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MEDRAD

®

Stellant CT Injection System with Certegra

®

Workstation

17 - 90

17.9.2 Certegra

®

Workstation Cybersecurity

When Informatics is enabled, the Certegra

®

Workstation hard drive can contain PHI. The security and

privacy of this information must be safeguarded by all individuals interacting with the device. Prior to
disposing of the workstation, this information must be removed from the hard drive inside the system.
Contact Bayer or a local authorized dealer for further information. Refer to the back cover of this man-
ual for contact information.

17.9.3 IT Network Connection

Connecting the system to an IT Network that includes other equipment could result in unidentified risks
to patients, operators, or third parties.

The organization responsible for managing the network should identify, analyze, evaluate, and control
risks associated with connecting the equipment to the IT Network.

Subsequent changes to the IT Network could introduce new risks and require additional analysis. For
example:

•

Changes in the IT Network configuration

•

Connecting additional items to the IT Network

•

Disconnecting items from the IT Network

•

Updating equipment connected to the IT Network

•

Upgrading equipment connected to the IT Network

17.10 Fuse Specification

FUSE,3.15A,250V,5X20MM,IEC TYPE T, HIGH.

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Summary of Contents for Certegra

Page 1: ... i a l n u m b e r s a n d d a t e o f i n s t a l l a t i o n i n f o r m a t i o n m u s t b e s u p p l i e S e n u m b e r s Operation Manual MEDRAD Stellant CT Injection System with Certegra Workstation ...

Page 2: ......

Page 3: ...ons for use and other materials provided 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 to remain functional after it is placed into use Report any serious incident that has occurred in relation to this device to Bayer radiology bayer com contact and to yo...

Page 4: ...MEDRAD Stellant CT Injection System with Certegra Workstation ii ...

Page 5: ...ew 4 13 4 1 System Diagram 4 13 4 1 1 Moving the System Within the Room 4 13 4 2 Fluid Delivery Basics 4 13 4 2 1 Protocol 4 13 4 2 2 Protocol Manager 4 14 4 2 3 Fluid Delivery System Design 4 14 4 2 4 Fluid Pressure and Pressure Limiting 4 14 4 2 5 Response to Occlusions 4 15 4 2 6 Volume and Flow Rate Protection 4 15 4 3 Syringe Installation Features 4 15 4 4 Programming Mode 4 16 4 5 Basic Info...

Page 6: ...and Fill a Syringe 9 38 9 2 3 Attach and Prime the Tubing 9 39 9 2 4 Connect the Tubing to Patient 9 40 10 Arming and Injecting 10 41 10 1 Add Volume Indicator 10 41 10 2 Arm the Injector 10 41 10 2 1 Arm from the Control Room 10 41 10 2 2 Arm from the Scan Room 10 43 10 3 Initiating an Injection 10 43 10 4 Operator initiated Hold 10 44 10 5 Injection Aborted 10 44 10 6 Viewing Injection Progress ...

Page 7: ...leaning and Disinfecting the Injector Head 15 69 15 3 3 Cleaning the Pistons and Syringe Interface 15 70 15 3 4 Cleaning the Pedestal With Integrated IV Pole Overhead Counterpoise System OCS and Base 15 71 15 3 5 Cleaning the Workstation Screen 15 72 15 4 Monthly 15 73 15 4 1 Operational Checkout 15 73 15 5 Annually 15 74 15 5 1 Injection System Calibration 15 74 15 5 2 Checking Leakage 15 74 15 6...

Page 8: ...g 17 86 17 5 3 Protection Against Electrical Shock 17 86 17 5 4 EMI RFI 17 86 17 5 5 Protection Against the Ingress of Fluids 17 86 17 5 6 Mode of Operation 17 86 17 5 7 Fluid Delivery Performance 17 87 17 6 Over and Under Infusion Protection 17 87 17 7 System Fluid Performance 17 88 17 7 1 Factors Affecting Flow Rates 17 88 17 7 2 Maximum Flow Rate Performance 17 88 17 7 3 Programmable Pressure S...

Page 9: ...zes and injection protocol parameters 1 3 Indications for Use The MEDRAD Stellant CT Injection System with Certegra Workstation is indicated for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography CT applications 1 4 Contraindications None known 1 5 Restricted Sales Federal USA law restricts these devices to sale by or on the order...

Page 10: ...electrically bonded terminal 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 EPC is not designed to be an electrical safety ground 1 9 Installation Contact Bayer for Installation information ...

Page 11: ...dicates electrostatic sensitive device IEC TR 60878 5134 MR Unsafe Known threat or poses a hazard in all MR environments as defined by the ASTM International Standards for MRI Device Marking IEC 62570 7 3 3 Indicates alternating current IEC 60417 5032 Consult instructions for use ISO 15223 1 5 4 3 Maximum weight of the injection system and accessories during normal use ISO 7000 1321B ISO 15223 1 5...

Page 12: ...vice Read and understand the notices before operating the injection system Note Indicates that the information that follows is additional important information a tip that will help you recover from an error or reference to related information within the manual 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 ...

Page 13: ... 7010 M002 Indicates the injection system is Class 1 medical equipment as defined by IEC 60601 1 standards Class II Equipment Double Insulated IEC 60417 5172 IPX1 Code that specifies the degree of protection provided by the enclosure against vertically falling water drops IEC 60529 Indicates separate collection for Electrical and Electronic Equipment per Directive 2002 96 EC Refer to the following...

Page 14: ...tifies a terminal suitable for direct current IEC TR 60878 5031 Identifies an on off switch for equipment IEC TR 60878 5009 Identifies a computer network IEC TR 60878 5988 Identifies a power supply IEC TR 60878 5534 Identifies a transfer of displayed image to a second screen IEC TR 60878 5892 Identifies service assistance IEC TR 60878 0717 Net Weight ISO 7000 1321B ...

Page 15: ...ements decrements 4 Prime button 5 Activates the forward and reverse piston controls Illuminates when pressed 6 Forward and reverse piston controls 7 The Check for Air icon illuminates after the operator has confirmed inspection of the fluid path for air 8 Indicates the protocol is locked Illuminates after the protocol has been locked 9 Arms the injector Illuminates after the injector has been arm...

Page 16: ...shown Button Icon Description Button Icon Description Button Icon Description Button Icon Description 1 Accesses the system settings 2 Displays most recent Fluid A values entered Press OK to select again or cancel to choose new values 3 Resets the protocol to the factory default values 4 Displays the remaining number of set Reminders 4 Displays that no Reminders are set 5 Indicates status of commu...

Page 17: ...e system is armed illuminates solid yellow when the system is injecting Not illuminated when system is idle 7 Informatics Panel and Modality Worklist Refer to the Certegra Applications and Workstation Accessories for more information Button Icon Description Button Icon Description Identifies the Equipotential connection IEC TR 60878 5021 Identifies the Protective Earth Ground point IEC TR 60878 50...

Page 18: ...MEDRAD Stellant CT Injection System with Certegra Workstation 2 10 ...

Page 19: ...is system to deliver any fluid other than intravenous contrast media and common flushing solutions This device is not intended for drug infusions chemotherapy or any other use for which the device is not indicated Handle and use contrast media and saline per the manufacturers instructions Hazard Do not service or perform maintenance on the injector system while in use with a patient Reuse of singl...

Page 20: ...stem power cord into an extension cord or multi outlet power strip Procedure Delay Hazard Serious patient and or worker injury or death may result Turn off any equipment that could generate a high level electrostatic discharge Hazard Do not connect or disconnect an accessory to the system while in use with the patient CAUTION Electro Mechanical Hazard Equipment damage may result Allow the system t...

Page 21: ...d the pedestal below the point indicated by the label on the pedestal arm If the pedestal does not contain this label hold the pedestal no higher than 36 inches above the floor 4 2 Fluid Delivery Basics The system is a programmable power injector that enables an operator to generate a defined fluid delivery protocol and execute a fluid injection 4 2 1 Protocol A protocol defines how the fluid inje...

Page 22: ...gures the phases pressure limit and optional reminders the protocol is complete and can be saved and recalled for later use Through the Protocol Manager the operator can save and sort protocols with unique operator defined names These protocols can then be recalled at a future point for repetitive utilization 4 2 3 Fluid Delivery System Design The system is flow controlled The flow rate specified ...

Page 23: ...tion system is designed with four features to decrease the amount of time and steps to load disposable syringes 1 Non rotational Orientation To install a syringe onto the injector snap the syringe onto the front of the injector head no alignment necessary 2 Auto Dock Once a syringe is installed the injector piston advances finds the syringe plunger and docks with it If the syringe was previously f...

Page 24: ...er injury may result Tighten all screws clamps and knobs during assembly and as needed during use Loose components may cause the pedestal to collapse Do not move or manipulate the injector mount by pulling or pushing the integrated IV pole Using the pole to maneuver the injector could bend the pole or cause an imbalance of the system Maneuver the injector as recommended Refer to Moving the System ...

Page 25: ...ocol An Add box displays the volume that needs to be added to complete the current protocol 3 Phase button edit phase Select to edit a phase type 4 Phase button new phase Select to enter a new phase type 5 Flow Rate Displays the programmed flow rate Select to modify if enabled 6 Volume Displays the programmed volume Select to modify if enabled 7 Duration Displays the programmed duration Select to ...

Page 26: ...er For more information refer to Figure 5 3 Protocol Manager 18 System Information For more information refer to Figure 5 2 System Information 19 Launch Menu For more information refer to Figure 5 4 Launch Menu Name Description 20 Injector icon The Injector icon identifies various states of the injector Not illuminated when the system is in the idle state Illuminates yellow and flashes when the sy...

Page 27: ...hted Region of Interest 27 Protocol Preview Displays details of selected protocol 28 View All Displays all stored protocols 29 P3T Displays only P3T stored presets 30 Current Protocol Shows details for current protocol in use 31 Exit Returns to the Home screen with no protocol selected Name Description 32 Setup Accesses the Setup options Refer to Advanced Operations for more information 33 Virtual...

Page 28: ...w 34 Help Launches the Help system Refer to Advanced Operations for more information 35 Shutdown Accesses the Shutdown options Name Description 1 3 2 Button Icon Description Button Icon Description 1 Terminates the injection and disarms the system 2 Powers the system On or Off Blinks or continuously illuminates amber or green based on power status Refer to Powering Up and Shutting Down the System ...

Page 29: ...rt 4 identified with yellow outline 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 Stellant Not for use with the system 9 Identifies input and output connections not applicable for MEDRAD Stellant Not for use with the system 10 Identifies injector head connection 11 Identifies han...

Page 30: ...d Pod Connections and Workstation with Pod Display Connections for more information 1 3 2 4 5 Button Icon Description Button Icon Description 1 Terminates the injection and disarms the system 2 Powers the system On or Off Refer to Powering Up and Shutting Down the System for more information 3 Launches the Help system Refer to Help for more information 4 Initiates the injection Holds the injection...

Page 31: ...Understanding the Injector Head and Handswitch Injector Head Control Injector Head Components Handswitch 6 1 Injector Head Control Figure 6 1 Injector Head Control Name Description A Syringe A Contrast syringe ...

Page 32: ...lume to the nearest multiple of 5 mL and then in increments decrements of 5 mL 7 Prime Activates the tube priming function 8 Move Piston Activates the forward and reverse piston controls Times out after ten seconds of inactivity 9 Piston Control Side A or B Advances and retracts the piston variable speed 10 Check for Air Reminds user to verify that air is purged from the syringe and tubing Must be...

Page 33: ...sted in Table 6 1 6 3 Handswitch The handswitch enables an operator to start hold and stop an injection The handswitch contains a light that identifies the state of the injector This light illuminates or flashes depending on the condi tions listed in Table 6 2 NOTE Handswitch light functions the same whether it is connected to the injector head or the workstation Air Embolism Hazard Serious patien...

Page 34: ...MEDRAD Stellant CT Injection System with Certegra Workstation 6 26 ...

Page 35: ...o perform a hard shutdown either Press and hold the Power button on the Workstation or Workstation with Pod Turn the power switch to Off on the Workstation with Pod in the event that the graphical dis play is unresponsive Unplug the power cord to the Workstation or Workstation with Pod in the event that the graphical display is unresponsive 7 3 Restore from Injector Shutdown When the system is in ...

Page 36: ...MEDRAD Stellant CT Injection System with Certegra Workstation 7 28 ...

Page 37: ...essel Hazard Serious patient injury or death may result Ensure that the programmed flow rate meets facility guidelines WARNING Table 8 1 Phase Types Phase Type Description Test Inject A Injects a programmed phase from Syringe A followed by a hold phase Test Inject B Injects a programmed phase from Syringe B followed by a hold phase Contrast Injects a programmed phase from Syringe A Saline Injects ...

Page 38: ...e system provides an on screen indication and displays how much fluid needs to be added in each syringe NOTE When modifications have been made to a protocol an asterisk displays to the right of the protocol name 3 Optionally modify the default pressure limit a Select Pressure Limit b Select a pressure limit from the pick list NOTE Ensure that the pressure is set for the patient per facility guidel...

Page 39: ...saved refer to Save a Protocol or it can be used for an injection refer to Arm ing and Injecting 8 2 Save a Protocol Operators can save protocols that have been created or edited on the Home screen NOTE Unique protocol names are required within the same region NOTE The injector can store up to 250 protocols 1 Select Protocol Manager 2 Under Region select the folder in which to store the protocol R...

Page 40: ...ection see Arming and Injecting NOTE P3T presets will be indicated with the P3T logo For more information regarding P3T Presets refer to the appropriate Certegra Workstation Personalized Patient Protocol Technology P3T module operation manual P3T Cardiac P3T Abdomen and P3T Pulmonary Angiography PA 8 4 DualFlow 8 4 1 Essential Claims The system provides the capability to program the contrast and s...

Page 41: ...lly calculates the percentage of Saline Figure 8 7 DualFlow Keypad 4 Enter the parameters for the phase Depending on the Programming Mode enter the Flow Rate Volume combined total volume of Contrast and Saline or Duration Regardless of the parameters entered the Contrast and Saline percentages are calculated based on the Volume and Flow Rate For more information on Programming mode refer to Progra...

Page 42: ...w rate of Contrast and Saline for the DualFlow phase would be as follows based on the sample percentages of Contrast NOTE To change the ratio once the phase has been programmed re select the phase and enter the new ratio values per step 3 Sample Ratio Syringe A Syringe B A90 B10 54 mL 3 6 mL sec 6 mL 0 4 mL sec A80 B20 48 mL 3 2 mL sec 12 mL 0 8 mL sec A75 B25 45 mL 3 0 mL sec 15 mL 1 0 mL sec A70...

Page 43: ...ger 1 ii Select View All to see all saved protocols 2 iii Select applicable protocol from list 3 iv Review all protocol values 4 v Select OK to use or edit the protocol 5 vi Refer to Create or Edit a Protocol for further information b To create or edit a protocol Vessel Hazard Serious patient injury or death may result Ensure that the programmed flow rate meets facility guidelines Minor or moderat...

Page 44: ...iDots does not indicate the total absence of air bubbles in the syringe tip FluiDots must be viewed in a properly illuminated environment with a light source behind the operator providing enough light to permit easy viewing To minimize air embolization risks ensure that one operator is designated the responsibility of filling the syringe s Do not change operators during the procedure If an operato...

Page 45: ... use syringes to store fluids Mechanical Hazard Serious patient injury could result from leaks or ruptures during an injection Use only disposables supplied by Bayer Refer to Sterile Disposables Use only syringes and tubing with a pressure rating greater than the maximum programmable pressure limit of the injection system which is 325 psi 2241 kPa Use catheters with pressure ratings compatible wit...

Page 46: ... filling device e g spike Quick Fill Tube onto the end of the syringe 4 Insert the filling device into the fluid source NOTE Refer to fluid manufacturer s instructions for use and or package insert 5 Fill syringe using Auto Load or manually NOTE Syringe A is the contrast syringe and Syringe B is the saline syringe a Auto Load i Press Auto Load on the injector head The volume indicators on the inje...

Page 47: ... 8 Connect the disposable tubing as outlined in Attach and Prime the Tubing 9 2 3 Attach and Prime the Tubing 1 Remove the connector tube from the package 2 Remove the dust covers 3 Ensure all air is purged from the syringe 4 Securely attach the connector tube luer fitting to the syringe tip NOTE If using a connector tube with a T connector first attach the straight portion to the contrast A syrin...

Page 48: ...tient 1 Rotate the injector head downward 2 Remove the Prime Tube 3 Press Check for Air button confirming that the operator checked the fluid path for the pres ence or air Figure 9 7 Connect Tubing to the Patient 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 of the hand or foot can ...

Page 49: ...Indicators Figure 10 1 Add Volume Indicators NOTE It is recommended that the operator resolve this condition prior to arming the injector by either adding more fluid to the syringe or modifying the protocol 10 2 Arm the Injector The system can be armed from either the control room or the scan room 10 2 1 Arm from the Control Room 1 Select Arm on the display NOTE If the last piston movement was a r...

Page 50: ...ndicator was not corrected prior to arming the Insufficient Volume mes sage is displayed Refer to Figure 10 3 Insufficient Volume Accept Modified Protocol Figure 10 3 Insufficient Volume Accept Modified Protocol The system generates a modified protocol based on the available Volume Remaining a Select Yes to accept the system modified protocol The system continues with the arm ing process Refer to ...

Page 51: ...tion has completed NOTE The Icon changes to indicate Disarm the injector head Arm button illuminates and the injector head Arm Lights blink 10 3 Initiating an Injection 1 Press Start Hold on the injector head on the workstation or handswitch NOTE Refer to Table 6 1 for description on how the Arm Lights function while armed injecting and or during a hold NOTE If a Reminder is set the operator is pr...

Page 52: ...he protocol NOTE If the system remains in a hold condition for 20 minutes the system aborts the injection automatically 10 5 Injection Aborted At any time press the Abort button or any other button on the injector head other than Start Hold to abort the injection 10 6 Viewing Injection Progress During an injection the system displays the following NOTE If the injection is aborted all remaining rem...

Page 53: ...7 Viewing Reminders A Reminder alert will display after the programmed time for the Reminder has elapsed Refer to Figure 10 5 Reminder Communication 1 Press OK to dismiss a Reminder Figure 10 5 Reminder Communication 6 Pressure Limit Line Displays the programmed pressure limit on the pressure graph 7 Injection Information Displays the injection 8 Indicators of Start of Phase Shows the start of eac...

Page 54: ...MEDRAD Stellant CT Injection System with Certegra Workstation 10 46 ...

Page 55: ... increment until an operator exits the Injection Completed screen NOTE Any remaining Reminders will display as they are triggered Figure 11 1 Injection Complete Summary 1 Procedure Data Displays operator defined parameters at the procedural level 2 Protocol Summary Displays details of the completed protocol 3 Allows the operator to toggle between Summary view and Graphical view 4 Allows the operat...

Page 56: ...n is displayed 11 2 Injection Aborted If the injection was halted the Injection Aborted screen displays 1 The system displays a reason why the injection aborted at the top of the screen 2 Displays the procedure data for the aborted injection 3 Displays information for how much of the protocol was completed Figure 11 3 Injection Complete Injection Aborted 11 3 Exiting Injection Complete 11 3 1 Cond...

Page 57: ...m keeps the previous protocol for the next injection 1 Select Same Patient a The operator is returned to the Home screen b Refer to Protocol Management to create or edit a protocol or repeat the steps for Arming and Injecting 2 Select New Patient a The operator is returned to the Home screen b Refer to Preparing for Injection for further instructions ...

Page 58: ...MEDRAD Stellant CT Injection System with Certegra Workstation 11 50 ...

Page 59: ... 2 above NOTE Once syringe has 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 pol icy Biological Contamination Hazard Serious patient and or worker injury or death may result Properly discard fluid source containers and disposable items after use refer to disposable label fo...

Page 60: ...MEDRAD Stellant CT Injection System with Certegra Workstation 12 52 ...

Page 61: ...up enables the operator to configure settings that affect operation of the overall system 1 From the launch menu select Setup 2 Select System Setup Refer to Figure 13 1 Setup Categories System Setup Figure 13 1 Setup Categories System Setup 3 Select a System Setup Option Refer to Figure 13 2 Setup Screen System Setup Screen Shown Figure 13 2 Setup Screen System Setup Screen Shown ...

Page 62: ... the display language Display Audio Level Sets the audio volume for the display Calibration Reminder Set the date for a calibration reminder Pressure Units Sets the pressure measurement to PSI or kPa Weight Units Sets the weight units Date Time Sets the system date and time Date Format Sets the date format Time Format Sets the time format Reminder Audio Enables or disables audio for Reminders ISI ...

Page 63: ...able and purchasable options 1 From the launch menu select Setup 2 Select P3T Preset Setup Refer to Figure 13 4 Setup Categories P3T Setup Figure 13 4 Setup Categories P3T Setup 13 2 1 P3T Setup Configurable Items Table 13 2 Configurable Items Configurable Item Description P3T Create and edit individual patient protocols Reference P3T manual ...

Page 64: ...e Protocol Manager section 1 From the launch menu select Setup 2 Select Protocol Manager Setup Refer to Figure 13 5 Setup Categories Protocol Manager Setup Figure 13 5 Setup Categories Protocol Manager Setup 13 3 1 Delete a Protocol 1 From the launch menu select Setup 2 Select Protocol Setup 3 Select the desired region or select View All 4 Select the protocol name 5 Select Delete Refer to Figure 1...

Page 65: ...ange Protocol List Figure 13 7 Rearrange Protocol List 13 3 3 Hide Show a Region 1 From the launch menu select Setup 2 Select Protocol Setup 3 Select the desired region 4 Select HIDE to hide a region and select SHOW to display a hidden region Refer to Figure 13 8 Hide a Region Figure 13 8 Hide a Region 13 3 4 Rename a Region 1 From the launch menu select Setup 2 Select Protocol Setup 3 Select the ...

Page 66: ...y Setup enables the operator to configure settings that affect the operation of the fluid delivery system specifically 1 From the launch menu select Setup 2 Select Fluid Delivery Setup Refer to Figure 13 10 Setup Categories Fluid Delivery Setup Figure 13 10 Setup Categories Fluid Delivery Setup 13 4 1 Fluid Delivery Setup Configurable Items NOTE Selecting the Other LPCT configuration setting will ...

Page 67: ...late the duration flow rate or volume The Programming Modes follow Calculate Flow Rate SYSTEM CALCULATES THE FLOW RATE based on volume and duration Calculate Volume SYSTEM CALCULATES THE VOLUME based on flow rate and duration Calculate Duration SYSTEM CALCULATES THE DURATION based on flow rate and volume Total Volume Display Sets the total volume to display the volumes in Syringe A and Syringe B o...

Page 68: ... instructions on Informat ics setup 13 6 Help This section provides instructions on how to access and use the Help system from the Launch Menu 13 6 1 Accessing the Help System 1 Access the system settings by opening the Launch Menu 1 Refer to Figure 13 11 Help System 2 From the Launch Menu select Help 2 Figure 13 11 Help System Figure 13 12 Help System Navigation ...

Page 69: ...at shows the most recent Fluid A contrast values entered Keep these values by pressing OK or select and enter new values by pressing Cancel Refer to Figure 13 13 Fluid A Value Selection Refer also to Certegra Applications and Workstation Accessories manual Figure 13 13 Fluid A Value Selection ...

Page 70: ...MEDRAD Stellant CT Injection System with Certegra Workstation 13 62 ...

Page 71: ...verable and Critical Error User Recoverable errors can be fixed by following the prompted instructions If a Critical Error occurs record the error code and message and try to reboot If the error persists contact Bayer 14 3 System Tones Both the Certegra Workstation and the injector head are capable of emitting tones These tones fall into two categories General Tones and Notification Tones The foll...

Page 72: ... to draw the attention of the User to the injector head and or the Certegra Workstation as indicated Upon hearing a Notification Tone users should direct their attention to the area of interest as important safety or system information may be displayed NOTE The provision of Notification Tones should not take the place of active attention by the User to the systems in use or the condition of the pa...

Page 73: ...posure to hazardous voltages existing within the system Do not remove any covers or disassemble the injector Periodically inspect for loose or frayed cables loose covers cracks dents or loose hardware Contact Bayer or a local dealer for service or repairs Do not expose system components to excessive amounts of water or cleaning solutions Disconnect the system from line power when cleaning Hazard D...

Page 74: ...l Disposable Cloth or CaviWipes Disinfecting Towelettes in all other countries except where noted If neither Sani Cloth Plus Germi cidal Disposable Cloth nor CaviWipes Disinfecting Towelettes are available within your country then use a disinfectant with 0 25 0 30 quaternary ammonium com pounds and 14 8 20 isopropanol 1 Turn off power to the injector 2 Clean the injector head surfaces excluding pi...

Page 75: ...ountry where Sani Cloth Plus or CaviWipes are not available and using an equivalent cleaning agent refer to the materials listed above follow the same instructions specified in step 4 5 Allow the injector head to thoroughly air dry 6 Inspect the injector head to ensure all surfaces are clean 7 If any visible contrast media or other debris is evident repeat cleaning instructions steps 2 through 6 u...

Page 76: ...n soft non linting wipe 4 Wipe all external surfaces with the exception of the syringe pistons and syringe interface refer to Figure 15 3 Piston with Sani Cloth Plus or CaviWipes for 1 minute or until vis ibly clean Make certain that all seams recessed areas and buttons are clean Refer to Cleaning the Pistons and Syringe Interface to clean the syringe pistons and syringe inter face NOTE If in a co...

Page 77: ...er or the local authorized dealer for service Do not use the system until the problem is corrected If visible contamination is evident on any surface of the device follow the cleaning process outlined below before using the system 15 3 1 Inspecting the Injection System Frequency Daily Inspect the housing for any damage or cracks that could allow fluid to leak inside or weaken the structural integr...

Page 78: ...o the injector 4 Clean all surfaces of pistons at least 1 time with a clean soft non linting 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 pistons to ensure all surfaces are clean Electro Mechanical Hazard Equipment damage may result Do not use cl...

Page 79: ...faces of the inner area of both syringe interfaces at least 1 time with a clean soft non linting wipe dampened with warm water wet but not dripping until visibly clean from contrast media and other debris 6 Inspect the syringe interface to ensure all surfaces are clean 7 If any visible contrast media or other debris is evident repeat cleaning instructions steps 5 and 6 until no visible soil is det...

Page 80: ...S and base to ensure all surfaces are clean 5 If any visible contrast media or other debris is evident repeat the cleaning instructions steps 2 through 4 until no visible soil is detected 15 3 5 Cleaning the Workstation Screen Frequency Daily Material Clean soft non linting wipe Warm water Cleaning Agent Use either Sani Cloth Plus Germicidal Disposable Cloth EPA registration 9480 6 or CaviWipes Di...

Page 81: ...edure carefully before beginning the checkout If problems are detected call your Services Representative NOTE Any problems detected during this or any other procedure should be addressed before using the system in patient procedures System Labels Ensure 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...

Page 82: ...ion Refer to the back cover of this manual for address tele phone and fax information 15 5 1 Injection System Calibration Bayer recommends a complete system calibration and performance checkout be performed annually Contact Bayer or a local office for Bayer for complete details 15 5 2 Checking Leakage As part of an annual maintenance program performed by a qualified Services Representative or auth...

Page 83: ...meant to connect with the specific devices listed in Options and Accessories and should not be used with other medical devices or medical device technologies NOTICE Catalog Number Description SHP 800 Pedestal EOC 700 S Ceiling Mounted Counterpoise system EOW 700 Wall mounted Counterpoise system OCS 155A Ceiling Mounted Counterpoise system for use with a ceiling track system ceiling track not suppl...

Page 84: ...tion System with Certegra Workstation Barcoding Accessory N A Radio Frequency Identification RFID Contrast Identification Accessory Catalog Number Description SSM 700 1 Service Manual Catalog Number Description SSS QFT Single Syringe with QFT SSS SPK Single Syringe with Spike SSS CTP QFT Single Syringe Tri Pak with QFT SSS CTP SPK Single Syringe Tri Pak with Spike SJS PT J Single Syringe with Spik...

Page 85: ...ow Pressure Connector Tubing with 6 T Connector and Prime Tube SJS LP 60 T J 60 Low Pressure Connector Tubing with 14 T Connector and Prime Tube LP 96 T CV 96 Low Pressure Connector Tubing with T Connector and Check Valve Catalog Number Description ...

Page 86: ...MEDRAD Stellant CT Injection System with Certegra Workstation 16 78 ...

Page 87: ...ion System Fluid Performance Power Cable Specifications Injection System Cybersecurity and IT Network Connection Fuse Specification 17 1 Workstation Specifications 17 1 1 Workstation Dimensions and Weight NOTE Listed weight and dimensions are approximate Weight 15 8 lbs 7 2 kg 1 15 12 in 38 40 cm 11 50 in 29 21 cm 7 94 in 20 17 cm 6 80 in 17 27 cm 10 19 in 25 88 cm 7 80 in 19 81 cm 10 76 in 27 33 ...

Page 88: ...n requires use of a Listed Class 2 LPS or Listed Information Technology Equipment 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 display for Bayer use only 5 Connection not applicable for system 6 Connections not applicable for system 7 Injector head co...

Page 89: ...od Connections Workstation with Pod Black Workstation with Pod White 15 75 in 40 00 cm 13 46 in 34 19 cm 10 50 in 26 67 cm 10 23 in 25 98 cm 17 6 lbs 8 0 kg 15 58 in 39 58 cm 12 71 in 32 28 cm 10 50 in 26 67 cm 10 23 in 25 98 cm 17 6 lbs 8 0 kg A B C D Weight A B C D Icon Description Icon Description 1 Identifies handswitch connection 2 Identifies ethernet connection for Bayer use only 5 4 3 2 1 1...

Page 90: ... for use with the system 5 Identifies injector head connection 2 Icon if applicable Description Icon if applicable Description 1 12V DC IN connection 2 LAN connections 3 Connections not applicable for MEDRAD Stellant Not for use with the system 4 USB connections 5 Connection not applicable for MEDRAD Stellant Not for use with the system 6 Connection not applicable for MEDRAD Stellant Not for use w...

Page 91: ...connection Icon if applicable Description Icon if applicable Description 1 Indicates power switch for display 2 Connection not applicable for MEDRAD Stellant Not for use with the system 3 Connection not applicable for MEDRAD Stellant Not for use with the system 4 COM1 connection 5 USB connection 6 USB connection 7 VGA connection 8 LAN 2 connection 9 LAN 1 connection 10 12V DC IN connection 1 2 3 4...

Page 92: ...e Unit Dimensions and Weight NOTE Listed weight and dimensions are approximate Weight 13 6lbs 6 17 kg 17 3 2 Base Unit Connections 1 Equipotential connection 2 Power connection 3 Injector head cable clamp 4 Service connection J112 5 Future use P115 6 Workstation connection P108 7 Injector head connection J113 ...

Page 93: ... 240 VAC 50 60 Hz 300 VA 17 4 Injector Head Specifications 17 4 1 Injector Head Dimensions and Weight NOTE Listed weight and dimensions are approximate Weight 76 0 lbs 34 5 kg 17 5 Environmental Specifications 17 5 1 Non Operating Transportation and Storage Temperature 20o C to 60o C 4o F to 140o F Humidity 5 to 100 R H non condensing Air Pressure 57 kPa to 106 kPa ...

Page 94: ...gainst the Ingress of Fluids Per IEC 60601 1 the injector head has been classified as drip proof equipment This component of the system is 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 This is indicated by the IPX1 designation on the injector head NOTE In the event of fluid ingress or spillage on th...

Page 95: ...1 mL to maximum syringe capacity in 1mL increments Flow Rate Range 0 1 to 10 mL sec in 0 1 mL sec increments Programmable Pressure limit PSI kPa 200 mL syringe pressure limit selections PSI kPa Choice of 50 345 100 689 150 1034 200 1379 225 1551 250 1724 300 2068 325 2241 Pause 1 second to 900 seconds in 1 second increments Hold Maximum Hold time is 20 minutes Syringes Volume Capacity Maximum two ...

Page 96: ...e of the fluid tube and syringes during the injection Maximum pressure setting on the injector If problems are experienced achieving the desired flow rate please contact a Clinical representative for suggestions that may increase it 17 7 2 Maximum Flow Rate Performance Maximum flow rates were achieved using the following catheters with inner diameters ID and lengths as noted Contrast was heated to...

Page 97: ...m Cybersecurity Protection System software cybersecurity controls include Internal data integrity checks Remote access requires valid credentials and a user at the workstation to approve a remote connection Service access requires valid credentials Access to the Operating System is restricted Firewall and Anti Virus Configurable Masking Protected Health Information PHI when sharing with external s...

Page 98: ...rmation 17 9 3 IT Network Connection Connecting the system to an IT Network that includes other equipment could result in unidentified risks to patients operators or third parties The organization responsible for managing the network should identify analyze evaluate and control risks associated with connecting the equipment to the IT Network Subsequent changes to the IT Network could introduce new...

Page 99: ...rbances induced by radio frequency fields IEC 61000 4 8 Electromagnetic compatibility EMC Part 4 8 Testing and measurement techniques Power frequency magnetic field immunity tests IEC 61000 4 11 Electromagnetic compatibility EMC Part 4 11 Testing and measurement tech niques Voltage dips short interruptions and voltage variations immunity tests This system is in compliance to IEC 60601 1 2 2nd 3rd ...

Page 100: ...m output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 KHz to 80 MHz d 3 5 V1 80 MHz to 800 MHz d 3 5 E1 800 MHz to 2 7 GHz d 7 E1 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 69 3 69 7 38 100 11 67 11 67 23 33 For transmitters rated at a maximum output power not listed above the rec...

Page 101: ...for use in the electromagnetic environment specified below The customer or user of the system should assure that it is used in such an environment Immunity test IEC 60601 Test Compliance Level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 8 kV contact 2 4 8 15 kV air Floors should be wood concrete or ceramic tile If floors are covered with a synthetic material the ...

Page 102: ...arked with the following symbol Non ionizing Radiation 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 absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless tele...

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Page 104: ...ed in this publication at any time without prior notice or obligation Please contact your authorized Bayer representative for the most current information All patient data that appear in this document are fictitious No actual patient information is shown Bayer the Bayer Cross MEDRAD Imaxeon Stellant MEDRAD Stellant Certegra P3T ULTRAVIST VirtualCare MEDRAD XDS XDS MEDRAD FluiDots and FluiDots are ...

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