Site-Rite Prevue Instructions for Use Rev Date Nov 2013

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 and a simple user interface. The system may incorporate various accessories, including an upright stand, A/C adapter, needle guide, 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 Authorized Accessories Site~Rite Prevue +™ Ultrasound System and Authorized Accessories include: • Site~Rite Prevue™ Ultrasound System A/C Adapter • Site~Rite Prevue™ Ultrasound System Line Cord • USB storage device with no external power connection (e.g., USB flash drive) • Mounting accessories with a ¼”-20 Camera-mount interface • Site~Rite Prevue™ Ultrasound System Storage Case • Site~Rite Prevue™ Ultrasound System Probe Holder • Site~Rite™ Needle Guide Kits and Probe Sheaths • Pinpoint™ Gel Cap with Guide • Pinpoint™ Assessment Cap 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 the 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.

2

Site~Rite Prevue +™ Ultrasound System

Warning: Misuse of the Site~Rite Prevue +™ Ultrasound System may result in damage to the equipment or personal injury. 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 all warranties. 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 all warranties 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. • Installation of unauthorized software on the Site~Rite Prevue +™ Ultrasound system. • Connecting the Site~Rite Prevue +™ Ultrasound System to any unauthorized accessory. Refer to Section 1.2. Warning: When using Site~Rite™ Needle Guides on the Site~Rite Prevue +™ Ultrasound System Probe, use only sterile legally marketed plastic probe covers that are 1 mil (0.001 inch of 0.0254 mm) thick. 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, resulting in system damage or patient injury. Warning: Avoid patient contact with the console. The console may get warm when it is on for an extended period of time. This may cause 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.

3

Instructions For Use

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. 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 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 and recommended disinfectants. 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: 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 do not contain latex. Caution: Always snap the needle guides on to the probe hook. Do not slide on to the needle guide hook, as the sterile sheath may tear. Caution: IV Catheter 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” 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 Probe Holder

2.2 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 all warranties. Warning: Inspect power cords for damage. If any of the prongs are damaged, use battery power until a replacement cord is obtained. Caution: Attach the power source in such a way as to prevent damage. Improper installation may damage power cords.

5

Instructions For Use

2.3 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

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

2.4 Probe Storage Store the probe in the probe holder or the probe pocket when not in use. Hold probe body for insertion/removal into the probe pocket. Do not pull the probe cable.

7

Instructions For Use

3 GETTING STARTED 3.1 Display Time Displays time in 24Hr Format

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

Catheter Size Icons 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

Depth Marks Displays depth markings in 0.5 cm increments

Save Button

Freeze Button

Depth Button

Depth Mark/ Catheter Size Button Settings Button

8

Gain Button

Site~Rite Prevue +™ Ultrasound System

FUNCTION ICON STATUS

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

Low

Medium

High

Saving File

Saving Error

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.

Freeze Button

Freeze Mode

Imaging Mode

Freezes the image (Blinking) Depth Mark/Catheter Size Icons Button Toggles between depth markers, catheter size icons, and off.

9

Instructions For Use

TITLE AND DESCRIPTION

FUNCTION ICON STATUS

Center Mark Toggles between gel cap center mark/ indicator and bar center mark. Note: The presence of a gel cap determines which face is the center front of the probe.

OR Center mark (no gel cap detected)

Center mark (gel cap present)

Orientation Mark Toggles between gel cap orientation and no gel cap orientation. See section 4.1, probe orientation Note: the presence of a gel cap determines the orientation of the probe.

OR no gel cap detected

gel cap present

Full Screen Mode Touch the imaging area to hide the control buttons for full screen imaging. Touch the imaging area again to display the control buttons.

10

OR

Site~Rite Prevue +™ Ultrasound System

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 and Errors.

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

11

Instructions For Use

12

Site~Rite Prevue +™ Ultrasound System

4 USING THE Site~Rite Prevue +™ ULTRASOUND SYSTEM PROBE 4.1 Probe Orientation The probe orientation changes when a gel cap is present. The Ultrasound image will adjust so that the orientation mark on the display corresponds to the appropriate orientation mark on the probe. WITHOUT GEL CAP

WITH GEL CAP

OR

4.2 Draping the Probe for Sterile Use When using the Site~Rite Prevue +™ 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. Warning: Use only sterile, legally marketed plastic probe covers that are 1 mil (0.001 inch or 0.0254 mm) thick. 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 do not contain latex. To purchase sterile plastic probe covers, contact Bard Access Systems Customer Service at: Customer Service: (800) 545-0890 www.bardaccess.com To drape the probe for sterile use: 1. Place the probe in the side arm probe holder. 2. Apply a layer of non-sterile ultrasound coupling gel on the acoustic window of the probe head. 3. Make sure that the probe cover is fully rolled up. 4. Place the probe cover over the probe head, being careful not to wipe off the coupling gel. 5. Cover the probe and cable with the probe cover. 6. Smooth the probe cover over the acoustic window of the probe head to remove any air bubbles or folds in the sheath. 7. Use the latex free poly-bands to hold the probe cover in place. 8. Apply a layer of sterile coupling gel to the covered acoustic window.

13

Instructions For Use

5 IMAGE SETTINGS 5.1 Image Depth The depth button toggles between 1.0cm, 2.5cm, and 4.0cm 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

0.5 cm

2.5 cm

1.25 cm

4.0 cm

2.00 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.

14

Site~Rite Prevue +™ Ultrasound System

6 USING SITE~RITE Prevue +™ ULTRASOUND SYSTEM FOR VASCULAR ACCESS Note: Always prepare the patient access site and the ultrasound system per appropriate institutional protocol for the procedure being performed. See Section 4.2, Draping the Probe for Sterile Use.

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

6.2 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

15

Instructions For Use

6.3 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.

6.4 Needle Visualization The needle may be visualized on the ultrasound image once it intersects the ultrasound beam.

Needle Visualization

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.

16

Site~Rite Prevue +™ Ultrasound System

6.5 Using Site~Rite™ Needle Guides and Probe Sheaths For instructions on proper use of Site~Rite™ Needle Guides, refer to Site~Rite™ Needle Guide Kits and Ultrasound Probe Cover Kits Instructions for Use. Warning: When using Site~Rite™ Needle Guides on the Site~Rite Prevue +™ Ultrasound System Probe, use only sterile, legally marketed plastic probe covers that are 1 mil (0.001 inch or 0.0254 mm) thick. Caution: Always snap the needle guides on to the probe hook. Do not slide the needle guide on to the needle guide hook, as the sterile sheath may tear.

1.

2.

3.

To purchase Site~Rite™ Needle Guides and sterile Plastic Probe Covers, contact Bard Access Systems Customer Service: (800) 545-0890 www.bardaccess.com

6.6 Using the Pinpoint™ Accessories For proper use of Pinpoint™ Accessories, refer to the Pinpoint™ Instructions for Use (IFU). Warning: The Pinpoint™ Gel Cap contains potassium metabisulfite and carrageenan which may cause allergic reactions in certain patient polulations. Patients with known sensitivity to these ingredients should avoid contact with the gel. Note: The Site~Rite™ Needle Guide hook prohibits attaching the probe to the Pinpoint™ Gel Cap in the provided tray per the Pinpoint™ Gel Cap IFU. The Gel Cap needs to be attached to the probe outside of the tray. To allow for aseptic attachment, remove the cap via the slide or Needle Guide as shown below, then attach to the probe without touching the Gel face or the Needle Guide channels.

17

Instructions For Use

7 IV MODE To enable IV mode, select

to open the settings window. Enable IV mode

. See Section 8.

7.1 IV Mode Display The IV Mode is designed to assist clinicians in selecting the appropriate IV Catheter length and gauge for a target vessel. Caution: IV Catheter Length in Vessel information should only be used in conjunction with a Pinpoint™ Needle Guide. Length in Vessel information is not valid with “freehand” insertion.

Selected IV 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.

IV Length Button See Section 7.4

18

Site~Rite Prevue +™ Ultrasound System

7.2 How to use IV Mode

1. Press and hold the Length button

.

Select available IV Lengths. Press

to set values.

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

Target Vessel

2

to see the

Length in Vessel information changes for different catheter sizes. Clinicians can use this information in selecting an appropriate catheter size and vessel.

1

19

Instructions For Use

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 length or percentage 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: IV Catheter Length in Vessel information should only be used in conjunction with a Pinpoint™ Needle Guide. Length in Vessel information is not valid with “freehand” insertion.

Catheter

Length through tissue Length in vessel

20