UroNav Version 4.5

Electrical and Mechanical safety warnings

WARNING Do not remove UroNav covers or cables from this product. Hazardous electrical voltages are present within this product's enclosure. Removing covers or cables could lead to serious or fatal personal injury. Covers or cables should only be removed by qualified and authorized service personnel. In this context, qualified means those legally permitted to work on this type of medical electrical product in the jurisdiction(s) in which the product is being used, and authorized means those authorized by the user of the product. WARNING Use this product in rooms or areas that comply with all applicable law (or regulations having the force of law) concerning electrical safety for this type of product. To avoid the risk of electric shock, this equipment must only be connected to a Supply Mains with protective earth. Grounding reliability can only be achieved when the equipment is connected to a hospital-grade receptacle. Use only power cords meeting the specifications provided in this Instructions for Use. See “Mains power cordset requirements” on page 34 for more information. WARNING Electrically isolate this product from the mains electrical supply before cleaning and disinfecting. WARNING Medical equipment needs to be installed and put into service according to the special electromagnetic compatibility (EMC) guidelines. See “Electromagnetic Compatibility” on page 36 for more information. WARNING Always properly turn off and unplug the system before cleaning, disinfecting, connecting, or disconnecting parts or performing maintenance. Do not use UroNav if any of the hardware components or connectors are damaged. Such damage may affect system functions and possibly cause personal injury.

Fire safety warnings

WARNING Use only Philips-approved cables, instrumentation, and accessories for the UroNav as detailed in this Instructions for Use. Electrical safety may be compromised otherwise. See “Approved Cables for Electromagnetic Compliance” on page 45 for more information. WARNING The UroNav has been tested for compliance to protect against electric shock with the monitor and UroNav medical grade power cords connected independently into AC Mains wall sockets. Additional Multiple Socket-Outlets (power strips) enabling one AC Mains plug connection or extension cords shall not be connected to the UroNav. Although the system has been manufactured in compliance with existing EMI/EMC requirements, the use of the UroNav in the vicinity of an electromagnetic field or large metal objects can affect the accuracy of the system. WARNING External equipment intended for connection to signal inputs, signal outputs, or other connectors shall comply with the relevant product standard, such as: IEC 60950-1 or IEC 62368-1 for IT equipment and the IEC 60601-series for Medical Electrical Equipment. In addition, all such combinations – Medical Electrical Systems – shall comply with the safety requirements stated in the general standard IEC 60601-1. Any equipment not complying with the leakage current requirements in IEC 60601-1 will be kept outside the patient environment (at least 1.5 m from the patient support, for example) or will be supplied via a separation transformer to reduce the leakage currents. Any person who connects external equipment to signal inputs, signal outputs, or other connectors has formed a Medical Electrical System and is therefore responsible for the system to comply with the requirements. If in doubt, contact a qualified medical technician or your local representative.

Fire safety warnings

Use of electrical product in an environment for which it was not designed can lead to fire or explosion. WARNING UroNav is not suitable for use in the presence of a flammable anesthetic mixture with AIR or with OXYGEN or NITROUS OXIDE. An explosion can result.

Biological safety warnings

Fire regulations for the type of medical area being used should be fully applied, observed, and enforced. Fire extinguishers should be available for both electrical and non-electrical fires. WARNING Only use extinguishers on electrical or chemical fires, which are specifically labeled for those purposes. Using water or other liquids on an electrical fire can lead to fatal or other serious personal injury. If it is safe to do so, attempt to isolate the product from electrical and other supplies before attempting to fight a fire. This will reduce the risk of electric shocks.

Biological safety warnings

When using UroNav, please observe the following warnings related to biological safety: If the system becomes contaminated internally with bodily fluids carrying pathogens, you must immediately notify your Philips service representative. Components inside the system cannot be disinfected. In that case, the system must be disposed of as biohazardous material in accordance with local or federal laws. WARNING Patients with Creutzfeldt-Jakob disease (CJD), VCJD, or other known or suspected slow virus infections are contraindicated for this device. WARNING UroNav utilizes both single-use disposable and reusable tools. Follow manufacturer cleaning and disinfection procedures to ensure biological safety for both patients and operators. For more information, see “Cleaning and disinfecting UroNav” on page 47. WARNING The EM Tracker is shipped non-sterile by the manufacturer. The EM tracker must be disinfected prior to every procedure. See “Cleaning and disinfecting the EM Trackers” on page 51 for more information.

Environmental warnings and conditions

WARNING The EM Tracker Probe Holder is shipped non-sterile by the manufacturer. Prior to use, the UroNav EM Tracker Probe Holder must be cleaned per the procedure in this Instructions for Use: See “Cleaning the disposable EM Tracker Probe Holder before use” on page 49 for more information. CAUTION The EM Tracker Probe Holder has been designed, tested, and manufactured for single use. Reuse or reprocessing has not been tested and could lead to device failure and patient injury. Do not reuse, reprocess, or sterilize this device. After use, dispose of the Probe Holder per hospital medical waste and environmental policies and procedures. WARNING The Stepper is shipped non-sterile by the manufacturer. Prior to use, the Stepper must be disinfected per the procedure in this Instructions for Use: See “Cleaning and disinfecting the Stepper” on page 54. See also “Cleaning and disinfecting the Stepper Arm and Stepper Stand” on page 70.

Environmental warnings and conditions

The parts of the UroNav which are suitable for use within the patient environment include the EM Sensor, Field Generator, Field Generator Articulating Arm, Stepper and Stepper Arm. Review the environment in which the system is used to identify possible sources of radiated emissions and interference. Such emissions could be from other electrical devices used in the same room or an adjacent room. Communication devices such as cellular phones and pagers can cause these emissions. The existence of radio, TV, or microwave transmission equipment located nearby can cause emissions. In cases where EMI is causing disturbances, it may be necessary to relocate the UroNav. WARNING The use of portable and mobile radio-frequency (RF) communications equipment can affect the operation of medical equipment. See “Electromagnetic Compatibility” on page 36 for more information. Use of the UroNav in the vicinity of other equipment or large metal objects may affect UroNav or other equipment. If inaccuracies are detected, try the following: • Increase the separation between the conflicting devices • Reorient the device cabling

Normal operating environment

The normal operating environment for UroNav, EM Tracker and the Transperineal Stepper, Stepper Stand, and Stepper Arm is: Ambient temperature range of +10°C to +30°C Relative humidity range of 30% to 70%, non-condensing Atmospheric pressure range of 70 kPa – 106 kPa

Protective packaging markings

The following markings are displayed on the shipping carton packaging to indicate special protective handling measures required for transport. Symbol descriptions are provided in “Use of symbols in labeling” on page 167. Fig. 1: Packaging labels for UroNav cart and transperineal hardware

Expected service life and disposal of waste products

Philips 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 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 material(s) that could be harmful to the environment if disposed of incorrectly. Use of such material(s) is essential to performing the functions of the product and to meeting statutory and other requirements. Philips supports users in: • Recovering reusable parts • Recycling of useful materials by competent disposal companies • Safe and effective disposal of product For advice and information, contact your Philips Service Organization. See “Help and guidance information” on page 8 for more details. The following list provides the expected service life and disposal requirements for UroNav and its components: • UroNav: Expected service life of 5 years; composed of electromechanical assemblies; dispose of at dedicated electronic equipment disposal facilities (E-Waste) NOTICE In this product, perchlorate material is present in a coin cell battery. Special handling may apply. See the following website: https://dtsc.ca.gov/hazardouswaste/perchlorate • UroNav cart: Expected service life of 5 years; composed of electro-mechanical assemblies; dispose of at dedicated electronic equipment disposal facilities (E-Waste) • Field Generator and Foot Pedal: Expected service life of 5 years; composed of electromechanical assemblies; dispose of at dedicated electronic equipment disposal facilities (E-Waste) • Stepper, Stepper Arm, Stepper Stand, Articulated Field Generator Mounting Arm: Expected service life of 5 years; composed of mechanical assemblies; dispose of per accepted biohazardous waste disposal methods • EM Tracker Probe Holder: Single-use, disposable device; clean prior to initial use; dispose of per accepted biohazardous waste disposal methods

• EM Tracker Cable Assembly: Re-usable device, 100x’s; disinfect prior to initial use, and clean and disinfect between each subsequent use; dispose of per accepted biohazardous waste disposal methods after 100 uses

NOTICE The entity accountable for the use and maintenance of the UroNav will be advised that the assembly of the UroNav and modifications during the actual service life require evaluation to the requirements of IEC 60601-1. NOTICE UroNav software counts the number of uses based on connections to UroNav computer; however, it is the end user’s sole responsibility to track the usage count. The EM Tracker can be cleaned and disinfected for 100 re-uses. It is the end user’s sole responsibility to track the usage count. Accurate and effective results cannot be guaranteed by Philips for the use of the UroNav EM Tracker beyond 100 re-use cycles.

Electromagnetic and interference guidance

The UroNav is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. You can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the UroNav as recommended in the following table, according to the maximum output power of the communications equipment. IEC 60601-1-2, – Recommended Separation Distances between portable and mobile RF communications equipment and UroNav ME equipment and ME systems that are not lifesupporting Separation distance according to frequency of transmitter (m) Rated Maximum Output Power of Transmitter (Watts) 150 kHz to 80 MHz d=(1.2)(Sqrt P) 80 MHz to 800 MHz d=(1.2/E1)(Sqrt P) 800 MHz to 2.5 GHz d=(2.3)(Sqrt P) 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 NOTICE These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. NOTICE For transmitters rated at a maximum output power not listed in the table, the recommended separation distance in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTICE At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Additional precautions must be taken to ensure that the electromagnetic tracking system is accurate and is not affected by cable handling and other issues.

Electromagnetic Interference

WARNING Always place the UroNav cart more than 1m (3.3ft) from the field generator. If placed closer, the measurement volume may be affected, contributing to inaccurate measurements and possible personal injury. WARNING It is important to place the system in a location that is known to be free of electromagnetic interference. Tracking in an untested environment or a location known to cause electromagnetic interference can contribute to inaccurate information and possible personal injury. WARNING The use of accessories and cables other than those specified, with the exception of accessories and cables qualified and sold by Philips, may result in increased emissions or decreased immunity of the equipment and may cause the system to be non-compliant with the requirements of EN/IEC60601-1-2. WARNING UroNav is intended for use by healthcare professionals only. This equipment/system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as reorienting or relocating the equipment or shielding the location.

Avoiding Electromagnetic Interference

The RF Emissions CISPR 11 Class A limits are designed to provide reasonable protection against harmful interference in a typical medical installation. The equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference with other devices, which can be determined by turning the equipment off and on, try to correct the interference by one or more of the following measures: • Reorient or relocate the receiving device. • Increase the separation between the equipment. • Connect the equipment into an outlet on a circuit different from that to which the other device is connected. • Consult the manufacturer or field service technician for assistance.

Recommended Separation Distance

The UroNav is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. You can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the UroNav as recommended in the following table, according to the maximum output power of the communications equipment. The following table provides recommended separation distances, which are guidelines on the distances that any RF transmitting equipment should be kept away from UroNav to reduce the risk of interference with the system. NOTICE This table indicates separation distances recommended for optimal EM Tracking performance. Another table provided in “Radio-Frequency Interference” on page 41 provides separation distance guidelines according to frequency of transmitter, but may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. These separation distances will help ensure maximum RF and EM immunity of the EM Tracking function. Rated Maximum Output Power of Transmitter (Watts) Separation Distance, D(m) 150 kHz to 80 MHz D=(3.5/V1)(Sqrt P) (for V1 = 0.30Vrms) 80 MHz to 800 MHz D=(3.5/E1)(Sqrt P) (for E1 = 0.06Vrms) 800 MHz to 2.5 GHz D=(7/E1)(Sqrt P) (for E1 = 0.06Vrms) 0.01 1.16m (45.7in) 6.0m (19.7ft) 11.5m (37.7ft) 0.1 3.67m (12.0ft) 18.97m (62.2ft) 36.37m (119.3ft) 1 11.6m (38.1ft) 60.0m (196.9ft) 115.0m (377.3ft) 10 36.68m (120.3ft) 189.0m (620.1ft) 363.66m (1193.1ft) 100 116.0m (380.6 ft) 600.0m (1968.5ft) 1150.0m (3773.0ft) Portable and mobile RF communications equipment should be used no closer to any part of the system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range as noted in the table. Interference may occur in the vicinity of equipment marked with the symbol shown in left margin.

Approved Cables for Electromagnetic Compliance

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast, cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the system is used exceeds the applicable RF compliance level in the table, the system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the system. NOTICE For transmitters rated at a maximum output power not listed in the table, the recommended separation distance in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTICE At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

Approved Cables for Electromagnetic Compliance

Cables connected to the system may affect its emissions. Use only the cable types and lengths listed here: Description Part # HDMI, 10ft, Shielded 4553-000-78711 (Quest HDI-1410) HDMI-DVI, 3m, Shielded 4553-000-79121 (L-com HD-DVI-MM-3) HDMI-Displayport, 10ft, Shielded 4553-000-81841 (C2G 54327) AC Mains Power Cord Reference the technical specifications and regulatory compliance information in “Mains power cordset requirements” on page 34 WARNING Using cables, instruments, and accessories other than those specified for use with the system may result in increased emissions from, or decreased immunity of, the system.

Use Restrictions Due to Interference

Use Restrictions Due to Interference The physician needs to determine if tracking is accurate. Tracking in an untested environment or a location known to cause electromagnetic interference can contribute to inaccurate information.

CAUTION

All components of the system are to be manually cleaned only, following the procedures provided in the following sections of the IFU. All automatic cleaning techniques, including using an autoclave, gamma radiation or gas, steam or heat sterilization, will result in severe damage. CAUTION Do not immerse any part of the field generator, computer, tool connection unit, articulated arm or connector-end of cables in a liquid or allow fluid to enter the equipment in any way to prevent equipment damage. WARNING More specific warnings and cautions are included within the care and cleaning procedures of this guide and on the labels of the cleaners or disinfectants. Do not immerse any part of the field generator, computer, tool connection unit or connectorend of cables in a liquid or allow fluid to enter the equipment in any way to prevent a fire or shock hazard or contribute to possible personal injury.

Removing blood and infectious materials

If you believe contamination of the UroNav might occur during an exam, Philips recommends that you take universal precautions and cover the system with a disposable drape. Consult your facility’s rules regarding equipment use in the presence of infectious disease. CAUTION Position the disposable drape so that it does not block the vents on the UroNav computer/ display or the peripherals. Should the UroNav become contaminated, it will be necessary to remove any blood or other infectious materials from the system: 1. Power the UroNav off. For more information, see “UroNav Power On/Off sequences” on page 93. 2. Disconnect the power cord from the AC power mains. 3. Use a gauze pad moistened with soap and water to remove blood on the system, connectors, and cables. To prevent corrosion, dry the equipment with a soft, dry or mildly damp, lint-free cloth after cleaning.

Cleaning the disposable EM Tracker Probe Holder before use

The EM Tracker Probe Holder is shipped non-sterile by the manufacturer and must be cleaned prior to initial use. The EM Tracker Probe Holder is for single use only and must be disposed of after use per accepted biohazardous waste disposal methods. Please use the following steps to clean the EM Tracker Probe Holder before use: Prepare a neutral enzymatic detergent, such as ENZOL ® Enzymatic Detergent, by following the manufacturer’s instructions. 2. Wet a lint-free cloth with the prepared detergent. Wipe all EM Tracker Probe Holder surfaces with the wet cloth for a minimum of 1 minute or until all surfaces are visibly clean. 3. Remove the detergent residue by wiping all surfaces at least 1 time with non-linting wipe(s) wet with tap water. 4. To remove detergent residue from hard-to-reach surfaces, use cotton swabs with small, tapered tips, such as Puritan part number 826-WC, or a soft bristled brush, such as Healthmark 200399, wetted with tap water to wipe/ brush until visibly clean. 5. Allow the EM Tracker Probe Holder to air dry or wipe dry with a lint-free cloth. 6. Inspect the device to ensure all surfaces are clean. If not clean, repeat the cleaning steps.

CAUTION

The EM Tracker Probe Holder has been designed, tested, and manufactured for single use. Reuse or reprocessing has not been tested and could lead to device failure and patient injury. Do not reuse, reprocess, or sterilize this device. After use, dispose of the Probe Holder per hospital medical waste and environmental policies and procedures.

Cleaning and disinfecting the EM Trackers

The EM Tracker is shipped non-sterile by the manufacturer. The UroNav EM Tracker must be disinfected prior to initial use. Prior to re-use, the EM Trackers must be first disassembled from the Stepper, cleaned, and then disinfected. Observe the following warnings and cautions during the cleaning and disinfection process. See also the general precautions given in “Cleaning and disinfecting UroNav” on page 47. WARNING The EM sensor must be cleaned and disinfected before each use. Cleaning the EM sensor is an essential step before effective disinfection. Be sure to follow the manufacturer’s instructions when using disinfectants. CAUTION Do not use alcohol or any alcohol-based chemicals to clean the EM Sensor. CAUTION Attempting to clean or disinfect the EM sensor by using a method other than the procedures herein can damage the device and voids the warranty. Upon receiving the new EM Tracker, you will need to disinfect it before performing the first study. Also, be sure to clean and disinfect the EM Tracker immediately after each use to protect patients and personnel from a variety of pathogens.

The following limitations apply to reprocessing:

• Throughout the cleaning and disinfection processes, protect the connector to keep liquid out of the connector's electrical contacts. • Handwash only per the procedures in this section of the Instructions for Use. • Do not allow sharp objects, such as scalpels or cauterizing knives, to come in contact with the EM sensor, cable, or connector. • Do not use a wire brush for cleaning. Prepare for decontamination by disassembling the EM Tracker sensor housing from the EM Tracker Probe Holder. Disassembly is described in more detail in the appendices of this IFU. For more information, see “Removal of the grid, EM sensor, and probe” on page 261 as well as subsections under “Transrectal workflow probe holder mounting instructions” on page 175 and “Transperineal workflow probe holder mounting instructions” on page 222.

To manually clean the EM Tracker:

1. Clean with a neutral or near-neutral pH detergent that contains enzymes, such as ENZOL ® Enzymatic Detergent (Johnson & Johnson) or Enzyclean II LS (Micro Scientific). Follow the manufacturer’s instructions and recommendations for concentration, temperature, and contact time of the detergent. 2. With the prepared detergent solution, wet a lint-free cloth. Squeeze out excess liquid so that the cloth is damp, but not dripping. 3. Use the damp cloth to wipe the entire surface of the EM sensor housing. Wipe the EM sensor housing for the minimum contact time given by manufacturer of the detergent until all visible soil is removed. 4. Rewet the cloth with detergent water and thoroughly wipe the entire cable and connector for a minimum contact time given by manufacturer of the detergent until all visible soil is removed. 5. Wet a new clean, soft, lint-free cloth with potable water. Squeeze out excess liquid so that the cloth is damp, but not dripping. 6. Use the damp cloth to thoroughly wipe the entire surface of the EM sensor housing for to remove cleaning residue. 7. Re-wet the cloth with potable water and thoroughly wipe the entire cable and connector to remove cleaning residue. 8. After removing all cleaning residue, thoroughly dry the EM sensor housing, cable, and connector with a clean, dry, lint-free. 9. Visually inspect the EM sensor, cable, and connector in a well-lit area to confirm the absence of any soil. 10. If you see any soil, repeat the previous steps using fresh cloths until you see no soil. 11. When you see no soil and the device is completely dry, the EM sensor, cable, and connector are ready for disinfection.

CAUTION

The EM Tracker can be cleaned and disinfected for 100 re-uses. It is the end user’s sole responsibility to track the usage count. Accurate and effective results cannot be guaranteed by Philips for the use of the UroNav EM Tracker beyond 100 re-use cycles.

Intermediate level disinfection of the EM sensor uses a wipe method with an intermediate level disinfectant. Before performing the disinfection, please read all warnings and cautions provided earlier in this section of the Instructions for Use.

To disinfect the EM Tracker: 1. Ensure the EM sensor, cable and connector have been manually cleaned according to previous instructions in this section. 2. Wipe all EM sensor, cable, and connector surfaces with disinfectant wipes, such as, Sani- Cloth ® AF3 wipes (PDI). Be sure to wipe all surfaces for the minimum contact time given by manufacturer of the disinfectant. 3. Allow the EM sensor, cable, and connector to air dry or dry the parts with a sterile cloth.

Cleaning and disinfecting the Stepper

The Stepper is shipped non-sterile by the manufacturer. Clean and disinfect the Stepper prior to initial use and immediately after each use to protect patients and personnel from a variety of pathogens. Cleaning and disinfecting the Stepper involves: • Following all warnings and cautions in “Precautions for cleaning the Stepper” on page 54 during the cleaning and disinfecting processes. • Using the proper cleaning supplies from the provided list of “Recommended equipment and supplies” on page 54 • “Initial cleaning of the Stepper” on page 55 • “Disassemble the Stepper” on page 56 • “Detailed cleaning of the Stepper” on page 58 • “Intermediate level disinfection of the Stepper” on page 66 • “Reassemble the Stepper” on page 67 • “Final inspection” on page 69

Precautions for cleaning the Stepper

Observe the following warnings and cautions during the cleaning and disinfection process. See also the general precautions given in “Cleaning and disinfecting UroNav” on page 47. WARNING The Stepper must be cleaned and disinfected before each use. Cleaning the Stepper is an essential step before effective disinfection. Be sure to follow the manufacturer’s instructions when using disinfectants. CAUTION Do not break down the Stepper assembly more than specified in the provided procedure: “Disassemble the Stepper” on page 56.

Recommended equipment and supplies

The following is a list of equipment and/or supplies needed for the proper cleaning and disinfection of the Stepper. • Soft bristle brush • ¾-inch cylindrical soft-bristle brush • 1.25-inch cylindrical soft-bristle brush • Compatible neutral or near-neutral pH detergent such as ENZOL ® Enzymatic Detergent from Johnson and Johnson or Enzyclean II LS from Micro Scientific • Compatible intermediate level disinfectant such as Sani-Cloth ® Prime Wipes and Sani-Prime ™ spray from PDI • Dry, lint-free cloths • Compressed air system

Initial cleaning of the Stepper

As soon as possible after a patient procedure, remove the ultrasound transmission gel, blood and other contaminates from the Stepper. 1. Place the Stepper under running potable water allowing the flowing water to remove debris. 2. Using a soft cloth moistened with potable water, wipe away any remaining debris. 3. Using a soft-bristle brush, remove debris from all crevices.

Disassemble the Stepper

After removal of all visible debris during initial cleaning, disassemble the Stepper for more detailed cleaning and disinfection. 1. Slide the front end out of the rack-and-pinon assembly. There are retaining grooves on the end of both sliding tubes, which catch on a spring and ball mechanism and help prevent accidental removal of the front end. However, with a little additional force, the front end can be removed from the rack-and-pinon assembly. 2. Locate and disengage the white release pin, as indicated by the blue highlight in the picture. To disengage, pull down on the release pin and rotate it 90 degrees. This prevents the release pin from springing back into place. 3. After the release pin is disengaged, slide the handle away from the rack-and-pinion assembly.

4.

Remove the EM tracker probe holder from the rack-and-pinion assembly by sliding the probe holder assembly out of the rack-and-pinion assembly.

The four pieces of the fully disassembled Stepper are shown in the following image:

Rack-and-pinion assembly Handle with release pin Front-end assembly EM tracker probe holder

Detailed cleaning of the Stepper

Each of the individual components must be cleaned as described in the following procedures: • “Clean the rack-and-pinion assembly” • “Clean the front-end assembly” • “Clean the probe holder assembly” • “Clean the handle” Clean with a neutral or near neutral pH detergent that contains enzymes, such as ENZOL ® Enzymatic Detergent (Johnson & Johnson) or Enzyclean II LS (Micro Scientific). Follow the manufacturer’s instructions and recommendations for concentration, temperature, and contact time of the detergent

Clean the rack-and-pinion assembly

1. Using the carriage knob, move the carriage so that it is fully extended, as shown in the following image. 2. Immerse assembly in detergent water. 3. Thoroughly clean all surfaces with a soft-bristle brush, paying particular attention to gear teeth. NOTICE There are two areas that need special attention during cleaning. These areas are discussed in the following two steps. The tube holes on the rack-and-pinion assembly must be clear and free of any debris or residual build up. While immersed in detergent water, use a ¾-inch cylindrical soft-bristle brush to clean these tubes.

For proper tracking, the probe holder on the rack-and-pinion assembly must be clear and free of any debris or residual build up. While immersed in detergent water, use a 1.25-inch cylindrical soft-brittle brush to clean the probe holder area.

6. Immerse assembly in clean water (no detergent), so that all surfaces are exposed to the rinse water. Follow detergent manufacturer’s recommendations for the duration of the rinse time. 7. Finish rinsing under running water, so that all surfaces are exposed to the running rinse water. 8. Exterior surfaces may be dried using a soft lint free cloth. However, the rack-and-pinion assembly must be hung so that gravity will drain the tubes and the interior of the tubes can air dry.

Clean the front-end assembly

1. Remove the front-end assembly thumb screws by turning the left side counter clockwise and right side clockwise. NOTICE The left side thumb screw is marked with II and the right side thumb screw is marked with I, which match markings on corresponding parts of the front-end assembly. 2. Use a soft-bristle brush and detergent water to clean the thumb screws, rinse with clean water as recommended by the detergent manufacturer, and set aside. 3. Immerse the front end assembly in detergent water and thoroughly clean all surfaces with a soft cloth and soft-bristle brush. 4. While still immersed in the detergent water, use the soft-bristle brush to clean all debris and residual build up from the grid-plate slots (see boxed area in the adjacent image). 5. Use a soft-bristle brush to clean the left and right side threaded thumb screw holes.

Clean the front-end assembly

With the front end assembly still immersed in the detergent water, use a soft-bristle brush to clean inside both tubes. Also, rotate each of the two control levers vigorously multiple times to loosen any potentially trapped debris, as illustrated in the following image sequence: 6. While still immersed in detergent water, clean the indicated areas (blue rectangles) around the bolt heads and lever joint crevices with a soft-bristle brush. During this cleaning, rotate the control levers (blue highlight) to ensure that all crevice areas are properly cleaned. 7. While still immersed in detergent water, thoroughly clean indicated areas with a soft cloth and soft-bristle brush. CAUTION Areas, indicated blue in images of this procedure, must be clean and free of all debris to ensure proper tracking of the grid plate. 8. Remove the front end assembly from the detergent water and observe the color of the liquid: ⇨ Dripping from the tubes while holding the plastic side up ⇨ Dripping from the lever joint crevices while holding the assembly tube side up or to the side. NOTICE Compressed air may be blown through the open ends of the tubes while observing the color of the dripping liquid. 10. If the dripping liquid’s color does not match the detergent water’s color, immerse the front end assembly in the detergent water and repeat the process of rotating the levers with cleaning as described in the steps above. Follow detergent manufacturer’s recommendations for the duration of the rinse time. 11. Immerse assembly in clean rinse water (no detergent). While submerged, rotate the frontend control levers. Ensure that all surfaces are exposed to the rinse water. Follow detergent manufacturer’s recommendations for the duration of the rinse time. 12. Finish rinsing under running water. While under the running water, rotate the front-end control levers. Ensure that all surfaces are exposed to the running rinse water. 13. Exterior surfaces may be dried using a soft lint-free cloth. However, the front end assembly must be hung so that gravity will drain the tubes and the interior of the tubes can air dry.

Clean the probe holder assembly

1. Immerse the probe holder assembly in detergent water. 2. Thoroughly clean all surfaces with a soft cloth and soft-bristle brush. 3. Open the probe clamp, indicated as blue area in the following image, and check for debris. CAUTION The interior areas of the probe clamp must be free of debris to ensure proper tracking. The EM sensor holder, which is located on the probe holder (and highlighted in the following image), must be cleaned and free of debris to ensure proper tracking of the probe. Immerse assembly in detergent water and thoroughly clean indicated areas with a soft cloth and soft-bristle brush. 4. Immerse assembly in clean water (no detergent), so that all surfaces are exposed to the rinse water. Follow detergent manufacturer’s recommendations for the duration of the rinse time. 5. Finish rinsing under running water, so that all surfaces are exposed to the running rinse water. 6. Exterior surfaces may be dried using a soft lint free cloth. However, the probe holder assembly must be hung so that gravity will drain the tubes and the interior of the tubes can air dry.

Clean the handle

1. Immerse the handle in detergent water. 2. Thoroughly clean all surfaces with a soft cloth and soft-bristle brush. 3. Use a 1.25-inch cylindrical soft-brittle brush to clean the interior of the handle. 4. Immerse assembly in clean water (no detergent), so that all surfaces are exposed to the rinse water. Follow detergent manufacturer’s recommendations for the duration of the rinse time. 5. Finish rinsing under running water, so that all surfaces are exposed to the running rinse water. 6. The handle may be dried using a soft lint free cloth or may be air dried.

Intermediate level disinfection of the Stepper

Before performing this procedure, read the warnings and cautions in “Precautions for cleaning the Stepper” on page 54. See also the general precautions given in “Cleaning and disinfecting UroNav” on page 47. Intermediate level disinfection of the Stepper uses the spray and wiping method with an intermediate level disinfectant. After all Stepper subassemblies are clean and dry per the detailed cleaning steps described above, follow the manufacturer’s instructions and recommendations for use of the wipes and spray. NOTICE Ensure that the thumb screws removed during the Stepper front-end assembly cleaning are included. 1. For surfaces inaccessible with the wipes, spray with a disinfectant spray such as Sani- Prime ™ spray (PDI). 2. Wipe all Stepper part surfaces with disinfectant wipes such as Sani-Cloth ® Prime wipes (PDI). 3. Make adjustments to the carriage position and the grid-plate holder so that all surfaces have been wiped or sprayed. 4. Do not let the Stepper parts remain wet longer than the minimum time needed for intermediate level of disinfection. 5. After the minimum contact time of the disinfectant expires, dry using a soft lint free cloth. Allow the surfaces inaccessible to the drying cloth to air dry.

Reassemble the Stepper

After intermediate disinfection, collect all the pieces of the Stepper and reassemble in accordance with the following steps: 1. Reinstall the probe holder assembly by sliding it into the appropriate hole on the rack-andpinion assembly. 2. Reattach the handle, by sliding it back on to the rack-and-pinion assembly. 3. After the handle is installed, ensure the release pin is back into its fully engaged position. 4. First, identify the left side and right side thumb screws: the left side thumb screw is marked with II and the right side thumb screw is marked with I.

Reinstall the front-end assembly thumb screws

Then, properly align the screws and reinstall the front-end assembly thumb screws by turning the left side thumb screw clockwise and the right side thumb screw counterclockwise. Ensure the markings on the thumb screws match those on the front-end assembly. Failure to do so may damage the threads in this assembly. Reinsert the front-end assembly into the rack-and-pinion assembly. There is a spring and ball mechanism that will catch as the front end is first installed. With a little additional force, the front-end assembly can be pushed back into the rack-and-pinon assembly.

Final inspection

After the Stepper is fully assembled, a visual inspection should be done to ensure no damage has occurred. The inspection should include, but not be limited to, examination for cracks or other defects. A functional test should be performed by completing the following steps: 1. Inspect the handle and probe holder. They should rotate freely. There should be no sticking or jamming during the rotation. 2. Inspect the front-end assembly. It should slide freely in and out of the rack-and-pinion assembly. There should be no sticking or jamming over the full range of movement. After the full range of motion is checked, slide the front-end assembly into its fully engaged position. 3. Using the carriage knobs, move the carriage to its full back position and then to its full forward position. Move the carriage to a mid-range position. The carriage should move with clicking detents as the carriage knobs are turned. Yet, the carriage should move without undue force or jamming. 4. Ensure that the grid-plate holder adjustments are also operating without sticking or jamming. These provided instructions have been validated by the manufacturer of the medical device as being capable of preparing a medical device for re-use. It remains the responsibility of the processor to ensure that the reprocessing as actually performed (by using equipment, materials, and personnel in the reprocessing facility) achieves the desired result. This normally requires validation and routine monitoring of the process.

Cleaning and disinfecting the Stepper Arm and Stepper Stand

Cleaning and disinfecting the Stepper Arm and Stepper Stand Clean and disinfect the Stepper Arm and Stepper Stand before first use and immediately after each use to protect patients and personnel from a variety of pathogens. Follow the instructions provided below to prepare the Stepper Arm and Stepper Stand for use: 1. The central handle of the articulated arm must be tightened for cleaning and disinfection, as shown in the following image: 2. Clean all parts of the Stepper Arm and Stepper Stand with neutral or near neutral pH detergent, such as ENZOL ® Enzymatic Detergent (Johnson & Johnson) or Enzyclean II LS (Micro Scientific). Follow the manufacturer’s instructions and recommendations for concentration, temperature, and contact time of the detergent. 3. With the prepared detergent solution, wet a lint-free cloth. Squeeze out excess liquid. 4. Use the damp cloth to wipe off all parts. Be sure to wipe off each part for the minimum contact time given by manufacturer of the detergent until all visible soil is removed. 5. After all Stepper Arm and Stepper Stand parts are clean, wet a clean lint-free cloth with potable water and thoroughly wipe off all of the parts again to remove cleaning residue. 6. After removing all cleaning residue, thoroughly dry the Stepper Arm and Stepper Stand parts with a clean, dry, lint-free cloth. 7. Visually inspect the Stepper Arm and Stepper Stand in a well-lit area to confirm the absence of any soil or cleaning residue. 8. If you see any soil or cleaning residue, repeat the previous steps using fresh cloths until you see no soil or cleaning residue. 9. After everything is dry, wipe all of the surfaces with an intermediate level disinfection wipe; such as, Super Sani-Cloth ® , Sani-Cloth Prime ® , or Sani-Cloth ® AF3 wipes—all from PDI. Be sure to wipe all surfaces for the minimum contact time given by manufacturer of the disinfectant. 10. Before reuse, ensure the Stepper Arm and Stepper Stand are completely dry; otherwise, wipe dry with a lint-free cloth.

Cleaning the System Air Filter

As part of routine maintenance on your UroNav, the system air filters should be inspected weekly and cleaned as needed. If you decide to clean the air filter with soap and water, you may want to install a spare filter while the other filter is drying. To order additional air filters, contact your local Philips representative. Before performing any system maintenance or cleaning, always turn off the system and disconnect it from the AC Mains power source. CAUTION Only install fully dry air filters to prevent damage to the system. Do not turn on the power before the filters are installed. To inspect and clean the system air filters: 1. Remove both air filter covers on the UroNav housing. 2. Pull the air filters out. 3. Inspect the filters. Depending on the condition of the air filter, vacuum or rinse the filter with water to clean it. If the filter is worn out or cannot be cleaned, replace it with a spare. 4. Reinstall the filters and filter covers into place.

Technical description

The UroNav is comprised of a mobile cart with the mounted UroNav computer (CPC) and monitor as depicted in the following image: The UroNav cart includes a keyboard tray and horizontal work surface for mouse operation. A USB interface HID 3-pedal foot switch — shown below — can be used to duplicate specific onscreen mouse functions for operator convenience. The 3-pedal foot switch is tethered to the UroNav with a 3m USB cable, plugged into either of the front or rear panel USB ports on the UroNav. The front USB port is marked in the following image: This allows the operator the freedom to position the foot pedal conveniently within reach, and allows hands-free operation for the SWEEP, FREEZE, and SCREEN CAPTURE functions. In the current configuration of this system, an EM sensor, the complete sensor and cable assembly referred to as the EM Tracker, is attached to the handle of a transrectal ultrasound (TRUS) probe by insertion into a TRUS adapter clip (“probe holder”). Alternatively, the EM sensor can be attached to the Stepper— shown below — for a transperineal procedure. The EM sensor, probe holder, and TRUS probe are all covered by a sterile transducer cover supplied by a third party. The EM tracker is a reusable device with a requirement for intermediate-level disinfection, and the probe holder is a single-use disposable device with a requirement for cleaning prior to use. The following image shows the stepper table rail mount: The EM sensor is used in conjunction with the field generator for probe position sensing during the ultrasound sweep. The EM sensors detect probe position by their orientation in the EM field created by the field generator. The following image shows the field generator attached to the articulating arm: EM sensor and field generator signals are processed to determine and display an image of the relative position of the probe. The UroNav software application provides the operator interface and data display functions for the prostate workflows. The prostrate workflows fuse a trans-rectal ultrasound (TRUS) with pre-procedure magnetic resonance (MR) images. This consists of motion compensation, deflection compensation as well as semi-automatic image-based registration to facilitate accurate navigation within the prostate gland. UroNav accepts HDMI ultrasound image video formats and connections. There are no user-serviceable parts inside the device. All service is performed by the manufacturer.

The Media Settings tab

Video recording of the workflow is captured in Full-Screen mode, which is configurable from the System Configuration dialog's Media Settings tab: 1 2 1 Resolution 2 Auto record mode Options for Auto record mode include: • On - Select to enable automatic video recording mode. • Skip Setup screen - Select the checkbox to skip the recording of "Set-up Instructions for Tracking" screen. • Pause video automatically if system idle time exceeds (seconds) - Lists system idle time options to automatically pause video recording. Multiple recordings can be saved per workflow. • Off - Select to enable manual video recording mode. NOTICE The system will prompt the user for an automatic restart to save the selected setting.

The Language tab

In the System Configuration dialog, the Language tab may be used to set the language of the user interface.

The License tab

In the System Configuration dialog, the License tab displays a list of features and expiration dates for the current system license.

The Service tab

In the System Configuration dialog, the Service tab displays the Service Equipment ID for the system. This information is used by Service users only. Additionally, the contact information for the manufacturer may also be viewed.

When connected to a configured local network, to start a remote support session:

1. Call Philips Customer Service. 2. When directed, click System Setup to open the System Configuration dialog. 3. Click the Service tab. 4. Select Start Support Session. From the Service tab, UroNav also enables the backup of both patient and configuration data for the purpose of both migration and future restoration. The Backup operation is considered a disaster recovery plan and carried out by a Philips service representative. Backed-up patient data can only be restored by a Philips service representative.

To access the backup feature:

► Click System Setup to open the System Configuration dialog. ► Click the Service tab. ► Select Start Backup to open Backup Settings.

A backup location, either USB or network, must be provided before the backup can be executed —click the Refresh icon (shown in previous image) to display newly connected devices—after which, the contents are stored at the root of the selected drive. The created folder is provided with a unique name based on the date and time of the operation. After the backup operation completes successfully, the USB will be automatically disconnected from UroNav.

A backup location, either USB or network, must be provided before the backup can be executed —click the Refresh icon (shown in previous image) to display newly connected devices—after which, the contents are stored at the root of the selected drive. The created folder is provided with a unique name based on the date and time of the operation. After the backup operation completes successfully, the USB will be automatically disconnected from UroNav.

Ultrasound video calibration

When using video connection to capture ultrasound images, the incoming images need to be calibrated to facilitate accurate size measurements and ensuring the availability of imaging planes and depths required for the different workflows. Ultrasound video calibration is an important service feature to ensure that all required imaging planes are calibrated and that the UroNav plane detection mechanism is functional. Properly calibrated imaging depths will ensure that UroNav handles size computations correctly whenever the computations are based on the ultrasound images. This concerns aspects like ROI volumes, line measurements, and displays of scales. A sub-optimal video calibration can be caused by a misalignment between the actual and expected video image due to individual differences between ultrasound systems (or through user error such as non-aligned depths). Ultrasound system settings must be properly configured by a Philips support team member before Video Calibration. It is the responsibility of the user to ensure that the proper ultrasound settings are utilized for UroNav. For more information, see “Required ultrasound system settings for transrectal workflows” on page 193 and “Required ultrasound system settings for transperineal workflows” on page 231. Any change to the pre-calibrated ultrasound system, such as a software upgrade, will require UroNav video calibration to be repeated. When connecting a new ultrasound system or probe combination to the UroNav system that has not been calibrated, the notice Video Calibration Required will appear on the UroNav Setup screen. Any change to the ultrasound system and probe combination will require UroNav video calibration to be repeated.

CAUTION

Although video calibration should be carried out by a trained Philips support team, it is the responsibility of the operator to ensure that the (pre-calibrated) video calibration is correct for the specific ultrasound system in use. This can lead to a misinterpretation of the scale of the incoming image, leading to inaccurate volume calculations and overall misrepresentations of the patient’s anatomy. This may result in potential misalignment of biopsy core overlays or (user-indicated) needle path overlays. Contact Philips customer support for assistance.

NOTICE

Multiple “different” US devices can be supported, with the software saving separate calibrations for each device. However, multiple “like” devices (such as two Philips Epiq Ultrasound units) cannot have separate calibrations saved. Therefore, customers must be sure to use the video-calibrated US system with their UroNav. Customers may want to add a label to that specific Ultrasound.

UroNav Home screen

The UroNav Home screen enables you to import data, configure settings, view patient history, and start a workflow. In order to start a workflow, patient studies should be available. Patient studies can either be imported from an external data source, or a new patient study can be created. Worklist: Shows a list of scheduled patients. Using left-mouse button, drag and drop a patient from the All Patients list to the Worklist to start the workflow. Available workflows: Shows all available workflows for the patient. Export Status: Flashes when patient data is exported. All patients list: Shows all imported patients. “Import” on page 103: Enables the import of patient studies. “New Patient” on page 105: Creates a new patient record for an ultrasound only workflow. “System Setup” on page 78: Enables the editing of system configuration settings. See also “Annotation Editor” on page 107 for more information. Shut down: Exits UroNav and powers down the system. See “Automatic screen blank and time synchronization” on page 16 for more information. “Completed workflows” on page 105: Displays history of workflows for selected patient.

device configuration that was already saved to UroNav, its parameters shall be updated. The saved device configurations can be reviewed in the Annotation Editor. See “Annotation Editor” on page 107 for more details.

device configuration that was already saved to UroNav, its parameters shall be updated. The saved device configurations can be reviewed in the Annotation Editor. See “Annotation Editor” on page 107 for more details.

New Patient

An Ultrasound Only patient study may be created without associated MR data by clicking the New Patient tab, as shown in the following image:

Completed workflows

You can view the history of all workflows performed with UroNav for a specific patient. Displayed as a list in descending chronological order; the following fields are provided: • Workflow Date • Workflow Type • Study Date • Export Status Additionally, you can delete, view and export of individual workflow data.

Data Export to DICOM Destination

UroNav workflow data can be manually exported to a preconfigured DICOM destination. If connected to the network, UroNav can also automatically export workflow data to a preconfigured DynaCAD server after the completion of a workflow, including screen captures and screen recordings. The user may cancel ongoing exports and start exports manually at a later time. Below are the instructions to manually transfer all workflow data associated with a specific patient or a range of patients to a preconfigured DICOM destination: Select the patient (or patients) from the All Patients list. 2. Right-click and select Export. 3. Choose a pre-defined DICOM destination.

Data Export to DICOM Destination (continued)

Select OK to begin exporting. UroNav will indicate data transfer progress per patient. The patient export status indicator is successful only if all of the workflows associated with the patient are successfully exported. Failure to export any of the workflows will result in an unsuccessful export status in the All Patients panel. The export status of individual workflows can be reviewed in the Completed Workflows panel. It is recommended that the user confirms that data has been successfully transferred to the DICOM destination before attempting to delete the corresponding data from UroNav.

Data Export to USB drive

UroNav workflow data can be exported to an external USB drive. The data will be encrypted before being exported to the USB drive.

To manually transfer all workflow data associated with a specific patient or a range of patients to an external USB drive:

1. Select the patient (or patients) from the All Patients list. 2. Right-click and select Export. 3. Choose USB as the export destination. 4. Select the appropriate USB drive and click OK to begin exporting. UroNav will indicate the data transfer progress per patient.

NOTICE

The patient export state indicator is not applicable for export to USB. It is recommended that the user confirms that data has been successfully transferred to the USB drive before attempting to delete the corresponding data from UroNav.

Annotation Editor

Any annotation device configuration saved onto UroNav can be reviewed in the Annotation Editor and optionally deleted. Annotation devices are first configured in DynaCAD Urology and then imported to UroNav via the pre-plan contained in a patient study. If a plan is imported with a different version of a device configuration, the Annotation Editor will show the most recent version. The same list of annotation devices can be selected within the Advanced Annotation workflow. To review an annotation device: Select System Setup > Annotation Editor. 2. Select the Expand button for an annotation device you want to review. 3. Inspect the configured parameters. 4. Close the Annotation Editor when finished.

NOTICE

The annotation device parameters cannot be edited on the UroNav system and can only be imported from DynaCAD Urology via a patient study.

To delete an annotation device:

Select System Setup > Annotation Editor. 2. Select the Expand button for an annotation device which you want to delete. 3. Select Delete and confirm.

Align US volume with MR screen

3. Use the Adjust Mesh Boundary tools to adjust the segmentation boundary by dragging the pink highlighted part of the boundary in any viewport. 4. Optionally, click the Smooth button to smooth out the edited segmentation boundary. To delete a segmentation landmark: ► Right-click the endpoint's crosshair and select Delete landmark. To align the segmented prostate from the ultrasound acquisition with the imported MR images and segmentations, click Next and continue to the Align U/S volume with MR screen. Align US volume with MR screen The Align US volume with MR consists of completing registration between the segmented ultrasound volume and the pre-operative MR data. A semi-automatic 3D rigid registration is applied to both volumes. Align and superimpose the green U/S prostate boundary with the red MR prostate boundary using anatomical landmarks. Image action commands: • Manually complete registration through Pan, Zoom, and Rotation tools. • Confirm complete alignment using multiple anatomical landmarks in at least two planes. • Use the Blend slider to vary the primary view of the superimposed U/S and MR boundaries for optimal visualization. CAUTION Verify the registration in all three orthogonal planes for use in tracking and targeting, and adjust if needed. NOTICE Verify depth setting selection when switching imaging planes with multi-planar US probes.

Biopsy workflow screen controls

EM Tracker Status:The color (green, yellow, or red) represents the range found within the EM field generated used for accurate navigation. U/S Imaging Plane: Lists supported imaging planes for the connected EM tracker. Sagittal: Automatically detected. It can be manually overridden. Transverse: Automatically detected. It can be manually overridden. Endfire: Automatically detected. It can be manually overridden. Automatic Detection: For multi-plane ultrasound probes, an automatic plane detection Segmentations list: This shows the MR segmentations that are available from DynaCAD, including targets. Undo/Redo: Enables the user to manipulate the registration between the MR and U/S data.. Elastic Deformation: Compute: Request an elastic registration be computed. Apply: Toggle between elastic (on) and rigid (off) registration modes. Blend: Adjusts the amount of blend of each modality (U/S and MR) to optimize visualization when adjusting registration. MR MPR views: Displays the MR volume shown in each of the orthogonal planes. U/S MPR views: Displays the reconstructed U/S volume shown in each of the orthogonal planes. Live U/S: Shows a live view of the U/S with superimposed MR. The red boundary represents the 3D volume of the prostate gland borders demarcated from the pre-procedure MR images; the green boundary represents the segmentation from the U/S sweep.

Elastic Deformation

The Registration screen provides the option to map the MR volume elastically to the ultrasound volume using the segmentation results, such as elastic deformation. NOTICE Elastic deformation computation is an option for use intra-procedure. Post-procedure results are viewed and stored on the imported, unedited MRI-defined prostate boundary. Once computed, the Elastic Deformation may be toggled on or off, allowing the use of either elastic or rigid registration for the procedure.

Navigation screen

This Biopsy Navigation screen enables a user to capture biopsy cores from created and imported targets, as well as from configured systematic regions. The locations, times, and screenshots of captured biopsies are recorded for subsequent review. CAUTION Always make sure that the displayed plane and depth setting in the live imaging view is the same as on the ultrasound machine before capturing biopsy cores. Ensure the procedure area is free from electromagnetic disturbance factors and the EM tracker statuses are all green. Always use the ultrasound image to verify the actual position of the biopsy gun and capture it as accurately as possible.

Transrectal Biopsy Navigation User Interface

1 9 2 3 5 4 12 11 8 13 10 6 14 7

Transperineal Biopsy Navigation User Interface

1 EM Tracker Status: The color (green, yellow, or red) represents the range found within the EM field generated used for accurate navigation. 2 U/S Imaging Plane: Lists supported imaging planes for the connected EM tracker. Sagittal: Automatically detected. It can be manually overridden. Transverse: Automatically detected. It can be manually overridden. Automatic Detection: For multi-plane ultrasound probes, an automatic plane detection control will appear. 3 Freeze button: Freezes the live ultrasound view to enable capture of a biopsy. 4 Target list: Displays a list of targets; the selected target is shown within the MPR views and 3D view. 5 Add biopsy button: Toggles the ability to add biopsies in the live U/S viewport. 6 Elastic deformation: Toggles between elastic (on) and rigid (off) registration modes. Not available during U/ S procedures. Systematic region: Toggles configured systematic targets on/off. 8 Blend: A slider to adjust the blend between U/S and MR views in the US/MR viewport. During an ultrasoundonly procedure, the slider adjusts the blend between the U/S segmentation and live U/S image. 9 Live U/S: Provides the live U/S with a superimposed MR view. 10 Superimposed MR: Projects over the live U/S view. Not available during U/S procedures. 11 UroNav Biopsy Needle Guide: Displays the needle guide for projected needle path for biopsy. 12 Target centroid: Highlights the center of the target. 13 3D view: Shows a rendering of the reconstructed prostate along with the position of the selected target. 14 Probe rotation indicator: This shows the probe’s projected plane with reference to the prostate.

Rotational Adjustment

The following function allows the user to adjust for variances in the apex location of an end-fire ultrasound transducer’s image plane. This variance is due to mechanical tolerances associated with the creation of the ultrasound transducer, the rendering of the image plane, and the measurement of the EM location. The following illustration shows how this variance may present to the user after rotating the probe 180° from the original sweep orientation. Depending on the tolerances listed above, an adjustment may or may not be deemed necessary by the clinician. NOTICE Initial registration should be performed prior to applying the rotational adjustment. The following steps are used to perform this adjustment when the user wants to fine-tune the initial registration while on the Navigation Screen. After selecting the Rotational Adjustment icon in the live ultrasound viewport, rotate the TRUS probe 180± 5° from the original sweep orientation used for volume acquisition and segmentation.

Rotational Adjustment Steps

When the guide ring indicates you are in the proper orientation, the dialog changes to “Step 2”. 3. Select Freeze via the button on the rotational adjustment control. Clicking Freeze again will return the procedure to live action and any adjustments made during the freeze will be cleared. 4. On the bottom panel (MR view), use the Pan function to adjust the registration to align with the U/S volume in the top panel. 5. Click Apply. The volumes should now be in alignment when the TRUS probe is rotated in either orientation. Only one rotational adjustment can be applied at any given time.

To clear the applied adjustment:

1. Select the Rotational Adjustment viewport icon. 2. Select Apply again.

Transrectal Biopsy Procedure

For transrectal procedures, the following steps apply to perform biopsies: 1. Ensure the EM tracker(s) display is green, indicating it is within range of EM field range. 2. Ensure the depth setting on UroNav matches the setting on the ultrasound system in both planes for a multi-plane probe. 3. Examine the Live Ultrasound viewport and bottom MR and U/S Live viewport for proper alignment throughout the procedure. NOTICE The 1cm on-screen grid lines are also convenient reference marks for authenticating alignment. NOTICE If manual adjustments do not successfully align the U/S with the MRI, it may be necessary to go back to the Sweep and Segmentation screen, repeat the sweep and replicate the alignment/registration steps. 4. Repeat step 3 as often as necessary throughout the procedure. 5. Select the target to be viewed or biopsied from the Target Selection list. 6. Use the color-coded guidance bars located on the right side of each viewport to locate the target. The length of the guidance bars indicates the distance away from the selected target. Navigation is easily achieved first by moving the transducer in one direction, shrinking the colored bars to get the target into view, then moving perpendicularly to align the bull’s-eye target with the biopsy guide line as shown below. It is helpful to have the biopsy needle slightly inserted within the needle guide while honing in on target regions. The following images are examples showing the probe positions:

Biopsy sample capture

Ensure the biopsy guide line intersects the pre-selected target and advance the needle, monitoring the needle trajectory and insertion line continuously to ensure safety and proper guidance. 8. When the biopsy sample is taken: ⇨ Select Freeze or press the Freeze foot pedal to temporarily interrupt real-time cine viewing. Scroll through the U/S images using the mouse wheel or the cine scroll slider bar on the right side of the viewport to locate the point in time where the distal tip of the biopsy needle is visualized. ⇨ Hover the mouse cursor over the biopsy guide line (color changes to green) and use the mouse wheel or left mouse button to place the line marker to the distal tip of the biopsy needle. Press the ADD button from the Biopsies list menu to record this location and associate it with the current target. A screen capture will be acquired and a time stamp will be recorded and displayed, as shown in the following image: When using an end-fire probe, the prostate model in the 3D viewport will automatically adjust to a perspective directly orthogonal to the orientation of the imaging plane.

Biopsy navigation controls

When the U/S Cine image is active, the middle mouse wheel has two functions. When the mouse cursor hovers over the biopsy needle guideline, it changes to green (active), which allows the user to use the mouse wheel to mark the distal tip of the biopsy needle. When the mouse cursor is away from the guide line (color turns magenta), the mouse wheel scrolls through the cine images. When the U/S Cine image is active, the left mouse button has an additional function. Doubleclicking allows the user to adjust the trajectory of the needle guideline. The needle guideline will be redrawn to accommodate the marked needle tip location. If systematic targets have been configured, toggle the Systematic Regions icon to activate biopsy regions.

Transperineal Biopsy Procedure

For transperineal procedures, the following steps apply to perform biopsies: 1. Select the target to be viewed or biopsied from the Target Selection commands. 2. Rotate the TRUS transducer. Use the projected ultrasound plane intersection in the 3D viewport to view the target in the ultrasound image. The following image is an example of transperineal navigation with grid plate overlay (intersecting U/S imaging plane).

Free-hand transperineal navigation

Navigation is easily achieved by rotating the transducer in the transperineal Stepper assembly. 3. In free-hand transperineal workflows where the needle guide is attached to the ultrasound probe, the displayed needle guideline can be adjusted vertically in live mode. This adjustment may be necessary, for example, if tape is added to the probe to improve grip of the attached needle. To vertically adjust the needle guideline, click the hollow magenta square and drag it, up or down, to align with the physical needle.

Needle guideline adjustment

The rectangular grid overlay provides navigation guidance on where the needle is to be inserted. Ensure the biopsy guide line intersects the pre-selected target and advance the needle in through the highlighted grid hole, monitoring the needle trajectory and insertion line continuously to ensure safety and accuracy. The clinician has the flexibility to use the highlighted grid hole or manually override the selection to insert the needle. 5. When the biopsy sample is taken, select Freeze or press the foot pedal to temporarily interrupt real-time, cine viewing. Scroll through the U/S images using the mouse wheel or the cine scroll slider bar on the right side of the viewport to locate the point in time where the distal tip of the biopsy needle is fully deployed. 4.

Biopsy sample marking and review

Hover the mouse cursor over the biopsy guideline (color changes to green) and use the mouse wheel or left mouse button to place the line marker to the distal tip of the biopsy needle. 7. Press the Add button from the Biopsies list menu to record this location and associate it with the current target. A screen capture will be acquired and a time stamp will be recorded and displayed. Procedure and Images Review screen The Procedure and Images Review screen lets you review the screen captures and video recordings of the procedure, as well as the segmentations and marked biopsy cores. NOTICE The Procedure and Images Review screen will display reconstructed ultrasound images for U/S Only patients. The screen has two tabs — one for the Procedure Review and the other for Images Review — that enable you to toggle between the reviews. The Procedure Review tab enables the 3D review of biopsies and targets projected in the unedited MRI-defined prostate boundary, in addition to captured screenshots and videos.

Procedure and Images Review screen controls

Biopsy/Screen Captures list: Displays a list of targets (white text) and associated captured biopsy cores (yellow text). Biopsy cores are defined by their number and time of capture. Manual screenshots taken during the procedure can also be reviewed from this list. PI-RADS: Displays a list of all screen captures taken during the procedure. View: Provides different views for targets (volume) and biopsies (volume/ automatic screen capture). It also enables the review of videos and manual screenshots taken during the procedure. 3D mesh: While Volume is selected in View, it shows a 3D summary of the prostate boundary, targets, and biopsy cores. Selected targets (both systematic and non-systematic) and cores are highlighted. The Images Review tab enables the review of the biopsies obtained overlayed on the imported multi-planar MRI.

Keyboard and mouse shortcuts

Not all shortcuts are available on all screens. Use the following legend to determine on which screens the biopsy-related shortcut functionality may be applied. Shortcut Function Workflow Context F2 Toggle visibility of segmentations All 2D/3D viewports: • In 3D views, the prostate mesh cannot be toggled off. • In the Biopsy Navigation screen, F2 toggles the visibility of grid template and uniform grid overlay. Toggle visibility of grid template visual overlay Navigation (3D viewport) F6

Keyboard and mouse shortcuts

Shortcut Function Workflow Context F7 Toggle visibility of uniform grid overlay Navigation (U/S, U/S and MR viewports) F12 Toggle visibility of patient information Available on all screens Hold middle Adjust window width/level values mouse button + drag Review Segmentation and Targets (MPR viewports) G Toggle needle guideline Navigation (U/S, U/S and MR viewports) Mouse Wheel Reposition needle guideline depth cursor (while Freeze Mode is enabled, and the guideline is Navigation (U/S, U/S and MR viewports) Sweep and Segmentation (Reconstructed images) active or green) Mouse Wheel Scroll through image frames/slices/cine by hovvering the mouse in the viewport, and while the guideline is active or magenta All MPR viewports Reposition needle guideline depth cursor (while Freeze Mode is enabled, and the guideline is active or green) Navigation (U/S, U/S and MR viewports) Add anatomical fiducial landmarks (while Landmark Placement Interactor is selected) Sweep and Segmentation Left Mouse Drag Reposition needle guideline depth cursor (while Freeze Mode is enabled, and the guideline is active or green Navigation (U/S, U/S and MR viewports) Right Mouse Drag Registration pan All Fusion viewports Left Mouse + Right Mouse Drag Registration rotate All Fusion viewports Left Mouse Double-Click Place needle tip marker off of needle guideline Navigation (U/S, U/S and MR viewports) and reposition depth cursor (while Freeze Mode is enabled) ALT+F Applies a horizontal flipping transformation to the ultrasound coordinate system All live viewports Up / Down Arrow Keys Scroll through images in 1mm increments All MPR viewports

Keyboard and mouse shortcuts

Shortcut Function Workflow Context Ctrl + Z Undo last action Multiple screens: • Review Segmentation and Targets • Sweep and Segmentation • Align U/S volume with MR • Navigation Ctrl + Y Redo last action Multiple screens: • Review Segmentation and Targets • Sweep and Segmentation • Align U/S volume with MR • Navigation

14 Advanced Annotation Workflow

Overview The Advanced Annotation workflow enables you to display imported regions of interest (ROIs) as overlays on MR and (live) TRUS images. You can add (volumetric) annotations as overlays to represent locations of applicators. To start a workflow: 1. Ensure that a patient case is available. See “UroNav Home screen” on page 102 for more information on how to import a patient case. 2. Click and drag the patient case from the All Patients list to the Worklist. 3. Click Advanced Annotation. You may use buttons on the Navigation toolbar (displayed on the top) to navigate between different workflow steps. Each step is represented by a dedicated button, which will take you to the corresponding screen. The workflow consists of the following steps: Button Workflow Step Description of main actions Review ROIs & targets Provides tools to review the imported MR images and associated ROIs. Setup Select the appropriate configuration for the workflow and start up the EM tracking system. Sweep & segmentation Acquire a volumetric ultrasound image and indicate the prostate boundary. Align U/S volume with MR Define the registration between the imported MRI data and live U/S images Navigate Add annotations on the live ultrasound imaging. Review workflow Review the screen captures, video recordings and workflow summary. When transitioning between the different screens or when stopping the workflow, the recorded data up to that point will be stored, enabling the possibility to resume an uncompleted workflow. In the Navigate screen, any procedure data will be stored regardless of screen transitioning.

In-Viewport toolbar

The In-Viewport toolbar provides quick access to several tools for making direct modifications to the image or visual overlays in the main display area. Tools are selected by clicking on the appropriate button or slider. Description Blend Adjusts the amount of blend of each modality (U/S and MR). Action Description Pick Point Sets cross-correlation point in all 2D image planes. Zoom Zooms image. Pan Pans image or pans the registration, depending on the workflow step. Rotate Rotates 3D image. Scroll Scrolls through 2D data set. Window gray-scale adjustment Automatically adjusts gray-scale to optimize image quality Reset view Restores to default the image settings Gray level Manual window width and window level adjustment Show selected Displays selected targets in all viewports Show all Displays all targets in all viewports Adjust Mesh Boundary tool Adjust boundary on active viewport.

In-Viewport toolbar

Button Action Description Adjust Mesh Boundary Boundary adjustment correlated and visualized in all three planes (default setting). (correlation) tool 3D Brush tool Edit a boundary. Applying from inside a selected boundary expands the boundary. Applying from outside a selected boundary reduces the boundary. Reduce brush size Reduce size of 3D Brush tool. Enlarge brush size Enlarge size of 3D Brush tool. Registration rotate Rotates the registration. Registration pan of selected ROI Pans the registration of individually selected ROI. Registration rotate of Rotates the registration of individually selected ROI. selected ROI Place annotation Toggles the ability to place an annotation in the ultrasound image. Axial Changes viewport to axial display. Coronal Changes viewport to coronal display. Sagittal Changes viewport to sagittal display. Show ROI centroid Displays or hides the calculated center (centroid). of ROIs Place landmark Placement of anatomical orientation landmarks for U/S segmentation. Hide all user-defined ROIs Toggles the visibility of all user-defined ROIs.

Advanced Annotation Workflow

Review ROIs and Targets screen Review ROIs and Targets screen The Review ROIs and Targets screen provides tools to enable you to review the imported MR images and associated ROIs. See “Import” on page 103 for more information on data import. You may designate any ROI as a target or no-go zone, and optionally, add margins or point targets. ROIs: Displays a list of ROIs, including target or no-go zone designations and volumes in cc. Axial: Displays the axial view of the imported MR images and its visual overlays. Sagittal: Displays the sagittal view of the imported MR images and its visual overlays. Coronal: Displays the coronal view of the imported MR images and its visual overlays. 3D: Displays MR ROIs in 3D.

Adjusting ROI boundaries

The imported prostate ROI boundary and margin boundaries may be manually edited. This functionality is not available for imported target ROI. NOTICE Boundary adjustments made in the Review ROI and Targets screen are only retained for the remainder of the workflow and will not be stored or exported. Workflow results are viewed and stored on the imported, unedited MRI-defined prostate ROI. The Adjust ROI Boundary tool will let you drag the boundary of an ROI to a specified location and update the boundary shape in 3D accordingly. The Adjust ROI Boundary and cursor tool functions the same, but will also update all 2D viewports to display the current image slice of where the mouse cursor is currently being dragged. To adjust ROI boundaries: 1. Click the prostate ROI or a margin in the ROIs list. 2. Select an Adjust ROI Boundary tool from the toolbar in the image viewport. 3. Use the mouse cursor to hover over an area of the ROI boundary that you want to move; it will light up in a pink color. 4. Click the left mouse button and drag the boundary to a different location. 5. Release the mouse button to end the action. 6. (Optional) Click the Smooth button to smooth out the edited boundary. To adjust ROI boundaries using the 3D Brush tool: Click the prostate ROI or a margin in the ROIs list. 2. Select the 3D Brush tool from the toolbar in the image viewport. 3. Move the mouse cursor over the images. If you hover on the inside of the selected ROI boundary, you will see a plus (+) sign. Click the left mouse button and drag the plus (+) sphere around to add areas to the existing ROI boundary. 4. If you hover on the outside of the selected ROI boundary, you will see a minus (-) sign. Click the left mouse button and drag the minus (-) sphere around to remove areas from the existing ROI boundary. 5. Release the mouse button to end the action. 6. (Optional) Click the Smooth button to smooth out the edited boundary. The 3D Brush tool may also be resized. ► Select one of the following icons in the toolbar to adjust the size of the 3D brush: Enlarge brush size (icon shown in left margin - above). Shrink brush size (icon shown in left margin - below). ► Alternately, press the Plus key (+) to increase or Minus key (-) to decrease the brush size. If necessary, you can clear a manually created ROI boundary and redo it using the 3D Brush tool. To clear an ROI boundary: ► Right-click the ROI in the ROIs list and select Clear.

Adding margins

A margin represents a copy of a selected ROI with a specified offset. 1. Select the ROI for which a margin should be added. 2. Click Add margin. 3. Specify the name and color. 4. Specify the size (positive or negative offset in millimeters) and whether the margin should be restricted to the prostate ROI boundary. 5. (Optional) Change the Is Target or Is no-go designation. 6. Click OK to add the margin. The margin is displayed as an additional ROI in the ROIs list and viewports. You may edit margin settings or delete the margin after it was created. To edit margin settings: ► Right-click the margin in the ROIs list and click Edit. You may also adjust the boundary of the margin like any other ROI. To reset a margin to its original offset: ► Click Re-apply margin.

Adjusting ROI designations

A Region of Interest (ROI) can have one of two designations for use during the workflow: Target or No-go zone. These ROI designations are input to constraint-driven planning; see “Navigate screen” on page 154 for more information. For a Target ROI, the system will propose a set of annotations that maximize its volumetric coverage. For a No-go zone, the system will avoid applicator paths that intersect the ROI and minimize its volumetric coverage. To adjust the ROI designation: 1. Right-click the ROI in the list and select one of two designations: 2. Either select the Is Target checkbox, 3. Or select the Is no-go checkbox. The ROI list will display the corresponding icon to represent the selected designation.

Deleting ROIs

Any ROI, except for the imported prostate ROI, can be deleted. To delete an ROI: 1. Right-click the ROI in the ROIs list. 2. Select Delete. 3. When a confirmation dialog appears, click OK to confirm the deletion.

Adding point targets

A point target can be added manually. The point target is represented as a point within the image volume and is displayed as an overlay in the subsequent workflow screens. To add a point target: ► Select the Pick Point tool and click a point within the MR images. ► Select Add Point Target to add a point target at the indicated location. The ROI list and viewports will display the added point. To continue to the Setup screen, click Next.

Advanced Annotation Workflow

4. If rotation is necessary, use the Registration rotate tool. 5. Select a planned annotation from the Annotations list. This will highlight the associated grid hole. 6. Rotate the TRUS probe to have the imaging plane intersect with the selected grid hole and the pink dots are displayed in the Live U/S view, representing the projection of the grid hole. 7. Click Place to display a virtual applicator on the planned location. 8. Insert the applicator through the selected grid hole and monitor its trajectory on the live TRUS image. 9. When the applicator has reached its intended location, mark the tip location with a leftclick. Ensure that the tip is marked accurately as this will determine where the associated annotation will be placed in relation to the MRI-derived ROIs. A screenshot is automatically collected at this time. 10. The annotation status in the Annotations list will change to Placed (as shown left). For more information about annotation status icons and their meanings, see "Annotation Status" in the section “Working with annotations” on page 157. To adjust the location of the virtual applicator tip: 1. Select a placed annotation from the Annotations list. 2. Click and drag the tip of the virtual applicator to edit its position. The automatically collected screenshot is updated at this time. To finalize the status of an annotation from Placed to Completed, do either of the following: ► Select an annotation, which currently has the Placed status, in the Annotations list, and then click the Complete button. The annotation status in the Annotations list will change to Completed. ► Alternatively, hover the mouse cursor over the status icon of any Placed annotation and left click to change the status to Completed. After you have completed the workflow, select Done to proceed to the Review Workflow screen.

CAUTION

Always ensure that the displayed plane and depth setting in the live imaging view is the same as on the ultrasound machine before marking applicator locations.

NOTICE

You can only edit applicators that are not yet completed.

NOTICE

Only annotations that have a Completed status will be visible in DynaCAD Urology for review.

Review Workflow screen

The Review Workflow screen allows the user to view the screen captures, ROIs, completed annotations, and video recordings of the workflow.

NOTICE

Review Workflow presents information relative to the MRI and the imported ROIs. Coverage percentages and renderings may differ between Review Workflow and Navigate screens whenever ROIs were modified or elastic registration was used. Screen captures and videos will reflect the situation as observed during the workflow.

To view screen captures:

Click one of the screen captures in the list to display the capture. 2. (Optional) Use the Zoom to inspect the capture.

3.

(Optional) Use the Pan to adjust the capture during inspection.

4.

Click any ROI in the ROIs list to return to the previous view.

To view video recordings:

1. Click one of the video recordings in the list to display the video. 2. Use the Play button to start playback of the video. 3. When done, click Close to end the playback.

Keyboard and mouse shortcuts

Not all shortcuts are available on all screens. Use the following legend to determine on which screens the shortcut functionality may be applied.

Shortcut

Function Workflow Context F2 Toggle visibility of ROIs All 2D/3D viewports: • In 3D views, the prostate ROI cannot be toggled off. F3 Toggle visibility of annotations Navigate (2D/3D viewports) Review Workflow (2D/3D viewports) F4 Toggle visibility for annotation layers if available Navigate (2D viewports) F5 Toggle visibility of virtual applicators Navigate (2D viewports) F6 Toggle visibility of grid template visual overlay Navigate (3D viewports) F7 Toggle visibility of uniform grid overlay Navigate (2D viewports) F12 Toggle visibility of patient information Available on all screens Hold middle Adjust window width/level values mouse button + drag Review ROIs and Targets (2D viewports) Setup (Live viewport) Sweep and Segmentation (2D viewports) Align U/S Volume with MR (Live viewport) Mouse Wheel Scroll through image frames/slices/cine by hovering the mouse in the viewport, and while the guideline is inactive or magenta. All 2D viewports Right Mouse Drag Registration pan All Fusion viewports Left Mouse + Right Mouse Registration rotate All Fusion viewports Drag ALT+F Applies a horizontal flipping transformation to the ultrasound coordinate system All Live viewports

Shortcut

Function Workflow Context + (Plus Key) Increase brush size (while 3D brush tool is selected) Review ROIs and Targets (2D viewports) - (Minus Key) Decrease brush size (while 3D brush tool is selected) Review ROIs and Targets (2D viewports) CTRL Overrule brush functionality (draw/erase, depending on mouse position, while 3D brush tool is selected) Review ROIs and Targets (2D viewports) Align U/S Volume with MR (2D viewports) Scroll through images in 1mm increments All 2D viewports Up / Down Arrow Keys

Use of symbols in labeling

Symbols Description Unique Device Identifier of the device To indicate generally elevated, potentially hazardous, levels of non- ionizing radiation, or to indicate equipment or systems, such as in the medical electrical area that include RF transmitters or that intentionally apply RF electromagnetic energy for diagnosis or treatment. 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 user or patient. A CAUTION alerts you to where special care is necessary for the safe and effective use of the product. Failure to observe a caution may result in minor or moderate personal injury or damage to the product or other property, and possibly in a remote risk of more serious injury, and/or cause environmental pollution. Date of manufacture and country of origin Manufacturer To indicate that the device that is normally provided sterile in the same or similar packaging has not been sterilized. YYYY-MM-DD Authorized representative in the European community. To indicate the maximum and minimum temperature limits at which the item will be stored, transported or used. To indicate the acceptable upper and lower limits of relative humidity for transport and storage. To indicate the acceptable upper and lower limits of atmospheric pressure for transport and storage. Use by date. Single use disposable; Do not reuse.

Use of symbols in labeling

Symbols Description To indicate that transport package shall not be exposed to sunlight. Do not use if package is damaged. No sitting No pushing Universal serial bus (USB) port/plug Computer network Video input Video output Equipotentiality Field generator connection General mandatory action Refer to instruction manual booklet This way up Do not stack

Use of symbols in labeling

Symbols Description To indicate that the contents of the transport package are fragile and the package will be handled with care. To indicate that the transport package will be kept away from rain and in dry conditions. To indicate the number of pieces in the package. Warning; Non-ionizing radiation No access for people with active implanted cardiac devices. Sweep Screen capture Freeze By affixing the CE marking to a product, the manufacturer declares that the product meets all the legal requirements for CE marking and can be sold throughout the EEA. This also applies to products made in other countries that are sold in the EEA.

Appendix A

Supported biopsy guns and needles The following table provides a list of supported biopsy guns and needles: Manufacturer Gun Needles Argon Medical Systems Pro-Mag Biopsy Needle, 18Gx20cm, 765018200 (Angiotech) Pro-Mag ™ Ultra Reusable Automatic Biopsy Instrument, 7675 Argon Medical Devices Fully Automated Core Biopsy System, MBD-23 Pro-Mag Biopsy Needle, 18Gx30cm, 765018300 (US Biopsy ® ) BARD ® Pro-Mag Biopsy Needle, 18Gx25cm, 765018250 Core Biopsy Needle, 18Gx20cm, CBN1820 Core Biopsy Needle, 18Gx25cm, CBN1825 Core Biopsy Needle, 18Gx30cm, CBN1830 MAX-CORE ® Disposable Core Biopsy Instrument, 18Gx20cm, MC1820 MAX-CORE Disposable Core Biopsy Instrument, 18Gx25cm, MC1825 MAGNUM ® Reusable Core Biopsy MAGNUM Disposable Core Tissue Biopsy Needle, Instrument, MG1522 18Gx20cm, MN1820 MAGNUM Disposable Core Tissue Biopsy Needle, 18Gx25cm, MN1825 MAGNUM Disposable Core Tissue Biopsy Needle, 18Gx30cm, MN1830 URO-1 ™ SUREcore ™ Plus Disposable Core Biopsy Instrument, 18Gx22cm, SP-LA18-22 SUREcore Plus Disposable Core Biopsy Instrument, 18Gx25cm, SP-LA18-25 CAUTION Use of unsupported biopsy guns and needles may cause EM interference and result in inaccurate registration and biopsy core marking.

Applicator compatibility

The following table provides a list of needles/applicators/tools that have been found compatible for use in the operating environment of the UroNav system. Manufacturer Needles Varian V-Probe ® , CVA2400RA TempProbe ® Short, CRYO-55-F CLS TRANBERG ® MR Introducer, 4013-14 TRANBERG ® Laser applicator non-cooled, Radial, 1 mm, 4012-01 TRANBERG Laser applicator non-cooled, Diffuser, 15 mm, 4017-01 TRANBERG Laser applicator non-cooled, Diffuser, 25 mm, 4017-03 TRANBERG ® Tissue Temp Probe, 100 mm, Blue, 1 sensor, 3001-01 TRANBERG Tissue Temp Probe, 100 mm, White, 1 sensor, 3002-01 TRANBERG Tissue Temp Probe, 100 mm, Green, 4 sensors, 3003-01 TRANBERG Tissue Temp Probe, 100 mm, Black, 4 sensors, 3004-01 TRANBERG Tissue Temp Probe, 200 mm, Blue, 1 sensor, 3001-02 TRANBERG Tissue Temp Probe, 200 mm, White, 1 sensor, 3002-02 TRANBERG Tissue Temp Probe, 200 mm, Green, 4 sensors, 3003-02 TRANBERG Tissue Temp Probe, 200 mm, Black, 4 sensors, 3004-02 Boston Scientific IcePearl ™ 2.1 CX, FPRPR3603 IceForce ™ 2.1 CX, FPRPR3604 IceRod ™ 1.5 i-Thaw ™ , FPRPR4009 Multi-Point Thermal Sensor, FPRPR4010 CAUTION Use of unsupported tools, needles, and applicators may cause EM interference and result in inaccurate registration and marking of tool, needle, and applicator locations.

Supported Stepper accessories

The following table provides a list of supported Stepper accessories: Manufacturer Description Manufacturer’s part number CIVCO Sterile 17G Grid 610-905 Sterile 18G Grid 610-906 Sterile 14G Grid 610-977 Sterile Flat Polyethylene Drape 610-870 Latex-Free Endocavity Balloon 610-898 Sterile 14G Grid GM13004030 DK

Fujifilm (Hitachi) C41V Probe Holder mounting instructions

Apply force until flush.

Install cover per the manufacturer's instructions over transducer and UroNav probe holder.

Apply force to reseat.

Tracker removal from Fujifilm (Hitachi) C41V

FujiFilm (Hitachi) CC41R2 Probe Holder mounting instructions

Apply force until flush.

Install cover per the manufacturer's instructions over transducer and UroNav probe holder.

Apply force to reseat.

NOTICE

The on-screen needle guideline as displayed on UroNav corresponds with the number 3 slot on the CC41R2 needle guide.

Tracker removal from FujiFilm CC41R2

Philips C10-4ec Probe Holder mounting instructions

Apply force until flush.

Install cover per the manufacturer's instructions over transducer and UroNav probe holder.

Apply force to reseat.

Tracker removal from Philips C10-4ec

Siemens MC9-4 Probe Holder mounting instructions

Apply force until flush.

Install cover per the manufacturer's instructions over transducer and UroNav probe holder.

Apply force to reseat.

Tracker removal from Siemens MC9-4

Required ultrasound system settings for transrectal workflows

This section provides the required ultrasound system settings for transrectal workflows that facilitates proper video calibration with UroNav used with specific transducer probes and needle guides. BK Flex Focus and 8808e Flex Focus Ultrasound Function Compatibility: Function Setting Preset “Uro Prostate: Prostate S” or “Uro Prostate: Prostate 6” Biopsy Must be ON Color Not Supported Depths 4.0cm, 4.1cm, 5.1cm, 5.4cm, 6.0cm, 6.3cm, 7.1cm, 7.4cm, 8.3cm, 8.5cm Doppler/M-mode Not Supported Dual View Not Supported Harmonic Not Supported Imaging 2D, Sagittal and Transverse Planes Orientation Bottom View (L/R Off, U/D On, Small BK Logo Bottom Left or Right). Note that the user may need to adjust the orientation on UroNav via the ALT-F key binding. Size 100% Only Video I/O Digital (DVI-HDMI): Must be Passive Display, Large Font, Black and White Width 100% Only Zoom Not Supported Font Size Large Supported Needle Guide: Description Manufacturer’s Part Number BK Medical Single-Use Biplane Biopsy Guide UA1322-S

BK Flex Focus and 8818

Flex Focus Ultrasound Function Compatibility: Setting Preset Digital (DVI-HDMI): “Uro Prostate: Prostate L” or “Uro Prostate: Prostate 12” Biopsy Must be ON Color Not Supported Depths Digital (DVI-HDMI): 4.0cm, 4.5cm, 5.0cm, 5.3cm, 5.9cm, 6.2cm, 6.9cm, 7.2cm, 8.1cm, 8.4cm, 9.0cm, 9.8cm Doppler/M-mode Not Supported Dual View Not Supported Harmonic Not Supported Imaging 2D, Sagittal, Transverse and Endfire Planes Orientation Bottom View (L/R Off, U/D On, Small BK Logo Bottom Left or Right). Note that the user may need to adjust the orientation on UroNav via the ALT-F key binding. Size 100% Only Video I/O Digital (DVI-HDMI): Must be Passive Display, Large Font, Black and White Width 100% Only Zoom Not Supported Font Size Large Supported Needle Guide: Description Manufacturer’s Part Number Imaging Plane BK Medical Single-Use Dual Biopsy Guide UA1329-S All BK Medical Single-Use Biplane Biopsy Guide UA1322-S Sagittal only

BK Flex Focus and 8819

Flex Focus Ultrasound Function Compatibility: Function Setting Preset “Uro Prostate: Prostate S” or “Uro Prostate: Prostate 6” Biopsy Must be ON Color Not Supported Depths 4.6cm, 5.4cm, 6.3cm, 6.4cm, 7.4cm, 7.5cm, 8.3cm, 8.6cm, 9.3cm, 10.0cm Doppler/M-mode Not Supported Dual View Not Supported Harmonic Not Supported Imaging 2D, Endfire Plane Orientation Bottom View (L/R Off, U/D On, Small BK Logo Bottom Left) Size 100% Only Video I/O Digital (DVI-HDMI): Must be Passive Display, Large Font, Black and White Width 100% Only Zoom Not Supported Supported Needle Guide: Description Manufacturer’s Part Number CIVCO Needle Guide 610-958

BK 3000/5000 (software version 5.8.0 - 5.14.8) and E10C4

BK 3000/5000 Ultrasound Function Compatibility: Function Setting Biopsy Must be ON Color Not Supported Depths 4.0cm, 5.0cm, 6.0cm, 7.0cm, 8.0cm, 9.0cm Doppler/M-mode Not Supported Dual View Not Supported Harmonic Not Supported Imaging 2D, Endfire Plane Orientation Bottom View (L/R Off, U/D On, Small BK Logo Bottom Left) Size 100% Only Video I/O Digital (DVI): Must be Passive Display, Large Font, Black and White Width 100% Only Zoom Not Supported Supported Needle Guide: Description Manufacturer’s Part Number CIVCO Needle Guide 610-958

BK 3000/5000 (software version 5.8.0 - 5.14.8) and E14C4t

BK 3000/5000 Ultrasound Function Compatibility: Function Setting Biopsy Must be ON Color Not Supported Depths 4.0cm, 5.0cm, 6.0cm, 7.0cm, 8.0cm, 9.0cm Doppler/M-mode Not Supported Dual View Not Supported Harmonic Not Supported Imaging 2D, Sagittal, Transverse, and Endfire Planes Orientation Bottom View (L/R Off, U/D On, Small BK Logo Bottom Left) Size 100% Only Video I/O Digital (DVI): Must be Passive Display, Large Font, Black and White Width 100% Only Zoom Not Supported Supported Needle Guide: Description Manufacturer’s Part Number Imaging Plane BK Medical Single-Use Dual Biopsy Guide UA1329-S All BK Medical Single-Use Biplane Biopsy Guide UA1322-S Sagittal only

BK 3000/5000 (software version 5.16.x) and E10C4

BK 3000/5000 (SW Version 5.16.x) Ultrasound Function Compatibility: Function Setting Exam Type Prostate (Any Preset) R/L Invert OFF Sector Width 100 U/D Invert ON Image Size 100% Dual Layout OFF Dual OFF Biopsy, E10C4 ON (Endfire) Video Output Mode Passive Video Output Port DVI Supported Needle Guide: Description Manufacturer’s Part Number CIVCO Needle Guide 610-958 When using Civco 610-958 needle guide for E10C4 TRUS probe, the needle guide UA1350 will be displayed in Ultrasound system.

BK 3000/5000 (software version 5.16.x) and E14C4t

BK 3000/5000 (SW Version 5.16.x) Ultrasound Function Compatibility Function Setting Exam Type Prostate (Any Preset) R/L Invert OFF Sector Width 100 U/D Invert ON Image Size 100% Dual Layout OFF Dual OFF Biopsy, E14C4t ON (Sagittal and Endfire) Video Output Mode Passive Video Output Port DVI Supported Needle Guide: Description Manufacturer’s Part Number Imaging Plane BK Medical Single-Use Dual Biopsy Guide UA1329-S All BK Medical Single-Use Biplane Biopsy Guide UA1322-S Sagittal only

BK Specto (software version 6.6.4) and E10C4

BK Specto (SW v6.6.4) Ultrasound Function Compatibility: Setting Biopsy Must be ON Color Not Supported Depths 4.0cm, 5.0cm, 6.0cm, 7.0cm, 8.0cm, 9.0cm, 10.0cm, 11.0cm, 12.0cm Doppler/M-mode Not Supported Dual OFF Dual Layout OFF Exam Type Prostate (Any Preset) Harmonic Not Supported Image Size 100% Only Imaging 2D, Endfire Plane Monitor Portrait Orientation Orientation Bottom View (Small BK Logo Bottom Left) R/L Invert OFF Sector Width 100 U/D Invert ON Video Output Mode Passive Width 100% Only Zoom Not Supported Video Output Port HDMI Supported Needle Guide: Manufacturer Description Manufacturer’s Part Number CIVCO Needle Guide 610-958 When using Civco 610-958 needle guide for E10C4 TRUS probe, the needle guide UA1350 will be displayed in Ultrasound system.

BK Specto and E14C4t

BK Specto Ultrasound Function Compatibility: Function Setting Biopsy Must be ON (Sagittal and Endfire) Color Not Supported Depths 4.0cm, 5.0cm, 6.0cm, 7.0cm, 8.0cm, 9.0cm, 10.0cm, 11.0cm, 12.0cm Doppler/M-mode Not Supported Dual OFF Dual Layout OFF Exam Type Prostate (Any Preset) Harmonic Not Supported Image Size 100% Only Imaging 2D, Sagittal, Transverse, and Endfire Planes Monitor Portrait Orientation Orientation Bottom View (Small BK Logo Bottom Left) R/L Invert OFF Sector Width 100 U/D Invert ON Video Output Mode Passive Width 100% Only Zoom Not Supported Video Output Port HDMI Font size Small (for BK Specto software version 6.6.8 and greater) Supported Needle Guide: Description Manufacturer’s Part Number Imaging Plane BK Medical Single-Use Dual Biopsy Guide UA1329-S All BK Medical Single-Use Biplane Biopsy Guide UA1322-S Sagittal only

bkActiv (S) and E10C4

Function Setting Exam Type Prostate (Any Preset) R/L Invert OFF Sector Width 100% U/D Invert ON Image Size 100 Live Dual OFF Dual Layout OFF Dual OFF Biopsy, E10C4 ON (Endfire) Video Output Mode Passive Font Size Large Monitor Portrait Orientation Video Output Port DVI Imaging Plane Endfire Depths 4.0cm, 5.0cm, 6.0cm, 7.0cm, 8.0cm, 9.0cm, 10.0cm, 11.0cm, 12.0cm

bkActiv (S) Ultrasound Function Compatibility:

NOTICE bkActive S can be used with UroNav by selecting the bkActiv entry in the Setup screen of a UroNav workflow.

Supported Needle Guide:

Manufacturer CIVCO Needle Guide 610-958

bkActiv (S) and E14C4t

Function Setting Exam Type Prostate (Any Preset) R/L Invert OFF Sector Width 100% U/D Invert ON Image Size 100 Live Dual OFF Dual Layout OFF Dual OFF Biopsy, E10C4 ON (Sagittal & Endfire) Video Output Mode Passive Font Size Large Monitor Portrait Orientation Video Output Port DVI Imaging Plane Sagittal, Transverse, Endfire Depths 4.0cm, 5.0cm, 6.0cm, 7.0cm, 8.0cm, 9.0cm, 10.0cm, 11.0cm, 12.0cm

bkActiv (S) Ultrasound Function Compatibility:

NOTICE bkActiv S can be used with UroNav by selecting the bkActiv entry in the Setup screen of a UroNav workflow.

Supported Needle Guide:

Manufacturer BK Medical Single-Use Dual Biopsy Guide UA1329-S All BK Medical Single-Use Biplane Biopsy Guide UA1322-S Sagittal only

GE Logiq F8 (software version R2.x.x) and E8C

Function Setting Biopsy Must be ON Preset Prostate Width 128 Colorize Tint Map D Depths 4.0cm, 5.0cm, 6.0cm, 7.0cm, 8.0cm, 9.0cm CrossXBeam Not Supported ECG-mode Not Supported Harmonics Not Supported Imaging Mode B-Mode, 2D M-mode Not Supported Orientation Down (Small “LOGIQ F” Logo Bottom Left or Right). Note that the user may need to adjust the orientation on UroNav via the ALT-F key binding. PDI-mode Not Supported PWD-mode Not Supported Video I/O HDMI Video Output, Resolution: 1280x1024 Zoom Not Supported (Default E8C Urology Prostate setting)

Logiq F8 Ultrasound Function Compatibility:

Supported Needle Guide: Description

Manufacturer CIVCO Needle Guide 742-306

Manufacturer CIVCO Needle Guide 742-306

GE Logiq F8 (software versions R2.x.x) and E8CS

Function Setting Biopsy Must be ON Preset Prostate Width 135 Colorize Tint Map D Depths 4.0cm, 5.0cm, 6.0cm, 7.0cm, 8.0cm, 9.0cm CrossXBeam Not Supported ECG-mode Not Supported Harmonics Not Supported Imaging Mode B-Mode, 2D M-mode Not Supported Orientation Down (Small “LOGIQ F” Logo Bottom Left or Right). Note that the user may need to adjust the orientation on UroNav via the ALT-F key binding. PDI-mode Not Supported PWD-mode Not Supported Video I/O HDMI Video Output, Resolution: 1280x1024 Zoom Not Supported (Default E8CS Urology Prostate setting)

Supported Needle Guide:

Manufacturer CIVCO Needle Guide 742-306

GE Logiq S7 (software versions R3.x.x) and IC5-9-D

NOTICE GE Logiq S7 R3.x.x is only compatible with UroNav 4.x when the S7 has been factory-installed with R3.x.x software versions. If the S7 system has been upgraded from R2.x.x to R3.x.x software versions, it is not compatible with UroNav 4.x.

Logiq S7 R3 Ultrasound Function Compatibility:

Setting Biopsy Must be ON Preset Prostate Width 146 Color Flow Mode Not Supported Depths 4.0cm, 5.0cm, 6.0cm, 7.0cm, 8.0cm, 9.0cm CrossXBeam Not Supported Dual View Not Supported ECG-mode Not Supported Harmonics Not Supported Imaging Mode B-Mode, 2D M-mode Not Supported Orientation Down (Small “LS7” Logo Bottom Left or Right). Note that the user may need to adjust the orientation on UroNav via the ALT-F key binding. Image Display Area Extra Large PDI-mode Not Supported PWD-mode Not Supported Video I/O Digital (HDMI): Resolution 1920x1080 Zoom Not Supported

Supported Needle Guide:

Manufacturer CIVCO Needle Guide 742-306

GE Versana Premier and E8Cs-RS

Function Setting Exam Preset Urology > Prostate Display Image Size Large Auto Zoom OFF (Not Supported) Automatic Wide Screen OFF (Not Supported) Depths 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0, 12.0 Imaging Mode B-Mode Zoom OFF (Not Supported) Rotation Down (Small “GE” Logo Bottom Left or Right) Biopsy Kit E8CS_TR5 Width 135 Video I/O HDMI Video Output, Resolution 1920x1080

Supported Needle Guide:

Manufacturer CIVCO Needle Guide 742-306

Hitachi Noblus and C41V

Function Setting Biopsy Must be ON Angle 5 B Gray Map 5 B Color 4 Up-Down Shift OFF Vertical Shift 0 Texture Smooth Depths 4.0cm, 5.0cm, 6.0cm, 7.0cm, 8.0cm, 9.0cm Hi REZ+ 5 dTHI OFF HI Support OFF PW OFF Imaging Mode B-Mode, 2D Orientation Down (Small “H” Logo Bottom Left or Right). Note that the user may need to adjust the orientation on UroNav via the ALT-F key binding. Video I/O Digital (DVI-HDMI): Resolution 1024x768 Zoom Not Supported

Hitachi Noblus Ultrasound Function Compatibility:

Supported Needle Guide: Manufacturer CIVCO Needle Guide 644-069

Fujifilm (Hitachi) Arietta Precision and C41V

Function Setting Condition, C41V Prostate Monoplane Initial Mode Single Single Format Size (W) Wide B Mode Format Size (H) Wide Scan Area (B) 100% Invert L/R OFF Image Rotation 180 deg Vertical Shift 0.0 cm Biplane Invert L/R (L) ON Biplane Invert L/R (T) OFF Biplane Image Rotation (L) 180 deg Biplane Image Rotation (T) 180 deg Full Image OFF Puncture Guide Line, C41V ON Puncture Guide Line, C41L47RP OFF Mirror Inversion Display OFF External Output HDMI Depths 4.0cm, 5.0cm, 6.0cm, 7.0cm, 8.0cm, 9.0cm

Supported Needle Guide:

Manufacturer CIVCO Needle Guide 644-069

Fujifilm (Hitachi) Arietta Precision and CC41R2

Function Setting Preset Prostate Biplane Plane + Sole Supported Function for Switching Planes Plane Not Supported Select Not Supported Initial Mode Single Single Format Size (W) Wide B Mode Format Size (H) Wide Scan Area (B) 100% Invert L/R OFF Image Rotation 180 deg Cine Memory Division 2 Vertical Shift 0.0 cm Biplane Invert L/R (L) ON Biplane Invert L/R (T) OFF Biplane Initial Plane T Biplane Image Rotation (L) 180 deg Biplane Image Rotation (T) 180 deg Biplane Label ON Real-time Biplane OFF Puncture Guide Line ON Puncture Angle Select 3 Single Full Image OFF Mirror Inversion Display OFF

Function

Setting External Output HDMI Depths 4.0cm, 5.0cm, 6.0cm, 7.0cm, 8.0cm, 9.0cm, 10.0cm, 11.0cm, 12.0cm

Supported Needle Guide:

Manufacturer Description Manufacturer’s Part Number CIVCO Needle Guide 644-102 (REF 134-217)

NOTICE

The on-screen needle guideline as displayed on UroNav corresponds with the number 3 slot on the CC41R2 needle guide.

Fujifilm (Hitachi) Arietta 65/650 and C41V

Fujifilm (Hitachi) Arietta 65/650 Ultrasound Function Compatibility: Function Setting Info Display Position Lower Vertical Shift [mm] 0 HI Zoom OFF PAN Zoom OFF Scan Area (B) 100 Biplane Scan Area (B) 100 (T) Initial Mode B B Mode Format Size (H) Normal B Invert L/R OFF B Invert U/R OFF B Image Rotation 180 deg Biplane Invert L/R (L) ON Biplane Invert L/R (T) OFF Biplane Invert U/L (L) OFF Biplane Invert U/L (T) OFF Biplane Image Rotation (L) 180 deg Biplane Image Rotation (T) 180 deg Trapezoidal Scanning OFF ON External Output EXTOUT HDMI port of the EU-9210 option box with the switches set to the following: Margin = Off, XGA = Off, and CLIP = On Depths 4.0cm, 5.0cm, 6.0cm, 7.0cm, 8.0cm, 9.0cm, 10.0cm, 11.0cm, 12.0cm Puncture Guide Line, C41V

NOTICE

Fujifilm (Hitachi) Arietta 650 can be used with UroNav by selecting the Arietta 65 entry in the Setup screen of a UroNav workflow.

Supported Needle Guide:

Manufacturer CIVCO Needle Guide 644-069

Fujifilm (Hitachi) Arietta 65/650 and CC41R2

Fujifilm (Hitachi) Arietta 65/650 Ultrasound Function Compatibility: Function Setting HI Zoom OFF PAN Zoom OFF Plane + Sole Supported Function for Switching Planes Plane Not Supported [Dual] key, [Single] key Not Supported Vertical Shift [mm] 0 Scan Area (B) 100 Wide Scanning OFF Biplane Scan Area (B) 100 [T] Biplane Scan Area (B) 100 [L] Initial Mode B B Mode Format Size (H) Normal B Invert L/R OFF B Invert U/L OFF B Image Rotation [deg] 180 degrees Biplane Invert L/R [L] ON Biplane Invert L/R [T] OFF Biplane Invert U/L [L] OFF Biplane Invert U/L [T] OFF Biplane Image Rotation [L] [deg] 180 degrees Biplane Image Rotation [T] [deg] 180 degrees Trapezoidal Scanning OFF ON Puncture Guide Line, CC41R2

Function

Setting Puncture Angle Select, CC41R2 #3(47°) Cine Memory Division 2 Biplane Initial Plane T Info Display Position Lower External Output (Must have the 1920x1080 EXTOUT HDMI port of the EU-9210 option box with the switches set to the following: EU-9210 option box installed) Margin = Off, XGA = Off, and CLIP = On Depths 4.0cm, 5.0cm, 6.0cm, 7.0cm, 8.0cm, 9.0cm, 10.0cm, 11.0cm, 12.0cm

NOTICE

Fujifilm (Hitachi) Arietta 650 can be used with UroNav by selecting the Arietta 65 entry in the Setup screen of a UroNav workflow.

Supported Needle Guide:

Manufacturer Description Manufacturer’s Part Number CIVCO Needle Guide 644-102 (REF 134-217)

NOTICE

The on-screen needle guideline as displayed on UroNav corresponds with the number 3 slot on the CC41R2 needle guide.

Philips Affiniti 50/70 and C10-4ec

To be used with CIVCO tracking bracket: Description Manufacturer’s Part Number Tracking Bracket for Endocavity Transducer 667-145 Setting XRES ON WideScan OFF Depths 4.0cm, 5.0cm, 6.1cm, 7.0cm, 8.0cm, 9.1cm SonoCT ON Harmonics OFF 2D OPT Gen Dyn Range 60 Loop Length 3 sec AutoScan OFF Contrast OFF Res/Spd Shaded area in the middle of fan Grey Map 3 Chroma Map OFF Persistence OFF Output Power -1.0dB ECG OFF M-Mode OFF CPA OFF PW OFF Color OFF 3D OFF External Video DisplayPort Format Digital (DisplayPort-HDMI): Select “Full-screen 1080p (S-video disabled)”

Supported Needle Guide:

Manufacturer CIVCO Needle Guide 667-133

Philips Epiq 5/7/Elite and C10-4ec

To be used with CIVCO tracking bracket: Description Manufacturer’s Part Number Tracking Bracket for Endocavity Transducer 667-145 Setting XRES ON WideScan OFF Depths 4.0cm, 5.0cm, 6.1cm, 7.0cm, 8.0cm, 9.1cm SonoCT ON Harmonics OFF 2D OPT Gen Dyn Range 60 Loop Length 3 sec AutoScan OFF Contrast OFF PercuNav OFF Res/Spd Shaded area in the middle of fan Grey Map 3 Chroma Map OFF Persistence OFF Output Power -1.0dB ECG OFF M-Mode OFF CPA OFF PW OFF Color OFF 3D OFF External Video DisplayPort Format Digital (DisplayPort-HDMI): Select “Full-screen 1080p (S-video disabled)”

Supported Needle Guide:

Manufacturer CIVCO Needle Guide 667-133

Siemens S2000/S3000 and MC9-4

Function Setting Biopsy ON Size 3 (to match fan beam) Preset Prostate (Factory Default) Depths 4.0cm, 5.0cm, 6.0cm, 7.0cm, 8.0cm, 9.0cm Live Dual OFF Full Screen Enable Imaging Mode 2D PW Mode OFF Orientation (Full Screen On, L/R Off, U/D On, Small A Bottom Left) Color Doppler (C) OFF (Not Supported) Dynamic TCE Low

Siemens S2000/S3000 Ultrasound Function Compatibility:

Supported Needle Guide: Manufacturer CIVCO Needle Guide 676-157

Appendix C

Supported ultrasound and transducer probe combinations for transperineal workflows The following table provides a list of supported transperineal workflow ultrasound systems and associated transducer probes: Ultrasound Transducer probes BK 3000/5000 E14CL4b (with UroNav Stepper) E14CL4b (with PrecisionPoint ™ , CIVCO TP Pivot Pro ™ ) BK FlexFocus 400/500/700/800 8848 (with UroNav Stepper) 8848 (with PrecisionPoint, CIVCO TP Pivot Pro) BK Specto (10) E14CL4b (with UroNav Stepper) E14CL4b (with PrecisionPoint, CIVCO TP Pivot Pro) bkActiv (S) E14CL4b (with UroNav Stepper) E14CL4b (with PrecisionPoint, CIVCO TP Pivot Pro) Hitachi Noblus C41L47RP (with UroNav Stepper) Fujifilm (Hitachi) Arietta Precision C41L47RP (with UroNav Stepper) C41L47RP (with PrecisionPoint) CL4416R1 (with UroNav Stepper) CL4416R1 (with PrecisionPoint) Fujifilm (Hitachi) Arietta 65/650 C41L47RP (with UroNav Stepper) C41L47RP (with PrecisionPoint) CL4416R1 (with UroNav Stepper) CL4416R1 (with PrecisionPoint) NOTICE Free-hand, transperineal workflows are only supported in the biopsy workflow and requires the use of the probe holder listed below: The following list provides part numbers for reordering probe holders for transperineal workflows: Ultrasound transducer probe Philips part number Reorder part number BK 8848 and E14CL4b 4598-014-79211 FCS0137 (Set of 25) Fujifilm (Hitachi) C41L47RP 3000-088-65321 FCS0147 (Set of 25) (10) For any potential limitations on supported ultrasound system software versions, contact your Philips representative for the latest UroNav specifications and compatibility list.

Ultrasound transducer probe / EM tracker reorder information

Ultrasound transducer probe Philips part number Reorder part number Fujifilm (Hitachi) CL4416R1 3000-137-74381 FCS0416 (Set of 25) The following list provides part numbers for reordering EM trackers: Description Philips part number Reorder part number EM tracker 4598-007-83602 FCS0140 (Set of 3) To order additional supplies, consumable instrumentation, or accessories, please contact Philips Customer Service. See “Help and guidance information” on page 8.

Transperineal workflow probe holder mounting instructions

Transperineal workflow probe holder mounting instructions

Failure to fully secure the EM Tracker to the Probe Holder

Failure to fully secure the EM Tracker to the Probe Holder will compromise the positional tracking of the TRUS probe resulting in grossly inaccurate registration between the US imaging and EM tracked tools.

CAUTION: Failure to fully secure the Probe holder to the Probe

CAUTION Failure to fully secure the Probe holder to the Probe will compromise the positional tracking of the TRUS probe resulting in grossly inaccurate registration between the US imaging and EM tracked tools.

CAUTION: Improper or insecure mounting of free-hand transperineal needle guide

CAUTION Improper or insecure mounting of free-hand transperineal needle guide can lead to the needle guideline moving out of imaging plane resulting in inaccurate targeting.

BK 8848 and E14CL4b free-hand transperineal probe holder mounting instructions

BK 8848 and E14CL4b free-hand transperineal probe holder mounting instructions Apply force until flush. Install cover per the manufacturer's instructions over transducer and UroNav probe holder.

Apply force to reseat

Apply force to reseat.

Tracker removal from BK 8848 and E14CL4b probe holders

Tracker removal from BK 8848 and E14CL4b probe holders

Fujifilm (Hitachi) C41L47RP free-hand transperineal probe holder mounting instructions

Fujifilm (Hitachi) C41L47RP free-hand transperineal probe holder mounting instructions Apply force until flush.

Install cover per the manufacturer's instructions

Install cover per the manufacturer's instructions over transducer and UroNav probe and holder.

Install free-hand transperineal needle guide

Install free-hand transperineal needle guide per the manufacturer's instructions.

Apply force to reseat

Apply force to reseat.

Appendix D

Stepper arm setup This appendix provides detailed instructions on the setup of the Stepper arm (shown below), the Stepper, and ultrasound probes, used for transperineal procedures. This appendix describes: • a “Stepper arm overview” on page 245 • “Attaching Stepper arm to examination table” on page 246 • the “Stepper setup” on page 251, which includes further details about attaching/removing EM sensors, probes, and grid plates. • and more information about the “Stepper stand” on page 266

Stepper arm overview

Diagram Description The Stepper arm clamps to EU tables with support bar dimensions of 10mm by 25mm and U.S. tables with support bar dimensions of 0.375 inches by 1.125 inches, as illustrated in the following image: The Stepper arm clamps to Japanese tables with support bar dimensions of 9mm by 32mm. The Stepper arm accommodates a maximum table width of 24 inches (610 mm).

Attaching Stepper arm to examination table

To attach the Stepper arm to the examination table: 1. Open the width adjustment handle. 2. Place left-side clamp onto the table support bar. 3. Adjust width of the right-side clamp to the width of the table and place right-side clamp onto the table support bar. 4. Clamp to the proper distance and tighten clamps down carefully.

NOTICE

When the width adjust handle is open, the clamp can slide off the end of the tube. Do not allow this to happen, as components of the clamp can fall out.

5.

Tighten the width adjustment handle once the proper width is found.

The articulated arm can be set for right-hand use or left-hand use. To change handedness:

6. Open the arm adjustment handle. 7. Remove the arm adjustment handle and pull the articulated arm out from the holder.

8.

Install the articulated arm on the opposite side. 9. Reinstall the arm adjustment handle and tight.

10. Find the optimal vertical and horizontal position for the articulated arm. The horizontal position is adjusted by sliding the articulated arm along the supporting rod. The vertical position is adjusted by rotating the articulated arm around the supporting rod.

11. After finding the optimal position, tighten handle.

NOTICE

The optimal position depends on the individual patient and therefore, the arm position may need adjustment before each procedure.

NOTICE

The Stepper Arm is designed to only hold the Stepper. Do not attach any additional devices to the holder assembly.

12. The hand knob releases all three joints of the articulated arm.

NOTICE

Before release, be ready to hold up the Stepper. After the articulated arm is adjusted, tighten hand knob properly. A loose hand knob can cause the joints to drift.

Do not use the Stepper arm if it feels loose or unsteady after installation and adjustment.

Stepper arm removal

To remove the Stepper arm: 1. Open the clamp handles. 2. Remove the clamps from the table support bar.

Stepper setup

This section provides further details, including visual examples, related to the Stepper, its installation to the arm, plus installation of EM sensors, probes, and the grid plate. For more information regarding probe or grid plate movements, see “Probe movements” on page 258 and “Grid plate linear and micro movements” on page 259. For information on how to remove EM sensors, probes, and the grid plate, see “Removal of the grid, EM sensor, and probe” on page 261.

Attaching Stepper to the Stepper arm

To install the Stepper to the arm: ► Slide the Stepper in the arm mount and close the lever.

Close the lever forward so it does not interfere with the Stepper.

EM sensor installation

To install the EM sensor: ► Push EM sensor into place. Ensure that the EM sensor is pushed down properly.

CAUTION

Improper mounting of EM sensor to the Stepper can result in inaccurate tracking of the grid compromising the accuracy of the procedure.

The following images depict examples of various EM sensor installations:

Fig. 7: BK 8848 and E14CL4B EM sensor installation Fig. 8: Fujifilm (Hitachi) C41L47RP/CL4416R1 EM sensor installation

CAUTION

Failure to fully secure the EM Tracker to the Probe Holder will compromise the positional tracking of the TRUS probe resulting in grossly inaccurate registration between the US imaging and EM tracked tools.

Probe installation

To install the probe:

1.

Slide the probe into place, aligning the reference pin with the holder hole. 2. Close the clamp and tighten the thumbscrew.

Ensure the probe is firmly and properly mounted.

CAUTION

Improper mounting of the probe to the Stepper could result in inaccurate tracking of the probe, thereby compromising the accuracy of the procedure.

The following images depict examples of various probe installations:

Fig. 9: BK 8848 and E14CL4B Probe Installation

Fig. 10: Fujifilm (Hitachi) C41L47RP Probe Installation

Fig. 11: Fujifilm CL4416R1 Probe Installation

Grid plate installation

To install the grid plate: 1. Loosen thumbscrews, if necessary, and push grid plate down into place.

2.

Tighten thumbscrews. The right side screw is left-hand threaded, so it works in a direction opposite than usual. Ensure that the grid plate is pushed properly down.

CAUTION

Improper mounting of the grid to the Stepper results in inaccurate tracking of the grid, compromising the accuracy of the procedure.

Probe movements

The following images illustrate possible probe movements: Use the rotation handle with caution. The opening on the rotation handle may create a pinching point hazard.

Grid plate linear and micro movements

Before the procedure, lift both levers to the highest position. This is the highest position where the grid plate can be, and it is centralized. When the levers are pushed down, the grid plate moves vertically downward.

NOTICE

The grid plate can go lower than the probe and interference is possible. Do not force the grid plate down if it touches the probe.

It is always possible to centralize the grid plate. Lift both levers up to centralize the grid plate.

Moving one lever while the other one remains stationary achieves horizontal movement of the grid plate.

Removal of the grid, EM sensor, and probe

This section provides further details, including visual examples, related to the removal of EM sensors, probes, and the grid plate.

Grid plate removal

To remove the grid plate: ► Loosen thumbscrews, if necessary, and pull grid plate out.

EM sensor removal

To remove the EM sensor from the grid plate mount: ► Push EM sensor out of its place.

Probe removal

To remove the probe: 1. Loosen the thumbscrew and open the clamp. 2. Lift and slide the probe out of its place.

Stepper removal

To remove the stepper: ► Open the lever and pull the stepper out.

Stepper stand

The following image shows the Stepper attached to the Stepper stand instead of the Stepper arm.

To install the Stepper on the Stepper stand:

► Slide the stepper in the arm mount. ► Close the lever.

Stand adjustments

The stand allows 10 inches of gross vertical adjustment. Set the adjustment to middle position before the procedure.

Gross left/right

Gross stepper/stand positioning

Relock all castors after any positioning adjustment.

CAUTION

After positioning the optional Stepper stand, ensure all castors are in the locked (down) position.

Universal adjustments

Retighten knob after adjustment to prevent stepper movement.

Publication details

18 Publication details Philips Corporation reserves the right to make changes to both this Instructions for Use and to the product it describes. Product specifications are subject to change without notice. Nothing contained within this Instructions for Use is intended as an offer, warranty, promise or contractual condition, and must not be taken as such. © 2026 Koninklijke Philips N.V. All rights reserved. Reproduction or transmission in whole or in part in any form or by any means, electrical, mechanical or otherwise is prohibited without the prior written consent of the copyright owner. Unauthorized copying of this publication may not only infringe copyright and reduce the ability of Philips Corporation to provide accurate and up-to-date information to users. Non Philips product names may be trademarks of their respective owners. Philips DS North America LLC 3630 SW 47th Avenue Gainesville, FL 32608 USA Philips Medical Systems Nederland B.V. Veenpluis 6 5684 PC Best The Netherlands Contact information for Switzerland: CH-REP + Importer: Philips AG, Seestrasse 87, CH-8810 Horgen, Switzerland The online repository for electronic Instructions for Use is located at: http://www.philips.com/ifu

Glossary

A/m Ampere per meter - international unit of magnetic field strength AC Alternating current BF Body floating - a part having conductive, medium or long-term contact with a patient CISPR Comité International Spécial des Perturbations Radioélectriques - as part of IEC, CISPR is the international standards organization regulating technical requirements related to RF interference of electronic devices. DICOM Digital Imaging and Communications in Medicine; sometimes referred to as DICOM standard. Specifies a non-proprietary digital imaging format and protocol for exchanging bio-medical images and associated information. EEA European economic area — consists of the European Union (EU) member states and three countries in the European Free Trade Association (EFTA) EFT Electrical Fast Transient EM Electromagnetic EMC Electromagnetic compatibility EMI Electromagnetic interference ESD Electrostatic Discharge FDA Food and Drug Administration - a federal agency within the U.S. Department of Health and Human Services. HDMI High definition multimedia interface I/O Input/output IEC International Electrotechnical Commission - headquartered in Switzerland, the organization publishes international standards for all electronic-related technologies. IFU Instructions for Use ISM Industrial, Scientific, and Medical

Glossary

kV kilovolt - a unit of electromotive force, equal to 1000 volts ME Medical Electrical - electrical equipment or system with a medical purpose MR Magnetic resonance MRI Magnetic resonance imaging RF Radio frequency ROI Region of Interest TLS Transport Layer TRUS Transrectal ultrasound U/S Ultrasound USB Universal serial bus V/m Volt per meter WEEE Waste of Electrical and Electronic Equipment

© 2026 Koninklijke Philips N.V. All rights are reserved.

Published in USA 300017899722 * 2026-07-29 - en-US