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Bard Site-Rite 5 Instructions For Use 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.
Cidex is a registered trademark of Johnson and Johnson Medical, Inc.
U.S. Patent: 5,235,987; U.S. Patents Pending.
Copyright © 2006 C. R. Bard, Inc. All Rights Reserved.
0712928 0605R

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  • 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 Medical Electrical Equipment BF Type 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 ­  Instructions­For­Use 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: Table Of Contents

    ­  Site~Rite * ­5 Ultrasound System Table­of­Contents Section 1­ Overview Indications For Use Site~Rite 5 Ultrasound System and Components Warnings, Precautions and Notes ­ Assembling­the­Site~Rite ­5­Ultrasound­System Roll Stand Options Assembling the Roll Stand Attaching the Site~Rite 5 Scanner to Approved Roll Stands Adjusting the Scanner Attaching the Power Source and Charging the Battery Connecting and Disconnecting Site~Rite...
  • Page 8 ­ 5 Instructions­For­Use Table­of­Contents Section 5­ Settings Date, Time and Image Size Image Parameters 6­ Installing­Software­ 7­ Calibrating­the­Internal­Battery­ 8­ Warranty 9­ Technical­Specifications Operating and Storage Conditions Scanner Specifications Probe Acoustic Output Specifications Probe Specifications Power Supply Specifications Standards Information 10­ Disposal­Information...
  • Page 9 Troubleshooting­&­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 10 The following actions void the warranty of the Site~Rite 5 Ultrasound 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 11 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. Note: When cleaning the system and components, it is important to remove all particles or other matter from all surfaces and crevices.

  • Page 12: 1­ Overview

    • Site~Rite disposable probe covers • Combination Site~Rite A/C adapter and battery charger • Roll stand mounted battery • Ultrasound gel • Ultrasound vessel phantom Contact your Bard Access Systems' Sales Representative or Customer Service at (800) 545-0890 to order.

  • Page 13: Warnings, Precautions And Notes

    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 14 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 15 ­ 1  Site~Rite * ­5 Ultrasound System 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.
  • Page 16 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 17 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 18: Assembling­the­site~Rite * ­5­Ultrasound­system

    ­ 1 5 Instructions­For­Use ­­Assembling­the­Site~Rite ­5­Ultrasound­System Unpack the Site~Rite 5 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. ­­­Roll­Stand­Options VAD­Bedside Standard Collapsible Roll Stand...

  • Page 19: Assembling The Roll Stand

    ­ 1 6 Site~Rite * ­5 Ultrasound System ­­­Assembling­the­Roll­Stand ­ Step­1: Step­: Attach probe holder to probe arm as shown. Attach Probe Arm to monitor mounting plate using rear two holes only as shown. Step­: Step­: Remove two screws from Swivel Mount Using two screws removed in Step 3 mount assembly as shown.
  • Page 20 ­ 1 7 Instructions­For­Use Assembling­the­Roll­Stand­(continued) Step­5: Step­6: Route cord in the lower rear corner of monitor Start two screws in the top two monitor mounting plate assembly as shown. mounting locations as shown. Step­7: Step­8: Slide monitor onto monitor mounting plate, insert Plug in cord as shown.

  • Page 21: Attaching The Site~Rite * 5 Scanner To Approved Roll Stands

    ­ 1 8 Site~Rite * ­5 Ultrasound System ­­­Attaching­the­Site~Rite ­5­Scanner­to­Approved­Roll­Stands­ Conforms to 100mm VESA Mount 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.

  • Page 22: ­­­Adjusting­the­scanner

    Tilt­and­Swivel­Adjustment ­­­Attaching­the­Power­Source­and­Charging­the­Battery Warning: Use only the combination Site-Rite A/C adapter and battery charger to charge Site-Rite 5. Use of any other device to charge Site-Rite 5 battery packs may damage the battery packs and will void your warranty. Warning: Only connect a Site-Rite 5 combination A/C adapter and battery charger to the Site-Rite 5 System.

  • Page 23: Connecting And Disconnecting Site~Rite * 5 Probes

    5 Ultrasound System Verify that the probe is connected to the Site~Rite 5 scanner. Depress and release the power button located on the front of the Site-Rite 5 scanner. Wait approximately 20 seconds for the display screen to illuminate. To power off the Site~Rite 5 System, depress and release the power button again. The...

  • Page 24: Resetting The Site~Rite * 5 Ultrasound System

    ­  1 Instructions­For­Use ­­­Resetting­the­Site~Rite ­5­Ultrasound­System 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 5 scanner. 2.

  • Page 25: Display Screen Information

    ­   Site~Rite * ­5 Ultrasound System ­­­Display­Screen­Information 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 26: Back Panel

    ­   Instructions­For­Use Display­Screen­Information 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 27: Using­the­site~Rite * ­5­Probe

    ­   Site~Rite * ­5 Ultrasound System ­­Using­the­Site~Rite ­5­Probe­ ­­­Probe­Orientation The Site~Rite 5 vascular access probe includes an orientation bump on the left side of the probe. This bump corresponds to the probe orienta- tion mark located on the Site~Rite 5 display screen.

  • Page 28: Draping The Probe For Sterile Use

    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...

  • Page 29: Ultrasound Guidance For Vascular Access

    8. Hold the needle, then gently rock the probe away from the need 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 30: 5­ Settings

    ­  7 Instructions­For­Use 5­­Settings ­­­Date,­Time­and­Image­Size­ To­modify­date,­time­and­image­size­settings:­­ Press the Freeze button ( ) to pause the system. Press and hold the Depth button ( ) to enter the time/image size mode. The year field will then be highlighted. Release the Depth button. Press the Depth button ( ) to select the desired date or time field to be modified.

  • Page 31: 6­ Installing­software

    ­  8 Site~Rite * ­5 Ultrasound System 6­­Installing­Software The Site~Rite* 5 Ultrasound System allows software installation through the USB connectors located on the rear of the scanner. To­install­software: 1. Press the Freeze button ( ) to pause the system. 2.

  • Page 32: 7­ Calibrating­the­internal­battery

    ­  9 Instructions­For­Use 7­­Calibrating­the­Internal­Battery­­ 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 33: 8­ 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 34: 9­ Technical­specifications

    ­  1 Instructions­For­Use 9­­Technical­Specifications­ ­­ ­­­Operating­and­Storage­Conditions 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) ­­­Scanner­Specifications­...

  • Page 35: Probe Specifications

    ­   Site~Rite * ­5 Ultrasound System **Abdominal, Intraoperative, Pediatric, Small Organ (breast, thyroid, testes, etc.), Neonatal Cephalic, Adult Cephalic. All measurements were conducted in accordance with the measurement procedures of the NEMA Standard Publications UD-2 [1] and UD-3 [2], and following the calibration procedures given in Appendices B, C, D and E of the 1985 FDA 510(k) Guide, and Part A, Sections III-IV, and Appendices A, B, C and D of the 1989 FDA 510(k) Guide, and the Track 1 and Track 3 reporting require- ments of the September 30, 1997 Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers...

  • Page 36: Power Supply Specifications

    ­   Instructions­For­Use ­­­Power­Supply­Specifications Note: For 240 V applications use only center tapped 240 VAC single phase power as shown below. A/C Adapter Specifications Output Voltage: 15 VDC Input Voltage: 100-240 VAC, 50/60 Hz. Output Current (Max): 6 Amps Input Current (Max): 1 Amp Internal Battery Pack Specifications Output Power (Full Charge): 52 Wh...

  • Page 37: Standards Information

    - EN 55011:2000 Class A - Industrial, Scientific, and Medical (ISM) Radio-Frequency Equipment -Radio Distrubance Characteristics-Limits and Methods of Measurement ­­­Disposal­Information 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 regulations.
  • Page 38 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.

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