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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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/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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About This Manual
INJECTOR REQUIRES SPECIAL PRECAUTIONS REGARDING EMC. Install and put into service according to the EMC information provided below: Table 2 - 2: Guidance and manufacturer's declaration - electromagnetic emissions The injector is intended for use in the electromagnetic environment specified below. The customer or user of the injector should assure that it is used in such an environment. Emission Test
Compliance
Electromagnetic Environment - Guidance
RF emissions CISPR 11
Group 1
The injector uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11
Class A
Harmonic current emissions IEC 61000-3-2
Class A
Voltage fluctuations/flicker emissions IEC 61000-3-3
Complies
Notice: This injector is intended for use by healthcare professionals only. This injector may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the injector or shielding the location.
Table 2 - 3: Guidance and manufacturer's declaration - electromagnetic immunity The injector is intended for use in the electromagnetic environment specified below. The customer or user of the injector should assure that it is used in such an environment. Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment - guidance
Electrostatic discharge (ESD) IEC 61000-4-2
+6 kV contact +8 kV air
+6 kV contact +8 kV air
Floors should be wood, concrete or ceramic tile. If floors are covered with a synthetic material, the relative humidity should be at least 30%
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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