Site-Rite Prevue Instructions for Use Rev Date April 2012

Instructions For Use

1 DEVICE DESCRIPTION The Site~Rite Prevue* Ultrasound System is a portable device that features real-time 2D ultrasound imaging. Additional features include compact size, simple user interface, and various calculations. The system may incorporate various accessories, including an upright stand, A/C adapter, needle guide/gel cap kits, etc. The system includes USB support for storage devices with no external power connections (e.g. USB flash drive). This manual provides instructions for the proper use of the Site~Rite Prevue* Ultrasound System. For additional information or product training, contact your local Bard Access Systems sales representative.

1.1 Indications For Use The Site~Rite Prevue* Ultrasound System is intended to provide ultrasound imaging of the human body. Specific clinical applications include: • Adult Cephalic • Neonatal Cephalic • Pediatric • Peripheral Vessel

1.2 Site~Rite Prevue* Ultrasound System and Components Site~Rite Prevue* Ultrasound System and Authorized Accessories include: • Site~Rite Prevue* Ultrasound System • Site~Rite Prevue* Ultrasound System A/C Adapter • Pinpoint* Gel Cap with Guide • Pinpoint* Assessment Cap • USB storage device with no external power connection (e.g., USB flash drive) • Mounting accessories with a ¼”-20 interface • Site~Rite Prevue* Storage Case Contact your Bard Access Systems’ Sales Representative or Customer Service at (800) 545-0890 to order.

1.3 Warnings, Precautions and Notes WARNINGS Warning: This product should only be operated by qualified medical personnel. Warning: Only qualified personnel should remove outer housing from the Site~Rite Prevue* Ultrasound System device. Hazardous voltages exist at several points within the system. Warning: Do not operate the Site~Rite Prevue* Ultrasound System or the Site~Rite Prevue* Ultrasound System A/C Adapter in the presence of flammable anesthetics or gases. Explosion may result. Warning: Do not use for ophthalmic indications. Ophthalmic use may cause patient injury. Warning: Misuse of the Site~Rite Prevue* Ultrasound System may result in damage to the equipment or personal injury.

2

Site~Rite Prevue* Ultrasound System

Warning: Use only the Site~Rite Prevue* Ultrasound System A/C Adapter to charge the Site~Rite Prevue* Ultrasound System. Use of any other device to charge the Site~Rite Prevue* Ultrasound System may damage the battery, may cause intermittent or unpredictable operation, may damage the system, may result in injury and will void warranty. Warning: If a probe is damaged in any way, discontinue use immediately. Damage to the system may occur. Warning: Avoid subjecting the system to excessive mechanical shock. Damage to the system may occur. Warning: Do not allow liquid to enter the system, A/C adapter or connectors. Damage to the system may occur. Warning: Do not attempt to sterilize the Site~Rite Prevue* Ultrasound System. Damage to the system may occur. Warning: Only qualified personnel should attempt to service this system. The Site~Rite Prevue* Ultrasound System contains static sensitive components and circuits. Failure to observe proper static control procedures may result in damage to the system. Warning: The following actions void the warranty of the Site~Rite Prevue* Ultrasound System and may result in injury or system damage: • Opening or servicing the system or the probe housing by anyone other than Bard Access Systems authorized service personnel. • Removal of system labels by anyone other than Bard Access Systems authorized service personnel. • Opening or servicing the A/C Adapter by anyone other than Bard Access Systems authorized service personnel. • Connecting the Site~Rite Prevue* Ultrasound System to any power source other than the Site~Rite Prevue* Ultrasound System A/C Adapter. • Connecting the Site~Rite Prevue* Ultrasound System to any unauthorized accessory. Refer to Section 1.2. Warning: Inspect power cords for damage. If any of the prongs are damaged, use battery power until a replacement cord is obtained. Warning: Mounting the Site~Rite Prevue* Ultrasound System to any unstable platform may cause the system and platform to tip resulting in system damage or injury. Ensure the system and platform will remain stable. Warning: Do not pull the device by the probe cable as this may cause the mounting platform to tip causing system damage or patient injury. Warning: The Pinpoint* Gel Cap contains potassium metabisulfite and carrageenan which may cause allergic reactions in certain patient populations. Patients with known sensitivity to these ingredients should avoid contact with the gel. PRECAUTIONS 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 Prevue* Ultrasound System acoustic output parameters fall well below all 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 principle of ALARA. Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. Caution: Do not twist or bend the probe cable in excess of that required during normal use of the probe. Excessive twisting or bending of the cable may cause failure, intermittent or unpredictable operation. Caution: Do not soak the system in any liquid including disinfectants. Doing so may damage the system. Caution: Only apply commercially available ultrasonic couplant, which has been specifically formulated for use in medical applications, to the acoustic window (or face) of the probe.

Instructions For Use

Caution: Use water or isopropyl alcohol and a soft cloth to remove couplant from the acoustic window (or face) of the probe. Failure to do so may scratch the acoustic window. Caution: Do not to allow ultrasonic couplant to dry on the acoustic window (or face) of the probe. If the couplant should dry, use water or isopropyl alcohol and a soft cloth to remove it. Never use a tool of any kind to remove dry couplant from the acoustic window (or face) of the probe. Caution: Do not subject the system to excessive vibration. Vibration may dislodge sensitive components and cause intermittent or unpredictable operation. 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: During use, the A/C wall plug needs to be easily accessible. In case of emergency remove the power cord as soon as possible. Caution: Get in a comfortable position to avoid unnecessary strain when using the device. Caution: Attach the power source in such a way as to prevent damage. Improper installation may damage power cords. Caution: Inspect the probe prior to each use. If damage to the cable or transducer face is noted, do not use the probe. Damage to the system may occur. Caution: Use only Bard Access Systems cleaning and disinfection procedures. Failure to do so may damage the device. Caution: Do not use the probe with high frequency surgical equipment. Doing so may damage the device. Caution: Vascular Access Device (VAD) Length in Vessel information should only be used in conjunction with a Pinpoint* Needle Guide. Length in Vessel information is not valid with “free hand” VAD insertion. Caution: This system, with its applicable accessories, is intended for use by healthcare professionals only. If used in a domestic environment, this system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures such as re-orienting or relocating the Site~Rite Prevue* Ultrasound System or shielding the location. Caution: The Site~Rite Prevue* Ultrasound System is not intended for fetal use. Note: During normal use, the portable Site~Rite Prevue* Ultrasound System should be positioned next to the patient using the provided mounting base, optional clamp mount, or positioned securely on a stable structure to allow for use of both hands throughout the procedure.

4

Site~Rite Prevue* Ultrasound System

2 ASSEMBLING THE SITE~RITE PREVUE* ULTRASOUND SYSTEM 2.1 Attaching the Power Source and Charging the Battery

Warning: Use only the Site~Rite Prevue* Ultrasound System A/C Adapter to charge the Site~Rite Prevue* Ultrasound System. Use of any other device to charge the Site~Rite Prevue* Ultrasound System may damage the battery, may cause intermittent or unpredictable operation, may damage the system, may result in injury and will void warranty. Warning: Inspect power cords for damage. If any of the prongs are damaged, use battery power until a replacement cord is obtained. Caution: Attach power source in such a way as to prevent damage. Improper installation may damage power cords.

Instructions For Use

2.2 Powering On and Off the Site~Rite Prevue* Ultrasound System Power Indicator

To power on the Site~Rite Prevue* Ultrasound System press and hold the Power Button located on the right side of the system for three seconds then release it.

Power Button Battery Indicator

The Power Indicator

located on the upper right side of the screen will remain illuminated when powered

and will blink when in Standby Mode. To display the Power Control Window press and release the Power Button while the system is powered on. The system can be Shut Down or placed in Standby Mode from the Power Control Window

Power Control Window.

To exit without changing the system’s power state, select cancel.

6

Site~Rite Prevue* Ultrasound System

The battery indicator

located in the upper right side of the screen has the following functionality:

SYSTEM STATUS System On

System Off

System Standby

BATTERY INDICATOR

AC Mode

Off

Battery Mode

Off

Low Battery Mode

Red, blinking

AC Mode

Green, static when fully charged Green, blinking when charging

Battery Mode

Off

Low Battery Mode

Off

AC Mode

Green, static when fully charged Green, blinking when charging

Battery Mode

Off

Low Battery Mode

Red, blinking

2.3 Probe Storage Hold probe body for insertion/removal. Do not pull the cable.

Probe Body

Instructions For Use

3 GETTING STARTED 3.1 Basic Mode Display Time Displays time in 24Hr

Center Mark Corresponds with the center of the ultrasound probe. Battery Status

Probe Orientation Marker Corresponds with the Probe Orientation Marker on the ultrasound probe See Section 4.1 Image Depth Scale

Depth Marks Displays depth markings in 0.5 cm increments

Pinpoint* Gel Cap Indicator Save Button Basic/Advanced Mode

Depth Button

Settings Button

8

Gain Button

Site~Rite Prevue* Ultrasound System

TITLE AND DESCRIPTION

FUNCTION ICON STATUS

Gain Adjusts the overall image gain to high, medium, and low.

Low

Medium

High

Saving File

Saving Error

Basic/Advanced Mode Advanced mode assists in selecting the appropriate length and gauge of the vascular access device for the target vessel.

Settings Button Opens the Settings Window, see Section 8. Save Saves image to USB drive (if attached). Save Icon will appear when a USB storage device is attached Depth Button Adjusts the display image depth.

Pinpoint* Gel Cap Indicator Indicates a Pinpoint* Gel Cap is attached or not.

WHITE

GRAY

Cap attached

Cap not attached

Instructions For Use

BATTERY STATUS 81% to 100% battery life.

61% to 80% battery life.

41% to 60% battery life.

21% to 40% battery life.

A blinking red bar indicates 0% - 20% battery life remains. Connect the system to A/C for operation and battery recharge. Battery Error – see Section 10 Troubleshooting Errors.

A/C status icon – indicates A/C power is connected and the system is charging.

10

Site~Rite Prevue* Ultrasound System

4 USING THE SITE~RITE PREVUE* ULTRASOUND SYSTEM PROBE 4.1 Probe Orientation

Instructions For Use

5 IMAGE SETTINGS 5.1 Image Depth The depth button toggles between 1cm zoom, 1cm, and 2.5cm depths. Adjusting the depth also adjusts the focus of the ultrasound. For optimal viewing, adjust the depth so that the structure of interest is centered in the image. IMAGE DEPTH

FOCAL DEPTH

1.0 cm, 1cm zoom

0.5 cm

2.5 cm

1.25 cm

5.2 Image Gain The image gain can be adjusted to amplify the signal which brightens the image. Increasing gain will brighten the target structure along with non-targeted structures. Press the gain button

to select the gain that provides the best ultrasound image.

5.3 Image Filter Press the image filter button

to toggle between a smooth and sharp image. Adjusting the

image filter affects the entire image. See Section 8.1 Settings.

12

Site~Rite Prevue* Ultrasound System

6 USING SITE~RITE PREVUE* ULTRASOUND SYSTEM WITH PINPOINT* ACCESSORIES For proper use of Pinpoint* Accessories refer to the Pinpoint* Instructions for Use (IFU).

6.1 Ultrasound Guidance for Vascular Access Scanning Technique: Very lightly scan patient to reduce vessel compression by holding probe with thumb and index finger (C Grip).

Vessel Identification: Veins can be distinguished from an artery by lightly pressing down on the vessel with the probe. With a viable vein the vessel will compress, with an artery the vessel will usually pulsate (unless low blood pressure), and a non-patent vein will not compress.

Viable vein Artery Non-patent vein

Compressible Pulsatile Non-Pulsatile non-compressible

Instructions For Use

Vessel Access: Identify vessel access by the anterior vessel wall indenting, once the puncture occurs the vessel will return to normal shape. Additional indications of vessel access may include needle visualization on the ultrasound image and blood flash. Needle Visualization: The needle may be visualized on the ultrasound image once it intersects the ultrasound beam.

Needle Visualization

Warning: The Pinpoint* Gel Cap contains potassium metabisulfite and carrageenan which may cause allergic reactions in certain patient populations. Patients with known sensitivity to these ingredients should avoid contact with the gel. 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 Prevue* Ultrasound System acoustic output parameters fall well below all 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 principle of ALARA.

14

Site~Rite Prevue* Ultrasound System

7 ADVANCED MODE Select

to open the Advanced Mode window.

7.1 Advanced Mode Display The Advanced Mode is designed to assist in selecting the appropriate vascular access device (VAD) length and gauge for a target vessel. Caution: Vascular Access Device (VAD) Length in Vessel information should only be used in conjunction with a Pinpoint* Needle Guide. Length in Vessel information is not valid with “freehand” VAD insertion. Selected Procedure Name and VAD Length

Length in Vessel Icon See Section 7.3 Length in Vessel Values See Section 7.3

Gauge Icons Displayed in proportion to the vessel image. Visually assists clinician in determining the appropriate device gauge for the vessel being imaged.

Pinpoint* Gel Cap Indicator

Vascular Access Device (VAD) Length Button See Section 7.4

Instructions For Use

7.2 How to use Advanced Mode Enter Advanced mode by pressing the Basic/Advanced button

1. Press and hold the Length button

.

.

Select available VAD Lengths. Press

to set values.

Target Vessel

3-

2.

Determine vessel depth. Set the appropriate Pinpoint* Gel Cap with Guide to this depth.

3.

Note the estimated length of catheter in vessel at final placement.

Toggle the Length button

to see the

Length in Vessel information change for different catheter sizes. Use this information to select an appropriate catheter size and vessel.

16

1-

-2

Site~Rite Prevue* Ultrasound System

7.3 Estimated Length in Vessel Values

For each selected catheter length, the estimated amount of catheter that will remain in the target vessel at final placement is shown at the left of the ultrasound image. The estimated length in vessel values can be displayed in percentage or length of the selected catheter (see Section 8.2)

The estimated length will change depending on what catheter length selected.

The image below explains the length in vessel values further. Part of the catheter travels through the tissue to get to the vessel and the rest of the catheter length will remain in the vessel at final placement. Caution: Vascular Access Device (VAD) Length in Vessel information should only be used in conjunction with a Pinpoint* Needle Guide. Length in Vessel information is not valid with “freehand” VAD insertion.

Catheter

Length through tissue Length in vessel

Instructions For Use

Note: The length in vessel values are an approximate value. The actual length may vary based on tissue compression, probe angle, and gel height. Note: Although a catheter is fully advanced, the entire catheter does not reside in the vessel. A portion of the catheter is left in the tissue and is required to reach the vessel. Note: Ensure the VAD Selected Length on the Site~Rite Prevue* matches the actual VAD length used during access otherwise the Length in Vessel values may be incorrect.

18

Site~Rite Prevue* Ultrasound System

7.4 VAD Length Button Press and hold the VAD Length Button

Select the VAD lengths available and press the

for the VAD Available screen to appear.

to set.

Select the appropriate VAD lengths available.

Once the lengths are set, toggle through the selected needle lengths by pressing the length button This will assist in choosing the appropriate device length for the target vessel. Note: Once the selected VAD Lengths have been set, the system will retain the settings.

.

Instructions For Use

8 USING THE SETTINGS WINDOW Select

to open the settings window.

8.1 System Settings Tab

Site~Rite Prevue* IFU Button Press the Site~Rite Prevue* IFU Button to view the Instructions for Use on the device. Pinpoint* IFU Button Press the Pinpoint* IFU Button to view the Instructions for Use on the device.

20