Product Information

The Vision RT product range is designed to improve the efficiency of radiation therapy clinics. Regulatory and quality procedures are an integral part of our development, manufacture and installation processes of the company’s medical devices.

DEVICE AND MANUFACTURER IDENTIFICATION INFORMATION
Vision RT Ltd. is the manufacturer of the following CE marked products: AlignRT Plus, OSMS, AlignRT, GateCT, GateRT, SafeRT-ID.

AlignRT Plus
All AlignRT Plus products are clearly labelled on the rear of their chassis. This labelling includes commercial, rating and regulatory (compliance) markings. The table below describes the label symbols/markings and their definitions.

Symbol/Marking Definition
This product is subject to the European Council Directive 2002/96/EC Waste Electrical and Electronic Equipment (WEEE) and The UK Waste Electrical and Electronic Equipment Regulations (WEEE) 2006 and WEEE (Amendment) Regulations 2007. The black
bar underneath the crossed out wheeled bin denotes that the product was placed on the market after 13 August 2005.
This logo identifies Vision RT as manufacturer of this product. Specifically, it acts as the ‘producer
identification mark
‘. For the purposes of WEEE.
Vision RT products meet the requirements of the European Council Directive 93/42/EEC (Medical Device Directive, MDD) and are CE marked.
AlignRT®, GateCT® and GateRT® are approved as class IIb medical devices.
Copies of this certificate are available from the Vision RT website: www.visionrt.com . BSI is a Notified Body for MDD 93/42/EEC and is identified by Notified body Number 0086.
Refer to instruction manual/booklet.
You should read the equipment’s operating instructions and pay particular attention to the warning messages that they contain, before installing and operating this equipment.
Manufacturer
This symbol and the accompanying name and address identifies the manufacturer of the device as defined in European Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC.
Model Number
Indicates the model number of the device.
Serial Number
Indicates the manufacturer’s serial number so that a specific medical device can be identified.
General warning sign
Indicates a hazard requiring attention.
No sitting
Indicates a surface that is unsuitable to sit on.
Type B Applied Part
Identifies a Type B Applied Part which complies with the requirements of EN 60601-1:2016 + A1:2014.
This product is ETL Classified by Intertek for Canada and the United States.
Intertek, originally Electrical Testing Laboratories, is an independent third-party product safety testing and certification organization.Products carrying this mark have been evaluated for specific properties, a limited range of hazards, or suitability for use under limited or special conditions:
CONFORMS TO UL STD 60601
CERTIFIED TO CAN/CSA C22.2
No 601.1.M903196227 and 500221 are separate control numbers issued to Vision RT by Intertek for this product. One of these numbers will be printed below the ETL Classified mark.
Date of manufacture
This symbol and the accompanying date identifies the date of manufacture of the device in the format month (2 digit) and year.
Prescription Only
This symbol identifies a prescription device which complies with the requirements of FDA 21 CFR Part 820.
Temperature Limit
Indicates the temperature limits to which the medical device can be safely exposed.
Humidity Limitation
Indicates the range of humidity to which the medical device can be safely exposed.
Keep dry
Indicates a medical device that needs to be protected from moisture.
Fragile, handle with care
Indicates a medical device that can be broken or damaged if not handled carefully.
This way up
Indicates the correction orientation to be adopted when shipping a medical device.
Do not stack
Indicates a medical device that should not be stacked.
IP20 Ingress protection (IP) classification provided by enclosures (IP code) in accordance with BS EN 60529:1992 (EN 60529:1991 l, IEC 60529:1989).
100 – 240V AC, 50/60Hz 150VA Max Electrical Rating for AlignRT HD 150W PSU.
115V AC 50-60Hz 300VA
115V AC 50-60Hz 600VA
100 – 240V AC, 50-60Hz 150VA Max
Electrical Rating for AlignRT 115V.
230V AC 50-60Hz 300VA
230V AC 50-60Hz 600VA
100 – 240V AC, 50-60Hz 150VA Max
Electrical Rating for AlignRT 230V.

USER SAFETY INFORMATION

This section contains important information about using these products in a safe manner.

The user is responsible for reading and acting on the important safety information.


60601
WARNING
Read this important safety information section carefully before you plug this equipment in to a power supply or operate the controls, or if you experience any problems with it.

The products are designed, manufactured and tested to meet the highest international standards for information technology equipment. As with any other electrical apparatus, however, care must be taken in their use. You should make sure that all safety instructions in this section are adhered to when using the systems.

If you are in doubt about any information given in this guide, contact your supplier, maintenance authority or Customer Support. Contact details are provided at the front of this manual.

ALWAYS:
Read the information contained in this section before attempting to operate the equipment.
Only use cables provided by Vision RT, or the appropriate equipment’s vendors.
Ensure that all electrical connections are properly made in accordance with the instructions in the documentation. Periodically check that connections have not become worn or damaged. If they have, contact your supplier, maintenance authority or Customer Support.
If you are not using equipment on a regular basis, disconnect it from the power supply.
Comply with any National Health and Safety at Work Regulations (see Section Health and Safety at Work).
Report any serious incident that has occurred through use of the device to Customer Support and your country’s regulatory body.
DO NOT:
Continue to operate the equipment if you have any doubt about it working properly or if you think that it is damaged. Disconnect the device to remove power and contact your supplier, maintenance authority or Customer Support.
Remove any fixed covers or replace components within this equipment.
Obstruct the ventilation slots in the equipment. This could cause overheating and shorten its life.
Trail cables across aisles or under carpets.
INFORMATION
During operation, the environmental temperature should be stable to within ±3°C. Larger temperature fluctuations could adversely affect patient monitoring.
  • The system may work independently of the linac and the R&V system or it may only work with them. This will depend on how your system has been configured. Users are not able to change the existing software configuration. For more information, contact Customer Support.
  • System performance may be affected by external environmental conditions. Building maintenance work being carried out in the vicinity of the installation, for example, could cause the cameras to vibrate.
  • If the real time deltas appear to be unstable, check that the cameras are not vibrating.
  • Always contact Customer Support before carrying out major changes to the treatment room environment, such as couch upgrades or changes to lighting.
  • The AlignRT, GateCT and GateRT applications currently support UK English only.
  • The components used in the system are sensitive to electrostatic discharge (ESD). Electrostatic discharge can cause equipment malfunction or failure. Use appropriate measures to prevent accidental electrostatic discharge (ESD) when installing any internal components.
  • There are no requirements for sterilization or disinfection of Vision RT equipment.
  • The switch used to disable power to the camera power supply unit (PSU) must be accessible at all times. Do not position Vision RT equipment so that it is difficult to disconnect the equipment’s power supply.
  • This documentation contains important safety information relating to the use of isolation transformers supplied with Vision RT products. This information only applies to new installations of Vision RT systems.
  • This unit is not fitted with an On/Off switch. It is recommended that you isolate the power supply before carrying out any maintenance activities on the power supply unit or any connected cameras.
  • The Remote Power Control (when available) is only intended for use by Vision RT-appointed service engineers.
  • If your system uses isolators for the cameras, do NOT turn them off when the system is operating. Cameras should, however, be isolated from the mains for cleaning and maintenance.
  • If the Vision RT software application is run without the cameras being powered on, the application will detect this condition and report the cameras as being unresponsive.
  • If the AlignRT cameras are powered off for longer than one hour, it is important to power them on for 20 minutes before use, to ensure they are thermally stable.
  • You should always dispose of batteries according to local hazardous waste policies.
  • Only use the RTC power adaptor in a dry environment.
  • During operation, the environmental temperature should be stable to within ±3°C. Larger temperature fluctuations could adversely affect patient monitoring.
  • UBTI is an optional component of the IBA PTS, please contact your local IBA sales representative for more information.

INFORMATION: NORTH AMERICA

This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

  • Reorient or relocate the receiving antenna
  • Increase the separation between the equipment and receiver
  • Connect the equipment into an outlet on a circuit different from that to which the receiver is connected
  • Consult the dealer or an experienced radio/TV technician for help

The following section contains a list of all the non-system warnings in the relevant Vision RT product documentation.

1.1 General User Information

Ref Warning
CFR Title 21 In the US, Federal law restricts these devices to sale by, or on the order of, a licensed healthcare practitioner.
1683 The system should not be used by anyone who has not received full training. The use of the system should be decided on the basis of the clinical needs of the patient. This decision must be made by someone authorised to do so according to local regulations.
3395 [AlignRT GateCT GateRT The Remote Control] should only be used by fully trained therapeutic radiographers, or under the supervision of fully trained medical physicists.
3440 In order to function correctly, [AlignRT GateCT GateRT] needs to operate within an environment which has a stable and defined treatment or imaging isocenter.
3489 Users should not assume that the internal target is necessarily directly related to the tracked surface. The relationship between the tumour and external surface can be complex. It is therefore important for users to utilise AlignRT and GateRT within
the context of other imaging modalities and clinical methodologies. The appropriate deployment of AlignRT and GateRT within the clinic is the responsibility of the expert user.
3517 AlignRT is not indicated for use for free-breathing respiratory gating. Note that GateRT and GateCT have been specifically designed and developed for free-breathing respiratory gating. AlignRT may however be used for breath hold treatments such as Deep Inspiration Breath Hold (DIBH).

1.2 Environmental and Safety Information

Ref Warning
3430 Warnings are shown in yellow boxes. They should be read very carefully as they may impact on the safe operation of your system.
3430 Electrical hazards are shown in yellow boxes. Care should be taken when working with potentially dangerous electrical components.
ISO60601 Read this important safety information section carefully before you plug this equipment in to a power supply or operate the controls, or if you experience any problems with it.
ISO60601 Read the important safety information section in the Vision RT Product Guide (0002-0001) and the warnings contained in this section carefully before you use these instructions.
ISO60601 Read the important safety information section in the Vision RT Product Guide (0002-0001) and the warnings contained in this section carefully before you use the RTC.
ISO60601 Read the important safety information section in the Vision RT Product Guide (0002-0001) and the warnings contained in this section carefully before you use the Calibration Phantom.
ISO60601 Read the important safety information section in the Vision RT Product Guide (0002-0001) and the warnings contained in this section carefully before you use the Head Adjuster.
1182 Check the correct functioning of all parts of the system prior to use. Do not operate the equipment if you have any doubt about it working properly or if you think that it is damaged.
1182 Inspect the Head Adjuster for any damage before use. Do not use a damaged Head Adjuster for patient treatment.
1126 Inspect the Remote Control for any damage before use. Do not use a damaged Remote Control if any damage is detected.
3474 To avoid the risk of electric shock, this equipment must only be connected to a mains supply with protective earth.
1362
1110
No modification of this equipment is allowed.
Changes and modifications to the equipment must be expressly approved by Vision RT. The User assumes all liability for the Vision RT device if it is changed or modified without approval.
This includes, but is not limited to, changes in the configuration of the network, or data coupling interface; connection of additional items; disconnection of items; and update or upgrade of connected equipment.
The use of components
and parts other than those provided by Vision RT may result in increased emissions and decreased immunity. Only use Vision RT-supplied parts.
MHSWR All persons involved with the installation of the system and its equipment must comply with current National Health and Safety at Work legislation. If you are in doubt about any information or instruction given in the User Guide, contact your manager.
IRR If the Vision RT system is being used to gate the treatment, you should follow your institution’s local rules. You should follow your institution’s procedures for working in an ionising radiation environment.
3618 Installation or servicing procedures involving any of the systems’ electrical power supply must not be undertaken by anyone except qualified engineers or authorised contractors.
3478 No Multiple Portable Socket Outlets (MPSO) should be used in Vision RT systems, except where an isolation transformer is installed as this includes an integrated MPSO.
3479 MPSOs provided with the system must only be used for supplying power to equipment which is intended to form part of the Vision RT system. No non-medical equipment may be connected to the Vision RT equipment.
3480 If against advice, a separate extension cord or multiple socket outlet (MPSO) without an integrated isolation transformer is present, it shall not be placed on the floor.
3481 Additional isolation transformers with integrated MPSOs or extension cords must not be connected to the system.
3578 Connection to other equipment could result in previously unidentified risks to patients, operators or third parties. It is the responsibility of the user to identify, analyse, evaluate and control these risks.
3434 If editing data at the time of a system crash, on recovery check the data to ensure its integrity and recapture it if necessary.
3295 Vision RT equipment should not be used adjacent to, or stacked with, other equipment. If it is necessary to use or stack it with other equipment, check that it is working properly when set up for use with patients.
3290 Vision RT equipment may be interfered with by other equipment, even if that other equipment complies with CISPR emission requirements.
1037 Keep batteries out of reach of children. If swallowed, consult a physician at once. Ingestion may lead to serious injury or death.
Store unused batteries in their original packaging. Always insert batteries correctly. Dispose of
used batteries promptly.DO NOT: charge; deform or damage; expose to water, fire or high temperature; insert incorrectly; mix different types or brands; mix new and used; open, dismantle or modify; short circuit or forcibly discharge. If used incorrectly
batteries may leak, explode and cause fire and personal injury.
3413 During operation, the environmental temperature should be stable to within ±3°C (±5.4°F), from when the system was calibrated. Larger temperature fluctuations could adversely affect patient monitoring.
3590 Patients and other persons are advised to avoid staring directly into the camera light source. Although the light is not dangerous, it may cause discomfort, particularly to users or patients who suffer from photophobia. Note that patients undergoing chemotherapy
may be more susceptible.
DFR Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the AlignRT Plus system, otherwise degradation of the performance of this system could
result.
3809 To safeguard against loss of data you should take regular backups of the patient database.
If you do not take regular backups of the patient database, this may lead to significant treatment delays if the database becomes unavailable for any reason.

1.3 Installation, Service and Maintenance

Ref Warning
1109 Vision RT products may only be installed, serviced and maintained by Vision RT-certified engineers.
The following warnings only apply to CIBSN20170002 27” Monitor Upgrade Instructions:
2176 The installation instructions shall warn that the system must be powered off, before the 27″ monitor upgrade is performed.
2177 The installation instructions shall warn that all cables should be run and secured on completion of the 27” monitor upgrade, to prevent them causing a trip or snag hazard.
2178 All connections must be correctly and securely made before powering the system on again.
3579 All service and maintenance of the cameras must be performed by Vision RT-certified engineers.
3775 Failure to meet the network requirements for EDI may result in unreliable network connections, which may cause delays to treatment delivery.

1.4 Cameras

Ref Warning
3516 Vision RT equipment should not be used for anything other than its intended purpose.
3569 All red LED indications (greater than half a second) indicate errors, and these must be urgently investigated and rectified before the system can be operated safely. Contact Customer Support.

1.5 Cleaning

Ref Warning
3485 Do not use any liquid, foam or gel cleaning agents when cleaning electrical equipment as they do not have any protection against liquid ingress.
0809 Do not use any alcohol-based cleaners or abrasive cleaning products when cleaning the remote control.
3483 Do not use any abrasive cleaning agents when cleaning the Calibration Phantom. The surface of the phantom may become damaged which may affect AlignRT’s ability to image the surface of the phantom accurately.
0992 Do not use any liquid, foam or gel cleaning agents when cleaning the coaching screen. The screen does not have any protection against liquid ingress
3483 Do not use any alcohol-based cleaners or abrasive cleaning products when cleaning the Head Adjuster.
3484 Isolate the unit from the mains supply before cleaning either the camera or the PSU.
1327 Prior to cleaning the RTC, if the charging cable is plugged in, ensure the cable is not connected to the mains power supply.

1.6 Remote Control

Ref Warning
1063 If the [remote control/RTC] becomes damaged, ensure small parts are disposed of to avoid accidental inhalation or ingestion which can cause damage.
1345 Do not leave the remote control in the vicinity of the patient or do not let the patient operate the remote control.

1.7 Fit for Use Check

Ref Warning
1222 Periodically check that the remote control works properly by capturing a surface with AlignRT.
1330 Periodically check the LED lights on the RTC to ensure the unit is working properly.
1108 AlignRT, GateRT and the Response™ system shall not be used if the user knows, or suspects, that the equipment is defective or incorrectly calibrated.

1.8 Third-Party Interface Statement

Ref Warning
3469 The system must not be used with radiographic (or volumetric) data from treatment planning systems or other sources that are not listed in the Third Party Interface in 0002-0116 Calibration Phantom User Guide, unless the accuracy of the calibration process
is validated against the results generated by an independent method.
3398 Only devices explicitly identified in the Vision RT Third Party Interface Statement may be connected to Vision RT medical devices. The User assumes all liability for both the Vision RT device and the connected device when non-approved third-party products are connected.

1.9 User Access

Ref Warning
3837 User access control to AlignRT is provided to ensure that the system is only accessed and used by trained users.
Vision RT strongly recommends that user accounts are configured, administered and used rigorously. Unauthorized access
by untrained users may result in harm to patients.
N/A Your account has been locked. Please contact an administrator to resolve the issue.

1.10 Calibration

Ref Warning
3838 If the plate is badly positioned it will result in poor isocenter calibration and reduced positioning accuracy.
Failure to reposition the plate may result in mistreatment.
3510 The system must be recalibrated in order to ensure continued accuracy. The application prevents normal clinical use of the system if no valid calibration data is available. The average frequency of full camera calibration, and calibration with respect
to the isocenter should, preferably, not exceed once per month. If it is clear, however, that there has been a physical drift of the cross-hairs (the isocenter) of the simulator or of the linear accelerator within a month of calibration,
then a full system calibration (both camera and isocenter calibration) should be performed. recalibrate the system, you will not be able to enter new patient data until the system is successfully recalibrated.
3511 System calibration must be checked daily in order to ensure continued accuracy. If Daily QA has not been performed within the last 24 hours, the system will advise you to do so. Certain users will be able to sign-off and continue without performing Daily
QA. If the last calibration check was unsuccessful, and you did not recalibrate the system, you will not be able to enter new patient data until the system is successfully recalibrated.
3833 Before performing monthly calibration, check that the calibration plate is flat, taking into account any inconsistencies in the surface of the couch.
Failure to check that the calibration plate is flat may result in inaccuracies in the product’s measurement performance.

1.11 System Settings

Ref Warning
1106 Before making changes to treatment thresholds, check that the coordinate system is correct. Failure to do so may result in a risk to health.
1489 The accuracy of Maximum Misalignment Duration may be reduced when the system is operating at low frame rates.

1.12 Record Mode Functions

Ref Warning
1105 It is important to capture appropriate references surfaces for any current threshold settings, especially if the thresholds are asymmetric.
1614
3508
3503
The site selected can affect system performance and accuracy of the patient’s treatment. Ensure that the correct site (including field, reference surface and ROI type) that you wish to use to monitor patient position has been selected.
3498 If one of the camera units has a restricted view of the surface due to clothing or gantry occlusion, then this camera should not be selected for Gated Capture.
3836 You should check the imported isocenter values after every DICOM import and to repeat the import process if these values are incorrect.
Failure to check the imported isocenter values after every DICOM import may result in incorrect
treatment delivery.
1134 It is important to ensure that there is nothing other than the intended surface and, where appropriate, bolus selected within the region of interest as positioning accuracy will otherwise be adversely affected.
3837 Only trained personnel should move the isocentre. Permission to carry out this procedure is governed by User Access Controls.
N/A Patient ID Mismatch: Application Patient ID [xxxx] DICOM Patient ID:[xxxx]. The Patient ID numbers do not match. Are you sure you want to import this data?
N/A DICOM RTPlan ID [xxxx] DICOM RTStruct ID:[xxxx]. The DICIM RTPlan and RTStruct IDs do not match. Are you sure you want to import this data?
N/A ROI propagation failed for “Default ROI”. Something may be blocking the cameras or improper skintone is used. Check this and recapture. Following recapture, you must manually reselect any data that was previously undetected.
N/A The computed translation values, if applied, will position the selected ROI around its centroid. If the computed rotational corrections are not also applied, it is possible that the patient will not be positioned correctly about the treatment isocentre.

1.13 Treatment Mode Functions

Ref Warning
3500 The deltas output may not be accurate if, from the outset, the patient is not reasonably well aligned to the original reference surface. Care should be taken to ensure that the patient is well aligned before the real time deltas are used for
final position adjustment or surveillance. Significant patient misalignment may cause AlignRT to calculate invalid or unstable RTDs.
3487
3488
It is strongly recommended that, following any movement of the couch, you confirm the position of the patient and you check whether the selected region is within the user-defined tolerance.
3784 Where your system is not configured for gating, when the warning message arising due to insufficient surface overlap is displayed, take action to improve the surface overlap before using the system further.
Failure to do so may result
in mistreatment.
3785 Failure to monitor and address changes in patient morphology (by modifying the ROI or capturing a new reference surface and modifying the propagated ROI, if required) may lead to inaccurate data.
3787 It is strongly recommended that after making adjustments based on a treatment capture, you confirm the position of the patient and you check whether the selected region is within the user-defined tolerance.
Failure to verify patient positioning
after making adjustments based on a treatment capture may result in incorrect treatment delivery.
3789 A new reference capture should only be taken when you are confident that the patient is in the correct treatment position as determined from internal imaging.
By taking a new reference capture, that image will immediately become the latest
approved surface.
3793 Where multiple ROIs exist, failure to use the correct ROI for monitoring may result in incorrect treatment delivery.
3795 For bolus treatments, you should capture a new reference surface soon after placement of bolus on a patient’s surface to reduce likelihood of patient movement from previous capture.
Any patient motion after placing the bolus on a patient’s
surface and before capturing a new reference surface may result in incorrect treatment delivery.
3797 Verify that the selected couch rotation matches the planned couch rotation prior to set up. Failure to select a couch rotation that matches the planned couch rotation may result in incorrect treatment delivery.
3798 By capturing a new reference surface, that image will immediately become the latest approved surface.
3800 After repositioning patient based on internal imaging, you should capture a new surface soon to reduce the likelihood of patient movement from the previous capture.
Any patient motion after repositioning patient based on internal imaging,
and before capturing a new reference surface, may result in incorrect treatment delivery.
3802 Before capturing a new reference surface, you should monitor the patient and ensure that they are in a stable position. Any patient motion during image acquisition may result in incorrect treatment delivery.
3493 Before carrying out any treatment on a patient, and before creating or making any changes to their data in AlignRT, you must confirm their identity and ensure that the correct patient is being treated and the correct record(s) are being updated.
3493 Check that the patient currently selected is the same as the patient currently selected on the treatment delivery system. If the selected patients are not the same mistreatment can occur.

1.14 Reports

Ref Warning
1116 All reports and the data contained within the reports are accurate at the time they are generated. The user assumes all liability for any subsequent modification of these reports. Clinical decisions affecting patient treatment should not be made on the basis of these reports alone.

1.15 GateCT

Ref Warning
1109 Only a Vision RT-certified engineer can configure the software to work with third-party scanners.
3515 Ensure that the couch motion values entered correspond to those displayed on the CT scanner.

1.16 Calibration Phantom

Ref Warning
3522 For normal use the cube must always be orientated with its ‘front’ face directed away from the gantry of the treatment delivery system.
3529 Under certain circumstances when using components with the treatment delivery system, for example cones, there may be a risk of collision between the phantom and the treatment delivery system. Always check there is no risk of collision before
use.
3545 Ensure that all extra objects that may obscure the radiographic and optical images are removed from the field of view. If such objects are not removed the accuracy of the isocenter calibration could be compromised.
1182 Always inspect the calibration phantom for evidence of damage before use. If the phantom is damaged, do not use.
3541 Care must be taken when exporting radiographic (or volumetric) data from the treatment planning system to select the correct data. Equally care must be taken to select the correct data when importing data into AlignRT. Selecting incorrect
data may result in an incorrect isocenter calibration.
3539 Performing an isocenter calibration effectively moves the target position for the patient’s treatment. Only apply the isocenter calibration if you are confident that the calibration is accurate.
3543 For high precision treatments, such as Stereotactic Radiosurgery and Stereotactic Radiotherapy, the position of the patient should be verified independently, for example using Cone Beam Computed Tomography (CBCT).
3843 When verifying the MV Isocentre calibration, if the results of the Radiographic Analysis are in excess of departmental limits, the recommended action is to select Recalibrate Isocentre, exit MV Isocentre Calibration and run verification again.
When verifying the MV Isocentre calibration, if the results of the Radiographic Analysis are in excess of departmental limits and you select the option Do not recalibrate, the previous MV
Isocentre calibration will continue to be used, which may result in reduced positioning accuracy. This may affect patient treatment and could be dangerous.

1.17 Head Adjuster

Ref Warning
3528 Follow local health and safety rules for manual handling when lifting the Head Adjuster on and off the Patient Couch.
3529 Care must be taken when placing and removing the Head Adjuster in relation to the treatment couch top. Make sure that there is no impact between the Head Adjuster and the treatment couch. Close attention to the area of the adjustment mechanism portion
is necessary so there is no damage to either the Head Adjuster or the treatment couch.
3546 The head adjuster shall not be used for any radiotherapy treatments other than for Cranial Treatments.
3615 The three rotational adjustments should be set to the mid-point of their range of movement prior to setting up the patient. This midpoint can be determined by using a spirit level.
3606 The Main Plate is located on the couch top using an indexing bar. Only indexing bars that are approved for use by the couch top manufacture can be used.
3604 The indexing bar must be used in accordance with the manufacturer’s instructions.
3608 The Main Plate is clamped to the couch top using two clamps that lock over the edge of the couch top. This clamping system is specific to your treatment couch type and therefore should not be used between two different couch tops. Contact Customer Support
if you have questions regarding which couch the clamps are designed to operate with.
60601 Help the patient to sit up and get down from the couch.
2188 To avoid damaging the adjustment mechanism, do not overtighten the knobs by forcing them beyond their permitted adjustment. A small rotation of more than 1/8 of a turn above the permitted adjustment can cause irreparable damage.

1.18 Real Time Coach (RTC)

Ref Warning
1182 Inspect the RTC for any damage before use. Do not use a damaged RTC for patient treatment.
1183 When placing and removing the RTC in relation to the treatment couch top, take care to ensure that there is no impact between the unit and the treatment couch or immobilization device.
1185 When attaching the RTC clamp to third party equipment, take care to avoid damaging the equipment, or preventing the normal operation, of the equipment.
1190 Only charge the RTC from either the AlignRT workstation or an adaptor supplied with the RTC kit.
1358 Do not attempt to change the battery. Removal of the battery by untrained personnel could result in excessive temperatures, fire or explosion Contact Customer Support.
1339 Position the RTC away from the area being imaged or treated. Failure to do so may result in the patient treatment being compromised or a need to re-image the patient.
1188 Do not connect any other devices to the RTC.
1192 Ensure your DIBH candidate is able to hold breath for an appropriate duration to allow correct treatment. Users of AlignRT should assess this with respect to the clinical practice within their facility.
1187 Instruct the patient to inform you if the RTC fails or freezes.
1184 Take care during the dry run to avoid any potential collisions with the RTC and any other equipment.
3805 The bar’s motion represents vertical motion (i.e. breath position) not the color of the bar. If the bar is displayed as yellow colour, but is in position between the lines, the patient may have physically moved out of position. Therefore, the user shall
instruct the patient not to struggle to achieve breath hold if the bar is displayed as yellow colour but is in the correct position between the lines.
Failure to instruct the patient not to struggle to achieve breath
hold if the bar is displayed as yellow colour, but is in the correct position between the lines, may result in patient discomfort as they struggle to achieve breath hold.
1337 Do not use the RTC for patients who have impaired vision that cannot be corrected.

1.19 Elekta User Guides

Ref Warning
1112 The user is responsible for determining whether or not to use AlignRT/GateRT for performing a gated delivery treatment. If the user chooses to use AlignRT/GateRT for performing a gated treatment delivery, they must enable gating on the Response™ system
and use the gating functionality provided by whichever system they choose to use.
1107 The user is responsible for complying with the labelling and/or accompanying documents supplied with the Response™ system.
1242 If AlignRT/GateRT is not powered up, do not press the Gating Enable/ Disable button on the Response™ control module as radiation will be interrupted.
1115 When using the VMAT delivery technique, the radiation delivery should not be less than two seconds as this can cause gantry position errors and an incorrect dose.
1111 If automatic gating is turned off on the Response™ control module, neither AlignRT/GateRT nor the Response™ control module have an effect on the linac. Only manual beam hold on the linac is available at this time and, if a treatment plan is in progress,
the treatment dose will be delivered. To re-activate automatic beam hold, hold down the Gating Enable/Disable button on the Response™ control module for three seconds.
1236 In the event of a relay fault on the Response™ control module, you must follow the steps described in Section 6.2 Rapid Gating of Treatment Delivery.

1.20 AlignRT with Hitachi Proton/Siemens

Ref Warning
1363 The user is responsible for determining if AlignRT should be selected for performing a gated treatment delivery.
1361 The user is responsible for complying with the labelling and/or accompanying documents supplied with the Hitachi Proton system.
2117 The user is responsible for complying with the labelling and/or accompanying documents supplied with the Siemens system.

1.21 Motion Management Interface (MMI)

Warning
Warning: Patient ID (name) on the Vision RT treatment console does not match the patient ID on AlignRT. Confirm that patient loaded on AlignRT is correct. Using the incorrect patient could lead to a misadministration. Sign off indicates that the proper
patient has been loaded on AlignRT for treatment. AlignRT will exit to the Patient Browse screen unless valid user details are provided.
Warning: Patient ID is currently overridden. Confirm patient ID prior to authorisation for treatment. Continue with treatment?
Warning: Isocentre position is undefined on the Vision RT treatment console. Confirm that the planned isocentre has been identified and approved in AlignRT. Loading the incorrect isocentre could lead to a misadministration.
Warning: Isocentre position is undefined on the Vision RT treatment console. Confirm that the planned isocentre has been identified and approved in AlignRT. Loading the incorrect isocentre could lead to a misadministration. Sign off indicates that the
planned isocentre has been loaded on AlignRT for treatment.
Warning: Isocentre position on the Vision RT treatment console matches multiple isocentres on AlignRT, including the currently selected isocentre. Please ensure the correct isocentre is selected for treatment. Loading the incorrect isocentre could lead
to a misadministration.
Warning: Isocentre position on the Vision RT treatment console does not match the isocentre on AlignRT. Please select the correct isocentre ‘Intracranial SRS site, Catphan (0.00, 0.00, -6.98)’ for treatment. Loading the incorrect isocentre could lead
to a misadministration.
Warning: Isocentre position on the Vision RT treatment console does not match the isocentre on AlignRT. Please select the correct isocentre ‘Intracranial SRS site, Catphan (0.00, 0.00, -6.98)’ for treatment. Loading the incorrect isocentre could lead
to a misadministration and treatment is not authorised.
Warning: Isocentre position on the Vision RT treatment console does not match the isocentre on AlignRT. Isocentre (0.00, 0.00, -6.98)cm received from the Vision RT workstation. Multiple matching isocentres are available on AlignRT. Please select the correct
isocentre for treatment. Loading the incorrect isocentre could lead to a misadministration.
Warning: Isocentre position on the Vision RT treatment console does not match any isocentre on AlignRT. Isocentre (-9.98, -9.98, -4.95)cm received from the Vision RT workstation. Multiple matching isocentres are available on AlignRT. Please confirm that
the isocentre is correct for treatment. Loading the incorrect isocentre could lead to a misadministration.
Isocentre position on the Vision RT treatment console does not match any isocentre in AlignRT. Using the incorrect isocentre could lead to a misadministration and treatment. Review Treatment plan isocentres prior to sign off. Sign off indicates that the
correct isocentre has been loaded on AlignRT for treatment.
A Patient Opened event indicated the plan has changed on the connected Vision RT workstation. The application will return to the Patient Browse screen unless valid user details are provided.
Failed to connect to Vision RT workstation. Please note that remote couch update, authorise and treatment will not be possible.
Authorise already sent to Vision RT workstation please Clear Mode Up and Mode Up once again to clear this dialogue or click ‘OK’ to return to browse patient dialogue.
A Mode Up event has been received but the application is not in an appropriate mode. Please return to the main menu and reopen the patient on the connected Vision RT workstation.
A Clinac Ready event has been received but the application is not ready to respond with an authorise. Please return to the main menu and reopen the patient on the connected Vision RT workstation.
A mismatch has been detected between the selected couch rotation in the application (2.9°) and the original planned rotation (0°) which is within the application tolerance (3°). Sign off required to send the deltas to the couch. Please ask a Physicist
to login and perform this function.
Unable to complete couch move. The couch move was rejected by the treatment machine.
A hardware fault has occurred. Ensure Beam delivery is off prior to disabling gating to prevent potential patient injury. The application will exit. All patient data will be saved.

PERFORMANCE INFORMATION

Performance and accuracy claims for AlignRT products.

AlignRT Accuracy123

Item Claim
Absolute Positioning Accuracy relative to MV or kV isocentre position4 ≤0.5mm translations
≤0.5° rotations
Motion Monitoring Accuracy 5(0° couch rotation with no camera occlusions at mid-isocentre depths) ≤0.2mm translations
≤0.1° rotations
Motion Monitoring Accuracy6 (at any couch rotation, with some camera pod occlusions due to gantry angle and at deep isocentres up to 18cm) Advanced Camera Optimisation (ACO)6
≤0.3mm translations
≤0.2° rotations
Plate Calibration
≤0.7mm translations
≤0.3° rotations
SSD Measurement Accuracy Root Mean Square error ≤2.0mm

AlignRT Latency

Item Claim
Display Latency The latency between AlignRT display refresh and RTC display refresh is ≤300ms

AlignRT Speed

Item Claim
3D reconstruction time Static capture (average processing time): ~3 seconds
Monitoring mode: typically < 1 second
Auto-positioning time ~1 second (for standard corrections)
Gated Capture frame reconstruction time < 0.2 seconds
Acquisition time (single frame) 2ms-25ms
Time from user initiation of capture until acquisition of data < 2 seconds
Frame rate 7 Typically 2 to 10 frames per second

If 3D surface data is not displayed within ten seconds of initiating a static capture (Record capture, or Treatment capture) or calibration capture then this may indicate that the software is not functioning correctly.

If 3D surface data is not displayed within five seconds of initiating monitoring, then this may indicate that the software is not functioning correctly.

If the breathing trace for a gated capture is not displayed on the 2D plotter area of the screen within twenty seconds, then this may indicate that the software is not functioning correctly.

AlignRT Robustness

Item Claim
Skin tone All above quoted figures apply to all skin tones
Body properties AlignRT is able to produce consistent data on all body shapes

AlignRT Coverage

Item Claim
Volume of capture8 (around isocenter) 650mm (across couch) x1000mm (along couch) x350mm (vertically)

AlignRT Environment

The equipment will operate effectively within the standard lighting conditions used in simulator and treatment rooms. Cameras are not adversely affected by radiation scatter from the treatment machine when they are located in their optimum positions9.

AlignRT Number of 3D points per reference model

Typically 10,000-20,000 points.

GateCT and GateRT Claims

Item Claim
Working Distance 10 The working distance of the centrally mounted camera of GateCT and GateRTmay range between 1.9m and 2.4m
Operating Environment GateCT and GateRT shall perform satisfactorily within standard operating temperatures, i.e. ranging from +16°C to +30°C.11 (60.8°F to 86°F)
System Accuracy GateCT and GateRT may track surface displacements with RMS errors
< 0.5mm over 10 or more breathing cycles
Tracking Signals GateCT and GateRT is able to track amplitude displacements, of at least one point, up to +/- 5cm
Automated detection of tracking and respiratory points GateCT and GateRT allow automatic detection of tracking and monitoring points from previous sessions

GateCT working volume

Throughout the entire process of CT scanning, the vicinity (i.e. within +/- 2.5cm) of each user-selected tracking point must be visible by GateCT within a scanning volume of 45cm along the longitudinal axis.

GateRT working volume

Throughout the entire course of treatment, regardless of the gantry angle, the vicinity (i.e. within +/- 2.5 cm) of each user selected tracking point must be visible by GateRT.

Footnotes

  1. Data available to customers on request.
  2. Measured on rigid object under controlled conditions.
  3. Figures quoted for standard installation configurations.
  4. On systems calibrated with stereotactic cube calibration.
  5. Motion monitoring accuracy relative to SGRT reference surface.
  6. Requires period maintenance visit.
  7. It is possible to obtain higher and lower frame rates using AlignRT, and actual frame rates achieved are very dependable on a number of variables.
  8. Figures quoted for standard installation, i.e. cameras ~3m laterally separated, ~1.2m vertically above isocenter, and 2m away from isocenter. These figures will vary if relative configuration of cameras is different.
  9. This assumes cameras are positioned ~1m above the isocenter and ~1m longitudinally displaced away from linac.
  10. For AlignRT and GateRT, the optimum Working Distance is 2m. For GateCT the optimum distance is 2.2m in a large bore CT and 2.3m in a normal bore CT.
  11. During operation, the environmental temperature should be stable to within ±3°C. Larger temperature fluctuations could adversely affect patient monitoring.

SafeRT-ID

SafeRT-ID’s labelling includes commercial, rating and regulatory (compliance) markings.

The following table details the label symbols.

Symbol Definition
The Vision RT logo identifies Vision RT as manufacturer of this product. Specifically, it acts as the ‘producer identification mark’.
Vision RT products meet the requirements of the European Council Directive 93/42/EEC Medical Device Directive (MDD) (MDR) and are CE marked.
Indicates the need to consult the instructions for use.
Manufacturer

The manufacturer of the device as defined in European Council Directives (MDD).

This symbol represents the Manufacturing Date.
Caution: Federal law restricts these devices to sale by, or on the order of, a licensed healthcare practitioner.

USER SAFETY INFORMATION

You must adhere to all the safety instructions provided with all the hardware components used with SafeRT-ID. Care should be taken when working with potentially dangerous electrical components.

The following information should be read very
carefully as they may impact on the safe operation of your system.

  • SafeRT-ID should only be used by healthcare professionals who have been fully trained.
  • Failure to independently confirm patient identity before preparation may lead to mistreatment.
  • Failure to adhere the QR code label on the correct accessory may lead to the incorrect accessory being selected for treatment and may lead to mistreatment.
  • Promoting a setup to treatment with incorrect information in the patient setup notes field may result in the patient being setup incorrectly and lead to mistreatment.
  • Promoting a setup to treatment with incorrect photos in the setup photos field may result in the patient being setup incorrectly and lead to mistreatment.
  • Failure to review the patient’s accessory list for the selected setup before promoting the setup to treatment may result in incorrect accessories being used or accessories being missed during treatment and the patient being positioned incorrectly.
  • Failure to independently verify the identity of patients and patient accessories before treatment delivery may lead to mistreatment.
  • Failure to review the patient setup notes may result in the patient being set up incorrectly and lead to mistreatment.
  • Failure to review the patient setup photos field may result in the patient being setup incorrectly and lead to mistreatment.
  • Failure to adhere to all the safety instructions provided with all the hardware components used with SafeRT-ID may result in injury caused by electric shock or fire, which could be fatal.
  • Failure to use hardware components that comply with applicable regulatory requirements for product safety may result in injury caused by electric shock or fire, which could be fatal.
  • Failure to correctly manage interconnecting cables may result in injury caused by trips, which could be fatal.
  • Failure to use hardware that meets the minimum hardware specifications may result in unreliable operation and treatment delays.

PERFORMANCE INFORMATION

Performance and accuracy claims of the SafeRT-ID system. Note: The facial ID verification software in the wall-mounted camera was tested under certain conditions. Your camera’s scanning accuracy may slightly differ to the case study shown below. This does not affect the safety of the camera or successful enrolments and verifications. The accuracy claim data for the facial ID verification software comes from a case study carried out in Heathrow airport in 2009.

 

Feature Claims
Patient facial ID Verification The system shall return a successful verification notification to the user within 10 seconds from the point of initiating a facial ID verification on a correct subject that is correctly positioned in front of the wall-mounted camera.
Facial recognition accuracy Enrollment accuracy:
8,395 passengers enrolled

  • 0% failure to enroll rate
  • 99.01% biometrically enrolled
  • 0.99% Manually enrolled

With a an average enrollment time of 7.8 seconds and 90.3% of passengers enrolled under 9 seconds. Verification accuracy:
8,374 passengers validated

  • 0% false rejection rate after manual checks
  • 97.7% recognition rate
  • Three attempts at verification allowed
  • 51.44% of passengers verified in under 1 second (biometric time)
  • 80.3% of passengers verified in under 2 seconds (biometric time)
  • Average 4.7 seconds (including rejections and spoofing)
Accessory Verification The system shall take no longer than 5 seconds from the point of the user requesting to verify an accessory which is correctly positioned for the mobile device to capture, to successful accessory verification.
Scanning accessory accuracy The system uses a QR code version 2, 21×21 Quartile (high-reliability on the accessory QR code labels). When 25% of the QR code is missing, it can still be scanned.