RITA® 1500X USER’S GUIDE AND SERVICE MANUAL (For software version 8.60 and above) Caution: Federal U.S. Law restricts this device to sale by or on the order of a physician.
AngioDynamics, Inc. Model 1500X User’s Guide and Service Manual Table of Contents 1. INTRODUCTION AND GENERAL INFORMATION ............................................................................ 2 2. SYSTEM DESCRIPTION ...................................................................................................................... 3 3. WARNINGS AND PRECAUTIONS ...................................................................................................... 4 3.1 3.2 3.3 3.4 3.5 3.6 4.
AngioDynamics, Inc. 1. Model 1500X User’s Guide and Service Manual INTRODUCTION AND GENERAL INFORMATION AngioDynamics, Inc. is dedicated to providing service and support to its customers. If there are any questions concerning the use of the RITA System, please contact your local sales representative/distributor. If you are unable to reach them please contact Customer Service at one of the following: United States: Authorized European Representative: AngioDynamics, Inc.
AngioDynamics, Inc. 2. Model 1500X User’s Guide and Service Manual SYSTEM DESCRIPTION Indications for Use The AngioDynamics, Inc. Model 1500X Electrosurgical Radiofrequency Generator is designed to provide monopolar radiofrequency (RF) energy to be used for coagulation and ablation of soft tissue.
AngioDynamics, Inc. Model 1500X User’s Guide and Service Manual 3. WARNINGS AND PRECAUTIONS 3.1 General Warnings and Precautions 3.2 3.3 • Read all instructions for use for the RITA System prior to its use. Safe and effective electrosurgery is dependent not only on equipment design but also on factors under control of the operator. It is important that the instructions supplied with this equipment be read, understood, and followed in order to enhance safety and effectiveness.
AngioDynamics, Inc. 3.4 Model 1500X User’s Guide and Service Manual • Cables connected to the RITA Device should not contact the patient or other electrical leads. • Skin-to-skin contact, such as between the torso and the arms, or between the legs of the patient should be avoided by insulating these contacts with sheets or dry towels. • Failure of high frequency surgical equipment could result in an unintended increase of output power.
AngioDynamics, Inc. Model 1500X User’s Guide and Service Manual Follow directions and recommended practices for the preparation, placement, surveillance, removal and use of any Dispersive Electrode used with this RF Generator in accordance with your facility’s standard operating procedure, the Dispersive Electrode’s Instruction for Use, and AAMI standards. 3.5 • Patients with peripheral vascular deficiency are at increased risk of thermal injury from Dispersive electrodes.
AngioDynamics, Inc. Model 1500X User’s Guide and Service Manual 4. SWITCHES, BUTTONS, CONNECTIONS, AND DISPLAYS 4.1 Front Panel Switches and Buttons: 1. “RF ON/OFF” Button. Pressing this button turns the RF energy ON and OFF. 1. “RF ON/OFF” LED. A blue light-emitting diode (LED) that flashes once a second when the system is in Ready mode. When RF energy is turned on, this LED stays on continuously. 2. “TRACK ABLATION ON/OFF” (cauterization/coagulation) Button.
AngioDynamics, Inc. Model 1500X User’s Guide and Service Manual power can be increased and decreased. (Note: Set power as low as possible for intended purposes.) 6. “DELIVERED POWER (W)” Display. Displays the actual power being delivered in whole units of Watts. 7. “TIMER (min)” Display. Displays the time to a resolution of 0.1 minutes. This display, prior to the start of the RF energy, shows the time set for RF energy delivery at the target temperature.
AngioDynamics, Inc. Model 1500X User’s Guide and Service Manual Connections/Ports: 13. “FOOT PEDAL” Port. Port for connecting a pneumatic foot pedal (for activating and deactivating RF energy delivery). The foot pedal functions like RF ON/OFF switch. The foot pedal may also be used to start and stop the purge operation when the RF Generator is used with an infusion pump. 14. “RETURN” Dispersive Electrode Port. Port for connecting the Dispersive (Return) Electrode(s) from the patient to the RF Generator.
AngioDynamics, Inc. Model 1500X User’s Guide and Service Manual 3. Equipotential Stud. Earth Ground connector. 4. Power Cord Connection. Port for connecting the RF Generator to power outlet via the power cord. 5. Fuse. To replace fuse see maintenance section. 6. Power Switch. Toggling this switch turns the RF Generator ON (starting the selftest) and OFF. CAUTION: Only modules supplied by AngioDynamics, Inc. should be plugged into the generator.
AngioDynamics, Inc. Model 1500X User’s Guide and Service Manual 5.1.2 Setting up the RF Generator • If the Device requires a Main Cable (see Device’s Instructions for Use), sterilize the Main Cable in accordance with the Instructions for Use accompanying the cable. Ensure that the cable interconnections are clean and dry prior to use. • Connect the Foot Pedal to the RF Generator. • Connect the Dispersive Electrodes to the RF Generator at the RETURN port.
AngioDynamics, Inc. Model 1500X User’s Guide and Service Manual To start the RF energy delivery, depress the Foot Pedal once or press the “RF ON/OFF” switch. • The RF Generator will continue to apply RF energy for three seconds or until it automatically shuts off. Note, RF can be turned off manually by pressing and Foot Pedal once or pressing “RF ON/OFF”. • At the completion of the ablation the RF Generator will automatically shut off and the LCD will display “ABLATION COMPLETE.” • 5.1.
AngioDynamics, Inc. 6. Model 1500X User’s Guide and Service Manual DESCRIPTIONS OF MODES OF OPERATION This section covers the general modes of the Model 1500X Helios RF Generator. For specific modes, refer for the Instructions for Use for each Device. 6.1 Standby Mode: This mode only exists when the Generator is first turned on. In this mode the Generator runs through its self test and all displays and indicators are off. To exit from this mode press the RF On/Off Icon. 6.
AngioDynamics, Inc. Model 1500X User’s Guide and Service Manual temperatures in the ablation area at the set temperature (target temperature). See “Device Temperatures Buttons and LEDs” for information on how to select or deselect a temperature into the average algorithm. • Once the target temperature is reached the buzzer beeps for 1 second and the timer (“TIMER (min)”) will start counting down. • If the target temperature is not reached within 10 minutes, the RF energy delivery automatically stops.
AngioDynamics, Inc. Model 1500X User’s Guide and Service Manual • In the track ablation mode “TRACK ABLATION” message will appear on the LCD. Note: The efficiency value (0-10) is not important to the efficiency of ablating the track. • Set Power if desired power level is different from the default. Set power as low as possible for intended purpose. • When ready to start, turn the RF energy on by pressing the “RF ON/OFF” button or depressing the foot pedal. • Watch the temperatures.
AngioDynamics, Inc. 8. CARE AND MAINTENANCE 8.1 Software Installation Model 1500X User’s Guide and Service Manual If you receive a software module separate from the RF Generator (for example, software with upgrades), follow these instructions for installation. You will need a Phillips screwdriver. 8.2 Software Updates 8.2.1 Removal of Existing Software Module Every RF Generator is shipped with a software module already installed.
AngioDynamics, Inc. 8.3 Model 1500X User’s Guide and Service Manual Maintenance The RF Generator is designed for indoor use in a dry operating room/procedure room environment. The RF Generator requires no maintenance or calibration by the user. The user should not remove the cover. Removal of unit cover voids the warranty. All maintenance and calibration must be referred to Customer Service at AngioDynamics, Inc. Refer to Section 1 for applicable phone numbers. 8.
AngioDynamics, Inc. 3) Remove the fuse from the fuse module and replace it with the type of fuse listed under fuses in the specifications section below. 8.6 Model 1500X User’s Guide and Service Manual 4) Insert the fuse module back and close the Line Input module access door. Calibration Verification There are no user calibration adjustments on the Model 1500X RF Generator.
AngioDynamics, Inc. Model 1500X User’s Guide and Service Manual 9. SPECIFICATIONS 9.1 RF Generator Specifications Operating Modes Output Power Constant Power, Constant Temperature, or Track Ablation 250 W into 40 – 60 Ω. Power drops outside this impedance range. (Refer to Figures 13.1 and 13.2.) Power accuracy (25 – 150 Ω) is ±20% or 2 W, whichever is greater. Efficiency Range Range of 0 – 10.
AngioDynamics, Inc. Model 1500X User’s Guide and Service Manual Output Power vs Power Setting (Power & ATC Modes-50 Ω Load) Output Power-Watts 250 200 150 100 50 0 0 50 100 150 200 250 Power Setting-Watts Figure 13.1 Output Power vs. Power Setting Figure 13.2 Output Power vs. Load Impedance (Infusion Mode is available in RF Generators with software version 5.
AngioDynamics, Inc. Model 1500X User’s Guide and Service Manual ) Output Power vs Load Impedance (Non-infusion (ATC) with Katecho Pads ) 250 Full Power Output Power - Watts Half Power 200 150 100 50 0 0 100 200 300 400 500 600 700 800 900 1000 1100 Impedance - Ohms Figure 13.3 Output Power vs. Load Impedance Peak Output Voltage vs Power Setting (Power & ATC Modes-50 Ω Load) Peak Output Voltage-Volts 160 140 120 100 80 60 40 20 0 0 50 100 150 200 250 Power Setting-Watts Figure 13.
AngioDynamics, Inc. Model 1500X User’s Guide and Service Manual Peak Output VoltageVolts Peak Output Voltage vs Load Impedance (Infusion Modes) 200 180 160 140 120 100 80 60 40 20 0 Full Pow er 0 50 100 150 200 250 300 350 400 Impedance - Ohms Figure 13.5 Peak Output Voltage vs.
AngioDynamics, Inc. Model 1500X User’s Guide and Service Manual GUIDE TO SYMBOLS V Volts Hz, kHz Hertz, WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL60601-1/CAN/ CSA C22.2 NO.601.1 IEC 60601-2-2 58HK Replace Fuse as Marked A W Ω °C Kilohertz Amps Watts Ohms 2X T6.
AngioDynamics, Inc. 10. Model 1500X User’s Guide and Service Manual TROUBLESHOOTING 10.1 RF Generator LCD Troubleshooting Messages 10.1.1 Self Test Troubleshooting Messages The following messages may appear if the RF Generator fails the self-test: LCD Display “SOFTWARE MODULE NOT CONNECTED TURN POWER OFF” Solution Turn Power off. Ensure that the software module is fully inserted with the correct side up (see arrow symbol) and the cover is completely closed. Turn Power back on.
AngioDynamics, Inc. SYSTEM FAILURE 15: RF PULSE: HI VOLTAGE Model 1500X User’s Guide and Service Manual Turn Power off. Contact Customer Service. TURN POWER OFF SYSTEM FAILURE 16: RF PULSE: LO VOLTAGE Turn Power off. Contact Customer Service. TURN POWER OFF 10.1.
AngioDynamics, Inc. Model 1500X User’s Guide and Service Manual “NO CONNECTION OR POOR CONNECTION” The needle device may not be connected properly to the generator. Check the connections by un-plugging and re-plugging in the device and/or Main Cable and press “RF ON/OFF” to start “SYSTEM TEMP TOO HIGH” Leave Power on. Ensure the vents on the RF Generator (back and bottom of unit) are not blocked. Listen to see if fans are running. If fans are not running, contact Customer Service.
AngioDynamics, Inc. Model 1500X User’s Guide and Service Manual During use of the RF Generator, the following tests are conducted.
AngioDynamics, Inc. Model 1500X User’s Guide and Service Manual WARRANTY LIMITED WARRANTY FOR AngioDynamics PRODUCTS (This warranty applies to all AngioDynamics, Inc. Products including its RF Generators and Accessories. “Purchaser” as used herein refers to any individual or entity that purchases any AngioDynamics, Inc. Product from AngioDynamics, Inc. or its authorized representative.) 1) AngioDynamics, Inc. agrees to repair or replace (at AngioDynamics, Inc.
