Bard Site-Rite 6 Instructions For Use Manual
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Bard Site-Rite 6 Instructions For Use Manual

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9770000
REF
ACCESS SYSTEMS
INSTRUCTIONS FOR USE

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  • Page 1 9770000 ACCESS SYSTEMS INSTRUCTIONS FOR USE...
  • Page 4 Site~Rite * 6 Ultrasound System Do not operate in the presence BF Type Equipment of flammable anesthetics Attention, see Dangerous Voltage instructions for use Medical Electrical Equipment Classified by ETL with respect Operating Humidity Parameters to Electric Shock, Fire, and Storage Humidity Parameters Mechanical Hazards only in (unpackaged)
  • Page 5 Instructions For Use Keep Dry Fragile Storage Temperature Ultrasound Probe Parameters Do not dispose with Operating Temperature ordinary municipal waste Parameters Federal Communications Direct Current Commission Manufacturer...

  • Page 6: Table Of Contents

    Site~Rite * 6 Ultrasound System Table of Contents Section Overview Indications For Use Site~Rite * 6 Ultrasound System and Components Warnings, Precautions and Notes Assembling the Site~Rite * 6 Ultrasound System Assembling the Roll Stand Adjusting the Scanner on the Roll Stand Attaching the Power Source and Charging the Battery Connecting and Disconnecting Site~Rite * 6 Ultrasound System Probe Powering on the Site~Rite * 6 Ultrasound System...
  • Page 7 Instructions For Use Table of Contents Section Image Parameters Sizing Tools Image Depth Image Gain Cleaning and Disinfection Cleaning Procedures Disinfection Procedures Troubleshooting & Error Screens Upgrading Software Calibrating the Rechargeable Batteries Warranty Service and Repair Technical Specifications 12.1 Operating and Storage Conditions 12.2 Scanner Specifications 12.3...
  • Page 8 Site~Rite * 6 Ultrasound System...

  • Page 9: Overview

    The Site~Rite* 6 Ultrasound System is an easy to use and portable ultrasound scanner. Site~Rite* 6 Ultrasound System and Authorized Accessories include: • Site~Rite* 6 Ultrasound System scanner • Site~Rite* 6 Ultrasound System vascular access probe • Site~Rite* 6 Ultrasound System roll stand • Site~Rite* 6 Ultrasound System printer • Site~Rite* 6 Ultrasound System base power unit • Site~Rite* 6 Ultrasound System A/C adapter • Site~Rite* 6 Ultrasound System line cord • Site~Rite* needle guides • Site~Rite* probe covers • Ultrasound gel • Ultrasound vessel phantom • USB storage device with no external power connection (e.g. USB flash drive) Contact your Bard Access Systems' Sales Representative or Customer Service at (800) 545-0890 to order.

  • Page 10: Warnings, Precautions And Notes

    Warning: Avoid subjecting the probe to excessive mechanical shock. Damage to the probe may occur. Warning: Use only Bard Access Systems probes with this system. Use of unapproved probes may result in patient injury or equipment damage. Warning: When using Site~Rite* Needle Guides on the Site~Rite* 6 Ultrasound System probe, use only sterile plastic probe covers that are 1 mil (0.001 inch or 0.0254 mm) thick.
  • Page 11 Warning: The following actions void the warranty of the Site~Rite* 6 Ultrasound System and may result in injury or equipment damage: • Opening or servicing the scanner 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 base power unit or the A/C adapter by anyone other than Bard Access Systems authorized service personnel.
  • Page 12 Site~Rite * 6 Ultrasound System Warnings (continued) Warning: Maximum shelf load on the VAD bedside roll stand is 22 lbs. Exceeding this weight may damage the roll stand. Warning: Do not overtighten screws when attaching the scanner to the roll stand mount. Doing so may damage the scanner. Warning: Use only screws provided in the packaging. Ensure the unit is secure against the roll stand mount.
  • Page 13 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: Do not force the probe connector. Damage to the connector and system could result.
  • Page 14 Hot water (in excess of 113 F or 45 C) may damage the probe. Caution: Use only Bard Access Systems cleaning and disinfection procedures. Failure to do so may damage the device. Notes Note: When cleaning the system and components, it is important to remove all particles or other matter from all surfaces and crevices.

  • Page 15: Assembling The Roll Stand

    6 Ultrasound System Unpack the Site~Rite * 6 Ultrasound System and verify the contents against the packing slip. Inspect all parts for damage. If any damage is found, please contact Bard Access Systems at 800- 443-3385. Assembling the Roll Stand Refer to roll stand assembly instructions.

  • Page 16: Attaching The Power Source And Charging The Battery

    Site~Rite * 6 Ultrasound System Attaching the Power Source and Charging the Battery When the Site~Rite* 6 Ultrasound System is attached to A/C power, the battery charges automatically. Warning: Use only the Site-Rite* 6 Ultrasound System A/C adapter to charge the Site-Rite* 6 Ultrasound System.

  • Page 17: Connecting And Disconnecting Site~Rite * 6 Ultrasound System Probe

    Instructions For Use Connecting and Disconnecting the Site~Rite * 6 Ultrasound System Probe Warning: Use only Bard Access Systems probes with this system. Use of unapproved probes may result in patient injury or equipment damage. Caution: Do not pull the cable to disconnect the probe connector from the scanner. Pulling the cable may damage the cable, cable connection or scanner.

  • Page 18: Front Panel Controls

    Site~Rite * 6 Ultrasound System Resetting the Site~Rite 6 Ultrasound System Should the scanner display ever appear blank or show an exclamation mark (!), the system may need to be reset. To reset the system: 1. Depress and release the power button located on the front of the Site~Rite* 6 Ultrasound System scanner. 2. Wait approximately 60 seconds for the unit to reset itself.

  • Page 19: Probe Controls

    Instructions For Use Probe Controls On/ Off/ Reset Increase Gain Decrease Gain Depth Freeze Image Hold for more than 5 seconds to print or save the image on the screen...

  • Page 20: Display Screen Information

    Site~Rite * 6 Ultrasound System Display Screen Information Probe Orientation Marker Software Version Number Time and Date Patient ID 1 Display The time is shown in 24 hour “00:00” format and the date is displayed in YYYY- MM-DD format. Catheter Size Icons Displayed in proportion Image Depth Markers to the vessel image...
  • Page 21 Instructions For Use Display Screen Information Probe Depth Indicator Indicates current image depth A/C Power Indicator Printer Indicator 6.0 cm Printer Error 4.5 cm Not Connected to A/C Wall Power 3.0 cm Printing in Progress 1.5 cm Connected to A/C No Printer Connected Wall Power Contrast Indicator Printer Connected...

  • Page 22: Back Panel

    Site~Rite * 6 Ultrasound System Back Panel VESA Mount USB Connectors Power Inlet Entering Patient Information Patient identification (PID) information can be entered for each ultrasound image. PID information could include patient name, patient chart number, or other identification information. To enter PID information: 1.

  • Page 23: Probe Orientation

    Instructions For Use 4 Using the Site~Rite 6 Ultrasound System Probe Probe Orientation The Site~Rite* 6 Ultrasound System vascular access probe includes an orientation bump on the left side of the probe. This bump corresponds to the probe orientation mark located on the Site~Rite* 6 Ultrasound System display screen.

  • Page 24: Draping The Probe For Sterile Use

    Refer to the US FDA alert titled: “Medical Alert: Allergic Reactions to La- tex-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.

  • Page 25: Ultrasound Guidance For Vascular Access

    8. Hold the needle, then gently rock the probe away from the needle for a smooth separation. The needle guide channel opens, and the needle smoothly disengages from the guide. To purchase Needle Guides and sterile plastic Probe Covers, contact Bard Access Systems' Customer Service at: Customer Service: (800) 545-0890 www.bardaccess.com...

  • Page 26: Settings

    Site~Rite * 6 Ultrasound System 5 Settings Date, Time and Image Size To modify date, time and image size settings: Press the Freeze button ( ) to pause the system. Press and hold the Depth button ( ) for more than 5 seconds to enter the time/image size mode. The year field will then be highlighted.

  • Page 27: Sizing Tools

    Instructions For Use Sizing Tools Gridlines can be viewed over the ultrasound image to provide an effective tool to estimate vessel diameter. • Press the Depth Marker button (/:\) to toggle the image gridlines on and off. Catheter size icons are displayed in proportion to the vessel image at a selected depth. These icons assist clinicians in determining the appropriate catheter size for the vessel being imaged.

  • Page 28: Cleaning And Disinfection

    Doing so may damage the probe. Caution: Hot water (in excess of 113°F or 45°C) may damage the probe. Caution: Use only Bard Access Systems cleaning and disinfection procedures. Failure to do so may damage the device. For a list of disinfectants recommended for use on the Site~Rite* 6 Ultrasound System and probe, con-...

  • Page 29: Troubleshooting & Error Screens

    Instructions For Use 7 Troubleshooting & Error Screens Missing/ Cause: Scanner does not recognize or identify a probe or probe not attached. Invalid Probe Solution: Ensure that a Site-Rite* 6 Ultrasound System probe is properly connected to the system. System Cause: Scanner is not operating within normal parameters.

  • Page 30: Upgrading Software

    Site~Rite * 6 Ultrasound System 8 Upgrading Software The Site~Rite* 6 Ultrasound System allows the software to be upgraded through the USB connectors located on the rear of the scanner. To install software: 1. Press the Freeze button ( ) to pause the system. 2.

  • Page 31: Calibrating The Rechargeable Batteries

    Instructions For Use 9 Calibrating the Rechargeable Batteries The Site~Rite* 6 Ultrasound System batteries may occasionally require calibration to ensure the battery power meter is accurate. The following icon indicates that the Site~Rite* 6 Ultrasound System rechargeable batteries require calibration. To calibrate the Site~Rite* 6 Ultrasound System Rechargeable Batteries: 1.

  • Page 32: Warranty

    Site~Rite* 6 Ultrasound System A/C adapter and/or base power unit. • Connecting the Site~Rite* 6 Ultrasound System to any unauthorized accessory. THE LIABILITY AND REMEDY STATED IN THIS LIMITED PRODUCT WARRANTY WILL BE THE SOLE LIABILITY OF BARD ACCESS SYSTEMS AND REMEDY AVAILABLE TO PURCHASER FOR THIS PRODUCT, WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE.

  • Page 33: Service And Repair

    Warning: Opening or servicing the scanner, probe, base power unit, or A/C adapter by anyone other than Bard Access Systems authorized service personnel will void the warranty and may result in injury or equipment damage.

  • Page 34: Probe Acoustic Output Specifications

    Site~Rite * 6 Ultrasound System 12.3 Probe Acoustic Output Specifications MI X I spta.X FDA I spta.3 (X denotes FDA MI Operating (X denotes statisti- Published statistically REF Number Published Values Mode cally determined Values determined maximum) maximum) Peripheral Vessel Peripheral Vessel <...

  • Page 35: Probe Specifications

    Instructions For Use 12.4 Probe Specifications L-VA : Linear Vascular Access Probe Frequency: 5 - 10 MHz Elevation Focus: 1.8 cm Maximum Scan Depth: 6.0 cm Scan Width: 1.9 cm Lateral Foci: Image Depth Focal Depth 1.5 cm 0.6 cm 3.0 cm 1.5 cm 4.5 cm 3.0 cm...

  • Page 36: Standards Information

    Site~Rite * 6 Ultrasound System Internal Battery Pack Specifi cations Output Current (Max): 6 Amps Battery Chemistry: Lithium Ion Output Power (Full Charge): 52 Wh Nominal Output Voltage: 10.8 VDC Base Power Unit Specifi cations (All base power units except 9760035) Input Voltage: 15 VDC Battery Output Current (Max): 6 Amps Input Current (Max): 6 Amps...

  • Page 37: Disposal Information

    Instructions For Use Disposal Information To return the Site~Rite* 6 Ultrasound System for end of life recycling, please contact your nearest Bard sales or distributor offi ce in the country of purchase. Warning: Always properly dispose of dead battery packs in accordance with local regulations.
  • Page 38 Site~Rite * 6 Ultrasound System Guidance and Manufacturer’s Declaration – Immunity The Site~Rite* 6 Ultrasound System is intended for use in the electromagnetic environment specified below. The customer or user of the Site~Rite* 6 Ultrasound System should ensure that it is used in such an environment.
  • Page 39 Instructions For Use Guidance and Manufacturer’s Declaration – Emissions The Site~Rite* 6 Ultrasound System is intended for use in the electromagnetic environment specified below. The customer or user of the Site~Rite* 6 Ultrasound System should ensure that it is used in such an environment.
  • Page 40 Site~Rite * 6 Ultrasound System Recommended Separations Distances between portable and mobile RF Communications equipment and the Site~Rite* 6 Ultrasound System The Site~Rite* 6 Ultrasound System is intended for use in the electromagnetic environment in which radi- ated disturbances are controlled. The customer or user of the Site-Rite* 6 Ultrasound System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the Site~Rite* 6 Ultrasound System as recommended below, according to the maximum output power of the communications equipment.
  • Page 41 No part of this document may be photocopied, reproduced, or translated without the expressed written consent of C. R. Bard, Inc. Site~Rite 6 Ultrasound System Manufactured by: Bard Access Systems, Inc. 605 North 5600 West Salt Lake City, UT 84116 U.S.A. (801) 522-5000 Customer Service: (800) 545-0890 Technical/Clinical Support: (800) 443-3385 www.bardaccess.com...
  • Page 44 Revision date: July, 2009 * Bard, Site~Rite and Sherlock are trademarks and/or registered trademarks of C. R. Bard, Inc. or an affiliate. All other trademarks are the property of their owners. Copyright © 2009 C. R. Bard, Inc. All Rights Reserved.

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