Operation Manual
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TM
I N J E C T I O N
95403-T-141 Rev. D S Y S T E M
Operation Manual VOM 600E
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MEDRAD TM
Vistron CT Injection System
Operation Manual
VOM 600E Rev. C 95403-T-141
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Labeling Specification, 95403-T-141, Rev:D - Prior to use, you are responsible to confirm that this revision is the latest released revision and to verify accuracy of printed content.
Medrad addresses, phone and fax numbers: North America Headquarters MEDRAD Service Department One Medrad Drive Indianola, PA 15051-0780 U.S.A. Tel: Fax:
412 -767-2400 412 -767-4126
European Headquarters MEDRAD Europe B. V. Postbus 3084 6202 NB Maastricht The Netherlands Tel:
+31- 0 - 43 3585600
Fax:
+31- 0 - 43 3650020
Copyright 2007 Medrad, Inc. All rights reserved. Printed in USA. MEDRAD, Qwik-Fit Syringe and FluiDot are registered trademarks of Medrad, Inc. Medrad Vistron CT is a trademark of Medrad, Inc. The Medrad Vistron CT Injection System and related syringes are the subject of the following U.S. patents: 4,677,980 and 5,383,858. 4 of 71
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Contents
Introduction ........................................................................................... 1 Important safety notice ............................................................................ 1 Understanding symbols ........................................................................... 1 Certifications ............................................................................................ 3 Indications for use ................................................................................... 3 Contraindications ..................................................................................... 3 Restricted sale .......................................................................................... 3 Warnings .................................................................................................. 3 Cautions ................................................................................................... 4 Minimizing extravasation ........................................................................ 4
Learning about the Medrad Vistron CT Injection System ...................... 7 Control panel ........................................................................................... 9 Programming controls ....................................................................... 9 Injector head power control .............................................................. 9 Injector head controls ........................................................................ 9 Arm/inject/disarm controls ............................................................... 9 Injector and Qwik-Fit Syringe disposable ............................................. 10 Remote monitor ..................................................................................... 10 System power console ........................................................................... 11
Preparing the injection system ........................................................... 13 Turning on the injector .......................................................................... 13 Installing the Qwik-Fit Syringe disposable (125 and 200 ml) ............... 13 Retracting the piston and installing the syringe .................................... 13 Filling the syringe ........................................................................... 14 Expelling air and attaching the connector tube .............................. 16 Using a syringe heater ..................................................................... 17 Reinstalling a syringe ...................................................................... 17 Bracco Prefilled Syringe Installation .............................................. 18
Setting up an injection protocol ........................................................... 21 Defining injection protocols .................................................................. 21 Setting the phase values ......................................................................... 21 Selecting the phase .......................................................................... 21 Setting the flow rate value ............................................................... 22 Setting the volume ........................................................................... 23 Setting the duration value ................................................................ 23 Setting the Scan Delay timer ................................................................. 23 Setting the protocol’s pressure limit value ............................................ 24 Viewing a protocol’s summary values ................................................... 25 Deleting a protocol ................................................................................. 25
Arming and injecting ............................................................................ 27 Preparing to arm the injector ................................................................. 27 Arming the injector ................................................................................ 28 Preparing to inject .................................................................................. 28 Injecting ................................................................................................. 29 Recognizing pressure limiting conditions ....................................... 29 Pausing an injection ........................................................................ 30 Medrad Vistron CT Injection System
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Contents, continued Disarming or resetting the injector .................................................. 30 Cleaning up the injector system after an injection .......................... 31 Putting the injector in standby mode ............................................... 31 Cleaning the injector system .................................................................. 31 Storing the injector system .................................................................... 31
Labeling Specification, 95403-T-141, Rev:D - Prior to use, you are responsible to confirm that this revision is the latest released revision and to verify accuracy of printed content.
Appendix A: System Messages ............................................................ 33 Defining the message codes ................................................................... 33 U message code descriptions ................................................................. 33 P message code descriptions .................................................................. 34 d message code descriptions .................................................................. 34 C message code definitions and troubleshooting .................................. 34 Other malfunctions ................................................................................ 35
Appendix B: Specifications ................................................................... 37 Injector head dimensions ....................................................................... 37 Injector head pedestal dimensions ......................................................... 37 Remote monitor dimensions .................................................................. 38 System power console dimensions ........................................................ 38 Medrad Vistron CT Injection System capabilities ................................. 39 Forward/reverse piston motion controls ......................................... 40 Syringe heater .................................................................................. 40 EMI/RFI .......................................................................................... 40 Protection against electrical shock .................................................. 40 Electrical requirements .................................................................... 40 Electrical leakage ............................................................................ 40 Ground continuity ........................................................................... 40 Environmental specifications .......................................................... 40 Protection against ingress of fluids (fluid entry)............................. 41 Mode of operation ........................................................................... 41 Response to occlusions ................................................................... 41 Over and under infusion protection ................................................ 41
Appendix C: Service, Maintenance and Contacting Medrad ................ 43 Servicing the injector ............................................................................. 43 Maintenance ........................................................................................... 43 Daily ................................................................................................ 43 Monthly ........................................................................................... 45 Annually .......................................................................................... 45 Operation check procedure .................................................................... 45 Contacting Medrad ................................................................................ 46
Appendix D: Cleaning the injection system ......................................... 49 Appendix E: System accessories .......................................................... 51 Appendix F: Installation ...................................................................... 53 Mounting and removing the injector head ............................................. 55 Mounting the remote monitor ................................................................ 55
Appendix G: Installation & Operation of AutoLink ............................. 57
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Introduction
Read the information contained in this section. Understanding the information will assist you in operating the device in a safe manner.
Important safety notice This device is intended to be used by individuals with adequate training and experience in computed tomography studies.
Understanding symbols The following symbols are used on the Medrad Vistron CT Injection System and components. Symbol
Description Attention, consult accompanying instructions. Indicates that this device conforms to the requirements of the European Medical Device Directive 93/42/EEC. Identifies the equipotential ground. Identifies the earth ground. Identifies the On switch position. Identifies the Off switch position. Indicates hazardous voltages. Indicates alternating current. Identifies a type BF applied part complying with EN 60601-1 standards.
CLASS 1
Indicates the injection system is Class 1 medical equipment as defined by EN 60601-1 standards.
Identifies connection of the injector head cable. Identifies the connection of the remote monitor. Identifies the Standby key. Identifies the connection on the injector head for the syringe heater.
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Introduction, continued Understanding symbols, continued Symbol
Description
IPX1
Identifies the degree of protection against fluid as drip proof.
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Identifies connection of the remote Start/Hold switch. Identifies the Fill Select key. Identifies the Autofill key. Identifies the Retract key. Identifies rotation direction on the manual knob for manually moving the piston. Clockwise is forward movement. Identifies the Start key. Identifies the Hold key. Identifies the Summary key. Identifies the Up Arrow key. Use to increase values when programming. Identifies the Down Arrow key. Use to decrease values when programming. J302
Identifies the AutoLink connector.
Identifies the power cord connector.
Additional symbols used in this manual indicate information that will assist you in operating this device in a safe and successful manner: Symbol
4
Description
Warning
Indicates that the information is a warning. Warnings advise you of circumstances that could result in injury or death to the patient or operator. Read and understand the warnings before operating the injector system.
Caution
Indicates that the information is a caution. Cautions advise you of circumstances that could result in damage to the device. Read and understand the cautions before operating the injector system. Indicates that the information that follows is a tip that will help you recover from an error or point you to related information within the manual.
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Introduction, continued Certifications This device is equipped to operate at 100-240 VAC, 50/60 Hz, and is designed to be in compliance with EN 60601-1 (safety), EN 60601-1-2 (EMC/ Emissions).
Labeling Specification, 95403-T-141, Rev:D - Prior to use, you are responsible to confirm that this revision is the latest released revision and to verify accuracy of printed content.
Medrad, Inc., is ISO 9001/EN 460001 certified. Medrad Europe B.V. is EN-ISO 90002/EN 46002 certified.
Indications for use The device is designed specifically for the injection of intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications.
Contraindications This device is not to be used for drug infusion, chemotherapy, or any other use for which the device is not indicated. This device is not for portable use.
Restricted sale Federal (USA) law restricts this device to sale by or on the order of a physician.
Warnings •
Patient injury may result from a system malfunction. If a system malfunction occurs, immediately turn the injector off and disconnect the injector from the patient. If a fault message is displayed that cannot be corrected, and/or the injector is not operating correctly, do not use the injector. Call MEDRAD for assistance. (See Appendix C, Service and maintenance.)
•
Patient injury could result from leaks or ruptures during an injection. To prevent leaks or ruptures, use only catheters and connectors with pressure ratings compatible with this system. Always program the pressure limit lower than the pressure ratings of the catheters and connectors. This will help prevent leaks or ruptures in the event of a blockage.
•
Explosion hazard. Do not use the injector in the presence of flammables (such as anesthetics).
•
Unsafe operation may result from using improper accessories. Use only accessories and options provided by MEDRAD designed for this system.
•
Patient or operator injury can occur from a falling injector head or pedestal. Do not move the head, pedestal, or counterpoise system by pulling on the injector head or cabling. Move the injector by grasping the center of the pedestal or vertical arm on the counterpoise.
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Introduction, continued
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Cautions •
Injector may disarm or fail to operate when exposed to high magnetic fields. Do not use radio transmitters, cellular phones, or devices generating electrostatic discharge in the vicinity of this system.
•
Condensation may cause electrical damage to the injector. Do not use the injector immediately after it has been brought indoors from extreme outside temperatures. Allow the injector to stabilize at room temperature before use.
•
Injector damage can occur as a result of incorrect voltage. Before plugging in the injector, check the following:
•
–
Verify that the voltage and frequency marked on the serial tag on the back of the injector matches the voltage and current of the electrical outlet.
–
Verify that the injector has the appropriate power cord plug for the power outlet.
Injector electronic assemblies contain potentially hazardous materials. Dispose of system components or accessories properly. Follow local regulations for proper disposal or contact MEDRAD Service for assistance.
Additional warnings, cautions, and notes are located throughout this manual, where applicable.
Minimizing extravasation As a manufacturer, Medrad, Inc. cannot recommend specific procedures for venipuncture in enhanced computed tomography. We offer this compilation of information, obtained from the following physicians, as suggestions relating to practices which have worked well at their institutions. Richard L. Baron, M.D. Elliot K. Fishman, M.D. Robert Zeman, M.D. Philip Costello, M.D. Patrick Freeny, M.D. Paul M. Silverman, M.D. W. Dennis Foley, M.D.
University of Pittsburgh Medical Center Johns Hopkins Hospital Georgetown University Hospital New England Deaconess Hospital University of Washington Georgetown University Hospital Medical College of Wisconsin
Extravasation can be greatly reduced when proper techniques are followed: 1. Use a 20 gauge or larger I.V. catheter-over-needle (a 22 gauge may be used with slower flow rates). 2. The preferred location for venipuncture is the medially located antecubital vein. 4A winged catheterover-needle allows easy insertion into the vein and secure taping.
3. Have at least 1/2 inch (1.3 cm) of the catheter positioned in a good vein with RAPID BACKFLOW. 4. Tape the catheter securely to avoid catheter movement.
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Introduction, continued 5. Use a 60 inch (152 cm) coiled low pressure tube securely attached to the catheter. The coiled tubing reduces motion effect during table incrementation.
Labeling Specification, 95403-T-141, Rev:D - Prior to use, you are responsible to confirm that this revision is the latest released revision and to verify accuracy of printed content.
6. Instruct the patient to communicate immediately any pain or change in feeling during the injection. 7. If possible, instruct the patient to put his/her arms vertically above the shoulder with the palm of the hand on the face of the gantry during the injection. This allows for uninterrupted passage of injected contrast media through the axillary and subclavian veins at the thoracic outlet. 8. A small volume test injection of contrast media or saline may be utilized to confirm venous access. A trained professional should remain by the patient during the initial stages of the injection palpating the venous access site to ensure proper placement of the I.V. catheter. If local pain, swelling or signs of extravasation are noted, the injection should be stopped immediately. Warning •
Patient injury or contrast media contamination could result from improper use of the injector head controls. Do not activate the Autofill feature or piston motion keys when a patient is connected to the injector. Use only the manual knob on the injector head when a patient is connected to the injector. Improper use of the injector head controls could cause collapsed veins or an uncontrolled injection.
9. Central lines and hep-locks should only be used in accordance with hospital policy guidelines. 10. Adhere to all instructions, warnings, and cautions listed for the specific products being used.
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Labeling Specification, 95403-T-141, Rev:D - Prior to use, you are responsible to confirm that this revision is the latest released revision and to verify accuracy of printed content.
Labeling Specification, 95403-T-141, Rev:D - Prior to use, you are responsible to confirm that this revision is the latest released revision and to verify accuracy of printed content.
Learning about the Medrad Vistron CT Injection System
The Medrad Vistron CT Injection System consists of the following: •
a control panel/injector head The control panel/injector head may be mounted on a pedestal (single height or adjustable height) or on a counterpoise mount.
4See Appendix E for system accessories.
Height adjustable pedestal
Single height pedestal
Counterpoise mount options •
a system power console
•
a remote monitor
4See Appendix F for installation instructions.
Scan Delay
In jected Volume
Injection Du ration
Phase
Flo w Rate
V olume
Phase
Flo w Rate
V olume
TM
I NJEC TION
S Y S
T E M
DIS A RM Star t
Hold
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Learning about the Medrad Vistron CT Injection System, continued
Labeling Specification, 95403-T-141, Rev:D - Prior to use, you are responsible to confirm that this revision is the latest released revision and to verify accuracy of printed content.
Below is a typical installation of the injection system in a CT suite.
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Learning about the Medrad Vistron CT Injection System, continued
Labeling Specification, 95403-T-141, Rev:D - Prior to use, you are responsible to confirm that this revision is the latest released revision and to verify accuracy of printed content.
Control panel
Programming controls
Injector head controls
1. Scan Delay window Scan Delay keys
9.
2. Phase indicator Phase/Total Phases window Total number of Phases indicator keys Phase
10. Retract indicator Retract key
3. Flow Rate indicator Flow Rate/Maximum Flow Rate window Maximum Flow Rate indicator Flow Rate keys 4. Volume indicator Volume/Total Volume window Total Volume indicator keys Volume
Syringe Volume ml indicator Syringe Volume/Autofill Volume window Autofill Volume ml indicator
11. Autofill indicator Autofill key 12. Fill Select indicator Fill Select key 13. Enable indicator Enable key Enable forward motion control Enable reverse motion control
5. Duration indicator Duration/Total Duration window Total Duration indicator keys Duration
Arm/inject/disarm controls
6. Pressure Limit indicator Pressure Limit window Pounds per Square Inch (PSI) indicator Kilo Pascals (kPa) indicator keys Pressure Limit
16. Multi Inject Mode indicator
7. Summary indicator Summary key
Injector head power control
14. Single Inject Mode indicator 15. Inject Mode key
17. Is Air Expelled? indicator Arm/Yes key 18. Start indicator Start key Hold indicator Hold key 19. Disarm/Reset key
8. Standby indicator Standby key Medrad Vistron CT Injection System
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Learning about the Medrad Vistron CT Injection System, continued Injector and Qwik-Fit syringe
Labeling Specification, 95403-T-141, Rev:D - Prior to use, you are responsible to confirm that this revision is the latest released revision and to verify accuracy of printed content.
1
2
3
4
5
6
Arm/Yes
1.
Manual knob
4. Piston
2. Armed indicator lens
5. Plunger
3. Qwik-Fit Syringe Disposable
6. FluiDot indicator
Remote Monitor
Scan Delay
Injected Volume
Injection Duration
Phase
Flow Rate
Volume
Phase
Flow Rate
Volume
1 2 3 TM
I NJECTION
4 5
S Y S
T E M
DIS ARM Star t
Hold
6
1. Scan Delay window Injected Volume window Injection Duration window
4. Disarm key
2. Phase window Flow Rate window Volume window
6. Start key Hold key
5. Start indicator Hold indicator
3. Phase window Flow Rate window Volume window
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Learning about the Medrad Vistron CT Injection System, continued
Labeling Specification, 95403-T-141, Rev:D - Prior to use, you are responsible to confirm that this revision is the latest released revision and to verify accuracy of printed content.
System power console (rear view) 1
2
4
5
3
1. On/Off switch
4. Power cable jack
2. Remote monitor jack
5. Equipotential ground cable jack
3. Injector head jack
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Labeling Specification, 95403-T-141, Rev:D - Prior to use, you are responsible to confirm that this revision is the latest released revision and to verify accuracy of printed content.
Labeling Specification, 95403-T-141, Rev:D - Prior to use, you are responsible to confirm that this revision is the latest released revision and to verify accuracy of printed content.
Preparing the injection system 4While you operate the injector, message codes will appear in the Pressure Limit window. The types of messages range from system status confirmation to an important condition that requires you to immediately disconnect the patient. See Appendix A for complete descriptions of the message codes.
This section describes how to turn on the injector and install and fill QwikFit Syringe 200 and 125 ml disposables.
Turning on the injector Press the On/Off switch on the back of the power console to turn on the injector. Do not press any keys while pressing the On/Off switch. The injector will perform the following procedures: 1. The system will perform self diagnostics and the injector will beep. 2. All indicators will illuminate and the windows on the control panel will display 8. 3. When the self-diagnostics are completed, the current version of software installed in the injector will be momentarily displayed. 4. Default values or previous injection values will appear in the Scan Delay, Flow Rate, Volume, Duration, and Pressure Limit windows. 5. The Syringe Volume ml window will display a value that reflects the current piston position.
4Do not install a syringe on the injector before you turn on the injector. If a syringe is attached when you turn on the power, the injector will display the message P125. Remove the syringe and the message will disappear.
Installing the Qwik-Fit Syringe (125 and 200 ml) Disposables Warnings •
Catheters and connectors must have pressure ratings compatible with the injector.
•
Delayed diagnosis or exposure to additional radiation (from having to repeat the procedure) could result from under flow rates, under volumes, or stall conditions. To help prevent these conditions, do not connect additional infusion systems/accessories to the fluid delivery path.
•
Biological contamination can result from reusing disposable items. Do not use disposable items on more than one patient. Properly discard disposable items after use.
Retracting the piston and installing the syringe 4Do not use the Retract key if a syringe is attached. Remove the syringe before pressing the Retract key.
1. Fully retract the piston by pressing the Retract key or by using the reverse motion controls. 2. Inspect the syringe for cracks or other damage. Discard damaged syringes.
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Preparing the injection system, continued
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3. Insert the end of the syringe in the horizontal cutouts in the injector head.
Note: Do not use the manual knob or attach or remove a syringe during forward/reverse motion control, Retract, Autofill, Arming or Injecting. Interfering with the manual knob or syringe during piston motion may result in a system error.
4. Rotate the syringe a quarter turn clockwise until it locks into place, the alignment marks line up, and the piston and plunger are interlocked.
Warning •
Patient injury could result if syringe is not properly engaged. Do not load or inject unless the syringe is properly engaged. Ensure the alignment marks on the syringe and injector head are properly aligned and the piston and plunger are interlocked. Improper engagement may cause air embolization or under-volume delivery.
Filling the syringe
4One person should
fill and arm the injector. If you must change the injector operator, be certain that the second operator verifies that the syringe was properly filled and that any air was eliminated.
Warnings •
Remove all trapped air from the syringe, connector tubing, and catheter-over-needle before connecting the patient to the injector.
•
Syringe sterility will be compromised, and patient infection may result, if the plunger is removed from the syringe. Do not remove the plunger to fill the syringe.
•
Bacterial contamination can occur if syringes are used to store contrast media. Use loaded syringes immediately. Do not store loaded syringes for later use. Discard unused loaded syringes.
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Preparing the injection system, continued To fill the syringe:
Labeling Specification, 95403-T-141, Rev:D - Prior to use, you are responsible to confirm that this revision is the latest released revision and to verify accuracy of printed content.
1. Tilt the injector head up.
2. Press the Enable key.
The Enable indicator lights. 3. Press and hold the Enable/Forward Motion controls until the piston is fully advanced (0-1 ml syringe volume). If the Enable indicator goes out (it stays lit for five seconds) before you press the forward motion controls, the piston will not advance. Press the Enable key again to light the Enable indicator. 4. Attach a sterile filling device onto the tip of the syringe. 5. Open the contrast media bottle and aspirate warmed contrast media into the syringe by one of two methods:
4Use a MEDRAD Quick Fill Tube or equivalent device to reduce the volume and size of air bubbles drawn into the syringe during filling. It is more difficult to remove the air bubbles if you use smaller diameter tubes, such as a catheter-overneedle, or a tube longer than 10 in. (25 cm).
•
reverse controls a. Press the Enable key. The Enable indicator lights. b. Press and hold the Reverse Motion controls until the syringe is filled with the volume of contrast media you desire.
•
Autofill a. Press the Fill Select key repeatedly to select the volume.
Each time you press the key, the Autofill Volume ml window will increment by 25 ml.
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Preparing the injection system, continued The volume selection for a 200 ml syringe is from 200 to 25 ml; the volume selection for a 125 ml syringe is from 125 to 25 ml. The Autofill indicator will flash while you are selecting the volume.
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b. Press the Autofill key to start filling the syringe.
Warning 4To stop piston
•
movement due to injector head controls, press any key on the injector head control panel. The injector will display the message U141.
If the Autofill indicator stops flashing (it flashes for five seconds after you press the Fill Select key) before you press the Autofill key, the syringe will not load. Press the Fill Select key again to light the Autofill indicator.
4FluiDot indicators must be viewed through the syringe barrel in a properly illuminated environment. The environment must provide enough light to permit the operator to view the FluiDot indicators easily through the syringe barrel.
Patient injury or contrast media contamination could result from improper use of the injector head controls. Do not activate the Autofill feature or piston motion keys when a patient is connected to the injector. Use only the manual knob on the injector head when a patient is connected to the injector. Improper use of the injector head controls could cause collapsed veins or an uncontrolled injection.
6. Use the FluiDot indicators to help you to detect the presence of contrast media in the syringe.
Empty syringe
Full syringe
Verify that the Qwik-Fit Syringe FluiDot indicators are round in the filled portion of the syringe. The rounded shape of the FluiDot indicators varies according to the type of contrast media, but an oblong shape indicates the presence of air. Rounded FluiDot indicators do not indicate the total absence of air bubbles in the syringe tip.
Expelling air and attaching the connector tube Warning •
4Do not hit the syringe
to remove air bubbles. Reverse the plunger 3 to 5 ml, then rock the injector head on the pivot to dislodge the bubbles. Expel the remaining air.
Air embolization can cause death or serious injury to the patient. Do not connect a patient to the injector until all trapped air has been cleared from the syringe and fluid path. Carefully read the instruction for loading and the use of FluiDot indicators to reduce the chance of air embolism.
After you fill the syringe, you must expel all air from the syringe and then attach the connector tubing. To do so: 1. Remove the filling device and expel air from the syringe. 2. Attach the connector tube to the syringe, making sure that the connector luer fitting is secured to the threaded tip of the syringe. 3. Verify that the tubing is not kinked or obstructed.
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Preparing the injection system, continued 4. Use the manual knob to advance the syringe plunger to provide a slow flow of contrast media to the connection. An absence of flow is an obvious indication of air in the fluid path. 5. Prime the connector tubing and make certain that the air is expelled.
Labeling Specification, 95403-T-141, Rev:D - Prior to use, you are responsible to confirm that this revision is the latest released revision and to verify accuracy of printed content.
6. Verify that all of the air has been expelled from the syringe and fluid path. The injector is now ready for programming. If you have already programmed the injector, see Arming and injecting.
Using a syringe heater
4Syringe heater for
Qwik-Fit Syringe 125 ml and 200 ml disposables: VSH 600.
You can use a syringe heater to maintain the temperature of the warmed contrast media in the syringe. To connect the syringe heater: 1. Plug the syringe heater into the syringe heater jack on the back of the injector head. 2. Snap the syringe heater onto the syringe.
Caution •
Syringe heat maintainer can be damaged from over heating. Immediately remove the heat maintainer from the syringe if the indicator light on it is lit continuously. This means the heat maintainer is overheating.
Reinstalling a syringe If you remove a syringe from the injector and then wish to reinstall it, perform the following steps: 1. Insert the end of the syringe in the horizontal cutouts in the injector head. 2. Advance the piston until it is past the plunger feet and the piston and plunger interlock. 3. Rotate the syringe 1/4 turn clockwise until the syringe locks and alignment marks are positioned. 4. Proceed as normal by aspirating and dislodging any air bubbles.
Warning •
Patient injury could result if syringe is not properly engaged. Do not load or inject unless the syringe is properly engaged. Ensure the alignment marks on the syringe and injector head are properly aligned and the piston and plunger are interlocked. Improper engagement may cause air embolization or under-volume delivery.
Do not use unless the plunger feet are properly engaged with the piston.
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Preparing the injection system, continued Bracco* Prefilled Syringe Installation * Catalog numbers: Isovue 250: 1317 43; Isovue 300: 1315 57 (100 ml fill), 1315 58 (150 ml fill); Isovue 370: 1316 56 (75 ml fill), 1316 57 (100 ml fill)
Labeling Specification, 95403-T-141, Rev:D - Prior to use, you are responsible to confirm that this revision is the latest released revision and to verify accuracy of printed content.
Warnings
Improperly engaged syringes may leak or be damaged. Ensure proper engagement of syringe and injector. Syringe and injector alignment marks must align. Improper engagement may cause an under volume injection, air embolization, or personal injury. To minimize the risk of air embolization, ensure that one operator is delegated the responsibility of installing the syringe and arming the injector. Do not change operators during the procedure. If an operator change must occur, the new operator must verify that air has been removed from the fluid path before injecting. 1. Apply power to the unit and fully reverse the piston. 2. Always visually inspect syringes before use. 3. To insert the syringe, align the rear flanges of the syringe with the vertical cut-outs in the plate on the front of the injector head. Alignment marks on the syringe should be horizontal when inserted.
4. Push the syringe until the alignment flange comes in contact with the plate. Turn the syringe 1/4 turn clockwise until the syringe can no longer be turned. Verify that the alignment marks on the syringe are positioned vertically so that the top syringe alignment mark is below the alignment mark on the injector head. 5. Attach the connector tubing onto the prefilled syringe. The connector tube will capture any contrast media (1 to 2 ml) that may be expelled from the syringe during syringe installation.
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Preparing the injection system, continued 6. Slowly advance the piston until the piston interlocks with and is secured by the flexible legs on the back of the syringe plunger. The illustration below displays the flexible legs on the bottom of the prefilled syringe plunger.
Labeling Specification, 95403-T-141, Rev:D - Prior to use, you are responsible to confirm that this revision is the latest released revision and to verify accuracy of printed content.
Prefilled syringe
Flexible legs
7. Follow the additional instructions in the Vistron CT Operation Manual (“Preparing the Injection System”) for instructions on expelling air and priming the connector tube.
Syringe Removal After Injecting Retract the syringe plunger 1 ml using the manual adjustment knob. Rotate the syringe 1/4 turn counterclockwise and remove it from the injector head.
Prefillled Syringe System Messages Message Code & Description U Message Codes (Identify conditions that require attention. U codes clear within 5 seconds or press any injector key to clear them after 2 seconds.) U133
Cannot activate Autofill - Prefilled syringe is attatched.
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Labeling Specification, 95403-T-141, Rev:D - Prior to use, you are responsible to confirm that this revision is the latest released revision and to verify accuracy of printed content.
Setting up an injection protocol
This section provides instructions for programming the Medrad Vistron CT injector for an injection protocol.
Defining injection protocols The injection protocol can consist of one injection phase or as many as four phases (multiphasic injections). A phase is an interval in a protocol in which a set volume is delivered at a set flow rate or for a set duration of time. To program a protocol, you may set the following values for each injection phase: •
flow rate
•
volume
•
duration
In addition, at any time while you are programming the phases of the protocol, you can set the following values for the protocol: •
scan delay
•
pressure limit Warning
•
Delayed diagnosis or exposure to additional radiation (from having to repeat the procedure) could result from over flow rates, under flow rates, over volume, or under volume delivery. Use extreme care when selecting flow rate and duration. Verify settings before injecting.
Setting the phase values Before you set up a protocol, the control panel will display default or previous protocol values in the following windows: Scan Delay, Flow Rate, Volume, Duration, and Pressure Limit. The value displayed in the Syringe Volume ml window reflects the current piston position. The remote monitor will not display any values until you arm the injector.
Selecting the phase
4The Phase window
keys scroll in one direction. The key scrolls from 1 to 4 and stops. The key scrolls from 4 to 1 and stops.
There are four phases available on the Medrad Vistron CT injector. You must set the phases in order (1-4) and you must set all the values for the phase before moving on to the next phase. To set the phase number: Press the Phase window
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Setting up an injection protocol, continued
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The phase you select is displayed in the Phase window. If the phase is unprogrammed, the Flow Rate and Volume windows will flash 0.0. If you attempt to scroll to a higher phase before setting all the values for the current phase, the control panel will display the U162 message code. Deleting a phase Phases may be deleted in sequence from the last phase down to the first. Only the highest phase in a protocol can be deleted. For example, if you wish to delete phase 3 of a 4-phase protocol, you must delete phase 4 first. To delete a phase: 1. Use the Phase window programmed.
keys to select the highest phase you have
The Phase window will display the phase number you wish to delete. 2. Use the Flow Rate window 3. Use the Volume window
keys to select 0.0 as the flow rate value. keys to select 0.0 as the volume value.
The Volume, Duration, and Flow Rate windows will display 0.0. The phase is deleted. 4. Use the Phase window key to select the next phase and then repeat steps 1-4 to delete additional phases.
4If you select two
values and the result of the calculation is a value outside of the programmable range, the calculated value will flash. Change one or both of the values you entered to display a calculated value that is within the programmable range.
Setting the flow rate value Flow rate is the rate at which fluid is delivered. You select the flow rate in units of ml/sec. Flow rate, volume, and duration calculations are interdependent. If you select flow rate and volume values, the injector will automatically calculate and display the duration time. Conversely, if you select the volume and duration values, the injector will calculate and display the flow rate value. You must always select the volume value and either the flow rate value or the duration value for the injector to perform the calculation. The flow rate value range is 0.1 to 9.9 ml/sec. To enter the flow rate: Use the Flow Rate window
4To view the protocols summary values, press the Summary key. (See Viewing a protocols summary values for more information.)
keys to select the flow rate.
The Flow Rate window will display the flow rate you selected. If you had previously selected the volume value, the Duration window will display the calculated duration value.
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Setting up an injection protocol, continued Setting the volume
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4The Scan Delay,
Flow Rate, Volume, Duration and Pressure Limit keys scroll in both directions through the ranges. Press and hold the keys to scroll the values at an accelerated rate.
The total programmed volume for a multiphasic injection cannot exceed the maximum syringe capacity. If you set up a protocol in which the combined volume of all the phases is higher than the syringe capacity, the control panel will display the U110 message code when you attempt to arm the injector. You will have to modify the protocol before you can attempt to arm the injector again. The volume value range is 10 ml to syringe capacity. To set the volume: Use the Volume window
keys to select the volume.
The Volume window will display the volume you selected. If you had previously selected the flow rate value, the Duration window will display the calculated duration value.
Setting the duration value
4If you increase the
duration value, the flow rate value may not update at the same rate due to rounding.
Duration is the length of time required to perform the programmed injection from the moment you press the Start key until the injector stops injecting. Duration is calculated by dividing the selected volume by the selected flow rate. For example, if you select 50 ml volume and 2 ml/sec flow rate, the duration will be 25 seconds (50 divided by 2 = 25). The injector will calculate and display the duration of a multiphase injection. Hold time is not included in this duration time. You must select the volume value before you select the duration value. If you don’t, the injector will display the U161 message code. If you change the duration already calculated and displayed by the injector, the injector will modify the flow rate. The duration range per syringe size (in min:sec) is: 200 ml syringe: 0:00 to 33:20 125 ml syringe: 0:00 to 20:50 To change the duration value: Use the Duration window
keys to select a new duration value.
The Duration window will display the new duration value. The injector will calculate and display a new flow rate.
Setting the Scan Delay timer The Scan Delay timer will notify you when to start the scanner in relation to the start of the protocol. After the injection starts, Scan Delay timer will begin to count down. The injector will beep every second for the last 10 seconds of the countdown. When
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Setting up an injection protocol, continued timer reaches 0, the injector will beep five times to signal that the time you selected has expired. Use of the Scan Delay timer is optional. The timer range is 0 to 99 sec. To set the timer:
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Use the Scan Delay window
keys to select the timer setting.
The Scan Delay window displays the timer setting.
Setting the protocol’s pressure limit value 4See Recognizing
pressure limiting conditions under Injecting in the Arming and injecting section. A pressure limiting condition can cause stalls, washed out images, or longer than expected duration times. You should understand pressure limiting conditions and how to correct them before arming.
4If after turning the
injector off and on again, the Pressure Limit indicator has reverted from kPa to PSI, press both Pressure Limit window keys simultaneously to change back. Always verify programmed values before arming the injector.
When you set the pressure limit value, you are determining the maximum amount of pressure the injector will allow during a protocol. You want to be certain that the pressure limit you set does not exceed the disposables’ rated pressure limit, so that the disposables do not break. The pressure limit range for 125 and 200 ml syringes is 50 to 300 psi or 345 to 2070 kPa.
Warning •
Patient injury could result from leaks or ruptures during an injection. To prevent leaks or ruptures, use only catheters and connectors with pressure ratings compatible with this system. Always program the pressure limit lower than the pressure ratings of the catheters and connectors. This will help prevent leaks or ruptures in the event of a blockage.
The pressure limit value may be viewed as a psi or kPa measurement. If the PSI indicator is lit, the Pressure Limit window value is expressed in psi. If the kPa indicator is lit, the value is expressed in kPa. To change the Pressure Limit window measurement: Press both the Pressure Limit window
keys simultaneously.
The indicator for the new measurement lights. To select the pressure limit: Use the Pressure Limit window
keys to select the pressure limit.
The psi value will change in 50 psi increments. The kPa value will change in 345 kPa increments. You have finished programming one phase of a protocol. If you would like to program additional phases, return to “Setting the phase values,” for instructions.
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Setting up an injection protocol, continued Viewing a protocol’s summary values You can check the summary values of your protocol at any time before you arm the injector. To view the total and maximum values:
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1. Press and hold the Summary key.
The Total and Maximum indicators light. The Phase, Volume, and Duration windows display total values. The Flow Rate window displays a maximum value. 2. Make sure the total volume does not exceed the syringe size. If it does, you must go back and revise your protocol. 3. When you are satisfied with your protocol settings, use the Phase window keys to select the highest phase. For example, if you programmed four phases, select 4. You will not be able to arm the injector if it is not set at the highest phase.
Deleting a protocol To delete the entire protocol, which will erase all of the phases that you set: 1. Press the Disarm/Reset key.
The control panel will flash summary information. 2. Press the Disarm/Reset key again. The entered values stop flashing. The injector displays phase 1 with default values in all windows. The protocol is erased. Press any key except Disarm/Reset while the unit is flashing to cancel the reset command or allow the 5 second reset time to elapse.
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Labeling Specification, 95403-T-141, Rev:D - Prior to use, you are responsible to confirm that this revision is the latest released revision and to verify accuracy of printed content.
Arming and injecting
Preparing to arm the injector 1. Verify that all injection values are correct. Use the Summary key to verify the total and maximum values.
Warning Note: Do not use the manual knob or attach or remove a syringe during forward/reverse motion control, Retract, Autofill, Arming or Injecting. Interfering with the manual knob or syringe during piston motion may result in a system error.
4FluiDot indicators must
be viewed through the syringe barrel in a properly illuminated environment. The environment must provide enough light to permit the operator to view the FluiDot indicators easily through the syringe barrel.
•
Patient injury could result from high flow rate venous injections. Use extreme care when selecting flow rate and duration. Before arming the injector, verify that high flow rate injection parameters have not been unintentionally programmed.
2. Scroll to the highest phase of a multiphase protocol before attempting to arm the injector. If the highest phase is not displayed before you press the Arm/Yes key, the control panel will display the U172 message code. When the message code clears, advance the injector to the highest phase. 3. Verify that all air has been removed from the syringe and fluid path. Use the FluiDot indicators to help you to detect the presence of contrast media in the syringe. Verify that the Qwik-Fit syringe FluiDot indicators are round in the filled portion of the syringe. The rounded shape of the FluiDot indicators varies according to the type of contrast media, but an oblong shape indicates the presence of air. Rounded FluiDot indicators do not indicate the total absence of air bubbles in the syringe tip. 4. Tilt the injector head down before attaching the syringe connector tube to the vascular entry device in the patient. After attaching the connector tube, be certain that the connector luer fittings are secure. The injector head must remain in this position during the injection. 5. Verify again that the air is expelled from the syringe and connector tubing. 6. Verify that the connections are secure and that there are no kinks or obstructions.
Warning: Do not use a closed stopcock during an injection.
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Arming and injecting, continued 4The arming process
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may be stopped at any time by pressing any key except the Arm/Yes and Start keys.
Arming the injector 1. Press the Arm/Yes key. Arm/Yes
The control panel displays the U321 message code. Then the P100 message code appears and the Is Air Expelled? indicator lights. 2. Verify that all air is expelled from the syringe and fluid path. 3. Press the Arm/Yes key to arm the injector. The Is Air Expelled?, Start, and Armed/Injecting indicators flash. On the remote monitor, the Start indicator flashes and the values for phases 1 and 2 are displayed. Press any key except Start or Inject Mode if you want to disarm the injector at this time. If the injector detects an insufficient volume in the syringe to complete the protocol, the Syringe Volume ml window and indicator will flash.
Warning •
Air embolization can cause death or serious injury to the patient. Do not connect a patient to the injector until all trapped air has been cleared from the syringe and fluid path. Carefully read the instruction for loading and the use of FluiDot indicators to reduce the chance of air embolism.
Preparing to inject Choose whether you want to start a single injection or a multi injection. •
Single injection In a single injection, the protocol is executed once and the injector disarms.
•
Multi injection In a multiple injection, the protocol is executed, but the system remains armed. If you press the Start key again, the protocol is repeated. You can repeat the protocol until the syringe volume is 0 ml.
The default injection mode setting is single. To change the injection mode to multi: Press the Inject Mode key.
The Multi indicator lights and the injector is set to multi injection mode.
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Arming and injecting, continued Injecting You are now ready to start the injection protocol. To begin injecting:
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Press the Start key on the control panel, the remote monitor, or the remote Start/Hold switch to begin the injection.
The first phase values are displayed on the control panel and the remote monitor. The remote monitor displays the Scan Delay timer, Injected Volume, and actual Injection Duration. If the scan delay timer was set, the scan delay timer will begin. The Armed/Injecting indicator lights. When the Scan Delay timer reaches 0, it beeps five times to alert you to start the scanner. If the protocol is multiphasic, the control panel displays phase 2 values when phase 1 has completed. This will continue until all of the phases are completed. At the end of each phase the injector beeps. The remote monitor also displays two phases at a time while the injection is in progress; phases 1 and 2, then phases 3 and 4. The active phase flashes. When the injection is complete, the injector will beep and the Armed/Injecting indicator and the Start indicator will turn off. Refer to the Remote Monitor for Injected Volume and Injection Duration displays.
Recognizing pressure limiting conditions
4If the blockage was
caused by a closed stopcock, remove the blockage and verify that no air was drawn into the syringe during the recoil. Disconnect the patient and purge or refill the syringe as necessary before repeating the injection.
If the injection durations during a protocol are longer than you would normally expect and the images are washed out, the injector may be experiencing a pressure limiting condition. If this condition occurs, the Pressure Limit indicator on the control panel will light and the injector will beep. A stall condition will occur if the flow rate falls to less than 2.5% of the programmed rate. If this occurs, the injector will disarm and the message code d108 will be displayed on the control panel. Warnings •
Incomplete procedure may result from stall conditions. Stall conditions can occur when a high flow rate is selected in conjunction with a low pressure limit. If a stall condition occurs, check the fluid path for blockage. If no blockage exists, adjust the flow rate or pressure limit according to physician’s orders.
•
Patient or operator injury could result from using a closed stopcock during an injection. A closed stopcock could cause an over-pressure condition, causing the syringe to burst.
Minimizing the potential of pressure limiting conditions To minimize the potential of pressure limiting and the resultant problems, use MEDRAD disposable products, which are designed specifically to maximize the performance of the total injection system and give consistent and reliable results. MEDRAD strives to design its injection systems to be compatible with Medrad Vistron CT Injection System
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Arming and injecting, continued
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common disposable products used for the administration of contrast media that are marketed in the imaging field. However, MEDRAD cannot guarantee the performance of the entire system when using a disposable product that is not manufactured by MEDRAD. Therefore, MEDRAD recommends that you use MEDRAD products. If you use a disposable product that is not manufactured by MEDRAD on your MEDRAD injector and you suspect that the system is not performing correctly, contact your local MEDRAD representative.
Pausing an injection You can pause an injection in progress by using the Hold key. The injection, including the scan delay, will pause without disarming the injector or deleting the protocol. The maximum hold time is 10 minutes. If you do not resume the injection within 10 minutes, the injector will disarm and the control panel will display the d115 message code. To pause an injection: Press the Hold key.
The injector will remain armed. The Hold indicator will light solidly and the Armed/Injecting indicator will flash. To resume an injection: Press the Hold key again or the Start key. or
Disarming or resetting the injector You can disarm the injector while an injection is in progress. To disarm the injector: Press any of the following keys: •
the Disarm key on the remote monitor
•
the Disarm/Reset key on the control panel
•
any other key on the control panel except the Hold key.
The injection stops and the control panel displays the d101 message code. The Armed/Injecting indicator extinguishes, and the phase 1 program values are displayed. The injector will be ready for programming after the message code clears.
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Arming and injecting, continued Injection complete The injector will beep to indicate that the injection is complete. The Armed/ Injecting indicator and the Start indicator will extinguish. You may refer to the remote monitor for the Injected Volume and Injection Duration.
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Cleaning up the injector system after an injection Remove and discard the syringe, connector tubing, and other disposable products.
Putting the injector in standby mode You sometimes may want to turn off the control panel display, such as during the time between patients. When the injector is in standby mode, the injector is still on. You may also need to put the injector in standby mode if you receive a C message code (a system error message). See Appendix A for more information about C message codes. To put the injector in standby mode: Press and hold the Standby key for three seconds.
The control panel display becomes blank and the Standby indicator lights. To return the injector to active mode: Press the Standby key again. The control panel will go through its self diagnostics, as explained in the section, Preparing to inject. Note:
Pressing the Standby key immediately after pressing another key may prevent the injector from entering standyby mode. Wait one second after pressing any key before pressing the Standby key.
Cleaning the injector system Please see Appendix D for information on cleaning the injector system.
Storing the injector system Store the injector system in an area free from extreme or changing temperatures, dust, and spills. See Appendix B for information on environmental specifications.
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Labeling Specification, 95403-T-141, Rev:D - Prior to use, you are responsible to confirm that this revision is the latest released revision and to verify accuracy of printed content.
Labeling Specification, 95403-T-141, Rev:D - Prior to use, you are responsible to confirm that this revision is the latest released revision and to verify accuracy of printed content.
Appendix A: System Messages
This section explains message codes and their definitions.
Defining the message codes There are four types of message codes: •
U codes Identify conditions that require your attention. The message codes clear within five seconds. Press any key to clear the message after two seconds.
•
P codes Identify conditions that require action. The message codes clear when you respond to the conditions identified in the code definitions.
•
d codes Identify conditions that disarm the system. The message codes clear within five seconds (or two seconds if you press any key).
•
C codes Identify errors that require additional attention. You can fix some of the conditions using the information in this section. Other conditions require you to contact MEDRAD Service for assistance. See Appendix C for additional information.
U message code descriptions Code
Description
U103
Cannot continue with injector head operation – Invalid piston or manual knob movement detected.
U110
Cannot arm – Total volume of the protocol exceeds syringe capacity. Attach a larger syringe or adjust volume.
U121
Cannot continue injector head operation – Syringe or adapter is not fully engaged.
U122
Cannot continue injector head operation – Syringe or adapter plate has been installed.
U131
Cannot activate Autofill – Press Enable/Forward Motion control or use manual knob to extend piston fully (0 - 1 ml syringe volume).
U132
A system failure occurred. Disconnect the patient and contact Medrad Service
U141
Cannot continue with injector head operation – Operator pressed a control panel key or Start switch.
U161
Cannot program duration before programming volume.
U162
Cannot change phases with an invalid or incomplete phase.
U171
Cannot arm with an incomplete or invalid phase.
U172
Cannot arm – Scroll to highest phase before proceeding.
U175
Cannot arm – Syringe volume is 0 ml.
U321
Arming – System diagnostics in progress. Press any key to interrupt process.
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Appendix A: System messages, continued
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P message code descriptions Code
Description
P100
Is air expelled from syringe and fluid path? Press the Disarm/Reset key to cancel or Arm/Yes to continue.
P 123, 124
A system failure occurred. Disconnect patient and contact MEDRAD Service.
P125
Cannot continue self diagnostics with syringe attached. Remove syringe.
d message code descriptions Code
Description
d101
System disarmed – Control panel key or the Disarm key was pressed.
d108
System disarmed – Injector stalled.
d115
System disarmed – Hold time exceeded 10 minutes.
d116
System disarmed – Start switch was inserted or removed.
d117
System disarmed – Manual knob was rotated.
d118
System disarmed – Syringe was detached.
d119
System disarmed – Backlash timer expired. Syringe pressure is greater than backlash pressure.
C message code definitions and troubleshooting Warning •
If a system malfunction occurs, immediately turn the injector off and disconnect the patient.
Code
Description
C500
Check Remote Start/Hold Switch If your system does not have a remote Start/Hold switch, contact MEDRAD Service. If your system does have one, follow the steps below: 1. Check the connection at the head of the remote Start/Hold switch. If the connection is loose, remove and reattach the connector. 2. Press the Standby key on the injector head. 3. Disconnect the patient and perform a trial injection using the remote Start/ Hold switch. If the system performs correctly, return the system to use. 4. If the error code reappears, remove the remote Start/Hold switch from the injector head. 5. Press the Standby key, and perform another trial injection, using the Start switch on the injector head. If the system performs correctly, contact MEDRAD Service to replace the remote Start/Hold switch. 6. If the error persists, contact MEDRAD Service.
C510
Check Remote Monitor If your system does not have a remote monitor, contact MEDRAD Service. If your system does have one, follow the steps below: 1. Check the remote monitor connection at the system power console. If the connection is loose, turn off the AC power at the system power console, then remove and reattach the connector.
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Appendix A: System messages, continued 2. Turn on the AC power, or press the Standby key on the injector head. 3. Disconnect the patient and perform a trial injection using the Start key on the remote monitor. Observe the remote monitor displays during the injection. If the system performs correctly, return the system to use.
Labeling Specification, 95403-T-141, Rev:D - Prior to use, you are responsible to confirm that this revision is the latest released revision and to verify accuracy of printed content.
4. If the error code reappears, turn off the AC power and disconnect the remote monitor from the system power console. 5. Turn on the AC power, and perform another trial injection, using the Start switch on the injector head. If the system performs correctly, contact MEDRAD Service for a replacement remote monitor. 6. If the error persists, contact MEDRAD Service.
The following error codes indicate that the injector detected pressure, volume, or flow rate in excess of the specification limits for the programmed value. Disconnect the patient immediately and examine the patient for injury. Contact MEDRAD Service before using the system again. C520
System pressure exceeded pressure limit or instantaneous pressure exceeded acceptable limits. This may occur when injecting into a blockage or a small catheter with the maximum setting of pressure limit selected. Check the fluid path for blockage, then press the Standby key to restart the injector. If no blockage exists, reduce the flow rate or pressure limit according to physician’s orders. If the error code persists, contact MEDRAD Service.
C530
Injected volume exceeded programmed value
C540
Flow rate exceeded programmed value
C560
Head overlay failure detected A key press was detected during power-up or arming when none should have been present. Press the Standby key to restart the system. Do not press any keys until self diagnostics are complete. If the error code persists, contact MEDRAD Service.
C599
System error, call MEDRAD Service A system failure occurred. Disconnect the patient and contact MEDRAD Service.
Other malfunctions The injector head or remote monitor displays are blank after you pressed the Standby key. •
Check the power cord, all cables, and connections.
•
Verify that the On/Off switch on the system power console is in the On position.
If the problem persists, call MEDRAD Service. Notify MEDRAD Service of all failures of individual windows or keys, damage to system components, or any other product problems.
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Labeling Specification, 95403-T-141, Rev:D - Prior to use, you are responsible to confirm that this revision is the latest released revision and to verify accuracy of printed content.
Appendix B: Specifications
Injector head dimensions
Weight:
4.3 kg (9.5 lbs)
Cable lengths:
7.6, 15.2, 22.9 and 30.5 m 25, 50, 75 and 100 ft
Injector head pedestal dimensions
Weight:
Adjustable pedestal Fixed pedestal
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Appendix B: Specifications, continued Remote monitor dimensions 5.2" 13.2 cm
2.1" 5.3 cm
Scan Delay
Injected Volume
Injection Duration
Phase
Flow Rate
Volume
Phase
Flow Rate
Volume
Labeling Specification, 95403-T-141, Rev:D - Prior to use, you are responsible to confirm that this revision is the latest released revision and to verify accuracy of printed content.
TM
I N JEC TI O N
S Y S T E
M
7.4" 18.8 cm
DISA RM Star t
Hold
Weight:
1 kg (2.2 lb)
Cable lengths:
7.6, 15.2, 22.9 and 30.5 m 25, 50, 75 and 100 ft
System power console dimensions
Weight:
2.1 kg (4.5 lb), does not include power cord
Power cord length:
American Continental
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3.6 m (12 ft) 3 m (9.8 ft)
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Appendix B: Specifications, continued
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Medrad Vistron CT Injection System capabilities Measure
Minimum
Maximum
Resolution
Accuracy
Scan delay
Seconds
0
99
1
± 1 second
Phase
——
1
4
1
——
Flow rate
ml/sec
0.1
9.9
0.1
± (5% + 0.1) ml/sec if steady state is achieved and injection is not pressure limited
125 ml syringe
ml
10
125
1
± (2% +1) ml over full injection
200 ml syringe
ml
10
200
1
± (2% +1) ml over full injection
125 ml syringe
mm:ss
1
20:50
1
——
200 ml syringe
mm:ss
1
33:20
1
——
50
300
50
+ (10% + 30) - (20% + 30)
kPa
345
2070
345
+ (10% + 207) - (20% + 207)
125 ml syringe
ml
25
125
25
——
200 ml syringe
ml
25
200
25
——
Autofill rate
ml/sec
7
7
——
——
Volume
Duration
Average pressure limit 125/200 ml syringes psi
Autofill volume
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Appendix B: Specifications, continued Forward/reverse piston motion controls •
125 and 200 ml Qwik-Fit Syringe disposables Lowest speed: typical 0.6 ml/sec Highest speed: typical 9.0 ml/sec
Retract
Labeling Specification, 95403-T-141, Rev:D - Prior to use, you are responsible to confirm that this revision is the latest released revision and to verify accuracy of printed content.
20 seconds + 5 seconds
Syringe heater Average fluid temperature maintained at 31° C to 41° C (88° F to 106° F) Maximum fluid temperature under fault conditions (indicator light on): 41° C (106° F)
EMI/RFI The injector system is classified as Group I, Class A equipment per the requirements of EN 60601-1-2.
Protection against electrical shock Per EN 60601-1, the Medrad Vistron CT Injector is designed as Class 1 equipment with a Type BF applied part.
Electrical requirements 100 - 240 VAC, 50/60 Hz, 200 VA
Electrical leakage Complies with UL, CSA, and IEC requirements for safe electrical leakage current limits for medical equipment: Earth leakage current:
<100 µA at 120 VAC <300 µA at 240 VAC
Chassis leakage current:
<10 µA
Patient connection leakage current:
<10 µA
Ground continuity The resistance from the earth ground connector at the plug of the AC mains power cord to any exposed metal on the system power console case will be less than 0.2 ohms.
Environmental specifications Non-Operating (transportation and storage) Temperature: -40° C to 70° C (-40° F to +158° F) Humidity: 5% to 100% R.H., non-condensing Air pressure: 48 kPa to 110 kPa (7 psi - 16 psi)
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Appendix B: Specifications, continued Operating The injector may not meet all performance specifications if operated outside of the following conditions:
Labeling Specification, 95403-T-141, Rev:D - Prior to use, you are responsible to confirm that this revision is the latest released revision and to verify accuracy of printed content.
Temperature: Humidity: Air pressure:
+5° C to +40° C (+41° F to +104° F) 20% to 93% R.H. at 104° F, non-condensing 70 kPa to 110 kPa
Protection against ingress of fluids (fluid entry) Per EN 60601-1, the injector head and remote monitor have been classified as drip proof equipment. The System power console is not classified for protection against the ingress of fluids.
Mode of operation Per EN 60601-1, the mode of operation for the System power console and the remote monitor is continuous operation. The mode of operation for the injector head is continuous operation with intermittent loading. Under normal operating conditions with a minimum of 10 minutes between injections, the internal temperature of the injector head will not rise enough to degrade system performance or reliability.
Response to occlusions In the event of pressure limit being reached, the injection will continue at a reduced flow rate. If an occlusion is encountered, a stall condition (due to flow rate less than 2.5% of programmed rate will result. A prolonged stall will result in the injection being automatically terminated within 10 seconds. After the injector has disarmed, the injector will beep and display the d108 message code. If a stall occurs due to an occlusion and the blockage is subsequently removed, less than 5 ml will be delivered as the pressure in the administration set dissipates.
Over and under infusion protection •
The operator is forced to view all programmed phases prior to arming.
•
The injector indicates when insufficient volume is loaded to complete the programmed injection.
•
Back-up monitoring will detect flow rates exceeding the programmed value by more than 25% or delivered volumes exceeding the total programmed volume.
•
When a fault condition, operator hold, or disarm is detected, the injection will be stopped before an additional 5 ml is delivered.
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Labeling Specification, 95403-T-141, Rev:D - Prior to use, you are responsible to confirm that this revision is the latest released revision and to verify accuracy of printed content.
Labeling Specification, 95403-T-141, Rev:D - Prior to use, you are responsible to confirm that this revision is the latest released revision and to verify accuracy of printed content.
Appendix C: Service, Maintenance and Contacting Medrad
Servicing the injector MEDRAD Service offers maintenance and service programs in the U.S., Canada, and Europe. Contact your MEDRAD representative for information. MEDRAD is not liable for and the warranty does not cover: •
user product modifications
•
the interface of this product with equipment not described in this manual
•
product failures caused by improper maintenance
MEDRAD Service will make available upon request: •
circuit diagrams, component parts lists, or other information that will assist qualified technicians to repair components classified as repairable
•
on-site consulting or consulting references upon request
Warnings •
High voltage hazard. To avoid lethal voltages, do not remove any covers or disassemble the injector. Periodically inspect for loose or frayed cables, loose covers, cracks, dents, or loose hardware. Contact MEDRAD Service for repairs.
•
Shock hazard when cleaning. Always unplug the injector before cleaning. Do not immerse any part of the injector or allow any liquids to enter the enclosure.
Caution •
System malfunction may be caused by failure to perform regular maintenance. Regular preventive maintenance is recommended to ensure the injector stays properly calibrated and functions properly. Refer to the maintenance section in this appendix.
Maintenance Your individual maintenance system and schedule depends upon how your injector system is used, the type of procedures performed, and frequency of use. MEDRAD recommends the following maintenance schedule:
Daily •
Clean the injector daily. Follow the cleaning instructions.
•
Inspect all cables and cords for cuts, cracks, worn areas and other obvious damage.
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Labeling Specification, 95403-T-141, Rev:D - Prior to use, you are responsible to confirm that this revision is the latest released revision and to verify accuracy of printed content.
Appendix C: Service, Maintenance and Contacting Medrad, continued •
Inspect all mechanical compnoents for damage, particularly the pedestal, base, and support arm or counterpoise arm.
•
Verify the operation of all displays.
Injector head pedestal or counterpoise • Inspect the injector head pivots. The head and stand arm must pivot freely. The injector head should not rotate more than 180°. The stand pivot should not rotate more than 350°. •
Verify that the height adjustment on the height adjustable pedestal moves freely on the column shaft.
•
Verify that the injector head/stand casters rotate smoothly and that the locking mechanisms function.
•
Make sure that all cables are fastened.
•
Inspect the pedestal, base and support arm or counterpoise arm for cracks or other defects.
•
Ensure all mounting bolts and screws are secure.
Injector head/control panel • Clean the piston rod. •
Inspect the housing for damage.
•
Examine the hand switch for cracks or loose parts. Ensure that the switch operates without sticking. Examine the hand switch cable for cuts, cracks, or worn areas.
•
Inspect all cables for cuts, cracks, or worn areas. Look for loose pins on the connectors. Ensure that all connectors are properly seated.
•
Inspect the syringe heater and cable. Look for cuts, cracks, or worn areas.
•
Inspect for contrast media build up in the syringe interface area. Follow the cleaning instructions in Appendix D.
System power console Inspect all cables for cuts, cracks or worn areas. Look for loose pins on the connectors. Ensure the connectors are properly seated. Remote monitor wall mount bracket • Inspect the bracket for cracks or other defects. •
Ensure that the bracket is securely attached to the wall.
•
Ensure that the cables are secured to the monitor.
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