knob operation
Injection and X-ray
XMC 947R
2 knob operation
No Injection/No X-ray
XMC 970A
Injection and X-ray
XMC 977A
Injection and X-ray
Toshiba
XMC 906i
Injection and X-ray
Shimadzu
XMC 906i
Injection and X-ray
Hitachi
XMC 906i
Injection and X-ray
Ziehm
XMC 951A
Injection and X-ray
Siemens
11.3.5.3 Injection System and Imaging System Initiate Protocol - (Philips Imaging Systems
Only)
Table 11 - 3 shows the results of pressing the Mark 7 Arterion Injection System hand switch or foot
switch and the Philips Imaging System start switch simultaneously to initiate the protocol.
NOTE: For the Imaging Systems listed in this chapter, only Philips requires an operator to
press the injector hand switch or foot switch and Imaging System switch
simultaneously to initiate a protocol.
Table 11 - 3: Injection System and Imaging System Initiate Protocol
OEM
Philips
11 - 68
Bayer Catalog Number
Action
XMC 925A
Injection and X-ray
XMC 927A
1 knob operation
Independent Actions - See
Tables 10-1 and 10-2
XMC 927A
2 knob operation
Injection and X-ray
Arming and Injecting
Table 11 - 3: Injection System and Imaging System Initiate Protocol
OEM
Bayer Catalog Number
Action
XMC 928A
1 knob operation
Independent Actions - See
Tables 10-1 and 10-2
XMC 928A
2 knob operation
Injection and X-ray
XMC 945 40
No Action
XMC947R
1 knob operation
Independent Actions - See
Tables 10-1 and 10-2
XMC 947R
2 knob operation
Injection and X-ray
11.4 Completing an Injection
The injection system stops an injection when the programmed volume is delivered, or an operator
terminates the injection. In the Sentinel window, an Injection Complete message displays for a
completed injection, and a Premature Termination message displays for an operator terminated
injection. The system emits an audible beep when the injection is complete.
NOTE: If finished with a Case, proceed to "Chapter 12 - Tear Down".
NOTE: To continue with a case, proceed to "11.5-Refilling Syringe During a Procedure" to
refill a syringe, or return to "11.2-Arming the Injector" to rearm.
NOTE: If End Case pressed inadvertently, press No on the popup that appears to return to
the current Case.
NOTE: To continue with a case after inadvertently pressing End Case and then pressing
Yes on the popup, disconnect the patient, rotate the Head in the Purge position
(upward), and purge the system of all air. Rearm the system.
11 - 69
MEDRAD® Mark 7 Arterion Injection System
11.5 Refilling Syringe During a Procedure
Air Embolism Hazard - Serious patient injury or death may result.
• Ensure that one operator is designated as being responsible for filling and refilling the
syringe. Do not change operators during the procedure. If an operator change must occur,
ensure that the new operator verifies that the fluid path is purged of air.
• Ensure that patient is not connected while purging air from syringe, or engaging or
advancing plunger.
• Orient the Injector Head to the upright (Purge) position during filling of syringe and purging
of air.
• Purge all air out of both the high pressure connector tubing and syringe after refilling
syringe.
• Tap syringe after filling to facilitate air removal.
• Verify that the FluiDots indicators are rounded to ensure that fluid is present in the
syringe.
Cross Contamination Hazard - Serious patient and/or worker injury or death may result.
• Use caution when removing air from the syringe. Component damage may result from the
use of tools during air removal.
CAUTION
Environmental Contamination Hazard - Minor or moderate patient and/ or worker injury may
result.
• Follow sterile technique principles, specifically, maintain sterility of the syringe tip, high
pressure connector tubing, and catheter.
Refill only using the high pressure connector tubing from an appropriately labeled fluid source within
the sterile field as described below.
1. Disconnect the high pressure connector tubing from the catheter.
2. Secure the distal connector of the high pressure connector tubing while using the handle and
the back of the Injector Head (but not the Manual Knob) to rotate the Injector Head in the
Purge (upright) position.
3. Insert the distal connector of the high pressure connector tubing into the contrast medium.
4. On the Injector Head, press the Enable button, and then press the reverse arrows on the Fill
Strip until the system fills the syringe with the desired contrast volume.
• Alternatively, on the Injector Head, press the Enable button and then press the Auto-Fill
button. The Mark 7 Arterion fills the syringe with the preconfigured contrast volume at
the preconfigured speed. The volume and speed are configured from the Display Control
Unit Options tab.
NOTE: Refer to "7.6.3.1-Auto-Fill Button with 15 mL Purge Configuration Options" for
Auto-Fill use with 15 mL Purge Configuration Options.
5. If air bubbles remain within the syringe, including the syringe plunger, use your free hand to
gently tap the base of the Pressure Jacket to facilitate migration of the bubbles to the syringe
tip to ensure that all air bubbles are expelled.
6. Carefully observe the FluiDots indicators to ensure that fluid is present in the syringe. Verify
that the FluiDots indicators are round in the filled portion of the syringe. The rounded shape
of the FluiDots indicators varies according to the type of contrast media, but an oblong shape
indicates the presence of air. Rounded FluiDots indicators do not indicate the total absence of
air bubbles in the syringe tip.
7. Turn the Manual Knob clockwise to purge all air out of the syringe.
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Arming and Injecting
8. Visually confirm that all air bubbles have been removed from the syringe. Tap the pressure
jacket after filling to facilitate air removal.
9. Secure the distal connector of the high pressure connector tubing.
10. Turn the Manual Knob clockwise to push contrast out until all of the air bubbles have been
removed from the high pressure connector tubing. Gentle tapping at any connection point
may be needed to facilitate air removal.
11. Use the handle and the back of the Injector Head (but not the Manual Knob or tubing) to
rotate the Injector Head to the Inject (downward) position.
12. Secure the catheter hub in one hand and the distal rotating luer of the high pressure
connector tubing in the other hand.
13. Advance the piston using the Manual Knob prior to connecting the high pressure connector
tubing to a catheter or other non-Bayer disposables including administration sets and
additions to administration sets, such as but not limited to bleed back control devices and
pressure transducers.
14. Securely tighten the high pressure connector tubing connection to the catheter or other nonBayer disposables including administration sets and additions to administration sets, such as
but not limited to bleed back control devices and pressure transducers.
15. Aspirate via the manual knob when connecting to the high pressure connector tubing and a
catheter or other non-Bayer disposables including administration sets and additions to
administration sets, such as but not limited to bleed back control devices and pressure
transducers to ensure all air has been removed from the fluid path.
16. Stop aspirating with manual knob once blood is visualized in high pressure connector tubing.
17. Verify that there is no air in the high pressure connector tubing.
a. If there is air in the tubing, disconnect from patient, remove air, and try fluid to fluid
connection again.
18. Once it has been established that all air has been removed, advance the Manual Knob
forward to clear blood from high pressure connector tubing.
11.5.1 Refilling Syringe with 15 mL Purge Feature Enabled
For a full explanation of the system’s purge options and configurations, refer to "10.7-Enabling 15 mL
Purge Feature and Choosing Configuration Options".
15 mL Purge ON
≥15 mL Plunger
Retraction
Arming
Requirements
MUST purge 3.5
mL or more with
Injector in upright
position
15 mL Purge OFF
<15 mL Plunger
Retraction
≥15 mL Plunger
Retraction
NOT REQUIRED to
purge
MUST purge 3.5
mL or more ONLY
when retraction
occurs in Injector’s
upright position
<15 mL Plunger
Retraction
NOT REQUIRED to
purge
Auto-Fill remains available for use
Auto-Fill only available in Injector’s
upright position
NOTE: Operator can still choose to
purge prior to arming, if desired, with
plunger retraction of < 15 mL but
system will not require it
NOTE: Operator can still choose to purge,
if desired, with plunger retraction of < 15
mL and/or upon plunger retraction in
Injector’s downward position
NOTE: With 15 mL Purge turned ON or OFF, the system will require a purge in the upright
position during system power-up, syringe installation, and new case.
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MEDRAD® Mark 7 Arterion Injection System
11 - 72
12
Tear Down
Biological Contamination Hazard - Serious patient and/or worker injury or death may result.
• Properly discard disposables after use or if contamination may have occurred during
setup or use.
This chapter discusses how to tear down and immediate cleaning of the injection system.
12.1 Remove Disposables
Bloodborne Contamination Hazard - Serious patient and/or worker injury or death may
result.
• Press the End Case button on the Display Control Unit. Select Yes to acknowledge that
you want to end the case, and that the patient has been disconnected from the system.
• Alternatively, turn the Manual Knob counter-clockwise to retract the syringe plunger
at least 2 mL.
• Properly discard disposables after use, in accordance with hospital hazard waste disposal
procedures.
1. Disconnect the disposable tubing set from the vascular entry device, such as a catheter or
sheath. The disposable tubing set does not need to be disconnected from the syringe.
2. Press the End Case button on the Display Control Unit. Select Yes to acknowledge that you
want to end the case, and that the patient has been disconnected from the system.
• Alternatively, turn the Manual Knob counter-clockwise to retract the syringe plunger at
least 2 mL.
3. Open the drop front.
4. Rotate the syringe 1/4 turn clockwise and gently pull the syringe out of the Pressure Jacket.
Discard the syringe with disposable tubing set into a bio-hazard container.
NOTE: Once the syringe is removed from the injector and the Injector Head is rotated into
the Purge position, the injector sounds an audible beep three times, and the piston
automatically retracts to the home position. Auto Retract must be enabled for this
feature to function.
5. If an operator used the Manual Knob to retract the syringe plunger, press End Case button on
the Display Control Unit to reset the Actuals window and History.
12.2 Clean up
Cross Contamination Hazard - Serious patient and/or worker injury or death may result.
• Do not clean disposables.
• Do not contact disposables with cleaning agent during cleaning.
• Do not conduct cleaning process during injection procedure.
1. Wipe off contrast spills with warm water before they dry.
2. For all body fluid spills, follow institutional decontamination procedures.
3. Clean the Syringe Heat Maintainer. Remove the Syringe Heat Maintainer before cleaning. To
clean the Syringe Heat Maintainer, refer to "Chapter 15 - Cleaning and Maintenance".
4. Clean the Pressure Jacket. Remove the Pressure Jacket from the syringe interface before
cleaning. To clean Pressure Jacket, refer to "Chapter 15 - Cleaning and Maintenance".
5. If cleaning the piston is required fully advance the piston, then turn off the power.
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MEDRAD® Mark 7 Arterion Injection System
6. Wipe components with:
• a germicidal wipe, or
• a bleach wipe, for isolation patients
NOTE: If contrast media has leaked inside any system component, turn off the power
immediately. The affected subassembly should be disassembled and cleaned by
Services personnel or returned to Bayer HealthCare Services.
12.3 Storing the Injector
Move the injector to a safe place, away from extreme or changing temperatures (hot or cold), dust, and
spills.
12 - 74
13
System Messages
The Mark 7 Arterion Injection System displays Sentinel Messages and Popups to alert the operator that
action is required.
This chapter describes:
•
•
•
"Error Messages"
"Sentinel Messages"
"Popup Messages"
13.1 Error Messages
Electric Shock Hazard - Serious patient and/ or worker injury or death may result.
• Perform calibration when specific components listed in “Disassembly/Assembly &
Replacement Parts” are replaced in the system.
CAUTION
Mechanical Hazard - Minor or moderate patient and/or worker injury may result.
• Remove power and disconnect patient when system malfunction occurs.
Error messages are system malfunction messages which require power to be removed from the
system. Error messages are accompanied by three beeps. Some error messages provide suggestions
to prevent the condition from recurring. If the condition cannot be corrected, record the code and
number from the lower left corner of the dialog box, then call Bayer HealthCare Services for assistance.
Error messages are divided into categories of function level. Each category is also divided into specific
errors. Below is a list of the categories and suggested repair sequences. These are to be tried in order,
not to be performed all at once. For further assistance, contact Bayer HealthCare Services or an
authorized dealer.
NOTE: Before replacing any parts, cycle power to the system. This initiates a system selftest. If this does not correct the problem, replacement of serviceable components
as needed may be required.
13.2 Sentinel Messages
Sentinel messages display in the Sentinel window located in the lower right of the touch screen. A
Sentinel message informs an operator of items that need attention. If multiple items need to be
corrected, the Sentinel window shows a list of the items that need to be corrected. As each item is
corrected, the system removes the corresponding message from the Sentinel window.
Table 13 - 1: Sentinel Messages
Sentinel Message
Description/Resolution
Attach hand controller
Attach hand controller
Attach start switch or enable ISI
Attach a start switch or enable ISI.
Install Syringe
Install a syringe.
Close Drop Front
Completely close the drop front.
Advance Plunger
Fully advance the plunger in the syringe.
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MEDRAD® Mark 7 Arterion Injection System
Table 13 - 1: Sentinel Messages
13 - 76
Sentinel Message
Description/Resolution
Rotate head up and purge
Use the handle and the back of the Injector
Head (but not the Manual Knob or tubing) to
rotate the Head in the Purge position (upward),
and purge the system of all air. A minimum
purge of 3.5 mL is required for the system to
recognize it as a purge.
Rotate head down to arm
Use the handle and the back of the Injector
Head (but not the Manual Knob or tubing) to
rotate the Injector Head in Inject position
(downward).
Flow Rate Reduced
The system reduced the flow rate during the
injection.
Injection Complete
The injection has completed.
Disconnect Patient
An operator has selected End Case and Yes on
the confirmation popup to end the case.
Disconnect the patient.
Case Ended
Displays after an operator has selected End
Case and Yes on the confirmation popup.
Rotate Syringe and Remove
Displays after an operator has selected End
Case and Yes on the confirmation popup and a
Syringe is present.
Procedure Halt - Display touch
The injection stopped, an operator touched the
display touch screen.
Procedure Halt - Head Touch
The injection stopped, an operator pressed a
button on the Injector Head.
Procedure Halt - ISI
The injection stopped, the imaging system
interface terminated the injection.
Procedure Halt - Low Volume
The injection stopped, an insufficient volume
condition occurs after an injection during a Multi
Arm injection.
Procedure Halt - Start Switch
The injection stopped, an operator released the
start switch during a mL/s injections or pressed
the start switch a second time during a mL/m
injection.
Calibration Needed
Have the system calibrated by Bayer HealthCare
Services or qualified Services personnel.
System Messages
13.3 Popup Messages
Popups display on the touch screen and require the operator to make a selection on the screen to close
the Popup.
Table 13 - 2: Popup Messages
Popup Message
Description/Resolution
WARNING - Do Not Inject Air. Have you expelled
all air from syringe/disposable?
The Check for Air popup displays when initially
arming the injector.
This message displays again after any powered
reverse piston motion or the drop front
disengages.
Confirm the disposable system is free of air, and
select Yes.
Ensure the patient is disconnected. Are you sure
you want to end the case?
Displays after an operator selects End Case.
Select Yes to acknowledge that you want to end
the case, and that the patient has been
disconnected from the system. Select No to
resume the case.
Purge Terminated. Check fluid path for
occlusion.
The high pressure connector tubing or catheter
may be kinked limiting the flow of contrast.
Insufficient volume. Continue with remaining
volume? (Single Protocol)
The programmed volume exceed the remaining
volume in the syringe.
Select Yes to allow the system to adjust the
protocol to use the volume remaining in the
syringe.
Select No to abort the arming process. Refill the
syringe with the appropriate volume and rearm
the system.
Lock released - User inactivity timeout.
The display control unit is no longer locked out.
The timeout period has elapsed.
Insufficient volume for phased protocol. Revise
protocol.
The programmed volume exceed the remaining
volume in the syringe.
Fill the syringe with the sufficient volume or
revise the protocol. Rearm the system.
Unplug or replace Syringe Heat Maintainer.
The syringe heat maintainer is non-functional.
Select OK to proceed with arming process.
Injector will keep syringe heat maintainer
disabled until it can determine that the fault is
corrected or the heat maintainer is removed.
System Disarmed - Fluid flow stopped. Check
for occlusion, reduce rate or increase pressure
limit.
The system was not able to achieve the
programmed flow rate.
The high pressure connector tubing or catheter
may be kinked limiting the flow of contrast.
The programmed pressure limit is insufficient.
Verify that the pressure limit matches the
pressure rating of the disposables being used.
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MEDRAD® Mark 7 Arterion Injection System
Table 13 - 2: Popup Messages
13 - 78
Popup Message
Description/Resolution
System Disarmed - Pressure limit exceed.
Check for occlusion, reduce rate or increase
pressure limit.
The system was not able to achieve the
programmed flow rate.
The high pressure connector tubing or catheter
may be kinked limiting the flow of contrast.
The programmed pressure limit is insufficient.
Verify the pressure limit matches the pressure
rating of the disposables being used.
System Disarmed - Drop front opened.
Drop front has dislodged from the syringe.
Disconnect Patient.
Close the drop front, Purge the system, and
rearm the injector.
System Disarmed - Head position changed.
The Injector Head was rotated out of the inject
position.
Use the handle and the back of the Injector
Head (but not the Manual Knob or tubing) to
rotate injector head to the Inject (downward)
position.
System Disarmed - Piston moved more than
2mL.
A reverse piston motion of more than 2mL
occurred via the manual knob. Rearm the
system.
System Disarmed - No start switch or ISI is
available.
All start switches have been disconnected from
the system, and/or ISI has been disabled.
Attach start switch and/or confirm ISI is
available, and rearm the system.
System Disarmed – Start switch disconnected.
A start switch was disconnected during an
injection. Attach a start switch, and rearm the
system.
System Disarmed - Hand switch disconnected.
A hand switch was disconnected when the
system was armed. Reconnect the hand switch,
and rearm the system.
System Disarmed - Hand switch connected.
Rearm.
A hand switch was connected to the system
when the system was armed. Rearm the
system.
System Disarmed - Foot switch disconnected.
A foot switch was disconnected when the
system was armed. Reconnect the foot switch,
and rearm the system.
System Disarmed - Foot switch connected.
Rearm.
A foot switch was connected to the system
when the system was armed. Rearm the
system.
System Disarmed - Injector temperature
exceeded.
The temperature of the Injector Head exceeded
the limits. Check the system.
System Messages
Table 13 - 2: Popup Messages
Popup Message
Description/Resolution
System Disarmed - User Inactivity Timeout.
The system remained idle for 30 minutes.
Rearm the system.
System Disarmed - ISI not ready
ISI is not communicating correctly with the
system. Check ISI connections and
communication.
System Disarmed ISI interface module failure.
Disable ISI to proceed.
The ISI interface is not functioning properly.
Disable ISI at the injector system to continue
with the injection.
System Disarmed - ISI not synchronized
The ISI remote start is already on when the
injector is armed, or the ISI hand switch disable
is turned on after an injection is started using
the injector hand switch or foot switch.
Local DCU communication lost.
The system lost communication withe Display
Control Unit. Check cable connections and
communication.
Remote DCU communication lost.
The system lost communication withe Display
Control Unit. Check cable connections and
communication.
Local DCU attempts to establish communication
with injector.
The system lost communication withe Display
Control Unit. Check cable connections and
communication.
Are you sure you want to delete?
Displays when an operator deletes a
protocol.
Select Yes to confirm the deletion.
Select No to return to the Protocol Edit screen.
Settings changed. Confirm?
Displays when an operator makes changes to
an option on the Options tab and selects
another tab without saving those changes.
Select Yes to save the change and go to the
selected tab.
Select No cancel the change and go to the
selected tab.
Select calibration Interval.
An interval has not been set for the calibration.
Enter a interval.
Protocol storage is full. Please delete a protocol
before adding a new one.
Displays when Protocol storage is full and an
operator attempts to save a new one. Delete a
protocol.
Please choose another name for this protocol.
Displays when an operator attempts to save a
protocol using the same name as an existing
protocol.
Please enter a valid day.
Displays when an operator enters an invalid
date. Enter a valid date.
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MEDRAD® Mark 7 Arterion Injection System
Table 13 - 2: Popup Messages
13 - 80
Popup Message
Description/Resolution
Please enter a valid month.
Displays when an operator enters an invalid
month. Enter a valid month.
Change flow mode?
Select Yes to change the flow mode to mL/m.
ISI interface module failure. Disable ISI to
proceed.
The ISI interface is not functioning properly.
Disable ISI at the injector system to continue
with the injection.
ISI not synchronized
The ISI remote start is already on when the
injector is armed, or the ISI hand switch disable
is turned on after an injection is started using
the injector hand switch or foot switch.
ISI not ready
ISI is not communicating correctly with the
system. Check ISI connections and
communication.
14
VirtualCare Option
VirtualCare is a Service expansion option that can be installed for the Mark 7 Arterion Injection System.
The VirtualCare provides remote service functionality that allows Bayer HealthCare Services to
remotely update injector firmware, diagnose injector errors, and retrieve logs.
Contact your local Bayer representative for additional information.
14 - 81
MEDRAD® Mark 7 Arterion Injection System
14 - 82
15
Cleaning and Maintenance
Cross Contamination Hazard - Serious patient and/or worker injury or death may result.
• Do not contact disposables with cleaning agent during cleaning.
• Do not conduct cleaning process during injection procedure.
NOTICE
Electro-Mechanical Hazard - Equipment Damage may result.
• Disconnect power before cleaning.
• Use a wipe or dampened cloth for cleaning.
• Do not soak or immerse components.
• Do not use strong cleaning agents.
• Perform routine cleaning and maintenance.
• Remove power when connecting or disconnecting cables.
• Do not clean the syringe.
This chapter identifies the proper methods for cleaning the injection system, the recommended
maintenance schedule, and an operational checkout of the injection system.
The injection system must be properly maintained to ensure it is in peak operating condition. Your
individual maintenance schedule depends upon how your injection system is used, the type of
procedures performed, and frequency of use.
Failures which occur due to lack of proper maintenance will not be covered under warranty.
NOTE: Bayer HealthCare Services will make available for purchase upon request:
• Service and schematic manuals that will assist qualified technicians to repair
components classified as repairable.
• On-site consulting services.
15.1 Daily
CAUTION
Mechanical Hazard - Minor or moderate patient and/or worker injury may result.
• Do not use an autoclave to sterilize the Pressure Jacket.
• Refer to Pressure Jacket cleaning instructions.
The following procedures are recommended for daily cleaning and inspection of all components on the
injection system. If any defects are detected, either repair the system, or call the local Bayer office or
the local authorized dealer for service. Do not use the system until the problem is corrected.
15.1.1 Cleaning the Injector Head, Syringe Heat Maintainer, Drop Front Cover, Pressure
Jacket, Piston, Syringe Interface, and Table Bracket
Clean components, except Heat Maintainer and Pressure Jacket, with:
•
•
a germicidal wipe, or
a bleach wipe, for isolation patients
1. Do not remove any covers except the Drop Front Cover. Do not disassemble the injector.
2. Remove the Syringe Heat Maintainer.
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MEDRAD® Mark 7 Arterion Injection System
3. Clean the Syringe Heat Maintainer with a dampened cloth using soap and water.
4. Remove the Drop Front Cover.
5. Clean the Drop Front Cover with a soft cloth or a paper towel dampened with a cleaning
solution to remove contrast media and other contamination.
6. Remove the Pressure Jacket.
7. Clean the Pressure Jacket with a soft cloth or a paper towel dampened with a cleaning
solution to remove contrast media and other contamination.
Some cleaning agents react with the plastic material and may cause structural degradation.
Bayer recommends that the Pressure Jacket be washed in a solution of warm tap water (35°
– 45° C) and mild non-abrasive detergent (neutral grade low pH, enzymatic cleaner), and
then rinsed thoroughly and dried with a soft towel.
A solution of dish washing detergent and water is compatible with the Pressure Jacket. If a
germicidal cleaning agent is desired, contact the germicide manufacturer to check the
recommended dilution and compatibility with polycarbonates. If the solution is acceptable,
follow the manufacturer’s directions exactly. Do not clean the Pressure Jacket with an
automatic dishwasher. The Pressure Jacket is not dishwasher safe. Do not leave the
Pressure Jacket in germicide for extended periods of time. Do not expose the Pressure
Jacket to fluorocarbons (such as Freon), or other solvents (acetone, benzol, carbon
tetrachloride, MEK, MIBK, toluol, trichlor, and triclene). Gasses used to pressurize aerosol
cans can be damaging to the Pressure Jacket. Therefore, do not use aerosols in or around
the Pressure Jacket.
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Cleaning and Maintenance
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
Fully advance the piston
Turn off the system at the Power Unit.
Clean the piston.
Clean the inner area of the syringe interface.
Clean the drop front. The drop front cone should pivot freely back and forth. If it does not, it
may be contaminated with contrast.
Clean the Injector Head case.
Re-install the clean Pressure Jacket.
Re-install the clean Drop Front Cover.
Re-install the clean Syringe Heat Maintainer.
Clean any spilled contrast media from the Table Bracket and table rail to assure free
movement of the bracket along the rail.
15.1.2 Inspecting the Injector Head
•
•
•
•
•
•
Inspect the housing for any damage or cracks that could allow fluid to leak inside, or weaken
the structural integrity of the unit.
Inspect all cables connected to the unit.
• Look for cuts, cracks, worn spots or other obvious damage to the cables.
• Ensure that all connectors are properly seated.
Ensure that all mounting bolts and screws are secure.
Inspect for contrast media build-up in the syringe interface area, including the Syringe Heat
Maintainer and the Pressure Jacket. Follow the cleaning guidelines outlined in this chapter.
Inspect the pivot points to ensure they move freely.
Inspect the Injector Head Controls for damage or excessive wear.
15.1.3 Inspecting the Pressure Jacket
Prior to each procedure, inspect the Pressure Jacket for signs of deterioration or fatigue by looking
through it with light shining through the Pressure Jacket. Bayer recommends replacing the Pressure
Jacket if defects are found during daily inspection.
Rotate the Pressure Jacket while looking through it to view all areas. This includes the front edges and
the entire cylindrical surface and the grooves that interface with the injector head.
A Pressure Jacket should be rejected for cracks, crazing, scratches (if a fingernail can catch on the
scratch), and opacity. These conditions indicate that the Pressure Jacket has been weakened and may
fracture during a high pressure injection. The Pressure Jacket should NOT BE USED if any of these
conditions exist.
Cracks are usually the result of a sharp impact (such as from dropping). A crack may appear simply as
a line, usually originating at the radius or edge and may also appear in conjunction with crazing.
Figure 15 - 1: Cracks
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MEDRAD® Mark 7 Arterion Injection System
Stress Cracks may appear after the Pressure Jacket has been subjected to a number of pressure
cycles. These tiny cracks appear around the front area of the Pressure Jacket, and usually form a
pattern around the jacket’s circumference. Stress cracks are easiest to see while rotating the Pressure
Jacket in front of a light source.
Figure 15 - 2: Stress Cracks
Crazing can occur when non-compatible cleaning solutions or solvents are used on the Pressure
Jacket. Crazing can also occur when the Pressure Jacket has reached the end of its expected life.
Crazing appears as small lines that interfere with the transparency of the Pressure Jacket. Crazing
usually appears localized to a point of impact or fatigue.
Figure 15 - 3: Crazing
Scratches result from objects striking or scraping the inside or outside surface of the Pressure Jacket.
Scratches may occur when the Pressure Jacket is improperly handled. Check depth of scratches by
pulling your finger across the scratch, perpendicular to the surface. If your fingernail catches on a
scratch, the Pressure Jacket should NOT BE USED.
Figure 15 - 4: Scratches
Normally the Pressure Jacket is transparent, enabling you to clearly see through the barrel.
Figure 15 - 5: Opacity
15.1.4 Inspecting the Heat Maintainer
•
Inspect the Heat Maintainer for cracks. Bayer recommends replacing the Heat Maintainer if
cracks are found during inspection.
15.1.5 Inspecting the Display Control Unit
•
•
Inspect the cable connected to the Display Control Unit.
• Look for cuts, cracks, or worn spots, or other obvious damage.
• Ensure that the connector is properly seated and fastened securely.
Inspect the housing for any damage or cracks that could allow fluid to leak inside, or weaken
the structural integrity of the unit.
15.1.6 Inspecting the Table Mount Bracket
•
•
•
•
15 - 86
Inspect the Clamp knob to ensure that it is tightened.
Inspect the Injector Head knob to ensure it is tight and the Injector Head fits securely in the
Table Bracket.
Inspect for broken or damaged parts.
Check the vertical motion of the Table Bracket. If the gas spring is not functioning properly,
do not use the bracket.
Cleaning and Maintenance
15.1.7 Inspecting the Pedestal
•
•
•
•
Inspect the base, column, casters and handle for cracks and other defects that could weaken
the structure
Ensure all mounting bolts and screws are secure.
Ensure that the casters roll smoothly with no binding or scraping.
Ensure all locking mechanisms on the casters are functional.
15.1.8 Inspecting the Power Unit
•
•
•
Inspect the cables connected to the Power Unit.
• Look for cuts, cracks, or worn spots, or other obvious damage.
• Ensure that the connectors are properly seated.
Inspect the housing for any damage or cracks that could allow fluid to leak inside, or weaken
the structural integrity of the unit.
Ensure that the air vents are not clogged.
15.2 Monthly
Once a month, the entire system should be thoroughly inspected and cleaned, and an Operation
Checkout should be performed using the procedures outlined in “15.2.3 Performing an Operational
Checkout”.
15.2.1 Cleaning the Display Control Unit, Pedestal, Power Unit, and Table Bracket
NOTICE
Electro-Mechanical Hazard - Equipment Damage may result.
• Remove power when connecting or disconnecting cables.
• Do not spray cleaning solutions directly onto the DCU touch screen.
Clean components, except Pressure Jacket, with:
•
•
a germicidal wipe, or
a bleach wipe, for isolation patients
Turn off the system at the Power Unit. Clean the Display Control Unit, Pedestal, and Power Unit.
Remove the table bracket from the rail and clean off accumulated contrast media using soapy water
and dry thoroughly.
15.2.2 Inspecting and Cleaning the Internal Air Filter
1. Turn off the system at the Power Unit.
2. Remove the two screws shown in the drawing below.
Figure 15 - 6: Power Unit Air Filter
3. Pull out the air filter.
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MEDRAD® Mark 7 Arterion Injection System
4. Vacuum or rinse the air filter with water and thoroughly dry before re-installing.
5. Re-install the clean, dry air filter (Note the direction of arrow for air flow - air should flow into
the unit).
6. Replace the two screws.
NOTE: Inspect the internal air filter monthly and clean at least once per year (this can be
done more frequently as needed).
15.2.3 Performing an Operational Checkout
Equipment Malfunction Hazard - Serious patient and/or worker injury or death may result.
• Do not use the injection system if any problems are detected during the operational
checkout.
A basic functional checkout of the injection system should be included as part of monthly maintenance.
Verify proper operation of the injection system to help detect any problems that may not be noticed in
day-to-day operation. The following procedure represents a suggested series of activities which
encompasses typical operation of the system. Read the following procedure carefully before beginning
the checkout. If problems are detected or any step fails this checkout, contact your Services
Representative.
An empty Syringe is required to perform this checkout.
1. Plug in the injection system.
2. Press the Power Switch on the Power Unit, and press the Power Switch on the Display
Control Unit. Both power switches should illuminate green.
a. Ensure that the system passes self-test with no error messages. When self-test
completes, a safety screen displays.
b. Press Continue to clear the safety information.
c. Ensure that the Home tab displays.
3. Press the brightness controls to ensure that the controls vary the display brightness without
completely obscuring information at either extreme. Adjust to a suitable brightness.
4. Use the handle and the back of the Injector Head (but not the Manual Knob) to rotate the
Injector Head to the Purge position (upright).
a. Ensure that the Volume Remaining display on the Injector Head is active and is properly
oriented.
b. Ensure that the Flow Rate, Volume, and Pressure Limit are not active.
5. Use the handle and the back of the Injector Head (but not the Manual Knob) to the Inject
position (downward).
a. Ensure that the Volume Remaining display inverts.
b. Ensure that the Flow Rate, Volume, and Pressure Limit display and are properly
oriented.
6. Insert an empty syringe into the syringe interface.
a. Completely close the drop front.
b. Ensure that the Volume Remaining icon on the Injector Head illuminates.
7. Press the Forward and Reverse on the Fill Strip.
a. Ensure the piston does not move.
8. Press the Enable button.
a. Ensure the green indicator near the enable key illuminates.
b. Ensure the green indicator goes out after approximately five seconds.
9. Press the Enable button, and press Forward on the Fill Strip within five seconds.
a. Ensure that the piston extends.
15 - 88
Cleaning and Maintenance
10.
11.
12.
13.
14.
15.
16.
17.
b. Vary the position of your finger on the Fill Strip to ensure the piston load speed varies.
c. Ensure that the Volume Remaining display on the head decreases.
Press the Enable button, and press Reverse on the Fill Strip within five seconds.
a. Ensure that the piston retracts.
b. Vary the position of your finger on the Fill Strip to ensure the piston load speed varies.
c. Ensure that the Volume Remaining display on the head increases.
d. Retract the piston to its rear limit. The Volume Remaining should read “150mL”.
From the Home tab, enter a protocol with the following parameters:
Volume - 20 mL
Flow Rate - 10 mL/s
Pressure Limit - 500 PSI
a. Ensure the Injector Head displays these value.
Select Arm Single to Arm the injector.
a. Ensure that the display indicates that the injector is in the Armed state.
b. Ensure that the Armed light on the injector head is on solid.
Using the hand switch or foot switch, initiate an injection.
a. Ensure that the Display Control Unit display indicates that the injector is in the
“Injecting” state and the Armed light on the injector head flashes.
b. Confirm that the injection completes in approximately 2 seconds.
c. Ensure that the Armed light on the Injector Head goes out.
d. When the injection is complete, release the switch.
e. Ensure the Actuals window on the Display Control Unit indicates that 20 mL volume was
delivered at a rate of 10 mL/s.
From the Display Control Unit touch screen, change the Volume to 50mL.
a. Select Arm Single to arm the injector.
b. Use the hand switch or foot switch to initiate an injection.
c. Release it within 2 seconds.
d. Ensure the injection stops and disarms.
e. Ensure a “Premature Termination” message displays in the Sentinel window.
From the Home tab, select the Variable tab and enter a protocol with the following
parameters: Volume - 10mL, Flow Rate - 1 mL/s, Pressure Limit - 300 PSI
a. Arm the system. the armed light should be solid while armed and the system should
initially beep.
b. Initiate the Variable Flow Rate injection via the Hand Controller. Vary the flow during the
injection. Confirm that the rate can be varied from 0 to 1 mL/s. Volume delivered should
indicate 10 mL (if the injection is completed). No pressure limiting should occur.
c. The flow rate of the delivery should change in accordance with Hand Controller trigger
position. The DCU should display instantaneous flow rate during injection.
d. The armed light should switch from solid to flashing illumination during injection. The
injection should complete without error. If the system has sufficient fluid for another
injection, the system should return tot he armed state. If the system has insufficient
fluid, the unit will disarm at the end of the injection and display “Procedure Halt - Low
Volume” in the sentinel window.
Retract the piston to its rear limit.
a. Select either Arm Single or Arm Multiple to arm the injector.
b. Open the drop front.
c. Ensure that the system disarms.
d. Close the drop front.
Select either Arm Single or Arm Multiple to arm the injector.
a. Press the Disarm button on the Display Control Unit.
b. Ensure the system disarms.
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MEDRAD® Mark 7 Arterion Injection System
18. Select either Arm Single or Arm Multiple to arm the injector.
a. Press any button on the Injector Head.
b. Ensure the system disarms.
19. Select either Arm Single or Arm Multiple to arm the injector.
a. Use the handle and the back of the Injector Head (but not the Manual Knob) to rotate the
Injector Head to the Purge position (upright).
b. Ensure the system disarms and cannot be re-armed unless the head is rotated back to
the Injection position.
20. If a Syringe Heat Maintainer is connected to the Injector Head, ensure that it is warm to the
touch.
a. Ensure the over-temperature message is not displayed in Sentinel window.
21. If ISI is connected, enable ISI and check for errors.
22. Power down the system and remove the syringe and dispose of it properly.
15.3 Annually
Bayer offers Preventative Maintenance Programs. These annual programs greatly assist in maintaining
accuracy and reliability, and can also extend the life of the system. Contact your local Bayer office or
your local authorized dealer for further information. Refer to the back of the title page of this manual for
address, telephone and fax information.
15.3.1 Injection System Calibration
Bayer recommends a complete system calibration and performance checkout be performed annually.
Contact Bayer HealthCare Services, or your local Bayer office for complete details.
15.3.2 Checking Leakage
As part of an annual maintenance program performed by a qualified Services Representative or
authorized dealer, both Electrical leakage and protective earth ground continuity checks should be
performed.
NOTE: Local regulations or hospital protocol may require electrical leakage checks at
more frequent intervals. If this applies, the local regulations for leakage must be
followed.
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16
Installation - System and Accessory
CAUTION
Mechanical Hazard - Minor or moderate patient and/ or worker injury may result.
• Do not create a trip hazard when routing cables.
• Follow installation procedures including use of proper screws and plugging all unused
holes.
This chapter describes:
•
•
•
•
•
•
"Unpacking the Injection System"
"Pedestal Mount Installation"
"Power Unit Installation"
"Injector Head Mounting Options"
"Display Control Unit Mounting Options"
"Accessory Installation"
NOTE: All relevant guidelines for institutional, local or national safety recommendations
related to cable routing and installation should be followed.
NOTE: After installation, it is recommended that an operational checkout be performed.
See "15.2.3-Performing an Operational Checkout" for more information.
16.1 Unpacking the Injection System
CAUTION
Mechanical Hazard - Minor or moderate worker Injury May Result.
• Use two persons to lift or move heavy or large packaging.
• Visually inspect contents and package before use.
• Do not use if package is damaged.
The system is shipped in multiple cartons, with the number of cartons depending on the type of
installation. The major components of the injector system are shipped in two cartons.
Shipper cartons:
•
•
Carton containing the injector head, display and base.
Carton containing the accessory items/interconnect cables.
Additional Shipper Cartons:
•
Carton containing the injector head mounting option, either a Pedestal or Overhead
Counterpoised System (OCS).
NOTE: Before installing, remove and inspect the contents from each carton and verify that
all components are present. Call Bayer immediately regarding damaged or missing
components.
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MEDRAD® Mark 7 Arterion Injection System
16.2 Pedestal Mount Installation
Air Embolism Hazard - Serious patient injury or death may result.
• Injector head shall be mounted on Articulating Arm.
CAUTION
Mechanical Hazard - Minor or moderate patient and/ or worker injury may result.
• Move Articulating Arm to upper position prior to removing head.
• Do not mount DCU to Articulating Arm.
The Mark 7 Arterion pedestal mount configuration ships in two boxes as noted in “Unpacking the
Injection System.” The installer needs to complete the pedestal assembly, attach the Injector Head and
Display Control Unit, route cables, and make the connections to the Power Unit.
1. Remove the pedestal from the box.
Figure 16 - 1: Pedestal
2. Insert the male end of the articulating arm into top of the upper mast (A).
• Tighten the thumb screw.
3. Attach the Injector Head to the articulating arm.
a. Loosen the Injector Head Knob (B) by turning counterclockwise until it spins freely.
Figure 16 - 2: Loosen the Injector Head Knob
b. Insert the Injector Head mounting pin into the top of the Articulating Arm.
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Installation - System and Accessory
Figure 16 - 3: Attach Injector Head to Articulating Arm
c. Secure the Injector Head by turning the Injector Head Knob as far as possible clockwise.
d. Ensure that the Injector Head Knob is as tight as possible to facilitate a secure fit of the
Injector Head in the Articulating Arm.
Figure 16 - 4: Injector Head Mounted on Articulating Arm
NOTE: Loosen the Injector Head Knob prior to repositioning the Injector Head.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
NOTE: Removing the Injector Head is the reverse of installation.
Remove the upper mast cover (C) and retain the screws.
Loosen the contrast tray (D) by pushing from the bottom.
Remove the lower mast (E) cover and retain the screw.
In the lower mast, remove the cable guide and retain the screws.
Route the injector head cable through the opening of the contrast tray and then down through
the hole in the top of the upper mast.
Attach the Fulcrum Mount to the Display Control Unit (see "Fulcrum Mount Kit Installation" in
this chapter).
Insert the mounting pin of the fulcrum mount into the Display Control Unit post (F).
• Tighten the thumb screw on the Display Control Unit mast.
Loosen the screws on the Display Control Unit mast cover (G) to remove the cover opposite
the screw heads.
Remove the hook plate (H) from the underside of the handle assembly and retain the screws.
Feed the Display Control Unit cable through hole adjacent to the Display Control Unit mast.
Insert Power Unit into base (I) from the handle side of the pedestal.
• Line up the target on the side of the power unit with the opening in the side of the
bracket.
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MEDRAD® Mark 7 Arterion Injection System
J
J
Figure 16 - 5: Insert Power Unit
• Secure the Power Unit with the four thumb screws (J) attached to the base.
15. Connect Display Control Unit cord to Display Control Unit connection on the top of the Power
Unit.
16. Connect the Injector Head connection on the top of the Power Unit.
17. Align the Display Control Unit cable into the channel on the bottom of the handle assembly
and attach the hook plate (H) to the bottom of the upper mast. Center the black tape on the
cord with the opening of the cover. Leave enough slack in the cable to allow the Display
Control Unit to turn freely.
Figure 16 - 6: Assemble Pedestal
16 - 94
Installation - System and Accessory
18. Attach the Display Control Unit mast cover (G), and reconnect the contrast tray (D).
19. Attach the Upper mast cover (C) while aligning the Injector Head cable into the molded guides
in the mast cover piece. Leave enough slack to allow full movement of the Injector Head on
the upper mast.
20. Loop the Display Control Unit and Injector Head cables and secure with the Cable loop as
shown in the figure below.
Figure 16 - 7: Pedestal Cable Routing
21. In the Lower mast, attach the cable guide with the Display Control Unit and Injector Head
cables behind it and in the channel on the lower mast. Ensure the flange hole for the upper
mast screw is facing up.
22. Attach the Lower Mast cover (E).
23. Connect the Power Unit power cord to the inlet plug on the Power Unit.
16.3 Power Unit Installation
Electric Shock Hazard - Serious patient and/ or worker injury or death may result.
• Use only power cord approved for use on Mark 7 Arterion.
• For U.S installations, equipment shall only be connected to Hospital Grade or Hospital Only
outlets.
NOTICE
Electro-Mechanical Hazard - Equipment damage may result.
• Do not block Power Unit Vents.
• Installation clearance should be a minimum of 3 to 5 inches (8 to 13 cm).
For U.S installations, equipment shall only be connected to Hospital Grade or Hospital Only outlets. This
section shows all of the Power Unit connection points, describes how to relocate the connections from
the top plate to the back plate, and shows how to assemble the Power Unit floor mount bracket,.
16 - 95
MEDRAD® Mark 7 Arterion Injection System
16.3.1 Power Unit Connections
The Power Unit has connection ports on the top plate, front plate, and back plate. When the Power Unit
ships from the factory, only the ports on the top plate and front plate have live connections. This
section shows the location of each port and provides a brief description of each.
NOTE: The connectors on the top plate should only be used for the Pedestal mount
configuration.
NOTE: See "16.3.3-Relocate Power Unit Connectors" for information on switching
connection ports from the top plate to the back plate.
Figure 16 - 8: Top Plate
A
Display Control Unit Connection for a single or first Display
Control Unit in a two Display Control Unit System
B
Injector Head Connection
Figure 16 - 9: Front Plate
16 - 96
A
A/C Inlet Plug
B
Hand Switch or Foot Switch
Connection
C
ISI connection
D
CAN Connection (Future Use)
Installation - System and Accessory
E
Display Control Unit Connection
for a second Display Control Unit
in a two Display Control Unit
system
G
Power Switch
F
Future Expansion Port
The connections on the back plate do not have live connections when the Power Unit ships from the
factory. To use these ports, see "16.3.3-Relocate Power Unit Connectors" for more information.
Figure 16 - 10: Back Plate
A
Future Expansion Port
B
Display Control Unit Connection
for a single or first Display Control
Unit in a two Display Control Unit
System
C
Display Control Unit Connection
for a second Display Control Unit
D
Injector Head Connection
16.3.2 Power Unit Floor Mount Bracket Assembly
Figure 16 - 11: Install Rubber Feet
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MEDRAD® Mark 7 Arterion Injection System
Figure 16 - 12: Attach Floor Mount
Figure 16 - 13: Attach Handle
16.3.3 Relocate Power Unit Connectors
NOTICE
Electro-Mechanical Hazard - Equipment damage may result.
• Follow Electrostatic Discharge (ESD) protection practices.
• Disconnect the power cord before removing or replacing PC boards.
The Display Control Unit and Injector Head connectors on the Mark 7 Arterion Power Unit can be moved
to accommodate different configurations. The Display Control Unit and Injector Head connectors found
on the top of the Power Unit can be moved to the back. The Display Control Unit 2 connection on the
front of the Power Unit can be moved to the back.
Contact your local service representative for assistance.
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Installation - System and Accessory
16.4 Injector Head Mounting Options
•
•
•
•
"Head Stand Installation (KMA 320RT)"
"Adjustable Height Stand Installation (KMA 330)"
"Overhead Counterpoised System Installation"
“Adjustable Table Bracket Installation (KMA 350)
NOTE: This section assumes that the operator has installed the mounting devices.
NOTE: See "16.3.1-Power Unit Connections" for connection locations.
16.4.1 Head Stand Installation (KMA 320RT)
Refer to DN-231999 for installation instructions.
16.4.2 Adjustable Height Stand Installation (KMA 330)
Refer to 201011 (English) or 201061 (Japanese) for installation instructions.
16.4.3 Adjustable Table Bracket Installation (KMA 350)
Refer to 3040373 for installation instructions.
16.4.4 Overhead Counterpoised System Installation
For OCS installation instructions refer to the MAVIG Portegra2 Suspension System for MEDRAD®
Injectors Installation Manual (MED01002E).
16.5 Display Control Unit Mounting Options
•
•
•
•
"Fulcrum Mount Kit Installation"
"Desk Stand Kit Installation"
"Fixed Table Mount Installation"
"Wall Mount Bracket Installation"
16.5.1 Fulcrum Mount Kit Installation
The Display Control Unit Display Mount Fulcrum interfaces with the Pedestal (ART 700 PED), Fixed
Table Mount (ART 700 DCU TM), and Universal Adjustable T-Rail Table Mount (KMA 350).
Figure 16 - 14: Attach Fulcrum Plate
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MEDRAD® Mark 7 Arterion Injection System
16.5.2 Desk Stand Kit Installation
A
P/N 3007412
#8-32 x 5/8”
Figure 16 - 15: Attach Bracket (A) to Display Control Unit Stand
P/N 600-5007-400
Figure 16 - 16: Attach Rubber Feet
Figure 16 - 17: Display Control Unit Back - Remove Screws
Figure 16 - 18: Display Control Unit Desk Stand Attached
NOTE: Reuse #8-32 1/2” screws removed in Figure 16 - 17.
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Installation - System and Accessory
16.5.3 Fixed Table Mount Installation
NOTICE
Electro-Mechanical Hazard - Equipment damage may result.
• Before installing the Table Mount, ensure the table rail can withstand a minimum vertical
static load of 18 kg (40 lbs.) Refer to the table manufacturer documentation for weight
load information.
• Do not over tighten Table Mount knob.
• Do not force the Table Mount onto the table rail.
• Loosen Table Mount knob prior to removal of components.
The Fixed Table Mount can be used to mount a Display Control Unit using the Fulcrum Mount Bracket
kit to a bed rail. The Fixed Table Mount bracket is designed to accommodate rails from 1/4” (6.4mm) to
1/2” (12.7mm) thick and 7/8” (22.2mm) high.
NOTE: The Fixed Table Mount is not intended to support the Injector Head.
1. Slightly angle the Fixed Table Mount bracket towards the center of the table and hook onto
the top of the accessory rail.
Figure 16 - 19: Attaching the Fixed Table Mount
2. Rotate bracket away from the center of the table until the Mounting Lever engages with table
rail.
NOTE: It may be necessary to adjust the Mounting Lever prior to attachment to get the
Mount Lever to engage properly (see step 4 and then return to step 3).
3. Tighten the Clamp Knob until the Bracket Mount is parallel to the rail.
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MEDRAD® Mark 7 Arterion Injection System
Figure 16 - 20: Tightening the Clamp Knob
4. Using the 3/16” Hex Key provided, turn the adjusting screw (A) clockwise until Mounting
Lever (B) contacts the bottom of the rail.
B
A
Figure 16 - 21: Adjust Screw and Mounting Lever
5. Turn the same adjusting screw (A) counterclockwise approximately 45 degrees; remove the
Hex Key.
C
Figure 16 - 22: Table Mount Knob
6. Tighten the Clamp Knob until the Bracket Mount is firmly attached to the rail.
7. Loosen the knob (C) by turning as far as possible counterclockwise.
8. With the Display Control Unit attached to the Fulcrum Mount, insert the Fulcrum Mount pin
into the top of the Fixed Table Mount bracket.
9. Secure the Display Control Unit by turning the knob (C) clockwise. When tightened properly,
the Display Control Unit should not move when pressing the touch screen.
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Installation - System and Accessory
16.5.4 Wall Mount Bracket Installation
NOTE: Before attaching the bracket to the wall, the installer must know if the wall studs in
the room are made of metal or wood. This will determine the kind of hardware
required to complete the installation.
NOTE: The bracket must be mounted to a stud to insure a secure mount. Wallboard and
wing anchors will not support the weight and movement created by swinging the
control console into position during routine use.
NOTE: Do not install the wall mount bracket on a wall which contains shielding unless the
installation does not violate the shield.
1.
2.
3.
4.
5.
NOTE: If the wallboard is thicker than 5/8 inch, longer screws must be purchased to
insure a secure mount.
Hold the bracket with the friction plates on the bottom and position the wall bracket on the
wall where it is to be installed and mark the mounting holes. The bracket must be mounted
to a stud to insure a secure mount.
Drill a 5/32” by 2” deep hole through the wall and into the stud (3/8” hole if there is a metal
stud).
On metal studs only, place the hollow wall anchors into the holes drilled.
Place the wall bracket onto the wall and secure with the fasteners provided. (#12 x 2” screws
for wood studs, #10-24 x 2 1/2“screws for metal studs)
Remove the four screws from the back of the Display Control Unit.
Figure 16 - 23: Remove Screws
6. Leave the cable retainers (A) attached to their respective cables.
7. Place the Display Control Unit onto the plate and secure the Display Control Unit to the
bracket with the #8-32 x 5/8” screws provided, as shown in Figure 16 - 24. Ensure to attach
the cable retainer clips to the upper right and lower right holes on the Display Control Unit.
Figure 16 - 24: Wall Mount Screws and Mounted Display Control Unit
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MEDRAD® Mark 7 Arterion Injection System
8. Connect the cable to the rear of the Display Control Unit (a small flat head screwdriver may
be required). Route the Display Control Unit cable toward the Display Control Unit wall
bracket hinge.
NOTE: The minimum bend radius for the cable is five inches.
9. Use the cable ties and cable mounts to fasten the cable to the wall. Allow sufficient length in
the Display Control Unit cable to permit full range of movement of the bracket. Route the
cable away from the bracket to prevent the cable from becoming pinched in the bracket
hinge.
To swing the Display Control Unit from side to side, push up on the bottom of the Display Control Unit.
While in this position, the bracket and Display Control Unit swings from side to side.
After the Display Control Unit is positioned, allow the Display Control Unit to drop down to lock into
position. A light tap on the top of the Display Control Unit will insure a lock condition.
Figure 16 - 25: Positioning a Wall Mounted Display Control Unit
16.5.4.1 Convert Wall Mount Swing Direction
The Display Control Unit Wall Mount Bracket swings from the right. It can be converted to swing from
the left.
Figure 16 - 26: Swing Right and Swing Left Wall Mount Configurations
1. Remove the Display Control Unit from the wall mount bracket.
16 - 104
Installation - System and Accessory
A
B
C
D
Figure 16 - 27: Wall Mount Friction Plate - Close-up
2.
3.
4.
5.
6.
7.
Remove the wing nut (B) from the top of the pivot bolt (A).
Remove the washer and spring (C).
Lift the mounting plate (D) off of the mounting pins and flip over.
Install the spring and washer (C) onto the mounting pin.
Install wing nut (B) on mounting bolt (A) and tighten down until it stops.
Install the Display Control Unit onto the wall mount bracket.
16.6 Accessory Installation
•
•
•
•
•
•
"Syringe Heat Maintainer Installation"
"Syringe Pressure Jacket Installation"
"Hand Switch and Foot Switch Installation"
"Hand Switch Mount Kit"
"Display Control Unit Sterile Sheath Installation"
"Cable Bracket Installation"
16.6.1 Syringe Heat Maintainer Installation
A
Figure 16 - 28: Syringe Heat Maintainer Port (A)
NOTE: Remove and discard cap covering the port (A).
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MEDRAD® Mark 7 Arterion Injection System
Figure 16 - 29: Syringe Heat Maintainer
Figure 16 - 30: Syringe Heat Maintainer Connected
16.6.2 Syringe Pressure Jacket Installation
Install the Pressure Jacket on to the front of the injector prior to installing a syringe.
1. Align the slot in the pressure jacket with the protrusion on the front of the injector.
2. Push firmly on the face of the pressure jacket until it snaps on to the injector.
3. Ensure that the syringe interface can close properly.
16.6.3 Hand Switch and Foot Switch Installation
Figure 16 - 31: Hand Switch and Foot Switch Power Unit Location
16 - 106
Installation - System and Accessory
Figure 16 - 32: Hand Switch Display Control Unit Location
Figure 16 - 33: Use Clip to Attach Hand Switch Cable to the Display Control Unit
16.6.4 Hand Switch Mount Kit
The hand switch mount kit contains hardware to allow the operator to mount the hand switch to any
flat surface (such as the back of the Display Control Unit) and onto a pole or similarly shaped object.
1. To mount using the metal bracket and double-sided tape,
a. Attach the hand switch holster (A) to the metal bracket using the included screws.
Figure 16 - 34: Hand Switch Holster with Bracket
b. Using the supplied alcohol wipe, thoroughly clean an area on the mounting surface
approximately the shape and size of the pre-cut double-sided tape.
c. Apply a thin film of the included surface primer to the area (B) where it will be mounted
and to the metal bracket.
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MEDRAD® Mark 7 Arterion Injection System
d. Orient as desired prior to applying to surface; the tape will adhere on contact. Apply the
double-sided tape to the metal bracket then affix to the prepared surface.
e. Apply firm pressure to fully seat the bracket.
2. To mount the hand switch using the Velcro strap,
a. Feed the Velcro strap through the two slots on the hand switch holster.
Figure 16 - 35: Hand Switch Holster with Velcro
b. Wrap the Velcro strap around a pole or similar object.
c. Ensure strap is snug to prevent the holster from slipping during use. The double-sided
tape can also be used between the holster and pole to help prevent slipping.
16.6.5 Display Control Unit Sterile Sheath Installation
Biological Contamination Hazard - Serious patient and/or worker injury or death may result.
• Properly discard disposables after use or if contamination may have occurred during
setup or use.
CAUTION
Environmental Contamination Hazard - Minor or moderate patient and/or worker injury may
result.
• Visually inspect contents and package before use.
• Do not use if package integrity is compromised.
• Follow sterile technique principles when installing the Display Control Unit Sheath.
NOTE: Contents are sterile. Display Control Unit sheath should be applied using sterile
technique.
The Mark 7 Arterion Display Control Unit Sterile Sheath is intended for single patient use.
1. Use sterile technique to open the Display Control Unit Sterile Sheath package.
2. Slip the sheath over the Display Control Unit.
3. Ensure the sheath completely covers the Display Control Unit.
Figure 16 - 36: Sheath Installation
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Installation - System and Accessory
16.6.6 Cable Bracket Installation
CAUTION
Mechanical Hazard - Minor or moderate patient and/ or worker injury may result.
• Do not create a trip hazard when installing cable bracket.
•
•
"Table Cable Bracket Installation"
"Floor Cable Bracket Installation"
16.6.6.1 Table Cable Bracket Installation
The Table Cable Bracket, cable insert, and panel mount plate, can be installed using the bracket and
insert only, or bracket and panel mount plate.
•
•
•
"Installing the Bracket and Insert"
"Installing the Insert Only"
“Installing the Bracket and Panel Mount Plate”
16.6.6.1.1 Installing the Bracket and Insert
NOTE: Before drilling, check clearance behind the desired mounting location inside the
table. Ensure that no cables or other hardware will interfere with the installation
and function of the Table Cable Bracket.
1. Pre-drill mounting holes (if not already provided on the table) using the Table Mount Cable
Bracket Hole Template provided in Appendix A as a guide.
NOTE: DO NOT photocopy the template as photocopying may distort the image. ALWAYS
MEASURE BEFORE DRILLING.
2. Route MEDRAD Mark 7 Arterion Injection System Injector Head Extension Cable and Display
Control Unit Cable through the table opening.
3. Locate the Table Cable Bracket (A). Remove the four screws (B) attaching the insert to the
bracket.
A
B
C
D
Figure 16 - 37: Table Cable Bracket Assembly
4.
5.
6.
7.
Disassemble the insert (C) by removing the socket head screws (D).
Insert and route cables through the bracket opening.
Attach the top of the insert (C) to the bracket.
Align the cables in the corresponding sized slots in the insert. Leave 4 to 6 inches of the
Injector Head Extension Cable extending beyond the opening of the bracket. Leave a suffi-
16 - 109
MEDRAD® Mark 7 Arterion Injection System
cient length of the Display Control Unit Cable extending beyond the opening of the bracket to
connect to the Display Control Unit in the desired location.
NOTE: When installing only one cable, insert the appropriate sized plug (included) into the
empty hole.
8. Re-assemble the insert (C) using the socket head screws (D) removed in step 4.
9. Mount the bracket to the table using existing hardware if already available on table. Use the
included #8 sheet metal screws if no existing hardware is available.
Figure 16 - 38: Table Mount Mounted to Table
NOTE: The minimum bend radius for the Injector Head Extension Cable is seven inches
and five inches for the Display Control Unit Cable.
16.6.6.1.2 Installing the Insert Only
1.
2.
3.
4.
5.
NOTE: Before drilling, check clearance behind the desired mounting location inside the
table. Ensure that no cables or other hardware will interfere with the installation
and function of the Table Cable Insert.
Pre-drill mounting holes using the Table Mount Cable Maintenance Insert Hole Template
provided in Appendix A.
Route Injector Head Extension Cable and Display Control Unit Cable through the opening on
the table.
Locate the Table Cable Bracket and disassemble. Remove the four screws attaching the
insert to the bracket.
Attach the top of the insert to the inside of the opening.
Align the cables in the corresponding sized slots in the insert. Leave 4 to 6 inches of the
Injector Head Extension Cable extending beyond the opening of the bracket. Leave a
sufficient length of the Display Control Unit Cable extending beyond the opening of the
bracket to connect to the Display Control Unit in the desired location.
NOTE: When installing only one cable, insert the appropriate sized plug (included) into the
empty hole.
6. Attach the bottom of the insert to the top of the insert.
NOTE: The minimum bend radius for the Injector Head Extension Cable is seven inches
and five inches for the Display Control Unit Cable.
16.6.6.1.3 Installing the Bracket and Panel Mount Plate
CAUTION
Mechanical Hazard - Minor or moderate patient and/ or worker injury may result.
• Do not create a trip hazard when installing cable bracket.
NOTE: Before drilling, check clearance behind the desired mounting location inside the
table. Ensure that no cables or other hardware will interfere with the installation
and function of the Table Cable Bracket.
1. Pre-drill mounting holes (if not already provided on the table) using the Table Mount Cable
Bracket Hole Template provided in Appendix A as a guide.
16 - 110
Installation - System and Accessory
NOTE: DO NOT photocopy the template as photocopying may distort the image. ALWAYS
MEASURE BEFORE DRILLING.
2. Route Mark 7 Arterion Injection System Injector Head Extension Cable and Display Control
Unit Cable through the table opening.
3. Locate the Table Cable Bracket (A). Remove the four screws (B) attaching the insert to the
bracket. Control Unit Cable through the table opening.
Figure 16 - 39: Table Cable Bracket Assembly
4. Discard the screws and the insert.
5. Align the cable connectors to the corresponding sized slots in the mount plate.
Figure 16 - 40: Attach Cables to Panel Mount Plate
NOTE: If attaching the DCU cable, remove the cover plate (C) from the plate.
6. Insert the cables connectors in the corresponding sized holes in the plate.
7. Attach the Panel Mount Plate to the bracket using the four 4-40 flat head, thread cutting
screws.
16 - 111
MEDRAD® Mark 7 Arterion Injection System
Figure 16 - 41: Mount Plate to Bracket
8. Mount the bracket to the table using existing hardware if already available on the table. Use
the included #8 sheet metal screws if no existing hardware is available.
Figure 16 - 42: Table Mount Mounted to Table
NOTE: The minimum bend radius for the Injector Head Extension Cable is seven inches
and five inches for the Display Control Unit CAble.
16.6.6.2 Floor Cable Bracket Installation
NOTE: Before drilling, check clearance behind the desired mounting location on the floor.
Ensure that no cables or other hardware will interfere with the installation and
function of the Floor Cable Bracket.
1. Pre-drill mounting holes using the template provided in Floor Mount Cable Bracket Hold
Template in Appendix A as a guide.
NOTE: DO NOT photocopy the template as photocopying may distort the image. ALWAYS
MEASURE BEFORE DRILLING.
2. Thread MEDRAD Mark 7 Arterion Injection System Injector Head Extension Cable and Display
Control Unit Cable through the floor opening.
16 - 112
Installation - System and Accessory
Figure 16 - 43: Cable Routing for Extension Cables
NOTE: Avoid routing extension cables with high power cables.
3. Locate the Floor Cable Bracket (A). Remove the four screws (B) attaching the insert to the
bracket.
A
B
C
D
Figure 16 - 44: Floor Cable Bracket Assembly
4.
5.
6.
7.
Disassemble the insert (C) by removing the three socket head cap screws (D).
Route extension cables through the opening in the floor bracket and the cable insert.
Attach the top of the cable insert to the bracket using the four #4-40 x 3/8” screws (B).
Align the cables in the corresponding sized slots in the insert. Leave a sufficient length of the
Display Control Unit Cable and Injector Head Extension Cable extending beyond the opening
of the bracket to connect to the Display Control Unit and Injector Head in the desired locations.
NOTE: When installing only one cable, insert the appropriate sized plug (included) into the
empty hole.
8. Attach the bottom of the insert to the top of the insert using the socket head cap screws (D).
Ensure that the top and bottom of the insert are fully seated to each other.
9. Apply RTV to the underside of the mounting bracket.
10. Mount the bracket to the floor. Hardware is included to mount the bracket to either concrete
or to wooden floors.
16 - 113
MEDRAD® Mark 7 Arterion Injection System
Figure 16 - 45: Floor Mount Mounted to Floor
NOTE: The minimum bend radius for the Injector Head Extension Cable is seven inches
and five inches for the Display Control Unit Cable.
16.6.6.2.1 Installing the Floor Bracket and Panel Mount Plate
CAUTION
Mechanical Hazard - Minor or moderate patient and/ or worker injury may result.
• Do not create a trip hazard when installing cable bracket.
NOTE: Before drilling, check clearance behind the desired mounting location on the floor.
Ensure that no cables or other hardware will interfere with the installation and
function of the Floor Cable Bracket.
1. Pre-drill mounting holes using the template provided in Floor Mount Cable Bracket Hole
Template in Appendix A as a guide.
NOTE: DO NOT photocopy the template as photocopying may distort the image. ALWAYS
MEASURE BEFORE DRILLING
2. Thread MEDRAD Mark 7 Arterion Injection System Injector Head Extension Cable and Display
Control Unit Cable through the floor opening.
NOTE: Avoid routing extension cables with high power cables.
3. Locate the Floor Cable Bracket (A). Remove the four screws (B) attaching the insert to the
bracket.
Figure 16 - 46: Floor Cable Bracket Assembly
4. Discard the screws and the insert.
5. Remove the cable strain relief from the cables to be mounted as shown below.
16 - 114
Installation - System and Accessory
Figure 16 - 47: Cable Strain Relief Removal
6. Insert the cables connectors in the corresponding sized holes in the plate.
Figure 16 - 48: Removing Cable Plate
NOTE: If attaching the DCU cable, remove the cover plate (C) from the plate.
7. Attach the Panel Mount Plate to the bracket using the four 4-40 flat head, thread cutting
screws.
Figure 16 - 49: Mount Plate to Bracket
8. Apply RTV to the underside of the mounting bracket.
9. Mount the bracket to the floor. hardware is included to mount the bracket to either concrete
or to wooden floors.
16 - 115
MEDRAD® Mark 7 Arterion Injection System
Figure 16 - 50: Floor Mount Mounted to Floor
NOTE: The minimum bend radius for the Injector Head Extension Cable is seven inches
and five inches for the Display Control Unit Cable.
16.7 Stand Mounting Kit Installation
The Mark 7 Arterion Pedestal Mounting Kit is for use with the KMA 320 RT and the KMA 330.
NOTE: Ensure the KMA 320 RT and KMA 330 have five (5) locking casters. If the stand
does not have five locking casters, contact service for part number 699-4645-100.
16.8 Power Unit Bracket Installation
A
C
D
B
E
1. Rotate the Pedestal Arm counterclockwise until you hit the stop.
2. Attach Power Unit Mounting Bracket Plate (A) to the Power Unit Tube Clamp (B) using two 1032 x 3/8 pan head Phillips screws.(C)
3. Repeat step 2.
4. Attach the assembled Power Unit Brackets to the top and bottom of the Power Unit.
NOTE: The screw head aligns with the hole in the bracket plate.
16 - 116
Installation - System and Accessory
5. Lock the casters on the pedestal.
6. Position Power Unit on the stand as shown below.
7. Loosely attach the Crescent Clamp (D) to the bottom half of the Tube Clamp using two 10-32
x 3/4 socket head screws (E) and 3/16 hex key.
8. Loosely attach the Crescent Clamp (D) to the top of the Tube Clamp using two 10-32 x 3/4
socket head screws (E) and 3/16 hex key. The Power Unit should be resting on the lowest
point of the stand.
9. Align the Power Unit as shown below and securely tighten the clamps.
16 - 117
MEDRAD® Mark 7 Arterion Injection System
16.9 Display Control Unit (DCU) Support Assembly Installation
B
A
D
F
E
G
C
1. Insert the DCU Mounting Bushing (A) into the DCU Support Post (B).
2. Align holes and secure with two 8-32 x 3/8 Phillips screws (C) using a #2 Phillips screw
driver. Do not overtighten.
16 - 118
Installation - System and Accessory
3.
4.
5.
6.
Ensure the Pedestal Arm has been rotated counterclockwise until you hit the stop.
Locate two DCU Mounting Bracket halves (D).
Orient halves together ensuring each threaded hole lines up with a through hole.
Position the DCU Mounting Bracket around the DCU post so that the bottom is approximately
41 inches from the ground.
7. Insert and loosely fasten one 1/4-20 x 1-1/4 screw (E) in the hole closest to the Stand Post.
8. Insert the assembled DCU Support Post into open hole of the DCU Mounting Bracket so that
the stop pin (H) is away from the Stand Post and bottom of the post is flush with the support.
See image below.
16 - 119
MEDRAD® Mark 7 Arterion Injection System
H
9. Insert and fasten one 1/4-20 x 1-1/4 screw (E) on the DCU Mounting Bracket into the hole
closest to the DCU Support Post.
10. Rotate DCU Support Bracket so that the bracket is positioned directly under the Pedestal
Arm.
11. Insert two 1/4-20 x 1-1/4 screws (E) into holes at ends of the DCU Mounting Bracket.
12. Position the Hand Switch and cable management (I) in between the DCU Support Post and
stand as shown below
I
13. Insert the 1/4-20 x 1 button head cap screw (G) and tighten.
14. Insert the remaining 1/4-20 x 1-1/4 screws (E) into the remaining holes on the DCU Mounting
Bracket.
15. Securely tighten all of the 1/4-20 x 1-1/4 screws on the DCU Mounting Bracket.
16 - 120
17
Specifications
This chapter lists:
•
•
•
•
"System Component Weights and Dimensions"
"Mounting Components Weights and Dimensions"
"ISI Technical Specifications"
"Environmental Specifications"
17.1 System Component Weights and Dimensions
NOTE: All listed weights and dimensions are approximate.
17.1.1 Pedestal System Weight and Dimensions
47.3 in
120.1 cm
90°
180°
150°
180°
22.0 in.
55.9 cm
45°
170°
8.6 in
21.8 cm
70°
57.4 in
145.8 cm
90°
55.8 in
141.7 cm
53.1 in
134.8 cm
48.2 in
122.4 cm
23.5 in
59.6 cm
26.1 in
66.2 cm
Weight: 146 lbs. (66.22 kg)
17 - 121
MEDRAD® Mark 7 Arterion Injection System
17.1.2 Display Control Unit Weight and Dimensions
3.040 in.
7.7 cm
12.62 in.
32.1 cm
11.042 in.
28 cm
Weight: 7lbs. (3.18kg)
17.1.3 Injector Head Weight and Dimensions
5.470 in.
13.9 cm
21.219 in.
53.9 cm
14.319 in.
36.6 cm
7.150 in.
18.2 cm
9.853 in.
25 cm
8.659 in.
22 cm
Weight: 18lbs. (8.16 kg)
17 - 122
Specifications
17.1.4 Power Unit Weight and Dimensions
9.765 in.
24.8 cm
15.213 in.
38.6 cm
4.641 in.
11.8 cm
9.765 in.
24.8 cm
Weight: 11 lbs. (4.99 kg)
17.2 Mounting Components Weights and Dimensions
NOTE: All listed weights and dimensions are approximate.
17.2.1 Pedestal Mount Weight and Dimensions
Weight*: 100 lbs. (45.35 kg)
*Weight does not include the Injector Head, Display Control Unit, or Power Unit weights.
17 - 123
MEDRAD® Mark 7 Arterion Injection System
17.2.2 Head Stand Weight and Dimensions
48.5 in.
123.19 cm
35.6 in.
90.42 cm
2 in.
5.08 cm
26.75 in.
67.95 cm
Weight*: 51.4 lbs. (23.32 kg)
*Weight does not include the Injector Head weight.
17.2.3 Adjustable Height Stand Weight and Dimensions
Weight: 56.0 lbs. (25.4 kg.)
*Measurements are in inches.
17 - 124
Specifications
17.2.4 Stand Mounting Kit Components Weights and Dimension.
17.2.4.1 Display Control Unit (DCU) Bracket Weight and Dimensions
Weight: 4.0 lbs. (1.8 kg)
*Measurements are in inches. Weight does not include DCU weight.
17.2.4.2 Power Unit Bracket Weight and Dimensions
Weight: 1.2 lbs. (0.54 kg)
* Measurement are in inches. Weight does not include Power Unit weight.
17 - 125
MEDRAD® Mark 7 Arterion Injection System
17.2.5 Adjustable Table Mount (KMA 350) Weight and Dimensions
1.99 in.
5.1 cm
12 in. Compressed
30.5 cm
17 in. Extended
43.2 cm
5.375 in.
1.44 in. 13.7 cm
3.7 cm
Weight*: 5.4 lbs. (2.44 kg)
*Weight does not include the Injector Head weight.
17.2.6 OCS Mount Weight and Dimensions
•
•
•
17 - 126
"Ceiling Mount Weight and Dimensions"
"Trolley Mount Weight and Dimensions"
"Wall Mount Weight and Dimensions"
Specifications
17.2.6.1 Ceiling Mount Weight and Dimensions
Long
39.4 in. (100.1 cm)
Medium 33.5 in. (85.1 cm)
Short
22.8 in. (57.9 cm)
29.5 in.
74.9 cm
360o
360 o
45
o
35.8 in.
90.9 cm
360 o
50 o
360 o
360o
32 in.
81 cm
System Weight*: Short Column 89.58 lbs (40.63 kg)
Medium Column 96.18 lbs (43.63 kg)
Long Column 100.66 lbs (45.66 kg)
*Weight does not include Injector Head weight.
17.2.6.2 Trolley Mount Weight and Dimensions
98.4 in. to max 157.5 in.
249.9 cm to max 400 cm
33.5 in. (85.1 cm) Medium
22.8 in. (57.9 cm) Short
29.5 in. (74.9 cm)
35.8 in. (90.9 cm)
System Weight*: Short Column 76.38 lbs (34.65 kg)
Long Column 78.58 lbs (35.64 kg)
*Weight does not include Injector Head weight.
17 - 127
MEDRAD® Mark 7 Arterion Injection System
17.2.6.3 Wall Mount Weight and Dimensions
70.5 in.
179 cm
Required for fully
extended rotation
45 °
31.5 in.
80 cm
31.5 in.
80 cm
22 in.
56 cm
1.5 in.
3.8 cm
Wall
2.5 in.
6.4 cm
50 °
57 in.
145 cm
4.5 in.
11.4 cm
28 in.
71 cm
80 in.
203 cm
Floor
System Weight*: 43.28 lbs (19.63 kg)
* Weight does not include Injector Head weight.
17 - 128
3.5 in.
9 cm
Specifications
17.2.7 Fixed Table Mount Weight and Dimensions
1.99 in.
5.1 cm
8.06 in.
20.5 cm
5.375 in.
1.438 in.13.7 cm
3.7 cm
Weight*: 3.8 lbs (1.72 kg)
*Weight does not include the Display Control Unit weight.
17.2.8 Display Control Unit Desk Stand Mount Weight and Dimensions
8.76 in.
22.3 cm
8.09 in.
20.5 cm
Weight*:
Weight*: 2.6 lbs (1.17 kg)
*Weight does not include the Display Control Unit weight.
17 - 129
MEDRAD® Mark 7 Arterion Injection System
17.2.9 Display Control Unit Wall Mount Weight and Dimensions
12.56 in.
31.9 cm
11.87 in.
30.1 cm
13.08 in.
33.2 cm
(1.00)
1 in.
2.5 cm
1.83 in.
4.6 cm
Weight*:
Weight*: 4.4 lbs (1.99 kg)
*Weight does not include the Display Control Unit weight.
17.2.10 Power Unit Floor Mount Weight and Dimensions
Weight*: 2.2 lbs (1 kg)
*Weight does not include the Power Unit weight.
17 - 130
Specifications
17.3 ISI Technical Specifications
This section outlines the Mark 7 Arterion specifications for the output signals and input signals for the
ISI, and shows pinouts for legacy ISI connector, universal cable, and Siemens cable.
NOTE: Systems are configured for Universal ISI operation. If configuring for Siemens system, contact local service for assistance.
17.3.1 ISI Output Specifications
The tables below list the output signals and the relay contact outputs for the Mark 7 Arterion ISI.
Table 17 - 1: Output Signals
Signal Name
Extended_Arm
Description
This signal is a pair of relay contacts output from the Injector. When active,
it indicates that the Injector is in an armed state and is ready to accept the
start input from the Imaging System. This signal operates as an Extended
Arm; it becomes active with the arming of the Injector and remains active
after an injection until the signal that initiated the injection (e.g.
INJ_START signal from the Imaging System) is deactivated.
NOTE: The Injector still disarms at the completion of the
injection; only this ISI armed signal is extended.
Injecting
This signal is a pair of relay contacts output from the Injector. It indicates
that the piston on the Injector is in motion.
X-Ray Trigger
This signal is a pair of relay contacts output from the Injector. When the
Injector X-ray delay has expired, this signal becomes active and notifies
the Imaging System to start the X-ray. Like the Extended Arm signal, the
X-RAY_TRIGGER signal remains active until the signal initiating the
injection (e.g. INJ_START signal from the Imaging System) is deactivated.
Inj_Hand_Switch_On
This signal is a pair of relay contacts output from the Injector. When the
INJ_HAND_SWITCH_DISABLE input is active and the Injector is armed,
this signal indicates when the Injector hand switch (contrast activation
only) or foot switch is in an “on” position; otherwise, this signal is inactive.
Table 17 - 2: Relay Contact Outputs
2A @ 28VDC or 0.5A @ 125VAC
17 - 131
MEDRAD® Mark 7 Arterion Injection System
17.3.2 ISI Input Specifications
The Mark 7 Arterion ISI is activated by a contact closure at the imaging system, and it is powered by
internal 24VDC isolated supply with short circuit protection at the Mark 7 Arterion Injector.
The tables below list the output signals and the Opto-isolated Input requirements.
Table 17 - 3: ISI Input Signals
Signal Name
Description
Inj_Start
This signal is an input to the Injector and is generated by the Imaging
System. Once the Injector is armed and the EXTENDED_ARM signal is
active, activating this signal enables the Injector to start. Deactivating
this signal during an injection will abort any injection in progress and
disarm the Injector.
Inj_Disarm
This signal is an input to the Injector and is generated by the Imaging
System. This signal must be inactive to allow the Injector to be armed.
When the Injector is armed or is injecting, activating this signal will disarm
the Injector and abort any injection in progress.
Inj_Hand_Switch_Disable
This signal is an input to the Injector and is generated by the Imaging
System. This signal must be inactive to allow the Injector hand switch and
foot switch to function normally when in ISI mode. When this signal is
active, the Injector hand switch (contrast activation only) and foot switch
are disabled from directly starting the Injector and the Injector can only be
started from a remote INJ_START control.
Table 17 - 4: Opto-isolated Inputs Requirements
10mA at 24VDC (nominal), 15mA at 30VDC (maximum).
17.3.3 ISI Connector Specifications
The figures below show the pinouts for the Legacy ISI connector, ISI Universal cable, and ISI Siemens
cable. Table 17 - 5 on page 17 - 133 provides a brief description of each pin in the Legacy ISI
Connector.
17 - 132
Specifications
Figure 17 - 1: ISI Legacy Connector (View Into Injector Connector)
1 - Injecting N/O
2 - Injecting N/O
3 - Extended_Arm N/O
4 - Extended_Arm N/O
5 - Handswitch Disable
6 - ISO_GND
7 - Remote Start
8 - Remote Disarm
9 -Remote Start
10 - X-Ray Trigger N/O
11 - X-Ray Trigger N/O
12 - Gate Out (unused)
13 - Gate Out (unused)
14 - Handswitch On N/O
15 - Handswitch On N/O
16 - AC Ground - cable shield
Table 17 - 5: ISI Legacy Connector Signals
Signal
Description
Injecting
Output signal to Imaging System that shorts pins 1 and 2 together when
the system is injecting. When not injecting, pins 1 and 2 are open.
Extended_Arm
Output signal to Imaging System that shorts pins 3 and 4 together when
the system is armed. When not armed, pins 3 to 4 are open.
Handswitch Disable
Input signal from Imaging System; when pins 5 and 6 are shorted, the
injector hand switch and/or foot switch is disabled from directly initiating
an injection. When open, the injector hand switch and/or foot switch
functions normally.
Remote Start
Input signal from Imaging System; when pins 7 and 9 are shorted, the
injector is commanded to start the injection.
Remote Disarm
Input signal from Imaging System; when pins 8 and 6 are shorted, the
injector is commanded to disarm.
X-Ray Trigger
Output signal to Imaging System that shorts pins 10 and 11 together when
active.
Gate Out
Output signal to Imaging System that shorts pins 12 and 13 together
based on an ECG R-wave signal. This signal will not be used in the Mark 7
Arterion design and is only presented for informational purposes.
Handswitch closed
Output signal to Imaging System that shorts pins 14 and 15 together as an
indication that the Mark 7 Arterion hand switch or foot switch is pressed.
17 - 133
MEDRAD® Mark 7 Arterion Injection System
ISOLATED
+24Vdc
INJ_START
9
7
ISOLATED
GROUND
RELAY
ISOLATED
+24Vdc
INJ_DISARM
8
6
ISOLATED
GROUND
RELAY
ISOLATED
+24Vdc
INJ_HAND_
SWITCH_DISABLE
5
RELAY
3
EXTENDED_ARM
4
RELAY
1
INJECTING
2
RELAY
10
X-RAY_TRIGGER
11
RELAY
14
INJ_HAND_SWITCH_ON
15
A closed relay contact
indicates the corresponding
signal is active
RELAY
Imaging System
Injector Side
Figure 17 - 2: ISI Universal Cable
17 - 134
Specifications
9
INJ_START
RELAY
ISOLATED
GROUND
ISOLATED
+24Vdc
INJ_DISARM
8
6
ISOLATED
GROUND
RELAY
ISOLATED
+24Vdc
INJ_HAND_
SWITCH_DISABLE
5
RELAY
ISOLATED
+24Vdc
EXTENDED_ARM
4
RELAY
3
ISOLATED
GROUND
ISOLATED
+24Vdc
INJECTING
2
ARMED_RETURN
ISOLATED
GROUND
10
X-RAY_TRIGGER
11
RELAY
14
INJ_HAND_SWITCH_ON
15
A closed relay contact
indicates the corresponding
signal is active
RELAY
Imaging System
Injector Side
Figure 17 - 3: ISI Siemens
17 - 135
MEDRAD® Mark 7 Arterion Injection System
17.4 Environmental Specifications
17.4.1 Operating
The system may not meet all performance specifications if operated outside the following conditions.
Temperature:
+15ºC to +30º C (+59ºF to +104ºF)
Humidity:
20% to 75% R.H.
Air Pressure:
70 kPa to 106 kPa after it has stabilized to within the operating pressure ranges.
17.4.2 Non-Operating: (Transportation and Storage)
Temperature:
-20ºC to 60ºC (-4ºF to +140ºF)
Humidity:
5% to 100% R.H.
Air Pressure:
57 kPa to 106 kPa after it has stabilized to ambient conditions.
17.4.3 EMI/RFI
The injector system is classified as Group 1, Class A equipment per the RF emission requirements of
EN 60601-1-2. Accessories provided by Bayer will also comply with this standard.
17.4.4 Equipment Classification
Type of protection against electrical shock: Class 1.
Degree of protection against electrical shock: Type CF Defibrillation-proof applied part.
Degree of protection against ingress of water: IPX1.
Degree of safety of application in the presence of a flammable anaesthetic mixture with air or with
oxygen or nitrous oxide: Equipment is not suitable for use in the presence of a flammable anaesthetic
mixture with air or with oxygen or with nitrous oxide.
Mode of operation: Continuous.
17.4.5 Class I Product
A product that is provided with a reliable protective earth (PE) such that all accessible metal parts
cannot become live in the event of a failure of basic insulation and therefore will provide protection
against electric shock in the case of failure of basic insulation.
17.4.6 Type CF Defibrillation-proof Applied Part
The Injection System is Type CF Defibrillation-proof as the System may be utilized in a situation when
the applied part is connected to the patient while defibrillation is applied. During the discharge of a
cardiac defibrillator to a patient connected to the Defibrillation-proof applied part, hazardous energies
do not appear on the enclosures, signal input and output parts.
17.4.7 IPX1
IEC 60529 classification of degree of protection (IP Code) provided by enclosures of electrical
equipment against ingress of vertically dripping water with harmful effects.
17 - 136
Specifications
17.4.8 Continuous Mode of Operation
Operation under normal load for an unlimited period, without the specified limits of temperature being
exceeded.
17.4.9 EU Directive
The MEDRAD Mark 7 Arterion Injection System complies with the essential requirements of the Medical
Device Directive 93/42/EEC and bears the CE Mark to show conformity with the provisions of this
Directive.
17 - 137
MEDRAD® Mark 7 Arterion Injection System
17 - 138
18
Options and Accessories
The sections below list catalog numbers for:
•
•
•
•
•
"Mark 7 Arterion System Mount Options"
"Mark 7 Arterion Accessory Devices and Kits"
"Mark 7 Arterion Cords and Cables"
"OCS Mounting Systems"
"OEM Imaging System Interface Cables"
18.1 Mark 7 Arterion Disposables/Syringe Kits
Description
Catalog Number
Disposable Syringe with Quick Fill Tube
ART 700 SYR
Display Control Unit Sheath
AVA 500 DCOV
18.2 Mark 7 Arterion System Mount Options
18.2.1 Injector Head Mount Options
Description
Catalog Number
Mark 7 Arterion Pedestal
ART 700 PED A
Adjustable Table Mount
KMA 350
Free Standing Stand on Wheels
KMA 320RT
Adjustable Height Stand
KMA 330
18.2.2 Power Unit Mount Options
Description
Catalog Number
Mark 7 Arterion Pedestal
ART 700 PED A
Floor Mount
ART 700 F PSU
18 - 139
MEDRAD® Mark 7 Arterion Injection System
18.2.3 Display Control Unit Mount Options
Description
Catalog Number
Mark 7 Arterion Pedestal
ART 700 PED
Adjustable Table Mount Kit (includes adjustable table mount and display mount fulcrum)
ART 700 DCU TM A
Fixed Table Mount Kit (includes fixed table mount and display mount
fulcrum)
ART 700 DCU TM
Display Mount Fulcrum
ART 700 DCU FMK
Desk Stand Kit
ART 700 DCU DM
Wall Mount
ART 700 DCU WM
18.2.4 Cable Brackets
Description
Catalog Number
Floor Cable Bracket
ART 700 CB F
Table Cable Bracket
ART 700 CB T
18.3 Mark 7 Arterion Accessory Devices and Kits
18.3.1 Switches
Description
Catalog Number
Foot switch 25 ft. (7 m) (Optional)
ART 700 FS
Hand switch 6 ft. (1.8 m) (Standard)
ART 700 HS6
Hand switch 12 ft. (3.7 m) (Optional)
ART 700 HS12
Hand switch Mount Kit
ART 700 HSM
VFlow Hand Controller
VF HC
18.3.2 Accessory Devices and Kits
Description
18 - 140
Catalog Number
Syringe Heat Maintainer
ART 700 HM
Dual Display Option (Does not include mounting)
ART 700 2DCU
Pressure Jacket
AVA 500 PJ150
Options and Accessories
18.4 Mark 7 Arterion Cords and Cables
18.4.1 Power Cords
Description
Catalog Number
Power Cord - North America and Japan - Standard Length
AVA 500 PC110V
Power Cord - North America and Japan - 20 ft. (6 m)
AVA 500 PP
Power Cord - International
AVA 500 PC220V
Power Cord - China
AVA 500 PCCHINA
Power Cord - Brazil
AVA 500 PCBRAZIL
Power Cord - Philips Cabinet - 20 ft. (6m)
ART 700 UMNL
18.4.2 Head Power and Communication Extension Cables
Description
Catalog Number
Cable Head Power - 15 ft. (4.5 m)
ART 700 HC 15
Cable Head Power - 40 ft. (12. m)
ART 700 HC 40
Cable Head Power - 65 ft. (20 m)
ART 700 HC 65
Cable Head Power - 90 ft. (27 m)
ART 700 HC 90
18.4.3 Display Cables
Description
Catalog Number
Cable Display - 10 ft. (3 m)
ART 700 DC 10
Cable Display - 25 ft. (7.5 m)
ART 700 DC 25
Cable Display - 50 ft. (15 m)
ART 700 DC 50
Cable Display - 75 ft. (23 m)
ART 700 DC 75
Cable Display - 100 ft. (30.5 m)
ART 700 DC 100
Display Extension Cable - 90 ft. (27.4m)
ART 700 DC 90
18 - 141
MEDRAD® Mark 7 Arterion Injection System
18.5 OCS Mounting Systems
18.5.1 Stationary Ceiling Mount
Description
Catalog Number
Portegra - Stationary Ceiling Mount - 22.8 in. (58 cm) Post
OCS CEIL 58-P
Portegra - Stationary Ceiling Mount - 33.5 in. (85 cm) Post
OCS CEIL 85-P
Portegra - Stationary Ceiling Mount - 39.4 in. (100 cm) Post
OCS CEIL 100-P
18.5.2 Mobile Ceiling Mount
Description
Catalog Number
Portegra 2 - Track Ceiling Mount - 22.8 in. (58 cm) Post
OCS TRACK 58-P
Portegra 2 Track Ceiling Mount - 33.5 in, (85 cm) Post
OCS TRACK 85-P
18.5.3 Wall Mount
Description
Portegra 2 - Wall mount - 33.5 in. (85 cm) Post
Catalog Number
OCS WALL-P
18.5.4 Ceiling Mount Plate
Description
Portegra 2 - Ceiling Mount Plate
Catalog Number
OCA PLATE CEIL
18.6 OEM Imaging System Interface Cables
18.6.1 General Electric
Description
18 - 142
Catalog Number
GE Advantx, 15 ft. (4.5 m)-ISI Signals Only
XMC 915R
GE Innova, 15 ft. (4.5 m)-ISI Signals Only
XMC 915R
GE Advantx, 20 ft. (6 m) Remote Power Unit, ISI Signals Only
XMC 917A
GE Innova, 20 ft. (6 m) Remote Power Unit, ISI Signals Only
XMC 917A
GE/OEC 25 ft. (8 m) - ISI Signals Only
XMC 990R
Options and Accessories
18.6.2 Philips
Description
Catalog Number
MultiDiagnost (MD) and Integris, 15 ft. (4.5 m)-ISI, Equipotential
XMC 925A
Integris (Including Integris Allura), 15 ft. (4.5 m) ISI, Equipotential
XMC 925A
XPER, 15 ft. (4.5 m)-ISI, Power, Equipotential
XMC 927A
XPER, 26 ft. (8m)-ISI, Power, Equipotential
XMC 928-A
MultiDiagnost (MD) and Integris, 40 ft. (12.2)-ISI SIgnals Only, Remote
Power Unit
XMC 945 40
XPER, 80 ft. (24 m) ISI Signals, Remote Power Unit
XMC 947R
18.6.3 Siemens
Description
Catalog Number
Axiom Artis, 16.5 ft. (5 m)-ISI, Power, Equipotential
XMC 977A
Multistar/Angiostar, 13 ft. (4 m)-ISI, Power, Equipotential
XMC 970A with 3016360
18.6.4 Ziehm
Description
Vision 26 ft. (8m) ISI Signals Only
Catalog Number
XMC 951 AI
18.6.5 Universal Imaging System Interface Cables
Description
Catalog Number
Universal Synchronization Cable, 25 ft. (8 m)
XMC 906I
Universal Synchronization Cable, 50 ft. (15 m)
XMC 906 50I
Universal Synchronization Cable, 75 ft. (23 m)
XMC 906 75I
Universal Synchronization Cable, 100 ft. (31 m)
XMC 906 100I
18.6.6 Equipotential Cables
Description
Catalog Number
Equipotential Cable, 16.4 ft. (5 m)
78101-15-AC-26
Equipotential Cable, 19.7 ft. (6 m)
GE EP TABL
18 - 143
MEDRAD® Mark 7 Arterion Injection System
18 - 144
Appendix - A Cable Bracket Installation Templates
TABLE MOUNT
CABLE BRACKET
HOLE TEMPLATE
NOTE TEMPLATE MAY NOT BE TO SCALE.
ALWAYS MEASURE BEFORE DRILLING.
3.70”
(93.98 mm)
0.17” (4.19 mm)
Through-Hole
1.0”
3 cm
DO NOT Photocopy.
Photocopying Can
Distort The Template.
5.90”
(149.86 mm)
3.00”
(76.20 mm)
MINIMUM
3.00” (76.20 mm)
Through-Hole
A - 145
MEDRAD® Mark 7 Arterion Injection System
TABLE MOUNT
CABLE INSERT
HOLE TEMPLATE
NOTE TEMPLATE MAY NOT BE TO SCALE.
ALWAYS MEASURE BEFORE DRILLING.
2.20”
(55.88 mm)
2.20”
(55.88 mm)
1.10”
(27.94 mm)
MINIMUM
2.60”(66.04 mm)
Through-Hole
DO NOT Photocopy.
Photocopying Can
Distort The Template.
A - 146
MINIMUM
0.14” (3.45 mm)
Through-Hole
1.0”
3 cm
5.00”
(127.00 mm)
0.28” (7.13 mm)
Through-Hole
FOR CABLE CONDUIT
INSTALLATION
OR
0.50” (12.70 mm) X
1.25” (31.80 mm)
FOR CEMENT FLOOR
INSTALLATION
FLOOR MOUNT
CABLE BRACKET
HOLE TEMPLATE
NOTE TEMPLATE MAY NOT BE TO SCALE.
ALWAYS MEASURE BEFORE DRILLING.
DO NOT Photocopy.
Photocopying Can
Distort The Template.
1.0”
3 cm
8.25”
(209.50 mm)
MINIMUM
3.00” (76.20 mm)
Through-Hole
3.50”
(88.90 mm)
MUST BE A MINIMUM OF 5.00” (127.00 mm)
FROM THE TABLE MOUNT PLATE
THIS END TOWARD TABLE MOUNT PLATE
A - 147
MEDRAD® Mark 7 Arterion Injection System
A - 148
A
Actuals window 29, 30
adjustable table mount
weight and dimensions 124
Arm Multi 64
prerequisites 64
Arm Single 62
armed light 33, 37
arming
Arm Multi 64
Arm Single
prerequisites 62
prerequisites 61, 63, 64
auto retract 35
Auto-Fill button 36, 37
C
cable bracket
floor 112
installation 109
table 109
catheter
connect 57
cleaning
daily 83
Display Control Unit 87
Injector Head 83
monthly 87
Pedestal 87
piston 83
Power Unit 87
Pressure Jacket 83
Syringe Heat Maintainer 87
syringe interface 83
Table Bracket 83, 87
D
desk stand 100
weight and dimensions 129
Display Control Unit 22
calibration 32
cleaning 87
desk stand 100
fixed table mount 101
fulcrum mount kit 99
Help tab 31
History tab 30
Home tab 29
inspection 86
installation 99
mounting options 99, 140
Options tab 30
sterile sheath 22
sterile sheath installation 108
wall mount 103
weight and dimensions 122
disposables
remove 73
specifications 21
drop front 33
E
Enable button 36, 37
Enable indicator 36
End Case button 30, 73
Environmental specifications
Class I Product 136
Continuous Mode of Operation 137
EMC Certifications 3
EMI/RFI 136
Equipment classification 136
EU Directive 137
IPX1 136
non-operating 136
operating 136
Safety Certifications 3
Type CF Defibrillation-proof Applied Part 136
F
fill
syringe 53
Fill Strip 36, 37
Fixed table mount
weight and dimensions 129
fixed table mount 101
floor cable bracket 112
flow rate 36
FluiDots indicators 54
foot switch 23
installation 106
fulcrum mount kit 99
H
hand switch 23
installation 106
Index - cxlvii
MEDRAD® Mark 7 Arterion Injection System
mount 107
head stand
weight and dimensions 124
Help tab 31
high pressure connector tubing
installation 54, 55
purge 55
specifications 21
History tab 30
Home tab 29
I
Imaging System Interface 23
Imaging System initiates protocol 67
Imaging System initiates protocol (Philips Imaging
Systems Only) 68
Injection system initiates injection 67
input specifications 132
output specifications 131
Inject position 34
injection
complete 69
initiate 65
initiate phased 66
initiate single ml/m 65
initiate single ml/s (Arm Multi) 65
initiate single ml/s (Arm Single) 65
perform with Imaging System Interface 66
injector
unpack 91
Injector Head
armed light 33, 37
cleaning 83
controls 33
displays 33, 36
drop front 33
handle 33
head stand installation 99
inspection 85
manual knob 33, 38
mounting options 99
OCS 99
Pressure Jacket 33
weight and dimensions 122
Injector Head displays 36, 37
Injector Head Orientation
Index - cxlviii
Inject position 34
Intermediate position 34
Purge position 34
syringe interface 34
injector storage 74
inspection
Display Control Unit 86
Injector Head 85
Pedestal 87
Power Unit 87
Air Filter 87
Pressure Jacket 85
Table Mount 86
installation
cable bracket 109
desk stand (Display Control Unit) 100
Display Control Unit 99
fixed table mount (Display Control Unit) 101
floor cable bracket 112
floor mount bracket (Power Unit) 97
foot switch 106
fulcrum mount kit (Display Control Unit) 99
hand switch 106
head stand (Injector Head) 99
high pressure connector tubing 54, 55
Injector Head 99
OCS (Injector Head) 99
Pedestal 92
Power Unit 95
syringe 51
Syringe Heat Maintainer 105
wall mount (Display Control Unit) 103
Intermediate position 34
ISI, see Imaging System Interface
M
manual knob 33, 38
modify options 31
O
OCS
installation 99
weight and dimensions 126
Operational Checkout 88
Options tab 30
modify 31
P
Pedestal
cleaning 87
inspection 87
installation 92
weight and dimensions 123
pedestal system
weight and dimensions 121
piston
cleaning 83
Popups 77
Power Unit 23
Air Filter 87
cleaning 87
connections 96
floor mount 97
input requirements 20
inspection 87
installation 95
relocate connectors 98
weight and dimensions 123
Power up 39
Pressure Jacket 33, 84
cleaning 83, 84
description 35
inspection 85
storage 35
pressure limit 36
pressure limiting 20
Programmed window 29
set Phased protocol 42
set Single protocol 41
protocol
create Phased on Protocols tab 45
create Single ml/m on Protocols tab 44
create Single ml/s on Protocols tab 44
define 59
delete 49
edit 48
edit phased 48
edit single ml/m 48
edit single ml/s 48
recall stored 47
set phased in Programmed window 42
set single in Programmed window 41
Protocols tab 30
create Phased protocol 45
create Single ml/m 44
create Single ml/s 44
purge
confirmation 61
high pressure connector tubing 55
purge action 61
syringe 53, 70
Purge position 34
purge, 15 mL Purge Feature 58, 71
Q
Quick Fill Tube 53
R
refill syringe 70
rise time 42
S
Sentinel window 29, 30
messages 75
sterile sheath installation 108
syringe
fill 53
installation 51
purge 53, 70
refill 70
Syringe Heat Maintainer 22, 38
cleaning 87
installation 105
syringe interface 34
cleaning 83
T
Table Bracket
cleaning 83, 87
table cable bracket 109
installation 109
insert only 110
Table Mount
inspection 86
V
volume 36
volume remaining 36
volume remaining icon 36
W
wall mount 103
convert swing direction 104
Index - cxlix
MEDRAD® Mark 7 Arterion Injection System
weight and dimensions 130
weight and dimensions
adjustable table mount 124
desk stand 129
Display Control Unit 122
Fixed table mount 129
head stand 124
Injector Head 122
OCS 126
Pedestal 123
pedestal system 121
Power Unit 123
wall mount 130
Index - cl
© 2011-2014, 2016 Bayer. All rights reserved. Reproduction of
this manual is strictly prohibited without express written
consent of Bayer Medical Care Inc.
Bayer, the Bayer Cross, MEDRAD, Mark 7 Arterion, MEDRAD
Mark 7 Arterion, ProVis, FluiDots, MEDRAD VFlow, Twist & Go
and VirtualCare may be registered trademarks of Bayer in the
US and other countries.
MAVIG, Portegra, Innova, Advantx, Allura, Integris, Integris
Allura, MultiDiagnost, XPER, Axiom, Artis, Multistar, Angiostar
and Ziehm Vision may be registered trademarks of their
respective owners and are used herein solely for informative
purposes. No relationship or endorsement should be inferred
or implied.
In accordance with data privacy and protection laws in the
United States and other countries, all patient data that
appear in this document are fictitious. No actual patient
information is shown.
Radiology
www.radiology.bayer.com
UNITED STATES
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U.S.A.
Phone: +1.412.767.2400
+1.800.633.7231
Fax:
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60725959 Rev. H October 25, 2016
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