Operation Manual
78 Pages
Preview
Page 1
Operation Manual
TABLE OF CONTENTS 1 - Introduction......................................................................................................1-1 Important Safety Notice ...................................................................................................... 1-1 Certifications ....................................................................................................................... 1-1 Indications for Use .............................................................................................................. 1-1 Contraindications ................................................................................................................ 1-1 Restricted Sale.................................................................................................................... 1-1 Required Training ............................................................................................................... 1-1 Disclaimers ......................................................................................................................... 1-1 The Equipotential Connector (EPC).................................................................................... 1-1 Understanding Symbols...................................................................................................... 1-2 Warnings............................................................................................................................. 1-5 Cautions.............................................................................................................................. 1-7
2 - System Basics .................................................................................................2-9 About the Injection System ................................................................................................. 2-9 Pressure Safety Limit........................................................................................................ 2-10 Response to Occlusions ................................................................................................... 2-10 Volume and Rate Protection ............................................................................................. 2-10 Control Room Unit ............................................................................................................ 2-11 Scan Room Unit................................................................................................................ 2-12 Injector Head..................................................................................................................... 2-13 Battery Charger................................................................................................................. 2-14 Optional Control Room Unit Accessories.......................................................................... 2-15 Touch Screen Calibration ................................................................................................. 2-16 Help Mode......................................................................................................................... 2-16 Setup Mode....................................................................................................................... 2-17
3 - Preparing to Inject .........................................................................................3-19 Applying Power ................................................................................................................. 3-19 Main Screen...................................................................................................................... 3-20 Battery Maintenance ......................................................................................................... 3-21 Storing a Protocol ............................................................................................................. 3-33 Recalling a Stored Protocol .............................................................................................. 3-34
4 - Arming and Injecting .....................................................................................4-35 Arming............................................................................................................................... 4-35 Single and Multi-Arm......................................................................................................... 4-35 Insufficient Volume............................................................................................................ 4-36 Injecting............................................................................................................................. 4-36 Disarming.......................................................................................................................... 4-37 Injection History ................................................................................................................ 4-39 Clean Up ........................................................................................................................... 4-40
Appendix A: System Messages........................................................................ A-43 Type 1 Messages..............................................................................................................A-43 Type 2 Messages..............................................................................................................A-44 Type 3 Messages..............................................................................................................A-44 i
MEDRAD® Spectris Solaris EP MR Injection System
Appendix B: Maintenance and Checkout ....................................................... B-45 Recommended Maintenance Schedule ............................................................................B-45
Appendix C: Specifications .............................................................................. C-51 Scan Room Unit............................................................................................................... C-51 Control Room Unit ........................................................................................................... C-52 Battery Dimensions.......................................................................................................... C-52 Battery Charger................................................................................................................ C-53 Power Cords .................................................................................................................... C-53 System Capabilities ......................................................................................................... C-54 Executable Flow Rates .................................................................................................... C-54 System Performance ....................................................................................................... C-55 Forward and Reverse Controls ........................................................................................ C-55 EMI/RFI............................................................................................................................ C-56 Electrical Requirements ................................................................................................... C-56 Power Supply DC Output Voltage.................................................................................... C-56 Electrical Leakage............................................................................................................ C-56 Ground Continuity ............................................................................................................ C-56 Environmental Specifications........................................................................................... C-56 Classifications .................................................................................................................. C-57
Appendix D: Options and Accessories............................................................ D-59 Appendix E: System Installation ...................................................................... E-61 Unpacking the Injection System........................................................................................E-62 Installation Considerations................................................................................................E-63 Fiber Optic Cable Installation............................................................................................E-65 Strain Relief Location........................................................................................................E-66 Recommended Routing ....................................................................................................E-66 Cable Routing: ..................................................................................................................E-66 Control Room Unit Setup ..................................................................................................E-66 Handswitch Mounting........................................................................................................E-67
Appendix F – Compliance to IEC 60601-1-2 / 2001 2nd Edition......................F-69
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1 - Introduction
1 - Introduction This manual applies to the MEDRAD® Spectris Solaris EP MR Injection System, Catalog Number 3012011. Read all of 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 medical professionals with adequate training and experience in magnetic resonance imaging (MRI) studies.
Certifications
This device is equipped to operate at 100-240 VAC, 50/60 Hz, 180 VA (Single), and is designed to comply with EN 60601-1/IEC 60601-1 Second/ Third Edition, and EN 60601-1-2 Second Edition and IEC 60601-1-2 Second/ Third Edition Standards.
Indications for Use
This system is intended for the purposes of injecting intravenous MR contrast media and common flushing solutions into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) procedures.
Contraindications
This device is not to be used in the arterial side of the vascular system, for drug infusion, chemotherapy, or any other use for which the device is not indicated. The system should not be used with a magnetic resonance imaging scanner having a magnetic field strength greater than 3.0 Tesla.
Restricted Sale
Federal (USA) law restricts this device to sale by or on the order of a physician.
Required Training
This device is intended to be used by individuals with adequate training and experience in diagnostic image studies.
Disclaimers
External wiring and modifications disclaimers: Bayer disclaims liability for any modifications or interfaces with other equipment which are not in conformity with the specifications and information contained within this manual. Accessory equipment connected to the device must be certified according to IEC 60601-1 Second/Third Edition standard. Furthermore, all configurations shall comply with system standard EN 60601-1/IEC 60601-1-1. Anyone who connects additional equipment to the signal input or output part configures a medical system and is therefore responsible that the system complies with the requirements of the standard IEC 60601-1-1. To obtain on-site consulting or consulting references, contact Bayer HealthCare Services. The MEDRAD Spectris Solaris EP MR Injection System is not intended for portable use.
The Equipotential Connector (EPC)
The Equipotential Connector (EPC) is an 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.
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MEDRAD® Spectris Solaris EP MR Injection System
Understanding Symbols
The following symbols are used on the MEDRAD Spectris Solaris EP MR Injection System and components: Warning: Refer to warnings and cautions on Instructions for Use packaged in each carton. Attention: Refer to warnings and cautions on Instructions for Use packaged in each carton.
Indicates that this device conforms to the requirements of the European Medical Device Directive 93/42/EEC. Indicates on/off switch for the Control Room Unit. Indicates hazardous voltages.
Indicates alternating current. Identifies a type BF applied part complying with EN 60601-1 standards.
CLASS 1 IPX1
Indicates the injection system is Class 1 medical equipment as defined by EN 60601-1 standards. Identifies the degree of protection against fluid as drip proof for the Spectris Solaris EP Injection system. Identifies connection of the handswitch.
Identifies injector head forward and reverse piston control keys. Identifies the direction of manual knob rotation relative to plunger movement. Identifies the ENABLE key. Identifies polarity of the battery pack terminals. Indicates DC power supply. Indicates the current charge level of the system battery.
Identifies Integrated Continuous Battery Charger system activity on Graphical User Interface. When illuminated yellow this indicates that the Continuous Battery Charger system is present and functioning.
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1 - Introduction
Indicates the AIR EXPELLED button on the injector head. When illuminated yellow on the touch screen, also indicates that the operator has acknowledged inspecting the fluid path for air. Identifies the Equipotential connection. Identifies the Earth Ground point.
IOIO
Identifies the Service Connection Port. Identifies the Locking Bracket. Indicates which direction to turn Locking Bracket knob to “lock” and “unlock” the bracket.
TX
Identifies the Communication Cable Transmit connection.
RX
Identifies the Communication Cable Receive connection. Indicates design for indoor use only. Identifies the Integrated Continuous Battery Charger System power supply connection. Indicates the presence of no serviceable parts.
I
Indicates the presence of AC power at the battery charger. Identifies the Control Room Unit brightness controls.
P109
Reserved for future use. Indicates the status of the battery charger. When a battery is properly inserted, the LED will illuminate while charging, and extinguish when the battery is fully charged.
Pushing Prohibited. Do not push at or above this point on the Injector.
Manufacturer.
Date of Manufacture / Sterilization
Authorized representative in the European community.
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MEDRAD® Spectris Solaris EP MR Injection System
Temperature range.
Humidity range.
Atmospheric pressure range.
This side up.
Keep dry.
Fragile.
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1 - Introduction This manual contains important information about use of the MEDRAD Spectris Solaris EP MR Injection System. Bayer urges you to read this manual carefully, become familiar with the procedures and system functions that it describes, and follow its recommendations to assure proper use of the system. Labels on the system or statements in this manual preceeded by any of the following words and/or symbols are of special significance, intended to help you to operate the system in a safe and successful manner: 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 injection 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 injection system. Note:
Warnings
Indicates that the information that follows is additional important information or a tip that will help you recover from an error or point you to related information within the manual.
Patient injury may result from a system malfunction. If a system malfunction occurs, immediately remove unit power (by pulling the battery from the Scan Room Unit), and disconnect the unit from the patient. If a fault message is displayed that cannot be corrected, and/or the system is not operating correctly, do not use the injection system. Call Bayer for assistance. Patient injury could result from leaks or ruptures during an injection. To prevent leaks or ruptures in the event of a blockage, use only catheters and connectors with pressure ratings compatible with this system. Explosion hazard. The MEDRAD Spectris Solaris EP MR Injection System is not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. Fire hazard. To avoid an electrical fire, assure the correct type of fuse is used for replacement. The fuse must be replaced with Type F, 250 V, 2.5 A fuse by qualified personnel only. Electrical shock hazard. Hazardous voltages exist within system components. Do not remove or open any enclosure. Electrical shock hazard. Avoid fluid entry into system components. Do not immerse any components in water or cleaning solutions. Use a damp cloth when cleaning on or around the battery and the Integrated Continuous Battery Charger system power supply. Electrical shock hazard. Serious injury or death may result from exposure to hazardous voltages existing within the system. Disconnect the Battery Charging System from line power and remove the battery from the Scan Room Unit before cleaning.
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MEDRAD® Spectris Solaris EP MR Injection System Electrical shock hazard. Equipment must only be connected to a supply mains with protective earth. Ventilation hazard. To avoid a build up of hydrogen gas from the battery, assure the room is well ventilated while battery is charging. Improper disposal of the battery pack may result in explosion, leakage, or personal injury. Do not open, or dispose of in a fire! Follow all local regulations concerning the disposal of spent lead-acid based batteries, or contact Bayer for assistance. System electronic assemblies contain potentially hazardous materials. Dispose of system components or accessories properly. Follow local regulations for proper disposal or contact Bayer HealthCare Services for assistance. Unsafe operation may result from using improper accessories. Use only accessories and options provided by Bayer designed for this system. Chemical burn hazard. Always carry the battery pack firmly by the battery pack hand grips. Damage to the housing may result in a chemical burn hazard. Do not use if the housing is severely cracked or damaged. Voltage hazard from worn cabling or unit disassembly. To avoid exposure to potentially hazardous voltages, do not disassemble the injection system in any way. Worn cabling also creates voltage hazards. If any worn or damaged cables are detected, do not use the injection system. Contact Bayer for service or replacement. The MEDRAD Spectris Solaris EP MR Injection System is a dual syringe system. Always ensure that the proper syringes are loaded with contrast media and flush solution prior to the injection. Failure to properly load and install the syringes may require the procedure to be repeated. Syringe A is designated for contrast agent use only. Syringe B is designated for flush solutions only. Injury or equipment damage may result from use of tools containing ferrous materials. Use only non-magnetic tools to install any scanner/ magnet room components. Patient injury and/or catheter damage may result from using connector tubing (LPCT) that is too short. Operator must consider tubing length and stretch limitations when moving the injector or the patient. Serious injury or death may result from syringe failure. Do not retract pistons with connector tubing installed. Retracting the pistons with the connector tubing installed on syringes will create a vacuum in the syringe due to the check valve in the connector tubing. This vacuum may accelerate the plunger rapidly toward the tip of the syringe when it is removed from the injector causing the syringe to break.
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1 - Introduction For devices labeled for single use, please note: This product is intended for single use only. Do not resterilize, reprocess or reuse. The disposable devices have been designed and validated for single use only. Re-use of the single use disposable devices pose risks of device failure and risks to the patient. Potential device failure includes significant component deterioration with extended use, component malfunction, and system failure. Potential risks to the patient include injury due to device malfunction or infection as the device has not been validated to be cleaned or re-sterilized. Do not use if sterile package is opened or damaged. Patient or operator injury may result if package is opened or damaged, or if damaged components are used. Visually inspect contents and package before each use.
Cautions
Condensation may cause electrical damage to the injection system. Do not use the system immediately after it has been brought indoors from extreme outside temperatures. Allow the system to stabilize at room temperature before use. Injector may disarm or fail to operate upon exposure to high electromagnetic fields that may be generated by radio transmitters or cellular phones, or upon exposure to high levels of electrostatic discharge. This injection system is in compliance to IEC-60601-1-2 / Second and Third Edition Standards. Special precautions regarding ElectroMagnetic Compatibility (EMC), are required for installation and use of this injection system. Detailed EMC information can be found in Appendix C of this manual. Damage can occur as a result of incorrect voltage. Before plugging in the system, check the following: •
Verify that the voltage and frequency marked on the serial tag on the back of the unit matches the voltage and frequency of the electrical outlet.
•
Verify that the Control Room Unit and the Battery Charger power supply have the appropriate power cord plugs for the power outlet.
Additional warnings, cautions, and notes are located throughout this manual, where applicable.
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MEDRAD® Spectris Solaris EP MR Injection System
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2 - System Basics
2 - System Basics About the Injection System
The MEDRAD® Spectris Solaris EP MR Injection System is a programmable, dual syringe system, designed to accurately administer controlled doses of intra-venous MR contrast agents and common flushing solutions to patients undergoing a contrast enhanced MR scan. The system consists of two basic components that communicate by a direct connection of fiber optic lines. •
The Control Room Unit houses the Touch Screen and electronic components used to program the injection system.
•
The Scan Room Unit, positioned near the magnet bore, contains the Injector Head, system battery pack, and the mechanical assemblies required for fluid delivery.
A battery charger is also supplied with the system, used to charge the Scan Room Unit battery pack. For convenience, the charger can be used in the control room, but should never be installed or operated in the scan room.
Note:
Follow all institutional, local, or national safety regulations related to routing cabling on the floor.
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MEDRAD® Spectris Solaris EP MR Injection System
Pressure Safety Limit
The MEDRAD Spectris Solaris EP MR Injection System is designed to allow varied flow rates for contrast injections. By automatically reducing the flow rate, the system can limit the pressure produced during an injection to prevent damage or failure of any connecting devices or tubing. This feature is called Pressure Safety Limit. Inability to maintain the desired flow rate while remaining below the Pressure Safety Limit can be caused by various conditions including contrast viscosity, catheter sizing, connector tube sizing, and stopcock restrictions. If the system is unable, for a period of three seconds, to maintain a flow rate of at least 10% of the programmed rate, the system will disarm due to a stall condition. If unable to automatically achieve the required level of flow rate reduction, thus reaching the Pressure Safety Limit, the system will terminate the injection and move to a disarm state.
Response to Occlusions
When injecting into an occlusion, a stall condition (flow rate less than 10% of programmed rate) will result. A stall condition lasting more than 3 seconds (3 minutes for programmed rates less than 0.1 ml/sec) will result in the injection being automatically terminated. If an occlusion occurs during KVO (Keep Vein Open) the system will detect the condition after 4 or less KVO boluses fail to be delivered. This will correspond to from 1 minute with a KVO interval of 15 seconds configured, to 5 minutes with a KVO interval of 75 seconds. Refer to the Setup screen to determine the current KVO setting. If a stall occurs due to an occlusion, and the blockage is subsequently removed, less than 10 ml will be delivered as the pressure in the administration set dissipates.
Volume and Rate Protection
The following means are provided to protect against over and under volume or rate conditions: •
Warnings displayed on the Safety screen and during the arming sequence remind the operator to check the programmed injection parameters prior to the system being armed.
•
An onscreen indication of insufficient volume is provided whenever the total volume programmed to be delivered is greater than the amount of fluid in the syringe.
•
Injection monitoring is performed to detect over rate or over volume conditions due to system faults. If either of these conditions is detected, the injection will be stopped before an additional 10 ml of fluid above programmed volume is delivered.
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2 - System Basics
Control Room Unit 1
3
2
1. Handswitch 2. System Power Switch 3. Touch Screen At rear of Touch Screen Assembly - Display Contrast Controls
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MEDRAD® Spectris Solaris EP MR Injection System
Scan Room Unit
5
2 1
3
4
1. Injector Head 2. Handswitch 3. Lower Console 4. System Battery Pack 5. Middle Pivot Clamp Not shown - Contrast Holder (optional)
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2 - System Basics
Injector Head
1. Manual piston movement knobs 2. Armed indicator lights 3. ENABLE button - Used to activate the forward/reverse controls - the appropriate direction must be selected within 5 seconds. 4. Syringe A forward/reverse controls 5. AIR EXPELLED button/indicator 6. Syringe B forward/reverse controls 7. Syringe A: Contrast agent 8. Syringe B: Flush solution
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MEDRAD® Spectris Solaris EP MR Injection System
Battery Charger
1
2
3
4 5
1. Battery Pack 2. Battery Charging Unit 3. Charging Indicator - Amber 4. Power Indicator - Green 5. Battery Charger Head
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2 - System Basics
Optional Control Room Unit Accessories
Adjustable Height Pedestal WARNING: Injury or equipment damage may result if the adjustable height pedestal is taken into the scanner room. Do not take the adjustable height pedestal in the scanner room. It contains ferrous material that could be attracted toward the magnet.
Wall Mounting Bracket Note:
These accessories contain ferrous material and are designed to be used in the Control Room only. Do not install or operate in the Scan Room.
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MEDRAD® Spectris Solaris EP MR Injection System
Touch Screen Calibration
To enter Touch Screen Calibration mode, simultaneously press both the Contrast UP and DOWN keys on the rear of the touch screen housing. A series of screens with instructions to press the appropriate calibration circles will appear. CAUTION: Do not touch the screen with a sharp object in order to perform the calibration.
Help Mode
The Help screen can be accessed by pressing the HELP button on the lower right corner of the Main screen. Besides safety information, the Help screen displays a variety of topics as displayed below.
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2 - System Basics
Setup Mode
The Setup screen can be accessed by pressing the SETUP button at the lower right corner of the Main screen. The Setup screen allows user configurable options and preferences to be selected, along with setting of date and time parameters. Select the appropriate option, then choose from the available selections in the display window. Select the DEFAULT key to return all options to original factory settings.
The system provides a calibration and maintenance reminder. This reminder will be displayed on the System Logo screen at each startup, beginning 30 days before the system is due to be recalibrated. The duration of time from one calibration to the next is programmed during system installation or by selecting the Calibration Reminder key and entering the correct due date.
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MEDRAD® Spectris Solaris EP MR Injection System
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3 - Preparing to Inject
3 - Preparing to Inject Applying Power
Place the power switch located on the right side of the Control Room Unit in the ON position. The System Logo screen will appear while the system performs a series of self diagnostic tests. Note:
Do not touch the screen or activate any controls while self diagnostics are in progress. If this occurs, diagnostic tests will interpret this activity as a hardware failure and halt the system. The system must then be powered down/up to reset the error.
After diagnostics have successfully completed, the System Logo screen will be replaced by the Safety screen
After reading the Safety screen, press CONTINUE to view the Main screen. Apply power to the Scan Room Unit by inserting the battery into the receptacle on the bottom of the Scan Room Unit. Upon power up of the CRU and SRU, verify that the indicators, lamps, and speaker are operational. Note:
The Control Room Unit can be programmed for an injection without power applied at the Scan Room Unit.
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MEDRAD® Spectris Solaris EP MR Injection System
Main Screen
The Main screen is entered from the Safety screen after power-up. The Main screen is used during programming, arming, and injecting, with applicable screen controls made visible based on the task currently being performed.
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3 - Preparing to Inject
Battery Maintenance
WARNING: Explosion Hazard. Serious injury or death may result from improper use of the battery charger. The battery charger, Bayer Catalog Number 3012424, is intended for use in a well ventilated area, with the injection system battery, Bayer Catalog Number 3012070, only. Do not use the charger with nonrechargeable batteries. When the Main screen appears, check the status of the system battery in the lower left corner of the screen. The battery icon will contain three horizontal bars when indicating full charge, two when indicating medium charge, one for low charge, and no indicators in the icon when the battery is fully depleted, not connected, or communication is not detected between the Control Room and Scan Room Units.
If the depleted battery is not replaced when only one bar is displayed, the system will complete any injection that is in progress. However, the system may not initiate a single or multi arm injection, the forward and reverse controls on the injector head may not function and system communications may be lost. Each battery pack should last for 4 to 6 typical injections using a 20 minute KVO, or approximately 5 hours in an idle state before requiring a recharge. Monitor battery status per injection and on a daily basis. Each battery is capable of being recharged approximately 300 times. When the life of a battery pack becomes shortened, noticeably sustaining fewer injections per charge, this signals that battery life is expiring and the battery pack should be replaced. Call Bayer HealthCare Services for battery pack replacement. To charge the battery, place the 3-pronged, charging head into the battery, then connect the charger to AC power. A green LED on the charger indicates that AC power is applied. An amber LED indicates that the battery is charging. The amber LED will turn off when full charge is reached. Battery charge time is approximately 5 hours.
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MEDRAD® Spectris Solaris EP MR Injection System
Syringe and Disposable Accessory Installation Retracting the Pistons
Fully retract each piston by using the reverse switches on the injector head. Note:
When using the reverse switches, first press the Enable switch; then within 5 seconds, press the reverse switch(es). Both pistons may be reversed simultaneously.
The forward and reverse switches have dual speed capabilities: When the switches are partially depressed, the pistons will move slowly. When fully depressed, the pistons will move quickly. Forward and reverse piston speeds are fully configurable (1 to 10 ml/sec) in the Setup mode. The manual knobs may also be used to move the pistons in the forward or reverse direction. Turn the knobs clockwise to advance the piston, counterclockwise to retract.
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3 - Preparing to Inject
Installing a Syringe
WARNINGS: Do not use if sterile package is opened or damaged. Patient or operator injury may result if package is opened or damaged, or if damaged components are used. Visually inspect contents and package before each use. Patient infection may result from the use of non-sterile components. Maintain sterility of all disposable components. Do not store pre-loaded syringes. For devices labeled for single use, please note: This product is intended for single use only. Do not resterilize, reprocess or reuse. The disposable devices have been designed and validated for single use only. Re-use of the single use disposable devices pose risks of device failure and risks to the patient. Potential device failure includes significant component deterioration with extended use, component malfunction, and system failure. Potential risks to the patient include injury due to device malfunction or infection as the device has not been validated to be cleaned or resterilized. Patient injury could result if the syringe is not 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 syringe damage or under-volume delivery. CAUTION: Improperly engaged syringes may leak or be damaged. Ensure proper engagement of syringe and injector. Syringe and injector engagement points must align. Note:
Syringe A is intended for contrast media, and Syringe B is intended for flushing solution only.
1. Align the flanges on the syringe with the notches in the injector head. (The syringe is keyed to properly fit in only one way.) 2. Insert the syringe. 3. Twist 1/4 turn clockwise until the syringe snaps into place. (Graduations will be facing the front of the injector head.)
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MEDRAD® Spectris Solaris EP MR Injection System WARNING: Air embolism can cause patient injury or death. Expel all trapped air from the syringe(s), connectors, tubing, and catheter-over-needle before injecting. Note:
Do not hit or tap the syringe to remove air bubbles.
To reduce the volume and size of air bubbles drawn into the syringe during loading, a Fluid Dispensing Device (FDD or “spike”) from Bayer is recommended. Air removal from the syringe(s) will be much more difficult if a small diameter tube, such as a catheter-over-needle, needle, or a tube longer than 10 inches (25 cm), is used for loading. Operator vigilance and care, coupled with a set procedure, is essential to minimizing the possibility of an air embolism. The injector head should be pointed upward during loading, enabling any air to accumulate at the syringe tip and to be expelled. The injector head should be pointed downward during an injection, enabling any small air bubbles which could still be in the fluid to float to the rear of the syringe(s). To help avoid air injection, syringes from Bayer are equipped with FluiDot indicators. These FluiDot indicators should be observed as part of an arming procedure. When the FluiDot is viewed through an empty syringe, the dots appear as small narrow ellipses as illustrated below in figure 1. However, when viewed through a full syringe, the dots become larger, almost round (or wider than round) as illustrated below in figure 2.
Fig. 1 Empty
Fig. 2 Filled
FluiDot indicators 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 operator change must occur, ensure that the new operator verifies that the fluid path is purged of air. WARNING: If a blockage occurs, disposable components with a lower pressure rating may leak or rupture. Use only catheter and connectors with ratings that are compatible with the MEDRAD Spectris Solaris EP MR Injection System. During installation of the low pressure connector tubing (LPCT) with Tconnector to the syringe(s), and before arming, manually advance the syringe plunger(s) to provide a very slow flow of fluid at the connection. An absence of flow is an obvious indication of air or a blockage in the fluid path.
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3 - Preparing to Inject
Loading a Syringe
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 any unused syringes. Note:
The presence of rounded FluiDot indicators does not indicate the total absence of air bubbles in the syringe tip.
Note:
FluiDot indicators must be viewed in a properly illuminated environment, with a light source behind the operator providing enough light to permit easy viewing.
1. Position the injector head so that the syringes are pointing upward. 2. Fully advance each piston plunger. The plungers may be advanced simultaneously after pressing ENABLE. 3. Attach a sterile filling device (spike or Female-toFemale Adaptor - Bayer Catalog Number FFA 50) onto the tip of the syringe. If loading contrast media and/or saline from a bag or bottle, use a spike. If loading contrast media from a pre-filled syringe, use an FFA 50. A. If using a spike, open the bottle(s) of contrast and/or bag(s) of flushing solution, then draw the contents (contrast for syringe A; flush for syringe B) into the syringe(s) by depressing ENABLE, and then the reverse load button for each syringe. B. If using the FFA 50, attach it to the tip of syringe A, then attach the pre-filled syringe to the FFA 50. Draw the contents from the prefilled syringe into syringe A by pressing ENABLE, then the reverse load button. 4. With the filling device still attached, advance the plunger to expel any air that may remain in the top of the syringe; then, if necessary, draw more fluid into the syringe to replace fluid loss. 5. Remove the filling device and expel any air bubbles from the syringes.
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MEDRAD® Spectris Solaris EP MR Injection System
6. Attach the long end of the T-connector to syringe B. 7. While the injector head is still in a vertical position, attach the short section of the Tconnector to syringe A. 8. Starting with syringe A, then syringe B, prime the T-connector, then fill the connector tubing with the appropriate fluid. Ensure that all air is expelled from the entire length of the tubing.
Saline Flush
Contrast
Note:
A MEDRAD SSIT 96VLD low pressure connector tube (LPCT) holds approximately 7 ml of fluid. If syringe B is used to flush, use at least 8 ml of flush to deliver this volume to the patient.
Note:
If the connector tube is filled with saline, contrast will be delivered to the patient with a delay dependent on the flow rate selected for syringe A.
Note:
When the connector tube is filled with contrast the volume remaining displayed on the protocol screen is approximately 7 ml less than what was loaded into the syringe.
9. Tilt the injector head downward before attaching to the vascular entry device in the patient. After attaching the connector tube to the vascular entry device verify that the connector luer fittings are secured. The injector head must be maintained in this position during the injection. WARNINGS: Patient injury could result from movement of the Scan Room Unit after the patient is connected to the fluid path. Lock the casters at the base of the unit and the Middle Pivot Clamp to prevent unintended movement. Patient injury and/or catheter damage may result from using connector tubing (LPCT) that is too short. Operator must consider tubing length and stretch limitations when moving the injector or the patient. 10. Secure the Scan Room Unit by locking the casters and the Middle Pivot Clamp, then verify that all air has been expelled from the fluid path by carefully inspecting all tubing and syringe(s). Acknowledge that the inspection has occurred by pressing the AIR REMOVED confirmation button/indicator on the injector head. The Air Removed Indicator will then illuminate yellow on the touch screen. Note:
Reverse movement of the pistons after the AIR EXPELLED button has been pressed will cancel the Air Expelled status. Re-check the fluid path for air, then press the AIR EXPELLED button again to continue.
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3 - Preparing to Inject
Reinstalling a Syringe
WARNING: Patient injury could result if the syringe is not 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 syringe damage or under-volume delivery. 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/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.
Note:
If bubbles appear in the syringe DO NOT hit the syringe to remove them. Reverse the plunger 3 to 5 ml, then rock the head on the pivot to gather and accumulate the small bubbles. Expel the remaining air.
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MEDRAD® Spectris Solaris EP MR Injection System
Programming If a program has not been previously entered or stored on the Main screen when the unit is powered up, the Main screen will display default settings; 1.0 ml/s flow rate and 1.0 ml volume, KVO off and No Delay.
Flow Rate and Volume
Begin programming by selecting any programmable block, such as FLOW RATE or VOLUME. When a programmable block on the screen is touched, a keypad will be displayed to permit the selection of numeric values. The numeric keypad is displayed when a Flow Rate, Volume or Delay value is selected. The keypad window will also display the appropriate programmable range for the parameter selected. To lock in values, press ENTER. Press << to edit a selection, or CANCEL to eliminate a selection if an error is made.
Pressure Limit
The pressure limit can be programmed by choosing a value between 100-325 PSI up to the greater of the syringes’ maximum pressure.
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3 - Preparing to Inject
Multiple Phases
If appropriate, select a second phase for the injection protocol by pressing the triangle block below the first phase of the injection. The Phase Type selector will appear in order to select the function of the new phase.
Hold and Pause Phases
A Hold or Pause phase can be programmed into a multi-phase injection. A Pause phase will stop the total injection process for a preprogrammed length of time, while the Hold phase will stop the injection until input from the operator resumes the injection. A Hold phase can be maintained for up to 20 minutes, at which time the system will disarm. After selecting the phase type, continue programming by entering Flow Rate and Volume values for the new phase.
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MEDRAD® Spectris Solaris EP MR Injection System
Programmed Delay
After entering Flow Rate and Volume parameters, press SET in the Delay Timer field to select the delay type (Scan Delay, Inject Delay, Stopwatch, or No Delay.)
Note:
There is no direct interface between the scanner and the injector. The scanner cannot trigger the injector, nor can the injector trigger the scanner.
Scan Delay
Scan Delay time will elapse in the timer block on the screen. The time remaining before the scan should be activated will decrement in one second intervals. (The scan delay countdown will continue through multiple arm injections.) When countdown is complete, the system will emit 5 beeps.
Inject Delay
Inject Delay will also countdown in one second intervals, commencing when the handswitch is pressed. The clock will display, in one second decrements, the time remaining before the injection will begin. When inject delay is chosen and the handswitch is pressed, the injection will automatically occur unless the injector is disarmed. When countdown is complete, the system will emit 5 beeps and the injection will automatically begin. If Hold is activated during an inject delay or a scan delay, the timer will stop during the hold interval and resume when the handswitch is pressed. For scan or inject delays that are longer than 3 minutes, the unit will beep 30 seconds before the delay is to terminate, then will beep every second from 5 seconds through 1 second before the delay is due to terminate.
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3 - Preparing to Inject
Stopwatch
The Stopwatch function initiates an incremental count of elapsed time from initial fluid injection. After selecting the delay type, enter the delay duration on the numeric keypad. To lock in values, press ENTER. Press CANCEL to eliminate a selection if an error is made.
KVO (Keep Vein Open)
The KVO function delivers small boluses of fluid from syringe B at configurable intervals. KVO can run during: •
Programming
•
Pre and post injection
•
Between multiple injections
•
During Pause and Hold
The delivery interval can be selected in the Setup mode, which is accessed using the Setup button on the Main Screen. After an initial KVO pulse of 2 ml, KVO delivery intervals include 0.25 ml pulsed every: 15 seconds 20 seconds 30 seconds (default) 45 seconds 60 seconds 75 seconds
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MEDRAD® Spectris Solaris EP MR Injection System
The KVO field displays the time available to support KVO based on the configured interval and the volume remaining in syringe B less any volume programmed from syringe B in the protocol.
Starting KVO: On the Main Screen, press START in the KVO field to initiate KVO. When KVO is running, “KVO” will appear, and the KVO Injecting arrows will flash in the Syringe B touch screen indicator. KVO will function during Pause, Hold and/or inject delay periods. KVO will resume post-injection until no fluid remains in syringe B, or until STOP KVO is pressed in the Injection Complete window. Note:
Volume displayed in the Volume Delivered window can be configured in the Setup mode to include the total KVO volume delivered in addition to volume delivered by the programmed injection.
KVO may be stopped at any time by pressing STOP in the KVO field, or by pressing any injector head control button (this will also disarm the system and terminate any injection in progress). Other actions that disarm the injector, such as syringe removal, disarm button press and injection stall, will also stop KVO. KVO and Occlusions: If an occlusion occurs during KVO the system will detect the condition after 4 or less KVO boluses fail to be delivered. This will correspond to from 1 minute with a KVO interval of 15 seconds configured, to 5 minutes with a KVO interval of 75 seconds. Refer to the Setup screen to determine the current KVO setting.
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3 - Preparing to Inject
Storing a Protocol
To store a protocol for future use, press the STORE button on the upper right corner of the Main screen.
An alpha-numeric keypad will appear with a flashing cursor in the title block. Type in a title of up to 20 characters, including spaces. Use the arrow key to backspace, individually erasing characters, and the CLEAR key to clear a string of text. When title entry is completed, press ENTER. To exit the Store screen without making changes, press the CANCEL button in the upper right corner.
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MEDRAD® Spectris Solaris EP MR Injection System
Recalling a Stored Protocol
To access program memory, press RECALL on the Main screen.
Select a previously stored injection protocol by pressing one of the names on either side of the screen. Key parameters of the selected injection will be displayed in the center of the screen. Once selected, the protocol can be deleted by selecting DELETE at the upper right corner of the screen, or brought to the Main screen by selecting OK.
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4 - Arming and Injecting
4 - Arming and Injecting Before beginning the arming process, ensure that the casters on the Scan Room Unit are locked, verify that all air has been expelled from the fluid path, and that the programmed parameters are correct. Carefully inspect all tubing and syringe(s), then acknowledge that the inspection has occurred by pressing the AIR EXPELLED button/indicator on the injector head. A yellow illuminated Air Expelled Indicator on the touch screen confirms that the button has been pressed. WARNINGS: 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. 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. Patient injury could result from inadvertent aspiration. To minimize the possibility of inadvertent aspiriation and injection, ensure the patient is disconnected from the injector when utilizing the forward/reverse plunger control(s). Extravasation can cause injury to the patient. Follow commonly accepted good clinical procedures to minimize the possibility of extravasation.
Arming
To begin the arming and injecting process, press ARM on the Main screen. If necessary, changes can be made to programmed injection parameters after the arming sequence is complete. Select the required parameter, then enter the correct value with the on-screen keypad. Pressure safety limit programmed by the user is indicated to the user and cannot be changed when the injector is armed. Note:
Single and MultiArm
If the AIR EXPELLED button on the injector head has not been pressed, the system will request user confirmation that air has been expelled before proceeding.
Select either a Single or Multiple arming sequence by pressing either SINGLE or MULTI. (The default is Single arm.) A single arm injection will perform the protocol once, then disarm. A multi-arm injection allows the protocol to be repeated, creating a series of injections. After the protocol is completed, the system will automatically rearm in preparation for the protocol to be repeated. Each injection in the series must be started with the handswitch.
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MEDRAD® Spectris Solaris EP MR Injection System
Insufficient Volume
If an insufficient volume condition occurs during a multi arm sequence, the system will remain armed to permit the injection of the remaining volume. However, the screen will update to display only the phases that are achievable with the volume that remains. In a single arm sequence, the screen will update when arming occurs to display only the phases that are achievable. While the system is armed, pressing DISARM or activating any injector head controls will return the system to the idle state.
Injecting
After the system has been armed, press the handswitch to begin the injection. Additional presses of the handswitch will alternately “hold” and resume the injection. The maximum duration for Hold is 20 minutes. If the maximum hold time is exceeded the injection will abort automatically. If an inject delay has been programmed, pressing the handswitch will activate the countdown timer. The programmed injection will automatically begin when the timer counts down to zero. If the handswitch is pressed during an inject delay, the countdown timer will stop counting until the switch is pressed again, or the Hold time is exceeded. If a scan delay is programmed, the scan delay countdown and the injection will start simultaneously. During the injection, additional presses of the hand switch will alternately “hold” and resume the injection and the scan delay timer. If KVO is running: KVO will function during Pause, Hold and/or inject delay periods as long as sufficient fluid remains in syringe B to complete the programmed injection. KVO will run post-injection until no fluid remains in syringe B, or until STOP KVO is pressed in the Injection Complete window. To stop KVO the operator can also press any injector head control buttons. If a Hold phase is entered, parameters for the remaining portion of the injection protocol can be altered.
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4 - Arming and Injecting On the Injecting Screen: •
As each phase is activated, the phase parameters will be highlighted to display injection progress.
•
The Duration window will also increment to display elapsed time.
•
The Delivered window will increment as the injection proceeds to display volume delivery (including KVO volume, if selected in Setup mode).
•
The Volume Remaining display will decrement.
•
The Programmed pressure limit and the current pressure will be indicated on the display. If a pressure limit condition occurs, it will indicate on the display.
•
If KVO is selected, the time available for KVO will decrement in the KVO Time Remaining window while KVO is active. (During an injection, KVO will stop and the time display will not count-down.)
On the Injector Head:
Disarming
•
While injecting, indicator lamps on the back of the injector head will be illuminated (white for syringe A, blue for syringe B). The appropriate lamps will be lit solid while injecting, and flash while either Armed or on Hold.
•
If multi-arm is selected, the indicator lamps will flash when the system rearms.
•
During KVO the blue indicator lamp for syringe B is illuminated.
•
AIR EXPELLED Indicator is illuminated.
Pressing DISARM, activating any injector head controls, or touching any portion of the touch screen while the system is injecting, will cause the system to disarm. The Hold mode can be entered at any time during an injection by pressing the handswitch. The system will remain in this state until the handswitch is pressed a second time, or the maximum hold time of 20 minutes is exceeded.
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MEDRAD® Spectris Solaris EP MR Injection System Note:
A MEDRAD SSIT 96VLD low pressure connector tube (LPCT) holds approximately 7 ml of fluid. If syringe B is used to flush, use at least 8 ml of flush to deliver this volume to the patient.
Note:
If the connector tube is filled with saline, contrast will be delivered to the patient with a delay dependent on the flow rate selected for syringe A.
Note:
When the connector tube is filled with contrast, the volume remaining displayed on the screen is approximately 7 ml less than what is present in the system.
When an injection (single or all multi-arm sequences) is completed, the following window, with a brief summary of the injection parameters, will be displayed.
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4 - Arming and Injecting
Injection History
To review injection parameters used in a procedure, along with actual achieved values for the injection, press the HISTORY button on the Main screen. The Injection History screen displays an injection summary block containing the following data: •
Time and Date Started
•
Programmed Flow Rate
•
Programmed Volume
•
Programmed Protocol
•
Total Fluid (plus KVO)
•
Delay Type
•
Delay Duration
•
Pressure Limit Programmed
•
Peak Pressure
•
Pressure Limit Status (YES/NO)
•
Premature Termination Status (YES/NO)
The system maintains status information of the 20 most recent injections, sorted by date and time. To delete any injection protocol history from the system, press DELETE while the protocol is selected. To scroll to the next page of protocols, press the ARROW key. To exit the Injection History screen, press CANCEL.
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MEDRAD® Spectris Solaris EP MR Injection System
Clean Up
Note:
Do not resterilize or reuse any disposable items.
When cleaning the injector, remove and discard all used disposable items. (Syringes should be removed without retracting the pistons.) It is not necessary to remove the connector tubing when removing and discarding syringes. WARNING: Serious injury may result from syringe failure. Do not retract pistons with connector tubing installed. •
Disconnect the Control Room Unit from line power and remove the battery from the Scan Room Unit before cleaning.
•
Avoid fluid entry into system components. Do not immerse any components in water or cleaning solution.
•
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 HealthCare Services for repairs.
•
Retracting the pistons with the connector tubing installed on syringes will create a vacuum in the syringe due to the check valve in the connector tubing. This vacuum may accelerate the plunger rapidly toward the tip of the syringe when it is removed from the injector causing the syringe to break. CAUTIONS: System malfunction may be caused by failure to perform regular maintenance. Regular preventive maintenance is recommended to ensure that the system stays calibrated and functions properly. Refer to Appendix B of this manual or contact Bayer for additional information. Do not expose system components to excessive amounts of water or cleaning solutions. Wipe components with a soft cloth or paper towel dampened with cleaning solution. Do not use strong cleaning agents and solvents. Warm water and a mild disinfectant are all that is required. Do not use strong industrial cleaning solvents such as acetone.
Note:
For all body fluid spills, follow institutional decontamination procedures.
Note:
If contrast medium has leaked inside any component of the system, the affected subassembly should be disassembled and cleaned by Services personnel or returned to Bayer HealthCare Services.
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4 - Arming and Injecting
Scan Room Unit
Using a soft non-abrasive cloth, warm water, and a mild disinfectant, carefully clean the assembly, paying particular attention to the following: •
Injector Head
•
Syringe Piston Plunger
•
Syringe Interface
•
SRU Lower Console covers
To clean the injector head, piston, and syringe interface: 1. Fully advance the piston. 2. Remove the battery from the Scan Room Unit. 3. Place the injector head in a vertical position. 4. Clean the piston with a soft cloth or paper towel dampened with cleaning solution. 5. Thoroughly dry the piston with a paper towel. 6. Re-install the system battery, then fully retract the piston. 7. Remove the battery from the Scan Room Unit again. 8. Clean the inner area of the syringe interface with a soft cloth or paper towel dampened with cleaning solution. 9. Wipe the injector head case and control panel with a soft cloth or paper towel dampened with cleaning solution. 10. Thoroughly dry the injector head case and control panel with a paper towel.
Control Room Unit
CAUTION: Do not spray cleaning solutions directly onto the touch screen. To prevent damage, wipe the touch screen with a soft non-abrasive cloth or paper towel dampened with cleaning solution.
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MEDRAD® Spectris Solaris EP MR Injection System
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Appendix A: System Messages
Appendix A: System Messages The system will display messages on the screen as conditions or events occur. There are three basic types of messages: WARNING: Patient injury may result from a system malfunction. If a system malfunction occurs, immediately remove Scan Room Unit power (by pulling the battery from the head stand), and disconnect the system from the patient. If a fault message is displayed that cannot be corrected, and/or the system is not operating correctly, do not use the injection system. Call Bayer for assistance.
Type 1 Messages
Type 1 messages are messages which provide information regarding the current status of the system, and will clear automatically from the screen. These messages are typically displayed in the lower right corner of the screen.
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MEDRAD® Spectris Solaris EP MR Injection System
Type 2 Messages
Type 2 messages are messages that convey information that must be explicitly acknowledged before proceeding. The message is displayed within a yellow dialog box - a button (or buttons) must be pressed to acknowledge and remove the message from the screen.
Type 3 Messages
Type 3 messages are system malfunction messages which require power to be removed from the system. Some Type 3 messages provide suggestions to prevent the condition from recurring. If the condition cannot be corrected, record the code and number from the lower left corner of the dialog box, then call Bayer HealthCare Services for assistance.
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Appendix B: Maintenance and Checkout
Appendix B: Maintenance and Checkout This section contains recommended procedures for maintenance, and an operational checkout of the MEDRAD® Spectris Solaris EP MR Injection System. Routine maintenance and inspection will:
Recommended Maintenance Schedule
•
Ensure continued performance of the injection system
•
Reduce the possibility of equipment malfunction
Your MEDRAD Spectris Solaris EP MR Injection System must be properly maintained to ensure that it is in peak operating condition. Your individual maintenance system and schedule depends upon how your injection system is used, the type of procedures performed, and frequency of use. The following maintenance schedule is recommended for the system: Daily: The piston rod should be thoroughly cleaned after each use. Before use each day, the system should be cleaned and inspected, using the procedures outlined in this section. Ensure that all system safety and warning labels are in place and are legible. Monthly: Once a month, the entire system should be thoroughly inspected and cleaned, and an Operational Checkout should be performed. Annually: As part of an annual maintenance program performed by a qualified Services Representative or authorized dealer, both Electrical Leakage and Ground Continuity checks should be performed. NOTE:
Local regulations or hospital protocol may require electrical leakage checks at more frequent intervals. If this applies, local regulations for leakage must be followed.
Bayer also recommends that a complete system calibration and performance checkout be performed annually. Contact Bayer HealthCare Services or your local Bayer office for complete details. In the United States, Canada, and Europe, the Bayer HealthCare Services offers Preventive Maintenance Programs. These annual programs greatly assist in maintaining accuracy and reliability, and can also extend the life of the system. Contact Bayer for details. In Europe, contact your local Bayer office or your local authorized dealer for further information. Refer to the back cover of this manual for address, telephone and FAX information.
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MEDRAD® Spectris Solaris EP MR Injection System
NOTE:
Bayer HealthCare Services
Failures which occur due to lack of proper maintenance will not be covered under warranty.
Bayer HealthCare Services 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.
Inspection Procedures The following procedures are recommended for daily inspection of all components in the MEDRAD Spectris Solaris EP MR Injection System. If any defects are detected, either repair the system, or call Bayer for service. Do not use the system until the problem is corrected.
Scan Room Unit
1. Inspect the housing for any damage or cracks that could allow fluid to leak inside, or weaken the structural integrity of the unit. 2. Inspect all cables connected to the unit: Look for cuts, cracks, worn spots or other obvious damage to the cables. Ensure that all connectors are properly seated. 3. Inspect for contrast media build-up in the syringe interface area. Follow the cleaning guidelines outlined in this section. 4. Inspect the stand, base, and support arm for cracks and other defects that could weaken the structure. 5. Ensure that all mounting bolts and screws are secure. 6. Ensure that all locking mechanisms on the casters are functional. 7. Inspect the pivot points. The head and support arm must pivot freely. The injector head should rotate on the support arm no more than 330o. The support arm should not rotate on the center post more than 350o. NOTE:
Control Room Unit
All relevant guidelines for institutional, local, or national safety recommendations related to cable routing and installation should be followed.
1. Inspect all cables connected to the unit: Look for cuts, cracks, or worn spots, or other obvious damage. Ensure that all connectors are properly seated. 2. Inspect the housing for any damage or cracks that could allow fluid to leak inside, or weaken the structural integrity of the unit.
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Appendix B: Maintenance and Checkout
Wall Mount Bracket
1. Inspect all parts of the bracket for cracks and other defects that would weaken the assembly. 2. Ensure that the bracket is securely attached to the wall. 3. Ensure that all cables are secured to the display control unit and do not interfere with the movement of the mounting bracket.
Height Adjustable Pedestal
1. Inspect the stand, base and support arm for cracks and other defects that could weaken the structure. 2. Ensure all mounting bolts and screws are secure. 3. Ensure that the casters roll smoothly with no binding or scraping. 4. Ensure all locking mechanisms on the casters are functional. 5. Verify that the vertical height adjustment of the column shaft moves freely without binding or scraping.
Battery Charger
1. Inspect all cables connected to the unit: Look for cuts, cracks, or worn spots, or other obvious damage. Ensure that all connectors are properly seated. 2. Inspect the housing for any damage or cracks that could allow fluid to leak inside, or weaken the structural integrity of the unit. 3. Inspect all parts of the wall mounting bracket for cracks or other defects that would weaken the assembly. If applicable, ensure that the bracket remains firmly attached to the wall.
Communication Link
1. Inspect the cables for cuts, cracks or worn spots. Ensure that the connectors are properly seated.
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