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Bard Site-Rite IV Manual

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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: January, 2007.
* Bard, Charge~Rite 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. Micro Fuse is a trademark of Littelfuse, Inc.
Copyright © 2007 C. R. Bard, Inc. All Rights Reserved.
0715117 0702R

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Summary of Contents for Bard Site-Rite IV

  • 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 2 Site~Rite * IV Ultrasound System Operator’s Manual...
  • Page 4 Do not operate in the presence of flammable anesthetics Medical Electrical Equipment Classified by UL with respect to Electrical Shock, Fire, and Mechanical Hazards only in accordance with UL 2601-1 and CAN/CSA C22.2 No. 601.1 Unfreeze Image Freeze Image European Conformity Do not dispose with ordinary municipal waste...

  • Page 5: Table Of Contents

    Table of Contents 1 Overview 1.1 Site~Rite IV Ultrasound System 1.2 Warnings, Cautions, and Notes 2 Material Safety Data 2.1 Standoff Probe Fluid 3 Setting up the Site~Rite * IV System 3.1 Assembling the Roll Stand 3.2 Attaching the Site~Rite IV Scanner to the Roll Stand 3.3 Adjusting the Roll Stand Height and Tilt 3.4 Attaching Feet to the Site~Rite IV Scanner (Optional) 3.5 Attaching Power Sources 3.6 Connecting and Disconnecting the Probes 3.7 Powering On the Scanner 4 Site~Rite * IV Scanner 4.1 Front Panel 4.2 Back Panel 4.3...

  • Page 6: Overview

    Explosion may result. Warning: Do not use for opthalmic indications. Warning: Misuse of the Site~Rite IV System may result in damage to the equipment or personal injury. Warning: Use only the Charge~Rite Battery Charger or Site~Rite Mini Battery Charger to charge Site~Rite IV Battery Packs. Use of any other charger to charge Site~Rite IV Battery Packs may damage the battery packs and will void your warranty. Warning: Only connect a Site~Rite IV A/C Adapter to the Site~Rite IV Ultrasound System. Use of any other A/C Adapter may cause intermittent or unpredictable operation, may damage the system and will void your warranty. Warning: Never connect a Site~Rite IV A/C Adapter to the Charge~Rite Battery Charger or Site~Rite Mini Battery Charger. Warning: Never incinerate a battery pack. Warning: Only use the battery packs or A/C adapter to power the scanner. Warning: If a probe is damaged in any way, discontinue use immediately. Warning: Do not subject the probe to mechanical shock. Dropping it or slapping it against an object, such as the palm of the hand, may dislodge sensitive components and cause intermittent or unpredictable operation. Warning: Do not subject the probe to excessive vibration. Vibration may dislodge sensitive components and cause intermittent or unpredictable operation. Warning: Use only Bard Access Systems probes with this system; otherwise, patient injury or equipment damage may result. ­ Site~Rite* IV Ultrasound System Operator’s Manual...
  • Page 7 Chapter 1: Overview Warning: When using Site~Rite Needle Guides on the fluid standoff probes, use only sterile plastic sheaths that are 1 mil (0.001 inch or 0.0254 mm) thick. Warning: Do not let liquid leak into the scanner, Charge~Rite Battery Charger, Site~Rite Mini Battery Charger, Battery Packs, A/C Adapter, Probe Connector or Probe Port. Warning: Do not attempt to sterilize the Site~Rite IV Scanner or Probes with ethylene oxide or heat sterilization methods. Damage to the devices will result. Warning: Do not soak the probe cable, cable bend reliefs or probe connectors in Cidex solution. Damage to the probe will result. Warning: Never use probes that are out of alignment for needle guidance. Warning: Always properly dispose of dead battery packs. Never incinerate a battery pack. If necessary, return Site~Rite IV Battery Packs to Bard Access Systems, for disposal. Warning: Only qualified personnel should attempt to service this equipment. Warning: The Site~Rite IV System contains dangerous voltages. Service attempts by unqualified personnel may result in serious injury or death. Warning: The Site~Rite IV 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 IV 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, A/C adapter, Charge~Rite Battery Charger, or the Site~Rite Mini Battery Charger by anyone other than Bard Access Systems authorized ser- vice personnel. •...
  • Page 8 Chapter 1: Overview Caution: Check the alignment of the 7.5 MHz and 9.0 MHz fluid standoff probes at least once a month, or after a probe has experienced any mechanical impact. Do not use a misaligned probe for needle guidance. For the alignment test, see Chapter 5.5, Periodic Probe Testing. 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. Use water or rubbing alcohol and a soft cloth to remove couplant from the acoustic window (or face) of the probe. Caution: Try not to allow ultrasonic couplant to dry on the acoustic window (or face) of the probe. If the couplant should dry, use water or rubbing 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: Some commercially available probe covers contain latex. Natural rubber latex may cause allergic reactions. On March 29, 1991, the U.S. FDA issued an alert titled: "Medical Alert: Allergic Reactions to Latex-Containing Medical Devices." Bard Access Systems distributes sterile kits that do not contain latex. Caution: Do not force the Probe connector. Damage to the connector and system could result. Caution: Use only warm water or rubbing alcohol for Probe cleaning. Use of hot water (temperature exceeding 113°F/45°C) may damage the probe. Caution: During disinfection immerse the probe up to, but not including, the colored cable bend relief. Caution: Always snap the needle guides on to the Probe hook. Do not slide the needle guide on to the needle guide hook, as you may tear the sterile sheath. Caution: Any given Ultrasound Procedure should be performed using the principle of ALARA (As Low As Reasonably Achievable). The Site~Rite IV System holds the acoustic output of the device constant. The licensed medical practitioner should limit the time of patient exposure to ultrasonic radiation using the principle of ALARA. Caution: Only accessories that are approved for use by country and local authorities are to be connected to the Site~Rite IV Scanner. Use of accessories that are not compliant to...

  • Page 9: ­­ Material­safety­data

    ): Causes eye irritation. May cause skin irrita- tion. Inhalation of high vapor concentrations may be harmful. Avoid contact with eyes, skin and clothing. Avoid breathing vapors. Use with adequate ventilation. Keep container closed. Wash thoroughly after handling. Ingestion of large quantities may cause liver or kidney damage. Protective Equipment: Wear impervious gloves and eye protection. Provide adequate ventilation. First Aid Inhalation – Remove from exposure area to fresh air immediately. If breathing has stopped, give artificial respiration. Keep affected person warm and at rest. Get medical attention. Skin Contact – Remove contaminated clothing and shoes. Wash affected area with soap or mild detergent and large amounts of water until no evidence of chemical remains (approximately 10 – 20 minutes). Get medical attention if necessary. Eye Contact – Wash eyes immediately with large amounts of water, occasionally lifting upper and lower lids until no evidence of chemical remains (approximately 15 – 20 minutes). Get medical atten- tion. Ingestion – If victim is conscious, immediately give 2 to 4 glasses of water and induce vomiting by touching finger to back of throat. Get medical attention immediately. Supplied To: Bard Access Systems, Inc., Salt Lake City, UT 84116 U.S.A. www.bardaccess.com Phone: (801) 595-0700 Supplied By: Fisher Scientific, 2000 Park Lane, Pittsburgh, PA 15275 U.S.A. Phone: (412) 460-8300 ­ Setting­up­the­Site~Rite ­IV­System Unpack the Site~Rite IV System and verify the contents against the packing slip. Assembling the Roll Stand The roll stand requires some assembly before use. Assembling the roll stand consists of three tasks: • Attaching the base to the post. • Attaching the wire basket. • Attaching the side arm. Tools Required •...
  • Page 10 Chapter 3: Setting up the Site~Rite * IV System roll stand from moving. Attaching the Wire Basket To attach the wire basket, Place the basket against the roll stand post, about a third of the way from the top of the post. The open side of the basket faces up. Position the two curved mounting clamps around the post so that the holes in the clamps align with those on the wire basket mounting plate. Use the Phillips head screwdriver to screw the inch-long screws through the mounting clamp holes and into the wire basket mounting plate. Tighten all of the screws. There are two screws per mounting bracket.3 Attaching the Side Arm To attach the side arm, Use the Allen wrench to unscrew the clamp screws. Position and hold the side arm on the roll stand post, just below the adjustment lever (or knob), so that the side arm projects to your right when you face the front of the roll stand. The additional probe and cord holder face toward the back of the roll stand. Position the side arm clamp around the roll stand post, so that the screw holes in both the side arm and the clamp align. Use the Allen wrench to loosely screw both of the Allen screws through the clamp and into the side arm. When the screws are in place, tighten both screws. When you tighten the screws completely, there is a small gap between the side arm and the clamp.

  • Page 11: Attaching The Site~Rite * Iv Scanner To The Roll Stand

    Chapter 3: Setting up the Site~Rite * IV System Attaching the Site~Rite IV Scanner to the Roll Stand To attach the Site~Rite IV Scanner to the roll stand, Rotate the roll stand so that the locking pin on the mounting plate faces you. Hold the Site~Rite IV Scanner with the front facing you. Position the scanner so that the mounting plate on the underside slides into the grooves on the roll stand’s mounting plate. Slide the scanner on to the mounting plate until it touches the locking pin. Identifier Label Locking Pin Mounting Plate Stop Screw Pull down on the locking pin, and slide the scanner past the pin. Release the pin when the edge of the scanner mounting plate passes over the locking pin. Continue to slide the scanner, until the locking pin snaps into the locking hole. A stop screw on the opposite side of the mounting plate prevents you from sliding the scanner off of the mounting plate. The Site~Rite IV Scanner is now attached to the roll stand. If the scanner is temporarily removed from the roll stand, use the scanner by placing it on a horizontal, flat surface. The Site~Rite IV Scanner has four black feet to protect both the bottom of the scanner and the surface on which you place it. The scanner has a retractable top handle for carrying the scanner when it is temporarily removed from the roll stand. Adjusting the Roll Stand Height and Tilt To adjust the height, unlock the locking mechanism on the roll stand post by turning the locking knob counterclockwise, slide the post up or down, and then lock the mechanism by turning the locking knob...

  • Page 12: Attaching Feet To The Site~Rite * Iv Scanner (Optional)

    Chapter 3: Setting up the Site~Rite * IV System Attaching Feet to the Site~Rite IV Scanner (Optional) The Site~Rite IV Scanner comes with four black rubber feet that can be attached to the bottom of the scanner to allow for tabletop use. The four black rubber feet are included in an individual package with the system. Since all Site~Rite IV Ultrasound Systems come with a roll-stand the rubber feet are not installed. The rubber feet can be easily installed on the scanner. Remove the screw in each corner of the scanner. Insert the screw into one of the black rubber feet. Replace the foot and screw back into the corner of the scanner, tightening the screw until secure. Attaching Power Sources The Site~Rite IV System can be powered by either a nickel-metal hydride battery pack or an A/C adapter. Both the battery pack and the A/C adapter attach in the same manner. For more information about the battery pack, see Chapter 7, Site~Rite Battery Charger. Note: If you are using the A/C adapter, the adapter automatically adjusts to the correct line voltage between 100 - 240 VAC, 50 - 60 Hz. The adapter ships with country-specific wall plugs. Verify that the A/C adapter has the appropriate plug for your country’s electrical system. To connect a power source (battery pack or A/C adapter) to the Site~Rite IV Scanner, Hold the power source so that the power connector projection points down. Align the power source with the scanner’s power source connector. Press together the spring clips located on the top and bottom of the power source. Place the power source against the back of the Site~Rite IV Scanner, between the upper and lower guides, and release the clips. The clips snap into the notches on the guides.

  • Page 13: Connecting And Disconnecting The Probes

    Chapter 3: Setting up the Site~Rite * IV System Connecting and Disconnecting the Probes To connect a probe, Place the probe into one of the Site~Rite IV Probe holders located on the side arm. Insert the probe connector into the probe port on the rear of Site~Rite IV Scanner. When properly inserted, the connector clicks into place. Identifier Label Probe Port Note: The Probe connector can only be inserted in one direction. If the connector does not fit into the probe port, turn the connector over and try again. Caution: Do not force the Probe connector. Damage to the connector and system could result. Tug lightly on the connector to verify that the connection is snug. To disconnect the probe, If the system power is on, power off Site~Rite IV System by pressing the power button on the front of the scanner. Press the sides of the probe connector. Gently pull the connector away from the back of Site~Rite IV Scanner. For information about probe types and handling, see Chapter 5, Site~Rite IV Probes. For more information about probe specifications, see Chapter 10.2, Site~Rite IV Probes Specifications. Powering On the Scanner To power on Site~Rite IV System, do the following: Verify that a probe is properly connected to the Site~Rite IV Scanner. A probe must be connected to the scanner for the system to power on.

  • Page 14: Site~Rite * Iv Scanner

    Chapter 4: Site~Rite * IV Scanner ­­ Site~Rite ­IV­Scanner Front Panel The following photograph illustrates the front of the Site~Rite IV Scanner: The following table lists and describes the front panel controls and features: Controls Description Turns scanner on and off. When on, a light illuminates in the Power Button button. Light blinks when 10 minutes of battery power are left. Switches between the different scan depths associated with the type of Site~Rite IV Probe attached to the scanner. The Depth selected depth is highlighted in the upper left-hand corner of Selection the screen; displayed depths are determined by the probe type. Button For more information about probe scan depths, see Chapter 5, Site~Rite IV Probes. Dot Marker Displays or removes dot markers that overlay the center of the image. Dot markers indicate scan depth from the surface of the Button skin. By default, dot markers are not displayed. For 9.0 MHz and 7.5 MHz Fluid Standoff Probes—the dots are spaced at intervals of approximately 0.5 cm. Dot markers are not intended for quantitative measurements. Reverses the image from left to right and vice versa. Cannot be used when in Freeze Frame mode. By default, the left edge Image Reversal of the probe displays on the left-hand side of the screen and Button the “R” icon is highlighted. For orientation information, see Chapter 5.3, Working with the Site~Rite IV Probes.

  • Page 15: Back Panel

    Chapter 4: Site~Rite * IV Scanner Controls Description Controls the gain, or intensity, of the scan image. Reduce gain by pressing on the left-hand side of button. Increase gain by pressing the right-hand side of button. The gain level is displayed as a marker on a horizontal bar at the Gain Control bottom of the screen, with the least amount of gain on the left- hand side, and greatest amount of gain on the right-hand side. Buttons By default, the gain is set to the middle setting. Increase Brightness Controls the brightness of the display. Increase brightness by Button pressing on the button. Decrease Brightness Controls the brightness of the display. Decrease brightness by pressing on the button. Button Back Panel The following photograph illustrates the back of the Site~Rite IV Scanner. The following table lists and describes the back panel features: Feature Description Fuse Location of External 5 A 125 V Micro Fuse. Use the Power Source Connector to connect a battery pack or Power Source an A/C adapter to the Site~Rite IV Scanner. See Chapter 3.4, Connector Attaching Power Sources. Battery Brackets to which the battery is attached by its clips.

  • Page 16: Setting The Time, Date And Date Format

    If you entered an invalid time or date, “Invalid Time” or “Invalid Date” displays beneath the time and date, and the scanner remains in edit mode. Note: When in the screens to change the day and time; to discard the changes made to the time and date, press the Freeze Frame button before saving the changes. The date format does not change. Using the Video Out Feature On the back of the Site~Rite IV Scanner is a video out port. You can use the video out feature to connect the Site~Rite IV Scanner to third party video equipment, such as a larger monitor. The video out port is a standard BNC plug. The plug is covered with a twist-off cap to protect it when not in use. The Site~Rite IV Scanner’s video out format is configured to be NTSC compatible. Note: You must follow any local safety requirements when attaching non-Bard Access Systems' manufactured accessories. Caution: Only accessories that are approved for use by country and local authorities are to be connected to the Site~Rite IV Scanner. Use of accessories that are not compliant to International Electrical Safety Standards may result in device failure. ­ ­ Site~Rite * IV Ultrasound System Operator’s Manual...

  • Page 17: Site~Rite * Iv Probes

    Chapter 5: Site~Rite * IV Probes ­ Site~Rite ­IV­Probes Overview Standoff Probe The following table describes the probe. Feature Description Standoff Used for superficial imaging to a depth of 4 cm. Probe Needle Guide Hook to which the short end of the needle guide is clipped. Hook For superficial imaging, there are two standoff probes: • 7.5 MHz probe, with a red cable bend relief, optimized for imaging at depths from 1.5 cm to 4 cm below skin surface. The probe images to a depth of 4 cm. • 9.0 MHz probe, with a blue cable bend relief, optimized for imaging at depths from 0 cm to 1.5 cm below skin surface. The probe images to a depth of 4 cm. The label on the connector of the probe indicates the probe’s frequency, the focal length, and the probe’s serial number. Each probe has two scan depths that you can select using the Site~Rite IV Scanner Depth Selection button. The following table lists the probe type and bend relief color, scan depths, and scan plane shape: 7.5 MHz 9.0 MHz Standoff Standoff (Red) (Blue) 2 cm 2 cm Scan Depth 4 cm...

  • Page 18: Handling The Probes

    Standoff Probe (red and blue cable bend relief ) When using a 7.5 MHz probe (red cable bend relief ) or 9.0 MHz probe (blue cable bend relief ), hold the probe so that the side with the needle guide hook points away from the heart. Caution: Check the alignment of the 7.5 MHz and 9.0 MHz standoff probes once a month, or after a probe has experienced any mechanical impact. Do not use a misaligned probe for needle guidance. For the alignment test, see Chapter 5.5, Periodic Probe Testing. Warning: If a probe is damaged in any way, discontinue use immediately. Draping the Probe for Sterile Use When using Site~Rite IV probe in a sterile environment, the probe and part of the probe cable must be covered with a sterile, acoustically transparent plastic sheath. Caution: Some commercially available probe covers contain latex. Natural rubber latex may cause allergic reactions. On March 29, 1991, the U.S. FDA issued an alert titled: "Medical Alert: Allergic Reactions to Latex-Containing Medical Devices."Bard Access Systems, Dymax Corporation distributed sterile kits do not contain latex. To drape the probe for sterile use, Place the probe in the side arm probe holder on the roll stand. Apply a layer of non-sterile ultrasonic coupling gel on the acoustic window of the probe head. Make sure that the sheath is fully rolled up. Place the sheath over the probe head, being careful not to wipe off the coupling gel. Cover the probe and cable with the sheath. Smooth the sheath over the acoustic window of the probe head to remove any air bubbles or folds in the sheath. Use the poly-bands to hold the sheath in place. Apply a layer of sterile coupling gel to the sheathed acoustic window. Sterile gel is included in the Site-Rite IV Sterile Kit. Warning: W hen using Site~Rite Needle Guides on the fluid standoff probes, use only sterile plastic sheaths that are 1 mil (0.001 inch or 0.0254 mm) thick.

  • Page 19: Cleaning And Disinfecting The Scanner And Probes

    Chapter 5: Site~Rite * IV Probes Cleaning and Disinfecting the Scanner and Probes Warning: Do not attempt to sterilize the Site~Rite IV Scanner or Probes with ethylene oxide or heat sterilization methods. Damage to the devices will result. Recommendations for Cleaning the Site~Rite IV Scanner To clean the scanner: Dampen a nonabrasive cloth with either warm water or rubbing alcohol. Gently wipe the dampened cloth over the areas of the scanner requiring cleaning. Note: When cleaning the system and components, it is important to remove all particles or other matter from all surfaces and crevices. Warning: Do not let liquid leak into the scanner, Charge~Rite Battery Charger, Site~Rite Mini Battery Charger, Battery Packs, A/C Adapter, Probe Connector, or Probe Port. Recommendations for Cleaning the Charge~Rite Battery Charger and Site~Rite Mini Battery Charger To clean the battery charger: Dampen a nonabrasive cloth with either warm water or rubbing alcohol.

  • Page 20: Periodic Probe Testing

    Chapter 5: Site~Rite * IV Probes The germicide level of activity selected should be consistent with the degree of risk of infection involved in the use of the device. Minimum Risk Patient Applications Germicide Level of Classification Activity Recommendation* Probe used in contact with intact Clean and low-level disinfect Non-critical skin only, e.g. abdominal or between uses. peripheral vascular imaging. Probe used in contact with mucous Clean, high-level disinfect. Use a Semi-critical membranes, e.g. transvaginal probe sheath during application. imaging. Probe used in contact with blood, Clean, high-level disinfect or compromised tissue, or in a sterile sterilize. Use a sterile probe sheath Critical field, e.g. intraoperative imaging, during application. biopsy procedures. *Refer to the solution manufacturer’s instruction on the soak time necessary to achieve these germicide levels of activity. Warning: Do not attempt to sterilize the Site~Rite IV Scanner or Probes with ethylene oxide or heat sterilization methods. Damage to the devices will result. Periodic Probe Testing The 7.5 MHz (red cable bend relief ) and 9.0 MHz (blue cable bend relief ) standoff probes should be tested for proper alignment on a monthly basis, or when the probe has been dropped or mistreated.
  • Page 21 Chapter 5: Site~Rite * IV Probes • If the needle aligns with the center dot markers—the probe is aligned properly. • If the needle displays to either side of the dot markers—the probe is misaligned and must be returned to Bard Access Systems for repair. For information about returning items to Bard Access Systems for repair, see Chapter 9.2, Service. ­ Site~Rite * IV Ultrasound System Operator’s Manual...

  • Page 22: Site~Rite * Iv Needle Guides

    Chapter 6: Site~Rite * IV Needle Guides ­­ Site~Rite ­IV­Needle­Guides The 7.5 MHz (red cable bend relief ) and 9.0 MHz (blue cable bend relief ) fluid standoff probes are designed to be used with the Site~Rite Disposable Needle Guides and have a needle guide hook on one of the broad sides of the probe. The Site~Rite Needle Guides direct a needle so that it will cross the ultrasound beam at a predetermined depth that lies along the path of the dot markers. The following table describes the needle guides. Feature Description Ultrasound Plane The plane that is viewed on the scanner display. Needle guides allow for needle depth location within the Intersection Depth ultrasound plane from 0.5 cm to 3.5 cm. Within the illustration the Jugular Vein and Carotid Artery are Jugular Vein depicted. Attaching the Needle Guide to the Probe To attach the needle guide to a probe, Choose the appropriate needle guide based on the depth of the structure to be punctured and the gauge of the needle to be used. Note: Needle guides can only be used over a sterile Site~Rite Probe sheath in order to maintain sterility of the Site~Rite IV Probe. For information about sterile draping, see Chapter 5.3, Working with the Site~Rite IV Probes.

  • Page 23: Using The Needle Guides

    Chapter 6: Site~Rite * IV Needle Guides 2. Clip the short end of the needle guide to the end of the needle guide hook closest to the top of the probe. 3. Push the larger end of the needle guide toward the probe until the needle guide snaps on to the needle guide hook. Do not slide. Caution: Always snap the needle guides on to the Probe hook. Do not slide the needle guide on to the needle guide hook, as you may tear the sterile sheath. Using the Needle Guides To use the needle guide, Slide the appropriately sized needle, beveled edge facing the probe, into the channel on the guide. ­ ­ Site~Rite * IV Ultrasound System Operator’s Manual...
  • Page 24 Chapter 6: Site~Rite * IV Needle Guides Place the probe against the skin, perpendicular to the target vessel. Hold the probe so that the needle guide points away from the heart. Center the dot markers on the target vessel. While keeping the dot markers centered on the target vessel, slowly advance the needle while looking at the screen of the Site~Rite IV scanner. When the needle approaches the target vessel, you should see the anterior wall indenting. Once puncture occurs, the vessel returns to normal shape. 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. ­ Site~Rite * IV Ultrasound System Operator’s Manual...

  • Page 25: Site~Rite * Iv Battery Charger

    Chapter 7: Site~Rite * IV Battery Charger ­ Site~Rite ­IV­Battery­Charger Site~Rite Mini Battery Charger US Version EU Version The following table lists and describes the indicator light features: Feature Description Rapid Charge Battery Charger LED indicator Flashes Green Charge Complete Battery Charger LED indicator Continuous Green Color Charge Pending Battery Charger LED indicator Continuous Amber Color Charge Failure Battery Charger LED indicator Flashes Amber Color No AC or No Battery Charger LED indicator OFF Battery The Site~Rite Mini battery charger is used to charge Site~Rite IV Battery Packs. The battery charger is plugged into any standard power outlet and automatically adjusts to run on any line voltage between 100 - 250 VAC, 50 - 60 Hz. Each battery charger is shipped with a country-specific wall plug. Be sure that the battery charger has the appropriate plug for your country’s electrical system. The Site~Rite Mini Battery Charger does not have an external fuse. Warning: Use only the Site~Rite Mini Battery Charger or Charge~Rite Battery Charger to charge Site~Rite IV Battery Packs. Use of any other charger to charge Site~Rite IV Battery Packs may damage the battery packs and will void your warranty. Never connect a Charge~Rite Battery Charger or Site~Rite IV A/C Adapter to a Site~Rite Mini Battery Charger.
  • Page 26 Chapter 7: Site~Rite * IV Battery Charger Charging the Battery with the Site~Rite Mini Battery Charger Site~Rite IV Battery Packs are fully charged prior to shipment, but may require charging before use. To charge a battery pack with the Site~Rite Mini Battery Charger, Plug the Site~Rite Mini Battery Charger into a power outlet. Verify that the LED indicator on the front of the Site~Rite Mini Battery Charger is not illuminated. Attach the battery pack to the Site~Rite Mini Battery Charger. The battery packs attach to the Site~Rite Mini Battery Charger by inserting the molded battery charger connector into the matching connector of the battery pack. • Hold the battery pack with the plug port visible. • Place the molded battery connector of the Site~Rite Mini Battery Charger into the plug port.

  • Page 27: Charge~Rite ™ Battery Charger

    Chapter 7: Site~Rite * IV Battery Charger Charge~Rite ™ Battery Charger The Charge~Rite Battery Charger is used to charge Site~Rite IV Battery Packs. The Charge~Rite Battery Charger plugs into a standard power outlet and automatically adjusts to run on any line voltage between 90 - 264 VAC, 47 - 63 Hz. The Charge~Rite Battery Charger is shipped with country-specific wall plugs. Be sure that the Charge~Rite Battery Charger has the appropriate plug for your country’s electrical system. Charge~Rite fuses are located next to the power switch on the back of the unit. Use only F250 V/3.0A fuses in the unit. Warning: Use only the Charge~Rite Battery Charger or Site~Rite Mini Battery Charger to charge Site~Rite IV Battery Packs. Use of any other charger to charge Site~Rite IV Battery Packs may damage the battery packs and will void your warranty. Never connect a Site~Rite IV A/C Adapter to a Charge~Rite Battery Charger or Site~Rite Mini Battery Charger. Indicator Lights The following table lists and describes the indicator light features: Feature Description Power Charge~Rite Battery Charger is powered on. Fast Charge Battery is charging in Fast Charge mode. Battery is charging in Slow Charge or Maintenance mode. Slow Charge Battery is either too hot or too cold to charge. If Temperature Fault and Power indicators illuminate—the battery is too hot. Turn the Charge~Rite Battery Charger off and wait several minutes for the battery to cool down. If Temperature Fault and Slow Charge indicators illumi- nate—the battery is too cold. The Charge~Rite Battery Charger Temperature Fault charges the battery in Slow Charge mode until the battery is warmed up.

  • Page 28: Charging The Battery With The Charge~Rite ™ Battery Charger

    Chapter 7: Site~Rite * IV Battery Charger Charging the Battery with the Charge~Rite ™ Battery Charger Site~Rite IV Battery Packs are fully charged prior to shipment, but may require charging before use. To charge a battery pack with the Charge~Rite Battery Charger, Plug the Charge~Rite Power Cord into a power outlet. Verify that the power switch on the back of the Charge~Rite Battery Charger is switched to Off and that the Power indicator on the front of the Charge~Rite Battery Charger is not illuminated. Attach the battery pack to the Charge~Rite Battery Charger. The battery packs attach to the Charge~Rite Battery Charger in the same manner as they attach to the Site~Rite 3 Scanner: • Hold the battery pack with the plug port pointing down, and press together the spring clips located on the top and bottom of the pack. • Place the battery pack against the front of the Charge~Rite Battery Charger, between the upper and lower guides, and release the clips. The clips snap into the notches on the guides. • Gently tug on the pack to verify that it is securely connected to the Charge~Rite Battery Charger. On the back of the Charge~Rite Battery Charger, turn the power switch to On. On the front of the Charge~Rite Battery Charger, the Power indicator and the Fast Charge indicator illuminate to indicate that the charger is in Fast Charge mode. After approximately 2 hours, the Fast Charge indicator turns off and the Slow Charge indicator illuminates. Slow Charge lasts for approximately 2 hours. The total charging cycle (both slow and fast charge) lasts approximately 5 hours, after which the battery is fully charged. Note: When placing a cold battery in a warm room to charge, the rapid temperature change of the battery occasionally causes the Charge~Rite Battery Charger to switch from the Fast...

  • Page 29: ­ Site~Rite * ­Iv­system­maintenance­and­troubleshooting

    Operating and Storage Conditions The Site~Rite IV System should not be operated or stored in conditions beyond the following tolerances: Condition Tolerance 59°F to 100°F Operating Temperature: (15°C to 38°C) 41°F to 113°F Storage Temperature: (5°C to 45°C) Operating and Storage Humidity: 5% to 95% Relative Humidity (non-condensing) -500 feet to 10,000 feet elevation Operating and Storage Atmospheric Pressure: (103 kPA to 70 kPA) Troubleshooting If you have problems with the operation of your Site~Rite IV System, review this section before contacting Bard Access Systems. Common Problems and Solutions The following table describes common problems, possible causes, and suggested solutions: Problem Possible Cause Solution Remove battery pack and Battery pack is depleted. replace with a fully charged battery pack. Verify that power source is Battery pack or A/C adaptor firmly connected to back of not properly connected to scanner. scanner. Probe not properly connected Verify that probe is properly or not connected at all.
  • Page 30 Chapter 8: Site~Rite * IV System Maintenance and Troubleshooting Problem Possible Cause Solution Remove battery pack and Scanner turns on for a Battery pack is depleted. replace with a fully charged moment, then shuts off. battery pack. Operator may be applying too much pressure on the probe Do not press on the sides of Scanner halts, stutters, then cap, thereby affecting the probe cap. Hold probe by restarts. operation of the internal the handle. bearings. Probe is too cold. Wait for probe to warm up. Probe is damaged. Return probe for repair. Scanner turns on, screen lights up, but no image displays. The Probe Assembly is not Properly connect the Probe connected or connected Assembly. improperly. Scanner turns on, display is Replace the Probe Assembly normal shaped, and the The Probe Assembly is...
  • Page 31 During normal operation the The low battery detection Remove battery pack and scanner shuts down without circuits are defective. replace with fully charged warning. battery pack. Return scanner for repair. Error Messages The Site~Rite IV Scanner displays error messages when certain conditions exist. The following table describes the error messages and actions to take to correct the error. Problem Possible Cause The system cannot identify the probe attached to the scanner. Turn scan- Invalid Probe ner off. Verify that probe is connected correctly, and then power scanner No Probe on. If message repeats, call Bard Access Systems, (in US) or local distribu- Invalid Depth tor (outside of US). (in US) or local distributor (outside of US). The probe attached to the scanner is not oscillating correctly. Turn scan- ner off. If probe is cold, warm probe to room temperature by immersing Probe over power error the cap in a cup of warm water. Verify that the probe is connected cor- rectly, and then power scanner on. If message repeats, call Bard Access Systems (in US) or local distributor (outside of US). Turn scanner off. Allow system to return to room temperature and LCD thermal shutdown then power system on. If message repeats, call Bard Access Systems imminent (in US) or local distributor (outside of US). (in US) or local distributor (outside of US). The software running the system is damaged. Call Bard Access CRC error Systems (in US) or local distributor (outside of US). The system hardware or software has failed. Call Bard Access Systems Watchdog time out (in US) or local distributor (outside of US).

  • Page 32: ­ Warranty­and­service

    Chapter 9: Warranty and Service ­ Warranty­and­Service Coverage The manufacturer, Bard Access Systems, warrants this product against defects in material or workman- ship 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. This warranty does not cover damages resulting from misuse, abuse, modification, or alteration of the Site~Rite IV System. The following actions void the warranty of the Site~Rite IV 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, A/C adapter, Charge~Rite Battery Charger or the Site~Rite Mini Battery Charger by anyone other than Bard Access Systems, Dymax Corporation authorized service personnel. • Connecting the Site~Rite IV Scanner to any battery source other than the Site~Rite IV Battery Pack. • Connecting the Site~Rite IV Battery Packs to any charger other than the Charge~Rite Battery Charger or Site~Rite Mini Battery Charger. • Connecting the Site~Rite IV Scanner to any A/C adapter other than the one provided with the scanner. imiTed producT warranTy is in Lieu of aLL oTher warranTies...

  • Page 33: Technical Specifications

    Chapter 10: Warranty and Service 0­Technical­Specifications 10.1 Site~Rite IV Scanner Specifications Dimensions: 10” x 6.75” x 8” (540 in 3 ) Weight: 6.2 lbs. (2.8 kg) Power Sources: AC adapter, DC Battery Pack Power Consumption: 14.4 VDC @ 1.5 A Monitor Size: 3.8” Y2K Compliant: yes IEC 60601- 1: Class I, Type BF Applied Part, Continuous Operation, Internally Powered Equiptment, Not Category AP or APG Equiptment, Not protected against ingress of water. Probes: 7.5 MHz, 9.0 MHz Fuse: 5 A 125 V MicroTM Fuse (Part Number: 273 005 Manufactured by Littelfuse, Inc.) 10.2 Site~Rite IV Probe Specifications 7.5 MHz Probe 9.0 MHz Probe Ultrasonic Frequency: 7.5 MHz Ultrasonic Frequency: 9.0 MHz Sector Angle: 26° Sector Angle: 26° Crystal to Cap Standoff Distance: 4.0 cm Crystal to Cap Standoff Distance: 4.0 cm Scan Depth from Probe Cap: 2.0/4.0 cm Scan Depth from Probe Cap: 2.0/4.0 cm Frame Rate: 24 frames/second Frame Rate: 24 frames/second Line Density: 129 lines/frame Line Density: 129 lines/frame Focal Length: 2.0 cm from cap...
  • Page 34 The Site~Rite IV Ultrasound System is designed to comply with applicable sections of the following International Standards: - IEC 60601- 1 - IEC 60601- 1- 2 - EN 55011: 2000 Class A - IEC 60601- 2- 37 - IEC 68- 2- 1 - IEC 68- 2- 2 - IEC 68- 2- 13 NEMA Standard Publications “Acoustic Output Measurement Standard for Diagnostic Ultrasound Equiptment” UD- 2 NEMA Standard Publications “Standard for Real-Time Display of Thermal and Machanical Acoustic Output Indices on Diagnostic Ultrasound Equiptment” UD- 3 10.5 Site~Rite IV Ultrasound System Disposal Information To return the Site~Rite 5 System for end of life recycling, please contact your nearest Bard sales or distribu- tor office in the country of purchase. Warning: Always properly dispose of dead battery packs in accordance with local regulations. Improper disposal may present an enviromental hazard. 10.6 Site~Rite IV Probe Acoustic Output Specifications Caution: Any given Ultrasound Procedure should be performed using the principle of ALARA (As Low As Reasonably Achievable). The Site~Rite IV System holds the acoustic output of the device constant. The licensed medical practitioner should limit the time of patient exposure to ultrasonic radiation using the principle of ALARA. MI X spta FDA I...
  • Page 35 Chapter 10: Technical Specifications Bard and Site~Rite are registered trademarks of C.R. Bard, Inc., or an affiliate. Charge~Rite is a trademark of C.R. Bard, Inc., or an affiliate. CIDEX is a registered trademark of Johnson and Johnson Corporation. Micro Fuse is a trademark of Littelfuse, Inc. Components of the Site~Rite IV Ultrasound System are covered by U.S. Patent No. 5,235,987. 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 docu- ment may be photocopied, reproduced, or translated without the expressed written consent of Bard Access Systems. SITE~RITE IV * Ultrasound System WITH RESPECT TO ELECTRIC SHOCK, FIRE, MECHANICAL AND OTHER SPECIFIED HAZARDS ONLY IN ACCORDANCE WITH CAN/CSA C22.2 NO. 601.1 <50TK> Warning This product is regulated by the Federal Food and Drug Administration in the United States of America, as well as other agencies throughout the world. This product is ISO certified and CE approved. Therefore, any modification to the product, except those made by the manufacturer, is strictly prohibited by law. Federal (U.S.A.) law restricts this device to sale by or on the order of physician. This product should only be operated by qualified medical personnel. Precaution Any given Ultrasound Procedure should be performed using the principle of ALARA (As Low As Reasonably Achievable). The Site~Rite IV System holds the acoustic output of the device constant. The licensed medical practitioner should limit the time of patient exposure to ultrasonic radiation using the principle of ALARA. Site~Rite IV Ultrasound System Manufactured by: Bard Access Systems, Inc.
  • Page 36 Chapter 10: Technical Specifications Site~Rite * Needle Guides Distributed by: Bard Access Systems, Inc. Salt Lake City, UT 84116 U.S.A. (801) 595-0700 Customer Service: (800) 545-0890 Clinical Information: (800) 443-3385 Fax: (801) 595-4948 www.bardaccess.com Authorised European Service Representative: Bard Limited Forest House, Brighton Road Crawley, West Sussex RH11 9BP England Phone: + 44 1293 527888 Fax: + 44 1293 528454 European Community Representative Contact: EEA Authorised Representative Bard Limited Forest House, Brighton Road Crawley, West Sussex RH11 9BP England Phone:...

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