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MEDRAD® MRXperion

2.3 Notified Body

2.4 Regulatory Classifications

Keep dry (ISO 15223-1, 5.3.4)

Fragile, handle with care (ISO 15223-1, 5.3.1)

Part Number

Net Weight (ISO 7000, 1321B)

Quantity (IEC TR 60878, 2794)

Indicates that this device conforms to the requirements of the European Union
Medical Device Regulation 2017/745

Identifies a type BF applied part complying with IEC 60601-1 standards
(IEC 60417, 5333)

Medical - General Medical Equipment
As To Electrical Shock, Fire, and Mechanical Hazards Only
In accordance with ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012)
CAN/CSA-C22.2 No. 60601-1 (2014)

See accompanying documentation. This symbol indicates the user shall refer to the
instructions-for-use to ensure safe operation. (ISO 7010, M002)

Indicates the injection system is Class 1 medical equipment as defined by IEC 60601-
1 standards for protection from electric shock

Class II Equipment, Double Insulated. (IEC 60417, 5172)

IPX0 Code that indicates non-protection against ingress of water (IEC 60529)

IPX1 Code that specifies the degree of protection provided by the enclosure against
vertically falling water drops (IEC 60529)

CLASS 1

Содержание MEDRAD MRXperion

Страница 1: ...Operation Manual...

Страница 2: ......

Страница 3: ...rovided with the device This also includes any hardware and software updates that may be required Expected Service Life The length of time that an individual unit lot or batch of devices is expected t...

Страница 4: ...MEDRAD MRXperion...

Страница 5: ...ng the System 15 4 3 Fluid Delivery Basics 16 4 3 1 Protocol 16 4 3 2 I Checked for Air 17 4 3 3 Test Injection 17 4 3 4 KVO Keep Vein Open 17 4 3 5 Protocol Manager 17 4 3 6 Fluid Delivery System Des...

Страница 6: ...g Calculator 44 9 3 Using the Calculators 44 9 3 1 Using the eGFR Calculator 45 9 3 2 Using the Weight Based Dosing Calculator 46 10 Protocol Management 47 10 1 Create or Edit a Protocol 47 10 2 Save...

Страница 7: ...ow a Region 74 15 3 5 Rename a Region 75 15 4 Fluid Delivery Setup 75 15 4 1 Fluid Delivery Setup Configurable Items 77 15 4 2 Contrast Type Setup 77 15 5 Help 80 15 5 1 Accessing the Help System 80 1...

Страница 8: ...e 102 18 4 2 Operating 102 18 4 3 Protection Against Electrical Shock 103 18 4 4 EMI RFI 103 18 4 5 Protection Against the Ingress of Fluids 103 18 4 6 Mode of Operation 103 18 5 System Capabilities 1...

Страница 9: ...Operation Manual v 19 8 Scan Room DC Power Cables 110 19 9 Prefilled Syringe Adapters PFA 110 20 Compliance to IEC 60601 1 2 2nd 3rd and 4th Editions 111...

Страница 10: ...vi MEDRAD MRXperion...

Страница 11: ...rpose of injecting intravenous MR contrast media and saline into the human vascular system for diagnostic studies in magnetic resonance imaging MRI applications with MRI scanners that have a magnetic...

Страница 12: ...e equipment The system is not intended to deliver contrast agents and or saline to more than one patient from the same saline container and Bayer disclaims any and all liability or consequences result...

Страница 13: ...nufacturing Symbols 2 2 Shipper Symbols Manufacturer ISO 15223 1 5 1 1 Authorized representative in the European community ISO 15223 1 5 1 2 Date of Manufacture ISO 15223 1 5 1 3 Temperature range ISO...

Страница 14: ...hock Fire and Mechanical Hazards Only In accordance with ANSI AAMI ES60601 1 2005 AMD 1 2012 CAN CSA C22 2 No 60601 1 2014 See accompanying documentation This symbol indicates the user shall refer to...

Страница 15: ...on the injector that is used as a connection point between other medical electrical equipment The EPC s function is to minimize any voltage potentials differences between all connected equipment The...

Страница 16: ...ronments as defined by the ASTM International Standards for MRI Device Marking IEC 62570 7 3 3 Pushing prohibited in this area Do not push the injector above this label ISO 7010 P017 Do not coil the c...

Страница 17: ...ings 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 oper...

Страница 18: ...2 8 MEDRAD MRXperion...

Страница 19: ...tective earth Q Do not remove or open any enclosure as hazardous voltages exist within system components Q Do not immerse any system components in water or cleaning solutions Q Disconnect the system f...

Страница 20: ...erformance and Section 18 5 System Capabilities for programmable pressure limit options Q Patient injury and or catheter damage may result from using tubing set that is too short Operator must conside...

Страница 21: ...Allow the system to stabilize at room temperature before use Q Condensation may cause electrical damage to the injection system Mechanical Hazard Equipment Damage may result Q Do not touch the display...

Страница 22: ...3 12 MEDRAD MRXperion...

Страница 23: ...m the facade of the scanner NOTE Consider limits on the length of the connector tubing and patient position when placing the injector NOTE Do not place the scan room unit in a magnetic field greater t...

Страница 24: ...Control Room 1 Scan Room Unit Injector 6 Control Room Unit Workstation 2 Power Cable 7 Workstation Power Supply 3 Scan Room Unit Power Supply 8 Fiber Optic Communication Link 4 Fiber Optic Communicat...

Страница 25: ...k 8 Workstation Power Supply 4 Fiber Optic Quick Disconnect 9 Fiber Optic Communication link 5 Penetration Panel 10 Control Room Unit Workstation 11 DC Power Cable 12 VirtualCare Network Cable WARNING...

Страница 26: ...as been moved into place turn the knob clockwise to lock the column to prevent the injector head from rotating about the column 4 Lock the casters at the base of the unit to prevent unintended movemen...

Страница 27: ...tocol is complete and are triggered by the completion of the injection prior to disconnecting the patient 4 3 2 I Checked for Air Before the system can be armed the operator must visually check that a...

Страница 28: ...ll detect the condition after 4 or less KVO boluses fail to be delivered The occlusion will be detected after 1 minute or less if the KVO interval is set to 15 seconds or after 5 minutes or less if th...

Страница 29: ...l with Integrated IV Pole The pedestal with integrated IV pole is on casters and can be located anywhere within the MR scan room to facilitate the enhanced MRI procedure WARNING Electric Shock Hazard...

Страница 30: ...4 20 MEDRAD MRXperion...

Страница 31: ...ume in the syringe to complete the current protocol the Add box displays the volume that needs to be added to complete the current protocol 3 Protocol Displays the name of the protocol When modificati...

Страница 32: ...6 KVO Administers small boluses of common flushing solution before and after the injection and during any hold or pause phases Illuminates blue when KVO is activated 17 System Information For more inf...

Страница 33: ...nd tubing have been inspected for the presence of air Name Description 25 Region of Interest Shows list of regions in which protocols are stored 26 Protocol List List of protocols stored in the highli...

Страница 34: ...on 32 Calculators Accesses the eGFR and Weight Based Dosing calculators Calculator button will only appear in the Launch Menu if one or more calculators are enabled 33 Virtual Care Displays the contac...

Страница 35: ...5 5 Workstation Front View Name Button Icon Description Name Button Icon Description 1 Abort Terminates the injection and disarms the system 2 Power Powers the system On or Off Blinks or continuously...

Страница 36: ...always remains on 7 Identifies connection for screen extension or transfer to a second display For Bayer use only 8 Identifies a connection not applicable for MEDRAD MRXperion Not for use with the sy...

Страница 37: ...Abort Terminates the injection and disarms the system 2 Power Powers the system ON and OFF Refer to Chapter 8 Powering Up and Shutting Down the System for more information 3 Help Launches the Help Sy...

Страница 38: ...5 28 MEDRAD MRXperion...

Страница 39: ...Injector Head Components 6 1 Injector Head Controls NOTE For more detailed information about injector head button light functionality refer to Section 7 1 Injector Head Lights and Indicators Name Icon...

Страница 40: ...o Fill volume for 10 seconds The total Auto Fill volume for Syringe A includes Q the programmed injection volume Q prime volume 10 mL if Syringe A is configured to be used for priming 4 Buttons Adjust...

Страница 41: ...in Open feature When blinking indicates that the operator can start KVO to maintain patency of the patient connection The head must be oriented with the syringes pointed downward and the I Checked For...

Страница 42: ...6 32 MEDRAD MRXperion...

Страница 43: ...tton Q Blinks to prompt the operator when the injector is ready to Arm I Checked for Air has been confirmed protocol is locked from the display injector head is tilted down Q Illuminates continuously...

Страница 44: ...to prompt the operator when KVO can be started Q Illuminates continuously when KVO is enabled Test Inject Button Q Blinks slow to prompt the operator when a test injection can be performed Q Blinks f...

Страница 45: ...d to a power source Q Continuously illuminates amber during Full System Shutdown Q Continuously illuminates green when full system is ON Q Blinks green during Injector Shutdown Workstation with Pod Po...

Страница 46: ...7 36 MEDRAD MRXperion...

Страница 47: ...to ON I is pressed in The injector powers up 3 The display will briefly show the system communication statuses and software versions NOTE If a communication error is displayed contact Bayer 4 Next th...

Страница 48: ...and hold the power button on the workstation for at least 7 seconds The injector and workstation shut down and the workstation LED flashes green 8 3 Restore from Injector Shutdown 1 While the worksta...

Страница 49: ...ulas and calculators must be chosen before use Calculator Setup allows the operator to enable or disable eGFR formulas set the units for creatinine and weight based dosing and configure the display of...

Страница 50: ...nu select Calculator 1 2 Select the Setup button 2 Figure 9 2 Accessing Calculator Setup from the Calculator screen 9 2 1 Setting Up the eGFR Calculator 1 Access the eGFR Calculator Setup by selecting...

Страница 51: ...alculator formula Table 9 1 eGFR Formulas Calculator Equation MDRD Modification of Diet in Renal Disease IDMS Traceable Cockcroft Gault Modified Cockcroft Gault CKD EPI Chronic Kidney Disease Epidemio...

Страница 52: ...ation Using standardized serum creatinine values in the modification of diet in renal disease study equation for estimating glomerular filtration rate Ann Intern Med 2006 Aug 15 145 4 247 54 Q Cockrof...

Страница 53: ...heck the Display Output Ranges box next to the enabled formula 2 Select Edit to configure parameters for each range individually Figure 9 5 Display Output Range Setup 3 From the drop down menu select...

Страница 54: ...ght Based Dosing Calculator 1 Access the Weight Based Dosing Calculator setup by selecting the Weight Based tab 1 on the Calculator Setup screen 2 Define a dosing unit from the pick list 2 Note This s...

Страница 55: ...Enter Serum Creatinine using the keypad Press Enter to save or Cancel to disregard Q Height Enter the patient s height using the keypad Press Enter to save or Cancel to disregard Q Weight Enter the p...

Страница 56: ...e information using the keypad Press Enter to save or Cancel to disregard Q Dose The dose field will automatically populate with the labeled dose stored with the selected contrast type but may be edit...

Страница 57: ...ly available when editing a protocol with more than one phase NOTE A hold phase cannot be the first phase in a protocol WARNING Blood Vessel Hazard Serious patient injury may result Q Ensure that the...

Страница 58: ...mount of volume in the syringe s Alternatively the recalculated values can be accepted on the Insufficient Volume Screen NOTE When modifications have been made to a protocol an asterisk appears to the...

Страница 59: ...s completed Post injection reminders begin counting once the injection is complete and will not display if the Injection Completed screen is exited before the operator defined amount of time has elaps...

Страница 60: ...ning parameters using the keypad 4 and select Enter 5 e Select OK to confirm and save 10 2 Save a Protocol Operators can save protocols that have been created or edited on the Home screen NOTE Unique...

Страница 61: ...t the desired region or select View All 1 3 Select the protocol name 2 4 Select OK 3 The Home screen displays the selected protocol Figure 10 7 Recall Protocol To edit the protocol refer to Section 10...

Страница 62: ...10 52 MEDRAD MRXperion...

Страница 63: ...m Flow Rate Performance and Section 18 5 System Capabilities for programmable pressure limit options Q Ensure that the programmed flow rate meets facility guidelines Air Embolism Hazard Serious patien...

Страница 64: ...er to Chapter 19 Options and Accessories for more information Q Use only syringes and tubing with a pressure rating greater than the maximum programmable pressure limit of the injection system which i...

Страница 65: ...en Auto Advance is complete for the corresponding syringe Q If Auto Advance is configured to be OFF manually advance the plunger to the end of the syringe using the for ward piston control on the inje...

Страница 66: ...e programmed injection volume volume to run KVO for 30 minutes if KVO is enabled prime volume if Syringe B is configured to be used for priming and volume to perform a test injection if Test Inject is...

Страница 67: ...using the Prime function a Prime Function i Press the Prime button on the injector head b Piston Control Prime i Press the Enable Piston Control button and use the piston controls to prime the tubing...

Страница 68: ...fluid path for the presence or air 4 Connect the tubing to the patient NOTE Antecubital or large forearm veins are the preferred venous access sites for power injections Alternatively veins on back o...

Страница 69: ...he syringe or modifying the protocol If the operator does not correct the insufficient volume prior to priming the Insufficient Volume Message is displayed and the operator can choose to accept the mo...

Страница 70: ...ringe and tubing or if air is observed while checking The system does not arm NOTE The system monitors the syringe presence and piston movement after the I Checked for Air has been confirmed If the sy...

Страница 71: ...a protocol has not been locked the Attention icon blinks and the system does not arm b If the I Checked for Air has not been confirmed the I Checked For Air Confirmation button blinks c If an insuffic...

Страница 72: ...tion in progress NOTE Other actions that disarm the injector such as syringe removal pressing the Disarm button and injection stall will also stop KVO NOTE If an occlusion occurs during KVO the system...

Страница 73: ...ed time starts when the operator re initiates the protocol 12 5 Aborting an Injection At any time press the Abort button on the workstation or injector head to abort the injection An injection will al...

Страница 74: ...fter the Test Inject After the test injection the system holds the injection until the operator presses Start Hold on the injector head NOTE If a reminder is set the operator is provided a communicati...

Страница 75: ...inues to dispense small boluses of saline until the operator stops KVO or until no fluid remains in Syringe B NOTE Any remaining reminders will display as they are triggered Figure 13 1 Injection Comp...

Страница 76: ...presentation 2 of the phases and pressure limits of the completed injection is displayed until the Injection Complete screen is exited NOTE Elapsed time continues while this screen is displayed 13 2 I...

Страница 77: ...e next injection 1 Select Same Patient a The operator is returned to the Home screen b Refer to Section 10 1 Create or Edit a Protocol to create or edit a protocol or repeat the steps in Section 12 2...

Страница 78: ...13 68 MEDRAD MRXperion...

Страница 79: ...been removed the piston automatically retracts to the start position if enabled 3 Discard fluid source containers and all used disposable items in accordance with facility policy WARNING Biological C...

Страница 80: ...14 70 MEDRAD MRXperion...

Страница 81: ...d A 15 1 System Setup System Setup enables the operator to configure settings that affect operation of the overall system 1 From the launch menu select Setup then select System Setup Figure 15 1 Setup...

Страница 82: ...play to loud medium soft or off Calibration Reminder Set the date month and year for a calibration reminder Pressure Units Sets the pressure measurement to PSI or kPa Weight Units Sets the weight unit...

Страница 83: ...te or edit a protocol refer to Section 10 1 Create or Edit a Protocol 1 From the launch menu select Setup 2 Select Protocol Manager Setup Figure 15 4 Setup Categories Protocol Manager Setup 15 3 1 Del...

Страница 84: ...SETUP PROTOCOL MANAGER SETUP and select the protocol to move 2 Select Change Region 3 Select the desired new region NOTE Configurable region s will not be accessible unless default name s replaced 4 S...

Страница 85: ...keyboard that pops up and select Enter 4 Select OK then select Yes on the confirmation window to save changes 15 4 Fluid Delivery Setup Fluid Delivery Setup enables the operator to configure settings...

Страница 86: ...toggle to the next screen for additional options 2 Figure 15 10 Setup Screen Fluid Delivery Setup 4 Set the parameter for the selected option Figure 15 11 Option Parameters Fluid Delivery Setup 5 Sel...

Страница 87: ...ow rate based on volume and duration Q Calculate Volume System calculates the volume based on flow rate and duration Q Calculate Duration System calculates the duration based on flow rate and volume Q...

Страница 88: ...list 3 or add a new vial size by selecting Add New 4 and enter ing the vial size 5 Select Enter 6 to save the new vial size to the list Select the vial size from the list Q Dosage Select an existing...

Страница 89: ...ve the new concentration to the list Select the concentration from the list Q Vial Size Select an existing vial size from the list 3 or add a new vial size by selecting Add New 4 and enter ing the via...

Страница 90: ...lect the Contrast Type on the Contrast Configuration screen and select Delete Select Yes to confirm deletion 15 5 Help From the Help screen users can view applicable patent information licensed featur...

Страница 91: ...gation 15 6 Fluid A When selected Fluid A displays the most recent Fluid A values entered Press OK to select again or Cancel to choose new values Refer to the Certegra Applications and Workstation Acc...

Страница 92: ...15 82 MEDRAD MRXperion...

Страница 93: ...on regarding the current system status and will clear automatically These messages typically display in the lower right corner of the screen Figure 16 1 Type 1 Message Example 16 2 Type 2 Messages Typ...

Страница 94: ...s as a Critical Error record the error code and message and try to reboot If the error persists contact Bayer Figure 16 3 Type 3 Message Example WARNING Patient injury may result from a system malfunc...

Страница 95: ...ng or consulting references WARNINGS Electro Mechanical Hazard Serious injury or death may result from exposure to hazardous voltages existing within the system Q Do not remove any covers or disassemb...

Страница 96: ...1 8 within the United States except as noted above Q Use either Sani Cloth Plus Germicidal Disposable Cloth or CaviWipes Disinfecting Towelettes in all other countries If neither Sani Cloth Plus Germi...

Страница 97: ...Cleaning the Pistons and Syringe Interface to clean the syringe pistons and syringe interface NOTE If in a country where Sani Cloth Plus or CaviWipes are not available and using an equivalent cleaning...

Страница 98: ...r CaviWipes for 1 minute or until visibly clean Make certain that all seams recessed areas and buttons are clean Refer to Section 17 3 3 Cleaning the Pistons and Syringe Interface to clean the syringe...

Страница 99: ...ore using the system 17 3 1 Inspecting the Injector Head and Mounting Frequency Daily Q Inspect the housing for any damage or cracks that could allow fluid to leak inside or weaken the structural inte...

Страница 100: ...wipe dampened with warm water wet but not dripping until visibly clean from contrast media and other debris 5 Thoroughly dry the pistons using a dry clean soft non linting wipe 6 Inspect the syringe...

Страница 101: ...ector 4 Rotate the injector head to have access into the syringe interface 5 Clean all surfaces of the inner area of both syringe interfaces at least 1 time with a clean soft non linting wipe dampened...

Страница 102: ...mmonium compounds and 14 8 20 isopropanol 1 Turn off power to the injector 2 Wipe the pedestal and base with a clean soft non linting wipe dampened with warm water for 1 minute 3 Wipe the pedestal and...

Страница 103: ...water for 1 minute 2 Wipe the workstation screen with Sani Cloth Plus or CaviWipes for 1 minute or until visibly clean NOTE If in a country where Sani Cloth Plus or CaviWipes are not available and us...

Страница 104: ...e that all system safety and warning labels are in place and legible Power Up 1 Apply power to the system 2 Verify that the Safety Screen displays 3 Press Continue to acknowledge the messages on the S...

Страница 105: ...of the system Contact your local Bayer office or your local authorized dealer for information Refer to the back of this manual for address telephone and fax information 17 5 1 Injection System Calibr...

Страница 106: ...17 96 MEDRAD MRXperion...

Страница 107: ...very Performance Q System Fluid Performance Q Forward and Reverse Controls Q Power Cable Specifications Q Ground Continuity Q Classifications Q MEDRAD MRXperion MR Injection System Cybersecurity and I...

Страница 108: ...ITE power supply with output rated 12Vdc minimum 6A marked LPS Use only Bayer P N 86100134 2 Computer network connection 3 USB connections 4 Connection for screen extension transfer to a second displ...

Страница 109: ...ation with Pod Pod Connections Icon Description Icon Description 1 Identifies handswitch connection 2 Identifies ethernet connection for Bayer use only 3 Identifies ethernet connection for connecting...

Страница 110: ...uirements 100 240 VAC 50 60 Hz 0 3A 5 Identifies connection not applicable for MEDRAD MRXperion Not for use with the system Icon if applicable Description Icon if applicable Description 1 Identifies p...

Страница 111: ...Operation Manual 18 101 18 3 Injector Scan Room Unit Specifications 18 3 1 Injector Scan Room Unit Dimensions NOTE Listed dimensions are approximate 94 lbs 43 kg...

Страница 112: ...nvironmental Specifications 18 4 1 Non Operating Transportation and Storage 18 4 2 Operating The system may not meet all performance specifications if operated outside of the following conditions Temp...

Страница 113: ...onents of the system scan room unit are provided with an enclosure that prevents the entry of such an amount of falling liquid as might interfere with the safe operation of the injector indicated by t...

Страница 114: ...the syringe Q Injection monitoring is performed in the injector head to detect over rate or over volume conditions due to system faults The delivered volume is also monitored against the total program...

Страница 115: ...inges during the injection Q Maximum pressure setting on the injector If problems are experienced achieving the desired flow rate please contact a Clinical representative for suggestions that may incr...

Страница 116: ...0 C minimum Q Receptacle Type IEC 60320 C13 Q Normal Cord Voltage 300 VAC minimum Q Wire Gauge 1 00mm2 minimum Q Cord Type IEC 60245 1 Annex A Designation 53 or IEC 60227 1 Annex A Designation 53 Cert...

Страница 117: ...lid credentials Q Certegra database encrypted and access restricted 18 14 2 Certegra Workstation Cybersecurity When Informatics is enabled the Certegra Workstation hard drive can contain PHI The secur...

Страница 118: ...18 108 MEDRAD MRXperion...

Страница 119: ...ical Hazard Equipment Damage may result or system may fail to operate Q The system is meant to connect with the specific devices listed below and should not be used with other medical devices or medic...

Страница 120: ...ual CD 3038565 Service Manual English 3038661 Installation Manual 3041584 Prefilled Syringe Adapter PFA Operation Manual English 86076586 Part Number Penetration Panel Filter Kit 84680761 Catalog Numb...

Страница 121: ...cted disturbances induced by radio frequency fields Q IEC 61000 4 8 Electromagnetic compatibility EMC Part 4 8 Testing and measurement techniques Power frequency magnetic field immunity tests Q IEC 61...

Страница 122: ...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 freq...

Страница 123: ...hospital environment Surge IEC 61000 4 5 0 5 kV 1 kV 2 kV line to ground 0 5 kV 1 kV line to line Mains power quality should be that of a typical commercial or hospital environment Voltage dips IEC 61...

Страница 124: ...diation Symbol IEC TR 60878 5140 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 abso...

Страница 125: ......

Страница 126: ...publication at any time without prior notice or obligation Please contact your authorized representative from Bayer for the most current information All patient data that appear in this document are...

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