Medrad Mark 7 Arterion User manual

Operation Manual
READ BEFORE USING

i
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

MEDRAD®Mark 7 Arterion Injection System
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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

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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

MEDRAD®Mark 7 Arterion Injection System
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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

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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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1 - 1
1Information
1.1 Important Safety Notice
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.
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.

MEDRAD®Mark 7 Arterion Injection System
1 - 2

2 - 3
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.

MEDRAD®Mark 7 Arterion Injection System
2 - 4
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.
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.
NOTICE
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
Rated maximum output
power of transmitter W
Separation distance according to frequency of transmitter
150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
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
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.
d3.5
V1
-------p=
d3.5
E1
-------p=
d7
E1
------p=

About This Manual
2 - 5
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 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.
Harmonic current emissions
IEC 61000-3-2 Class A
Voltage fluctuations/flicker
emissions
IEC 61000-3-3
Complies
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%
Electrical/fast
transient/burst
IEC 61000-4-4
2 kV for power supply
lines
1 kV for input/output
lines
2 kV for power supply
lines
1 kV for input/output
lines
Mains power quality should be that of a
typical commercial or hospital
environment.
Surge
IEC 61000-4-5
1 kV differential
mode
2 kV common mode
1 kV differential
mode
2 kV common mode
Mains power quality should be that of a
typical commercial or hospital environment

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Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the injector
requires continuous operation during
power mains interruptions, it is
recommended the injector be powered
from an uninterruptible power supply or
battery
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic fields should be
at levels characteristic of a typical location
in a typical commercial or hospital
environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
Table 2 - 3: Guidance and manufacturer's declaration - electromagnetic immunity
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
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz 3 V/m 80 MHz to 800 MHz
d1.17 p=
d1.17 p=

About This Manual
2 - 7
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.
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,ashould 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.
Table 2 - 4: Guidance and manufacturer's declaration - electromagnetic immunity
d2.33 p=

MEDRAD®Mark 7 Arterion Injection System
2 - 8

3 - 9
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
3.2 Regulatory Classifications
.
3.3 Warnings
Indicates that this device conforms to requirements of the European Medical
Device Directive 93/42/EEC
Type Cardial Floating (CF) Defibrillation-Proof applied part as defined by IEC
60417-2.
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
IPX1
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.

MEDRAD®Mark 7 Arterion Injection System
3 - 10
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
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.
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.

Symbols and Icons
3 - 11
3.4.2 Injector Head Buttons 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.
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.

MEDRAD®Mark 7 Arterion Injection System
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3.4.3 Power Unit Icons
Hand Controller.
Identifies the Service Port.
Pressure Jacket Syringe Alignment.
J31
J32
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.