Bayer HealthCare MEDRAD MRXperion Operation Manual Download Page 13

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Operation Manual

2 - 3

Symbols

"Manufacturing Symbols"

"Shipper Symbols"

"Notified Body"

"Regulatory Classifications"

"MR Icons and Classifications"

"Warning Labels and Symbols"

2.1 Manufacturing 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 15223-1, 5.3.7)

Humidity range (ISO 15223-1, 5.3.8)

Atmospheric pressure range (ISO 15223-1, 5.3.9)

Serial number (ISO 15223-1, 5.1.7)

Catalog number (ISO 15223-1, 5.1.6)

This side up (ISO 7000, 0623)

Summary of Contents for MEDRAD MRXperion

Page 1: ...Operation Manual...

Page 2: ......

Page 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...

Page 4: ...MEDRAD MRXperion...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 10: ...vi MEDRAD MRXperion...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 18: ...2 8 MEDRAD MRXperion...

Page 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...

Page 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...

Page 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...

Page 22: ...3 12 MEDRAD MRXperion...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 30: ...4 20 MEDRAD MRXperion...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 38: ...5 28 MEDRAD MRXperion...

Page 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...

Page 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...

Page 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...

Page 42: ...6 32 MEDRAD MRXperion...

Page 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...

Page 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...

Page 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...

Page 46: ...7 36 MEDRAD MRXperion...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 62: ...10 52 MEDRAD MRXperion...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 78: ...13 68 MEDRAD MRXperion...

Page 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...

Page 80: ...14 70 MEDRAD MRXperion...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 92: ...15 82 MEDRAD MRXperion...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 106: ...17 96 MEDRAD MRXperion...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 118: ...18 108 MEDRAD MRXperion...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 125: ......

Page 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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