Operation Manual
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Operation Manual
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MEDRAD Mark 7 Arterion™ Injection System Operation Manual
Mark 7 Arterion Injection System
MEDRAD Contact Information MEDRAD, INC. One Medrad Drive Indianola, PA 15051-0780 U.S.A. Phone: +1 (412) 767-2400 +1 (800) MEDRAD1 +1 (800) 633-7231 Fax: +1 (412) 767-4120
MEDRAD Europe B.V. P.O. Box 205 6190 AE Beek The Netherlands Phone: +31(0)43-3585600 Fax: +31(0)43-3656598 Nihon MEDRAD KK Breeze Tower 2-4-9, Umeda, Kita-ku, Osaka 530-0001, Japan Phone: +81(0)66-133-6250 Fax: +81(0)66-344-2395 MEDRAD Medical Equipment Trading Company - Beijing Air China Plaza Xiao Yun Lu #36, 401-402 Chao Yang District, Beijing Phone: 400-810-7070 Fax: +86(10)8447-5292 ©2011-2014, 2016 MEDRAD, INC. All rights reserved. Reproduction of this manual is strictly prohibited without express written consent of MEDRAD, INC. For more information about MEDRAD products and services, please visit WWW.MEDRAD.COM
Table of Contents 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 - 3 2.5 Restricted Sales .........................................................................................................................................2 - 7 2.6 Trademarks................................................................................................................................................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 - 23 5.11 Pedestal and Stand Movement...............................................................................................................5 - 24 5.11.1 Pedestal System ..........................................................................................................................5 - 24 5.11.2 Head Stand (KMA 320 RT) and Adjustable Height Stand (KMA 330)...........................................5 - 25 5.11.3 Mark 7 Arterion Stand Mounting Kit Configuration......................................................................5 - 26
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6 Using and Understanding the Display Control Unit Screen ...................................... 6 - 27 6.1 Home Tab ................................................................................................................................................6 - 27 6.1.1 Programmed Window....................................................................................................................6 - 27 6.1.2 Actuals Window.............................................................................................................................6 - 28 6.1.3 Sentinel Window............................................................................................................................6 - 28 6.2 Protocols Tab...........................................................................................................................................6 - 28 6.3 History Tab ..............................................................................................................................................6 - 28 6.4 Options Tab .............................................................................................................................................6 - 28 6.4.1 Modify Options ..............................................................................................................................6 - 29 6.5 Help Tab...................................................................................................................................................6 - 29 6.6 Display Control Unit Lock-outs ................................................................................................................6 - 30 6.7 Performing Touch Screen Calibration ......................................................................................................6 - 30
7 Using and Understanding the Injector Head............................................................... 7 - 31 7.1 Injector Head Components ......................................................................................................................7 - 31 7.2 Injector Head Position..............................................................................................................................7 - 32 7.3 Syringe Interface......................................................................................................................................7 - 33 7.3.1 Piston Auto Retract........................................................................................................................7 - 33 7.4 Pressure Jacket .......................................................................................................................................7 - 33 7.4.1 Pressure Jacket Storage ................................................................................................................7 - 33 7.5 Injector Head Displays .............................................................................................................................7 - 33 7.5.1 Flow Rate (A) .................................................................................................................................7 - 34 7.5.2 Volume (B) ....................................................................................................................................7 - 34 7.5.3 Pressure Limit (C) .........................................................................................................................7 - 34 7.5.4 Volume Remaining (D) ..................................................................................................................7 - 34 7.6 Injector Head Controls .............................................................................................................................7 - 34 7.6.1 Enable Button (F) ...........................................................................................................................7 - 35 7.6.2 Fill Strip (H) ...................................................................................................................................7 - 35 7.6.3 Auto-Fill Button (I) .........................................................................................................................7 - 35 7.7 Armed Light .............................................................................................................................................7 - 35 7.8 Manual Knob............................................................................................................................................7 - 36 7.9 Syringe Heat Maintainer...........................................................................................................................7 - 36 7.10 Injector Head Lock-outs.........................................................................................................................7 - 36
8 Power Up and Shutdown the Injector.......................................................................... 8 - 37 8.1 Powering up the System ..........................................................................................................................8 - 37 8.2 Shutdown ................................................................................................................................................8 - 37 8.3 Emergency Shutdown ..............................................................................................................................8 - 37
9 Setting and Managing Protocols.................................................................................. 9 - 39 9.1 Set Injection Parameters from the Home Tab ..........................................................................................9 - 39 9.1.1 Set Injection Parameters on Home Tab - Single ............................................................................9 - 39 9.1.2 Set Injection Parameters on Home Tab - Phased...........................................................................9 - 40 9.1.3 Set Injection Parameters on Home Tab - Variable Flow Rate .........................................................9 - 41 9.2 Manage Protocols from the Protocols Tab...............................................................................................9 - 42 9.2.1 Create Protocols ............................................................................................................................9 - 42 9.2.2 Recall a Stored Protocol ................................................................................................................9 - 46 9.2.3 Edit an Existing Protocol................................................................................................................9 - 46 9.2.4 Delete a Protocol ...........................................................................................................................9 - 47
10 Preparing for Injection .............................................................................................. 10 - 49 10.1 Installing the Mark 7 Arterion or Twist & Go Syringe...........................................................................10 - 49 10.2 Filling and Purging the Mark 7 Arterion or Twist & Go Syringe............................................................10 - 51
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10.3 Installing and Purging Standard High Pressure Connector Tubing .....................................................10 - 52 10.4 Installing and Purging Twist & Go HPCT .............................................................................................10 - 53 10.5 Installing the MEDRAD® VFlow™Hand Controller ...............................................................................10 - 54 10.6 Connecting to and Purging the Catheter ..............................................................................................10 - 55 10.7 Define a Protocol .................................................................................................................................10 - 56 10.8 Turn ISI On or Off ................................................................................................................................10 - 56
11 Arming and Injecting ................................................................................................. 11 - 59 11.1 Purged Air Confirmation ......................................................................................................................11 - 59 11.2 Arming the Injector ..............................................................................................................................11 - 59 11.2.1 Arm Single Mode .......................................................................................................................11 - 60 11.2.2 Arm Multi Mode.........................................................................................................................11 - 62 11.3 Performing an Injection .......................................................................................................................11 - 63 11.3.1 Performing a Single mL/s Injection in Arm Single Mode ...........................................................11 - 63 11.3.2 Performing a Single mL/m Injection in Arm Single Mode .........................................................11 - 63 11.3.3 Performing a Single mL/s or Variable Flow Rate Injection in Arm Multi Mode...........................11 - 63 11.3.4 Performing a Phased Injection ..................................................................................................11 - 64 11.3.5 Performing an Injection with Imaging System Interface (ISI) ....................................................11 - 64 11.4 Completing an Injection ......................................................................................................................11 - 67 11.5 Refill Syringe During a Procedure........................................................................................................11 - 68
12 Tear Down .................................................................................................................. 12 - 71 12.1 Remove Disposables ...........................................................................................................................12 - 71 12.2 Clean up...............................................................................................................................................12 - 71 12.3 Storing the Injector ..............................................................................................................................12 - 72
13 System Messages...................................................................................................... 13 - 73 13.1 Error Messages....................................................................................................................................13 - 73 13.2 Sentinel Messages ...............................................................................................................................13 - 73 13.3 Popup Messages .................................................................................................................................13 - 75
14 VirtualCARE® Option ................................................................................................ 14 - 79 15 Cleaning and Maintenance ....................................................................................... 15 - 81 15.1 Daily.....................................................................................................................................................15 - 81 15.1.1 Cleaning the Injector Head, Syringe Heat Maintainer, Drop Front Cover, Pressure Jacket, Piston, Syringe Interface, and Table Bracket ................................................................................................................................15 - 81 15.1.2 Inspecting the Injector Head ......................................................................................................15 - 83 15.1.3 Inspecting the Pressure Jacket ..................................................................................................15 - 83 15.1.4 Inspecting the Heat Maintainer ..................................................................................................15 - 84 15.1.5 Inspecting the Display Control Unit ...........................................................................................15 - 84 15.1.6 Inspecting the Table Mount Bracket...........................................................................................15 - 84 15.1.7 Inspecting the Pedestal..............................................................................................................15 - 85 15.1.8 Inspecting the Power Unit..........................................................................................................15 - 85 15.2 Monthly................................................................................................................................................15 - 85 15.2.1 Cleaning the Display Control Unit, Pedestal, Power Unit, and Table Bracket..............................15 - 85 15.2.2 Inspecting and Cleaning the Internal Air Filter ...........................................................................15 - 85 15.2.3 Performing an Operational Checkout .........................................................................................15 - 86 15.3 Annually ...............................................................................................................................................15 - 88 15.3.1 Injection System Calibration ......................................................................................................15 - 88 15.3.2 Checking Leakage ......................................................................................................................15 - 88
16 Installation - System and Accessory ....................................................................... 16 - 89 16.1 Unpacking the Injection System...........................................................................................................16 - 89
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16.2 Pedestal Mount Installation..................................................................................................................16 - 90 16.3 Power Unit Installation.........................................................................................................................16 - 93 16.3.1 Power Unit Connections ............................................................................................................16 - 94 16.3.2 Power Unit Floor Mount Bracket Assembly................................................................................16 - 95 16.3.3 Relocate Power Unit Connectors ...............................................................................................16 - 96 16.4 Injector Head Mounting Options ..........................................................................................................16 - 97 16.4.1 Head Stand Installation (KMA 320RT) .......................................................................................16 - 97 16.4.2 Adjustable Height Stand Installation (KMA 330) ........................................................................16 - 97 16.4.3 Adjustable Table Bracket Installation (KMA 350) .......................................................................16 - 97 16.4.4 Overhead Counterpoised System Installation ............................................................................16 - 97 16.5 Display Control Unit Mounting Options................................................................................................16 - 97 16.5.1 Fulcrum Mount Kit Installation...................................................................................................16 - 97 16.5.2 Desk Stand Kit Installation.........................................................................................................16 - 98 16.5.3 Fixed Table Mount Installation ...................................................................................................16 - 99 16.5.4 Wall Mount Bracket Installation ...............................................................................................16 - 101 16.6 Accessory Installation ........................................................................................................................16 - 103 16.6.1 Syringe Heat Maintainer Installation ........................................................................................16 - 103 16.6.2 Syringe Pressure Jacket Installation ........................................................................................16 - 104 16.6.3 Hand Switch and Foot Switch Installation................................................................................16 - 104 16.6.4 Hand Switch Mount Kit ...........................................................................................................16 - 105 16.6.5 Display Control Unit Sterile Sheath Installation........................................................................16 - 106 16.6.6 Cable Bracket Installation.........................................................................................................16 - 107 16.7 Stand Mounting Kit Installation..........................................................................................................16 - 114 16.8 Power Unit Bracket Installation ..........................................................................................................16 - 115 16.9 Display Control Unit (DCU) Support Assembly Installation................................................................16 - 117
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
A Cable Bracket Installation Templates ...................................................................... A - 145 Index................................................................................................................................... 1-149
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1
Information
1.1 Important Safety Notice This manual and the equipment it describes are for use by qualified medical professionals with proper training and experience in angiographic procedures and the use of the 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 MEDRAD syringes and that use of other, unauthorized syringes, may result in syringe rupture or leaking. Accordingly, only authentic MEDRAD syringes should be used in the operation of Arterion Injector system. The safe and effective use of the Mark 7 Arterion Injection System to a large degree depends upon factors solely under the control of the medical professionals using the system. There is no substitute for a properly trained and vigilant angiographic team. It is important that the operating instructions and the user warnings and cautions supplied with this injection system be read, understood and followed. Before starting any angiographic injection procedure, the angiographic team should be trained in the particular angiographic procedures to be performed. In addition, the angiographic team should be familiar with the medical literature related to angiographic procedures and the benefits of performing angiographic procedures with automated injection systems versus the potential complications and risks, including but not limited to air embolism. Read and understand all the information contained in this manual. Understanding this information will assist you in operating the Mark 7 Arterion Injection System in a safe and effective manner.
1.2 Disclaimers Operating specifications and feature availability may vary by country. Check with your local product representative and county-specific operating instructions. External wiring and modifications disclaimers: MEDRAD 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 MEDRAD Service.
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 MEDRAD Customer Service or local MEDRAD representative if any of these resources are needed.
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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/CSAC22.2 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/CSA 601-1 - 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.
2.4 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.
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The following statements are notices. Notices advise of circumstances that could result in damage to the device. Read and understand these cautions before operating the injector system.
NOTICE Electro-Mechanical Hazard - Equipment Damage may result. • For proper operation, use only accessories and options provided by MEDRAD that are designed specifically for the injector system. Other non-MEDRAD 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 3.5 d = ------V1
80 MHz to 800 MHz 3.5 d = ------E1
p
800 MHz to 2.5 GHz 7 d = -----E1
p
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74
1
1.17
1.17
2.33
10
3.69
3.69
7.38
100
11.67
11.67
23.33
p
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1
At 80 MHz and 800 MHz, the separation distance for the higher frequency applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
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INJECTOR REQUIRES SPECIAL PRECAUTIONS REGARDING EMC. Install and put into service according to the EMC information provided below: Table 2 - 2: Guidance and manufacturer's declaration - electromagnetic emissions The injector is intended for use in the electromagnetic environment specified below. The customer or user of the injector should assure that it is used in such an environment. Emission Test
Compliance
Electromagnetic Environment - Guidance
RF emissions CISPR 11
Group 1
The injector uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11
Class A
Harmonic current emissions IEC 61000-3-2
Class A
Voltage fluctuations/flicker emissions IEC 61000-3-3
Complies
Notice: This injector is intended for use by healthcare professionals only. This injector may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the injector or shielding the location.
Table 2 - 3: Guidance and manufacturer's declaration - electromagnetic immunity The injector is intended for use in the electromagnetic environment specified below. The customer or user of the injector should assure that it is used in such an environment. Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment - guidance
Electrostatic discharge (ESD) IEC 61000-4-2
+6 kV contact +8 kV air
+6 kV contact +8 kV air
Floors should be wood, concrete or ceramic tile. If floors are covered with a synthetic material, the relative humidity should be at least 30%
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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Table 2 - 3: Guidance and manufacturer's declaration - electromagnetic immunity
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 NOTE:
<5% UT (>95% dip in UT) for 0.5 cycle
<5% UT (>95% dip in UT) for 0.5 cycle
40% UT (60% dip in UT) for 5 cycles
40% UT (60% dip in UT) for 5 cycles
70% UT (30% dip in UT) for 25 cycles
70% UT (30% dip in UT) for 25 cycles
<5% UT (>95% dip in UT) for 5 sec
<5% UT (>95% dip in UT) for 5 sec
3 A/m
3 A/m
Mains power quality should be that of a typical commercial or hospital environment. If the user of the injector requires continuous operation during power mains interruptions, it is recommended the injector be powered from an uninterruptible power supply or battery
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
UT is the a.c. mains voltage prior to application of the test level.
Table 2 - 4: Guidance and manufacturer's declaration - electromagnetic immunity The injector is intended for use in the electromagnetic environment specified below. The customer or user of the injector should assure that it is used in such an environment. Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the injector, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended Separation Distance
Conducted RF IEC-61000-4-6
3 V rms 150 kHz to 80 MHz
3 V rms
Radiated RF IEC 61000-4-3
3 V/m 80 MHz to 2.5 GHz
3 V/m
2-6
d = 1.17 p
d = 1.17 p
80 MHz to 800 MHz
About This Manual
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 survey,a should be less than the compliance level in each frequency range.b d = 2.33 p
Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the injector is used exceeds the applicable RF compliance level above, the injector should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the injector. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
2.5 Restricted Sales Rx Only - U.S. Federal law restricts this device to sale by or on the order of a licensed health care practitioner.
2.6 Trademarks Unless otherwise indicated, all trademarks are owned by MEDRAD, INC. or licensed for its use.
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Symbols and Icons The symbols and icons discussed in the sections below describe the requirements to which the Mark 7 Arterion Injection System conforms, how warnings are displayed in manual, and the icons used on the equipment and equipment packaging.
3.1 Notified Body Indicates that this device conforms to requirements of the European Medical Device Directive 93/42/EEC
3.2 Regulatory Classifications .
Type Cardial Floating (CF) Defibrillation-Proof applied part as defined by IEC 60417-2.
Indicates that this device conforms to CSA requirements.
IPX1 Code that specifies the degree of protection against vertically falling water drops (IEC 60529). Indicates separate collection for Electrical and Electronic Equipment per Directive 2002/96/EC . Refer to the following website for additional information: http://www.medrad.com/en-us/resources/Pages/WEEE.aspx
3.3 Warnings
Indicates risk of electric shock.
Indicates a pinch or crush hazard.
Attention, consult accompanying instructions.
Indicates hot surface. Item can be hot and should not be touched without taking care.
Pushing Prohibited. Do not push at or above this point on the Injector.
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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 MEDRAD® Syringes.
Table Mount Warning Patient or operator injury could occur if all knobs are not properly tightened. Ensure that all knobs are securely tightened before use. Do not overtighten.
WARNING
Indicates that the information is a warning. Warnings advise you of circumstances that could result in serious injury or death to the patient or operator. Read and understand the warnings before operating the injection system.
CAUTION
Indicates that the information is a caution. Cautions advise you of circumstances that could result in minor or moderate injury to the patient or operator. Read and understand the cautions before operating the injection system.
NOTICE
Indicates that the information is a notice. Notices advise you of circumstances that could result in damage to the device. Read and understand the notices before operating the injection system.
NOTE
Indicates that the information that follows is additional important information or a tip that will help you recover from an error or point you to related information within the manual.
3.4 Buttons and Icons The buttons on the Display Control Unit (DCU), Injector Head, and Power Unit allow operators to access functions on the injector system. The icons used on the DCU, Injector Head, and Power Unit notify operators about system processes and identify connection ports.
3.4.1 Display Control Unit Buttons and Icons The Display Control Unit brightness controls. Purged Air Confirmation icon - indicates that the operator has confirmed that all air has been purged. Indicates that Display Control Unit is locked because someone is accessing another Display Control Unit or the Injector Head controls.
The On/Off Switch.
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Symbols and Icons
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.
J31
Hand Controller.
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Mark 7 Arterion Injection System
J32
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 MEDRAD 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.
Identifies the service port. NOTE: Used by MEDRAD Service or MEDRAD trained personnel.
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Symbols and Icons
Future expansion port. Future expansion port. Future expansion port.
3.5 Packaging Catalog Number
Consult instructions for use.
Do not Re-sterilize.
Do not use if package is damaged.
Do Not Reuse
Batch Code
Date of Manufacture/Sterilization
Non-Pyrogenic Fluid Path
Rx Only
Prescription Device - U.S. Federal law restricts this device to sale by or on the order of a (licensed health care practitioner). Serial number Sterilized using Irradiation.
Sterilized with Ethylene Oxide.
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Mark 7 Arterion Injection System
Use By
Atmospheric Pressure Limitation
Chinese Recycling symbol for paperboard.
CB
Chinese Recycling symbol for corrugated cardboard.
Do Not Stack
Authorized Representative in the European Community.
Fragile, Handle with care
Humidity limitation
ISTA tested
Keep Dry
Manufacturer
China ROHS - Environmental Protection use Period Mark.
Temperature Limitation
This Way Up
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Symbols and Icons
Not made with natural rubber latex.
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Mark 7 Arterion Injection System
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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 MEDRAD 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-MEDRAD 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. Environmental Contamination Hazard - Serious patient or worker injury or death may result. • Visually inspect contents and package before use. • Do not use if package integrity is compromised. Cross contamination hazard - Serious patient and/or worker injury or death may result. • Ensure only MEDRAD syringes are used on the system. • Do not store filled syringes for later use. • Discard previously filled unused syringes. • Do not reuse disposables. 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 MEDRAD Service or MEDRAD 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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Mark 7 Arterion Injection System
4.2 Cautions CAUTION Environmental Contamination Hazard - Minor or moderate patient and/ or worker injury may result. • Follow sterile technique specifically, maintain sterility of the syringe tip and plunger, syringe barrel internal surface, Quick Fill Tube, high pressure connector tubing, catheter, and Display Control Unit Sheath. • Properly discard disposables after use, in accordance with hospital hazard waste disposal procedures. Mechanical Hazard - Minor or moderate patient and/ or worker injury may result. • Do not use injector head handle to move injector system. • Do not use the cabling or syringe to position injector system. • Do not use system in the presence of flammable or combustible gases or other agents. • Turn off system power and disconnect patient when system malfunction occurs.
4.3 Notices NOTICE Mechanical Hazard - Equipment Damage may result. • Do not hang items on the Display Control Unit or Wall Mounting Bracket. • Do not oil the friction plate on the Wall Mount Bracket. Electro-Mechanical Hazard - Equipment Damage may result. • Do not use tools to over tighten connections or to assist in the removal of disposables. • Do not roll pedestal over cables. • Regular preventive maintenance is recommended to ensure that the system stays calibrated and functions properly. Refer to maintenance section of this manual or contact MEDRAD 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"
Figure 5 - 1: Mark 7 Arterion Injection System
A
Display Control Unit
B
Injector Head
C
Power Unit
5.1 Injection Protection The following means are provided to protect against over and under injections: An on-screen indication of insufficient volume is provided whenever the total volume programmed to be delivered is greater than the amount of fluid in the syringe. The system monitors injections to detect over rate or over volume conditions due to system faults. The delivered volume is also monitored against the total programmed volume for the injection.
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Mark 7 Arterion Injection System
Once the system has disarmed a tone will sound and a disarm message displays on the Display Control Unit screen. When any fault condition is detected, the injection will stop.
5.2 Pressure Limiting The purpose of the programmed pressure limit is to protect the patient, the catheter, and any disposable device attached to the injector. As a general rule, set pressure limit no higher than the max pressure rating of the weakest component in the fluid path (tubing, stopcocks, connectors, catheters, administration sets, etc.). Max pressure rating examples for an example scenario: • • •
Tubing - 1200 psi Stopcock - 1050 psi Catheter - 1200 psi
In this case, set the pressure limit no higher than 1050 psi because anything higher could potentially cause the component to fail. Typical factors to consider and how they affect Pressure: Effects on Pressure Factors
Decrease Pressure
Increase Pressure
Fluid Viscosity
Low
High
Catheter and Tubing Length
Short
Long
Catheter ID
Large
Small
Consider the above factors when setting pressure limit to achieve the desired injection flow rate. Proper pressure limit setting optimizes the angiographic images. The injector applies the minimum pressure needed to achieve the programmed flow rate. If the pressure from the injector exceeds the programmed pressure limit, the system cannot achieve the flow rate and a Sentinel message displays. Pressure information can be found in the History tab.
5.3 System Technical Specifications 5.3.1 Input Power Requirements 100-240 VAC 50/60 Hz 1000 VA
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System Overview
5.3.2 Technical Specifications Table 5 - 1: System Technical Specs 0.1-45.0 mL/s in 0.1 mL/s increments (single and phased) Flow Rate: 0.1-59.9 mL/m in 0.1 mL/m increments (single mL/m) 1.0-10.0 mL/s in 0.1mL/s increments (variable) Volume:
1-150 mL in 1 mL increments 100-1200 psi in 1 psi increments
Pressure Limit (150 mL syringe):
689-8273 kPa in 1 kPa increments
Rise Time:
0.0-9.9 seconds in 0.1s increments
Delay Time:
0.0-99.9 seconds in 0.1s increments
Fill Speed:
1-20 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
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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Mark 7 Arterion Injection System
5.5 Display Control Unit The injection system Display Control Unit consists of a touch screen display. From the Display Control Unit, an operator can manage protocols, arm and disarm the injector, review injection history, set options, and view help topics.
Figure 5 - 2: Display Control Unit The injection system supports the connection of a second Display Control Unit. In a two Display Control Unit system, both Display Control Units have the same controls and functionality. Depending on operational situations, only one of the Display Control Units may be active at a time. For example, if an operator is entering a protocol on a Display Control Unit in the Control room, the system locks-out the Display Control Unit in the Scan room. See “6.6 Display Control Unit Lock-outs” for more information. For more information about the navigating through Display Control Unit screens, see Chapter 6 “Using and Understanding the Display Control Unit Screen”
5.5.1 Display Control Unit Sterile Sheath If the Display Control Unit will be used in the Sterile Field, a sheath such as the MEDRAD Display Control Unit Sheath (AVA 500 DCOV) should be used. See “16.6.5 Display Control Unit Sterile Sheath Installation.”
5.6 Injector Head The Injector Head has a handle that is used to rotate the head. The Injector Head position determines what functions are active and what values display on the Injector Head. The Injector Head keypad and Manual Knob can be used to fill and purge a syringe. A drop front allows operators to load syringes from the front. The Syringe Heat Maintainer clamps onto the Pressure Jacket and connects to the underside of the Injector Head and is designed to keep pre-warmed contrast in the syringe. For more information about the Injector Head or the Syringe Heat Maintainer, see Chapter 7 “Using and Understanding the Injector Head.”
Figure 5 - 3: Injector Head
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System Overview
5.7 Power Unit The injection system Power Unit supplies power to the Injector Head and the Display Control Unit. As the main communications hub, the Power Unit provides system communications to all connected components. A green light illuminates when the Power Unit is on. The front plate on the Power Unit contains a serviceable air filter. For cleaning instructions, see Chapter 15 “Cleaning and Maintenance.”
5.8 Imaging System Interface The Imaging System Interface (ISI) allows the injection system to interface with an imaging system to provide synchronization of an injection and an X-ray exposure. To use ISI on the injection system, configure the system from the Display Control Unit Options tab. See Chapter 6“Using and Understanding the Display Control Unit Screen.” For more information on how ISI interacts with the injection system, see “11.3.5 Performing an Injection with Imaging System Interface.”
5.9 MEDRAD® VFlow™ MEDRAD® VFlow™ enables the use of Variable Flow Rate injections. In the Variable Flow Rate injection mode, the injector automatically re-arms after each injection. A Variable Flow Rate injection can be initiated by the Hand Controller and ranges from 1 - 10 mL/sec in increments of 0.1 mL/sec. Variable Flow Rate is intended for use in those procedures where low volumes are injected and Variable Flow Rate control is desired. The system has an option for receiving audible feedback when using the Hand Controller. The feedback indicates the flow rate. See “6.4 Options Tab” for instructions on how to enable MEDRAD® VFlow™.
5.10 Start Switches The injection system can be used with a hand switch, foot switch and/or hand controller. The switches allow the operator to initiate an injection. Single mL/s Hand switch Foot switch Hand Controller
X X X
Phased X X X
Variable Flow Rate
X
Single mL/m X X X
5.10.1 Hand Switch and Foot Switch
Figure 5 - 4: Hand Switch and Foot Switch For installation instructions, see “16.6.3 Hand switch and Foot switch Installation.”
5.10.2 MEDRAD® VFlow™ Hand Controller The MEDRAD® VFlow ™ Hand Controller is a sterile device intended for single patient use. The Hand Controller works in two different modes, Variable Flow Rate and Fixed Flow Rate. When in the Variable Flow Rate injection mode, the flow rate increases incrementally as the Hand Controller plunger (A) is depressed, and decreases as the Hand Controller is released. In the Fixed Flow Rate injection mode, the Hand Controller acts as a start switch, and release of the device ceases all flow.
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Mark 7 Arterion Injection System
The Hand Controller button (B) is non-functional and will beep from the Injector head and DCU when depressed. A
B Figure 5 - 5: Hand Controller NOTE: The hand controller is required to perform Variable Flow Rate injections. For installation instructions, see “10.5 Hand Controller Installation.”
5.11 Pedestal and Stand Movement 5.11.1 Pedestal System Place pedestal system components into the approximate positions shown in Figure 5 - 6 prior to moving the system. When necessary, lift pedestal by using the handle to move over obstacles.
Figure 5 - 6: Approximate Component Positions for System Movement
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System Overview
5.11.2 Head Stand (KMA 320 RT) and Adjustable Height Stand (KMA 330) Place hands in the positions shown in Figure 5 - 7 to move an injector Head mounted on a Head Stand and Adjustable Height Stand over obstacles.
Figure 5 - 7: Approximate Hand Positions to Move Head Stand and Adjustable Height Stand Over Obstruction
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Mark 7 Arterion Injection System
5.11.3 Mark 7 Arterion Stand Mounting Kit Configuration Place the Mark 7 Arterion Stand Mounting Kit components into the approximate positions and place hands in the positions shown in Figure 5 - 8 prior to moving the system.
Figure 5 - 8: Approximate Hand Positions to Move Stand Mounting Kit Configuration over Obstruction
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6
Using and Understanding the Display Control Unit Screen The Display Control Unit touch screen has five tabs from which an operator can manage protocols, arm and disarm the injector, review injection history, set options, and view help topics. NOTE: An operator will be locked-out from a Display Control Unit if another operator is performing functions on the Injector Head or another Display Control Unit connected to the same system. The chapter discusses: • • • • • • •
"Home Tab" "Protocols Tab" "History Tab" "Options Tab" "Help Tab" "Display Control Unit Lock-outs" "Performing Touch Screen Calibration"
6.1 Home Tab Operators can set protocols, select the Single or Phased protocol, or arm the injector on the Home tab. This tab has a Programmed window (A), Actuals window (B), and Sentinel window (C). Each of these windows is discussed below.
Figure 6 - 1: Home Tab
6.1.1 Programmed Window The Programmed window displays the protocol parameters for an injection including Flow Rate, Volume, Pressure, Rise time (Rise Time is not listed for Variable Flow Rate or mL/m protocols), and Delay (Delay is not listed for phased and Variable Flow Rate or mL/m protocols). Operators can set Single mL/s and mL/m, Phased, and Variable Flow Rate protocols from the Programmed window. For more information, see “9.1 Set Protocols Parameters from the Home Tab.”
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Mark 7 Arterion Injection System
6.1.2 Actuals Window The Actuals window displays Peak (maximum Flow Rate achieved), Delivered (actual total volume delivered), Total Contrast (total volume delivered for the current case), and the End Case button. An operator presses the End Case button after completing a patient procedure and before removing the disposables to retract the syringe plunger. This button also zeroes the Total Contrast and creates a new case entry on the History tab. For more information on cases, see “6.3 History Tab.”
6.1.3 Sentinel Window The Sentinel window displays system messages, such as “Rotate head down to arm”. The Sentinel window also displays the status of the last injection. The Sentinel window message flashes momentarily when the system cannot arm. A list of messages is available in Chapter 13 “System Messages.”
6.2 Protocols Tab Operators can store new protocols, recall stored protocols, and edit existing protocols on the Protocols tab. For information on how to manage protocols from the Protocols tab, see “9.2 Manage Protocols from the Protocols Tab.” NOTE:To set protocol parameters from the Home tab, see “9.1 Set Protocols Parameters from the Home Tab.”
6.3 History Tab The History tab shows a list of recent injections with date and time of the injection and the programmed parameters and actuals. Injections are grouped by case. Cases are reset when an operator selects the End Case button from the Home tab. For example, an operator may want to group all of the injections for one patient together. The operator performs all of the injections for a patient. The operator then selects the End Case button after the last injection has completed. The system groups all of the injections for that patient together. This group of injections can be retrieved from the History tab.
6.4 Options Tab Operators can modify system settings from the Options tab. A green LED displays beside the current setting for each option. When an operator changes a setting, the system adds an asterisk next to the option name to identify unconfirmed setting changes. To enable the new settings, select one of the other tabs, such as Home. A popup displays requesting confirmation for the new value. Select Yes to confirm the setting. Select No to go to the selected tab without saving the changes; the system reverts to the previous settings. Table 6 - 1: Options
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Option
Description
Language
Sets the Display Control Unit display language.
Flow Rate
Select mL/m or mL/s.
Fill Volume
Determines the volume of contrast drawn into the syringe when an operator presses the Auto-Fill button on the Injector Head.
Using and Understanding the Display Control Unit Screen
Table 6 - 1: Options Option
Description
Fill Speed
Determines the speed at which the injector draws contrast into the syringe when an operator presses the Auto-Fill button on the Injector Head.
ISI
Enables or disables Imaging System Interface (Single mL/s protocols only).
Auto Retract
Enables or disables the piston auto retract feature. See “7.3.1 Piston Auto Retract” for more information.
Phased
Enables or disables Phased protocols.
Date/Time
Sets the system date and time and the calibration date.
Pressure Units
Sets the pressure measurement to PSI or kPa. PSI is set by default.
Head Audio Volume
Sets the audio volume level for the Injector Head.
DCU Audio Volume
Sets the audio volume level for the Display Control Unit.
Upgrade
Used by MEDRAD Service or MEDRAD trained personnel to activate features.
MEDRAD® VFlow™
Enables Variable Flow Rate injections when this feature is activated from Upgrade. Contact MEDRAD to enable this feature.
Audio Feedback
When MEDRAD® VFlow™ is enabled, the system provides a sound when the Hand Controller plunger is depressed.
6.4.1 Modify Options To modify an option: 1. Select the Options tab. A list of options displays. For an explanation of the options, see Table 6 - 1. 2. Select an option. A center panel displays with setting choices or a numeric keypad based on the option. 3. Make the appropriate changes. 4. Select another tab to save the changes. A popup displays requiring confirmation to save the changes or revert back to previous settings. Select Yes to save changes. Select No to revert back to previous settings.
6.5 Help Tab The Help tab provides a list of help topics. To view a help topic 1. Select the Help tab. 2. Select the topic name.
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Mark 7 Arterion Injection System
6.6 Display Control Unit Lock-outs The Display Control Unit will be locked-out while an operator is interacting with the Injector Head controls, or while an operator is accessing another Display Control Unit in a dual Display Control Unit system. The inactive Display Control Unit remains in lock-out until (A): 1. the operator finishes accessing the active Display Control Unit, and active Display Control Unit displays the Home tab, 2. or, an operator has accessed the active Display Control Unit and doesn’t do anything for a minute, 3. or, an operator has not interacted with the Injector Head controls for a period of several seconds.
Figure 6 - 2: Display Control Unit Locked Out
6.7 Performing Touch Screen Calibration Calibrate the Display Control Unit if the touch screen does not respond appropriately when pressing buttons on the screen. To calibrate at the Safety Screen, simultaneously press the Brightness Up and Brightness Down buttons on the back of the Display Control Unit. Follow the on-screen instructions that display. NOTE: Touch the center of the calibration targets to ensure proper touch screen calibration.
Figure 6 - 3: Touch Screen Calibration
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7
Using and Understanding the Injector Head This chapter describes: • • • • • • • • • •
"Injector Head Components" "Injector Head Position" "Syringe Interface" "Pressure Jacket" "Injector Head Displays" "Injector Head Controls" "Armed Light" "Manual Knob" "Syringe Heat Maintainer" "Injector Head Lock-outs"
7.1 Injector Head Components
Figure 7 - 1: Injector Head A
Drop Front
B
Pressure Jacket - See “7.4 Pressure Jacket”
C
Injector Head Handle.
D
Injector Head Displays - See “7.5 Injector Head Displays”
E
Injector Head Controls - See “7.6 Injector Head Controls”
F
Armed Light - See “7.7 Armed Light”
G
Manual Knob - See “7.8 Manual Knob”
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Mark 7 Arterion Injection System
7.2 Injector Head Position The Mark 7 Arterion Injector Head contains a sensor that monitors the head’s position: Purge (upright) (X), Intermediate (Y), or Inject (downward) (Z). The head position determines how the data displays and the available functions. Use the handle and the back of the Injector Head (but not the Manual Knob) to rotate the head into position.
X
Y
Z
Figure 7 - 2: Injector Head Position Table 7 - 1: Injector Head Position and Functionality Injector Head Position Functions Purge (X)
Intermediate (Y)
Inject (Z)
Enabled
Enabled
Enabled
Purge
Enabled
Enabled (the system does not recognize a purge in this position and will not arm)
Enabled (the system does not recognize a purge in this position and will not arm)
Inject
Disabled
Disabled
Enabled
Fill
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Using and Understanding the Injector Head
7.3 Syringe Interface The syringe interface supports a single 150 mL syringe. Operators can attach a syringe to the head from the front of the injector (front loading). The syringe locks into place when the drop front is fully closed. An operator can remove the syringe from the piston rod at any point within the normal travel of the piston by rotating the syringe 1/4 turn clockwise, while the Injector Head is powered on or off, and without removing the disposable set from the syringe.
7.3.1 Piston Auto Retract The Mark 7 Arterion Injection System has an auto retract option that automatically retracts the piston when the Injector Head is in the Purge position. Below are the two scenarios that describe how this feature functions when the Injector Head is in the Purge Position or in the Intermediate and Inject Positions (see “7.2 Injector Head Position” for a description of the positions). • •
Purge position - The operator lowers the drop front and removes the syringe. The Injector Head beeps three times and auto-retracts to the syringe ready position. Intermediate and Inject Positions - The operator lowers the drop front, removes the syringe, and rotates the Injector Head into the Purge (upright) position. The injector Head beeps three times and auto-retracts to the syringe ready position. NOTE: Press any key on the Injector Head to halt the auto retract. NOTE: Enable the auto retract feature from the Options tab. See “6.4 Options Tab” for more information.
7.4 Pressure Jacket The Mark 7 Arterion has a Pressure Jacket designed to hold the syringe in place and help to maintain syringe integrity during use.
Figure 7 - 3: Pressure Jacket The Pressure Jacket is manufactured from high impact resistant material; however, sharp impacts such as from dropping, may cause small barely visible cracks to form, which may propagate during subsequent pressure cycles.
7.4.1 Pressure Jacket Storage When not in use, the Pressure Jacket should remain securely attached to the Injector Head. Alternatively, the Pressure Jacket may be wrapped in a cloth and stored where it will not be hit or dropped. After each procedure, check the Pressure Jacket for contrast build up. For Pressure Jacket cleaning and maintenance, Chapter 15 “Cleaning and Maintenance.”
7.5 Injector Head Displays The Injector Head has two display areas. One area shows the programmed parameters for flow rate, volume, and pressure limit. The other area shows the volume remaining in the syringe.
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Mark 7 Arterion Injection System
A
B
D
C G
F
H
I E
Figure 7 - 4: Injector Head Display A
Flow Rate
B
Volume
C
Pressure Limit
D
Volume Remaining
E
Volume Remaining Icon
F
Enable Button
G
Enable Indicator
H
Fill Strip
I
Auto-Fill Button
7.5.1 Flow Rate (A) The flow rate displays the programmed rate. For Phased protocols, the Injector Head displays the values of the current phase. The flow rate displays in per second or per minute mode based on the protocol parameters. Operators can change the flow rate mode using the Options tab. See the “6.4 Options Tab” for more information.
7.5.2 Volume (B) The volume displays the programmed volume in milliliters. For Phased protocols, the Injector Head displays the values of the current phase.
7.5.3 Pressure Limit (C) The pressure limit indicates the maximum pressure that the system can use to inject contrast for the programmed protocol. The limit displays in either psi or kPa. To understand more about pressure limiting, see “5.3 Pressure Limiting” or the Display Control Unit Help Tab.
7.5.4 Volume Remaining (D) The volume remaining indicates the amount of contrast currently in the syringe.
7.6 Injector Head Controls The Injector Head Controls on the injection head display contain the Enable button, Enable Indicator, Fill Strip, and Auto-Fill button.
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Using and Understanding the Injector Head
7.6.1 Enable Button (F) The Enable button activates the Fill Strip and Auto-Fill button. After pressing the Enable button, the Enable Indicator (G) illuminates and the Fill Strip and Auto-Fill button stay active while in use or for five seconds of inactivity.
7.6.2 Fill Strip (H) The Fill Strip allow operators to advance and retract the piston on the Injector Head. After pressing the Enable button, press the forward arrows (closest to syringe) to advance the piston, or press the reverse arrows (farthest from syringe) to retract the piston. The piston speed increases progressively as an operator presses the arrows farther away from the Enable button.
7.6.3 Auto-Fill Button (I) The Auto-Fill button fills the syringe with a user defined contrast volume and at a user defined speed. After pressing the Enable button, press the Auto-Fill button. Configure the volume and speed from the Options tab. See the “6.4 Options Tab.”
7.7 Armed Light The Armed Light (J) remains illuminated when the system is armed. The light flashes once every second when injecting
Figure 7 - 5: Armed Light
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Mark 7 Arterion Injection System
7.8 Manual Knob Use the Manual Knob (K) to manually advance or retract the piston. Turn the knob clockwise to advance the piston and counterclockwise to retract the piston.
Figure 7 - 6: Manual Knob
7.9 Syringe Heat Maintainer The Syringe Heat Maintainer clamps onto the Pressure Jacket and connects to the underside of the Injector Head and is designed to keep pre-warmed contrast in the syringe. For information on installing the Syringe Heat Maintainer, see the “16.6.1 Syringe Heat Maintainer Installation.”
7.10 Injector Head Lock-outs The Injector Head will be locked-out while an operator is accessing a Display Control Unit. LOC displays in the volume remaining. The Injector Head remains in lock-out until: 1. An operator finishes accessing the active Display Control Unit, and active Display Control Unit displays the Home tab, 2. or, an operator has accessed the active Display Control Unit and doesn’t do anything for a minute.
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8
Power Up and Shutdown the Injector This chapter describes: • •
"Powering up the System" "Shutdown"
8.1 Powering up the System CAUTION Electric Shock Hazard - Minor or moderate patient and/ or worker injury may result. • Verify that the voltage and frequency marked on the serial tag on the Power Unit matches the voltage and frequency of the electrical outlet. • Do not use extension cord or power adaptor with the system. 1. Press the Power Switch on the Power Unit. 2. Open the power switch cover on the Display Control Unit, and press the Power Switch. A splash screen and then a safety screen displays. 3. Close the power switch cover. 4. Read the warnings and press Continue. The Home tab displays.
8.2 Shutdown 1. Open the power switch cover on the Display Control Unit, and press the Power Switch. 2. Close the power switch cover. 3. Press the Power Switch on the Power Unit.
8.3 Emergency Shutdown CAUTION Mechanical Hazard - Minor or moderate patient and/ or worker injury may result. • Turn off system power and disconnect patient when system malfunction occurs. In the event of an emergency such as a fire, explosion, or electrical shock, press the Power Switch at either the Display Control Unit or Power Unit, or disconnect the power cord from the wall outlet to shut down the system.
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Mark 7 Arterion Injection System
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Setting and Managing Protocols
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Setting and Managing Protocols Over Volume Hazard - Serious patient injury or death may result. • Do not program a protocol outside of the clinically accepted volume range. • Ensure that the correct volume is programmed in the protocol for the target anatomy. Vessel Dissection Hazard - Serious patient injury or death may result. • Do not program a protocol outside of the clinically accepted flow rate range. • Ensure that the correct flow rate is programmed in the protocol for the target anatomy. • Do not program a protocol outside of the clinically accepted pressure limit. • Ensure that the correct pressure limit is programmed in the protocol for the target anatomy. Foreign Body Embolism Hazard - Serious patient injury or death may result. • Do not program a pressure greater than the lowest rated disposable’s pressure rating. Bloodborne contamination hazard - Serious patient and/or worker injury or death may result. • Do not program a pressure greater than the lowest rated disposable’s pressure rating. This chapter discusses how to: • •
"Set Injection Parameters from the Home Tab" "Manage Protocols from the Protocols Tab"
9.1 Set Injection Parameters from the Home Tab NOTE: Refer to syringe and disposable packaging to confirm lowest pressure rating prior to programing an injection.
9.1.1 Set Injection Parameters on Home Tab - Single A Single protocol injects a set Volume of contrast at one flow rate, pressure, rise time, and delay time (if using ISI). NOTE: Delay and rise time are not available for mL/m protocols. 1. Select the Single tab (A).
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Mark 7 Arterion Injection System
Figure 9 - 1: Set Single Protocol 2. 3. 4. 5.
NOTE: The displayed values are based on the last used protocol or the default values. Select the box corresponding to a parameter to change it. Use the numeric keypad to enter the protocol parameter. Commit the value by selecting Enter or another parameter. Select Delay. A numeric keypad displays with X-Ray and Inject buttons. a. Enter the delay time. Setting delay time to zero is equivalent to having no delay. b. Select X-Ray or Inject. c. Select Enter to commit the value.
NOTE: A programmed delay parameter only functions when using ISI. 6. Repeat steps 2-4 to change additional parameters.
9.1.2 Set Injection Parameters on Home Tab - Phased Phased Protocols have up to four different sets of flow rates and volumes for single continuous injection. Operators can enter up to four phases per protocol. The pressure limit remains consistent for each phase. NOTE: The initial rise time is dependent on the value the operator enters. The intraphase rise time is fixed. NOTE: If the Phased option is not visible, go to the Display Control Unit Options tab to enable Phased injections. See “6.4 Options Tab.” NOTE: ISI does not function with Phased protocols. 1. Select the Phased tab (A).
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Setting and Managing Protocols
Figure 9 - 2: Set Phased Protocol From the Programmed window, operators can modify protocol parameters and existing phases, add phases, or delete phases. • To modify an existing phase, go to step 2. • To modify the pressure limit, rise time, or delay, go to step 3. • To add a phase, go to step 4. • To delete a phase, go to step 5. 2. To modify values for an existing Phase, select the Flow Rate or Volume to the right of the index number (B) for that phase. a. Select either Flow Rate or Volume. b. Use the numeric keypad to enter the protocol parameter. c. Commit the value by selecting Enter or another parameter. d. Repeat this step to change additional parameters. NOTE: When editing a phase, an operator cannot delete a phase. 3. Select Pressure Limit or Rise Time to change that parameter. a. Use the numeric keypad to enter the protocol parameter. b. Commit the value by selecting Enter or another parameter. 4. To add a phase, select the index number (C) for the phase directly below the last entered phase. A new phase is added with flow rate and volume both equal to “1”. a. In the new phase, select either Flow Rate or Volume. b. Use the numeric keypad to enter the protocol parameter. c. Commit the value by selecting Enter or another parameter. d. Repeat this step to add additional parameters. 5. To delete a phase, select the index number for the phase. If a lower numbered phase is deleted, the higher number remaining phases are renumbered. For example, in a three phase protocol, if Phase 1 is deleted, Phases 2 and 3 become Phases 1 and 2. NOTE: If values for only one phase exist, that phase cannot be deleted.
9.1.3 Set Injection Parameters on Home Tab - Variable Flow Rate A Variable Flow Rate protocol injects a set Volume of contrast at a Flow Rate determined by the Hand Controller. As an operator depresses the Hand Controller plunger, the system increases the Flow Rate until it reaches the maximum Flow Rate set by the operator.
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