Site-Rite 8 Ultrasound System Instructions for Use Rev Nov 2015

SYMBOLS Storage Humidity Limitation

Consult instructions for use

Operating Humidity Limitation

Operating Temperature Limitation

Keep Dry

Storage Temperature Limitation

Do not dispose with ordinary municipal waste

Manufacturer

Federal Communications Commission

Type BF Applied Part

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

Date of Manufacture

Class II electrical equipment

IPX1

Drip Proof Equipment

Quantity

Catalog Number

Atmospheric Pressure Limitation

The Greendot

Caution

Serial Number

Direct Current

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Site~Rite 8 Ultrasound System

PINPOINT™ GT TECHNOLOGY SYMBOLS (if enabled) 95%

85% Operating Humidity Limitation

10%

Storage Humidity Limitation

5%

40° C

32° C

Operating Temperature Limitation 10° C

-18° C

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Site~Rite 8 Ultrasound System

Storage Temperature Limitation

TABLE OF CONTENTS 1.

OVERVIEW ... 3 1.1.

Site~Rite® 8 Ultrasound System Device Description ... 3

1.2.

Pinpoint™ GT Technology Description (if enabled) ... 3

1.3.

Site~Rite® 8 Ultrasound System Indications for Use ... 3

1.4.

Pinpoint™ GT Technology Indications for Use (if enabled) ... 3

1.4.1.

2.

3.

4. 5.

6.

7.

Clinical Applications for Pinpoint™ GT Technology ... 3

1.5.

Site~Rite® 8 Ultrasound System Compatible Accessories... 4

1.6.

Pinpoint™ GT Technology Compatible Accessories ... 4

1.7.

Needles for Use with Pinpoint™ GT Technology ... 4

WARNINGS AND CAUTIONS... 5 2.1.

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

2.2.

Pinpoint™ GT Technology Warnings (if enabled) ... 6

2.3.

Site~Rite® 8 Ultrasound System Cautions ... 6

2.4.

Pinpoint™ GT Technology Cautions (if enabled) ... 8

PHYSICAL FEATURES ... 9 3.1.

Console ... 9

3.2.

LED Status Indicators ... 10

3.3.

Mounting Accessories ... 10

CONNECTING THE BATTERY... 10 POWER OPTIONS ... 11 5.1.

Power On ... 11

5.2.

Power Menu ... 11

NAVIGATING THE DISPLAY ... 11 6.1.

Touch Screen ... 11

6.2.

USB Keyboard (optional) ... 11

6.3.

Probe ... 12

MAIN ULTRASOUND SCREEN ... 13 7.1.

Information Bar... 13

7.1.1.

Time ... 14

7.1.2.

Date ... 14

7.1.3.

Patient Information ... 14

7.1.4.

Catheter Trim Length ... 14

7.1.5.

Exit Site Marking... 14

7.1.6.

File Management - Accessing Saved Patient Images ... 14

7.1.7.

Battery Information ... 14

7.2.

Catheter Icons ... 15

7.3.

Main Toolbar ... 15

7.3.1.

Depth ... 15

7.3.2.

Gain ... 15

7.3.3.

Freeze ... 15

7.3.4.

Pinpoint™ GT Technology Mode (if enabled) ... 15

7.3.5.

Sherlock 3CG™ TCS Mode (if enabled) ... 15

7.3.6.

Settings ... 16

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Site~Rite 8 Ultrasound System

7.4.

Depth Markers and Image Depth Scale ... 16

7.5.

Probe Orientation ... 16

8.

FREEZE MODE ... 17 8.1.

Save/Print ... 17

8.2.

Measurement Tool ... 17

PINPOINT™ GT TECHNOLOGY MODE (if enabled) ... 20

9.

9.1.

Pinpoint™ GT Technology Home Screen. ... 20

9.2.

Pinpoint™ GT Technology Calibration ... 21

9.3.

Pinpoint™ GT Technology Needle Tracking ... 22

9.4.

Pinpoint™ GT Technology Freeze Mode ... 23

9.4.1.

Save/Print... 23

9.5.

Pinpoint™ GT Technology Errors ... 24

9.6.

Pinpoint™ GT Technology Virtual Needle Image – Out-of-Plane Needle Insertion. ... 25

9.7.

Pinpoint™ GT Technology Virtual Needle Image – In-Plane Needle Insertion ... 27

10.

SYSTEM SETTINGS ... 30

10.1.

Ultrasound Settings ... 30

10.2.

General Settings ... 31

10.2.1.

Add Feature Activation Key ... 31

10.2.2.

System Password. ... 32

10.3.

Connectivity Settings (if enabled) ... 33

10.3.1.

WiFi Profiles (if enabled) ... 33

10.3.2.

Configure Network Settings (if enabled) ... 34

10.3.3.

DICOM Settings (If enabled) ... 35

10.3.4.

DICOM Conformance Statement ... 35

10.3.5.

Bluetooth™ Wireless Technology (if enabled)... 35

10.4.

System Information ... 35

11.

PATIENT INFORMATION ... 36

12.

CLINICIAN PRESETS... 37

13.

ACCESSING SAVED PATIENT IMAGES ... 37

14.

OPERATING THE SITE~RITE® 8 ULTRASOUND SYSTEM ... 39 Access Using Pinpoint™ GT Technology (if enabled) ... 40

14.1. 15.

TROUBLESHOOTING ... 44 Pinpoint™ GT Technology Troubleshooting ... 47

15.1. 16.

CLEANING AND DISINFECTING THE EQUIPMENT ... 48

17.

WARRANTY ... 49

18.

SERVICE AND REPAIR ... 49

19.

UPGRADING ... 49

20.

DISPOSAL INFORMATION ... 50

21.

ACOUSTIC INFORMATION... 51

22.

EMC TABLES ... 53

23.

TECHNICAL SPECIFICATIONS ... 55

24.

SITE~RITE® 8 ULTRASOUND SYSTEM WIRELESS TECHNOLOGIES (if enabled) ... 56

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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. Pinpoint™ GT Technology Description (if enabled) The Pinpoint™ GT Technology 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 probe. The sensors detect a passive magnetic field emitted from a 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. Needle Guidance A permanent magnet is contained within the safety canister of the Pinpoint™ GT Safety Introducer Needle. No magnetic energy is generated by the sensors contained in the Pinpoint™ GT Technology Probe or the Site~Rite® 8 Ultrasound System. The Pinpoint™ GT Technology displays the relative position of the needle to the Probe. It does this in two steps: 1. The Pinpoint™ GT Technology takes a background measurement of the ambient magnetic field during the calibration cycle. 2. The Pinpoint™ GT Technology senses changes in the magnetic field. When Pinpoint™ GT Technology detects the needle, it displays the needle, needle trajectory, and point of intersection with the ultrasound plane. ®

1.3. Site~Rite 8 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 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

Vascular

Vascular Access

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) 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

1.4. Pinpoint™ GT Technology Indications for Use (if enabled) Pinpoint™ GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data.

1.4.1. Clinical Applications for Pinpoint™ GT Technology Clinical applications which are appropriate when using the Pinpoint™ GT Technology are: ®

Site~Rite 8 Ultrasound System

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

Peripheral Vessel ®

1.5. Site~Rite 8 Ultrasound System Compatible Accessories The Site~Rite® 8 Ultrasound System is compatible with the following accessories:         

Site~Rite® Needle Guides Site~Rite® Probe Covers MER Roll Stand Brother™ Printer MW-260 with mounting hardware Kickstand mounting accessory Probe holder accessory Site~Rite® Keyboard USB storage device (flash/pen drive) with no external power connection Site~Rite® 8 Ultrasound System Roller Bag

1.6. Pinpoint™ GT Technology Compatible Accessories Pinpoint™ GT Technology is compatible with all Site~Rite® 8 Ultrasound System compatible accessories EXCEPT: 

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

Warning:

1.7. Needles for Use with Pinpoint™ GT Technology Needles for use with PinpointTM GT Technology: 

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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 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 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, 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.

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Site~Rite 8 Ultrasound System

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

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

Warning:

Do not place and/or use the Pinpoint™ GT Technology Probe 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. The magnetic and RF fields associated with the MRI environment may interfere with the display of needle location. Consult the MRI manufacturer for more information.

Warning:

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

Warning:

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

Warning:

Use only Bard approved accessories. Failure to do so may result in patient injury or equipment damage.

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2.3. 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 access ble. In case of emergency, remove the power cord as soon as poss ble.

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.

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 acousticoutput 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.

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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, 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 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 v bration; 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; 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. If operating the device in temperatures exceeding 32°C, the battery charging functionality may be disabled to protect the battery. To charge the battery in temperatures exceeding 32°C, the system may need to be turned off.

Caution

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Site~Rite 8 Ultrasound System

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2.4. Pinpoint™ GT 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 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 5 ft (1.5 m).

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 cal bration error.

Caution:

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

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3. PHYSICAL FEATURES 3.1. Console Power Switch

USB 2.0 (3 ports)

USB 3.0

Ethernet HDMI video out

Power Connection

Kensington Slot (for security cable)

Probe Holder Slot

Mounting Plate

Battery Switch Cover

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3.2. 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)

3.3. Mounting Accessories 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.

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. ®

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

Close power menu and return to the previous screen.

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

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.

Lock the system (if enabled - see Section 10.2.2).

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.

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

Linear 32 mm 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 Pinpoint™ GT Technology 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.

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Site~Rite 8 Ultrasound System

Cursor Down Press to move cursor down.

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

Information Bar

Image Depth Scale

Catheter Icons

Main Toolbar

Depth Markers

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

Date

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Site~Rite 8 Ultrasound System

Patient Information

Catheter Trim Length

File Management

Exit Site Marking

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 above. The patient information screen will appear, allowing you to enter information. For instructions on this process, refer to section 11.

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 13.

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

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Site~Rite 8 Ultrasound System

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 15 for troubleshooting.

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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: Gain Depth

Pinpoint™ GT Technology Mode (if enabled) Freeze Settings

Sherlock 3CG™ Tip Confirmaion System (TCS) Mode (if enabled)

7.3.1.

Depth When the user selects the depth button, the image depth will toggle through the following depth offerings: 1.5 cm, 3 cm, 4.5 cm, and 6 cm. 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 Technology Mode (if enabled) If Pinpoint™ GT Technology Mode is enabled, the Pinpoint™ GT Technology button shall appear as shown. If Pinpoint™ GT Technology Mode is not enabled on the system, the Pinpoint™ GT Technology button shall not be shown. When selected, the Pinpoint™ GT Technology button shall switch the system to Pinpoint™ GT 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.

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7.3.6.

Settings The settings button shall appear as shown. When selected, the system settings window shall appear. Refer to section 10.

7.4. Depth Markers and Image Depth Scale

Image Depth Scale in cm.

Depth Markers Displays centered depth markers in 0.5 cm increments. To enable, refer to Section 10.1.

7.5. Probe Orientation

The probe orientation icon corresponds to the button pad on the ultrasound probe. When using the Site~Rite® 8 Ultrasound System probe for vascular access, hold it so that the side with the Needle Guide hook and button pad points away from the patient’s heart.

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8. FREEZE MODE Access freeze mode by pressing the freeze button on the main ultrasound screen. The following screen will appear.

Date/Time when image was frozen.

Catheter Icons Toggles through available catheter icon sizes.

Sherlock 3CG™ TCS Mode Switches to Sherlock 3CG™ TCS Mode when selected (if enabled).

Unfreeze Returns to active imaging.

Save/Print See Section 8.1.

Measurement Tool Toggles On/Off the measurement tool. See Section 8.2.

8.1. Save/Print When the Save/Print button is selected, the current ultrasound image is saved to the system hard drive and any attached USB storage devices. The image is also printed if a compatible printer is connected.

8.2. Measurement Tool The Site~Rite® 8 Ultrasound System Measurement Tool is used to estimate the vessel occupancy percentage of the selected catheter in a vessel. It also allows for measurements of vessel area and diameter. The following steps describe how to take measurements with the Site~Rite® 8 Ultrasound System Measurement Tool.

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1.

After freezing an ultrasound image, select the measurement tool button.

2.

Select the desired catheter size. Additional catheter icon sizes can be selected by pressing the Catheter Icons button.

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