Catheter Tip Positioning Systems

ARROW® G4 Vascular Positioning System

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Is the ARROW® VPS G4 Device easy to use?

Navigation with the ARROW® VPS G4 Device is easy, during central venous catheter (PICC or CVC) placement. Just follow the illuminated directional symbols located on the VPS G4 Interface. On average it takes about 15-25 cases for new users to become fully accustomed to placing catheters with the device.


How long does it take to set up the ARROW® VPS G4 Device?

Setup takes just a few minutes. In addition to your existing catheter placement procedure, additional steps include:

  1. Connecting the VPS G4 Base Unit to the VPS G4 Interface and placing the appropriate accessory items inside sterile bags.
  2. Connecting to Wi-Fi, if appropriate (one time requirement per system).
  3. Connecting the ECG cable to the system and attaching the ECG electrodes to the patient.
  4. Setting up the ARROW VPS® Stylet.

How long does it take to become an experienced ARROW® VPS G4 Device user?

According to our experience, many clinicians have exhibited proficiency with the ARROW® VPS G4 Device after approximately 15-25 cases.


Can a single person operate the device while maintaining sterility and placing the PICC line?

Yes. The VPS G4 Device has been designed for single user interface and is easily operated from the sterile field. Accessories such as the Remote Control, Stylet Extension Cable and sterile covers are provided, so that you can easily maintain your sterile field during the procedure. (Sterile Covers may be ordered separately).


Do we still have to take a chest X-ray?

The ARROW® VPS G4 Device is indicated for use as an alternative method to fluoroscopy or chest X-ray for central venous catheter tip placement confirmation in adult patients when a steady Blue Bullseye is obtained.

NOTE: If a steady Blue Bullseye is not obtained, or where exclusions limit use of the device, standard hospital practice should be followed to confirm catheter tip location.*

Usually hospital policy will have to be amended to reflect this change in clinical practice. A sample policy can be provided. Ask your local ARROW Products Sales Representative or Clinical Specialist for a copy.


Can the ARROW® VPS G4 Device be used on all patients, or are there any exclusions?

The VPS G4 Device provides reliable, symbol-based directional navigation through the upper vasculature. You can expect to achieve a steady Blue Bullseye in approximately 90% of your patients.

In the remaining cases, if a steady Blue Blue Bullseye is not obtained, or where exclusions limit use of the device, experienced users are able to use the intravascular Doppler and ECG information to place the catheter tip at the lower 1/3 of the Superior Vena Cava (SVC)—Cavo-Atrial Junction (CAJ).

However, if a steady Blue Bullseye is not obtained, or where exclusions limit use of the device, another method of tip confirmation, such as chest X-ray, or fluoroscopy, is required to confirm tip placement.


How does the VPS G4 Device adjust for different patient anatomy and vascular flow?

The ARROW® VPS G4 Device detects the patient's own physiologic blood flow and intravascular ECG readings to calibrate a baseline. The algorithm identifies the baseline for each patient and provides accurate real-time information for that specific patient.


How accurate is the ARROW VPS® Technology? Do you have a clinical study to support it?

According to the IRB study conducted at Georgetown University Hospital, Washington, DC, accuracy of tip positioning with the ARROW VPS® technology is 98.4%.

Specific symbols on the VPS G4 Interface provide information to let you know when you can continue to advance the catheter (Green Arrow symbol), or if you are going in the wrong direction (Orange No-Entry symbol). It will also tell you if the Doppler signal is damped (Yellow Triangle symbol), meaning the catheter may be against a vessel wall, or the ARROW VPS® Stylet may have retracted inside the catheter.

The unique software algorithm can differentiate between antegrade blood flow, (toward the heart) and retrograde blood flow (from incoming veins, away from the heart). This information can help you prevent serious issues such as inadvertent arterial puncture, azygos, or right atrium catheter tip placement.


How will I know if I have to reposition the PICC after initial placement?

If you observe a steady Blue Bullseye and the Blue REPORT button is illuminated, you can have confidence that the catheter has reached the lower 1/3 of the SVC-CAJ and therefore no repositioning is needed.


Does your screen visually indicate the turn of the catheter into the SVC (as do other manufacturer's devices?)

The ARROW® VPS G4 Device gives you both visual and audible indicators during catheter navigation through the vasculature. When the catheter drops into the SVC a very distinct SVC "flow" sound and images are generated by the Doppler. Look for the Blue Bullseye symbol to be displayed soon thereafter.


How does the Doppler work?

As blood cells move in the vasculature, they generate shorter sound waves when moving toward the tip of the ARROW VPS® Stylet, and longer sound waves when moving away from the Stylet tip. The ARROW® VPS G4 Device monitors blood flow direction using Doppler ultrasound technology, while the software algorithm translates this information, along with intravascular ECG interpretation, into easy-to-follow symbols on the VPS G4 Interface.


Why does the ARROW VPS® Stylet need to extend from the catheter tip?

The very tip of the ARROW VPS® Stylet needs to extend 1 mm from the distal tip of the catheter. This ensures good Doppler signal function. The Doppler sensor has to operate in an unobstructed environment for full functionality.

If the tip of the VPS® Stylet retracts inside the catheter, a Yellow Triangle symbol will appear on the VPS G4 Interface screen letting you know that the Doppler signal is not being received. The VPS® Stylet will need to be re-adjusted to extend 1 mm from the catheter tip again, and the Touhy Borst securely tightened to prevent this from recurring.


Do you need the catheter tip to enter the Right Atrium before you land the tip of the catheter at the lower 1/3 of the SVC-CAJ?

No. The ARROW® VPS G4 Device traces distinctive ECG and Doppler signatures unique to the lower 1/3 of the SVC-CAJ. When these signatures are detected, the Blue Bullseye symbol is illuminated. When a steady Blue Bullseye is achieved, a Blue REPORT button appears on the VPS G4 Interface and the catheter can be left at that location.


Do you need the catheter tip to enter the Right Atrium before you land the tip of the catheter at the lower 1/3 of the SVC-CAJ?

No. The ARROW® VPS G4 Device traces distinctive ECG and Doppler signatures unique to the lower 1/3 of the SVC-CAJ. When these signatures are detected, the Blue Bullseye symbol is illuminated. When a steady Blue Bullseye is achieved, a Blue REPORT button appears on the VPS G4 Interface and the catheter can be left at that location.


Is there any documentation you provide for the patient record to show I have placed the PICC directly?

A Blue REPORT button is highlighted on the VPS G4 Interface when a steady Blue Bullseye is achieved. Press the Blue REPORT button and a PDF file of the Procedure Report (a screenshot with the Blue Bullseye) and the statement: "Tip Placed At Lower 1/3 Of The SVC or At CAJ" is created. This report can be printed and placed in the patient record and can be considered valid evidence of correct tip placement at the lower 1/3 of the SVC-CAJ.


Does the ARROW VPS® Stylet interfere with cardiac rhythm devices?

The ARROW® VPS G4 Device can be used on patients who have cardiac rhythm devices implanted, e.g. pacemakers and defibrillators; however, tip placement will need to be confirmed via chest X-ray or fluoroscopy. The ARROW® VPS G4 Device itself does not generate any type of field to interfere with those devices.


Does the ARROW VPS® Stylet work with all PICC lines?

The ARROW VPS® Stylet was used in an animal study to test any potential vessel trauma. The examined porcine vessels showed no intravascular damage. In fact, the ARROW VPS® Stylet will retract inside the catheter if it contacts a vessel wall, causing a Yellow Triangle symbol to appear on the VPS G4 Interface, alerting the user of the need to reposition the catheter. This reduces the chance of vessel wall damage.


Does the ARROW VPS® Stylet work with all PICC lines?

The ARROW VPS® Stylet is compatible with most commercially available central venous catheters with an internal lumen diameter at least 0.021".


What if a clinician enters the Right Atrium accidentally?

The ARROW® VPS G4 Device recognizes the RA signature and the Orange No-Entry symbol will be illuminated. The user should then slowly retract the catheter until a Blue Bullseye or Green Arrow symbol is achieved. If a Green Arrow symbol is achieved, advance the catheter in 1⁄2 centimeter increments pausing for 5-10 seconds between moves until a Blue Bullseye symbol is achieved. If a Blue Bullseye cannot be achieved, end the procedure on a Green Arrow and use an alternative method of tip confirmation, such as chest X-ray, per your hospital policy.


How long should I wait after placing the PICC before I can release it?

If the appropriate protocol is in place, you can release the PICC line immediately: after a steady Blue Bullseye has been achieved; you have pressed the Blue REPORT button to save the Procedure Report for the patient record; and the procedure is complete.


Will I still need to interpret the P-wave on the ECG?

No P-wave interpretation is required. The algorithm translates the intravascular Doppler and ECG information for you, providing graphical information and symbols for you to follow.


Will I still need to have anyone review my PICC placement after we have eliminated the chest X-ray?

No, unless dictated by hospital policy.


Are there many hospitals that have replaced the chest X-ray with the use of the ARROW VPS® Technology?

Yes, many hospitals have replaced the chest X-ray after implementing the ARROW VPS® Technology, from large teaching organizations to independent PICC companies.


Can the VPS G4 Device be mounted on a GCX® or other cart?

Yes, both the VPS G4 Interface and VPS G4 Base Unit can be mounted using standard VESA mounting brackets. The VPS G4 can be integrated with GCX, SiteRite* and SonoSite® carts. You can also purchase a locking frame for the VPS G4 Interface. Contact your ARROW Products Sales Representative for ordering information.


There is a glass top to the VPS G4 Base Unit; will it break easily?

The system has been thoroughly tested and meets Medical Electrical Equipment Safety and Performance Standards: IEC 60601-1-1, IEC 60601-1-2 and ISTA2A Transportation Testing. The top of the VPS G4 Base Unit is made from chemically strengthened and reinforced glass with a safety film to prevent shattering.

We recommend that care is taken around the unit, as you would with any computer system, and that nothing is dropped directly onto the top of the Base Unit.


Is the VPS G4 Device Wi-Fi accessible?

The ARROW® VPS G4 Interface has Wi-Fi connectivity. Wi-Fi only needs to be set up once for each VPS G4 Interface. See the ARROW® VPS G4 Device Operator's Manual for complete details. After the Wi-Fi is initially set up, the VPS G4 Interface will automatically connect via Wi-Fi each time the system is turned on.


Can the VPS G4 Device connect with hospital electronic record systems?

Yes, the VPS G4 Device has Wi-Fi capability and has been designed to download data (PDF report) directly into the hospital electronic record system. Further compatibility information will be available later in 2013.


How do I order a printer for the VPS G4 Device?

A "plug and play" printer can be ordered at the same time your VPS G4 Device order is placed, or at a later date through your ARROW Products Sales Representative or from ARROW Products Customer Service. The printer facilitates printing of the Blue Bullseye Procedure Report for the patient record and is connected to the VPS G4 Base Unit via a USB cable.


How long will the VPS G4 Interface battery last before it needs to be recharged?

The VPS G4 Interface battery is designed for a minimum of 3 hours of continuous use after it has been fully charged. It is recommended to charge the VPS G4 Base Unit and Interface for a full 8 hours before it is used for the first time.


What happens if the VPS G4 Interface battery depletes during a patient procedure?

The VPS G4 Device has a backup screen that can be used to complete a patient procedure if the Interface battery is depleted.


How long will the VPS G4 Base Unit battery last before it needs to be recharged?

The battery should be fully charged (approximately 8 hours) prior to initial use. After a full charge, the VPS G4 Base Unit can operate for at least 3 hours unplugged from an AC outlet. If the device is going to be operated using battery only, adequate battery life should be verified before starting a new procedure — above 50%. The estimated amount of battery life can be seen in the battery icon in the upper right corner of the Interface and on the Base Unit.

A warning message will appear notifying you when there is 1 hour of battery life remaining. The system will not allow you to start a new procedure with less than 1 hour of battery life remaining.


How long will the VPS G4 Base Unit battery last before needing replacement?

The VPS G4 Device contains two non-user-accessible Lithium Ion Battery packs. For battery replacement and inspection, we recommend returning the VPS G4 Base Unit to VasoNova Inc, every 18 months from the date of purchase.


What is the Warranty on the VPS G4 Device?

New VPS G4 Base Units include a 1-year warranty from date of purchase.

An extended warranty and service program is available, at the time of purchase of the VPS G4 Device, in increments of 1 and 2 years from the expiration of the original manufacturer's warranty. The program includes, subject to certain limitations and exclusions:

  • Extension of the manufacturer's warranty
  • Provision of loaner device during extended repairs
  • Annual inspection and diagnostic testing of VPS G4 Base Units and batteries
  • Installation of periodic software updates

Ask your ARROW Products Sales Representative for details.


How can I obtain the VPS G4 Device?

There are two different VPS G4 Device purchase programs:

  • Standard capital purchase, via purchase order
  • Lease option

If your facility wants a loaner device, the original VasoNova VPS® Device is available with an annual commitment, from your facility, to purchase a specified number of VPS® Stylets.

*The ARROW VPS G4 is CE Marked and FDA cleared for use as an alternative method to fluoroscopy or chest X-ray for central venous catheter tip placement confirmation, in adult patients, when a steady Blue Bullseye is obtained. Refer to the VPS G4 Device Operator's Manual and the ARROW VPS Stylet Bedside Procedure Kit Instructions for Use for the complete Indications for Use statement. GCX is a trademark or registered trademark of GCX Corporation. All rights reserved. SonoSite is a registered trademark of FUJIFILM SonoSite, Inc. SiteRite is a trademark or registered trademark of C. R. Bard, Inc. Teleflex, Arrow, the Blue Bullseye symbol, Never Settle, Vascular Positioning System, VPS and VPS G4 are trademarks or registered trademarks of Teleflex Incorporated or its affiliates. © 2013 Teleflex Incorporated. All rights reserved. 2013-2220