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Bard Site-Rite 5 Technical Manual

Ultrasound system
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Site~Rite
*
5 Ultrasound System
Manufactured by:
Bard Access Systems, Inc.
Salt Lake City, UT 84116
U.S.A.
(801) 595-0700
Customer Service: (800) 545-0890
Technical/Clinical Support: (800) 443-3385
Fax: (801) 595-4948
www.bardaccess.com
An issued or revision date for these instructions is included for the users information. In the event two years have elapsed between this date and
product use, the user should contact Bard Access Systems, Inc. to see if additional product information is available.
Revision date: May, 2006.
* Bard and Site~Rite are trademarks and/or registered trademarks of C. R. Bard, Inc. or an affiliate.
Copyright © 2006 C. R. Bard, Inc. All Rights Reserved.
0712929 0605R

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Summary of Contents for Bard Site-Rite 5

  • Page 1 An issued or revision date for these instructions is included for the users information. In the event two years have elapsed between this date and product use, the user should contact Bard Access Systems, Inc. to see if additional product information is available.
  • Page 5 ­  Site~Rite ­5 Ultrasound System Do not operate in the presence Dot Markers Active of flammable anesthetics Warning: Refer to Manual Before Use Dangerous Voltage Power/Stand-by BF Type Equipment Medical Electrical Equipment Classified by ETL with respect to Electric Shock, Fire, and Mechanical Hazards only in accordance with UL60601-1 and CAN/CSA C22.2 No.
  • Page 6 ­  Technical­Manual Freeze Image Prescription Only Battery Pack Fragile Storage Temperature Ultrasound Probe Parameters Operating Temperature Depth (In Centimeters) Parameters Do not dispose with Gain ordinary municipal waste...
  • Page 7 ­  Site~Rite ­5 Ultrasound System...
  • Page 8 ­ 5 Technical­Manual Table­of­Contents Section 1­ Warranty ­ Warnings,­Precautions­and­Notes ­ Site~Rite ­5­Ultrasound­System­Description Power Source Scanner Assembly Transducer Assembly Front Panel Controls Display Screen Information ­ Installing­Site~Rite ­5­Software ­ 5­ Calibrating­the­Internal­Battery 6­ Troubleshooting­&­Error­Screens 7­ Site~Rite ­5­System­Specifications Operating and Storage Conditions Scanner Specifications Probe Specifications Power Supply Specifications 8­...

  • Page 9: Warranty

    The manufacturer, Bard Access Systems, warrants this product against defects in material and work- manship for a period of one year from the date of original purchase, and agrees to repair, or at Bard Access Systems' discretion, replace any defective unit free of charge. The warranty on the repaired or replaced unit continues from the purchase date of the original unit.

  • Page 10: Warnings,­Precautions­and­notes

    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 probe, use only sterile plastic probe covers that are 1 mil (0.001 inch or 0.0254 mm) thick.
  • Page 11 The following actions void the warranty of the Site~Rite* 5 System. • Opening or servicing the scanner or the probe housing. • Removal of system labels by anyone other than by Bard Access Systems authorized service personnel. • Opening or servicing the battery pack or the combination A/C adapter and battery charger by anyone other than Bard Access Systems authorized service personnel.
  • Page 12 ­ 9 Technical­Manual Warnings­(continued) Warning: Do not overtighten screws when attaching to the VESA roll stand mount. Doing so may damage the scanner. Warning: Use only screws provided in packaging. Ensure the unit is secure against the VESA roll stand mount. Failure to do so may cause the scanner to disconnect from the VESA 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.
  • 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 ­ 1  Site~Rite ­5 Ultrasound System ­­­Site~Rite*­5­Ultrasound­System­Description The Site~Rite* 5 Ultrasound system contains three major components. (See Figure 1) • Power Source (External AC Adapter or Base Unit Battery System/AC Adapter) • Scanner Assembly • Transducer Assembly External AC Adapter Transducer Scanner Assembly...
  • Page 16 ­ 1  Technical­Manual .1­­­Power­Source­ The power source supplies 15 volts direct current (VDC) nominal to the Scanner Assembly. Power source options include an External AC Adapter or a Base Unit Battery Assembly. The Base Unit Battery assembly contains a battery and built-in AC Adapter that permits portable sys- tem operation.
  • Page 17 The electrical data is then transmitted to the scanner assembly where an ultrasonic image is generated from multiple pulse echo frames. NOTE: The transducer assembly is NOT field-serviceable. If a problem is found with the transducer please contact Bard Access Systems at (800) 443-3385.
  • Page 18 ­ 1 5 Technical­Manual .­­­Front­Panel­Controls ­ Increase Gain Depth Markers (In Time Set mode, this Toggles depth button increases or toggles markers on/off. the selected field.) Print Sends the current image to the printer if connected. If a USB storage device is con- nected to the system, this button will also save the current...

  • Page 19: Display­screen­information

    ­ 1 6 Site~Rite ­5 Ultrasound System .5­­­Display­Screen­Information Mechanical­Index The mechanical index is shown in increments of 0.1 with an accuracy of +/- 0.09. Probe­Orientation­Marker Time­and­Date The time is shown in 24 hour “00:00” format and the date may be displayed in MM/DD/YY or DD.MM.YY format.
  • Page 20 ­ 1 7 Technical­Manual Display­Screen­Information­(continued) ­ AC­Power­Indicator­ The indicator is shown in solid grayscale when connected to AC wall power and is shown as a dark gray outline when disconnected. Battery­Indicator­ The 5 charge levels for the batteries are displayed as shown. When the unit is recharging, the indicator is green for all 5 levels.
  • Page 21 ­ 1 8 Site~Rite ­5 Ultrasound System 5­­Calibrating­the­Internal­Battery­­ ­ The Site~Rite 5 internal battery may occasionally require calibration to ensure the battery power meter is accurate. The following icon indicates that the Site~Rite 5 battery requires calibration. ­ To­calibrate­the­Site~Rite­5­Internal­Battery:­ 1. Disconnect all Site~Rite 5 power sources. 2.
  • Page 22 6­­­Troubleshooting­&­Error­Screens Missing/­ Cause: Scanner does not recognize or identify a probe or probe not attached. Invalid­Probe Solution: Ensure that a Site-Rite 5 probe is properly connected to the system. System­ Cause: Scanner is not operating within normal parameters. Malfunction Solution: Discontinue use immediately.

  • Page 23: Troubleshooting Guide

    ­  0 Site~Rite ­5 Ultrasound System 6­­­Troubleshooting­&­Error­Screens­Continued...­ ­ Troubleshooting Guide ­ Problem Possible Cause Solution ­ Press the power button for at least 1 second. The system will not power on. Did not press power button long enough (Power LED is not illuminated, ­...
  • Page 24 ­  1 Technical­Manual 7­­­Site~Rite­5*­System­Specifications 7.1­­­Operating­and­Storage­Conditions­ Operating Temperature: 59°F to 100°F (15°C to 38°C) Storage Temperature: 50°F to 95°F (10°C to 35°C ) Operating Humidity: 5% to 85% Relative Humidity (non-condensing) Storage Humidity (packaged): 5% to 95% Relative Humidity (non-condensing) Storage Humidity (unpackaged): 5% to 85% Relative Humidity (non-condensing) 7.­­­Scanner­Specifications­...
  • Page 25 ­   Site~Rite ­5 Ultrasound System 7.­­­Power­Supply­Specifications Note: For 240 V applications use only center tapped 240 VAC single phase power as ­ shown below. A/C Adapter Specifications Input Voltage: 100-240 VAC, 50/60 Hz. Output Voltage: 15 VDC Input Current (Max): 1 Amp Output Current (Max): 6 Amps...

  • Page 26: Standards­information

    ­   Technical­Manual Standards­Information ­­­ The Site~Rite* 5 Ultrasound System is designed to comply with applicable sections of the following International Standards: - UL 60601-1: 2003, Medical Electrical Equipment, Part 1: General Requirements for Safety - IEC 60601-1: 1988, Medical Electrical Equipment - Part 1: General Requirements for Safety - IEC 60601-1-1: 2000, Medical Electrical Equipment - Part 1-1: General Requirements for Safety - Collateral Stanard: Safety Requirements for Medical Electrical Systems - IEC 60601-1-2: 2004, Medical Electrical Equipment - Part 1-2: General Requirements for Safety -...

  • Page 27: Disposal Information

    ­­­ To return the Site~Rite* 5 System for end of life recycling, please contact your nearest Bard sales or distributor office in the country of purchase. Warning: Always properly dispose of dead battery packs in accordance with local regula- tions. Improper disposal may present an environmental hazard.
  • Page 28 The information contained in this document is subject to change without notice or obligation. This document contains proprietary information that is protected by copyright. No part of this document may be photocopied, reproduced, or translated without the expressed written consent of Bard Access Systems. Site~Rite 5 Ultrasound System Manufactured by: Bard Access Systems, Inc.

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