FCC ID: M82-DMSSA47 Medical Computer

BD Prevue II Peripheral Vascular Access System (DMS-S47) Instructions for Use and Technical Manual SYMBOLS Consult instructions for use Temperature Limitation Humidity Limitation Manufacturer Keep Dry Type BF Applied Part Do not dispose with ordinary municipal waste Federal Communications Commission This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician IPX1 Drip Proof Equipment Catalog Number Date of Manufacture Serial Number Class II electrical equipment Direct Current Quantity Warning: Magnetic Field Atmospheric Pressure Limitation Caution BD Prevue II Peripheral Vascular Access System Page 2 FCC Statement :

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

-Reorient or relocate the receiving antenna.

-Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.

-Consult the dealer or an experienced radio/TV technician for help. You are cautioned that changes or modifications not expressly approved by the part responsible for compliance could void the users authority to operate the equipment. FCC frequency stability Statement: (for WIFI 5G) Frequency Stability: The grantee ensured that the EUT meets Section 15.407(g) requirements. Industry Canada Statement :

This device complies with Industry Canada's licence-exempt RSSs. Operation is subject to the following two conditions:

(1) this device may not cause interference, and

(2) this device must accept any interference, including interference that may cause undesired operation of the device. Avis dindustrie Canada Le present appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisee aux deux conditions suivantes:

(1) l'appareil ne doit pas produire de brouillage, et, and

(2) l'utilisateur de l'appareil doit accepter tout brouillage radioelectrique subi, meme si le brouillage est susceptible d'en compromettre le fonctionnement. Industry Canada Class B Emission Compliance Statement This Class B digital apparatus complies with Canadian ICES-003. Avis de conformite a la reglementation d'Industrie Canada Cet appareil numerique de la classe B est conforme a la norme NMB-003 du Canada. BD Prevue II Peripheral Vascular Access System Page 3 RF Exposure Information (SAR) This device meets the governments requirements for exposure to radio waves. This device is designed and manufactured not to exceed the emission limits for exposure to radio frequency (RF) energy set by the Federal Communications Commission of the U.S. Government. The exposure standard for wireless devices employing a unit of measurement is known as the Specific Absorption Rate, or SAR. The SAR limit set by the FCC is 1.6W/kg. The FCC has granted an Equipment Authorization for this device with all reported SAR levels evaluated as in compliance with the FCC RF exposure guidelines. SAR information on this device is on file with the FCC and can be found under the Display Grant section of www.fcc.gov/oet/ea/fccid after searching on FCC ID: M82-DMSSA47 IC Radiation Exposure Statement:

The portable device is designed to meet the requirements for exposure to radio waves established by the ISED. These requirements set a SAR limit of 1.6 W/kg averaged over one gram of tissue. The highest SAR value reported under this standard during product certification for use when properly worn on the body. L'appareil portable est concu pour repondre aux exigences d'exposition aux ondes radio etablies par l'ISED. Ces exigences fixent une limite DAS de 1,6 W/kg en moyenne sur un gramme de tissu. La valeur SAR la plus elevee signalee dans le cadre de cette norme lors de la certification du produit a utiliser lorsqu'il est correctement porte sur le corps. BD Prevue II Peripheral Vascular Access System Page 2 Table of Contents 1. OVERVIEW ............................................................................................................................................. 4 1.1. 1.2. 1.3. 1.4. 1.5. 1.6. BD Prevue II Peripheral Vascular Access System Device Description ........................................ 4 Cue Needle Tracking System Description ................................................................................... 4 BD Prevue II Peripheral Vascular Access System Indications for Use ........................................ 4 Clinical Applications for Cue Needle Tracking System ............................................................... 5 BD Prevue II Peripheral Vascular Access System Components .................................................. 5 BD Prevue II Peripheral Vascular Access System Compatible Accessories ................................ 5 1.7. Needles for Use with Cue Needle Tracking System ................................................................... 5 2. WARNINGS AND CAUTIONS .................................................................................................................. 6 2.1. 2.2. 2.3. 2.4. 2.5. BD Prevue II Peripheral Vascular Access System Residual Risks ................................................ 6 BD Prevue II Peripheral Vascular Access System Warnings ....................................................... 6 Cue Needle Tracking System Warnings ...................................................................................... 7 BD Prevue II Peripheral Vascular Access System Cautions ........................................................ 7 Cue Needle Tracking System Cautions ....................................................................................... 9 3. PHYSICAL FEATURES ............................................................................................................................ 10 3.1. 3.2. 3.3. 3.4. 3.5. Console Features ......................................................................................................................... 10 Compatible Probes ...................................................................................................................... 11 Connecting the Ultrasound Probe............................................................................................... 11 Power Button LED Status Indicator ............................................................................................. 12 Connecting the Cord Wrap ......................................................................................................... 12 4. CONNECTING THE BATTERY ................................................................................................................ 13 5. POWER OPTIONS ................................................................................................................................. 14 5.1. 5.2. Power On .................................................................................................................................... 14 Power Menu ................................................................................................................................ 14 6. NAVIGATING THE DISPLAY .................................................................................................................. 14 7. MAIN ULTRASOUND SCREEN .............................................................................................................. 15 7.1. Main Toolbar ............................................................................................................................... 16 7.1.1. Menu ................................................................................................................................... 16 7.1.2. 7.1.3. 7.1.4. Clinician Login ..................................................................................................................... 16 Patient Information ............................................................................................................. 17 Voice Commands (if enabled) ............................................................................................. 17 BD Prevue II Peripheral Vascular Access System Page 3 7.1.5. 7.1.6. 7.1.7. Capture/Scan....................................................................................................................... 17 Brightness ............................................................................................................................ 17 Depth ................................................................................................................................... 17 7.2. 7.3. Battery Information .................................................................................................................... 17 Catheter Icons ............................................................................................................................. 18 7.4. Depth Markers and Image Depth Scale ...................................................................................... 19 7.5. Probe Orientation ....................................................................................................................... 19 8. System Menu ...................................................................................................................................... 20 9. CAPTURE MODE .................................................................................................................................. 21 9.1. 9.2. Save ............................................................................................................................................. 21 Evaluate Vein .............................................................................................................................. 22 10. CUE NEEDLE TRACKING SYSTEM MODE ....................................................................................... 24 10.1. 10.2. Activating and Magnetizing the Cue Needle Tracking System Compatible Needle ............. 24 Cue Needle Tracking System Home Screen ......................................................................... 25 10.2.1. Probe Face Overlay ............................................................................................................. 26 10.2.2. Performance Indicator ........................................................................................................ 27 10.3. Cue Needle Tracking System Overlay ................................................................................... 29 10.3.1. Out-of-Plane Insertion ........................................................................................................ 29 10.3.2. In-Plane Insertion ................................................................................................................ 31 10.3.3. Remaining Catheter Length Tool ........................................................................................ 32 10.3.4. Insertion Angle Tool ............................................................................................................ 33 11. SYSTEM SETTINGS ........................................................................................................................... 34 11.1. Ultrasound Settings ................................................................................................................. 35 11.1.1. Transducer Element Test .................................................................................................... 35 11.2. Cue Needle Tracking System Settings .................................................................................. 36 11.2.1. Calibration ........................................................................................................................... 37 11.3. General Settings ...................................................................................................................... 38 11.3.1. System Password ................................................................................................................ 39 11.3.2. Backup Menu ...................................................................................................................... 40 11.4. Connectivity Settings............................................................................................................... 41 11.4.1. WiFi Networks ..................................................................................................................... 42 11.4.1.1. WPA2 Enterprise ............................................................................................................. 44 11.4.2. Configure Network Settings ................................................................................................ 45 BD Prevue II Peripheral Vascular Access System Page 2 11.4.3. DICOM Settings (If enabled) ................................................................................................ 45 11.4.4. DICOM Conformance Statement ........................................................................................ 46 11.4.5. CCE (if enabled) ................................................................................................................... 46 11.5. System Information ................................................................................................................. 47 12. 13. 14. 15. PATIENT INFORMATION .................................................................................................................. 48 CLINICIAN PRESETS.......................................................................................................................... 50 ACCESSING SAVED PATIENT IMAGES .............................................................................................. 52 OPERATING THE BD PREVUE II PERIPHERAL VASCULAR ACCESS SYSTEM.................................... 54 15.1. Access Using the Cue Needle Tracking System .................................................................... 55 16. TROUBLESHOOTING ........................................................................................................................ 58 16.1. 16.2. BD Prevue II Peripheral Vascular Access System Troubleshooting ...................................... 58 Cue Needle Tracking System Troubleshooting..................................................................... 61 16.2.1. Cue Needle Tracking System Troubleshooting................................................................. 63 17. CLEANING AND DISINFECTING THE EQUIPMENT ............................................................................ 64 17.1. 17.2. 17.3. Cleaning of the Equipment (Point-of-Use Processing) ............................................................ 64 Disinfection of the Equipment ................................................................................................ 64 Compatible Cleaners ............................................................................................................... 65 18. WARRANTY...................................................................................................................................... 66 19. SERVICE AND REPAIR ...................................................................................................................... 67 19.1. Accessory Replacement .......................................................................................................... 67 19.1.1. Cue Magnetizer Replacement .......................................................................................... 67 19.1.2. Probe Holder Replacement ................................................................................................. 69 19.1.3. Cord Wrap Replacement ..................................................................................................... 72 19.2. Battery Replacement .............................................................................................................. 73 20. 21. 22. UPGRADING .................................................................................................................................... 76 DISPOSAL INFORMATION ................................................................................................................ 76 ACOUSTIC INFORMATION ............................................................................................................... 77 22.1. 22.2. Acoustic Output Summary Table ............................................................................................ 77 Acoustic Output Reporting Table ............................................................................................ 77 23. 24. 25. EMC TABLES .................................................................................................................................... 78 TECHNICAL SPECIFICATIONS ........................................................................................................... 81 BD Prevue II Peripheral Vascular Access System WIRELESS TECHNOLOGIES (if enabled) ........... 84 BD Prevue II Peripheral Vascular Access System Page 3 1. OVERVIEW 1.1. BD Prevue II Peripheral Vascular Access System Device Description The BD Prevue II Peripheral Vascular Access System is a portable device that features real-

time 2D ultrasound imaging, customized vascular access applications, procedure documentation, vessel measurement tools, and electronic connectivity (if enabled). 1.2. Cue Needle Tracking System Description The BD Prevue II Peripheral Vascular Access System is equipped with Cue Needle Tracking System which is designed to track and display the location and trajectory of a needle under ultrasound guidance. The technology consists of software installed on an ultrasound system and sensors incorporated into the ultrasound probes. The sensors detect a passive magnetic field emitted from the needle. The software interprets the data from the sensors and creates a virtual image of the needle on the ultrasound display, providing clinicians with a visual representation of the needle during the insertion process. The Cue Needle Tracking System requires the use of either the Cue Traditional Probe or Cue Vascular Access Probe, the Cue Magnetizer and a Cue enabled needle. The Cue Traditional Probe and Vascular Access Probe contain sensors for tracking Cue compatible needles (following magnetization by the Cue Magnetizer). The tracked needles current position, trajectory, and intersection window are displayed over the ultrasound image. 1.3. BD Prevue II Peripheral Vascular Access System Indications for Use The BD Prevue II Peripheral Vascular Access System is intended for diagnostic ultrasound imaging of the human body. Specific clinical applications include:

Pediatric Peripheral Vessel Vascular Access. Typical examinations performed using the BD Prevue II Peripheral Vascular Access System include:

Imaging Applications Vascular Exam Type (Adult and Pediatric) Assessment of vessels in the extremities and neck (e.g., jugular, carotid) leading to or coming from the heart, superficial veins in the arms and legs (e.g., basilic, cephalic, brachial, femoral, radial, saphenous), and vessel mapping. Assessment of superficial thoracic vessels (e.g., axillary, innominate, subclavian). Vascular Access Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial line placement, access to fistula and grafts, and general vein and artery access. Cue Needle Tracking System is intended to provide visual needle tracking to assist with ultrasound guided vascular access. BD Prevue II Peripheral Vascular Access System Page 4 1.4. Clinical Applications for Cue Needle Tracking System Clinical applications which are appropriate when using the Cue Needle Tracking System are:

Pediatric Peripheral Vessel Vascular Access 1.5. BD Prevue II Peripheral Vascular Access System Components BD Prevue II Peripheral Vascular Access System Console BD Prevue II Peripheral Vascular Access System Traditional Probe BD Prevue II Peripheral Vascular Access System Vascular Access Probe BD Prevue II Peripheral Vascular Access System Cue Magnetizer 1.6. BD Prevue II Peripheral Vascular Access System Compatible Accessories The BD Prevue II Peripheral Vascular Access System is compatible with the following accessories:

Site~Rite Probe Covers BD Prevue II Peripheral Vascular Access System Roll Stand Probe holder accessory Cable Wrap Accessory USB storage device (flash/pen drive) with no external power connection Prevue II Cue Magnetizer Cover 1.7. Needles for Use with Cue Needle Tracking System Needles for use with Cue Needle Tracking System:

Cue Needle Tracking System enabled needles, marked with Cue compatibility symbol BD Prevue II Peripheral Vascular Access System Page 5 2. WARNINGS AND CAUTIONS 2.1. BD Prevue II Peripheral Vascular Access System Residual Risks Potential complications related to the insertion and use of BD Prevue II Vascular Access System include but are not limited to delayed procedure; prolonged procedure; allergic reaction; anaphylaxis; infection;

current leakage - electric shock; fire hazard; first degree burn; cavitation; misdiagnosis; blockage; multiple sticks; puncture of unintended structure; tissue/vessel injury; cardiac device failure; multiple sticks;

impact- device falling-tipping; repeat motion injury; patient discomfort; minor scrape or cut; eye injury. 2.2. BD Prevue II Peripheral Vascular Access System Warnings Warning: Do not operate the BD Prevue II Peripheral Vascular Access System or the AC adapter in the presence of flammable anesthetics or gases; explosion may result. Warning: Use only the BD Prevue II Peripheral Vascular Access System AC adapter to charge the system. Using any other device to charge the system may damage the battery, cause intermittent or unpredictable operation, damage the system, result in injury, and will void the warranty. Warning: The following actions will void the warranty of the BD Prevue II Peripheral Vascular Access System and may result in injury or equipment damage:

Opening or servicing any component by anyone other than service personnel authorized by BD. Removing system labels by anyone other than service personnel authorized by BD. Connecting the BD Prevue II Peripheral Vascular Access System to any AC adapter other than the system adapter. Connecting the BD Prevue II Peripheral Vascular Access System to any unauthorized accessory. Refer to the list of authorized accessories in the Overview section. Installing unauthorized software. Modification of system software without authorization by BD. Warning: Inspect the AC adapter and battery cord for damage. If any of the prongs are damaged, use battery power until a replacement cord is obtained. Warning: Verify that all accessories attached to the system comply with applicable safety standards. Use of non-compliant accessories may increase the risk to the patient or user. Warning: The use of accessories other than those specified in the Overview section may result in increased emissions or decreased immunity of the BD Prevue II Peripheral Vascular Access System. Warning: Equipment that relies on basic insulation only should not be used with this system. Failure to comply could result in increased risk to the patient or user. Warning: Do not pull on cables or overload the roll stand; doing so may cause the system to tip. Refer to the roll stand instructions for weight limits or additional warnings. Warning: Prior to use each time, inspect the system for damage. If any problems are found, discontinue use immediately and contact service personnel authorized by BD. Using a damaged system could cause injury to a patient or user. Warning: Unapproved power cords should not be used with this system; doing so may increase risk to the patient or user and/or damage the system. Warning: This product should only be operated by qualified medical personnel. BD Prevue II Peripheral Vascular Access System Page 6 Warning: Do not use the BD Prevue II Peripheral Vascular Access System for ophthalmic indications; ophthalmic use may cause patient injury. Warning: Misuse of the BD Prevue II Peripheral Vascular Access System may result in damage to the equipment or increase risk to the patient or user. Warning: Do not place and/or use the BD Prevue II Peripheral Vascular Access System and its components or accessories in the presence of strong magnetic fields such as Magnetic Resonance Imaging (MRI) devices. The high magnetic fields created by an MRI device will attract the equipment with a force sufficient to cause death or serious injury to persons between the equipment and the MRI device. This magnetic attraction may also damage the equipment. If a needle tracking technology is enabled, the magnetic and the RF fields associated with the MRI environment may interfere with the display of needle location. Consult the MRI manufacturer for more information. Warning: Failure to properly clean and disinfect the system can lead to cross contamination between patients. 2.3. Cue Needle Tracking System Warnings Warning: Use only Cue Needle Tracking System enabled needles with the Cue Needle Tracking System. Use of unapproved needles may result in patient injury. Warning: Misuse of the Cue Needle Tracking System may result in damage to the equipment or personal injury. Warning: The Cue Magnetizer contains strong magnets which may affect devices sensitive to magnetic fields. 2.4. BD Prevue II Peripheral Vascular Access System Cautions Caution: To avoid unnecessary strain on the user, use the medical device in a manner that is ergonomically correct. Caution: During use, the AC connector needs to be easily accessible. In case of emergency, remove the power cord as soon as possible. Caution: Do not force connections; improper installation may damage the connector or system. Caution: Use only BD cleaning and disinfection procedures. Failure to do so may damage the device. Caution: Use only approved or recommended cleaners or disinfectants to avoid damaging the device. Caution: Do not attempt to sterilize the BD Prevue II Peripheral Vascular Access System or probe;

damage to the equipment may occur as a result. Caution: Ensure the unit is secure to the roll-stand mount. Failure to do so may cause the display to disconnect from the mount. Caution: The BD Prevue II Peripheral Vascular Access System contains an internal battery. Dispose of dead battery packs in accordance with local regulations; improper disposal may present an environmental hazard. Caution: Do not allow liquid to enter the system, AC adapter, connectors, or ports; damage to the equipment may occur. BD Prevue II Peripheral Vascular Access System Page 7 Caution: Only qualified personnel should attempt to service this equipment. The BD Prevue II Peripheral Vascular Access System contains static sensitive components and circuits. Failure to observe proper static-control procedures may result in damage to the system. Caution: To avoid damage to the device operating system, shut down the device through the power control window. (See Section 5.2) Caution: The adverse biological effects of ultrasound on tissue appear to be threshold effects. When tissue is repeatedly exposed to ultrasound, with intervals in between, there will likely be no cumulative biological effect. If, however, a certain threshold has been passed, biological effects may occur. While the BD Prevue II Peripheral Vascular Access System acoustic-

output parameters fall well below all US Food and Drug Administration (FDA) thresholds for adverse biological effects, any given ultrasound procedure should be performed using the principle of ALARA (As Low As Reasonably Achievable). The licensed medical practitioner should limit the time of patient exposure to ultrasonic radiation using the principles of ALARA. Caution: Hot water (in excess of 113F or 45C) may damage the system or the probe. Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. Caution: Cardiac-rhythm disturbances during perfusion studies using gas ultrasound contrast agents have been observed in the diagnostic range of Mechanical Index (MI) values. See the specific package insert for the specific contrast agent being used for details. Caution: Do not twist, bend, swing, or pull the probe cable in excess of that required during normal use of the probe. Excessive force on the cable may cause equipment failure, intermittent operation, or unpredictable operation. Caution: When using the BD Prevue II Peripheral Vascular Access System probe in a sterile environment, the probe and part of the probe cable must be covered with a sterile, acoustically transparent plastic probe cover. Caution: When disinfecting the probe with a liquid disinfectant, do not soak the probe cable, cable bend relief, or probe buttons; doing so may damage the probe. Caution: Apply to the acoustic window (or face) of the probe only commercially available ultrasonic couplant that has been specifically formulated for use in medical applications. Caution: Use water or rubbing alcohol and a soft cloth to remove ultrasonic couplant from the acoustic window (or face) of the probe; failure to do so may scratch the acoustic window. Caution: Do not allow the ultrasonic couplant to dry on the acoustic window (or face) of the probe. If the couplant should dry, use water or rubbing alcohol and a soft cloth to remove it. Never use a tool of any kind to remove dry ultrasonic couplant from the acoustic window (or face) of the probe. Caution: Some commercially available probe covers contain latex. Natural rubber latex may cause allergic reactions. Refer to the US FDA alert titled: Medical Alert: Allergic Reactions to Latex Containing Medical Devices, issued March 29, 1991. BD distributes sterile probe covers and needle-guide kits that are not made with natural rubber latex. Caution: Do not subject the probe to excessive vibration; doing so may dislodge sensitive components and cause intermittent or unpredictable operation. Caution: If a probe is damaged in any way, discontinue using it immediately, as damage to the system may occur. Caution: Avoid subjecting the system or probe to excessive mechanical shock (e.g. throw and/or drop);

damage to the system may occur as a result. BD Prevue II Peripheral Vascular Access System Page 8 Caution: Do not use the probe with high-frequency surgical equipment; doing so may damage the BD Prevue II Peripheral Vascular Access System. Caution: Do not connect to an unsecured network; doing so may compromise data security. Caution: This equipment is not designed to meet the standards for Home Healthcare Environments in accordance with IEC 60601-1-11:2010. This equipment should be operated in clinical environments only. Caution: Do not submerge the probe in liquid or allow fluid to enter the connectors. Damage to the equipment may occur. Caution: Prior to each use, inspect the integrity of all power cords and connectors as well as the integrity of the unit itself. If any problems are found, discontinue use immediately and contact an authorized service representative. Use of a damaged power cord could damage the machine. Caution: Do not force the probe connector; damage to the connector and system could result. Caution: Only use the provided screw when attaching the Cue Magnetizer to the system as others may impact the functionality of the Cue Magnetizer. 2.5. Cue Needle Tracking System Cautions Caution: Keep the needle and any ferromagnetic objects, e.g., wired undergarments, metal instruments, watches, jewelry, Cue Magnetizer, electronics, metal bed rails, etc. at least 3 feet away from probe when calibrating. Failure to do so may impact the accuracy of needle tracking. Caution: Equipment operating in close proximity may emit strong electromagnetic or radio frequency interference which could affect the performance of this device. Avoid operating the device near pumps, cauterizers, diathermy equipment, cellular phones, or other portable and mobile radio frequency communications equipment. Maintain equipment separation of at least 3 feet. Caution: Excessive movement of the probe may result in a temporary loss of needle tracking. Caution: The Cue Magnetizer produces a magnetic field. It should be kept away from any device that is sensitive to magnetic fields. Caution: Follow all care, handling and/or installation instructions included in this guide and on the packaging provided with the Cue Magnetizer and needles. Caution: Single-use items (e.g. needle trays, needles and sheaths/ covers) must not be reused under any circumstances. Caution: Movement of the probe during calibration may result in calibration error. Caution: If needle tracking is not functioning properly, discontinue use of Cue Needle Tracking System. Caution: Improper technique and environmental conditions may introduce variation in accuracy Caution: Magnetize the needle with its needle cover on. Failure to do so will cause the needle to be magnetized improperly Caution: Prior to magnetization, keep the needle away from magnetic sources. Failure to do so may negatively impact needle tracking functionality BD Prevue II Peripheral Vascular Access System Page 9 3. PHYSICAL FEATURES 3.1. Console Features Power Connection/USB Port Cover Probe Connector Power Button Cue Magnetizer RFID Reader

(Radio-frequency Identification Reader) Probe Holder Battery Compartment Battery Switch Cover For installation of approved mounting accessories, see Section 19.1. BD Prevue II Peripheral Vascular Access System Page 10 3.2. Compatible Probes BD Prevue II Peripheral Vascular Access System Traditional Probe BD Prevue II Peripheral Vascular Access System Probe 3.3. Connecting the Ultrasound Probe To connect the probe, align the probe connector and gently insert the probe into the console. Note: If the EC204 error appears, connect/reconnect the probe and restart the system. Caution: Do not force the probe connector; damage to the connector and system could result. To remove the probe:

1. Press the two latches on the probe connector. 2. Gently pull on the connector to disconnect the probe. BD Prevue II Peripheral Vascular Access System Page 11 3.4. Power Button LED Status Indicator The power button LED indicates the following:

Static white: system is on Blinking white: The system is in sleep mode Blinking red: the battery power is low Blinking blue: the system is off and charging Static blue: The system is fully charged 3.5. Connecting the Cord Wrap 1) Identify the four screw holes on the back of the console. 2) Screw in the Cord Wrap on the upper 2 screw holes. Note: If a Roll Stand Mount is also being used. Attach the Roll Stand Mount with the lower 2 screws and attach the Cord Wrap to the top 2. Caution: Ensure the unit is secure to the roll-stand mount. Failure to do so may cause the display to disconnect from the mount. BD Prevue II Peripheral Vascular Access System Page 12 4. CONNECTING THE BATTERY During shipping or storage, the battery may be disconnected from the system to allow extended storage life. To enable the system to be powered from the battery, the battery switch must be turned on prior to use. To activate the battery, open the battery cover on the back of the system. Move the switch to the position. Battery Switch Cover To extend the storage life of the battery, return the switch to the X position prior to prolonged storage. Failure to do so will degrade battery life. BD Prevue II Peripheral Vascular Access System Page 13 5. POWER OPTIONS 5.1. Power On To turn on the system, press the power switch on the lower right side of the front of the unit. 5. 2. Power Menu The power menu can be accessed the following ways:

1. To access the power menu, press the power button on the front of the device. 2. To access the power menu using the touch screen, select the menu button on the main ultrasound screen. Select the power button towards the bottom of the menu (see Section 8). Power off Sleep Lock the system

(if Lock Screen is enabled) Close power menu and return to the previous screen. 6. NAVIGATING THE DISPLAY Use the touchscreen to navigate through the different features shown on the screen. Any feature or control can be selected by touching the corresponding button on the screen. BD Prevue II Peripheral Vascular Access System Page 14 7. MAIN ULTRASOUND SCREEN Main Toolbar Depth Markers Battery Information Image Depth Scale Catheter Icons Cue Needle Tracking System Performance Indicator An explanation of the various parts of the main ultrasound screen is provided throughout the remainder of Section 7. BD Prevue II Peripheral Vascular Access System Page 15 7.1. Main Toolbar The main toolbar is located on the left side of the main ultrasound screen and contains the following buttons:

Menu Patient Info Capture Brightness Clinician Login Voice Commands

(if enabled, see section 7.1.4) Scan Depth 7.1.1. Menu Selecting the menu button displays the System Menu. See section 8. 7.1.2. Clinician Login To login or add a user, select the clinician login button. The clinician login screen will appear, allowing you to add a user or select an already entered user. For instructions on this process, refer to Section 13. BD Prevue II Peripheral Vascular Access System Page 16 7.1.3. Patient Information To enter patient information, select the button shown. The patient information screen will appear, allowing you to enter information. For instructions on this process, refer to Section 12. 7.1.4. Voice Commands (if enabled) Selecting the Voice Commands button displays a list of available commands that can be used to vocally modify system settings. The following voice commands are available:

Prevue Capture Image Prevue Scan Image Prevue Save Image Prevue Change Depth Prevue Volume Up Prevue Volume Down Prevue Brightness Up Prevue Brightness Down Pauses scanning, allowing for measurement or saving of images. Resumes active scanning. Saves the captured image. Sets the ultrasound depth. Increases volume. Decreases volume. Increases the brightness of the ultrasound image. Decreases the brightness of the ultrasound image. 7.1.5. Capture/Scan Selecting the capture button when the system is actively scanning will show a static image of the last acquired ultrasound frame. If the scan button is selected when the system is showing a static image, the system will return to active scanning. Additional tools are available, as described in Section 9. 7.1.6. Brightness Selecting the small brightness icon will reduce the brightness of the entire image. Selecting the large brightness icon will increase the brightness of the entire image. Select the brightness that provides the best ultrasound image for the targeted structure. 7.1.7. Depth When the user selects the depth button, the image depth will toggle between a depth of 1.5 cm and 2.5 cm. The BD Prevue II Peripheral Vascular Access System image depth may be changed to image structures at different depths. 7.2. Battery Information BD Prevue II Peripheral Vascular Access System Page 17 Four bars indicate 75%100% of the batterys power remains. Three bars indicate 50%74% of the batterys power remains. Two bars indicate 25%49% of the batterys power remains. One blinking bar indicates 0%24% of the batterys power remains. In this case, connect the system to AC power to continue operation and/or recharge the battery. While the system charges, the icon of the battery will progressively be filled with bars until it reaches full battery charge. The charging icon indicates that the battery is connected to AC power and is charging. A red exclamation point indicates a battery malfunction. See Section 16 for troubleshooting. 7.3. Catheter Icons The catheter icons are displayed in proportion to the vessel image at a selected depth. Icons assist clinicians in determining the appropriate catheter size for the vessel being imaged. BD Prevue II Peripheral Vascular Access System Page 18 7.4. Depth Markers and Image Depth Scale Image Depth Scale in cm. 7.5. Probe Orientation Depth Markers Displays centered depth markers in 0.5 cm increments. To enable, refer to Section 11.1. The probe orientation icon corresponds to the triangular center mark shown on the probe When using the BD Prevue II Peripheral Vascular Access System probe for vascular access, hold it so that the triangular center mark points away from the patients heart. BD Prevue II Peripheral Vascular Access System Page 19 8. System Menu The access the system menu select the System Menu button (

) from the main ultrasound screen. The following menu will be shown on the left side of the screen:

Returns to main ultrasound screen Opens Patient Information window (see Section 12) Opens Training window Opens Ultrasound Help Screen Opens Clinician Presets window (see Section 13) Opens File Management window (see Section 14) Opens Settings (see Section 11) Opens Power Menu (see Section 5.2) BD Prevue II Peripheral Vascular Access System Page 20 9. CAPTURE MODE Access capture mode by pressing the capture/scan button on the main ultrasound screen. The following screen will appear:

Scan Returns to active imaging. Save See Section 9.1. Evaluate Vein Toggles On/Off vessel assessment tools. See Section 9.2 9.1. Save When the Save button is selected, the current ultrasound image is saved to the system hard drive and any attached USB storage devices (if enabled see section 11.4). BD Prevue II Peripheral Vascular Access System Page 21 9.2. Evaluate Vein The BD Prevue II Peripheral Vascular Access System is equipped with vessel assessment tools to measure vessel diameter, determine maximum gauge size based on a given vein occupancy rule, and determine minimum IV catheter length based on a given remaining catheter length rule and assumed insertion angle. The following steps describe how to take measurements with the BD Prevue II Peripheral Vascular Access System Measurement Tool. 1) Ensure the rules are set in the ultrasound settings screen (see Section 11.2). 2) After capturing an ultrasound image, select the Evaluate Vein button. 3) Place the dotted circle in the middle of the vessel by pressing and holding the dotted circle or the move icon to the desired location. Resize the circle so that it matches the size of the vessel. Move icon Resize icon 4) The screen will display the maximum gauge size and minimum catheter length that should be used to access the vessel in accordance with the rules that are set (see Section 11.2). BD Prevue II Peripheral Vascular Access System Page 22 Note:

See section 24 for system measurement error information. BD Prevue II Peripheral Vascular Access System Page 23 10. CUE NEEDLE TRACKING SYSTEM MODE 10.1. Activating and Magnetizing the Cue Needle Tracking System Compatible Needle Scan the RFID tag located on the Cue compatible vascular access device packaging. When the RFID tag is scanned, the following window will appear. Needle Information If selected, this window will not be shown for the currently selected Clinician. Dip a Cue Needle Tracking System enabled needle into the Cue Magnetizer for 1 second then remove. Select continue when complete. Optional: Place the Cue Magnetizer Cover into the Cue Magnetizer prior to dipping the needle. The Cue Needle Tracking System enabled needle and software are now ready for needle tracking. Caution:

Caution:

Magnetize the needle with its needle cover on. Failure to do so will cause the needle to be magnetized improperly Prior to magnetization, keep the needle away from magnetic sources. Failure to do so may negatively impact needle tracking functionality. BD Prevue II Peripheral Vascular Access System Page 24 10.2. Cue Needle Tracking System Home Screen Catheter size of current selected needle Current selected needle information Exit Cue Needle Tracking System mode. Remaining Catheter Length tool value (See section 10.3.3). Insertion Angle tool value (See section 10.3.4). Probe face overlay

(See section 10.2.1). Performance Indicator Measures the quality of the magnetic environment for tracking. (See section 10.2.2). Select when Performance Indicator is low for tips on how to improve the Performance Indicator. BD Prevue II Peripheral Vascular Access System Page 25 10.2.1. Probe Face Overlay The probe face overlay shows the needle position with respect to the probe face. Out-of-Plane Insertion Probe View Probe Face Overlay View The probe face overlay for an out-of-plane insertion may be turned off in the Cue Needle Tracking System settings screen (see section 11.2) In-Plane Insertion When the needle is well aligned with the probe face, the needle graphic is green. Note: In-plane needle tracking is not available with the BD Prevue II Vascular Access Probe. Probe View Probe Face Overlay View Well Aligned When the needle is not aligned with the probe face, the needle graphic is red. Probe View Probe Face Overlay View Not Aligned BD Prevue II Peripheral Vascular Access System Page 26 10.2.2. Performance Indicator The Performance Indicator measures the quality of the magnetic environment around the probe. Stray magnetic fields can inhibit the probes ability to detect an activated needle. More bars indicate a cleaner magnetic environment for detecting an activated needle. Performance Indicator Indication:

Low magnetic fields are present. Conditions are optimal for the Cue Needle Tracking System. Moderate magnetic fields are present. Conditions are moderate for the Cue Needle Tracking System. Strong magnetic fields are present. Conditions are poor for the Cue Needle Tracking System, and needle tracking is disabled. The system is detecting probe movement. Hold the probe still and wait for the Performance Indicator to stop blinking. 2-4 bars 1 bar 0 bars Blinking Indicator Loading Cue Needle Tracking System Cue Needle Tracking System Error The system is restarting the Cue Needle Tracking System to load in a new needle or to recover from an error. Please wait until the loading is complete. The Cue Needle Tracking System has encountered an error. Refer to section 16.2. BD Prevue II Peripheral Vascular Access System Page 27 Perform the following steps to improve the Performance Indicator:

Hold the probe still. If the Performance Indicator decreases during needle approach, withdraw the needle and slowly reapproach. Remove metal, magnetic, and electronic objects in close proximity (bed rails, jewelry, mobile phone, pumps, bed/table frames, Cue Magnetizer, etc.). If the problem persists, hold the probe stationary in the air away from all metal, magnetic, and electronic devices. o o If the Performance Indicator improves, review previous troubleshooting tips. If the Performance Indicators remains low, calibration may be required. This should be uncommon. See section 11.2.1. BD Prevue II Peripheral Vascular Access System Page 28 10.3. Cue Needle Tracking System Overlay 10.3.1. Out-of-Plane Insertion Note: Adjusting the angle of the needle up or down or changing the distance between the needle and probe will change the position of the Intersection Window. A flat angle is required for shallow insertion. Needle Shaft Needle Tip Needle Trajectory Intersection Window Ultrasound Beam Note: Adjusting the angle of the needle up or down or changing the distance between the needle and probe will change the position of the Intersection Window. A steep angle is required for deeper insertion. Needle Shaft Ultrasound Beam Needle Tip Needle Trajectory Intersection Window BD Prevue II Peripheral Vascular Access System Page 29 Actual View On-Screen View Needle Shaft Needle Tip Needle Trajectory Intersection Window Ultrasound Beam BD Prevue II Peripheral Vascular Access System Page 30 10.3.2. In-Plane Insertion Note: In-plane needle tracking is not available with the BD Prevue II Vascular Access Probe. Needle Shaft Needle Trajectory Needle Tip Ultrasound Beam Needle Shaft Needle Tip Needle Trajectory Needle Shaft Needle Tip Needle Trajectory Needle Trajectory Needle Shaft Needle Tip Ultrasound Beam BD Prevue II Peripheral Vascular Access System Page 31 10.3.3. Remaining Catheter Length Tool The Remaining Catheter Length tool displays the calculated remaining catheter length from the location of the calculated needle intersection point. Rules can be set (either by clicking on the button in scan mode or in the settings see section 11.2) to dictate a minimum remaining catheter length threshold based upon a needle type and length. When the remaining catheter length value drops below the set threshold, the overlay, including the target box, and the remaining catheter length value text will change color to indicate the value is below the threshold. Actual View On-Screen View Probe Surface Needle Tip Ultrasound Beam Remaining Catheter Length Needle Shaft Needle Trajectory Intersection Window Note: The further the needle is from the probe and/or the shallower the approach, the lower the value of the Remaining Catheter Length with a lined-up vessel. Note: For the most accurate result, ensure the probe is imaging perpendicularly to the imaged surface. Remaining Catheter Length Needle Shaft Needle Trajectory Intersection Window Probe Surface Needle Tip Ultrasound Beam Caution:

If needle tracking is not functioning properly, discontinue use of Cue Needle Tracking System. Caution:

Improper technique and environmental conditions may introduce variation in accuracy. BD Prevue II Peripheral Vascular Access System Page 32 10.3.4. Insertion Angle Tool The Insertion Angle tool displays the calculated angle measurement between the needle and the probe surface

(refer to image below). Rules can be set (by clicking on the button in scan mode or in the settings see section 11.2) to indicate a maximum insertion angle threshold. When the insertion angle value surpasses the set needle angle threshold, the overlay, including the target box, and the insertion angle value text will change color to indicate the value is above the threshold. Actual View On-Screen View Needle Shaft Probe Surface Insertion Angle Needle Tip Needle Trajectory Intersection Window Ultrasound Beam Needle Shaft Probe Surface Insertion Angle Needle Tip Needle Trajectory Intersection Window Note: For the most accurate result, ensure the probe is imaging perpendicularly to the imaged surface. Ultrasound Beam Caution:

If needle tracking is not functioning properly, discontinue use of Cue Needle Tracking System. Caution:

Improper technique and environmental conditions may introduce variation in accuracy. BD Prevue II Peripheral Vascular Access System Page 33 11. SYSTEM SETTINGS To access the system settings, press the menu button on the main ultrasound screen. In the menu, select the settings button. The settings window consists of the following tabs:

Returns to the menu General Settings Ultrasound Settings Clinician Preset Cue Connectivity System Information BD Prevue II Peripheral Vascular Access System Page 34 11.1. Ultrasound Settings To access the ultrasound settings, click on the ultrasound settings tab on the settings screen. The following screen will appear:

Toggles the center marks On/Off. Close and return to Main Ultrasound Screen Toggles the Image Filter. User defined Assumed Insertion Angle User defined Remaining Catheter Length Rule Remaining Catheter Length percentage is calculated by the following equation:

% Remaining Catheter Length =

Total Catheter Length Travel Distance Total Catheter Length 100

*Travel Distance is calculated using the assumed insertion angle and location of the vessel evaluation tool 11.1.1. Transducer Element Test To carry out a transducer element test:

Opens Transducer Element Test window. See section 11.1.1 User defined Vessel Occupancy Rule Vessel Occupancy Percentage is calculated by the following equation:

% Occupied =

Diameter of the Catheter Diameter of Vessel Evaluation Tool Circle 100 1. Open the Transducer Element Test window by selecting the Transducer Element Test button in the Ultrasound Settings screen. 2. Select Run Test (ensure that the probe surface is clean and dry prior to running). BD Prevue II Peripheral Vascular Access System Page 35 11.2. Cue Needle Tracking System Settings To access the Cue Needle Tracking System settings, click on the Cue Needle Tracking System settings tab on the settings screen. The following screen will appear:

Toggles the Insertion Angle Overlay On/Off User defined Maximum Insertion Angle Displays information on how to improve the Performance Indicator. See section 11.2.1. Opens Cue Tutorial Toggles the Remaining Catheter Length Overlay On/Off Toggles the Probe Face Overlay On/Off User defined Remaining Catheter Length Rule BD Prevue II Peripheral Vascular Access System Page 36 11.2.1. Calibration Calibration may be required when the Performance Indicator (see section 10.2.2) measures a poor magnetic environment. To determine if calibration is necessary, hold the probe stationary in the air away from all metal, magnetic, and electronic devices. If the Performance Indicator improves, calibration is not required. To calibrate the probe:

1. Select the calibrate button on the Cue Needle Tracking System settings screen. 2. Follow the on-screen instructions to hold the probe in the air, at least 3 feet from any metal, magnetic, or electronic devices (including watches, cell phones, etc.). 3. While holding the probe still in the air, press the calibrate button. Maintain this position until the system indicates that calibration is complete. 4. Upon completion of calibration, the Performance Indicator should improve. A Performance Indicator of 3 bars or higher is recommended before beginning any procedure. Note: Maintain a distance of 4 inches between the Cue probe and Cue Magnetizer to minimize the potential need for calibration. BD Prevue II Peripheral Vascular Access System Page 37 11.3. General Settings To access the general settings, click on the general settings tab on the settings screen. The following screen will appear. Sets the system language Sets the system date. Format is Year/Month/Day Sets the system volume Sets the system time. Format is Hour:Min.

(24 hour time) Toggles the Battery Saver feature. Battery Saver puts the system into sleep mode after extended periods of inactivity. Opens a window with battery health information. Toggles the Privacy Disclosure shown upon system startup On/Off Toggles the Voice Command feature On/Off (if available) Opens Admin Logs Opens Backup Menu. See Section 11.3.2 Toggles the system password on/off. See Section 11.3.1 BD Prevue II Peripheral Vascular Access System Page 38 11.3.1. System Password To configure password protection, enable the password option in the general settings tab. The first time password protection is enabled, the system will display a prompt to create an administrator password. The administrator password will be used to make any future configuration changes to the system password. If the administrator password is forgotten, contact customer service for a temporary password. Upon creating or entering the administrator password, the following options will be displayed:

BD Prevue II Peripheral Vascular Access System Page 39 11.3.2. Backup Menu To backup and restore patient and settings, select the Backup button in the General Settings Tab (the admin password is required for access). Backup patient data files. Backup settings. Select drop-down to select and restore from a previous backup file. BD Prevue II Peripheral Vascular Access System Page 40 11.4. Connectivity Settings Note: The actions described in this section should only be taken by authorized personnel. To configure the BD Prevue II Peripheral Vascular Access System, contact your network administrator or a PACS administrator. To access the connectivity settings, click on the connectivity settings tab on the settings screen. The following screen will appear:

Media Access Control (MAC) address Enable/Disable WiFi

(if enabled) WiFi Signal Strength WiFi Settings (if enabled). See section 11.4.2. Select WiFi Network (if enabled). See section 11.4.1. Enable/Disable Saving images to USB DICOM Settings

(if enabled). See section 11.4.3. CCE Settings

(if enabled) FHIR Settings

(if enabled) Opens a window to allow a PING to a specified IP address. When the PING window opens, input the IP address and select the PING button. BD Prevue II Peripheral Vascular Access System Page 41 11.4.1. WiFi Networks Select the WiFi network button to access and connect to WiFi networks. See sections 24 and 25 for technical specifications. Add WiFi network Edit WiFi network settings WiFi signal strength Delete WiFi network settings Select to connect to WiFi network Add a custom or hidden WiFi network. WiFi #1 WiFi #2 WiFi #3 WiFi #4 WiFi #5 WiFi #6 To connect the BD Prevue II Peripheral Vascular Access System to a WiFi network, perform the following steps:

1. Select the Menu button. 2. Select the Settings button. BD Prevue II Peripheral Vascular Access System Page 42 3. In the Settings window, select Connectivity Settings. 4. Enable Wifi (if not already enabled). 5. Select the WiFi network button. 6. Add a visible WiFi network, or select the Add Configuration button to add a custom or hidden WiFi network. 7. Fill in the required information and select the Save button. WiFi #1 WiFi #2 WiFi #3 WiFi #4 WiFi #5 WiFi #6 BD Prevue II Peripheral Vascular Access System Page 43 8. The system should now be connected to the WiFi network. WiFi #1 11.4.1.1. WPA2 Enterprise To connect to a WPA2 Enterprise network, fill out the fields provided when Enterprise is selected on the Configuration Window when adding a WiFi Network. BD Prevue II Peripheral Vascular Access System Page 44 11.4.2. Configure Network Settings Press the Configuration button to configure network settings for Wifi. Select Auto to automatically configure the network settings. Select Static to manually configure the network settings. 11.4.3. DICOM Settings (If enabled) To configure DICOM settings, press the DICOM Settings button. Fill in the information to configure the PACS server. Opens a window to allow a PING to a specified IP address. Input the IP address and select the PING button. Sends a standardized DICOM ECHO request to the specified PACS system. A indicates success and a red X indicates a failure. Exports a client certificate to USB for Secure DICOM server-

client authentication. Multiple PACS servers may be configured. To select from configured PACS servers or to add/modify a PACS server, press the DICOM Settings button. BD Prevue II Peripheral Vascular Access System Page 45 Delete PACS server. Edit PACS server settings. Select desired configured PACS server. Highlight indicates currently selected PACS server. Add new PACS server. 11.4.4. DICOM Conformance Statement Files are formatted according to Digital Imaging and Communications in Medicine. The DICOM conformance statement is available upon request. Call Customer Service at 1-800-545-0890. 11.4.5. CCE (if enabled) To connect to your hospitals CCE network, select CCE from the Connectivity Settings screen and fill in the fields provided on the resulting screen. BD Prevue II Peripheral Vascular Access System Page 46 11.5. System Information To access the system information, click on the system information tab at the top of the settings screen. The following screen will appear:

BD Prevue II Peripheral Vascular Access System software serial number. BD Prevue 2 Vascular Access System software version number. Customer Service contact information On-board Upgrade button. See section 20 once an upgrade is available. Electronic Literature QR Code. BD Prevue II Peripheral Vascular Access System Page 47 12. PATIENT INFORMATION To enter patient information into the BD Prevue II Peripheral Vascular Access System:

1. Select the Patient Name patient information button from the main ultrasound screen or Patient Information from the menu. 2. The following options will appear:

Add new patient. Previously unsaved patient data will be deleted. Allows the user to edit existing patient information. These changes will be applied to previously saved images for the current patient. Exits to the previous window. BD Prevue II Peripheral Vascular Access System Page 48 3. Enter the desired patient information. All fields are optional. Entered data will be saved with images. Backspace Enters patient data for image annotation and returns to the previous screen. Shift / Display additional Characters. Double click to lock the shift key. Space Enter 4. Select the Save button to retain the information and exit this screen. BD Prevue II Peripheral Vascular Access System Page 49 13. CLINICIAN PRESETS The BD Prevue II Peripheral Vascular Access System allows individual clinicians to retain their unique settings. Clinician presets will automatically retain the following settings for each clinician name:

Ultrasound image depth Ultrasound image brightness Center marks being on/off Probe Face Overlay being on/off Delete Clinician Discard changes and exit window Drop down menu to select the clinician Add Clinician Log Out Save changes and exit window To access the clinician presets menu, select the clinician button on the main ultrasound screen or in the menu. BD Prevue II Peripheral Vascular Access System Page 50 To access a preset, select the clinician name from the drop-down menu in the clinician presets menu. Any changes made to the settings will automatically be saved to the selected clinician name. To create a preset:

In the clinician preset menu select Add New Clinician. In the window that appears, type the clinician name and select Continue. In the clinician preset menu select save. 1. 2. 3. 4. Adjust the system settings as desired. To delete a clinician preset, select the clinician in the drop-down menu and press the Remove Clinician button. BD Prevue II Peripheral Vascular Access System Page 51 14. ACCESSING SAVED PATIENT IMAGES The BD Prevue II Peripheral Vascular Access System allows you to view and manage saved images. To access saved images, do the following:

1. Open the menu and select File Management (see Section 8). 2. A list of all saved patients appears in the window. Select patients to view their respective images. BD Prevue II Peripheral Vascular Access System Page 52 3. After selecting the patients, select the images to be managed. 4. To preview an image, touch the center of the image in the image list. The following preview will appear:

5. Once the desired image(s) have been selected, choose an action to perform from the toolbar. If available, export will send the selected image(s) to any of the pre-configured methods (see section 11.4). Note: To delete all patient data from the system, select all the patients in the patient list (see step 2) and press the delete button. BD Prevue II Peripheral Vascular Access System Page 53 15. OPERATING THE BD PREVUE II PERIPHERAL VASCULAR ACCESS SYSTEM The basic steps for operating the system in a procedure are listed below. 1) Turn on the system (by pressing the power switch on the bottom right side of the front of the system). 2) Verify the battery charge is sufficient for the procedure; otherwise connect the power adapter to the BD Prevue II Peripheral Vascular Access System. 3) Enter Patient Information as needed. 4) Position the patient and perform ultrasound assessment. 5) Apply conductive gel and probe covers per the Site~Rite Probe Cover instructions for use. Refer to all notes, cautions, and warnings at the end of this section. To drape the probe for sterile use, do the following:

a. Place the probe in the probe holder. b. Apply a layer of ultrasonic coupling gel on the acoustic window of the probe head. c. Make sure that the probe cover is fully rolled up. d. Place the probe cover over the probe head, being careful not to wipe off the coupling gel. e. Cover the probe and cable with the probe cover. f. Smooth the probe cover over the acoustic window of the probe head to remove any air bubbles or folds in the cover. g. Use the latex-free poly-bands to hold the probe cover in place. h. Apply a layer of sterile coupling gel to the covered acoustic window. 6) Adjust the image, as necessary. 7) Perform the procedure. 8) After use, the probe cover should be removed and disposed according to facility protocol. For cleaning the system, refer to Cleaning and Disinfecting the Equipment, Section 17. Caution:

Caution:

When using the BD Prevue II Peripheral Vascular Access System probe in a sterile environment, the probe and part of the probe cable must be covered with a sterile, acoustically transparent plastic probe cover. Some commercially available probe covers contain latex. Natural rubber latex may cause allergic reactions. Refer to the US FDA alert titled: Medical Alert: Allergic Reactions to Latex Containing Medical Devices, issued March 29, 1991. BD distributes sterile probe covers and needle-guide kits that are not made with natural rubber latex. Note:

To purchase Site~Rite Probe Covers, contact Bard Access Systems customer service at 1-800-545-0890 or visit our website at www.bardaccess.com. BD Prevue II Peripheral Vascular Access System Page 54 15.1. Access Using the Cue Needle Tracking System 1. Prepare the BD Prevue II Peripheral Vascular Access System. a. Verify the battery charge is sufficient for the procedure; otherwise connect the power adapter to the BD Prevue II Peripheral Vascular Access System. b. Enter Patient Information as needed. 2. Position the patient and perform ultrasound assessment. 3. Prepare the sterile field. a. Ensure all metallic objects are removed from the surrounding location (at least 4 inches away). If an object, such as a bed rail, cannot be moved, take precautions to make the object stationary during the procedure. b. Ensure all magnetic objects (e.g. magnets, mobile phones, electric motors, etc.) are removed from the surrounding location (at least 3 feet away). c. Retrieve the Cue Needle Tracking System compatible device, open the device packaging and scan the RFID tag on the device onto the scan icon on the system handle. d. Drape the ultrasound probe for sterile use (Refer to Probe Cover Instructions for Use.) e. If applicable, anesthetize the insertion site (per institution protocol). 4. Prepare for insertion a. Re-scan the anatomy of interest using the BD Prevue II Peripheral Vascular Access System. b. Ensure the Performance Indicator indicates an adequate environment for needle tracking, see section 10.2.2. c. Remove the needle from the packaging, and dip the needle with the needle cover still on into the Cue Magnetizer (Optional: place the Cue Magnetizer Cover into the Cue Magnetizer prior to dipping the needle). Remove the needle from the Cue Magnetizer. Caution:

Keep the needle and any ferromagnetic objects, e.g., wired undergarments, metal instruments, watches, jewelry, Cue Magnetizer, electronics metal bed rails, etc. at least 3 feet away from probe when calibrating. Failure to do so may impact the accuracy of needle tracking. BD Prevue II Peripheral Vascular Access System Page 55 Caution:

Equipment operating in close proximity may emit strong electromagnetic or radio frequency interference which could affect the performance of this device. Avoid operating the device near pumps, cauterizers, diathermy equipment, cellular phones, or other portable and mobile radio frequency communications equipment. Maintain equipment separation of at least 3 feet. Caution:

Excessive movement of the probe may result in a temporary loss of needle tracking. 5. Out-of-Plane Ultrasound Guided Insertion Using the Cue Needle Tracking System a. Retrieve the activated needle and move it towards the probe center mark at a 45 degree angle until it is within 0.5 cm from the probe. Ensure the Cue Needle Tracking System virtual needle overlay appears on the display and follows needle movement. Caution:

If needle tracking is not functioning properly, discontinue use of Cue Needle Tracking System. b. Position the needle by adjusting the insertion angle and distance from the probe to align the Intersection Window with the intended target structure. A steeper insertion angle may be necessary for deep structures while a shallow angle may be appropriate for superficial anatomy. Needle Trajectory Needle Shaft Intersection Window c. While maintaining the needle angle, insert the Cue Needle Tracking System compatible needle into the skin. Refer to the specific devices Instructions for Use for more information. d. Proceed with insertion watch needle advancement onscreen. The solid green lines represent the needle shaft and tip. The green square represents the area where the needle will intersect the ultrasound plane (color of line may vary, see sections 10.3.3 and 10.3.4). e. During advancement, maintain the Intersection Window centered with the intended target structure. f. When the solid green lines reach the Intersection Window, it means the needle has intersected the plane of the ultrasound beam within the Intersection Window. It does not mean insertion has been successful or the structure of interest has been reached. g. When attempting vessel access, watch for:

Anterior vessel wall indenting (once the puncture occurs the vessel will return to normal shape) Blood return in the device Needle reflection (flash of the needle tip) on the ultrasound image h. Complete procedure per suggested institutional guidelines. BD Prevue II Peripheral Vascular Access System Page 56 6. In-Plane Ultrasound Guided Insertion Using the Cue Needle Tracking System Note: In-plane needle tracking is not available with the BD Prevue II Vascular Access Probe. a. Retrieve the activated needle and move it towards the side of the probe at a 45o angle until it is within 0.5 cm from the probe. Ensure the Cue Needle Tracking System virtual needle overlay appears on the display and follows needle movement. Caution:

If needle tracking is not functioning properly, discontinue use of Cue Needle Tracking System. b. Position the needle by adjusting the insertion angle and distance from the probe to align the Cue Needle Tracking System Overlay with intended target structure. Note: In-Plane Mode does not have an Intersection Window. c. While maintaining the desired needle angle, insert the needle into the skin. Refer to the specific devices Instructions for Use for more information. d. Proceed with insertion watch needle advancement onscreen. The solid green lines represent the needle shaft and tip. e. During advancement, maintain the needle trajectory in the center of the intended target structure. Maintain the needle so that the virtual needle is centered in the Probe Face Overlay and the virtual needle is green. f. When attempting vessel access, watch for:

Anterior vessel wall indenting (once the puncture occurs the vessel will return to normal shape) Blood return in the needle hub Needle reflection (flash of the needle) on the ultrasound image g. Complete procedure per suggested institutional guidelines BD Prevue II Peripheral Vascular Access System Page 57 16. TROUBLESHOOTING 16.1. BD Prevue II Peripheral Vascular Access System Troubleshooting Troubleshooting - BD Prevue II Peripheral Vascular Access System SYMPTOM DESCRIPTION SOLUTIONS Error Code EC: 201-203 EC: 205 EC: 211 Error Code EC: 204 System plays a sound every minute Ultrasound Hardware Failure Probe Disconnect Error Reboot the System. Note: If error persists, call Customer Service at 1-800-545-0890. An alternate number may be available in the System Information Tab (see Section 11.5). If applicable, ensure the probe is securely connected to the system. See Section 3.3. Note:

If error persists, call Customer Service at 1-800-545-0890. An alternate number may be available in the System Information Tab (see Section 11.5). Low Battery Connect system to power for continued operation and to recharge battery. Error Code EC: 110 Battery Error Power Problem System will not turn on or turns on but immediately turns off A/C adapter indicator does not change states when A/C power is connected Connection error Connect AC adapter for operation. Ensure the battery switch is in the position. (See Section 4.) Note: If error persists, call Customer Service at 1-800-545-0890. An alternate number may be available in the System Information Tab (see Section 11.5). 1. Press and hold the power switch for at least 2 seconds to turn the system on. 2. Connect system to AC power for operation and to recharge the battery. Note: If error persists, call Customer Service at 1-800-545-0890. An alternate number may be available in the System Information Tab (see Section 11.5). 1. Unplug the AC adapter and plug it back in to the system. 2. Restart the system if necessary. Note: If error persists, call Customer Service at 1-800-545-0890. An alternate number may be available in the System Information Tab (see Section 11.5). The USB storage device may be full or may not be a compatible USB storage device. Error Code EC:102 Error Code EC:103 USB storage device error Replace the USB storage device. Note: If error persists, call Customer Service at 1-800-545-0890. An alternate number may be available in the System Information Tab (see Section 11.5). Restart the system. Hard Drive error Note: If error persists, call Customer Service at 1-800-545-0890. An alternate number may be available in the System Information Tab (see Section 11.5). BD Prevue II Peripheral Vascular Access System Page 58 Troubleshooting - BD Prevue II Peripheral Vascular Access System SYMPTOM DESCRIPTION SOLUTIONS Poor Image System becomes unresponsive Cannot connect to desired network System password is lost Error Code EC:105 Error Code EC:106 Deleting Error Network Error Error Code EC:107 PACS Error 1. Adjust the image settings

- Depth (see Section 7.1.7)

- Brightness (see Section 7.1.6) 2. Lack of couplant. Apply ultrasound gel. Note: If error persists, call Customer Service at 1-800-545-0890. An alternate number may be available in the System Information Tab (see Section 11.5). Press and hold the power switch on the front of the device until the system shuts down. (Note: This will take approximately 10 seconds.) Turn on the system. Note: If error persists, call Customer Service at 1-800-545-0890. An alternate number may be available in the System Information Tab (see Section 11.5). 1. Confirm that the DICOM features are activated on the system (see Section 11.4.3). 2. Confirm that WiFi is enabled and the device is connected to your network

(see Section 11.4.1). 3. Check the WiFi signal strength. 4. Contact your network administrator. Refer to section 11.4. Note: If error persists, call Customer Service at 1-800-545-0890. An alternate number may be available in the System Information Tab (see Section 11.5). 1. Contact customer service and provide the system date and serial number for a temporary password. Call Customer Service at 1-800-545-0890. An alternate number may be available in the System Information Tab (see Section 11.5). 1. Restart the system. Attempt to delete the file(s). Note: If error persists, call Customer Service at 1-800-545-0890. An alternate number may be available in the System Information Tab (see Section 11.5). 1. Ensure the device is connected to the desired network. 2. 3. Contact your network administrator. If using a static IP address, verify the static network settings. Note: If error persists, call Customer Service at 1-800-545-0890. An alternate number may be available in the System Information Tab (see Section 11.5). 1. Ensure you are connected to the desired network. 2. Ensure that the system DICOM settings are compatible with the destination PACS system settings. 3. Contact your network administrator. Note: If error persists, call Customer Service at 1-800-545-0890. An alternate number may be available in the System Information Tab (see Section 11.5). 1. Ensure you are connected to the desired network. 2. Ensure that the system DICOM settings are compatible with the destination Error Code EC:108 Error Code EC:111 PACS ECHO Error PACS system settings. 3. Contact your network administrator. General System Error Note: If error persists, call Customer Service at 1-800-545-0890. An alternate number may be available in the System Information Tab (see Section 11.5). 1. Restart the system. Note: If error persists, call Customer Service at 1-800-545-0890. An alternate number may be available in the System Information Tab (see Section 11.5). BD Prevue II Peripheral Vascular Access System Page 59 Troubleshooting - BD Prevue II Peripheral Vascular Access System SYMPTOM DESCRIPTION SOLUTIONS Error Code EC:112 File Reading Error WiFi Connection Error Error in WiFi Networks list 1. Failed to read configuration file. Some user settings may be lost. Note: If error persists, call Customer Service at 1-800-545-0890. An alternate number may be available in the System Information Tab (see Section 11.5). 1. Ensure the security key is correct. 2. Ensure the WiFi configuration is correct. 3. Contact your network administrator Note: If error persists, call Customer Service at 1-800-545-0890. An alternate number may be available in the System Information Tab (see Section 11.5). Note: This device is equipped with a lithium ion battery. Lithium ion battery performance is known to degrade over time based on environmental and use conditions. These messages are intended to help manage the life of the battery. Pre-Critical Warning This window appears when the battery is approaching the end of its useful life. It is recommended that the battery be replaced. Critical Warning This window appears when the batterys integrity has reached a critical stage, indicating the system detected the battery has reached the end of its useful life and that without AC power, the system is likely to shut down. The message will only disappear at startup when the system is connected to AC power. BD Prevue II Peripheral Vascular Access System Page 60 16.2. Cue Needle Tracking System Troubleshooting SYMPTOM DESCRIPTION SOLUTIONS Troubleshooting - Cue Needle Tracking System Error Code EC: 501 Error Code EC: 502 Error Code EC: 503-509 Cue Needle Tacking System Sensor Disconnect Error Calibration Error 1. Ensure the Cue Needle Tacking System Probe is securely connected to the system. 2. Restart the system. Note: If error persists, call Customer Service at 1-800-545-0890. An alternate number may be available in the System Information Tab (see Section 11.5). 1. Restart the system. 2. Ensure the probe is held in the air during calibration, see section 11.2.1. Note: If error persists, call Customer Service at 1-800-545-0890. An alternate number may be available in the System Information Tab (see Section 11.5). Cue Needle Tacking System Error Restart the system. Note: If error persists, call Customer Service at 1-800-545-0890. An alternate number may be available in the System Information Tab (see Section 11.5). Cue Needle Tracking System is not activated when the RFID is scanned. Likely cause: The system is in capture mode. Select the scan button to exit capture mode. Likely cause: The needle was introduced or re-introduced too quickly. If tracking signal drops during needle approach, remove the needle at least two feet (61cm) away from the probe for at least three seconds, allow the Performance Indicator to stabilize, and slowly re-approach the probe. Likely cause: Magnetic field interference. Cue Needle Tracking System Probe does not detect Cue Needle Tracking System Enabled Needle Likely cause: Probe is in need of calibration. If the Performance Indicator is low, perform the following steps:

Hold the probe still If the Performance Indicator decreases during needle approach, withdraw the needle and slowly re-approach. Remove metal, magnetic, and electronic objects in close proximity to the probe (bed rails, jewelry, mobile phone, pumps, bed/table frames, Cue Magnetizer, etc.). If problem persists, hold the probe stationary in the air away from all metal, magnetic, and electronic devices. If the Performance Indicator improves, review previous troubleshooting tips If the Performance Indicator remains low, calibration may be required. This should be uncommon. See section 11.2.1. If problem persists, hold the probe stationary in the air away from all metal, magnetic, and electronic devices. If the Performance Indicator improves, review previous troubleshooting tips If the Performance Indicator remains low, calibration may be required. This should be uncommon. See section 11.2.1. Note: If error persists after calibration, call Customer Service at 1-800-545-0890. An alternate number may be available in the System Information Tab (see Section 11.5). BD Prevue II Peripheral Vascular Access System Page 61 SYMPTOM DESCRIPTION SOLUTIONS Troubleshooting - Cue Needle Tracking System Likely cause: Magnetic field interference If the Performance Indicator is low, perform the following steps:

Hold the probe still If the Performance Indicator decreases during needle approach, withdraw the needle and slowly re-approach. Remove metal, magnetic, and electronic objects in close proximity to the probe (bed rails, jewelry, mobile phone, pumps, bed/table frames, Cue Magnetizer, etc.). If problem persists, hold the probe stationary in the air away from all metal, magnetic, and electronic devices. If the Performance Indicator improves, review previous troubleshooting tips If the Performance Indicator remains low, calibration may be required. This should be uncommon. See Section 11.2.1. Note: If error persists after calibration, call Customer Service at 1-800-545-

0890. An alternate number may be available in the System Information Tab

(Section 11.5). Needle tracking virtual needle image has erratic behavior Likely cause: Excessive movement of probe and/or needle. 1. Anchor the probe in a stationary and upright position. 2. Stabilize the hand holding the needle. 3. Only modify the position of the needle to change the location of the Intersection Window. Likely cause: Needle detection reset is required. 1. 2. 3. If prior to insertion, withdraw the needle and slowly re-approach. If after needle insertion, withdraw the probe away from the needle and slowly re-approach. If problem persists, activate a new needle. Difficulty aligning and maintaining the Intersection Window on the target structure Likely cause: Performance Indicator too low. If the Performance Indicator is low, perform the following steps:

Hold the probe still If the Performance Indicator decreases during needle approach, withdraw the needle and slowly re-approach. Remove metal, magnetic, and electronic objects in close proximity to the probe (bed rails, jewelry, mobile phone, pumps, bed/table frames, Cue Magnetizer, etc.). If problem persists, hold the probe stationary in the air away from all metal, magnetic, and electronic devices. If the Performance Indicator improves, review previous troubleshooting tips If the Performance Indicator remains low, calibration may be required. This should be uncommon. See Section 11.2.1. If the needle overlay disappears during insertion, withdraw the probe away from the needle and slowly re-approach to restart tracking. Note: If error persists after calibration, call Customer Service at 1-800-545-

0890. An alternate number may be available in the System Information Tab

(Section 11.5). BD Prevue II Peripheral Vascular Access System Page 62 SYMPTOM DESCRIPTION SOLUTIONS Troubleshooting - Cue Needle Tracking System Drop out the needle overlay disappears during insertion Likely cause: Needle detection reset is required. 1. 2. 3. If prior to insertion, withdraw the needle and slowly re-approach. If after needle insertion, withdraw the probe away from the needle and slowly re-approach. If problem persists, activate a new needle. 16.2.1. Cue Needle Tracking System Troubleshooting To test the functionality of the Cue Needle Tracking System, perform the following steps:

1) Move all metal objects (including the needle) at least 4 inches away from the Cue Needle Tracking System Probe. 2) Move all active electronic devices and magnetic articles at least 3 feet away. 3) Obtain a small container of water. 4) 5) Check the Performance Indicator bars. Verify there are three or more bars. If there are less than Immerse the end of the probe into the container of water. 6) three bars, perform calibration. Introduce the needle to the probe slowly to observe the overlay. Place the Intersection Window at 1 cm depth below the ultrasound beam. 7) Advance the needle to the Intersection Window until there is a strong needle flash in the Intersection Window. Observe the location of the needle flash and the needle advancement lines, making sure they contact the Intersection Window and the needle flash appears in the Intersection Window. BD Prevue II Peripheral Vascular Access System Page 63 17. CLEANING AND DISINFECTING THE EQUIPMENT Thorough cleaning of all the contaminated surfaces is the first crucial step in providing adequate removal of contaminants and debris prior to the disinfection step. The reduction of patient-to-patient cross-contamination and the reduction of the risk of patient infection significantly depends on the thoroughness of the initial cleaning. The following cleaning and disinfections steps should be performed as soon as possible at the point-of-use of the equipment. Prompt cleaning after use is the most effective measure to prevent the drying of soil on the device surface and to facilitate the subsequent disinfection steps. Any delay between the Cleaning step (Section 17.1) and the Disinfection step (Section 17.2) should be minimized as much as possible, as delays may create conditions favorable to microbial growth, possibly reducing the effectiveness of a proper disinfection. 17.1. Cleaning of the Equipment (Point-of-Use Processing) 1) Turn off the system. 2) Dampen a nonabrasive cloth with either warm water or isopropyl alcohol. 3) Thoroughly wipe the dampened cloth over exterior surfaces that require cleaning (e.g., probes, console, etc.), making sure to completely remove all soil, debris and other visible contaminants, including the removal of all particles or other matter from all surfaces and crevices. 4) Visually inspect the surfaces of the equipment to verify the adequacy of the cleaning. If the equipment is determined not to be visually clean, repeat the cleaning steps #2 and #3 above. If it is not possible to remove all soil and contaminants, properly dispose of the contaminated components and contact Customer Service at 1-800-545-0890 for replacements. Do not use visibly soiled equipment. 5) Allow the equipment to dry completely before proceeding to the Disinfection step below. 17.2. Disinfection of the Equipment 1) Use only medical grade disinfectants approved for use in a hospital setting. The disinfectants listed in Section 17.3 below are compatible with this equipment. 2) Use two or more towelettes to thoroughly disinfect all probe and other soiled surfaces for at least two minutes. Follow any specific directions for use specified by the manufacturer of the cleaning product used. 3) Repeat Step 2 using two new towelettes. 4) Allow the equipment to dry completely (if applicable, follow the drying instructions recommended by the disinfectant manufacturer) before using the equipment with the next patient. 5) Visually inspect the equipment for any damage or deterioration. Should the equipment show signs of unacceptable deterioration, properly dispose of the damaged components and contact Customer Service at 1-800-545-0890 for replacements. Do not use damaged equipment. BD Prevue II Peripheral Vascular Access System Page 64 17.3. Compatible Cleaners The following cleaning agents are compatible with the BD Prevue II Peripheral Vascular Access System and probes:

PDI Super Sani-Cloth Germicidal Disposable Wipes PDI Sani-Cloth AF3 PDI Prime Clorox Healthcare Hydrogen Peroxide Cleaner Disinfectant Wipes Clorox Healthcare Bleach Germicidal Cleaner Metrex Research CaviWipes Disinfecting Towelettes Metrex Research CaviWipes1 An updated list may be available by contacting Bard Access Systems for the BD Prevue II Peripheral Vascular Access System Compatible Disinfectants document. (800) 545-0890. Warning:

Failure to properly clean and disinfect the system can lead to cross contamination between patients. Caution:

Caution:

Caution:

Caution:

Note:

Note:

Note:

Do not allow liquid to enter the system, AC adapter, connectors, or ports; damage to the equipment may occur. Do not attempt to sterilize the BD Prevue II Peripheral Vascular Access System or probe; damage to the equipment may occur as a result. Use only BD cleaning and disinfection procedures. Failure to do so may damage the device. Use only approved or recommended cleaners or disinfectants to avoid damaging the equipment. When cleaning the system and components, it is important to remove all particles or other matter from all surfaces and crevices. Do not spray cleaners directly onto the BD Prevue II Peripheral Vascular Access System display. If disinfecting the probe with a liquid disinfectant, do not soak the probe cable or cable bend relief. Note:

Disinfection can take place under normal hospital environmental conditions. BD Prevue II Peripheral Vascular Access System Page 65 18. WARRANTY BD warrants to the original purchaser that this product will be free from defects in material and workmanship for a period of one (1) year from the date of purchase. If this product proves to be so defective, purchaser may return same to BD for repair, replacement, refund, or credit at BDs option. All returns must be authorized in advance in accordance with BDs Returned Goods Policy found in its then current Price List. The warranty on the repaired or replaced unit continues from the purchase date of the original unit. The liability of BD under this limited warranty does not extend to any abuse, misuse, modification, improper storage, alteration, further manufacture, packaging or processing of this product or repair by anyone other than a BD representative. The following will also void this limited warranty:

Opening or servicing any component of the BD Prevue II Peripheral Vascular Access System by anyone other than BD authorized service personnel. Removing system labels by anyone other than service personnel authorized by BD. Connecting the BD Prevue II Peripheral Vascular Access System display to any AC adapter other than the system adapter. Connecting the BD Prevue II Peripheral Vascular Access System to any unauthorized accessory. Refer to the list of authorized accessories in the Overview section. Installing unauthorized software. Modification of system software without authorization by BD. THIS LIMITED PRODUCT WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, (INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE). THE LIABILITY AND REMEDY STATED IN THIS LIMITED PRODUCT WARRANTY WILL BE THE SOLE LIABILITY OF BARD ACCESS SYSTEMS INC. AND REMEDY AVAILABLE TO PURCHASER FOR THIS PRODUCT, WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, AND BARD ACCESS SYSTEMS INC. WILL NOT BE LIABLE TO PURCHASERS FOR ANY INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES ARISING OUT OF ITS HANDLING OR USE. Some states/countries do not allow an exclusion of implied warranties, incidental or consequential damages. You may be entitled to additional remedies under the laws of your state/country. BD Prevue II Peripheral Vascular Access System Page 66 19. SERVICE AND REPAIR The BD Prevue II Peripheral Vascular Access System does not require any scheduled maintenance, system checks, or calibration. For servicing information or to return your BD Prevue II Peripheral Vascular Access System for repair, please contact BD technical/clinical support at 1-800-443-3385. 19.1. Accessory Replacement 19.1.1. Cue Magnetizer Replacement If a Cue Magnetizer is needed, contact BD technical/clinical support at 1-800-443-3385. Once the new Cue Magnetizer is received, do the following (if a Cue Magnetizer is not already attached, skip to step 3):

1) Remove the Cue Magnetizer by pulling up and removing the Cue Magnetizer from the mount. 2) Remove the screw to remove the Cue Magnetizer Mount. BD Prevue II Peripheral Vascular Access System Page 67 3) Identify the screw slot for the mount on the right side of the console. 4) Screw in the Cue Magnetizer Mount with the screw provided Caution:

Only use the provided screw when attaching the Cue Magnetizer to the system as others may impact the functionality of the Cue Magnetizer. BD Prevue II Peripheral Vascular Access System Page 68 5) Slide the Cue Magnetizer onto the Cue Magnetizer Mount. 19.1.2. Probe Holder Replacement If a Probe Holder is needed, contact BD technical/clinical support at 1-800-443-3385. Once the new Probe Holder is received, do the following (if a Probe Holder is not already attached, skip to step 3):

1) Remove the Probe Holder by pulling up and removing the Cue Magnetizer from the mount. BD Prevue II Peripheral Vascular Access System Page 69 2) Remove the screw to remove the Probe Holder Mount. 3) Identify the screw slot for the mount on the left side of the console. BD Prevue II Peripheral Vascular Access System Page 70 4) Screw in the Probe Holder Mount. 5) Slide the Probe Holder onto the Probe Holder Mount. BD Prevue II Peripheral Vascular Access System Page 71 19.1.3. Cord Wrap Replacement If a Cord Wrap is needed, contact BD technical/clinical support at 1-800-443-3385. Once the new Cord Wrap is received, do the following:

1) Identify the four screw holes on the back of the console. 2) Screw in the Cord Wrap on the upper 2 screw holes. Note: If a Roll Stand Mount is also being used. Attach the Roll Stand Mount with the lower 2 screws and attach the Cord Wrap to the top 2. BD Prevue II Peripheral Vascular Access System Page 72 19.2. Battery Replacement If a new battery is needed, contact BD technical/clinical support at 1-800-443-3385. Once the new battery is received, do the following:

1) Power off the system. 2) Remove the screws on the plate that covers the BD Prevue II battery. BD Prevue II Peripheral Vascular Access System Page 73 3) Remove the plate covering the battery. 4) Remove the battery from the console. BD Prevue II Peripheral Vascular Access System Page 74 5) Disconnect the battery from the internal battery cable, replace with the new battery, and reassemble the device. BD Prevue II Peripheral Vascular Access System Page 75 20. UPGRADING The BD Prevue II Peripheral Vascular Access System is equipped with On-board Upgrade functionality. For upgrading via On-bard Upgrade, do the following:

1) Ensure the device is connected to the internet. The On-board Upgrade process will download the upgrade automatically once connected. 2) Once the upgrade has been fully downloaded, navigate to the system information settings tab, which will provide information on the upgrade including the software version and the estimated upgrade time. 3) Select the upgrade button next to the upgrade information and select confirm to begin the upgrade process. 4) Do not attempt to cancel the upgrade procedure as this may cause applications to malfunction. If an error occurs during the upgrade procedure, reboot the system and repeat the upgrade procedure again. If the error persists, contact the BD technical/clinical support at 1-800-

443-3385. 5) Restart the system. 6) Confirm desired software version is displayed in the system information (section 11.5). Additionally, the software upgrade information will indicate that the system is up to date and the upgrade button will no longer be selectable. If you are unable to connect to the internet, contact your local BD representative for a USB drive with the latest version of BD applications. For U.S. customers only, available upgrades may also be obtained by visiting www.bardaccess.com/products/ultrasound. Once received, do the following:

1) Insert USB drive into one of the USB ports on the BD Prevue II Peripheral Vascular Access System. 2) Answer yes when prompted to proceed with the upgrade. 3) Do not attempt to cancel the upgrade procedure or remove the USB drive, as this may cause applications to malfunction. Follow the onscreen prompts to complete the software upgrade. If an error occurs during upgrading procedure, reboot the system and repeat the upgrade procedure again. If the error persists, contact the BD technical/clinical support at 1-800-

443-3385. 4) Restart the system. 5) Confirm desired software version is displayed in the system information (section 11.5). Now it is safe to remove the USB drive. 21. DISPOSAL INFORMATION To return the BD Prevue II Peripheral Vascular Access System for end-of-life recycling, please contact your nearest Bard sales or distribution office in the country of purchase. Caution:

The BD Prevue II Peripheral Vascular Access System contains an internal battery. Dispose of dead battery packs in accordance with local regulations; improper disposal may present an environmental hazard. BD Prevue II Peripheral Vascular Access System Page 76 22. ACOUSTIC INFORMATION The following acoustic information pertains to both the Traditional probe and the Vascular Access Probe, which are acoustically identical. 22.1. Acoustic Output Summary Table Description Operating Mode Ispta.X (X denotes statistically determined maximum) BD Prevue II Probes (Traditional probe and Vascular Access Probe) B 12.69 mW/cm2 FDA Ispta.3 Published Values Peripheral Vessel

< 720 mW/cm2 Cardiac

< 430 mW/cm2 Fetal Imaging &

Other**

< 94 mW/cm2 MI X (X denotes statistically determined maximum) 0.91 FDA MI Published Values Peripheral Vessel

< 1.9 Cardiac

< 1.9 Fetal Imaging &

Other**

< 1.9

** Abdominal, Intraoperative, Pediatric, Small Organ (breast, thyroid, testes, etc), Neonate Cephalic, Adult Cephalic. 22.2. Acoustic Output Reporting Table Operating Mode: B-Mode (Traditional Probe and Vascular Access Probe) Index Label Maximum Index Value Index Component Value MI 0.65 TIS TIB At Surface Below Surface At Surface Below Surface 0.0542 0.0542 0.0542 0.0542 0.0542 0.0542 TIC 0.22 Acoustic Parameters Other Information Operating Control Conditions 1.75

(MPa)

(mW)

(mW)

(cm)

(cm)

(cm)

(cm)

(MHz)

(Hz)

(Hz) pr, at zMI P P1X1 zs zb zMI Zpii, fawf Prr Srr npps Ipa, at zpii, Ispta, at zpii, or zsii, Ispta at zpii or zsii Pr at zpii 10 MHz 9mm or 14mm focus (Max Value Reported) 1.13 1.13 7.18 7424.0 116.0 1 136.56 7.48 13.17 2.10

(W/cm2)

(mW/cm2)

(mW/cm2)

(MPa) 1.13 3.05 1.58 7.18 3.05 1.58 0.97 7.18 7.18 Note 1 Note 2 Note 3 Note 4 Note 5 Note 6 Note 7 Only one operating condition per index. Data should be entered for at surface and below surface both in the columns related to TIS or TIB. Information need not be provided regarding TIC for a TRANSDUCER ASSEMBLY not intended for transcranial or neonatal cephalic uses. If the requirements of 201.12.4.2a) are met, it is not required to enter any data in the columns related to TIS, TIB or TIC. If the requirements of 201.12.4.2b) are met, it is not required to enter any data in the column related to MI. Unshaded cells should have a numerical value. The equipment setting related to the index has to be entered in the operating control section. The depths zpii and zpii, apply to NON-SCANNING MODES, while the depths zsii and zsii, apply to SCANNING MODES. BD Prevue II Peripheral Vascular Access System Page 77 23. EMC TABLES Warning: The use of accessories other than those specified in the Overview section may result in increased emissions or decreased immunity of the BD Prevue II Peripheral Vascular Access System. BD Prevue II Peripheral Vascular Access System EMC Tables Guidance and Manufacturers Declaration - Emissions The BD Prevue II Peripheral Vascular Access System is intended for use in the electromagnetic environment specified below. The customer or user of the BD Prevue II Peripheral Vascular Access System should ensure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions CISPR 11 /

EN55011 RF Emissions CISPR 11 /

EN55011 Harmonics IEC 61000-3-2 Flicker IEC 61000-3-3 Group 1 Class A Class A Complies The BD Prevue II Peripheral Vascular Access System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The BD Prevue II Peripheral Vascular Access System is suitable for use in all establishments, other than domestic, and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Guidance and Manufacturers Declaration Immunity The BD Prevue II Peripheral Vascular Access System is intended for use in the electromagnetic environment specified below. The customer or user of the BD Prevue II Peripheral Vascular Access System should ensure that it is used in such an environment. Immunity Test EN/IEC 60601 Test Level Compliance Level ESD EN/IEC 61000-4-2 6kV Contact 8kV Air 6kV Contact 8kV Air EFT EN/IEC 61000-4-4 2kV Mains 1kV Input/Output Lines 2kV Mains 1kV Input/Output Lines Surge EN/IEC 61000-4-5 1kV Differential 2kV Common 1kV Differential 2kV Common Electromagnetic Environment Guidance Floors should be wood, concrete or ceramic tile. If floors are synthetic, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. BD Prevue II Peripheral Vascular Access System Page 78 Guidance and Manufacturers Declaration Immunity The BD Prevue II Peripheral Vascular Access System is intended for use in the electromagnetic environment specified below. The customer or user of the BD Prevue II Peripheral Vascular Access System should ensure that it is used in such an environment. Immunity Test EN/IEC 60601 Test Level Compliance Level

>95% Dip for 0.5 Cycle

>95% Dip for 0.5 Cycle Voltage Dips/Dropout EN/IEC 61000-4-11 60% Dip for 5 Cycles 60% Dip for 5 Cycles 30% Dip for 25 Cycles 30% Dip for 25 Cycles

>95% Dip for 5 Seconds

>95% Dip for 5 Seconds Power Frequency 50/60 Hz Magnetic Field EN/IEC 61000-4-8 3 A/m 3 A/m Electromagnetic Environment Guidance Mains power quality should be that of a typical commercial or hospital environment. If the user of the BD Prevue II Peripheral Vascular Access System requires continued operation during power mains interruptions, it is recommended that the BD Prevue II Peripheral Vascular Access System be powered from an uninterruptible power supply or battery. Power frequency magnetic fields should be that of a typical commercial or hospital environment. BD Prevue II Peripheral Vascular Access System Page 79 Guidance and Manufacturers Declaration Emissions The BD Prevue II Peripheral Vascular Access System is intended for use in the electromagnetic environment specified below. The customer or user of the BD Prevue II Peripheral Vascular Access System should ensure that it is used in such an environment. EN/IEC 60601 Test Level Electromagnetic Environment Guidance Compliance Level Immunity Test Conducted RF EN/IEC 61000-4-

6 Radiated RF EN/IEC 61000-4-

3 3 Vrms 150 kHz to 80 MHz 3 Vrms 3 V/m 80 MHz to 2.5 GHz 3 V/m Portable and mobile communications equipment should be separated from the BD Prevue II Peripheral Vascular Access System by no less than the distances calculated/listed below:

D = 1.2 ( P) D = 1.2 ( P) 80 to 800 MHz D = 2.3 ( P) 800 MHz to 2.5 GHz where P is the max power in watts and D is the recommended separation distance in meters. Field strengths from fixed transmitters, as determined by an electromagnetic site survey, should be less than the compliance levels. Interference may occur in the vicinity of equipment containing a transmitter. Recommended Separation Distances between portable and mobile RF Communications equipment and the BD Prevue II Peripheral Vascular Access System The BD Prevue II Peripheral Vascular Access System is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of the BD Prevue II Peripheral Vascular Access System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the BD Prevue II Peripheral Vascular Access System as recommended below, according to the maximum output power of the communications equipment. Separation (m) 150 kHz to 80 MHz D = 1.2 ( P)

.1166

.3689 1.1666 3.6893 11.6666 Separation (m) 800 MHz to 2.5 GHz D =2.3 ( P)

.2333

.7378 2.3333 7.3786 23.3333 Separation (m) 80 to 800 MHz D = 1.2 ( P)

.1166

.3689 1.1666 3.6893 11.6666 Max Output Power

(Watts) 0.01 0.1 1 10 100 BD Prevue II Peripheral Vascular Access System Page 80 Essential Performance The BD Prevue II Peripheral Vascular Access System complies with Essential Performance Requirements specified in IEC 60601-1-2 and IEC 60601-2-37. The BD Prevue II Peripheral Vascular Access System is free from the following:

- Noise on a waveform or artifacts or distortion in an image or error of a displayed numerical value which cannot be attributed to a physiological effect and which may alter the diagnosis. The display of incorrect safety-related indications. The production of unintended or excessive ultrasound output. The production of unintended or excessive Transducer Assembly surface temperature.

- Deviations from reported system accuracy.

- Display from inaccurate Cue Needle Tracking System information that could negatively affect the procedure. BD Prevue II Peripheral Vascular Access System Page 81 24. TECHNICAL SPECIFICATIONS Operating and Storage Conditions Operating Temperature Storage Temperature Operating Humidity Storage Humidity 41 F to 95 F (5C to 35C) 0 F to 104 F (-18C to 40C) 90% Relative Humidity (non-condensing) 90% Relative Humidity (non-condensing) Dimensions Weight Power Sources Power Consumption IEC 60601-1 System Specifications 226 x 197.5 x 95 mm 4.0 lb (1.8 kg) A/C adapter, Internal Battery Pack 65 Watts Class II, Type BF Applied Part, Continuous Operation, Internally Powered Equipment, Not Category AP or APG Equipment, IPX1. Battery Chemistry Battery Capacity (Full Charge):

Nominal Battery Output Voltage:

Battery Output Current (Max):

System Run Time on Full Charge Charge Time (Full) System Battery Specifications Lithium Ion 3250mAh 10.8VDC 3.0A Up to 2 Hours 3 Hours Input voltage Input Current (Max) Output Voltage Output Current (Max) Frequency Elevation Focus Maximum Scan Depth Scan Width System AC Adapter Specifications 100-240 VAC, 50/60 Hz 1.8A 19V 3.43A Probe Specifications 7.513 MHz 20mm 2.5cm 20mm Vessel Evaluation Error Measurement Diameter Vessel Occupancy Remaining Catheter Length Error

< 10%

< 10%

< 10%

Range 020mm 0100%

0100%

BD Prevue II Peripheral Vascular Access System Page 82 Needle tracking accuracy is within the Intersection Window*

Cue Needle Tracking System Accuracy

*Results have 95% confidence with 99.4% reliability from bench top testing in a controlled environment. Remaining Catheter Length and Insertion Angle error is <10%. Caution:

Improper technique and environmental conditions may introduce variation in accuracy. 25. BD Prevue II Peripheral Vascular Access System WIRELESS TECHNOLOGIES (if enabled) Function Technology Wireless Ethernet The BD Prevue II Peripheral Vascular Access System incorporates a standard IEEE 802.11 b/g/n transceiver to provide a wireless Ethernet connection to DICOM servers and network PCs. This connection can be used for archiving data. Bluetooth capabilities are also included for wireless pairing to approved accessories. The Cue Activator contains an RFID reader. RF and Wireless Technology Summary Bluetooth Bluetooth V5.0, V4.2, V4.1, V4.0 LE, V3.0+HS, V2.1+EDR, compatible with versions 1.1, 1.2 and 2.0. Transmit/Receive 802.11 ac/a/b/g/n ISO 14443 Transmit/Receive RFID Transmit/Receive Frequency Modulation Operating Range

(meters) Bandwidth Transmit/Receive ISM frequency Band

(2.4/5 GHz) 802.11 a/ac 5.15-5.85 GHz 802.11 b/g 2.412-2.4835 GHz 802.11ac: 256QAM, 64QAM, 16QAM, QPSK, BPSK 802.11a: 64QAM, 16QAM, QPSK, BPSK 802.11b: CCK, DQPSK, DBPSK 802.11g: 64QAM, 16QAM, QPSK, BPSK 802.11n: BPSK, QPSK, 16QAM, 64QAM 2.4 GHz ISM Bands 2.412-2.4835

<38 GHz 802.11 a/ac 2.402 - 2.480 GHz 13.56 MHz 7kHz GFSK,

/4-DQPSK and 8-

DPSK ASK modulation with a modified Miller encoding

<10 4.5cm 2.402 - 2.480 GHz 13.56 MHz 7kHz 5 GHz ISM Band 5.15-5.85 GHz 802.11 b/g Operating Range

(meters)

<38

<10 4.5cm BD Prevue II Peripheral Vascular Access System Page 83 Transmit Output Power Quality of Service (QoS) Since the BD Prevue II Peripheral Vascular Access System uses WLAN to transmit patient data to a DICOM system and does not relate to real-time scanning operations, these communications are on a best-efforts basis, where other data on the network may be given higher priority if there is a bandwidth conflict. BD Prevue II Peripheral Vascular Access System Page 84 Quality of Service (QoS) Wireless Ethernet The wireless Ethernet on the BD Prevue II Peripheral Vascular Access System operates as a best-efforts device, as it does not directly involve or interfere with active scanning. As such, it does not require a formal QoS WLAN. If used on a QoS network, its transmitted data may receive a lower priority than video or voice that is also transmitted on the same network. The following table provides recommended metrics to achieve a high level of performance from the BD Prevue II Peripheral Vascular Access System wireless configuration. Parameter IEEE 802.11 Level Wireless Signal Rate Distance to Access Point Security type*

Encryption Types Specification Comment Stated maximum for each standard. Data transfer will be lower and is directly affected by separation distance between the console and the wireless access point, network conditions, building layout, etc. Though the stated maximum may be 38 meters, it is not usually achievable in hospital settings. WPA2 provides better security than former methods.

IEEE 802.11 ac/a/b/g/n 54 Mbps (IEEE 802.11a) 11 Mbps (IEEE 802.11b) 54 Mbps (IEEE 802.11g) MCS 15 (IEEE 802.11n) MCS 9 (IEEE 802.11ac)

< 38 meters WPA2 WEP/WPA-PSK/WPA2-PSK AES DHCP DHCP basic DHCP renewal FreeRadius Ping Test PSK PSK-AES PSK-TKIP TKIP TLS TLS WPA2 TTLS WPA2 WPA WPA2 WPA2-PEAP WPA2-PEAP (Certificate) WPA2-PEAP-EAPMSCHAPV2 WPA2-PEAP-EAPMSCHAPV2

(Certificate) WPA2-PEAP-EAPTLS WPA2-PEAPv0 (EAPTLS) (Certificate) WPA2-PEAPv0 (MS-CHAPv2)

(Certificate) WPA2-PSK ASCII WPA2-PSK hex key WPA2-TTLS WPA2-TTLS-CHAP WPA2-TTLS-CMSCHAP BD Prevue II Peripheral Vascular Access System Page 85 Comment Parameter Encryption Types (Cont.) Specification WPA2-TTLS-EAPMSCHAPV2 WPA2-TTLS-EAPTLS WPA2-TTLS-MSCHAP WPA2-TTLS-MSCHAPV2 WPA2-TTLS-PAP WPA-MSCHAPV2 WPA-PEAP WPA-PEAP (Certificate) WPA-PEAP-EAPMSCHAPV2 WPA-PEAP-EAPMSCHAPV2

(Certificate) WPA-PEAP-EAPTLS WPA-PEAP-EAPTLS (Certificate) WPA-PEAPv0 (EAPTLS) WPA-PEAPv0 (EAPTLS) (Certificate) WPA-PEAPv0 (MS-CHAPv2) WPA-PEAPv0 (MS-CHAPv2)

(Certificate) WPA-PSK ASCII WPA-PSK hex key WPA-TTLS WPA-TTLS-CHAP WPA-TTLS-CMSCHAP WPA-TTLS-EAPMSCHAPV2 WPA-TTLS-EAPTLS WPA-TTLS-MSCHAP WPA-TTLS-MSCHAPV2 WPA-TTLS-PAP Quality of Service (QoS) Bluetooth The Bluetooth functionality for the BD Prevue II Peripheral Vascular Access System operates on a best efforts basis, since latency in data transmission will not affect critical ultrasound imaging. As these connections are point to point, they do not require or rely on a formal QoS WLAN. The link capacity between devices is designed to provide the necessary bandwidth for proper data transmission, without competition for resources between devices. To ensure a proper connection, keep the separation distance between Bluetooth devices and the BD Prevue II Peripheral Vascular Access System console as short as possible. The maximum operating distance for Bluetooth technology is < 10 meters. Bluetooth devices generally perform better at shorter distances however, on the order of ~3 meters, with a direct line of sight preferable. IEEE 802.11b/g/n Wireless Security To guard against unauthorized access to network resources, ensure that the BD Prevue II Peripheral Vascular Access System is connected to a secure network. Use of WPA2 security is preferred over older protocols, such as WEP, as it provides a more secure network. Contact your local IT administrator for more information on which networks can be used and what settings should be used. BD Prevue II Peripheral Vascular Access System Page 86 Bluetooth Security The BD Prevue II Peripheral Vascular Access System employs Bluetooth connectivity for use with approved accessories. Bluetooth technology does not provide rigorous security measures to prevent unauthorized access, as wifi does. As such, appropriate measures should be taken to ensure that access is limited to approved accessories to be used with the system. Wireless coexistence issues and mitigations:

There is a potential for wireless conflicts, as 802.11b/g/n and Bluetooth both operate on the 2.4 GHz frequency band, as well as interference from other RF devices. If you encounter problems connecting to a network or Bluetooth device, remove or separate possible interfering sources as much as possible. Objects and people obstructing line of sight connections between wireless devices can also cause interference. Maintain a clear path between the BD Prevue II Peripheral Vascular Access System and paired accessories as much as possible to ensure highest performance. Manufacturer:

Bard Access Systems, Inc. 605 North 5600 West Salt Lake City, UT 84116 U.S.A. Customer Service: 1-800-545-0890 Technical/Clinical Support: 1-800-443-3385 Fax: 1-801-522-4948 www.bardaccess.com BD, the BD logo, Bard, Cue, and Prevue are trademarks and/or registered trademarks of Becton Dickinson and Company or its affiliates. All other trademarks are the property of their respective owners. 2021 C. R. Bard, Inc. All rights reserved. 0753451 2106R BD Prevue II Peripheral Vascular Access System Page 87

SW-1770 AD\ANTECH ADVANTECH Co. Ltd BROS) ERE RA A)) http://www.advantech.com Made in Taiwan @ Sis (4 78 Aik) Computer (2 it #8) im (iB) Model No: DMS-SA47 Bek (BS) Input: 19Vdc ===3.43A max. !

IA (BA) FCC ID : M82-DMSSA47 IC : 9404A-DMSSA47 FE CEA cad This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:

(1) this device may not cause harmful Interference, and aa device must accept any interference received, including Interference that may cause undesired operation. CAUTION! To prevent shock. Do not remove cover. No user serviceable parts inside. Refer servicing to quallfled personnel. TER || Paaee. DAT FAN. MAABEEATA Bee Saamaaas 45* 45mm LARARAERA (Item A)*1, RAR RS 1.Paste label(Item A)*1 on the machine

Advantech Co., Ltd. No.1, Alley 20, Lane 26, Rueiguang Road Neihu District, Taipei 114, Taiwan, R.O.C. Tel:886-2-7732-3399 Fax:886-2-2794-7334 hppts://WWW.advantech.com.tw U.S. Agent Designation for Service of Process -

Certification Attestation Letter May 4, 2023 Nemko North America, Inc. 303 River Road Ottawa K1V 1H2 Canada ATTN.: Reviewing Engineer Per section 2.911(d)(7) of the FCC rules, Advantech Co., Ltd. certifies that the equipment for which authorization is sought is designated to the following U.S. Designated agent* for service of process:

Company Name:

Physical U.S. Company Address:

Agent name:

FRN:

Advantech Corp. 380 Fairview Way, Milpitas, CA 95035-3062, USA Stanley Huang 0033467994 The above contact person accepts the obligation for service of process. The applicant accepts to maintain an agent for no less than one year after the grantee has terminated all marketing and importation or the conclusion of any Commission-related proceeding involving the equipment. Applicant Signed:

Designated Agent Signed:

(Required, if different to Applicant):

Signed:

Signed:

Printed name:

Title:

Company Name: Advantech Co., Ltd. Date:

Lily Huang Manager May 4, 2023 Printed name:

Title:

Company Name: Advantech Corp. Date:

Stanley Huang Supervisor May 4, 2023

* the applicant must designate a contact located in the United States for purposes of acting as the applicants agent for service of process, regardless of whether the applicant is a domestic or foreign entity. An applicant located in the United States may designate itself as the agent for service of process.

Advantech Co., Ltd. 26 20 1 No.1, Alley 20, Lane 26, Rueiguang Road Neihu District, Taipei 114, Taiwan, R.O.C. Tel:886-2-7732-3399 Fax:886-2-2794-7334 WWW.advantech.com.tw Covered Equipment Certification Attestation Letter 5/4/2023 Nemko North America, Inc. 303 River Road Ottawa K1V 1H2 Canada ATTN.: Reviewing Engineer FCC ID: M82-DMSSA47 Advantech Co., Ltd. certifies that the equipment for which authorization is sought is not covered equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. Note: If the equipment for which the applicant seeks authorization is produced by any of the entities identified on the current Covered List, the applicant should include an explanation on why the equipment is not covered equipment. Advantech Co., Ltd. certifies that, as of the date of the filing of the application, the applicant is not identified on the Covered List as an entity producing covered equipment. Signed:

Printed name: Lily Huang Title: Manager Company Name: Advantech Co., Ltd. Date: 5/4/2023

UNII Declaration Letter We have declared below featured for FCC equipment authorization, device FCC ID: M82-DMSSA47

(1) DFS Device --

Master, Client without radar detection capability, Client with Radar detection capability , N/A Frequency Band

(MHz)

(2) Active / Passive Scanning , adhoc mode access point capability Active Scanning

(the device can transmit a probe

(beacon)) Yes, Yes, Yes, Yes, Yes, Yes, Yes, Yes, 2412 2462 MHz 2422 2452 MHz 5180 5240 MHz 5190 5230 MHz 5210 5210 MHz 5260 5320 MHz 5270 5310 MHz 5290 5290 MHz 5500 5700 MHz Yes, passive scanning

(where the device is can listen only with no probes) No No No No No No No No No No No No No No Yes, Yes, Yes, Yes, Yes, Yes, Yes, Yes, Yes, Yes, Yes, Yes, Yes, Yes, 5510 5670 MHz 5530 5690 MHz 5745 5825 MHz 5755 5795 MHz 5775 5775 MHz No No No No No No No No No No No No No No Yes, Yes, Yes, Yes, Yes, Ad Hoc Mode capability Access point capability Yes, Yes, Yes, Yes, Yes, Yes, Yes, Yes, Yes, Yes, Yes, Yes, Yes, Yes, No No No No No No No No No No No No No No Yes, Yes, Yes, Yes, Yes, Yes, Yes, Yes, Yes, Yes, Yes, Yes, Yes, Yes, No No No No No No No No No No No No No No No

(3) Country code selection ability -

If yes, pls explain how it was implemented: (pls also help to provide detail of options for each country selection) Yes ,

(4) Transmit Power Control ability -

Yes , No

(5) Meet 15.202 requirement -

pls check below :

Yes , No , A master device is defined as a device operating in a mode in which it has the capability to transmit without receiving an enabling signal. In this mode it is able to select a channel and initiate a network by sending enabling signals to other devices A client device is defined as a device operating in a mode in which the transmissions of the device are under control of the master. A device in client mode is not able to initiate a network.

(6) For client devices that have software configuration control to operate in different modes (active scanning in some and passive scanning in others) in different bands (devices with multiple equipment classes or those that operate on non-DFS frequencies) or modular devices which configure the modes of operations through software, the application must provide software and operations description on how the software and / or hardware is implemented to ensure that proper operations modes can not be modified by end user or an installer. No Apply , Apply , If apply , pls help to provide explanation on how it was implement (By hardware or software, and how software was controlled) ______________________ Signatory Name / Title : Lily Huang / Manager Company Name: Advantech Co., Ltd. Address: No. 1, Alley 20, Lane 26, Rueiguang Road, Neihu District, Taipei, Taiwan Tel: 886-2-7732-3399 Ext:1412 Fax: 886-2-2794-7334 Email: Lily.Huang@advantech.com.tw

Advantech Co., Ltd. 26 20 1 No.1, Alley 20, Lane 26, Rueiguang Road Neihu District, Taipei 114, Taiwan, R.O.C. Tel:886-2-7732-3399 Fax:886-2-2794-7334 WWW.advantech.com.tw DateMay 26, 2022 Nemko North America, Inc. 303 River Road Ottawa, Ontario, Canada K1V 1H2 FCC ID: M82-DMSSA47 Model: DMS-SA47 ; DMS-SA47XXXXXXXXXXXXXXXX (where X may be any alphanumeric character , - or blank) Dear Sir or Madam, Due to the business consideration, we hereby declare that our product of Medical Computer , Model: 1) DMS-SA47 ; DMS-SA47XXXXXXXXXXXXXXXX (where X may be any alphanumeric character , - or blank) have as following difference for all the specification and layout are identical except they come with different model number for marketing purposes. Any questions regarding this declaration, please dont hesitate to contact us. Your Sincerely, Name / Title : Lily Huang / Manager Company Name: Advantech Co., Ltd. Address: No. 1, Alley 20, Lane 26, Rueiguang Road, Neihu District, Taipei, Taiwan Tel: 886-2-7732-3399 Ext:1412 Fax: 886-2-2794-7334 Email: Lily.Huang@advantech.com.tw

Advantech Co., Ltd. 26201 No.1, Alley 20, Lane 26, Rueiguang Road Neihu District, Taipei 114, Taiwan, R.O.C. Tel:886-2-7732-3399 Fax:886-2-2794-7334 WWW.advantech.com.tw Long/Short-term Confidentiality Request Date: 26 May 2022 Nemko North America, Inc. 303 River Road, Ottawa, Ontario, Canada K1V 1H2 FCC ID: M82-DMSSA47 To whom it may concern, Pursuant to sections 0.457(d) and 0.459 of CFR 47 and to avoid premature release of sensitive information prior to marketing or release of the product to the public, we hereby requests long-term confidential treatment of information accompanying this application as outlined below:

Schematics Block Diagram Operational Description The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to the applicant and provide unjustified benefits to its competitors. The applicant understands that pursuant to rule 0.457(d), disclosure of this application and all accompanying documentation will not be made before the date of the GRANT for this application. If you have any questions, please feel free to contact me. Yours sincerely, ________________ Signatory Name / Title : Lily Huang / Manager Company Name: Advantech Co., Ltd. Address: No. 1, Alley 20, Lane 26, Rueiguang Road, Neihu District, Taipei, Taiwan Tel: 886-2-7732-3399 Ext:1412 Fax: 886-2-2794-7334 Email: Lily.Huang@advantech.com.tw

Advantech Co., Ltd. 26201 No.1, Alley 20, Lane 26, Rueiguang Road Neihu District, Taipei 114, Taiwan, R.O.C. Tel:886-2-7732-3399 Fax:886-2-2794-7334 WWW.advantech.com.tw Date: 26 May 2022 Nemko North America, Inc. 303 River Road, Ottawa, Ontario, Canada K1V 1H2 Attn: Director of Certification Authority to Act as Agent On our behalf, I appoint Compliance Certification Services Inc. / William Chen to act as our agent in the preparation of this application for equipment certification. I certify that submitted documents properly describe the device or system for which equipment certification is sought. I also certify that each unit manufactured, imported or marketed, as defined in the Federal Communications Commissions regulations will have affixed to it a label identical to that submitted for approval with this application. For instances where our authorized agent signs the application for certification on our behalf, I acknowledge that all responsibility for complying with the terms and conditions for certification, as specified by Nemko Canada Inc, still resides with Advantech Co., Ltd. Yours sincerely, ____________________ Signatory Name / Title : Lily Huang / Manager Company Name: Advantech Co., Ltd. Address: No. 1, Alley 20, Lane 26, Rueiguang Road, Neihu District, Taipei, Taiwan Tel: 886-2-7732-3399 Ext:1412 Fax: 886-2-2794-7334 Email: Lily.Huang@advantech.com.tw

Advantech Co., Ltd. 26201 No.1, Alley 20, Lane 26, Rueiguang Road Neihu District, Taipei 114, Taiwan, R.O.C. Tel:886-2-7732-3399 Fax:886-2-2794-7334 WWW.advantech.com.tw Date: 26 May 2022 Nemko North America, Inc. 303 River Road, Ottawa, Ontario, Canada K1V 1H2 Subject: Declaration Operating Channel Limitation FCC ID: M82-DMSSA47 IC: 9404A-DMSSA47 To whom it may concern, The operating channels in 802.11 b/g/n mode for the device marketed to the US/Canada are firmware limited to channel 1 ~ 11 (2412 ~ 2462 MHz). The end-user has no possibility to select any other operating channels. If you have any questions, please feel free to contact me. Thank you. Sincerely, ____________________ Signatory Name / Title : Lily Huang / Manager Company Name: Advantech Co., Ltd. Address: No. 1, Alley 20, Lane 26, Rueiguang Road, Neihu District, Taipei, Taiwan Tel: 886-2-7732-3399 Ext:1412 Fax: 886-2-2794-7334 Email: Lily.Huang@advantech.com.tw