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Mark 7 Arterion
Operation Manual
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Medrad Mark 7 Arterion Operation Manual

READ BEFORE USING
Operation Manual
1 Information .......................................................................................................................1 - 1
1.1 Important Safety Notice..................................................................................................................................... 1 - 1
1.2 Disclaimers ....................................................................................................................................................... 1 - 1
2 About This Manual...........................................................................................................2 - 3
2.1 Intended Use..................................................................................................................................................... 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
9.1.1 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
9.2.1 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

1Information

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 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.
®
Mark 7

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
NOTICE
d
3.5
V
1
-------
p=
d
3.5
E
1
-------
p=
d
7
E
1
----- -
p=

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.
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
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.
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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
RF emissions CISPR 11
Harmonic current emissions IEC 61000-3-2
Voltage fluctuations/flicker emissions IEC 61000-3-3
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
Electrical/fast transient/burst IEC 61000-4-4
Group 1
Class A
Class A
Complies
6 kV contact8 kV air
2 kV for power supply
lines
1 kV for input/output
lines
6 kV contact8 kV air
2 kV for power supply
lines
1 kV for input/output
lines
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.
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.
Floors should be wood, concrete or ceramic tile. If floors are covered with a synthetic material, the relative humidity should be at least 30%
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
2 - 5
MEDRAD® Mark 7 Arterion Injection System
d 1.17 p=
d 1.17 p=
Table 2 - 3: Guidance and manufacturer's declaration - electromagnetic immunity
<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
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
Power frequency (50/60 Hz) magnetic field
3 A/m 3 A/m
IEC 61000-4-8
NOTE: UT is the a.c. mains voltage prior to application of the test level.
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.
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
Radiated RF IEC 61000-4-3
3 V rms 150 kHz to 80 MHz
3 V/m 80 MHz to 2.5 GHz
3 V rms
3 V/m
80 MHz to 800 MHz
2 - 6
About This Manual
d 2.33 p=
Table 2 - 4: Guidance and manufacturer's declaration - electromagnetic immunity
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
a
survey,
should be less than the
compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked with the following symbol:
b
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.
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MEDRAD® Mark 7 Arterion Injection System
2 - 8

3 Symbols and Icons

IPX1
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

.

3.3 Warnings

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
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.
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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.
Indicates that the information is a warning. Warnings advise you of
WARNING
circumstances that could result in serious injury or death to the patient or operator. Read and understand the warnings before operating the injection system.
Indicates that the information is a caution. Cautions advise you of
CAUTION
NOTICE
NOTE
circumstances that could result in minor or moderate injury to the patient or operator. Read and understand the cautions before operating the injection system.
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.
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.
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Indicates that Display Control Unit is locked because someone is accessing another Display Control Unit or the Injector Head controls.
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.
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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.
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3.5 Packaging

Rx Only
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.
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
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.
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MEDRAD® Mark 7 Arterion Injection System
CB
Sterilized with Ethylene Oxide.
Use By
Atmospheric Pressure Limitation
Chinese Recycling symbol for paperboard.
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
This Way Up
Not made with natural rubber latex.
Symbols and Icons
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.
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MEDRAD® Mark 7 Arterion Injection System
CAUTION
NOTICE

4.2 Cautions

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

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.
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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"
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.
Figure 5 - 1: Mark 7 Arterion Injection System
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
Fluid Viscosity Low High
Catheter and
Tubing Length
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
Decrease
Pressure
Short Long
Increase Pressure
5 - 20

5.3.2 Technical Specifications

Flow Rate:
Volume: 1-150 mL in 1 mL increments
System Overview
Table 5 - 1: System Technical Specs
0.1-45.0 mL/s in 0.1 mL/s increments (single and phased)
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)
Pressure Limit (150 mL syringe):
Rise Time: 0.0-9.9 seconds in 0.1s increments
Delay Time:
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
100-1200 psi in 1 psi increments
689-8273 kPa in 1 kPa increments
0.0-99.9 seconds in 0.1s 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.
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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.
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"
Figure 5 - 2: Display Control Unit
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".
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Figure 5 - 3: Injector Head
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