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Users Manual | Users Manual | 5.51 MiB | / January 04 2019 | |||
1 2 | Cover Letter(s) | / August 02 2019 | ||||||
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1 2 | ID Label/Location Info | / August 02 2019 | ||||||
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1 2 | Test Report | / August 02 2019 | ||||||
1 2 | Test Setup Photos | / January 04 2019 |
1 2 | Users Manual | Users Manual | 5.51 MiB | / January 04 2019 |
Instructions for Use English 4322 070 31061 Philips AltaTrack Equipment - US Release 1.0 Contents 1 Introduction 1.1 1.2 1.3 1.4 1.5 2 Safety 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10 2.11 2.12 2.13 About These Instructions for Use Intended Use 1.2.1 Intended Use of the AltaTrack Equipment Compatibility 1.3.1 1.3.2 Data Sets Sterile Covers Training Contacting the Manufacturer Emergency Procedures Radiation Safety Electrical Safety Mechanical Safety Laser Safety Explosion Safety Fire Safety Electromagnetic Compatibility 2.8.1 FCC Part 15.19 Equipment Labels Symbols Used on the Equipment Hazardous Substances Applied Parts Warning Messages 3 Equipment Overview 3.1 3.2 3.3 3.4 3.5 AltaTrack Trolley AltaTrack Docking Base AltaTrack Software 3.3.1 Tasks AltaTrack Docking Top AltaTrack Devices 4 Preparing the AltaTrack Equipment for Use 4.1 Setting Up the AltaTrack Equipment 4.1.1 Setting Up the AltaTrack Trolley 6 6 7 7 8 8 9 9 9 10 10 10 10 11 12 12 12 13 13 14 14 15 16 16 18 18 20 21 23 23 24 26 26 26 AltaTrack - US Release 1.0 Instructions for Use 3 Philips 4322 070 31061 Contents 4.1.2 4.1.3 Setting Up the AltaTrack Docking Base Setting Up the AltaTrack Docking Top 4.2 Starting the AltaTrack Software 4.2.1 4.2.2 4.2.3 Segmentation Planning Volume Registration 4.3 4.4 Setting Up the AltaTrack Devices Performing Shape Registration 4.4.1 Adjusting the AltaTrack Device Shape Tips 5 Navigating with the AltaTrack Equipment 5.1 5.2 5.3 5.4 5.5 5.6 Performing Live Guidance Correcting Volume Registration Changing an AltaTrack Device During a Procedure Changing an AltaTrack Device for a Conventional Device During a Procedure Navigating Without AltaTrack Devices Disposing of an AltaTrack Device 6 Performing Post-Operative Steps 7 Maintenance 7.1 7.2 Cleaning the AltaTrack Equipment Final Disposal of the AltaTrack Equipment 8 Technical Information 8.1 Electromagnetic Compatibility 8.1.1 8.1.2 8.1.3 8.1.4 Emissions Immunity ISM Frequency RFID 9 Appendix 9.1 9.2 9.3 Main Display Area Setting User Preferences Viewing Tools 9.3.1 9.3.2 9.3.3 9.3.4 9.3.5 Zooming Panning Rotating Spatial Navigation Adjusting the Contrast and Brightness of the X-ray Image 29 30 32 33 36 39 49 52 58 60 63 64 65 66 66 66 67 70 71 72 73 74 75 75 76 77 78 78 78 78 79 79 79 80 81 AltaTrack - US Release 1.0 Instructions for Use 4 Philips 4322 070 31061 Contents 9.3.6 9.3.7 9.3.8 9.3.9 Adjusting Window Width and Window Level Settings Adjusting the Opacity of the Volume Panning the AltaTrack Device Shapes Adjusting the Opacity of the AltaTrack Device Shapes 9.3.10 Selecting a Preset Orientation 9.3.11 Enlarging a View 9.4 9.5 Common Tools Panel Snapshots and Movies 9.5.1 9.5.2 9.5.3 Making a Snapshot Making a Movie Movie Export tool 9.6 Storing and Reviewing Series 81 82 82 83 83 83 83 84 84 85 85 85 AltaTrack - US Release 1.0 Instructions for Use 5 Philips 4322 070 31061 Introduction About These Instructions for Use 1 Introduction About the AltaTrack Equipment The AltaTrack equipment is used in conjunction with a Philips Interventional X-ray system and with AltaTrack angiographic devices such as AltaTrack Catheter and AltaTrack Guidewire. The AltaTrack equipment uses FORS (Fiber-Optic RealShape) technology to provide a real-time 3D image of the shape of a connected AltaTrack angiographic device. The AltaTrack equipment overlays the FORS shape on anatomical images such as a pre-procedural CT volume and X-ray images from the X-ray system. Figure 1 AltaTrack equipment in the examination room After setting up the AltaTrack equipment in examination room and starting the procedure, the equipment displays live guidance images on the monitors. Tasks in the AltaTrack software guide you through the following phases to prepare and view the overlay image:
Segmenting the pre-operative 3D data set to identify vessels. Planning views and tagging anatomical landmarks to assist with device navigation. Registering the pre-operative 3D data set with the X-ray system to provide a matched overlay image. Registering the AltaTrack device or devices with the X-ray system. Providing live guidance through a real-time 3D image of the shape of the AltaTrack devices and pre-
operative 3D data-set with X-ray images during the interventional procedure. 1.1 About These Instructions for Use These Instructions for Use are intended to assist you in the safe and effective operation of the AltaTrack equipment. The AltaTrack equipment can be identified by the label on the AltaTrack trolley. All Instructions for Use supplied with the AltaTrack equipment are identified using the name and release number (first two digits) of the software, as indicated in the footer of the document. Before using these Instructions for Use with the AltaTrack equipment, ensure that it corresponds with the software installed. AltaTrack - US Release 1.0 Instructions for Use 6 Philips 4322 070 31061 Introduction Intended Use These Instructions for Use may describe some products or features that are not available in all countries. Please contact your local sales representative for the availability of products and features in your region. Before attempting to operate the product, you must read these Instructions for Use, noting and strictly observing all WARNING and CAUTION notices. WARNING A warning alerts you to a potential serious outcome, adverse event, or safety hazard. Failure to observe a warning may result in death or serious injury to the operator or patient. CAUTION A caution alerts you when special care is necessary for the safe and effective use of the system or equipment. Failure to observe a caution may result in moderate personal injury or damage to the equipment, and presents a remote risk of more serious injury or environmental pollution. NOTE Notes highlight unusual points as an aid to the operator. Pay special attention to all the information given and procedures described in the Safety section. To identify the Instructions for Use and the software tool for which they are intended to be used, the product can be identified using the About box of the related software tool. The About box indicates the following:
Name of the software tool Release number of the software tool 1.2 Intended Use This Philips product is intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in these Instructions for Use for the purposes for which it was designed. The purposes for which the product is intended are given below. However, nothing stated in these Instructions for Use reduces operators responsibilities for sound clinical judgment and best clinical procedure. Installation, use, and operation of this product are subject to the law in the jurisdictions in which the product is being used. Operators must only operate the product in such a way as to not conflict with applicable laws, or regulations that have the force of law. Uses of the product for purposes other than those intended and expressly stated by the manufacturer, as well as incorrect use or operation, may relieve the manufacturer (or the manufacturers agent) from all or some responsibility for resultant non-compliance, damage, or injury. CAUTION In the United States, Federal law restricts this device to sale, distribution, and use by, or on the order of, a physician. 1.2.1 Intended Use of the AltaTrack Equipment The AltaTrack Equipment is an imaging device with Fiber Optic RealShape (FORS) technology intended to aid the positioning and navigation of a connected AltaTrack Catheter and/or AltaTrack Guidewire during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real time of an AltaTrack Catheter and/or AltaTrack Guidewire. AltaTrack - US Release 1.0 Instructions for Use 7 Philips 4322 070 31061 Introduction Compatibility 1.3 Compatibility AltaTrack can be used with a compatible Philips interventional X-ray system that is equipped with appropriate options. For details of compatible systems, contact the manufacturer. The product described in this manual should not be used in combination with other products or components unless such other products or components are expressly recognized as compatible by Philips Medical Systems. A list of such products and components is available from the manufacturer. The AltaTrack Catheter and AltaTrack Guidewire are not to be robotically actuated. Changes or additions to the product should only be carried out by Philips Medical Systems or by third parties expressly authorized by Philips Medical Systems to do so. Such changes or additions must comply with all applicable laws and regulations that have the force of law within the jurisdictions concerned, and with best engineering practice. AltaTrack is only intended to be used with the PC hardware configuration on which it is initially installed by the manufacturer. AltaTrack may only be installed or reinstalled by authorized service personnel. Changes to the network connection or configuration may lead to non-performance or reduced performance of the product or the connected system. 1.3.1 Data Sets You can open AltaTrack data indicated by the following icon:
Overlay Data Sets You can use a preoperative CT volume as a roadmap (overlay) during device navigation with the AltaTrack equipment. You can import overlay volumes and data sets from CD, DVD, USB memory device, or from a PACS server. For details, refer to the Interventional Workspot Instructions for Use. CT Volumes To use a CT volume as an overlay with the AltaTrack equipment, the volume must be DICOM compliant and satisfy the following requirements:
CT angiography volume Single phase No gantry tilt Reconstructed with a regular grid NOTE Volumes should contain peripheral vasculature and should not contain only cardiac or intercranial anatomy. NOTE Volumes larger than 400 MB are automatically down-sampled when imported. CT Data Sets CT images should be used wherever possible to assist with live guidance. The AltaTrack equipment supports CT data sets that are DICOM-compliant and that fulfill the following requirements. The distance between the slices is equal. The pixel spacing for each slice in both directions in the series is equal (square pixels). AltaTrack - US Release 1.0 Instructions for Use 8 Philips 4322 070 31061 Introduction Training Two bytes per voxel shall be used (bit allocated is 16). The series contains at least 4 slices with a different slice location. All slices must have the same dimensions: 512 512 voxels of 2 bytes each. The format is classic DICOM (enhanced DICOM is not supported). The CT series must be contrast enhanced. NOTE The recommended slice thickness is between 0.6 mm and 0.8 mm, with a maximum of 1 mm. NOTE When using a data set with more than 1600 slices, AltaTrack truncates the whole volume from cranial to caudal, using only the first 1600 slices. NOTE If you use derived DICOM data sets, AltaTrack may not work correctly. It is recommended that you do not use this type of data set. For details of importing data, refer to the Interventional Workspot Instructions for Use. For details of compatible CT scanners, refer to the DICOM conformance statement for this product
(available from the manufacturer). Rotational Series To assist with registering a CT volume with the X-ray system, you can use a 3D-RA volume or an XperCT volume. The AltaTrack equipment supports all standard non-neuro and non-intercranial 3D-RA series and XperCT series that have been created with the frontal stand of a compatible X-ray system. 1.3.2 Sterile Covers Sterile covers up to a thickness of 0.5 mm are supported. The hospital should evaluate the integrity and suitability of a particular sterile cover when used with the clamping mechanism of the AltaTrack docking base and the AltaTrack Docking Top before using the sterile cover during a procedure. 1.4 Training Operators of this product must have received adequate training on its safe and effective use before attempting to operate the product described in this Instructions for Use. Training requirements for this type of device will vary from country to country. Operators must make sure they receive adequate training in accordance with local laws or regulations. As a minimum level of training, operators should read and understand these Instructions for Use. If you require further information about training in the use of this product, please contact your local Philips Medical Systems representative. Alternatively, contact the manufacturer. 1.5 Contacting the Manufacturer Manufacturer's Address Philips Medical Systems Nederland B.V. Veenpluis 4-6 5684 PC Best The Netherlands AltaTrack - US Release 1.0 Instructions for Use 9 Philips 4322 070 31061 Safety Emergency Procedures 2 Safety All Philips Medical Systems products are designed to meet stringent safety standards. To safeguard human safety all medical device software requires proper installation, use, and maintenance. It is vital that you read, note, and where applicable strictly observe all notices and safety markings on the equipment. To help ensure the safety of both patients and operators, it is vital that you strictly follow all directions under the heading Safety and all warnings and cautions displayed on the equipment or provided in these Instructions for Use. Only qualified and authorized personnel may operate this product. In this context, qualified means those legally permitted to operate this type of medical electrical product in the jurisdictions in which the product is being used, and authorized means those authorized by the responsible organization. Personnel operating the product and personnel in the examination room must observe all laws and regulations which have the force of law within the jurisdictions concerned. If you are in any doubt about the laws and regulations which apply to the operation of this product, do not use it. The equipment has no performance that is determined to be essential performance. 2.1 Emergency Procedures Loss of Roadmap You should revert to using the interventional X-ray system if any of the following situations occur:
The CT volume does not follow the geometry. APC is unavailable. The AltaTrack live image guidance software does not receive X-ray images. 2.2 Radiation Safety For radiation safety please refer to the Safety section of the Instructions for Use supplied with the X-ray system. 2.3 Electrical Safety Follow the electrical safety guidelines in this section. Failure to do so could cause serious or fatal injury to the patient, and could damage the equipment. The room where the system is used must comply with all applicable laws and regulations, or regulations concerning electrical safety for this type of equipment. The combination of the system and the connected equipment must comply with the requirements for medical electrical systems as specified in the IEC 60601-1 standard. Voltages Dangerous electrical voltages are present within the system. Covers or cables should only be removed by qualified and authorized service personnel. AltaTrack - US Release 1.0 Instructions for Use 10 Philips 4322 070 31061 Safety Mechanical Safety WARNING Do not touch electrical or network connectors on the patient table, the AltaTrack trolley, or the AltaTrack equipment cable while simultaneously touching the patient. Connector contact pins may carry low voltages that are safe to touch, but that may be harmful to the patient. Electrical Grounding (Earth) WARNING To avoid risk of electric shock, this equipment must only be connected to supply mains with protective earth. You can only connect medical equipment to the system if that equipment is galvanically isolated from the system. For medical equipment interfacing using Ethernet, video, or USB, galvanic isolation is ensured by using a wall connection box. For more information, contact technical support. Protection Against Patient Leakage Current An equipotential ground connection point is provided at the base of the patient table. If an operating table is installed, the ground connection point is located on the surgery wall connection box. For more information, contact technical support. Cables Electrical current may still be present in cables that are no longer connected to the system, but that are still connected to the wall connection box. Store these cables on the cable holder outside the patient environment. If the cable holder is located inside the patient environment, ensure that the connectors are covered with a rubber cap. If a cap is not available, take precautions to prevent cable connectors from coming into contact with liquids. Do not use multiple socket outlets or extension cables for installing or connecting any part of the system. Such cables can compromise the electrical safety of the system, especially for equipment in the examination room near the patient. Cleaning Switch the system off before cleaning or disinfecting it. Do not use cleaning agents or damp cloths on connector contact pins. For more information, see Cleaning the AltaTrack Equipment (page 71). 2.4 Mechanical Safety Avoiding Collisions WARNING No modification of this equipment is allowed. WARNING Do not modify this equipment without authorization of the manufacturer. WARNING Ensure that the AltaTrack docking base is securely fixed to the table rail at an appropriate position. If the AltaTrack docking base falls off, or if there is any intentional or unintentional movement of the AltaTrack docking base, there is a risk of injury to the patient and the sterile field may be compromised. You must also perform registration for all devices again. AltaTrack - US Release 1.0 Instructions for Use 11 Philips 4322 070 31061 Safety Laser Safety CAUTION The connection box hangs below the level of the tabletop and is susceptible to collisions with the table base or the stand if the table is moved. Take care to avoid such collisions to prevent damage to the equipment or loss of registration. If necessary, re-register the device after moving the table. CAUTION If the patient moves during the procedure, or if the AltaTrack docking base is moved along the table rail, or if any movement causes any part of the AltaTrack equipment to collide with the stand, table, or personnel in the examination room, you must perform registration for all devices again. X-ray System For safety information about avoiding collisions when using equipment belonging to the X-ray system
(for example, the stand or the table), refer to the Instructions for Use supplied with the X-ray system. 2.5 Laser Safety The AltaTrack equipment contains a class 1 laser (IEC classification). WARNING Laser radiation. Avoid direct eye exposure. Class 1 laser product. 2.6 Explosion Safety Using the system in an environment for which it was not designed can cause fire or explosion. Do not use the system in the presence of explosive gases or vapors, such as certain anaesthetic gases. Do not use flammable or potentially explosive disinfectant sprays. For more information, see Cleaning the AltaTrack Equipment (page 71). 2.7 Fire Safety Fire regulations for the type of medical environment being used should be fully observed, applied, and enforced. Using the system in an environment for which it was not designed can cause fire or explosion. Fire extinguishers should be available for both electrical and non-electrical fires. Only use fire extinguishers on electrical or chemical fires that are specifically labeled for those purposes. Using water or other liquids on an electrical fire can cause fatal or serious personal injury. AltaTrack - US Release 1.0 Instructions for Use 12 Philips 4322 070 31061 Safety Electromagnetic Compatibility If it is safe to do so, switch off the system before attempting to fight a fire. This reduces the risk of electric shocks. 2.8 Electromagnetic Compatibility Medical electrical products require precautions regarding electromagnetic compatibility, and shall be installed and put into service according to information provided in the accompanying documents. WARNING Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. WARNING Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. WARNING 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 AltaTrack equipment, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. NOTE The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-
frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment. The AltaTrack equipment is a medical electrical system consisting of class A, group 1 equipment. Do not use the AltaTrack equipment in the vicinity of magnetic resonance imaging (MRI) equipment or high-frequency (HF) equipment. The AltaTrack equipment is intended for use in a professional healthcare environment. Operation in any other environment may compromise electromagnetic compatibility. The AltaTrack equipment and its components shall not be directly connected to the public low-voltage power supply network. The AltaTrack equipment complies with relevant international and national laws and standards
(IEC60601-1-2) on electromagnetic compatibility for this type of product, when it is installed and used as intended. These laws and standards define both the permissible electromagnetic emission levels from the AltaTrack equipment and its required immunity to electromagnetic interference from external sources. Other electronic products that exceed the limits defined in these standards could, in unusual circumstances, affect the operation of the AltaTrack equipment. Note the following:
Radio services operating in frequency bands and disturbance characteristics that are not covered by CISPR11 edition 5 may be disturbed. If safety critical radio services are used in or near the facility where the AltaTrack equipment is used, the responsible organization should evaluate the risks associated with radio disturbance. Mobile devices can affect medical electrical equipment. Use caution when using such devices within the specified range of medical electrical devices. 2.8.1 FCC Part 15.19 This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
AltaTrack - US Release 1.0 Instructions for Use 13 Philips 4322 070 31061 Safety Equipment Labels This device may not cause harmful interference. This device must accept any interference received including interference that may cause undesired operation. 2.9 Equipment Labels AltaTrack Equipment Figure 2 AltaTrack equipment label For information about the symbols used on this label, see Symbols Used on the Equipment (page 14). AltaTrack Docking Top For more information about the AltaTrack Docking Top, refer to the Instructions for Use supplied with the AltaTrack Docking Top. AltaTrack Devices For more information about the AltaTrack Catheter or AltaTrack Guidewire, refer to the Instructions for Use supplied with the respective device. 2.10 Symbols Used on the Equipment Power On: This symbol identifies the mains switch on the AltaTrack trolley. When the green indicator light of the mains switch is illuminated, the AltaTrack trolley is powered on. Power Off: This symbol identifies the mains switch on the AltaTrack trolley. When the green indicator light of the mains switch is not illuminated, the AltaTrack trolley is powered off. NOTE The mains switch isolates its circuits electrically from the supply mains on all poles simultaneously. Alternating Current: This symbol indicates the presence of alternating current. Type B: For more information, see Applied Parts (page 16). IPNN: This symbol indicates the degree of protection of an enclosure and is regulated by IEC 60529. The first digit indicates the degree of protection for dust or solid objects, and the second digit indicates the protection against ingress of water. AltaTrack - US Release 1.0 Instructions for Use 14 Philips 4322 070 31061 Safety Hazardous Substances Manufacturer: This symbol identifies the medical device manufacturer, as defined in EU Directive 93/42/EEC. The date of manufacture, as well as the name and address of the manufacturer, can be combined in one symbol. Date of Manufacture: This symbol indicates the date when the medical device was manufactured. Catalog Number: This symbol indicates the manufacturer's catalogue number so that the medical device can be identified. This symbol may be shown without the enclosure. Serial Number: This symbol indicates the manufacturer's serial number so that a specific medical device can be identified. This symbol may be shown without the enclosure. Consult the Instructions for Use: This symbol instructs the user to consult the Instructions for Use. Radio Frequency Transmitters: This symbol indicates the presence of radio frequency transmitters. Product Disposal: For more information, see Final Disposal of the AltaTrack Equipment (page 72). CE Certification: This symbol indicates that the equipment complies with the European Communities regulation. The number of the notified body is indicated, if applicable. FCC: This symbol, together with the FCC ID, indicates that the product conforms to FCC regulations. MET Certification: This symbol indicates that the equipment is tested and approved by the National Test Laboratory MET. Prescription Only: This symbol indicates that the device shall only be used by a practitioner qualified to use the device. 2.11 Hazardous Substances Parts of the system may contain hazardous substances that must be recycled or disposed of in accordance with local, state, or federal laws. Perchlorate Perchlorate material is present in lithium coin cells or batteries that are used in the system. Special handling may apply. For information, go to the following website:
www.dtsc.ca.gov/hazardouswaste/perchlorate REACH Declaration REACH requires that Philips Medical Systems provides chemical content information for Substances of Very High Concern (SVHC) if they are present in amounts above 0.1% of the product weight. Components with electric or electronic equipment may contain phthalates above the threshold (for example, bis(2-ethyl(hexyl)phthalate), CAS nr.: 117-81-7). Philips Medical Systems is still in the process of investigating its supply chain to further establish which components contain phthalates. The SVHC list is updated on a regular basis. For the latest list of products that contain SVHC above the threshold, go to the following website:
www.philips.com/about/sustainability/reach AltaTrack - US Release 1.0 Instructions for Use 15 Philips 4322 070 31061 Safety Applied Parts 2.12 Applied Parts An applied part is a part of the equipment that in normal use satisfies one of the following conditions:
The part must come into physical contact with the patient for the equipment to perform its function. The part can be brought into contact with the patient. The part needs to be touched by the patient. Normal use is defined as "operation, including routine inspection and adjustments by any OPERATOR, and stand-by, according to the instructions for use". The following parts are regarded as applied parts:
AltaTrack Catheter AltaTrack Guidewire For more information about these parts, refer to the Instructions for Use supplied with the part. 2.13 Warning Messages The following warning messages may be displayed in the Live Guidance task of the AltaTrack software. Message ID Warning Message Guidance Int5 Int6 Int19 Int20 Int39 Int40 Int41 SS14 SS17 VS2 VS3 Optical issue. See the AltaTrack touch screen for resolution Optical issue. See the AltaTrack touch screen for resolution System issue. See the AltaTrack touch screen for resolution Optical issue. See the AltaTrack touch screen for resolution AltaTrack issue AltaTrack issue. Relax the distal device bend AltaTrack issue. Relax the proximal device bend Unsupported device combination. See the Alta-
Track touch screen for resolution The device has been used before. See the Alta-
Track touch screen for resolution Shapes are not registered. Perform shape registra-
tion Shape registration may be inaccurate. Check fluo-
roscopy VS4 The table or stand has moved. Check fluoroscopy VS5 The roadmap may be inaccurate. Check the posi-
tion of the X-ray system These are AltaTrack equipment (optical) issues. Follow the instructions on the AltaTrack touch screen. If the problem cannot be resolved contact technical support. These are AltaTrack angiographic device issues. Relax the bend in the device. If the problem can-
not be resolved, replace the device. The AltaTrack equipment has detected that there is an unsupported AltaTrack device combination connected. When two AltaTrack devices are con-
nected, it should be an AltaTrack Guidewire and an AltaTrack Catheter. The AltaTrack equipment has detected that the connected device has been used before, 24 HOURS PRIOR TO THIS CONNECTION. The AltaTrack equipment has detected that the Al-
taTrack devices are not registered to the X-ray sys-
tem. Perform shape registration first. The AltaTrack equipment has detected that the shape accuracy could have been compromised. Use fluoroscopy to check the alignment of the shape to X-ray. The AltaTrack equipment has detected that the ta-
ble or the gantry has been moved. These move-
ments could compromise the shape accuracy. Use fluoroscopy to check the alignment of the shape to X-ray. The X-ray system is in an uncalibrated position and could compromise the shape accuracy. Move X-ray system back to a calibrated position. AltaTrack - US Release 1.0 Instructions for Use 16 Philips 4322 070 31061 Safety Warning Messages Message ID Warning Message Guidance VS6 VS22 No imaging performed for 5 minutes. Check fluoro-
scopy The patient data does not match with the current patient on the X-ray system. Verify the patient's identity and merge the patient information The AltaTrack equipment has detected that there was no X-ray used for more than 5 minutes. The AltaTrack equipment must always be used in com-
bination with X-ray. Use fluoroscopy to check the alignment of the shape to X-ray. The AltaTrack equipment has detected that patient selected in the AltaTrack software differs from the current patient on the X-ray system. Verify the pa-
tient identity and merge the patient information on the AltaTrack software. AltaTrack - US Release 1.0 Instructions for Use 17 Philips 4322 070 31061 Equipment Overview AltaTrack Trolley 3 Equipment Overview The AltaTrack equipment integrates with the existing Philips interventional X-ray system in the examination room and in the control room. Figure 3 AltaTrack equipment overview Legend 1 2 3 AltaTrack trolley AltaTrack touch screen AltaTrack docking base 4 5 6 AltaTrack Docking Top AltaTrack devices AltaTrack software displayed in the examination room You can use the touch screen module (TSM) and the tableside mouse of the X-ray system to view images produced by the AltaTrack equipment on the monitors in the examination room. If a mouse is not available in the examination room with the X-ray system, one is provided with the AltaTrack equipment. AltaTrack images can be viewed on monitors in the control room, where data preparation tasks can also be performed. 3.1 AltaTrack Trolley The AltaTrack trolley contains the core hardware of the AltaTrack equipment. It is connected to the AltaTrack docking base by the AltaTrack equipment cable. The AltaTrack trolley has a storage hook for the docking base when it is not in use. The AltaTrack trolley is also connected to AltaTrack workstation, providing real-time 3D visualization of device shapes on monitors in the examination room and in the control room. AltaTrack - US Release 1.0 Instructions for Use 18 Philips 4322 070 31061 Equipment Overview AltaTrack Trolley Figure 4 AltaTrack trolley Legend 1 2 3 AltaTrack touch screen AltaTrack docking base storage hook AltaTrack equipment cable The AltaTrack trolley can be moved to any suitable position outside the sterile zone in the examination room. A parking mechanism provides stability during use. A rail and hook are provided on the front side of the AltaTrack trolley to store the AltaTrack docking base and the AltaTrack equipment cable while not in use. A hook is also provided on the rear side of the AltaTrack trolley to store the network cable and the power cable. The AltaTrack trolley also has an adjustable touch screen accessible by non-sterile staff. Figure 5 AltaTrack touch screen The AltaTrack touch screen display provides pre-procedural instructions for preparing the AltaTrack equipment. A status diagram displays the types of AltaTrack devices that are connected or parked. AltaTrack - US Release 1.0 Instructions for Use 19 Philips 4322 070 31061 Equipment Overview AltaTrack Docking Base Figure 6 AltaTrack touch screen display The AltaTrack touch screen also provides user assistance if the AltaTrack equipment encounters issues during use. If an issue arises, an information bar is displayed at the top of the AltaTrack touch screen
(the message is also displayed in the AltaTrack software window). Tap the information icon follow the instructions on the AltaTrack touch screen. The AltaTrack touch screen is not suitable for use when wearing surgical gloves. For normal use, it is not necessary to touch the tablet's screen with gloves. 3.2 AltaTrack Docking Base The AltaTrack docking base is clamped to the rail of the patient table. It provides an attachment point for the AltaTrack Docking Top and a fixed reference point that allows the AltaTrack device shapes to be registered with X-ray images. CAUTION The connection box hangs below the level of the tabletop and is susceptible to collisions with the table base or the stand if the table is moved. Take care to avoid such collisions to prevent damage to the equipment or loss of registration. If necessary, re-register the device after moving the table. The AltaTrack docking base consists of the following parts. AltaTrack - US Release 1.0 Instructions for Use 20 Philips 4322 070 31061 Equipment Overview AltaTrack Software Figure 7 AltaTrack docking base Legend 1 2 AltaTrack docking base AltaTrack table clamp 3 4 AltaTrack connection box AltaTrack equipment cable The AltaTrack docking base can be attached to either side of the table. The AltaTrack Docking Top has an orientation indicator to guide you when attaching the AltaTrack Docking Top to the docking base. The AltaTrack Docking Top should be oriented so that inserted devices are always angled toward the feet end. For more information, see Setting Up the AltaTrack Docking Base (page 29). The AltaTrack docking base can be detached from the table between procedures. WARNING Detaching the AltaTrack docking base during a procedure may damage the sterile cover and cause a sterility breach. NOTE The AltaTrack docking base does not restrict X-ray geometry movements, or longitudinal and transverse patient table movements. However, the patient table cannot be tilted or cradled while using the AltaTrack equipment. AltaTrack Connection Box The AltaTrack connection box connects AltaTrack devices that are inserted in the AltaTrack Docking Top to the AltaTrack equipment. Additional slots are provided to assist with changing devices. 3.3 AltaTrack Software The AltaTrack software is accessible in the control room and examination room to assist the physician during an endovascular interventional procedure by overlaying live reconstructed shapes on pre- and intra-procedural image data. AltaTrack - US Release 1.0 Instructions for Use 21 Philips 4322 070 31061 Equipment Overview AltaTrack Software In preparation for the procedure, you can import the following volumes and images for use as a roadmap:
Pre-procedural CT data from PACS or portable media Intra-procedural angiographic exposure images The AltaTrack software database can only store a limited amount of image data. After the procedure, you should export acquired X-ray images and DICOM screenshots to PACS or other storage devices to ensure that free space is available for the next procedure. For information about exporting images, refer to the Instructions for Use supplied with the Interventional Workspot. CAUTION If the free space in the AltaTrack software database falls below 10%, the AltaTrack equipment may not function as expected. Figure 8 AltaTrack software display layout Legend 1 2 3 4 Patients button: Closes the application and displays the patient list. Patient information panel: Provides information about the patient including allergies and other health warnings. Task selection panel: Provides quick access to each task in the workflow. Task panel: Provides the functions associated with the task being performed. Moving to another task changes the controls and functions available in the task panel. 5 6 7 User message area: Messages relating to device sta-
tus and shape registration are displayed here when user action is needed to resolve an issue. Main display area: Displays X-ray images and de-
vice shape overlays. The CT volume is also dis-
played, if applicable. The configuration of the dis-
play depends on the selected task. Common tools panel: Provides tools for configura-
tion, export, movies, and snapshots. AltaTrack - US Release 1.0 Instructions for Use 22 Philips 4322 070 31061 Equipment Overview AltaTrack Docking Top 3.3.1 Tasks The task selection panel provides an overview of the workflow when using the AltaTrack software. Segmentation The Segmentation task is used with a preoperative CT volume (optional) to select anatomy to visualize and to identify vessels of interest for a clinical procedure. Segmentation activities include:
Selecting a visualization method Setting a suitable viewing angle Segmenting the table and bones Segmenting vessels of interest Removing areas of anatomy to make segmentation easier Planning The Planning task is used with a preoperative CT volume (optional) to plan the procedure by preparing the AltaTrack equipment and the volume:
Adding landmarks Preparing and storing viewing angles for use in the live guidance task Volume Registration The Volume Registration task is used with a preoperative CT volume (optional) to align the 3D volume with the images from the X-ray system. Two methods of performing registration are available:
2D registration, using 2D X-ray images 3D registration, using 3D rotational series Shape Registration The Shape Registration task is used to align the AltaTrack device shapes with the images from the X-ray system. Live Guidance The Live Guidance task provides a continuous overlay of the AltaTrack device shapes on the X-ray images and preoperative CT volume (if applicable). Live Guidance activities include:
Recalling angles stored in the Planning task Navigating with the AltaTrack device shapes Making minor adjustments to registration to compensate for patient movement The task selection panel can be opened or closed by clicking the expander. 3.4 AltaTrack Docking Top The AltaTrack Docking Top is a single-use accessory that is supplied sterile. It attaches to the AltaTrack docking base on top of the sterile cover that covers the docking base. AltaTrack - US Release 1.0 Instructions for Use 23 Philips 4322 070 31061 Equipment Overview AltaTrack Devices Figure 9 AltaTrack Docking Top attached to the AltaTrack docking base The AltaTrack Docking Top contains sterile slots for AltaTrack devices and is intended to provide a mechanical fixation of an AltaTrack Catheter or an AltaTrack Guidewire to the AltaTrack equipment within the sterile zone. The AltaTrack equipment automatically identifies devices when they are inserted in the AltaTrack Docking Top. For more information about the AltaTrack Docking Top, refer to the Instructions for Use supplied with the AltaTrack Docking Top. 3.5 AltaTrack Devices An AltaTrack device is a single-use item that used with the AltaTrack equipment and is supplied sterile. An AltaTrack device consists of a fiber-optic sensor integrated in an angiographic catheter or guidewire. Figure 10 AltaTrack devices Legend 1 2 AltaTrack Guidewire AltaTrack Catheter (Berenstein) 3 4 AltaTrack Catheter (Cobra 2) Torque-absorbing section When using the AltaTrack equipment, you can use one or two AltaTrack devices and visualize them simultaneously. You can use the following configurations:
An AltaTrack Guidewire with an AltaTrack Catheter A single AltaTrack device with any conventional angiographic device of a compatible size. NOTE It is not possible to visualize two AltaTrack Catheter devices or two AltaTrack Guidewire devices simultaneously. The AltaTrack device is visualized as a real-time 3D shape by the AltaTrack equipment, providing live guidance and navigation in the vascular system when overlaid on a pre-procedural CT volume and X-
ray images. AltaTrack - US Release 1.0 Instructions for Use 24 Philips 4322 070 31061 Equipment Overview AltaTrack Devices The AltaTrack devices have a torque-absorbing section that decouples rotation of the device's in-body section from the device's mechanical interface connected to the AltaTrack Docking Top. WARNING The length of an AltaTrack device is limited. Be aware of the torque-absorbing section of the device. Do not pull on this section as this may pull the device from the patient with strong force and cause an injury to the patient. For more information about each AltaTrack device, refer to the Instructions for Use supplied with the device. AltaTrack - US Release 1.0 Instructions for Use 25 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Setting Up the AltaTrack Equipment 4 Preparing the AltaTrack Equipment for Use 4.1 Setting Up the AltaTrack Equipment This section provides information about setting up the AltaTrack trolley, docking base, and AltaTrack Docking Top. Figure 11 AltaTrack equipment overview 4.1.1 Setting Up the AltaTrack Trolley 1
(Non-sterile user) Position the trolley in the examination room as follows:
At least 1.5 m from the tabletop Outside the sterile field With the front of the trolley facing the patient table (the airflow outlet is located on the back of the trolley) Without blocking the working area of the clinical staff AltaTrack - US Release 1.0 Instructions for Use 26 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Setting Up the AltaTrack Equipment Figure 12 AltaTrack trolley positioning CAUTION If the AltaTrack trolley is incorrectly positioned and you have to move it during the procedure, you must perform registration for all devices again. WARNING Position the AltaTrack trolley in the examination room so that the airflow of the trolley does not influence the laminar airflow in the surgery room. Guidance on how to position the trolley is available on the AltaTrack touch screen. 2
(Non-sterile user) Apply the trolley brakes to park the AltaTrack trolley. Figure 13 AltaTrack trolley brakes: applying the brake (left) and releasing the brake (right) AltaTrack - US Release 1.0 Instructions for Use 27 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Setting Up the AltaTrack Equipment 3
(Non-sterile user) Connect the AltaTrack trolley cables:
a Connect the power cable to the power supply. b Connect the network cable to the network. Figure 14 AltaTrack trolley cables Legend 1 2 Power cable Network cable WARNING Do not touch electrical or network connectors on the patient table, the AltaTrack trolley, or the AltaTrack equipment cable while simultaneously touching the patient. Connector contact pins may carry low voltages that are safe to touch, but that may be harmful to the patient. CAUTION Position the power cable and network cable of the AltaTrack trolley so that they do not interfere with the working area of the clinical staff and cause anyone to trip. CAUTION Ensure that the network cable of the AltaTrack trolley is connected to the correct network port to allow proper communication of the equipment. NOTE The network connection of the trolley is only intended for point-to-point connection to the AltaTrack workstation. The connection characteristics are managed by the AltaTrack equipment. 4 (Non-sterile user) Press the Power On switch on the trolley. AltaTrack - US Release 1.0 Instructions for Use 28 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Setting Up the AltaTrack Equipment Figure 15 AltaTrack trolley power switch An indication of the start-up process is displayed on the AltaTrack touch screen on top of the trolley. The AltaTrack equipment takes approximately 8 minutes to start up before it is available for use. This includes the time required for the laser to become available. However, controls for the AltaTrack equipment set-up software are available approximately 60 seconds after starting, for procedure preparation. If a power outage occurs, the AltaTrack equipment restarts when power is restored and is available in approximately 3 minutes. 5
(Non-sterile user) Initialize the optical processing unit using the AltaTrack touch screen. 4.1.2 Setting Up the AltaTrack Docking Base 1
(Non-sterile user) Position the patient on the table. Do not place sterile covers yet. CAUTION If a Maquet table is used, check that the rail is not fully extended as this will compromise the stability of the AltaTrack docking base. 2
(Non-sterile user) Release the AltaTrack table clamp and remove the AltaTrack docking base from its storage position on the trolley. Figure 16 Removing the AltaTrack docking base from its storage position 3 Using the AltaTrack table clamp, attach the AltaTrack docking base to the table accessory rail in a suitable position:
AltaTrack - US Release 1.0 Instructions for Use 29 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Setting Up the AltaTrack Equipment At the level of the patient's knees So that it does not obstruct personnel or equipment in the examination room. So that the AltaTrack Catheter and AltaTrack Guidewire can comfortably reach the area of interest in the patient's body. Figure 17 Attaching the AltaTrack docking base to the table accessory rail NOTE Do not attach the AltaTrack Docking Top to the AltaTrack docking base yet. Guidance on how to attach the AltaTrack docking base is also available on the AltaTrack touch screen. WARNING Ensure that the AltaTrack docking base is securely fixed to the table rail at an appropriate position. If the AltaTrack docking base falls off, or if there is any intentional or unintentional movement of the AltaTrack docking base, there is a risk of injury to the patient and the sterile field may be compromised. You must also perform registration for all devices again. 4 (Non-sterile user) On the AltaTrack touch screen, tap Dock position and then select the AltaTrack docking base orientation. Figure 18 Selecting the AltaTrack docking base orientation on the AltaTrack touch screen 5
(Sterile user) Place sterile covers over the patient and the AltaTrack docking base. 4.1.3 Setting Up the AltaTrack Docking Top 1
(Non-sterile user) Unpack the AltaTrack Docking Top and open the sterile pouch without touching the tray inside. WARNING While unpacking single-use devices, pay close attention to sterility information labels on the packaging to avoid compromising the sterile field. AltaTrack - US Release 1.0 Instructions for Use 30 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Setting Up the AltaTrack Equipment For information about unpacking the AltaTrack Docking Top, refer to the AltaTrack Docking Top Instructions for Use. 2
(Sterile user) Take the tray, remove the AltaTrack Docking Top, and do the following:
Figure 19 Attaching the AltaTrack Docking Top a Ensure that the AltaTrack docking base is covered with the sterile cover. b Carefully push the sterile cover into the AltaTrack docking base recess to ensure that the AltaTrack Docking Top fits securely in the docking base. c Ensure that the orientation indicator on the AltaTrack Docking Top matches the orientation of the patient on the table. Figure 20 AltaTrack Docking Top orientation d Carefully insert the grooved edge of the AltaTrack Docking Top into the clip on the AltaTrack docking base. e Carefully push the other edge of the AltaTrack Docking Top down into place on the AltaTrack docking base. WARNING Take care when placing the AltaTrack Docking Top. Incorrect or repeated placing of the AltaTrack Docking Top may damage the sterile cover and compromise the sterile field. Guidance on how to attach the AltaTrack Docking Top is also available on the AltaTrack touch screen. If an issue is detected, guidance is provided on the AltaTrack touch screen: follow the steps to resolve the issue (the message is also displayed in the AltaTrack software window). AltaTrack - US Release 1.0 Instructions for Use 31 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Starting the AltaTrack Software Figure 21 Guidance is displayed on the AltaTrack touch screen when an issue is detected Keep the AltaTrack Docking Top clean. Excessive blood may reduce the effectiveness of the docking action. WARNING Do not apply force to the sterile cover or lean on the patient table, the AltaTrack Docking Top, or other items attached to the patient table. Doing so may cause misalignment of the shape with the anatomical roadmap. 4.2 Starting the AltaTrack Software NOTE Ensure that only one Interventional Workspot is turned on to ensure proper communication with the interventional X-ray system. You can use the AltaTrack software with or without a preoperative CT volume from the patient. If you use a preoperative CT volume, it provides additional navigation information during the Live Guidance task. 1 On the X-ray system, select or add the patient. 2 To start the AltaTrack software without using a preoperative CT volume during the procedure, do the following:
a On the touch screen module of the X-ray system, tap Tools. b In the Tools screen, tap Workspot, then tap AltaTrack, and then tap AltaTrack without CT. When using the AltaTrack software without a preoperative CT volume, the workflow consists of the following tasks:
AltaTrack workflow without preoperative CT volume 1 2 Setting up the AltaTrack devices Shape Registration task (the AltaTrack software opens in this task) AltaTrack - US Release 1.0 Instructions for Use 32 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Starting the AltaTrack Software AltaTrack workflow without preoperative CT volume 3 Live Guidance task c Go to Setting Up the AltaTrack Devices (page 49) to continue this workflow. 3 To start the AltaTrack software with a preoperative CT volume available for reference during the procedure, do the following:
a On the Interventional Workspot, select the patient in the Patients activity. b In the patient folder, right-click the preoperative CT volume, point to View With, and click AltaTrack. NOTE If session data from a previous session is available in the patient folder, you can also start the AltaTrack software by double-clicking the session data object. AltaTrack session data displays the following icon:
NOTE When using the AltaTrack software with a preoperative CT volume, it is not recommended to start the software from the touch screen module of the X-ray system. When using the AltaTrack software with a preoperative CT volume, the workflow consists of the following tasks:
AltaTrack workflow with preoperative CT volume 1 2 3 4 5 6 Segmentation task (the AltaTrack software opens in this task) Planning task Volume Registration task Setting up the AltaTrack devices Shape Registration task (the AltaTrack software opens in this task) Live Guidance task c Go to the next section to continue this workflow. 4.2.1 Segmentation You can view and segment volumes in the Segmentation task to identify vessels of interest and show relevant image content for the Planning task. You can manipulate the volume in several ways:
Select a visualization method Select a suitable orientation angle Segment vessels of interest Remove areas of anatomy to make segmentation easier AltaTrack - US Release 1.0 Instructions for Use 33 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Starting the AltaTrack Software Segmentation Viewports Four viewports are displayed in the Segmentation task, each displaying a different direction of view for the same volume. Figure 22 Segmentation viewports Legend 1 2 3 4 Volume view Slab view Slab view Slab view Removing the Table Default orientation Anterior posterior (coronal-anterior) Caudo cranial (axial-feet) Anterior posterior (coronal-anterior) Lateral left (saggital-left) If a table is detected in the volume, the system attempts to remove the table from the view before displaying the volume. If table removal is successful, the Hide Table tool in the task panel is enabled. Using this tool, you can turn the visibility of the table on or off. NOTE Table removal can only be performed on CT volumes in axial, nose-up orientation. Removing Anatomy Areas of anatomy that are not required in the view or that are obstructing a clear view of the region of interest can be removed from the volume view. AltaTrack - US Release 1.0 Instructions for Use 34 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Starting the AltaTrack Software 1 2 Adjust the windowing settings if necessary, to ensure that the vessels of interest are clearly visible. To provide better visibility of the vessels of interest, you can remove the rib cage from the view by clicking Hide Ribcage in the task panel. The Hide Ribcage tool allows you to turn the visibility of the rib cage on or off as desired. 3 Click Cut Anatomy in the task panel. 4 Draw a line around the anatomy to be removed by dragging the pointer in the volume viewport. 5 Release the left mouse button when the required area has been highlighted. The area of anatomy is removed from the volume. 6 To remove all cuts that you have made in the volume, right-click in the volume viewport and click Remove All Cuts in the shortcut menu. 7 To undo the last change that you made, click Undo in the task panel. 8 To reapply the last change that was undone, click Redo in the task panel. Segmenting Vessels of Interest 1 Adjust the windowing settings if necessary, to ensure the vessels of interest are clearly visible. 2 Click Select Vessels in the Segmentation task panel. 3 In the volume view, position the cursor over the vessel you wish to segment. The vessel is highlighted. 4 Click the left mouse button to confirm segmentation of the section of the vessel highlighted. Segmentation of this section of the vessel is confirmed and the vessel remains highlighted. 5 Position the pointer over the next section of the vessel you wish to segment. 6 Click the left mouse button to confirm segmentation of the next portion of the vessel. 7 Alternatively, position the pointer over the vessel you wish to segment and use the mouse scroll wheel to extend the length of the highlighted section. The vessel is highlighted further until scrolling is stopped. 8 Confirm the vessel segmentation by clicking the left mouse button. 9 Repeat these steps for all vessels to be segmented. 10 To remove a vessel, right-click the vessel and click Remove Vessel in the shortcut menu. 11 To remove all vessels, right-click in the volume viewport and click Remove All Vessels in the shortcut menu. AltaTrack - US Release 1.0 Instructions for Use 35 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Starting the AltaTrack Software 12 To undo the last change that you made, click Undo in the task panel. 13 To reapply the last change that was undone, click Redo in the task panel. 14 Click Show vessels to verify the segmented vessels. The vessels are shown over a transparent background. 4.2.2 Planning You can plan the procedure in the Planning task, including preparations for the procedure:
Adding landmarks Preparing and storing viewing angles for use in the Live Guidance task Planning Viewports Four viewports are displayed in the Planning task, each displaying a different direction of view for the same volume. Figure 23 Planning viewports View 1 2 3 4 Default orientation Volume view Anterior posterior (coronal-anterior) Slab view Slab view Slab view Caudo cranial (axial-feet) Anterior posterior (coronal-anterior) Lateral left (saggital-left) Slab views are linked. Actions performed in one view are performed in the other slab views. The content of a slab view can be enlarged by displaying it in the volume viewport. AltaTrack - US Release 1.0 Instructions for Use 36 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Starting the AltaTrack Software The volume view is not linked to the slab views. Basic viewing tools are available on a toolbar in each view port to allow you to manipulate the image in the viewport. Placing Landmarks You can place landmarks to the volume to assist in later tasks in the procedure. There are two types of landmark:
Ring landmarks are used to mark vessel ostia and landing zones to assist in catheter navigation during the procedure. Anatomical landmarks are used to mark a point of interest in the anatomy. To provide a clear view of the segmented vessels, click Tissue presets and select a suitable preset. For example, select the Segmentation preset to show only the segmented vessels. 1 2 Click Place Ring Landmark in the Planning task panel. 3 In the volume view or in the 2D view, click on the vessel at the point where you would like the ring landmark placed. A landmark is placed in the location identified. Landmarks are numbered sequentially by default but can be renamed. The landmark is also shown in the slab views. 4 Using the slab views, adjust the diameter and position of the landmark to ensure it is in the correct position. 5 Position the cursor over the landmark in the relevant slab view. Adjustment handles are shown. 6 Click and drag the desired handle to change the diameter of the landmark. 7 Click and drag the landmark to reposition it. 8 To place an anatomical landmark point, click Place Landmark in the task panel. 9 Position the cursor where you would like the landmark to be placed and click the left mouse button. A landmark is placed as a point on the anatomy. 10 To rename a landmark, right-click on the landmark and click Rename Ring Landmark or Rename Landmark in the shortcut menu. The landmark name becomes editable. 11 Enter a new name for the landmark and press Enter. 12 To delete a landmark, right-click on the landmark and click Delete Ring Landmark or Delete Landmark in the shortcut menu. 13 To change the color of a landmark, right-click on the landmark and click Change Ring Landmark Color or Change Landmark Color in the shortcut menu. A sub-menu is displayed showing available colors. AltaTrack - US Release 1.0 Instructions for Use 37 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Starting the AltaTrack Software 14 Click on the desired landmark color from the list. 15 To change how landmarks are displayed, click the landmark visualization button in the toolbar and choose a new setting. No landmarks Landmarks with text Landmarks without text The setting that you choose is applied to ring landmarks and anatomical landmarks. Storing Viewing Angles You can manipulate the viewing angle of the 3D volume to provide suitable views of the areas of interest for use during the Live Guidance task. These planned angles relate to the rotation and angulation positions of the stand and can be stored and recalled when needed. 1 Click the Store View Angles expander. The Store View Angles controls are displayed in the task panel. 2 Manipulate the volume until the desired viewing angle and optimal visibility of the area of interest is achieved. A preview of the stand position for the current angle of the volume is shown below the list of planned angles with the rotation and angulation values displayed. NOTE Changes made in the slab views do not affect the view and angles to be stored. 3 Click Store Angle in the task panel. The planned angle is stored and displayed in the list in the task panel showing the associated stand rotation and angulation values. A preview image of the volume at the planned angle is shown beside each planned angle in the list. 4 Repeat these steps until all of the required viewing angles have been stored as planned angles. The Store Angle button is disabled when the maximum number of stored angles is reached. 5 To rename a planned angle, double-click on the angle name and enter a new name. 6 To delete a planned angle, right-click on the planned angle to be deleted and click Remove Angle in the shortcut menu. 7 To enlarge the preview image of the planned angle, position the pointer over the planned angle in the list. The preview image enlarges. AltaTrack - US Release 1.0 Instructions for Use 38 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Starting the AltaTrack Software 4.2.3 Volume Registration NOTE It is not mandatory to register a pre-procedural 3D volume when using the AltaTrack equipment. However, if you do not use a 3D volume, visualization options are limited during live guidance. The Volume Registration task allows you to register the 3D volume with the images from the X-ray system being used for the procedure. You can choose between 2D registration (with 2D X-ray images) or 3D registration (with a 3D rotational series). 2D registration can be performed using the AltaTrack software in the control room or using the touch screen module of the X-ray system at the tableside, whereas 3D registration can only be performed using the AltaTrack software. Therefore, the following registration options are available:
2D registration in the control room using the AltaTrack software 2D registration at the tableside using the touch screen module of the X-ray system 3D registration in the control room using the AltaTrack software All registration options are described in this section. CAUTION Do not move the stand or table while acquiring series for registration. Such movements may compromise the accuracy of the registration. Merging Patient Data When there is a mismatch between the patient data in the AltaTrack equipment and the patient data on the X-ray system, you cannot continue to the Volume Registration task, the Shape Registration task, or the Live Guidance task. (A message is displayed if there is a mismatch.) If both sets of data are from the same patient, you can merge the patient data and then continue with registration and guidance. If there is no mismatch between the data, merging is not required. 1 Click Merge with current X-Ray patient in the general toolbar. The Merging with current patient on X-ray system dialog panel is displayed. 2 Verify the identity of the patient and ensure both sets of details displayed relate to the same patient. WARNING To avoid the risk of mixing patients, it is your responsibility to ensure that you only merge personal data originating from the same patient. 3 If you are certain the details relate to the same patient, click OK to merge the patient details. Performing 2D Volume Registration To perform 2D volume registration, two reference series must be obtained using the X-ray system from different projection angles and at least 30 degrees apart. The system provides suggested angles to assist to you. After acquiring the reference series, you align the volume with the images in the reference series. Other Registration Options If you want to perform 2D volume registration at the tableside using the touch screen module of the X-
ray system, see Performing 2D Volume Registration at the Tableside (page 44). If you want to perform 3D volume registration using a 3D rotational series, see Performing 3D Volume Registration (page 45). AltaTrack - US Release 1.0 Instructions for Use 39 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Starting the AltaTrack Software Starting 2D Volume Registration 2D volume registration is the default registration method. 1 Select the Volume Registration task. The Volume Registration task controls are displayed in the task panel with the Registration Method menu open. 2 In the Registration Method step in the task panel, click 2D Images. The screen layout changes to display three viewports in normal view mode. Figure 24 Normal view mode screen layout Legend 1 2 3 Live view Reference 1 (Ref 1) Reference 2 (Ref 2) Acquiring Reference Series 1 Click the Acquire images from 2 angles expander. The Acquire images from 2D images controls are displayed in the task panel. A list of suggested angles is displayed, and the first angle is selected automatically. 2 Do one of the following:
To use the selected angle, press the ACC button on the geometry module of the X-ray system. To use one of the other suggested angles, select the desired angle, and then press the ACC button on the geometry module of the X-ray system. The X-ray system repositions the stand to the selected rotation and angulation. AltaTrack - US Release 1.0 Instructions for Use 40 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Starting the AltaTrack Software 3 Acquire a fluorscopy series. During acquisition, the images are displayed in the live viewer, overlaid on the 3D volume. After acquisition, the live view switches to review mode automatically. The Copy button in the Ref 1 viewport is blinking. Once a reference series has been acquired, you can copy the series to a reference view. Reference series are not copied to a reference view automatically. The system suggests which reference viewer is suitable to maintain an optimum angle difference between the two reference series being used:
For the first series acquired, Ref 1 is always suggested. For the second series acquired, Ref 2 is suggested if the difference in projection angle is sufficient. 4 Click Copy in the Ref 1 viewport. The series is copied to the Ref 1 viewport and a new list of suggested angles is displayed in the task panel for the next reference series. A suitable angle is automatically selected, but you can select a different one, if desired. 5 Press the ACC button on the geometry module of the X-ray system to use the currently selected angle. The X-ray system repositions the stand to the selected rotation and angulation. 6 Acquire another fluoroscopy series. During acquisition, the images are displayed in the live viewer, overlaid on the 3D volume. After acquisition, the live view switches to review mode automatically. The Copy button in the Ref 2 viewport is blinking. Where more than two series have been acquired or where the second series had an unsuitable projection angle difference, the system suggests the most suitable reference view for the series:
If the series is acquired at a projection angle which is identical to a previous reference series, the system suggests that the previous identical series is replaced with the newer series. If the series is acquired at a projection angle which is suitable, the system suggests that the new series replaces the existing series with the largest projection angle difference to the new series. NOTE If a reference series is acquired at a projection angle that is unsuitable to replace any of the existing series, the system does not make a suggestion to replace to any existing reference series. A message is displayed to inform you that there is insufficient difference in the projection angle. 7 Click Copy in the Ref 2 viewport. The series is copied to the Ref 2 viewport. The Acquire images from 2 angles task is closed, the screen layout changes to Reference view mode and the Align volume with images task is displayed in the task panel. Aligning the Volume with the Reference Series Following the Acquire images from 2 angles task, the Align volume with images controls are displayed automatically and the screen layout is changed to Reference view mode. The purpose of this task is to align the CT volume and the 2D image based on the anatomical landmarks
(bones) that are visible in the images. AltaTrack - US Release 1.0 Instructions for Use 41 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Starting the AltaTrack Software Figure 25 Registration view mode Legend 1 2 Reference 1 (Ref 1) Reference 2 (Ref 2) 1 To change the tissue visualization, click Tissue presets and select a different preset for the volume. NOTE The default tissue preset that is already selected is optimized for performing registration and does not usually need to be changed. 2 To enhance visualization of bone structure in the X-ray image, click Boost Bone. The outlines of bones are enhanced in the X-ray image. 3 If desired, adjust the contrast and brightness of the X-ray image. See Adjusting the Contrast and Brightness of the X-ray Image (page 81) for information about how to adjust the contrast and brightness of the X-ray image. 4 Click Translate Volume and click and drag the volume in each viewport to align the bone structures. 5 To roll the volume freely in any direction, click Roll Volume and do the following in each viewport as desired:
Move the pointer inside the boundary of the volume. Drag the volume to roll it to the desired orientation. 6 To rotate the volume in the viewing plane, click Rotate Volume and do the following in each viewport as desired:
Move the pointer outside the boundary of the volume. Drag the volume to rotate it to the desired orientation. AltaTrack - US Release 1.0 Instructions for Use 42 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Starting the AltaTrack Software 7 To change the center of rotation, drag the rotation point interactor to a new position before rolling or rotating the volume. NOTE The rotation point interactor is visible in the viewports when you select the Roll Volume tool or Rotate Volume tool. Figure 26 Rotation point 8 Verify alignment of the volume and the X-ray image by clicking Auto Fade. The volume fades in and out repeatedly to allow you to see whether the volume and the X-ray image are sufficiently aligned. You can leave the auto fade cycle turned on while you make adjustments. To turn it off, click Auto Fade again. 9 Check alignment of the volume with the X-ray image. 10 If necessary, repeat the steps above until the volume and X-ray image are sufficiently aligned. 11 To reset the volume to the original position and orientation, click Reset Alignment. All alignments of the volume are undone. 12 To reset only the translation alignment performed, right-click in the viewport and select Reset alignment translation. Only translation alignments are undone. 13 To reset only the rotation alignment performed, right-click in the viewport and select Reset alignment rotation. Only rotation alignments are undone. AltaTrack - US Release 1.0 Instructions for Use 43 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Starting the AltaTrack Software Performing 2D Volume Registration at the Tableside To perform 2D volume registration, two reference series must be obtained using the X-ray system from different projection angles and at least 30 degrees apart. The system provides suggested angles to assist to you. After acquiring the reference series, you align the volume with the images in the reference series. If the touch screen module or the tableside mouse of the X-ray system is not functioning, you can continue this task using the AltaTrack software in the control room. Other Registration Options If you want to perform 2D volume registration using the AltaTrack software in the control room, see Performing 2D Volume Registration (page 39). If you want to perform 3D volume registration using a 3D rotational series, see Performing 3D Volume Registration (page 45). Starting 2D Volume Registration at the Tableside Volume registration of 2D X-ray images can also be performed at the tableside using the touch screen module of the X-ray system. For information about acquiring X-ray images, refer to the Instructions for Use for the X-ray system in use. 1 2 Tap AltaTrack on the touch screen module of the X-ray system. Tap Goto 2D Images Registration (this is the default method). Acquiring Reference Series at the Tableside 1 Tap Select Registration Angle. A set of suggested angles is displayed, and the first angle is selected automatically. 2 Do one of the following:
To use the selected angle, press the ACC button on the geometry module of the X-ray system. To use one of the other suggested angles, select the desired angle, and then press the ACC button on the geometry module of the X-ray system. The X-ray system repositions the stand to the selected rotation and angulation. 3 Acquire a fluoroscopy series. Any acquisition setting and projection angle can be used. 4 Tap Copy to Ref 1 to copy the acquired series to the Ref 1 view. 5 Tap Select Registration Angle. A new set of suggested angles is displayed in the task panel for the next reference series. A suitable angle is automatically selected, but you can select a different one, if desired. 6 Press the ACC button on the geometry module of the X-ray system to use the currently selected angle. The X-ray system repositions the stand to the selected rotation and angulation. 7 Acquire a second fluoroscopy series. AltaTrack - US Release 1.0 Instructions for Use 44 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Starting the AltaTrack Software This reference series should be obtained using a projection angle difference of at least 30 degrees. 8 Tap Copy to Ref 2 to copy the acquired series to the Ref 2 view. Aligning the Volume with the Reference Series at the Tableside 1 2 Tap Adjust Registration to begin aligning the volume and the X-ray images. Select the reference view to be manipulated by tapping Active View to select Ref 1. Tapping Active View allows you to select which reference view you are manipulating by toggling between Ref 1 and Ref 2. 3 Select an adjustment method by tapping Movement until the desired method is displayed on the button. Tapping Movement cycles the function through the following adjustment methods. Translate Roll Rotate In-plane Rotation Center 4 Use Translate to translate the volume using the arrow buttons. 5 Use Roll to roll the volume freely around the center of rotation using the arrow buttons. If desired, use Rotation Center to adjust the center of rotation for the roll action. 6 Use Rotate In-plane to rotate the volume in the viewing plane around the center of rotation using the arrow buttons. If desired, use Rotation Center to adjust the center of rotation for the rotate action. 7 Tap Active View to toggle to Ref 2. 8 Repeat the steps above for the Ref 2 image. 9 Check alignment of the volume with the X-ray image by tapping Auto Fade. 10 When you have confirmed that the volume and X-ray images are properly registered, tap Go to Live Guidance. Performing 3D Volume Registration To register the volume (pre-op) using a 3D rotational series, a suitable XperCT series or 3DRA series
(intra-op) must be acquired, or if such a series is available, it must be loaded. Other Registration Options If you want to perform 2D volume registration using the AltaTrack software in the control room, see Performing 2D Volume Registration (page 39). If you want to perform 2D volume registration at the tableside using the touch screen module of the X-
ray system, see Performing 2D Volume Registration at the Tableside (page 44). AltaTrack - US Release 1.0 Instructions for Use 45 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Starting the AltaTrack Software Starting 3D Volume Registration 1 Select the Volume Registration task. 2 In the Registration Method step in the task panel, select 3D Scan. Figure 27 Registration view mode Legend 1 2 Intra-op Pre-op 3 You can either acquire a 3D rotational series at this point, or load a previously acquired 3D rotational series. Until a suitable volume is acquired or loaded, the intra-op viewport displays the recommended process to be followed to acquire a suitable intra-op volume. For information about how to acquire a rotational series, refer to the Instructions for Use for the X-ray system in use. If you acquire a 3D rotational series, it is loaded automatically. After the series is acquired and loaded, see Aligning the Volume with the 3D Rotational Series (page 47). If you want to load a previously acquired 3D rotational series, see Loading a 3D Rotational Series (page 46). Loading a 3D Rotational Series 1 Click Load in the intra-op viewport or on the intra-op viewport toolbar. The Open Xper CT/3DRA volume dialog panel is displayed. 2 From the list of available series, select the desired XperCT or 3DRA series and click OK. AltaTrack - US Release 1.0 Instructions for Use 46 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Starting the AltaTrack Software NOTE When loading an older XperCT, 3DRA, or X-ray run for volume registration, the patient may have moved or the anatomy may have deformed in the meantime, limiting the quality of the registration. A progress bar is displayed while the series loads. The series is displayed in the intra-op viewport. Aligning the Volume with the 3D Rotational Series To register the volume with the 3D rotational series, a minimum of three registration points must be placed in the series and in the corresponding positions in the volume. Figure 28 Placing registration points 1 Manipulate the intra-op series and the pre-op volume to identify a suitable matching anatomical point, ensuring the same anatomical point is clearly visible in both viewports. For example, a vessel calcification. 2 Click Place Point Couple in the task panel or in the toolbar. 3 Click on the identified anatomical point in the intra-op viewport. The point is marked in the series and is identified as point 1. 4 Click on the same anatomical point in the pre-op viewport. Each point couple displays the same annotation number to indicate that the points are paired. 5 Repeat the steps above until you have placed at least three point couples. NOTE For accurate registration of the volume with the 3D rotational series, a minimum of three points is recommended. AltaTrack - US Release 1.0 Instructions for Use 47 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Starting the AltaTrack Software The system matches the point couples to align the series and volume in three dimensions. If any of the point couples cannot be matched, an error message is displayed telling you that one or more registration points may have been placed incorrectly. If this happens, check the point couples. 6 To move a point, click and drag the point to the new desired position. 7 To delete a point, right-click on the point to be deleted and click Remove Point in the shortcut menu. 8 To delete a point couple, right-click on one of the points in the couple or on the point couple in the task panel list, and click Remove Point Couple in the shortcut menu. 9 To delete all points, right-click anywhere in the viewport and click Remove All Points in the shortcut menu. 10 To increase the size of the viewport being manipulated, click the maximize view toggle button. 11 To return to the split screen reference view mode, click the maximize view toggle button again. 12 Once all point couples have been correctly placed, click Compute Alignment in the task panel. The screen layout changes and three orthogonal views of the overlaid series and volume are shown. 13 To adjust the alignment, click Translate Volume and click and drag the volume to align the anatomy. 14 To rotate the volume in the viewing plane, click Rotate Volume and do the following in each viewport as desired:
Move the pointer outside the boundary of the volume. Drag the volume to rotate it to the desired orientation. 15 To change the center of rotation, drag the rotation point interactor to a new position before rolling or rotating the volume. NOTE The rotation point interactor is visible in the viewports when you select the Roll Volume tool or Rotate Volume tool. Figure 29 Rotation point AltaTrack - US Release 1.0 Instructions for Use 48 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Setting Up the AltaTrack Devices 16 Verify alignment of the volume and the series by clicking Auto Fade. The volume fades in and out repeatedly to allow you to see whether the volume and the rotational series are sufficiently aligned. You can leave the auto fade cycle turned on while you make adjustments. To turn it off, click Auto Fade again. 17 Check alignment of the volume with the series. 18 If necessary, repeat the steps above until the volume and rotational series are sufficiently aligned. Adjusting Opacity You can adjust the opacity of a 3D volume to blend it more easily with 2D X-ray images or a 3D rotational series. The volume opacity can be adjusted from 0%, where only the 2D X-ray image or 3D series is visible, to 100%, where only the 3D volume is visible. The default volume opacity is 40%. 1 Select the volume opacity mode by clicking Volume Opacity on the toolbar. 2 Adjust the opacity by doing one of the following:
Drag the pointer upward to increase transparency. Drag the pointer downward to decrease transparency. When dragging, the pointer changes to indicate the opacity level is being adjusted. NOTE Volume opacity settings are linked in all viewports where the volume is displayed. 3 To reset the volume opacity, double-click in the viewport. Reviewing 2D Series in Volume Registration To assist in checking the registration match of images with the 3D volume or to assist in reporting, you can review a 2D series overlaid on the 3D volume. Review mode is automatically started after acquiring exposure series. Automatic review of fluoroscopy series can be turned on or off in the task panel. 1 In the live view, click Play in the review toolbar. The series is played at the speed at which the images were acquired. 2 To pause the review of the series, click Pause on the reviewing toolbar. The series is paused at the image displayed when the pause button was clicked. 3 Navigate to the next or previous images using Next Image or Previous Image on the reviewing toolbar. 4 Navigate to the start or end of the series using First Image and Last Image on the review toolbar. 4.3 Setting Up the AltaTrack Devices WARNING Ensure that you use correctly sized devices for the procedure. AltaTrack - US Release 1.0 Instructions for Use 49 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Setting Up the AltaTrack Devices 1
(Non-sterile user) Open the outer packing of the device without touching the tray inside. WARNING While unpacking single-use devices, pay close attention to sterility information labels on the packaging to avoid compromising the sterile field. For information about unpacking the AltaTrack device, refer to the AltaTrack device Instructions for Use. 2
(Sterile user) Take the tray, remove the device, and pass the empty tray back to the non-sterile user. Handle the AltaTrack devices carefully to avoid impacting the performance of the AltaTrack equipment. 3
(Non-sterile user) Move the empty tray away from the working area. 4 (Sterile user) Place the docking fin in the AltaTrack Docking Top. Figure 30 Connecting the device to the AltaTrack Docking Top The display on the AltaTrack touch screen indicates that the device is docked. 5
(Sterile user) Pass the device connector to a non-sterile user. Figure 31 Handing over the device connector 6 (Non-sterile user) Connect the device connector to the connection box using one of the active connection slots. WARNING Do not to use X-ray while a non-sterile user connects or disconnects a device at the connection box, as the connection box is close to the X-ray tube. AltaTrack - US Release 1.0 Instructions for Use 50 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Setting Up the AltaTrack Devices Figure 32 Inserting the device connector When the device connector is connected successfully, the equipment responds with an audible and tactile confirmation. The display on the AltaTrack touch screen indicates that initialization is in progress. Refer to the AltaTrack software window for confirmation that the device is correctly connected. Connection status can be viewed in the task panel of the Shape Registration task. Figure 33 AltaTrack device connection status in the task panel The device is ready for use after approximately 10 seconds. 7 If you are using two devices, such as a catheter and guidewire, repeat these steps for the second device. Figure 34 Inserting a second device connector You can set up one, two, or three AltaTrack devices, depending on the procedure and your workflow. Although only two devices can have a simultaneous optical connection to provide visualization on the AltaTrack equipment, an additional connection slot is provided so that you can set up a third device in advance. This makes switching devices during the procedure faster and easier. You can set up all devices without the risk of compromising the sterile field. NOTE It is not possible to visualize two AltaTrack Catheter devices or two AltaTrack Guidewire devices simultaneously. AltaTrack - US Release 1.0 Instructions for Use 51 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Performing Shape Registration Figure 35 Setting up an additional device connector 8 (Sterile user) Follow the procedure provided in the AltaTrack device Instructions for Use to flush or wipe each device in use. 9 If you are using two AltaTrack devices, front-load the catheter on to the guidewire. Connecting the device provides initial registration in relation to the AltaTrack docking base. 4.4 Performing Shape Registration This procedure describes the steps to register the AltaTrack devices (AltaTrack Guidewire and AltaTrack Catheter). You can also use this procedure if you are registering a single AltaTrack device (AltaTrack Guidewire or AltaTrack Catheter). If you are only registering a single AltaTrack device, the procedure is the same, but note that when actions for two AltaTrack devices are described, you need only perform the action once. The AltaTrack software recognizes how many AltaTrack devices are connected and the user guidance in the task panel and main display area will be appropriate for your configuration. NOTE You can perform Shape Registration out-of-body (on-body) or in-body close to the target anatomy. After you have performed out-of-body registration, and after you have inserted the devices in body so that they are visible in the X-ray field of view, use fluoroscopy to ensure that the registration is valid. WARNING If you register the devices at a location that is not near the target anatomy, you should check with fluoroscopy to ensure that the registration is still valid. 1 If not already selected, click Shape Registration in the task selection panel and verify that the AltaTrack devices are connected correctly. Figure 36 AltaTrack device connection status in the task panel 2 Advance the AltaTrack Guidewire so that the guidewire tip extends at least 2 cm (0.8 in) from the catheter. WARNING When using an AltaTrack Guidewire with an AltaTrack Catheter, avoid tangling the tips of the two devices. AltaTrack - US Release 1.0 Instructions for Use 52 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Performing Shape Registration NOTE If you are using an AltaTrack Catheter as a single device, the predicate device should be inserted in the AltaTrack device and should extend at least 2cm (0.8 in) from its tip. 3 Bring the AltaTrack devices into the X-ray field of view near the location of the target anatomy and confirm their position with fluoroscopy. Figure 37 Bringing the AltaTrack devices into the X-ray field of view 4 Click Next Step in the task panel to continue the shape registration procedure: Acquire X-ray runs from 2 angles. Guidance is provided in the main window for positioning and orienting the AltaTrack devices for registration:
Figure 38 AltaTrack device positioning and orientation guidance WARNING For optimal registration, observe the following guidelines:
Ensure that a significant part of the AltaTrack device is visible in the field view, with the tip of the device near the center of the view. If necessary, select a larger field of view. Ensure that there is some curvature in the tip of the device that is visible in the image. Ensure that there is some curvature where the devices overlap. 5 Acquire the first registration series using fluoroscopy. CAUTION Do not move the stand or table while acquiring series for registration. Such movements may compromise the accuracy of the registration. AltaTrack - US Release 1.0 Instructions for Use 53 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Performing Shape Registration 6 Click Copy in the Ref1 viewport to copy a reference image from the registration series to the viewport. Figure 39 Acquiring reference images 7 Do one of the following to position the stand for the second registration series:
Select an angle from the list in the task panel. Position the stand manually. The difference in angle with the first registration series should be at least 30 degrees and no more than 150 degrees. Unsuitable or unobtainable angles are grayed in the list. 8 Acquire the second registration series using fluoroscopy. 9 Click Copy in the Ref2 viewport to copy a reference image from the registration series to the viewport. After both reference viewports are filled, the registration task automatically moves to the next step:
Place Points. The reference viewports are displayed side by side so that you can identify the AltaTrack devices. AltaTrack - US Release 1.0 Instructions for Use 54 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Performing Shape Registration Figure 40 Reference images displayed side by side for AltaTrack device identification The Place Point tool is automatically enabled in the task panel to allow you to place points on the devices. 10 Click on the tip of the AltaTrack Guidewire in the first reference image to identify it. NOTE If desired, rotate the wheel button on the mouse to zoom in while performing this step. NOTE If you are using an AltaTrack Catheter as a single device, click on the tip of the AltaTrack Catheter. The software identifies the AltaTrack device and automatically adds markers (white crosses) along the device. AltaTrack - US Release 1.0 Instructions for Use 55 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Performing Shape Registration Figure 41 Identifying the AltaTrack device in the first registration image 11 Verify that the markers are correctly positioned on the AltaTrack device. If the markers are not correctly positioned, click on the device at a more proximal position. The software updates the device identification markers according to the newly placed marker. 12 Click on the tip of the AltaTrack Guidewire in the second reference image to identify it. Figure 42 Identifying the AltaTrack device in the second registration image AltaTrack - US Release 1.0 Instructions for Use 56 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Performing Shape Registration 13 Verify that the device points in the second reference viewport are correctly positioned on the AltaTrack Guidewire device. 14 When all device points are correctly positioned, click Next Step in the task panel: Compute Registration. The AltaTrack equipment computes the registration of the shapes and displays them as overlays on the reference images. The shape overlays are faded in and out for a short duration to assist with viewing the results of shape registration. You can also activate this function manually by clicking Auto Fade in the task panel. Alternatively, click the Shape Opacity tool in the toolbar and adjust the opacity of the shapes manually by dragging upward or downward. Figure 43 Shape overlays on the reference images 15 Do the following to verify the accuracy of the shape registration:
a Examine the position of the shape overlay in each reference viewport and ensure that it follows the AltaTrack device in the X-ray image. b Examine the position of the tips of the AltaTrack shapes compared to the tips of the devices in the X-ray images and ensure the following:
Any difference in position is minimal (approximately 2mm (0.1 in)). Any difference in position is of a similar magnitude in each reference image, even if one tip is shorter and the other is longer. There is no warning displayed about the registration result. 16 If the position of the AltaTrack device shapes is satisfactory, click Accept in the task panel. After accepting the registration, the AltaTrack software automatically moves to the next task: Live Guidance. For more information, see Navigating with the AltaTrack Equipment (page 60). Alternatively, the following actions are available:
AltaTrack - US Release 1.0 Instructions for Use 57 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Performing Shape Registration a If the position of the tips of the AltaTrack shapes do not match the tips of the AltaTrack devices in the X-ray images, click Next Step in the task panel to display the Verify Device Tip functions. For more information, see Adjusting the AltaTrack Device Shape Tips (page 58). b If the results of the registration are not satisfactory, click Reject to discard the registration results and restart the Shape Registration task. NOTE While it is possible to adjust the registration of the AltaTrack device shapes manually using the Pan Shape and Rotate Shape tools in the toolbar, these complex actions are recommended for advanced users only. 4.4.1 Adjusting the AltaTrack Device Shape Tips This optional step is part of the Shape Registration task. Follow this procedure if the tips of the AltaTrack device shapes are not close to the position of the device tips in the X-ray images in the reference viewports. 1 Display the Verify Device Tip functions by clicking Next Step in the task panel of the Compute Registration step of the Shape Registration task. 2 In the task panel, select the AltaTrack device shape that you want to adjust using the color-coded options. 3 Use the left and right arrow buttons in the task panel to increase or decrease the shape tip length. Figure 44 Adjusting the AltaTrack device shape tips lengths NOTE It is not necessary to select a registration viewport; when you adjust the length of the tip, the adjustment is applied to both viewports simultaneously. The goal of this step is to adjust the tips of the AltaTrack device shapes for the following conditions:
AltaTrack - US Release 1.0 Instructions for Use 58 Philips 4322 070 31061 Preparing the AltaTrack Equipment for Use Performing Shape Registration Any difference in position is minimal (approximately 2mm (0.1 in)). Any difference in position is of a similar magnitude in each reference image, even if one tip is shorter and the other is longer. There is no warning displayed about the registration result. 4 If needed, select the other AltaTrack device shape option in the task panel and use the arrow buttons to adjust the tip shape. 5 If the position of the AltaTrack device shapes is satisfactory, click Accept in the task panel. After accepting the registration, the AltaTrack software automatically moves to the next task: Live Guidance. For more information, see Navigating with the AltaTrack Equipment (page 60). AltaTrack - US Release 1.0 Instructions for Use 59 Philips 4322 070 31061 Navigating with the AltaTrack Equipment 5 Navigating with the AltaTrack Equipment After registration, the Live Guidance task allows you to overlay the 3D volume, if used, and the device shapes on X-ray images in the main view to determine the position of interventional devices during the procedure. During live guidance, longitudinal and lateral table movements are supported, but tilt, cradle, pivot, and swivel movements are not supported. You can perform Live Guidance at the tableside using the touch screen module of the X-ray system. Live Guidance functions are also available using the AltaTrack software in the control room. Figure 45 Device navigation in the Live Guidance task NOTE Automatic replay of fluoroscopy series can be turned on or off in the Live Guidance task, according to your preferences. For details, see Setting User Preferences (page 78). Secondary views are also available, displaying a 3D roadmap with either an X-ray image and 3D volume or just a 3D volume. AltaTrack - US Release 1.0 Instructions for Use 60 Philips 4322 070 31061 Navigating with the AltaTrack Equipment Figure 46 Device navigation with 3D roadmap in the Live Guidance task Figure 47 Device navigation with 2D roadmap in the Live Guidance task The size of the AltaTrack device shape as displayed in the primary view is enhanced to improve visibility. The tip of the AltaTrack device shape is displayed in white to indicate the direction of the device. AltaTrack - US Release 1.0 Instructions for Use 61 Philips 4322 070 31061 Navigating with the AltaTrack Equipment If the AltaTrack equipment detects a degradation in the quality of theAltaTrack device shape, a warning message is displayed in the AltaTrack software window. Figure 48 Device shape warning in the Live Guidance task If the quality of AltaTrack device shape degrades for a short time, a dashed, blinking centerline is displayed over the AltaTrack device shape and a warning symbol is displayed at the tip of the shape. AltaTrack - US Release 1.0 Instructions for Use 62 Philips 4322 070 31061 Navigating with the AltaTrack Equipment Performing Live Guidance Figure 49 Degraded device shape in the Live Guidance task NOTE In this situation the AltaTrack software displays guidance on how to attempt to resolve the issue. WARNING The accuracy of the shape displayed may be compromised if there is a very tight bend at any point along the AltaTrack Catheter or AltaTrack Guidewire. WARNING The accuracy of the shape displayed cannot be fully guaranteed in all circumstances. Use frequent X-ray and tactile feedback from the device itself during the procedure to ensure that device registration and visualization is maintained. WARNING To avoid injury to the patient, do not pull strongly on the device while it is in use and avoid putting excessive strain on the torque-absorbing section. CAUTION If the patient moves during the procedure, or if the AltaTrack docking base is moved along the table rail, or if any movement causes any part of the AltaTrack equipment to collide with the stand, table, or personnel in the examination room, you must perform registration for all devices again. In any of the following situations, you should revert to using images from the X-ray system:
The CT volume (if applicable) does not follow the geometry APC is unavailable Live Guidance does not receive X-ray images 5.1 Performing Live Guidance The touch screen module of the X-ray system provides the following functions at the tableside during the Live Guidance task:
AltaTrack - US Release 1.0 Instructions for Use 63 Philips 4322 070 31061 Navigating with the AltaTrack Equipment Correcting Volume Registration Recalling planned angles Correcting volume registration Correcting shape registration Adjusting the visualization Storing series, snapshots, and movies If the touch screen module or the tableside mouse of the X-ray system is not functioning, you can continue this task using the AltaTrack software in the control room. 1 2 3 Check that the system is operational, the devices are connected, and shapes are acquired. Tap Layout repeatedly to cycle through the viewport options (Single View, Dual View 1, and Dual View 2) and select a layout. The examination room monitor displays live 3D FORS shapes of the connected devices overlaid on the preoperative CT volume (if applicable). Tap either Main View Control or Ref View Control to apply visualization controls in the selected viewport. 4 To align the volume with the X-ray image (if applicable), tap Main View Control, then tap Align Volume, and then tap the corresponding arrow buttons to make adjustments. 5 To align the shape with the X-ray image (if applicable), tap Main View Control, then tap Align Shape, and then tap the corresponding arrow buttons to make adjustments. 6 Acquire an X-ray image to start navigation. The examination room monitor displays live 3D FORS shapes of the connected devices overlaid on the preoperative CT volume (if applicable) and the X-ray image. 7 Navigate the device toward the target anatomy, manipulating the AltaTrack device as a regular angiographic device. Handle the AltaTrack devices carefully to avoid impacting the performance of the AltaTrack equipment. WARNING The length of an AltaTrack device is limited. Be aware of the torque-absorbing section of the device. Do not pull on this section as this may pull the device from the patient with strong force and cause an injury to the patient. 5.2 Correcting Volume Registration During the Live Guidance task, small corrections to the volume registration may be required to realign the volume, for example if the patient moves. 1 Click Correct Alignment in the toolbar of the main viewport to turn correction mode on. 2 Use a combination of the following actions to realign the volume with the anatomy:
Move the pointer over the volume and drag to change its position. Move the pointer outside the boundary of the volume and drag to rotate the volume in the viewing plane. 3 When the volume is realigned, click Correct Alignment again to turn correction mode off. NOTE You can also start correction mode using the Modify Alignment function on the touch screen module of the X-ray system. Then tap the Movement function to select Translate or Rotate In-plane. Use the arrow buttons to make corrections. AltaTrack - US Release 1.0 Instructions for Use 64 Philips 4322 070 31061 Navigating with the AltaTrack Equipment Changing an AltaTrack Device During a Procedure 5.3 Changing an AltaTrack Device During a Procedure The AltaTrack connection box provides two active connection slots and two standby slots. During a procedure, you can switch devices from an active connection slot to the standby slot, and from the standby slot to an active connection slot. You can switch between devices in the optical connections at any time without compromising the sterile field. Keep the AltaTrack connection box clean. Excessive blood may reduce the effectiveness of the docking action. Handle the AltaTrack devices carefully to avoid impacting the performance of the AltaTrack equipment. NOTE To assist you when swapping devices, AltaTrack devices are color-coded. If you store a device in the standby slot and then reconnect the device later, the registration information is retained, but you should verify the accuracy of the registration with X-ray. If you store a device in the standby slot, and then reconnect the device later to a different slot than the one from which it was removed you must verify the accuracy of the registration. The following procedure assumes that you are exchanging an active AltaTrack device with an AltaTrack device that is already parked in the standby slot and is already registered. 1 Remove all devices from the patient and wipe or flush them. WARNING Do not cut the device during or after removal. If you are using an AltaTrack Guidewire with an AltaTrack Catheter, and you intend to move the catheter to the standby slot on the AltaTrack connection box, you must remove both devices from the patient. Withdraw the guidewire from the catheter and secure the catheter away from the X-ray field of view. 2 3 Secure the device to the covers using a hook-and-loop fastener.
(Non-sterile user) Disconnect the device connector from the AltaTrack connection box and ensure that the optical connector is properly stored in a standby slot. WARNING Do not to use X-ray while a non-sterile user connects or disconnects a device at the connection box, as the connection box is close to the X-ray tube. Figure 50 Disconnecting a device connector from the AltaTrack connection box 4 (Non-sterile user) Connect the device connector of the new AltaTrack device to the AltaTrack connection box. AltaTrack - US Release 1.0 Instructions for Use 65 Philips 4322 070 31061 Navigating with the AltaTrack Equipment Changing an AltaTrack Device for a Conventional Device During a Procedure Figure 51 Connecting a new device to the AltaTrack connection box 5 Combine the two AltaTrack devices and introduce the devices into the patient. 6 Use X-ray to confirm that the registration is still accurate. 5.4 Changing an AltaTrack Device for a Conventional Device During a Procedure 1 Ensure that the AltaTrack device that you want to use for navigation is connected. 2 Disconnect all other devices and secure them away from the X-ray field of view. 3 Combine the AltaTrack device and the conventional device that you want to use. 4 Introduce the devices in-body. 5 Check the registration of the AltaTrack device shape to X-ray and re-register if necessary. NOTE You will need to use fluoroscopy more often during the procedure as the conventional device is only visible with X-ray imaging. 5.5 Navigating Without AltaTrack Devices At any point during a procedure, you can revert to navigation using two conventional devices. 1 Ensure that the AltaTrack devices are secured away from the X-ray field of view. 2 Continue navigation using conventional devices with fluoroscopy according to your standard practice. 5.6 Disposing of an AltaTrack Device You can detach and dispose of an AltaTrack device without compromising the sterile field, using the following standard hospital technique. 1 2 3
(Sterile user) Remove the AltaTrack device from the patient.
(Sterile user) Remove the AltaTrack device's docking fin from the AltaTrack Docking Top.
(Non-sterile user) Remove the device connector from the AltaTrack connection box. 4 (Sterile user) Pass the device to the non-sterile user. 5
(Non-sterile user) Disposes of the AltaTrack device in the appropriate bin. AltaTrack - US Release 1.0 Instructions for Use 66 Philips 4322 070 31061 Performing Post-Operative Steps 6 Performing Post-Operative Steps 1 Remove the AltaTrack devices from the patient. 2 Close the AltaTrack software. 3 Do any of the following to store patient data:
Archive DICOM snapshots to a PACS system using the Export activity on the Interventional Workspot. For information about using the Export activity, refer to the Instructions for Use supplied with the Interventional Workspot. Transfer snapshots and movies to a USB storage device using the movie export tool. For more information, see Movie Export tool (page 85). For information about cleaning the destination drive of the AltaTrack workstation, refer to the Instructions for Use supplied with the Interventional Workspot. 4 Remove the AltaTrack devices from the AltaTrack Docking Top. 5 Disconnect the device connectors from the AltaTrack connection box. 6 Dispose of the AltaTrack devices in the appropriate bin. 7 Tap Shut Down in the lower-right corner of the AltaTrack touch screen and then confirm your action to shut down the AltaTrack equipment. Figure 52 Shut Down button on the AltaTrack touch screen 8 Follow the guidance on the AltaTrack touch screen until you are instructed to press the Power Off switch on the rear side of the AltaTrack trolley. Figure 53 AltaTrack trolley power switch AltaTrack - US Release 1.0 Instructions for Use 67 Philips 4322 070 31061 Performing Post-Operative Steps 9 Remove the AltaTrack Docking Top from the AltaTrack docking base and dispose of it in the appropriate bin. Figure 54 Removing and disposing of the AltaTrack Docking Top WARNING The AltaTrack Docking Top is a single-use component and it should be properly disposed of after the procedure. Do not reuse the AltaTrack Docking Top for another procedure. 10 Remove the sterile cover. 11 Release the AltaTrack table clamp and remove the AltaTrack docking base from the table. Figure 55 Removing the AltaTrack docking base NOTE If the AltaTrack docking base is contaminated, it should be cleaned before it is stored. For information about cleaning, see Cleaning the AltaTrack Equipment (page 71). 12 Follow your local procedures for managing the patient. 13 Store the AltaTrack docking base and the AltaTrack equipment cable in the storage location on the AltaTrack trolley. AltaTrack - US Release 1.0 Instructions for Use 68 Philips 4322 070 31061 Performing Post-Operative Steps Figure 56 Storing the AltaTrack docking base 14 Disconnect the power cable and the network cable of the AltaTrack trolley from the wall sockets and store the cables on the hooks on the trolley. 15 Clean the AltaTrack trolley and wipe the power cable and the network cable, if needed. For information about cleaning, see Cleaning the AltaTrack Equipment (page 71). 16 Release the brakes of the AltaTrack trolley, move it to its park position, and reapply the brakes. AltaTrack - US Release 1.0 Instructions for Use 69 Philips 4322 070 31061 Maintenance 7 Maintenance Planned Maintenance Program To ensure that maintenance is performed at the required intervals, the responsible organization should issue a request to the maintenance organization for maintenance to be carried out in accordance with the Planned Maintenance Program described in this section. Planned maintenance may only be carried out by qualified and authorized personnel, and is comprehensively described in the service documentation. Philips Medical Systems provides a full planned maintenance and repair service on both a call basis and a contract basis. Full details are available from your Philips representative. A summary of the planned maintenance program appears in the table below. You should always take all practical steps to make sure that the Planned Maintenance Program is fully up to date before using the product with a patient. Philips Medical Systems will make available, on request, circuit diagrams, component part lists, descriptions, calibration instructions, or other information that will assist technical support personnel to repair those parts of the equipment that are designated by Philips Medical Systems as repairable by technical support personnel. For a complete list of consumables, contact technical support. Operators may perform cleaning tasks on the AltaTrack equipment. For more information, see Cleaning the AltaTrack Equipment (page 71). Planned Maintenance Checks Task Check labels Check thermal aspects Check electrical aspects Check cleanliness Check mechanical aspects and functions Update device database Perform 3D calibration Check electrical safety Frequency Every 6 months Every 2 months Every 2 months Every 2 months Every 2 months Every 2 months Every year Every 2 years Required personnel User Technician Technician Technician Technician Technician Technician Technician User Checks To maintain optimal operating performance, restart the AltaTrack equipment daily. Field Service The field service function provides the capability for Philips to perform service actions on the equipment. The field service function is provided by the Philips SupportConnect application installed on your equipment. Field service is designed to reduce equipment down time and improve equipment performance through proactive maintenance. Geometry Calibration If a system message indicates that geometry calibration of the X-ray system has not been performed, contact technical support. AltaTrack - US Release 1.0 Instructions for Use 70 Philips 4322 070 31061 Maintenance Cleaning the AltaTrack Equipment Malware Despite preventive measures already implemented, a remote possibility remains that the equipment may become infected with malware. When malware is detected, or if you notice that unfamiliar behavior or degraded performance occurs repeatedly, including after the equipment is switched off and on again, you should contact technical support. If an inspection confirms an infection by malware, be sure to take measures to contain and remove the source of infection. Technical support will reinstall the equipment's software to bring the equipment back into specification. Technical support can also assist in accessing the equipments event log, which may provide information useful for the investigation. Whitelist Protection Whitelist protection software is installed on this equipment. The whitelist identifies all trusted software that is allowed to execute on the equipment. The protection software prohibits the execution of untrusted software, thus effectively blocking malware before damage is done. Instead of relying on frequent updates, as for antivirus software, it offers proactive protection against a wide spectrum of malware and malware alterations. Since only known trusted software is allowed to run, no regular updates are required. Security Patches The systematic analysis on cyber security vulnerabilities includes an assessment on the applicability and need for applying security patches taking into account mitigating circumstances in the intended use and design of this equipment. Security patches alter the equipments design and thus require proper validation and approval by Philips Medical Systems. The latest information, including recommended customer actions, can be found at:
www.philips.com/productsecurity 7.1 Cleaning the AltaTrack Equipment All parts of the AltaTrack equipment including accessories may be cleaned by the hospital staff. Cleaning Guidance Clean the AltaTrack equipment after every intervention. Prevent cleaning fluid from dripping inside any enclosures. Clean the equipment by wiping it gently and without undue force with a mild soap solution. The AltaTrack Docking Top should not be cleaned, but should be disposed of immediately after use. For more information, see Performing Post-Operative Steps (page 67). Cleaning Agents The following cleaning agents are permitted for cleaning any part of the AltaTrack equipment:
Cleaning Agent Ethanol 70%
Isopropanol 100%
Application Cleaning and disinfecting small and large surfaces Cleaning and degreasing small surfaces The following cleaning agents are permitted for cleaning the AltaTrack equipment cable and the AltaTrack components attached to the table:
Cleaning Agent Ethanol 70%
Application Cleaning and disinfecting small and large surfaces AltaTrack - US Release 1.0 Instructions for Use 71 Philips 4322 070 31061 Maintenance Final Disposal of the AltaTrack Equipment Cleaning Agent Isopropanol 100%
0.5% Chlorehexidine in 70% Ethanol Haemo-sol, 1% in water Application Cleaning and degreasing small surfaces Cleaning, disinfecting, and degreasing small and large sur-
faces and instrumentation Removing blood, disinfecting small surfaces and instrumen-
tation 500 ppm Chlorine solution Cleaning, disinfecting, and degreasing large surfaces 7.2 Final Disposal of the AltaTrack Equipment Philips Medical Systems is concerned to help protect the natural environment, and to help ensure continued safe and effective use of this product, through proper support, maintenance, and training. Therefore Philips Medical Systems products are designed and manufactured to comply with relevant guidelines for environmental protection. As long as the product is properly operated and maintained, it presents no environmental risks. However, the product may contain materials that could be harmful to the environment if disposed of incorrectly. Use of such materials is essential to performing the functions of the product, and to meeting statutory and other requirements. This section of these Instructions for Use is directed mainly at the owner of the product. Philips Medical Systems supports users in the following actions:
Disposing of the product safely and effectively Recovering reusable parts Recycling of useful materials by competent disposal companies For advice and information, contact the manufacturer. Passing the System to Another User If this product passes to another user, it must be in its complete state, including all product support documentation. Make the new user aware of the support services that Philips Medical Systems provides for installing, commissioning, and maintaining the product. Before passing on the product or taking it out of service, all patient data must be deleted and unrecoverable on the product (backed up elsewhere, if necessary). It must be remembered by all existing users that passing on medical electrical products to new users may create serious technical, medical, and legal risks (concerning privacy, for example). Such risks can arise even if the product is given away. Existing users are strongly advised to seek advice from their local Philips Medical Systems representative before committing themselves to passing on any product. Alternatively, contact the manufacturer. Once the product has been passed on to a new user, a previous user may still receive important safety-
related information, such as bulletins and field change orders. In many jurisdictions, there is a clear duty on the previous user to communicate such safety-related information to new users. Previous users who are not able or prepared to do this should inform Philips Medical Systems about the new user, so that the new user can be provided with safety-related information. AltaTrack - US Release 1.0 Instructions for Use 72 Philips 4322 070 31061 Technical Information 8 Technical Information Environmental Conditions for Storage and Performance Item Temperature range Relative humidity Air pressure Classifications Item AltaTrack equipment Specification For performance: +18C to +26C For storage and transportation: -20C to +60C For performance: 20% to 80%
For storage and transportation (non-condensing): 10% to 90%
For performance: 88 kPa to 110 kPa For storage and transportation: 70 kPa to 110 kPa Classification According to the IEC60601-1 definition, the equipment is classified as class I equipment for continuous operation. Mains type Single phase AC AltaTrack Catheter (Berenstein) Applied part type B AltaTrack Catheter (Cobra 2) Applied part type B AltaTrack Guidewire Applied part type B Standards and Regulations Item Laser safety Complies with IEC60825-1:2007 Standard IEC 60825-1:2014 IEC 60825-1:2007 Safety of laser products - Part 1:
Equipment classification and require-
ments Safety of laser products - Part 1:
Equipment classification and require-
ments Working Conditions The AltaTrack equipment has the following working states:
Starting up Ready for reconstruction Reconstructing one or two shapes Shutting down Accessories The following items are compatible accessories to the AltaTrack equipment:
AltaTrack Docking Top Other Equipment The following items are compatible with the AltaTrack equipment:
AltaTrack Catheter (Berenstein) AltaTrack Catheter (Cobra 2) AltaTrack Guidewire AltaTrack - US Release 1.0 Instructions for Use 73 Philips 4322 070 31061 Technical Information Electromagnetic Compatibility AltaTrack Trolley Item Weight IP protection Voltage Peak power consumption Average power consumption Fuses Specification 220 kg IP20 120 V, 60 Hz (single phase) 1000 VA 700 VA T 12 A, 120 V, size 6.3 x 32 mm NOTE Fuses should only be replaced by an authorized Philips service engineer. AltaTrack Docking Base Item Weight IP protection AltaTrack Workstation Item Weight Voltage Peak power consumption Average power consumption Optical Processing Unit Specification 3 kg AltaTrack docking base: IP23 AltaTrack equipment cable: IP54 Specification 40 kg 100-240 V, 50-60 Hz 1000 W 1000 W Item Number of interrogators Number of lasers for each interrogator Specification 2 1 Laser type Wavelength range Output power Laser safety class External cavity tunable laser 1520-1600 nm 5 mW (on the accessible point on the AltaTrack docking base Class I according to IEC 60825:2007/IEC 60825:2014 Open-Source Software Open-source software is used in this product. Refer to the installation media for license information and source code. 8.1 Electromagnetic Compatibility You should only use the system in an electromagnetic environment similar to the environment described in this section. The system, has been tested and complies with IEC60601-1-2:2014 (edition 4: collateral standard -
electromagnetic disturbances) for medical electrical equipment. AltaTrack - US Release 1.0 Instructions for Use 74 Philips 4322 070 31061 Technical Information Electromagnetic Compatibility Intended Use Environment The system has been designed for the professional healthcare environment and do not require additional shielding against electromagnetic disturbances. If the responsible organization requires continued operation during power mains interruptions, it is recommended that the system is powered from a compatible uninterruptable power supply. Contact a Philips representative for details. 8.1.1 Emissions IEC60601-1-2 Edition 4 The system uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. Guidance and manufacturers declaration electromagnetic emissions: The system is intended for use in the electromagnetic environment specified below. The operator of the system or the responsible organization should ensure that it is used in such an environment. Emissions Test RF emissions Test Standard Compliance CISPR 11 Group 1 Class A Harmonic emissions IEC 61000-3-2 Voltage fluctuations/flicker emissions IEC 61000-3-3 Not applicable, the system is not intended to be connected to the public mains network Not applicable, the system is not intended to be connected to the public mains network 8.1.2 Immunity Description of Immunity Test Electrostatic discharge (ESD) Test Standard IEC 61000-4-2 Radiated RF electromagnetic fields IEC 61000-4-3 Proximity fields IEC 61000-4-3 Electrical fast transients and bursts IEC 61000-4-4 Surges Conducted disturbances, induced by RF fields IEC 61000-4-5 IEC 61000-4-6 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power frequency magnetic fields IEC 61000-4-8 Compliance 8 kV contact 2, 4, 8, 15 kV air See note 3 80-2700 MHz 80% AM 1 kHz 3 V/m Frequencies and levels determined by EMC risk management. Refer to the table below. See notes 2 and 3 1 kV (signal ports), see note 2 2 kV (AC power ports) 0.5, 1 kV (line-line) 0.5, 1, 2 kV (line/PE) 0.15 80 MHz 80% AM 1 kHz 3 Vrms, see note 2 6 Vrms ISM freq. (refer to the table below) Voltage dips:
0% UT 0, 45,.. ,315 - 10 ms 0% UT 0 - 20 ms 70% UT 0 - 500 ms 0% UT 0 - 5000 ms 50 Hz 30 A/m Note 1: UT is the AC mains voltage prior to application of the voltage dip or short interruption test. AltaTrack - US Release 1.0 Instructions for Use 75 Philips 4322 070 31061 Technical Information Electromagnetic Compatibility Description of Immunity Test Test Standard Compliance Note 2: A loss of LAN communication may be detected for the following cases: conducted disturbance between 750 kHz and 50 MHz on the LAN port, Electrical Fast Transients of 1 kV on the LAN port, or conducted disturbance between 1.2 and 1.5 MHz on the mains port. Basic safety and essential performance are not affected by this loss of communication. Note 3: A system error may be detected for contact discharges on the tablet screen or cover around the tablet in excess of
+2 kV or -8 kV or air discharges in excess of +4 kV or -15 kV. Follow the instructions on the tablet screen to resolve the issue. In case the error cannot be resolved, please call service. Basic safety and essential performance are not affected by these system errors. 8.1.3 ISM Frequency The following table of reasonable foreseeable ISM frequencies for conducted disturbance testing has been determined via EMC risk management. ISM frequency table 0.15 MHz-80 MHz conducted disturbances induced by RF fields testing:
Frequency band [MHz]
Test frequencies [MHz]
6.765-6.795 13.553-13.567 26.957-27.283 40.66-40.70 6.765, 6.795 13.56 26.957, 26.03, 27.283 40.66, 40.70 Modulation 80% AM, 1 kHz 80% AM, 1 kHz 80% AM, 1 kHz 80% AM, 1 kHz Compliance (see note) 6 V 6 V 6 V 6 V Note: A loss of LAN communication may be detected for the following cases: conducted disturbance between 750 kHz and 50 MHz on the LAN port, Electrical Fast Transients of 1 kV on the LAN port, or conducted disturbance between 1.2 and 1.5 MHz on the mains port. Basic safety and essential performance are not affected by this loss of communication. The following table of reasonable foreseeable ISM frequencies for proximity field testing has been determined. Test Frequency
(MHz) Band (MHz) Modulation Maximum Power (W)
(V/m) Immunity Test Level 385 450 710 745 790 810 870 930 1,720 1,845 1,970 2,450 5,240 5,500 5,785 380-390 430-470 704-787 Pulse modulation 18 Hz FM 5 kHz deviation 1 kHz sine Pulse modulation 217 Hz 800-960 Pulse modulation 18 Hz 1,700-1,990 2,400-2,570 5,100-5,800 Pulse modulation 217 Hz Pulse modulation 217 Hz Pulse modulation 217 Hz 1.8 2 0.2 2 2 2 0.2 27 28 9 28 28 28 9 AltaTrack - US Release 1.0 Instructions for Use 76 Philips 4322 070 31061 Technical Information Electromagnetic Compatibility 8.1.4 RFID RFID communication frequency between the equipment and AltaTrack devices. Item Frequency of reception Frequency of transmission Specification 13.56 MHz 13.56 MHz 500 kHz Bandwidth of the receiving section 3.1 MHz Type and frequency characteristics of the modulation Effective radiated power Modulation acc. To ISO15693 (10% to 30% ASK or 100% ASK Manchester coding 26 kbit/sec) 100 mW AltaTrack - US Release 1.0 Instructions for Use 77 Philips 4322 070 31061 Appendix Main Display Area 9 Appendix This section provides background information and reference information for the AltaTrack equipment. 9.1 Main Display Area The main display area is divided into smaller viewing areas called viewports. The layout of viewports changes according to the task being performed to provide the optimum layout for each task. Each viewport contains a toolbar for manipulating the image and an orientation indicator to indicate the orientation of the image in the viewport. Figure 57 Orientation indicator 9.2 Setting User Preferences You can configure your preferences for the viewing environment using the User Preferences dialog box. 1 Click User Preferences in the common tools panel. 2 Configure the settings in the User Preferences dialog box. Settings Orientation indicator Patient info level Angle flavor Options On Off None Essential All Radiology Cardiology Automatically replay Fluo-
ro in Live Guidance On Off 3 Click Close to close the User Preferences dialog box and save your settings. 9.3 Viewing Tools Viewing tools are available on a toolbar in each viewport to allow you to manipulate the image in the viewport. NOTE Slab views are linked. Actions performed in one view are also performed in the other slab views. NOTE The volume view is not linked to the slab views. AltaTrack - US Release 1.0 Instructions for Use 78 Philips 4322 070 31061 Appendix Viewing Tools 9.3.1 Zooming You can enlarge or reduce the image displayed in the viewport by zooming in or out of the image. 1 Click Zoom on the toolbar and do the following:
To zoom in, drag upward. To zoom out, drag downward. NOTE The orientation indicator, patient information, and annotations are not zoomed. 2 3 To reset the image to the default zoom level, double-click in the viewport. To access the Zoom tool while another tool is selected, use the following mouse shortcut:
Rotate the mouse wheel forward to zoom in. Rotate the mouse wheel backward to zoom out. This mouse shortcut is only available when a volume view is displayed. 9.3.2 Panning Panning the image allows the area of interest to be positioned in the center of the viewport. 1 Click Pan on the toolbar. 2 Pan the image by dragging it. The image pans in the direction of movement. 3 To reset the image to the default position, double-click in the viewport. 4 To access the Pan tool while another tool is selected, drag with the right mouse button. 9.3.3 Rotating The volume can be rotated to provide better visibility of the vessels of interest and to achieve the desired viewing or rotation angle. 1 Click Rotate on the toolbar. 2 3 To roll the volume freely in any direction around the center of rotation, move the pointer over the volume and drag in direction that you want to roll it. To rotate the volume in the viewing plane, move the pointer outside the boundary of the volume and drag in the direction that you want to rotate it. The volume rotates in the viewing plane around the center of rotation. When you roll or rotate the volume, the rotation indicator is displayed at the center of rotation. It indicates the volume axes and direction of rotation. 4 To move the center of rotation, drag it to the desired position. 5 To reset the image to the default orientation, double-click in the viewport. AltaTrack - US Release 1.0 Instructions for Use 79 Philips 4322 070 31061 Appendix Viewing Tools 9.3.4 Spatial Navigation You can navigate through the slices of a volume in a direction perpendicular to the view. In the volume view, the Cutplane function is used. In the slab views, the Scroll function is used. Cutplane (Volume) 1 Select Cutplane on the toolbar. A box is displayed showing your viewing position in the volume. The slice that you are currently viewing is highlighted. Figure 58 Cutplane indication box 2 Click and drag the pointer upward to move through the slices towards the rear of the volume. The indicator moves towards the rear of the box, indicating your new viewing position. Slices that you have navigated past are no longer visible. 3 Click and drag the pointer downward to move through the slices towards the front of the volume. The indicator moves towards the front of the box, indicating your new viewing position. Slices that you previously navigated past are now visible again. 4 To reset the view to the default position, click Click here to reset. The viewing position is set to the front of the volume, showing all slices. Scroll (slab) 1 Select Scroll on the toolbar. 2 Click and drag the pointer upward to move through the slices towards the rear of the slab. AltaTrack - US Release 1.0 Instructions for Use 80 Philips 4322 070 31061 Appendix Viewing Tools Slices that you have navigated past are no longer visible. 3 Drag the pointer downward to move through the slices towards the front of the slab. Slices that you previously navigated past are now visible again. 4 To reset the view to the default position, double-click in the slab view. The viewing position is set to the front of the volume, showing all slices. 5 To access the Scroll tool while another tool is selected, use the following mouse shortcut:
Rotate the mouse wheel forward to move through the slices towards the rear of the slab. Rotate the mouse wheel backward to move through the slices towards the front of the slab. This mouse shortcut is only available when a slab view is displayed. 9.3.5 Adjusting the Contrast and Brightness of the X-ray Image During the procedure, you can adjust the contrast and brightness of the X-ray image in the Live Guidance task if necessary. 1 Click Contrast and Brightness on the toolbar and do the following:
Drag the pointer upward to decrease the brightness level. Drag the pointer downward to increase the brightness level. Drag the pointer to the right to decrease the contrast level. Drag the pointer to the left to increase the contrast level. 2 To access the Contrast and Brightness tool while another tool is selected, use the following mouse shortcut:
Drag the middle mouse button upward to increase the window level. Drag the middle mouse button downward to decrease the window level. Drag the middle mouse button left to decrease the window width. Drag the middle mouse button right to increase the window width. This mouse shortcut is only available in the 2D views of the Segmentation and Planning tasks. 9.3.6 Adjusting Window Width and Window Level Settings To provide optimum visualization of anatomy and vessels of interest, you can adjust the window width and window level (WW/WL) settings using the windowing function. The windowing function adjusts what anatomy is visible in the volume based on the differing densities of anatomical objects. 1 Click Windowing on the toolbar and do the following:
Drag the pointer upward to increase the window level. Drag the pointer downward to decrease the window level. Drag the pointer to the left to decrease the window width. Drag the pointer to the right to increase the window width. Windowing settings are displayed in the histogram, which provides a graphical representation of grey value distribution. AltaTrack - US Release 1.0 Instructions for Use 81 Philips 4322 070 31061 Appendix Viewing Tools Figure 59 Histogram 2 To access the Windowing tool while another tool is selected, use the following mouse shortcut:
Drag the middle mouse button upward to increase the window level. Drag the middle mouse button downward to decrease the window level. Drag the middle mouse button left to decrease the window width. Drag the middle mouse button right to increase the window width. 9.3.7 Adjusting the Opacity of the Volume Adjusting the opacity of the CT volume (if applicable) allows you to view the AltaTrack device shapes or anatomical objects in the vicinity of the volume more easily. 1 Click Volume Opacity on the toolbar and do the following:
Drag the pointer upward to decrease the opacity of the volume. Drag the pointer downward to increase the opacity of the volume. 9.3.8 Panning the AltaTrack Device Shapes Panning the AltaTrack device shapes allows you to adjust the registration of the shapes manually. NOTE While it is possible to adjust the registration of the AltaTrack device shapes manually using the Pan Shape and Rotate Shape tools in the toolbar, these complex actions are recommended for advanced users only. 1 Click Pan Shape on the toolbar. 2 Pan the AltaTrack device shape by dragging it. The AltaTrack device shape pans in the direction of movement. AltaTrack - US Release 1.0 Instructions for Use 82 Philips 4322 070 31061 Appendix Common Tools Panel 9.3.9 Adjusting the Opacity of the AltaTrack Device Shapes Adjusting the opacity of the AltaTrack device shapes allows you to view anatomical objects in the vicinity of the shapes more easily. 1 Click Shape Opacity on the toolbar and do the following:
Drag the pointer upward to decrease the opacity of the device shapes. Drag the pointer downward to increase the opacity of the device shapes. 9.3.10 Selecting a Preset Orientation You can select a preset orientation for viewing the volume. 1 2 To select a preset orientation, click the orientation button in the toolbar of the viewport to be changed. Select the desired orientation in the drop-down list. Preset Orientations Coronal (anterior-posterior, this is the de-
fault orientation) Saggital (lateral left) Saggital (lateral right) Axial (caudo cranial) 9.3.11 Enlarging a View You can enlarge a slab view and display it in the volume viewport. 1 Click Enlarge view in the slab view toolbar. The image from the slab view is shown in the main volume viewport. 2 Click Enlarge view again to return to the previous viewing configuration. 9.4 Common Tools Panel The common tools panel is available in all tasks, but not all tools in the panel are available in each task. Common Tools Merge with X-ray Modality Patient This tool is only available in the Volume Registration task and the Live Guidance task. User Preferences AltaTrack - US Release 1.0 Instructions for Use 83 Philips 4322 070 31061 Appendix Snapshots and Movies Common Tools Export to USB Snapshot DICOM Snapshot Movie 9.5 Snapshots and Movies The following sections provide information about making snapshots and movies while using the AltaTrack software, and how to export them to a USB storage device. 9.5.1 Making a Snapshot You can make the following kinds of snapshot in all tasks:
A standard snapshot in JPEG format that can be exported and viewed on a standard computer. A DICOM snapshot in Secondary Capture (SC) format that can be sent to a PACS. 1 To make a standard snapshot, do one of the following:
a In the AltaTrack software window, click Snapshot in the common tools panel. b On the touch screen module of the X-ray system, tap Movie/Snapshot and then tap Fullscreen Snapshot. A snapshot of the whole display is created. You can export the snapshot to a USB device using the Movie Export tool. NOTE When you make a snapshot, the patient information overlay is automatically hidden. NOTE If you make a snapshot using the Snagit capture tool, the snapshot may contain personal information about the patient, which is not de-identified. The snapshot may be accessible by other operators after export. It is your responsibility to ensure that patient privacy is not compromised at the export destination. 2 To create a DICOM snapshot, do one of the following:, click DICOM Snapshot in the common tools panel. a In the AltaTrack software window, click DICOM Snapshot in the common tools panel. b On the touch screen module of the X-ray system, tap Movie/Snapshot and then tap DICOM Snapshot. A snapshot of the current viewports is created. You can export the DICOM snapshot using the Export activity. NOTE Personal data that appears in the DICOM snapshot cannot be de-identified. Set the patient information overlay to none before creating the snapshot. You must ensure that snapshots do not contain information that may identify a patient before exporting them. The DICOM snapshot may be accessible by other operators after export. It is your responsibility to ensure that patient privacy is not compromised at the export destination. AltaTrack - US Release 1.0 Instructions for Use 84 Philips 4322 070 31061 Appendix Storing and Reviewing Series 9.5.2 Making a Movie The Movie function is available in all tasks. NOTE When you record a movie using the movie function, the patient information overlay is automatically hidden. 1 To record a movie, do one of the following:
a In the AltaTrack software window, click Movie in the common tools panel. b On the touch screen module of the X-ray system, tap Movie/Snapshot and then tap Movie. The recording function starts and captures the whole display. The recording time is indicated in the common tools panel. Recording stops after 30 minutes or when you manually stop recording. Closing the application also stops any recording that is in progress. 2 To stop recording, click or tap Movie again. The Movie function is unavailable for a short time while the movie is stored. You can export the movie to a USB device using the Movie Export tool. The movie is exported in MP4 format. For details, see Movie Export tool (page 85). 9.5.3 Movie Export tool You can use the Movie Export tool to export snapshots and movies to a USB device. 1 Click Export to USB in the general toolbar. 2 Click the USB Memory Stick arrow and select the drive letter of a connected USB device. Snapshots and movies are exported to the root directory of the USB device. Subfolders cannot be used. 3 Select the capture on the left side that you want to export. 4 Click Export to export them to the USB device. 5 To delete captures, select the capture you want to delete, and then click Delete. You can delete captures from the system (left side) or from the USB device (right side). 6 To refresh the view, click Refresh. 7 To close the Movie Export tool, click Close. 9.6 Storing and Reviewing Series You can store series that you acquired during an intervention and review them later to assist with reporting tasks. 1 To store a series using the touch screen module of the X-ray system, do the following:
AltaTrack - US Release 1.0 Instructions for Use 85 Philips 4322 070 31061 Appendix Storing and Reviewing Series a Tap Advanced. b Tap Store 2D Runs and then tap Store Run. c Tap Back to close the Advanced screen. 2 To store a series using the AltaTrack software window, click Store Fluoroscopy Image on the toolbar of the main viewport. The current series is saved to the database and the button is unavailable until a new series is acquired. 3 To review a previously stored series, do the following:
a Click Load Run on the toolbar of the main viewport. A dialog box displays available series. b Select the series to be loaded and click OK. c Review the series using the reviewing toolbar at the bottom of the viewport. AltaTrack - US Release 1.0 Instructions for Use 86 Philips 4322 070 31061 Index Changing a device 65, 66 Disposing of devices 66, 67 A Accessories 73 AltaTrack connection box 21, 50, 67 AltaTrack devices 24, 49, 6567 AltaTrack docking base 20, 21, 29, 68, 74 AltaTrack Docking Top 21, 24, 30, 50, 67, 68 AltaTrack equipment cable 21 AltaTrack network cable 28, 69 AltaTrack power cable 28, 69 AltaTrack software 22, 23, 3241, 4447, 49, 52, 58, Disposing of the AltaTrack Docking Top 68 60, 63, 64, 78, 83 AltaTrack table clamp 21 AltaTrack touch screen 19, 30, 31, 67 AltaTrack trolley 18, 26, 67, 69, 74 AltaTrack workstation 22, 74 Angle flavor (user preferences) 78 Applied parts 16 Switching off 67 Switching on 28 C Changing an AltaTrack device during a procedure 65, 66 Classifications 73 Cleaning 68, 69, 71 Common tools panel 83 Compatibility 8 Contacting the manufacturer 9 Contrast and brightness 81 Correcting registration during Live Guidance 64 Cutplane 80 Supported data sets 8 D Data sets (supported data sets) 8 DICOM snapshots 84 Display layout 22 Disposal 6668, 72 AltaTrack devices 66, 67 AltaTrack Docking Top 68 FCC part 15.19 13 E Electrical safety 10 Electromagnetic compatibility (EMC) 13, 7477 Emergency procedures 10 Environmental requirements 73 Error messages 16 Explosion safety 12 Exporting snapshots and movies 85 F FCC part 15.19 13 Fire safety 12 H Hazardous substances 15 I Intended use of the product 7 Anatomical landmarks 37 Ring landmarks 37 L Landmarks Laser safety 12 Live Guidance task 23, 60, 6366 Loading a 3D rotational series 46 Contacting 9 M Maintenance 7072 Manufacturer Mechanical safety 11 Merging patient data 39 Movie Export tool 85 Movies 84, 85 O Opacity 49, 82, 83 Adjusting the opacity of the device shapes 83 Adjusting the opacity of the volume 82 Orientation indicator (user preferences) 78 Other equipment used with the system 73 Overlays (supported data sets) 8 Panning the device shape 82 P Panning 79, 82 Patient information (user preferences) 78 Planned angles 38 Planning task 23, 3638 Post-operative steps 67 Preset orientation 83 R Radiation safety 10 Recording a movie 85 Registration Regulations and standards 73 Removing anatomy 34 Correcting registration during Live Guidance 64 AltaTrack - US Release 1.0 Instructions for Use 87 Philips 4322 070 31061 Pan Device 82 Panning 79 Preset orientation 83 Removing the table 34 Rotating 79 Scroll 80 Shape Opacity 83 Volume Opacity 82 Window width/window level 81 Zooming 79 Viewports Volume Registration task 23, 3941, 4447, 49 Volumes (supported volumes) 8, 9 Planning 36 Segmentation 34 W Warning messages 16 Window width/window level 81 Workflow 23, 32, 33 X X-ray contrast and brightness 81 Z Zooming 79 Index Replay of fluoro in Live Guidance (user preferences) 78 Reviewing 2D series 49 Reviewing series 85, 86 Rotating 79 S Safety 1016, 7477 Applied parts 16 Electrical grounding 11 Electrical safety 10 Electromagnetic compatibility (EMC) 13, 7477 Emergency procedures 10 Error and warning messages 16 Explosion safety 12 Fire safety 12 Labels 14 Laser safety 12 Mechanical safety 11 Radiation safety 10 Symbols used with the product 14 Toxic or hazardous substances 15 Scroll 80 Segmentation task 23, 3335 Segmenting vessels 35 Shape Registration task 23, 52, 58 Snapshots 84 Spatial navigation 80 Standards and regulations 73 Sterile covers 9 Storing series 85, 86 Storing viewing angles 38 Symbols used with the product 14 System label 14 Cutplane 80 Scroll 80 T Tasks 23, 3341, 4447, 49, 52, 58, 60, 6366 Toxic substances 15 Training 9 Live Guidance 23, 60, 6366 Planning 23, 3638 Segmentation 23, 3335 Shape Registration 23, 52, 58 Volume Registration 23, 3941, 4447, 49 U User preferences 78 V Viewing angles 38 Viewing tools 78, 82, 83 Contrast and brightness 81 Cut anatomy 34 Cutplane 80 Opacity 49 AltaTrack - US Release 1.0 Instructions for Use 88 Philips 4322 070 31061 2019 Koninklijke Philips N.V. All rights are reserved. Reproduction in whole or in part in any form or by any means, electrical, mechanical or otherwise is prohibited without the written consent of the copyright holder. www.philips.com/healthcare healthcare@philips.com Printed in The Netherlands 4322 070 31061 * 2019-01 The device meets the requirements of the 93/42/EEC Medical Device Directive, 2014/53/EU Radio Equipment Directive, and Directive 2011/65/EU Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment. Manufacturer's address Philips Medical Systems Nederland B.V. Veenpluis 4-6 5684 PC Best The Netherlands
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2019-02-08 | JAB - Part 15 Class B Digital Device | Original Equipment | |
2 | 13.56 ~ 13.56 | DXX - Part 15 Low Power Communication Device Transmitter |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 2 | Effective |
2019-02-08
|
||||
1 2 | Applicant's complete, legal business name |
Philips Medical Systems Nederland B.V.
|
||||
1 2 | FCC Registration Number (FRN) |
0027812734
|
||||
1 2 | Physical Address |
gert.de.vries@philips.com
|
||||
1 2 |
Best, N/A 5684 PC
|
|||||
1 2 |
Netherlands
|
|||||
app s | TCB Information | |||||
1 2 | TCB Application Email Address |
c******@telefication.com
|
||||
1 2 | TCB Scope |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
|
||||
app s | FCC ID | |||||
1 2 | Grantee Code |
2AQ4B
|
||||
1 2 | Equipment Product Code |
432207025350
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 | Name |
G****** d****
|
||||
1 2 | Title |
Senior regulatory affairs manager
|
||||
1 2 | Telephone Number |
00316********
|
||||
1 2 | Fax Number |
+31 4********
|
||||
1 2 |
g******@philips.com
|
|||||
app s | Technical Contact | |||||
1 2 | Firm Name |
Philips Medical Systems Nederland B.V.
|
||||
1 2 | Name |
G**** d********
|
||||
1 2 | Physical Address |
Veenpluis 4-6, Best
|
||||
1 2 |
Netherlands
|
|||||
1 2 | Telephone Number |
31601********
|
||||
1 2 |
G******@philips.com
|
|||||
app s | Non Technical Contact | |||||
1 2 | Firm Name |
Philips Medical Systems Nederland B.V.
|
||||
1 2 | Name |
G****** d******
|
||||
1 2 | Physical Address |
Veenpluis 4-6, Best
|
||||
1 2 |
Netherlands
|
|||||
1 2 | Telephone Number |
31601********
|
||||
1 2 |
G******@philips.com
|
|||||
app s | Confidentiality (long or short term) | |||||
1 2 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 04/01/2019 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 2 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 | Equipment Class | JAB - Part 15 Class B Digital Device | ||||
1 2 | DXX - Part 15 Low Power Communication Device Transmitter | |||||
1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | AltaTrack - Table Side Launch Base | ||||
1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 | Modular Equipment Type | Does not apply | ||||
1 2 | Purpose / Application is for | Original Equipment | ||||
1 2 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | Yes | ||||
1 2 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 2 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 2 | Firm Name |
Telefication B.V.
|
||||
1 2 | Name |
W******** J****
|
||||
1 2 | Telephone Number |
00318********
|
||||
1 2 | Fax Number |
31-31********
|
||||
1 2 |
w******@telefication.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15B | CC | ||||||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15C | CC | 13.56000000 | 13.56000000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC