troubleshooting LEVEL 1 training

Transcription

1 troubleshooting LEVEL 1 training

2 EQUIPMENT TROUBLESHOOTING GENERATOR ERRORS AND SOLUTIONS? FOOT PEDAL UNRESPONSIVE - Check foot pedal connection and check line for signs of bends and kinks. - Review temperature levels and adjust. Temperatures out of range (possibly caused by hot or cold storage temperatures of RF generator or Stretta catheter) can also prevent start of a treatment. DO NOT REUSE SYMBOL APPEARS ON SCREEN This is a used device, dispose of properly and connect new unused Stretta disposable catheter. UNIT ENTERS SAFE MODE - DISPLAY FROZEN WITH RED LED (SAFE MODE) - ALARM GRAPHIC IS DISPLAYED This indicates a system failure. An audible alarm signal will also occur. Restart the system using these steps to clear the failure error: 1. Remove the Stretta catheter from the patient (make sure needles are retracted). 2. Disconnect the connecting cable from the generator. 3. Disconnect the return electrode cable from the RF generator. 4. Power down using the main switch on back of the unit. CAUTION: Disconnect return electrode and connecting cable prior to restart. 5. Wait 30 seconds. 6. Restart following proper power up procedure. If unit continues to exhibit failure, or repeats same failure during procedure, please contact Mederi Customer Service. 2

3 EQUIPMENT TROUBLESHOOTING GENERATOR ERRORS AND SOLUTIONS UNIT ENTERS SETUP MODE FROM OPERATION MODE When this happens, the component causing the error will flash on the screen. Check connections to components listed below, then complete the remaining steps in the setup procedure. FLASHING DISPOSABLE DEVICE Disconnect, wait 5 seconds and then reconnect the cable at the connection point on the handle of the disposable instrument. Be sure disposable is an authentic Mederi disposable. If this problem continues, first replace the connecting cable and if that does not work, replace with new Stretta device. FLASHING RETURN ELECTRODE Check connection to generator and check proper attachment to patient using standard protocol. POWER UP DOES NOT PERFORM AUTOMATICALLY? 1. Power down using main switch on back of unit 2. Wait 30 seconds 3. Restart following proper power up procedure If unit continues to exhibit this problem, please contact Mederi Customer Service. 3

4 PROCEDURE TROUBLESHOOTING TEMPERATURE AND IMPEDANCE Surface STANDBY MODE In Standby mode, if ovals are yellow with <10 indicated, the room temperature is too low for equipment operation. Needle Tip Impedance It is important to understand temperatures and impedance and how to keep them in optimal range throughout the procedure. In monopolar RF energy delivery as used in the STRETTA Procedure, energy flows from the RF generator to the active needle electrode within the Stretta catheter to the return electrode commonly referred to as a ground pad. Energy IMPEDANCE in Stretta is the measured opposition to the electric currents in the circuit that exists between the device and the return electrode pad. LOWER ENERGY IMPEDANCE is realized when there is optimal contact between the Stretta needle electrodes and the target tissue in the LES or Gastric Cardia. HIGHER ENERGY IMPEDANCE occurs when there is less than optimal contact between the target tissue and the needle electrodes. READY MODE In Ready mode, if surface temperature ovals are yellow with <10 indicated, the temperature is too low. Check temperature of irrigation fluid. Optimal impedance can be achieved by certain adjustments made to improve contact, such as repositioning of the device. High impedance is often seen as a result of improper return pad placement or contact with the skin. 4

5 PROCEDURE TROUBLESHOOTING TEMPERATURE AND IMPEDANCE 46C RF READY MODE RF ON MODE - IMPEDANCE RF ON MODE - SURFACE TEMPERATURE Low impedance (<100) indicates guidewire/ needle contact, reposition guidewire. High impedance (>250) indicates poor needle contact - Reposition needles by slightly increasing retraction tension or slightly extend the needles to seat needles deeper. - Check that balloon is properly inflated, and that the dispersive electrode pad is placed on patient properly. - Ensure that all connections are secure. In this mode, surface and tip temperature should be body temperature. For optimal needle performance ambient temperature of >15 C is recommended RF READY Working Optimal Surface NA Tip NA Impedance <1000 Review the chart for working and optimal ranges as well as shutoff limits for temperatures and impedance. High impedance (>250) indicates poor needle contact - Reposition needles by slightly increasing retraction tension or slightly extend the needles to seat needles deeper. Low impedance (<100) indicates guidewire/needle contact, reposition guidewire. When oval color changes to yellow - this is a warning that surface temperature levels are nearing shutoff limits. Slow rising surface temperature is optimal. Rapid rise requires attention: remove a small amount of balloon inflation to allow irrigation free-flow to cool surface, and/or increase flow rate. Low temperatures (unable to reach optimal) indicate insufficient needle penetration, and may be due to inadequate balloon inflation, irrigation too high or due to specific patient anatomy. RF ON Working Optimal Shutoff Surface >50 Tip >100 Impedance <250 >1000 5

6 PROCEDURE TROUBLESHOOTING TEMPERATURE AND IMPEDANCE 1000Ω NORMAL RF ON SCREEN RF ON SCREEN SHOWING MULTIPLE HIGH IMPEDANCE SHUTOFFS 1000Ω 50C 50C RF ON SCREEN SHOWING MULTIPLE SURFACE TEMPERATURE SHUTOFFS REPEATED HIGH IMPEDANCE SHUTOFFS Check that return electrode pad is placed on patient properly and plugged into the RF generator securely. Check that connecting cable is securely connected to generator and catheter. Replace the connecting cable if there are frayed edges, cracks, exposed wires or damaged connectors. REPEATED SURFACE TEMPERATURE SHUTOFFS MAX FLOW First, increase irrigation flow to Max. If Max flow fails to correct the problem: Flush irrigation port of catheter with sterile water using a syringe. Ensure that PRECAUTIONS are taken to avoid inadvertent activation of RF energy when flushing. Check irrigation lines for air bubbles, kinks, and loose connections, and for possible occlusion by other equipment or instruments. Check proper loading and orientation of silastic section of tubing into peristaltic pump. Reprime disposable device, make sure irrigation flows at base of all 4 needles. Reconnect irrigation tubing and resume procedure. 8 Sound Shore Drive, Suite 304 Greenwich, CT mederitherapeutics.com 6