Site-Rite Ultrasound System Instructions for Use Feb 2020

SYMBOLS Consult Instructions for Use

Temperature Limitation

Humidity Limitation

Manufacturer

Keep Dry

Type BF Applied Part

Do not dispose with ordinary municipal waste

Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician

Federal Communications Commission

IPX1

Drip Proof Equipment

Date of Manufacture

Catalog Number

Class II Electrical Equipment

The Green Dot

Quantity

Serial Number

Atmospheric Pressure Limitation

Direct Current

Caution

Warning: Magnetic Field

Site~Rite® 8 Ultrasound System

Table of Contents 1.

OVERVIEW... 4 1.1.

Site~Rite® 8 Ultrasound System Device Description ... 4

1.2.

Needle Guidance (if enabled) ... 4

1.2.1.

Cue™ Needle Tracking System Description ... 4

1.2.2.

Pinpoint™ GT Needle Technology Description ... 4

1.3.

Site~Rite® Ultrasound System Indications for Use ... 5

1.4.

Clinical Applications for Cue™ Needle Tracking System ... 5

1.5.

Clinical Applications for Pinpoint™ GT Needle Technology ... 5

1.6.

Site~Rite® 8 Ultrasound System Components ... 5

1.7.

Site~Rite® 8 Ultrasound System Compatible Accessories ... 6

1.8.

Cue™ Needle Tracking Compatible Accessories ... 6

1.9.

Needles for Use with Cue™ Needle Tracking System ... 6

1.10.

Pinpoint™ GT Needle Technology Compatible Accessories ... 6

1.11.

Needles for Use with Pinpoint™ GT Needle Technology ... 6

2.

WARNINGS AND CAUTIONS ... 7 2.1.

Site~Rite® 8 Ultrasound System Warnings ... 7

2.2.

Cue™ Needle Tracking System Warnings (if enabled) ... 8

2.3.

Pinpoint™ GT Needle Technology Warnings (if enabled) ... 8

2.4.

Site~Rite® 8 Ultrasound System Cautions ... 8

2.5.

Cue™ Needle Tracking System Cautions (if enabled) ... 10

2.6.

Pinpoint™ GT Needle Technology Cautions (if enabled) ... 10

3.

PHYSICAL FEATURES ... 11 3.1.

Console Features ... 11

3.2.

Compatible Probes... 12

3.3.

Connecting the Ultrasound Probe (if applicable) ... 12

3.4.

LED Status Indicators... 13

4.

CONNECTING THE BATTERY ... 13

5.

POWER OPTIONS ... 14 5.1.

Power On ... 14

5.2.

Power Menu ... 14

6.

NAVIGATING THE DISPLAY ... 14 6.1.

Touch Screen... 14

6.2.

USB Keyboard (optional)... 14

6.3.

Probe ... 15

7.

MAIN ULTRASOUND SCREEN ... 16 7.1.

Information Bar ... 16

7.1.1.

Time ... 17

7.1.2.

Date ... 17

7.1.3.

Patient Information ... 17

7.1.4.

Catheter Trim Length... 17

7.1.5.

Exit Site Marking... 17

7.1.6.

File Management – Accessing Saved Patient Images... 17

Site~Rite® 8 Ultrasound System

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7.1.7.

Battery Information ... 17

7.2.

Catheter Icons... 18

7.3.

Main Toolbar ... 18

7.3.1.

Depth ... 18

7.3.2.

Gain ... 18

7.3.3.

Freeze ... 18

7.3.4.

Pinpoint™ GT Needle Technology Mode (if enabled) ... 18

7.3.5.

SHERLOCK 3CG™ TCS Mode (if enabled)... 18

7.3.6.

Settings ... 18

7.4.

Depth Markers and Image Depth Scale ... 19

7.5.

Probe Orientation ... 19

8.

FREEZE MODE ... 20 8.1.

Save/Print ... 20

8.2.

Measurement Tool ... 20

9.

CUE™ NEEDLE TRACKING SYSTEM MODE (if enabled) ... 23 9.1.

Enabling Cue™ Needle Tracking System ... 23

9.2.

Activating the Cue™ Needle Tracking System Compatible Needle ... 23

9.3.

Cue™ Needle Tracking System Home Screen ... 24

9.3.1.

Probe Face Overlay... 24

9.3.2.

Performance Indicator ... 26

9.4.

Cue™ Needle Tracking System Overlay ... 27

9.4.1.

Out-of-Plane Insertion... 27

9.4.2.

In-Plane Insertion ... 29

10.

PINPOINT™ GT NEEDLE TECHNOLOGY MODE (if enabled) ... 30

10.1.

Pinpoint™ GT Needle Technology Home Screen. ... 30

10.2.

Pinpoint™ GT Needle Technology Calibration... 31

10.3.

Pinpoint™ GT Needle Technology Needle Tracking ... 32

10.4.

Pinpoint™ GT Needle Technology Freeze Mode ... 33

10.4.1.

Save/Print... 33

10.5.

Pinpoint™ GT Needle Technology Errors ... 34

10.6.

Pinpoint™ GT Needle Technology Virtual Needle Image – Out-of-Plane Needle Insertion ... 35

10.7.

Pinpoint™ GT Needle Technology Virtual Needle Image – In Plane Needle Insertion ... 37

11.

SYSTEM SETTINGS... 40

11.1.

Ultrasound Settings ... 40

11.2.

Cue™ Needle Tracking System Settings (if enabled) ... 41

11.2.1. 11.3.

Calibration ... 42 General Settings ... 43

11.3.1.

Add Feature Activation Key ... 43

11.3.2.

System Password ... 44

11.3.3.

Patient/Clinician Backup/Restore ... 46

11.4.

Connectivity Settings ... 46

11.4.1.

WiFi Networks ... 47

11.4.2.

Configure Network Settings ... 48

Site~Rite® 8 Ultrasound System

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11.4.3.

DICOM (if enabled)... 49

11.4.4.

DICOM Conformance Statement ... 50

11.4.5.

Bluetooth™ Wireless Technology (if enabled) ... 50

11.5.

System Information ... 50

12.

PATIENT INFORMATION ... 51

13.

CLINICIAN PRESETS ... 52

14.

ACCESSING SAVED PATIENT IMAGES... 52

15.

OPERATING THE SITE~RITE® 8 ULTRASOUND SYSTEM ... 54

15.1.

Access using the Cue™ Needle Tracking System (if enabled) ... 55

15.2.

Access Using Pinpoint™ GT Needle Technology (if enabled)... 57

16.

TROUBLESHOOTING ... 60

16.1.

Site~Rite® 8 Ultrasound System Troubleshooting ... 60

16.2.

Cue™ Needle Tracking System Troubleshooting (if enabled) ... 63

16.2.1. 16.3.

Pinpoint™ GT Needle Technology Troubleshooting (if enabled) ... 65

16.3.1. 17. 17.1. 17.2.

Cue™ Needle Tracking System Troubleshooting... 65

Pinpoint™ GT Needle Technology Troubleshooting Steps ... 66

CLEAN AND DISINFECTING THE EQUIPMENT ... 67 Cleaning and Intermediate Disinfection Procedure using PDI® Super Sani-Cloths® ... 67 Additional Cleaning and Compatible Chemical Information ... 67

18.

WARRANTY ... 68

19.

SERVICE AND REPAIR... 68

20.

UPGRADING ... 68

21.

DISPOSAL INFORMATION ... 68

22.

ACOUSTIC INFORMATION ... 69

22.1.

Acoustic Output Summary Table ... 69

22.2.

Acoustic Output Reporting Table – Linear Probe 32mm ... 70

22.3.

Acoustic Output Reporting Table – Linear 20mm Cue™ Needle Tracking System Probe ... 71

22.4.

Acoustic Output Reporting Table – Linear 20mm Pinpoint™ GT Needle Technology Probe ... 72

23.

EMC TABLES ... 73

24.

TECHNICAL SPECIFICATIONS ... 75

25.

SITE~RITE® 8 ULTRASOUND SYSTEM WIRELESS TECHNOLOGIES (if enabled) ... 77

Site~Rite® 8 Ultrasound System

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1. OVERVIEW 1.1. Site~Rite® 8 Ultrasound System Device Description The Site~Rite® 8 Ultrasound 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. Needle Guidance (if enabled) The Site~Rite® 8 Ultrasound System has two optional needle guidance technologies available depending on the selected probe. Both available needle guidance technologies are designed to track and display the location and trajectory of a needle under ultrasound guidance. The technologies consist 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.

1.2.1.

Cue™ Needle Tracking System Description Cue™ Needle Tracking System requires the use of a Cue™ 20mm Linear Probe, the Cue™ Needle Tracking System Activator and a Cue™ compatible needle. The Cue™ 20mm Linear Probe contains sensors for tracking Cue™ compatible needles (following magnetization by the Cue™ Needle Tracking System Activator). The tracked needle’s current position, trajectory, and Intersection Window are displayed over the ultrasound image.

1.2.2.

Pinpoint™ GT Needle Technology Description Pinpoint™ GT Needle Technology requires the use of a 20mm Pinpoint™ GT Linear Probe and a Pinpoint™ GT Safety Introducer Needle. The 20mm Pinpoint™ GT Linear Probe contains sensors for tracking Pinpoint™ GT Safety Introducer Needles, which contain a permanent magnet within the safety canister of the needle. The tracked needle’s current position, trajectory, and point of intersection with the ultrasound plane are displayed over the ultrasound image.

Site~Rite® 8 Ultrasound System

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1.3. Site~Rite® Ultrasound System Indications for Use The Site~Rite® 8 Ultrasound System is intended for diagnostic ultrasound imaging of the human body. Specific clinical applications include: • • • • •

Pediatric Peripheral Vessel and Vascular Access Small Organ (breast, thyroid, parathyroid, testicles) Musculo-skeletal (conventional and superficial) Cardiac (adult and pediatric)

Typical examinations performed using the Site~Rite® 8 Ultrasound System include: Imaging Applications

Exam Type (Adult and Pediatric)

Vessel

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

Interventional

Guidance for biopsy and drainage

Superficial

Assessment of breast, thyroid, parathyroid, testicle, lymph nodes, hernias, musculoskeletal procedures (e.g., joints, ligaments, tendons), soft tissue structures, and surrounding anatomical structures

Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology are each intended to provide visual needle tracking to assist with ultrasound guided vascular access.

1.4. Clinical Applications for Cue™ Needle Tracking System Clinical applications which are appropriate when using the Pinpoint™ GT Needle Technology are: • •

Peripheral Vessel Vascular Access

1.5. Clinical Applications for Pinpoint™ GT Needle Technology Clinical applications which are appropriate when using the Pinpoint™ GT Needle Technology are: • •

Peripheral Vessel Vascular Access

1.6. Site~Rite® 8 Ultrasound System Components Site~Rite® 8 Ultrasound System Components include: • • • • •

Console Linear 32mm Probe Linear 20mm Cue™ Needle Tracking System Probe Linear 20mm Pinpoint™ GT Needle Technology Probe Cue™ Activator

Site~Rite® 8 Ultrasound System

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1.7. Site~Rite® 8 Ultrasound System Compatible Accessories The Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology is compatible with the following accessories: • • • • • • • • • • •

Cue™ Activator mounting arm Pinpoint™ GT Needle Guides Site~Rite® Needle Guides Site~Rite® Probe Covers MER Roll Stand Optional printers with mounting hardware Kickstand mounting accessory Probe holder accessory Site~Rite® Keyboard USB storage device (flash/pen drive) with no external power connection Silex® Wireless Bridge

1.8. Cue™ Needle Tracking Compatible Accessories Cue™ Needle Tracking is compatible with all Site~Rite® 8 Ultrasound System compatible accessories listed in Section 1.7 EXCEPT: •

Site~Rite® Needle Guides

Warning:

Cue™ Needle Tracking is not qualified for use with Site~Rite® Needle Guides. Using Site~Rite® Needle Guides with Cue™ Needle Tracking may result in injury to the patient.

1.9. Needles for Use with Cue™ Needle Tracking System Needles for use with Cue™ Needle Tracking System: •

Cue™ Needle Tracking System Compatible needles, marked with Cue™ compatibility symbol

1.10. Pinpoint™ GT Needle Technology Compatible Accessories Pinpoint™ GT Needle Technology is compatible with all Site~Rite® 8 Ultrasound System compatible accessories listed in Section 1.7 EXCEPT: •

Site~Rite® Needle Guides

Warning: Pinpoint™ GT Needle Technology is not qualified for use with Site~Rite® Needle Guides. Using Site~Rite® Needle Guides with the Pinpoint™ GT Needle Technology may result in injury to the patient.

1.11. Needles for Use with Pinpoint™ GT Needle Technology Needles for use with PinpointTM GT Needle Technology: •

Pinpoint™ GT Safety Introducer Needle

Site~Rite® 8 Ultrasound System

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2. WARNINGS AND CAUTIONS 2.1. Site~Rite® 8 Ultrasound System Warnings Warning:

Do not operate the Site~Rite® 8 Ultrasound System or the AC adapter in the presence of flammable anesthetics or gases; explosion may result.

Warning:

Use only the Site~Rite® 8 Ultrasound 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 Site~Rite® 8 Ultrasound System and may result in injury or equipment damage:

•

Opening or servicing any component by anyone other than service personnel authorized by Bard Access Systems.

•

Removing system labels by anyone other than service personnel authorized by Bard Access Systems.

•

Connecting the Site~Rite® 8 Ultrasound System to any AC adapter other than the system adapter.

•

Connecting the Site~Rite® 8 Ultrasound 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 Bard Access Systems.

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 noncompliant 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 Site~Rite® 8 Ultrasound 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 Bard Access Systems. 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.

Warning:

Do not use the Site~Rite® 8 Ultrasound System for ophthalmic indications; ophthalmic use may cause patient injury.

Warning:

Misuse of the Site~Rite® 8 Ultrasound System may result in damage to the equipment or increase risk to the patient or user.

Warning:

When using Site~Rite® Needle Guides and Pinpoint™ GT Needle Guides, use the sterile legally marketed plastic probe cover included in the kit with the needle guides. To ensure proper performance, follow the Site~Rite® Needle Guides instructions for use.

Warning:

Do not place and/or use the Site~Rite® 8 Ultrasound 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.

Site~Rite® 8 Ultrasound System

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2.2. Cue™ Needle Tracking System Warnings (if enabled) Warning:

Use only Cue™ Needle Tracking System compatible 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:

Cue™ Needle Tracking is not qualified for use with Site~Rite® Needle Guides. Using Site~Rite® Needle Guides with Cue™ Needle Tracking may result in injury to the patient.

Warning:

The Cue™ Activator contains strong magnets which may affect devices sensitive to magnetic fields.

2.3. Pinpoint™ GT Needle Technology Warnings (if enabled) Warning:

Use only Pinpoint™ GT Needles with the Pinpoint™ GT Needle Technology. Use of unapproved needles may result in patient injury or equipment damage.

Warning:

Pinpoint™ GT Needle Technology is not qualified for use with Site~Rite® Needle Guides. Using Site~Rite® Needle Guides with the Pinpoint™ GT Needle Technology may result in injury to the patient.

Warning:

Misuse of the Pinpoint™ GT Needle Technology may result in damage to the equipment or personal injury.

2.4. Site~Rite® 8 Ultrasound System Cautions Caution:

To avoid unnecessary strain on the user, use the medical device in a manner that is comfortable.

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 Bard Access Systems 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 Site~Rite® 8 Ultrasound System or probe; damage to the equipment may occur as a result.

Caution:

When attaching the system to the roll stand or kickstand, do not over-tighten the screws; doing so may damage the system.

Caution:

Use only the screws provided in the packaging. Ensure the unit is secure against the roll-stand or kickstand mount. Failure to do so may cause the display to disconnect from the mount.

Caution:

The Site~Rite® 8 Ultrasound 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.

Caution:

Only qualified personnel should attempt to service this equipment. The Site~Rite® 8 Ultrasound 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). 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 Site~Rite® 8 Ultrasound 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 113°F or 45°C) 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.

Site~Rite® 8 Ultrasound System

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Caution:

When using the Site~Rite® 8 Ultrasound 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. Bard Access Systems distributes sterile probe covers and needle-guide kits that are not made with natural rubber latex.

Caution:

Always snap the needle guides on the probe hook. Do not slide the needle guide onto the needle-guide hook, as the sterile cover may tear.

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.

Caution:

Do not use the probe with high-frequency surgical equipment; doing so may damage the Site~Rite® 8 Ultrasound 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. If operating the device in temperatures exceeding 90°F (32°C), the battery charging functionality may be disabled to protect the battery. To charge the battery in temperatures exceeding 90°F (32°C), the system may need to be turned off.

Caution

Site~Rite® 8 Ultrasound System

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2.5. Cue™ Needle Tracking System Cautions (if enabled) Caution:

Keep the needle and any ferromagnetic objects, e.g., wired undergarments, metal instruments, watches, jewelry, Cue ™ Activator, 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 Activator 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 Activator and needles.

Caution:

Single-use items (e.g., needle trays, needle guides, 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.

2.6. Pinpoint™ GT Needle Technology Cautions (if enabled) Caution:

Keep the needle and any ferromagnetic objects, e.g., wired undergarments, metal instruments, watches, jewelry, electronics, metal bed rails, etc. at least 2 feet away from probe when calibrating. Failure to do so may impact 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 5 feet (1.5m).

Caution:

Excessive movement of the probe after calibration may result in reduced needle tracking accuracy.

Caution:

During insertion, use a light touch to prevent needle deflection and/or bending. Needle deflection and/or needle bending may reduce needle tracking accuracy.

Caution:

To ensure accuracy, do not apply force or pressure that may leverage the needle. This may result in needle deflection, bending or altering needle trajectory.

Caution:

Movement of the probe during calibration may result in calibration error.

Caution:

If needle tracking is not functioning properly, discontinue use of Pinpoint™ GT Needle Technology.

Caution:

To avoid reduced needle tracking accuracy, prior to insertion do not modify the straightness of the needle by bending.

Caution:

Improper technique and environmental conditions may introduce variation in accuracy.

Site~Rite® 8 Ultrasound System

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3. PHYSICAL FEATURES 3.1. Console Features Power Switch

USB 3.0 USB 2.0 (3 ports)

Ethernet

HDMI video out Kensington Slot (for security cable) Power Connection

Probe Holder Slot

Mounting Plate

Probe Connector (if applicable) Battery Switch Cover

For installation of approved mounting accessories, please see the appropriate assembly instructions. Caution:

When attaching the system to the roll stand or kickstand, do not over tighten the screws; doing so may damage the system.

Caution:

Use only the screws provided in the packaging. Ensure the unit is secure against the roll-stand or kickstand mount. Failure to do so may cause the display to disconnect from the mount.

Site~Rite® 8 Ultrasound System

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3.2. Compatible Probes

Linear 32mm Probe

Linear 20mm Cue™ Needle Tracking System Probe

Linear 20mm Pinpoint™ GT Needle Technology Probe

3.3. Connecting the Ultrasound Probe (if applicable) To connect the probe: 1.

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.

Site~Rite® 8 Ultrasound System

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3.4. LED Status Indicators The LED icons, shown below, are located along the top of the display.

Power Green indicates the unit is on.

WiFi Green indicates WiFi is enabled (if enabled).

Battery Life Indicates the battery status: • Red and blinking when the battery power is low. • Green and blinking when the system is off and the battery is charging. • Green and static when the system is off and the battery is fully charged.

Ethernet Green indicates the Ethernet connection is active (if enabled).

Bluetooth™ Wireless Technology (if enabled)

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.

Site~Rite® 8 Ultrasound System

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5. POWER OPTIONS

Close power menu and return to the previous screen.

5.1. Power On To turn on the system, press the power switch on the upper left side of the unit.

Power off

5.2. Power Menu The power menu can be accessed the following ways: 1.

To access the power menu, press the power switch on the side of the device.

2.

To access the power menu using the probe or touch screen, select the settings button on the main ultrasound screen. Select the power button on the top right of the settings screen.

Restart

Lock the system (if enabled - see Section 11.3.2).

6. NAVIGATING THE DISPLAY To navigate through the different features shown on the screen, you can use the touch screen, USB keyboard, or probe. Each one of these methods is described in more detail below. When using the USB keyboard or probe, the button navigation is tracked via highlight as shown below:

Selected

Not Selected

6.1. Touch Screen Any feature or control can be selected by touching the corresponding button on the screen.

6.2. USB Keyboard (optional) The keyboard can be used to enter data into the system. The arrows and enter key on the USB keyboard can be used to navigate through procedurally applicable buttons.

Site~Rite® 8 Ultrasound System

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6.3. Probe The probe controls can be used to navigate procedurally applicable buttons.

Linear 32mm Probe Cursor Up Press to move cursor up.

Cursor Right Press to move cursor right.

Cursor Left Press to move cursor left.

OK Press to select the current control.

Cursor Down Press to move cursor down.

Linear 20mm Cue™ Needle Tracking System Probe

Cursor Up Press to move cursor up.

Cursor Left Press to move cursor left.

Cursor Down Press to move cursor down.

Cursor Right Press to move cursor right.

OK Press to select the current control.

Linear 20mm Pinpoint™ GT Needle Technology Probe

Cursor Up Press to move cursor up. Cursor Left Press to move cursor left.

OK Press to select the current control.

Site~Rite® 8 Ultrasound System

Cursor Right Press to move cursor right.

Cursor Down Press to move cursor down. Press to select the

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7. MAIN ULTRASOUND SCREEN After starting the system, the main ultrasound screen will appear.

Information Bar

Catheter Icons

Image Depth Scale

Depth Markers

Cue™ Needle Tracking System Activator Icon (if enabled - see Section 9)

Main Toolbar

An explanation of the various parts of the main ultrasound screen is provided below.

7.1. Information Bar The information bar is located at the top of the ultrasound screen. This bar contains the following information: Time

Patient Information

File Management

Date

Catheter Trim Length

Exit Site Marking

Site~Rite® 8 Ultrasound System

Battery Information

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7.1.1.

Time The time is displayed in 24-hour format, as follows: hour:minute:second

7.1.2.

Date The date is displayed in the following format: year-month-day.

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.

Catheter Trim Length This is optional and is intended to allow the clinician to note the trim length of the catheter. If the trim length button is selected, a window will open with a numeric keypad. If a numeric value is entered, the number shall appear on the trim length button.

7.1.5.

Exit Site Marking This is optional and is intended to allow the clinician to note the exit site marking of the catheter. If the Catheter Exit Site button is selected, a window will open with a numeric keypad. If a numeric value is entered, the number shall appear on the Catheter Exit Site button.

7.1.6.

File Management – Accessing Saved Patient Images By selecting this button, previously saved images can be viewed, saved, printed, or sent to your configured PACS server. For instructions on these actions, refer to Section 14.

7.1.7.

Battery Information Five green bars indicate 81%–100% of the battery’s power remains. Four green bars indicate 61%–80% of the battery’s power remains.

The charging icon indicates that the battery is connected to AC power and is charging.

Three green bars indicate 41%–60% of the battery’s power remains.

A red exclamation point indicates a battery malfunction. See Section 16 for troubleshooting.

Two yellow bars indicate 21%–40% of the battery’s power remains. One blinking red bar indicates 0%–20% of the battery’s 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 green bars until it reaches full battery charge.

Site~Rite® 8 Ultrasound System

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7.2. Catheter Icons Catheter Icons Toggles through available catheter icon sizes.

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.

7.3. Main Toolbar The main toolbar is located at the bottom of the main ultrasound screen and contains the following buttons: Depth

Gain

Freeze

SHERLOCK 3CG™ Tip Confirmation System (TCS) Mode (if enabled)

Pinpoint™ GT Needle Technology Mode (if enabled)

7.3.1.

Settings

Depth When the user selects the depth button, the image depth will toggle through the depths selected in the ultrasound settings (see Section11.1). The circle indicators that are greyed out correspond to depths that have been disabled in the ultrasound settings. The Site~Rite® 8 Ultrasound System image depth may be changed to image structures at different depths. Adjusting the depth also adjusts the focus of the ultrasound. Adjust the depth to place the structure of interest in the middle of the ultrasound image. This will provide the appropriate focus.

7.3.2.

Gain Selecting gain will change the brightness of the entire image. Select the gain that provides the best ultrasound image for the targeted structure.

7.3.3.

Freeze Selecting the freeze button will show a static image of the last acquired ultrasound frame. Additional tools are available, as described in Section 8.

7.3.4.

Pinpoint™ GT Needle Technology Mode (if enabled) If Pinpoint™ GT Needle Technology Mode is enabled, the Pinpoint™ GT Needle Technology button shall appear as shown. If Pinpoint™ GT Needle Technology Mode is not enabled on the system, the Pinpoint™ GT Needle Technology button shall not be shown. When selected, the Pinpoint™ GT Needle Technology button shall switch the system to Pinpoint™ GT Needle Technology Mode.

7.3.5.

SHERLOCK 3CG™ TCS Mode (if enabled) If SHERLOCK 3CG™ TCS Mode is enabled, the SHERLOCK 3CG™ TCS button shall appear as shown. If SHERLOCK 3CG™ TCS Mode is not enabled on the system, the SHERLOCK 3CG™ TCS button shall not be shown. When selected, the SHERLOCK 3CG™ TCS button shall switch the system to SHERLOCK 3CG™ TCS Mode. For further instructions, refer to the applicable SHERLOCK 3CG™ TCS Instructions for Use.

7.3.6.

Settings The settings button shall appear as shown. When selected, the system settings window shall appear. Refer to Section 11.

Site~Rite® 8 Ultrasound System

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