Table of Contents
Advertisement
Quick Links
Advertisement
Table of Contents
Related Manuals for Boston Scientific EPT-1000 XP
Summary of Contents for Boston Scientific EPT-1000 XP
- Page 1 EPT-1000 XP Cardiac Ablation System Aflutter IDE 110V Operator’s Manual CAUTION- Investigational Device. Limited by Federal (or United States) law to investigational use. EP Technologies, Inc. 2710 Orchard Parkway San Jose, CA 95134 Phone: 408.895.3500 P/N 13754-901 EAW Ver AA 6/01...
-
Page 3: Preface
• Catheter information pertaining to both Catheter styles: “Catheter.” General Information The use of all components and accessories of the EPT-1000 XP Cardiac Ablation System is fully described in this Manual, except for the Steerable Ablation Catheters. This Manual provides a description of the Controller, its controls and displays, and a sequence for its operation. -
Page 4: Table Of Contents
Contents Preface Manual Conventions....................i General Information..................i 1. System Description .................1-1 System Features .......................1-2 Safety Features ....................1-2 Control Modes ....................1-3 2. Indications/Contraindications ...............2-1 Indications for Use ....................2-1 Contraindications ....................2-1 3. Warnings, Precautions, and Adverse Reactions ........3-1 Warnings........................3-1 Precautions ......................3-2 Adverse Reactions....................3-4 4. - Page 5 Rear Panel .......................5-13 Accessories ......................5-16 Footswitch ......................5-16 High Power Automatic Personality Module (XP APM)........5-16 6. Operational Sequence ................6-1 Initial Installation ....................6-1 Turning the Controller “ON”..................6-5 READY Mode......................6-6 Calibrating the Controller Analog Outputs for the Recorder .........6-8 Selecting the Control Mode ..................6-8 Selecting the Power Output ..................6-9 Selecting the Desired Catheter Tip Temperature ............6-10 Selecting Temperature When Using the Catheter(T°) in TEMPERATURE...
- Page 6 List of Figures Figure 1-1: System Installation Diagram ................. 1-4 Figure 1-2: Cable Configuration for Quick Connect XP APM ........1-5 Figure 5-1: Controller Front Panel................... 5-1 Figure 5-2: CONTROL Panel Indicator LEDs and Button..........5-2 Figure 5-3: POWER Display and Buttons ............... 5-4 Figure 5-4: TEMPERATURE Display and Buttons ............
- Page 7 List of Tables Table 1-1: Power Delivery Protocol ................1-3 Table 5-1: Maximum Amount of Power Output for Catheters........5-3 Table 5-2: Summary of TEMPERATURE Display Readings ......... 5-6 Table 5-3: Individual Analog Outputs ................5-12 Table 6-1: TEMPERATURE Display Readings............6-15 Table 6-2: Impedance Display Readings ...............
-
Page 9: System Description
XP APM. If accessing up to 100 W/2 A power levels, both an XP APM and a special high power catheter must be used. The Footswitch usage is optional as the Controller can be operated directly from its front panel controls. The EPT-1000 XP Cardiac Ablation System is operated in conjunction with commercially available external Disposable Indifferent (Dispersive) Patch (DIP) Electrodes, which are in compliance with ANSI/AAMI Standard HF-18. -
Page 10: System Features
Operator’s Manual System Features The EPT-1000 XP Cardiac Ablation System features the following: • The Controller produces a continuous unmodulated radio frequency (RF) output at 500 kHz. • The front panel displays the actual power output, tissue impedance, and if a Catheter(T°) is connected to the Controller, catheter tip temperature. -
Page 11: Control Modes
" Note When using the EPT-1000 XP Cardiac Ablation Controller in the Temperature Control mode, ALWAYS ensure that the TEMP LED on the Control Panel is illuminated. -
Page 12: Figure 1-1: System Installation Diagram
Operator’s Manual Figure 1-1: System Installation Diagram... -
Page 13: Figure 1-2: Cable Configuration For Quick Connect Xp Apm
System Description Figure 1-2: Cable Configuration for Quick Connect XP APM... -
Page 15: Indications/Contraindications
2. Indications/Contraindications Indications for Use The System is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia, for treatment of atrial flutter tachycardia, and for creation of complete AV block in patients with a rapid ventricular response to an atrial arrhythmia –... -
Page 17: Warnings, Precautions, And Adverse Reactions
3. Warnings, Precautions, and Adverse Reactions Warnings Before operating the System, read these warnings carefully: • The displayed temperature is not the maximum tissue temperature. Do not set the maximum temperature higher than 80°C. • Use Lower Power First - When first delivering RF energy, begin by using a low power setting (i.e., 50W). -
Page 18: Precautions
HF-18 be used as the ablation return electrodes or skin burns may result. • It is recommended not to exceed thirty (30) RF power applications per Catheter. • The EPT-1000 XP Cardiac Ablation Controller is intended for use with EP Technologies Steerable Ablation Catheters and accessories only. - Page 19 Warnings, Precautions, and Adverse Reactions • Do not attempt to operate the EPT Cardiac Ablation System before thoroughly reading the EPT-1000 Cardiac Ablation Controller Operator's Manual. • The IMPEDANCE Display of the Controller should be continuously monitored during RF power delivery. If a sudden rise in impedance is noted, power delivery should be discontinued.
-
Page 20: Adverse Reactions
Operator’s Manual • Regularly inspect and test re-usable cables and accessories. • EP Technologies relies on the physician to determine, assess and communicate to the individual patient all foreseeable risks of the cardiac ablation procedure. Potential Adverse Reactions The risks involved in RF ablation for the treatment of conditions outlined in the Indications for Use include those associated with all cardiac catheter ablation procedures. -
Page 21: Unpacking The Controller
$ 1 - Controller $ 1 - Footswitch $ 1 - XP APM with Quick Connect Connectors $ 2 - EPT-1000 XP Cardiac Ablation System Operator’s Manuals $ 1 - Interconnect Cable for XP APM to EGM Equipment $ 1 - Quick Connect Temperature Instrument Cable... -
Page 23: Controls And Displays
5. Controls and Displays Front Panel The operator controls for the EPT-1000 XP Cardiac Ablation System are located on the front panel of the Controller. The buttons on the Controller’s front panel allow the user to control the operation of the Controller. The lights/LEDs on the front panel show the Controller’s status and/or report error conditions. -
Page 24: Control Panel
Operator’s Manual CONTROL Panel CONTROL Indicator LEDs The control mode of the Controller is indicated by either of two green LEDs (POWER or TEMP) on the CONTROL Panel (see Figure 5-2). When the Controller is initially powered on, one of the green LEDs displays the control mode which depends on the type of Catheter connected to the Controller. -
Page 25: Table 5-1: Maximum Amount Of Power Output For Catheters
Controls and Displays CONTROL Button The Controller is capable of operating in Power Control or Temperature Control mode. Press the CONTROL Button to toggle (or change) to a new control mode, as indicated by a flashing LED. The Power Control mode is compatible with Catheter(T°) and Catheter(Non-T) and allows selection of the quantity of RF power that is delivered by the Steerable Ablation Catheter (see Table 5-1). -
Page 26: Power Panel
Operator’s Manual POWER Panel POWER Display The POWER Display (see Figure 5-3) shows the RF power output in Watts. The available power output ranges are dependent on the catheter type and the control mode. Ranges are from a value of 0 Watt to the maximum amount of power output (see Table 5-1). When the Controller is initially powered on, the POWER Display indicates the default power setpoint of 0 Watt. -
Page 27: Temperature Panel
Controls and Displays & & & & /' ' ' ' POWER Buttons The POWER &/' (increase/decrease) Buttons select the desired level of delivered RF power for the Power Control mode, or the maximum amount of RF power available for the Temperature Control mode. -
Page 28: Table 5-2: Summary Of Temperature Display Readings
Operator’s Manual Table 5-2 lists all possible temperature display readings under specific operating conditions. Refer to the instructions specified in the table for additional information. Table 5-2: Summary of TEMPERATURE Display Readings Catheter Type Control Mode TEMPERATURE Display Readings • At initial power on, display reading is 30°C. Catheter(T°) Temperature Control Mode... -
Page 29: Impedance Panel
Controls and Displays display, flashing at 1-second intervals. • Display shows three dashes (---) Catheter(Non-T)* * Temperature Control is not accessible for this Catheter. In Power Control mode only, when the measured catheter tip temperature Note decreases to a value that is below the upper temperature limit, the Controller resumes delivery of RF power at a value that is 50% of the power which caused the upper temperature limit to be exceeded. -
Page 30: Figure 5-5: Impedance Display
Operator’s Manual When RF power is discontinued, the last measured value of impedance remains on the display, flashing at one second intervals. If the Controller is placed into the CALIBRATION mode (by depressing the CALIBRATION Button) and if a Catheter has been positioned within the heart, then the Controller delivers 1 Joule of energy which allows a single measurement of impedance, and continuously displays the value of impedance measured. -
Page 31: Time Panel
Controls and Displays TIME Panel TIME Display The TIME Display (see Figure 5-6) shows the user-selected duration (in seconds) of RF power delivery to the Catheter. When the Controller is initially powered on, the TIME Display reads zero. After the user sets the duration and presses the RF POWER CONTROL Button, the displayed value changes to zero and initiates counting upward at 1-second intervals until the preset time limit is reached (or the RF POWER CONTROL Button is actuated a second time or the Footswitch is released), stopping RF power... -
Page 32: Counter Panel
Operator’s Manual COUNTER Panel COUNTER Display The COUNTER Display (see Figure 5-7) automatically counts and displays each delivery of RF power. When the Controller is initially power on, the display clears and reads zero. The range of values available is 0 to 99 in increments of one. CLEAR (Counter) Button The CLEAR Button clears the COUNTER Display (Figure 5-7) to zero and allows the user to keep an accurate count of the number of RF power deliveries to the patient. -
Page 33: Calibration Panel
Controls and Displays If the Controller is in the Temperature Control mode, a test of the temperature sensor functionality is made prior to delivery of RF power. If a faulty temperature sensor is detected by the Controller, which can be caused by the temperature sensor indicating a temperature outside the operating range of 31 C to 43 C, or a short or open in the... -
Page 34: Isolated Patient Connector
Operator’s Manual All of the above functions continue to operate as described above until either the CALIBRATION or RF POWER CONTROL Buttons are pressed again. Pressing either of these buttons causes the Controller to return to the READY mode. The minimum-to-full- scale values for the individual analog outputs are shown in Table 5-3. -
Page 35: Rear Panel
Controls and Displays Rear Panel This section describes the output ports and power controls on the rear panel shown in Figure 5-10. Figure 5-10: Controller Rear Panel Volume Mains Auxiliary Analog Control Power Fuse Power Outputs Knob Switch Holder Outlet CAUTION: THE TOTAL SYSTEM CHASSIS RISK CURRENT SHOULD NOT EXCEED 100 µ... - Page 36 Operator’s Manual There are 4 analog output ports (see Figure 5-10), which are labeled as follows: RF POWER, IMPEDANCE, TEMPERATURE, and SPARE. Power Analog Output RF POWER – This output port provides direct connection to an electrically isolated general-purpose recorder or monitor, satisfying the requirements of IEC-601, using a standard BNC connector to facilitate recording of the RF power output during delivery of RF power.
- Page 37 Controls and Displays Volume Control Knob This knob provides the user with volume control for the audio signal that accompanies RF power delivery. If no audio tone is heard, check the knob to determine if the volume level has been adjusted too low. Serial Port This port is labeled “RS-232.”...
-
Page 38: Accessories
Operator’s Manual Accessories Footswitch An easy-to-use Footswitch (see Figure 1-1) can alternatively be used to provide ON/OFF control of the RF power delivery. The connecting cable’s 10-ft length allows the user to stand at the catheterization table near the patient without requiring another person for starting/stopping RF power delivery. -
Page 39: Figure 5-11: High Power Automatic Personality Module With Quick Connect
Controls and Displays Figure 5-11: High Power Automatic Personality Module with Quick Connect Top View EPT-1000 XP APM EP Technologies, Inc. CARDIAC ABLATION SYSTEM XP AUTOMATIC PERSONALITY MODULE FOR USE WITH EP TECHNOLOGIES CARDIAC ABLATION SYSTEM ONLY! ELECTRODES CATHETER INDIFFERENT... -
Page 41: Operational Sequence
6. Operational Sequence Initial Installation Follow the instructions in this section carefully to prepare the System for operation: 1. Connect the Controller Power Cord plug into a properly grounded AC electrical outlet designated “Hospital Grade” or “Hospital Only.” Never use an outlet without a grounding connection. Precaution 2. -
Page 42: Figure 6-2: Connecting The Xp Apm To The Recording Equipment
Operator’s Manual 4. To disconnect the XP APM from the Controller, rotate the locking ring counter clockwise to unlock; then grasp the connector and gently pull it out of the socket. " Note Do not twist the XP APM Patient Cable connector while inserting or removing it from the Controller ISOLATED PATIENT CONNECTOR socket or the connector pins may be damaged. -
Page 43: Figure 6-3: Connecting The Catheter To The Xp Apm Front Panel
Controls and Displays 6. Position the XP APM near the table where the procedure is to be performed. The System may only be connected to recording systems providing patient electrical isolation in accordance with IEC-601. 7. Install the Catheter Quick Connect Instrument Cable fitting into the XP APM front panel fitting labeled “CATHETER.”... -
Page 44: Figure 6-4: Connecting The Disposable Indifferent Patch Electrodes
Operator’s Manual f) The DIP Electrode(s) should be placed on a well-vascularized, convex skin surface that is in close proximity to the ablation site (left upper quadrant of the back is suggested unless the patient’s scapula is especially prominent or patient is extremely thin). -
Page 45: Turning The Controller "On
Controls and Displays 9. If using the Footswitch, install its cable connector into the FOOTSWITCH Cable Connector on the Controller rear panel (see Figure 6-5). Carefully push the cable connector into the FOOTSWITCH connector until it is seated firmly in place. "... -
Page 46: Ready Mode
Operator’s Manual 2. If a system malfunction is detected during self-test, all front panel displays remains lit and the Controller does not operate. To clear any malfunctions found during self- test, the Controller must be powered OFF, then back ON. The self-test repeats. Call EPT for Service A second self-test failure is indicative of a Controller malfunction and should be referred to EPT for service (Telephone Number:... -
Page 47: Figure 6-7: Ready Mode, Initialization - Catheter(T°) Connected
Controls and Displays Controller in Power Control Mode - Catheter(T°) Connected If the control mode is manually changed to Power Control, by pressing the RF POWER CONTROL Button, the TEMPERATURE Display indicates 85 C during the READY mode of the Controller, indicating the upper temperature limit at which the Controller continues to deliver set power. -
Page 48: Calibrating The Controller Analog Outputs For The Recorder
Operator’s Manual Calibrating the Controller Analog Outputs for the Recorder Each time the Controller is powered on, the analog outputs (see Figure 5-10) should be placed in the CALIBRATION mode to verify that the optional strip chart recorder and/or monitor are calibrated correctly, if used. To perform calibration of the Controller analog outputs, follow these steps: 1. -
Page 49: Selecting The Power Output
Controls and Displays To select the proper control mode, follow these steps: 1. Ensure that the Controller is in the READY mode. " The control mode can only be changed when the Controller is in the Note READY mode. 2. Press the CONTROL Button to select the appropriate control mode. The CONTROL Indicator LEDs display the selected mode. -
Page 50: Selecting The Desired Catheter Tip Temperature
Operator’s Manual Selecting the RF Power Setpoint To set the RF power setpoint (in W), follow these steps: 1. Press the appropriate POWER (&/') Button to increase or decrease the RF power setpoint by 1 W. 2. To scroll rapidly to the desired power setpoint, depress and hold the appropriate POWER (&/') Button down. -
Page 51: Mode
Controls and Displays 2. Press the appropriate TEMPERATURE (&/') Button to increase or decrease the temperature setpoint by 1°C. 3. To scroll rapidly to the desired temperature setpoint, depress and hold the appropriate TEMPERATURE (&/') Button down. 4. Release the TEMPERATURE (&/') Button when the TEMPERATURE Display shows the appropriate temperature setpoint. -
Page 52: Clearing The Counter
Operator’s Manual To select the duration for RF power delivery, follow these steps: 1. Ensure that the Controller is in READY mode. 2. Press the appropriate TIME (&/') Button to increase or decrease the RF power output duration (up to a maximum of 120 seconds). 3. -
Page 53: Adjusting The Audio Control
Controls and Displays Adjusting the Audio Control The user may adjust the volume of the audio signal when the Controller is initially powered on or during a clinical procedure. 1. Adjust the volume of the audio signal by rotating the Volume Control Knob on the Controller rear panel (see Figure 6-10). -
Page 54: Turning The Rf Power Delivery "On
Operator’s Manual Turning the RF Power Delivery “ON” " Important Do not continue with this procedure unless all preceding procedures in this chapter have been completed. To deliver RF power to the Catheter, follow these steps: 1. Ensure that all connections are secure and correct. 2. -
Page 55: Table 6-1: Temperature Display Readings
Controls and Displays TEMPERATURE Display The readings on this display depends on the current control mode of the Controller (Power Control and Temperature Control), the operational mode, and the type of catheter connected. Table 6-1 summarizes the readings on the display under specified operating conditions. -
Page 56: Table 6-2: Impedance Display Readings
Operator’s Manual IMPEDANCE Display This display shows measured impedance. The displayed readings may fluctuate slightly due to variation in the stability of electrode/tissue contact as the heart beats. If the measured value demonstrates a significant fluctuation, the Catheter should be repositioned. - Page 57 Controls and Displays Correcting a High Impedance Condition If a high impedance value is detected during RF power delivery, follow these steps: 1. Ensure that the connection between the Catheter and XP APM is correct and secure. 2. Ensure that the connection between each DIP Electrode and XP APM is correct and secure.
-
Page 58: Directions For Use
Precise placement of the catheter prior to ablation is accompanied by endocardial mapping using the tip and/or ring electrodes. Once appropriate positioning has been achieved, RF power is delivered via the EPT-1000 XP Cardiac Ablation Controller resulting in the ablation of the targeted cardiac tissue. -
Page 59: Turning The Rf Power Delivery "Off
Controls and Displays 8. Connect the Steerable Ablation Catheter to the XP APM by plugging the Quick Connect Instrument Cable. 9. When the ablation site has been accessed and the tip of the catheter is in contact against the endocardial surface, intracardiac electrogram signals may be obtained. Unipolar electrograms can be obtained between the distal tip electrode and any commercially available low impedance ECG electrode. - Page 60 Operator’s Manual • Temperature is less than 20 C for greater than one second. • Temperature exceeds temperature setpoint in Power Control mode (e.g., If temperature is set at 60 C and measured temperature exceeds 60 C, RF power shuts off).
-
Page 61: Service And Maintenance
Service and Maintenance The Controller requires no routine service or maintenance. If the Controller fails to operate when plugged into a proper AC power receptacle and the power switch is turned on, check the fuse (refer to Replacing the Fuses in this chapter). The Controller contains no user-serviceable parts;... - Page 62 Operator’s Manual Auxiliary Power Outlet Fuses 1. Before replacing a fuse in the Controller, disconnect the mains power cord from the Controller. 2. Replace the fuse with another of the same type and rating. Refer to the fuse label on the rear panel (see Figure 5-10).
-
Page 63: Product Specifications
8. Product Specifications General Specifications Table 8-1 lists the specifications for the System (Controller and XP APM). Table 8-1: System Specifications Description Specification Power Specifications Line Power 100 - 120 VAC (Model #800XP) Current Rating Fuse Rating 3 A, 50/60 Hz (100 - 120 VAC) Auxiliary Power 100 - 120 VAC (Model #800XP) Current Rating... - Page 64 Operator’s Manual Table 8-1: System Specifications, Continued Description Specification High Power Automatic Personality Module, Continued Recorder Connectors Quick Connect Connector Catheter Connectors Quick Connect Connector Indifferent Electrode Connectors Standard male 2-pin for commercial pads Recorder Filters Low Pass Filters Referenced to the INDIFFERENT ELECTRODE 7 kHz, -3dB at 7 kHz ±...
- Page 65 Controls and Displays Table 8-1: System Specifications, Continued Description Specification Controller, Continued Temperature With Catheter(T°) Connected and Allows selection of desired catheter tip Controller in Temperature Control Mode temperature (temperature setpoint) within the range of 30° to 80°C. With Catheter(T°) Connected and Allows selection of upper temperature limit or Controller in Power Control Mode maximum temperature at which the Controller...
- Page 66 Operator’s Manual Table 8-1: System Specifications, Continued Description Specification Back Panel Analog Outputs Standard BNC connections to output signals representing RF power, impedance, and tip temperature. Calibration Mode Power Output 0 - 1 volt corresponds to 0 - 100 W, continuous square wave 0 - 1 volt corresponds to 0 - 300 Ω, Impedance...
-
Page 67: Environmental Specifications
Controls and Displays Environmental Specifications Table 8-2 lists the environmental specifications for the System. Table 8-2: Environmental Specifications Description Specification Storage Temperature -40°C to 70°C The unit should be gradually returned to the operating temperature range before use and stabilized for one hour before operation. Relative Humidity 10% to 100%, non-condensing Atmospheric pressure... -
Page 68: Power Delivery
Operator’s Manual Power Delivery As an enhanced patient safety feature, the output voltage and current of the System has been limited. Under normal circumstances (normal patient impedances), the maximum output power of the System is either 50 or 100 W, depending on catheter type and control mode. -
Page 69: Error Codes
Controls and Displays Error Codes Table 8-3 defines the error codes for the EP Technologies Cardiac Ablation System. Table 8-3: Error Codes Code Description Apparent power (Vrms * Irms) not greater or equal to real power Apparent power (Vrms * Irms) measured greater than the setpoint Limit exceeded: V 〉... -
Page 70: Figure 8-2: Labeling Symbols
Operator’s Manual Figure 8-2: Labeling Symbols Power ON Power OFF Temperature at Alternating Distal Electrode Current Degree C Increase Decrease Protective Defibrillator-Proof Earth Ground Type Equipment Variability Clock: Dangerous Attention, Consult Time Switch: Voltage Accompanying Timer Documents Non-Ionizing Loudspeaker Fuse Counter Radiation 0 00... -
Page 71: Limited Warranty And Disclaimer
9. Limited Warranty and Disclaimer Limited Warranties Boston Scientific Corporation (BSC) warrants that reasonable care has been used in the design and manufacture of this instrument. This warranty is in lieu of and excludes all other warranties not expressly set forth herein, whether expressed or implied by operation of law or otherwise, including, but not limited to, any implied warranties of merchantability or fitness. -
Page 73: Index
Index ablation procedures Catheter(T°) temperature control, 6-10 temperature selection, 6-10, 6-11 temperature sensing catheter, 6-18 catheter tip temperature warnings, 3-1 selection, 6-10 accessories connecting footswitch, 1-1, 5-16 DIP electrodes, 6-3 XP APM, 1-1 footswitch, 6-5 accessory atrioventricular conduction power cord, 6-1 pathways quick connect instrument cable, 6-3 indications for use, 2-1... - Page 74 controller in other operating modes control panel, 5-2, 5-10 Catheter(T°) connected, 6-7 illustration, 5-1 controller in power control mode impedance panel, 5-7 Catheter(Non-T) connected, 6-9 isolated patient connector, 5-12 Catheter(T°) connected, 6-7, 6-9 mains display, 5-12 controller in temperature control mode power panel, 5-4 Catheter(T°) connected, 6-6, 6-9 RF power control panel, 5-10...
- Page 75 mains display serial port, 5-15 description, 5-12 volume control knob, 5-15 mains fuse holder repackaging the system, 4-1 description, 5-14 RF power control panel naming conventions, v button/light, 5-10 pacemakers illustration, 5-11 warnings, 3-1 status, 6-14 power control mode RF power delivery compatibility, 1-3 causes of interruption, 6-19 power cord...
- Page 76 power delivery, 8-6 illustration, 5-5 system, 8-1 readings, 5-6 XP APM, 8-1 temperature increase button, 5-7 standards time control ANSI/AAMI Standard HF-18, 1-1, 3-3 selection, 6-12 IEC-601, 5-14, 6-3, 6-8 time panel steerable ablation catheter display, 5-9 use of, 6-18 illustration, 5-9 warnings, 3-1 readings, 6-17...
Need help?
Do you have a question about the EPT-1000 XP and is the answer not in the manual?
Questions and answers