20 Series Transmitters User Manual Copyright 2002 Data Sciences International St.
Dataquest, the Data Sciences logo and PhysioTel are registered trademarks of Data Sciences International in the United States and certain other foreign countries. Multiplus is a trademark of Data Sciences International. All other trademarks are the property of their respective holders. 20 Series Transmitters User Manual All Rights Reserved Printed in U.S.A. Issued January 2002 Part Number: 390-0083-001 Revision A Data Sciences International 4211 Lexington Ave. N. Suite 2244 St. Paul, MN 55126-6164 U.S.A.
Table of Contents Functional Specifications Device Operation Storage of Transmitters Storage of Resterilized Transmitters Handling of Pressure Transmitters Checking Accuracy Prior to Implantation Checking Accuracy at Explantation Regelling the PA-C20 Precautions Against Blown Sensors On-Site Resterilization of Transmitters TA-F20 Transmitters EA-F20 and ETA-F20 Transmitters PA-C20 Transmitters Refurbishment of Transmitters Benefits of Refurbishment During Warranty Period 20 Series Transmitters User Manual
Functional Specifications All statements about transmitter accuracy assume data is collected using the Dataquest system software, an OpenART partner system, UA10 Universal Analog adaptor, or another approved analog adapter that uses factory or custom calibrations. Transmitters may contain recycled electronic components. Recycled components must pass the same final inspection and tests as new components. TX FCC ID MHA20DSI These devices comply with part 15 of the FCC rules.
TA-F20 General Specifications Parameters measured Temperature and physical activity Outer material Silicone elastomer Temperature operating range 33-43 °C Shelf life Battery 12 months Sterility 12 months Battery life (warranted/nominal) 6 months/9 months Turn-off mechanism Magnetically activated Modes available Off, On Receiver compatibility Any PhysioTel receiver Temperature Measurement Specifications Initial accuracy 0.1 °C Resolution 0.01 °C Maximum drift over 0.
Device Operation All 20 series transmitters have two operational modes: On and Off. Transmitters are shipped in the Off mode, with the batteries not activated. When switched to the On mode, the transmitters begin to sense and transmit data. The switch to change modes is magnetically activated. All transmitters should be turned on 24 hours before use to allow the electronics to stabilize. The data from the transmitters may not be completely accurate until this has occurred.
Handling of Pressure Transmitters When measuring blood pressure telemetrically, it is essential to verify that the measurements are accurate, since a small percentage of these devices exhibit long-term drift. Verification can be done in a variety of ways, including pressure chambers, arterial cannulation, comparison to a mercury manometer, etc. Arterial cannulation is normally used only if it is necessary to check the accuracy of the device at a time other than at implantation or explantation.
Gently clean the catheter to remove any blood or tissue debris from the tip. It is essential that the temperature of the transmitter be stable while the offset is checked. This can be done by placing it in a beaker of 37° Celsius water immediately upon removal from the animal. The water in the beaker should be just barely deep enough to cover the body of the implant to avoid any affect of head pressure on the offset measurement.
Precautions Against Blown Sensors The pressure sensors in Data Sciences' blood pressure implants are extremely sensitive; and can be easily damaged. Therefore, it is necessary to use proper care when handling the transmitters. Here are some preventative measures to take when handling the blood pressure transmitters to reduce the possibility of a blown sensor. Handle the device with care and make sure not to drop it.
On-Site Resterilization of Transmitters This procedure will increase the number of times an investigator can use each transmitter before returning it to Data Sciences for refurbishment, helping to reduce overall costs per study. Supplies Needed: 1. Bio- or enzymatic detergent These are available from most hospital supply companies. They are generally labeled for use on fabrics or surgical equipment/instruments; check to be sure they are considered safe for these applications.
PA-C20 Transmitters Following removal from the animal, the transmitter should be rinsed to remove gross contamination from blood and tissue. Carefully remove any residual tissue adhesive from the surface of the catheter. Remove any suture material present. If there is blood in the tip of the catheter, remove as much as possible by directing a stream of saline at the tip to flush it out. The transmitter can then be placed into the enzymatic detergent.
damage during shipment. Return your products to the USA shipping address listed on the RMA form. Include your name, Customer Service Number and telephone number on the RMA form. Check the contents of the box to assure that it matches the information you provided on the RMA form. 6) Make a copy of the RMA form for your own records, and put the original in the pouch on the zip-lock bag with the goods being returned.