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Boston Scientific EPT-1000 XP, Руководство оператора

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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

Control Mode........................................................................................6-10

Selecting Temperature When Using the Catheter(T°) in POWER Control

Mode .....................................................................................................6-11

Setting the Time Control..........................................................................................6-11
Clearing the Counter ...............................................................................................6-12
Adjusting the Audio Control ....................................................................................6-13
Turning the RF Power Delivery “ON” ...................................................................6-14
Directions for Use....................................................................................................6-18
Turning the RF Power Delivery “OFF” .................................................................6-19

Possible Causes of RF Power Delivery Interruption .......................................6-19

7. Service and Maintenance ....................................................................... 7-1

Cleaning/Disinfecting ..............................................................................................7-1
Replacing the Fuses .................................................................................................7-1

8. Product Specifications............................................................................ 8-1

General Specifications.............................................................................................8-1
Environmental Specifications ..................................................................................8-5
Power Delivery ........................................................................................................8-6
Error Codes .............................................................................................................8-7

9. Limited Warranty and Disclaimer......................................................... 9-1

Limited Warranties ..................................................................................................9-1
Disclaimer and Exclusion of Other Warranties ......................................................9-1
Limitation of Liability for Damages ........................................................................9-1

10. Index...................................................................................................... 10-4

Содержание EPT-1000 XP

Страница 1: ...m 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 ...

Страница 2: ......

Страница 3: ...ring capability Catheter Non T Catheter information pertaining to both Catheter styles Catheter General Information The use of all components and accessories of the EPT 1000 XPTM 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 In addi...

Страница 4: ...nings Precautions and Adverse Reactions 3 1 Warnings 3 1 Precautions 3 2 Adverse Reactions 3 4 4 Unpacking the Controller 4 1 Unpacking 4 1 Repackaging the Controller 4 1 5 Controls and Displays 5 1 Front Panel 5 1 CONTROL Panel 5 2 POWER Panel 5 4 TEMPERATURE Panel 5 5 IMPEDANCE Panel 5 7 TIME Panel 5 9 COUNTER Panel 5 10 RF POWER CONTROL Panel 5 10 CALIBRATION Panel 5 11 Isolated Patient Connect...

Страница 5: ...perature When Using the Catheter T in POWER Control Mode 6 11 Setting the Time Control 6 11 Clearing the Counter 6 12 Adjusting the Audio Control 6 13 Turning the RF Power Delivery ON 6 14 Directions for Use 6 18 Turning the RF Power Delivery OFF 6 19 Possible Causes of RF Power Delivery Interruption 6 19 7 Service and Maintenance 7 1 Cleaning Disinfecting 7 1 Replacing the Fuses 7 1 8 Product Spe...

Страница 6: ...igure 5 11 High Power Automatic Personality Module with Quick Connect 5 17 Figure 6 1 Connecting the XP APM to the Controller Front Panel 6 1 Figure 6 2 Connecting the XP APM to the Recording Equipment 6 2 Figure 6 3 Connecting the Catheter to the XP APM Front Panel 6 3 Figure 6 4 Connecting the Disposable Indifferent Patch Electrodes 6 4 Figure 6 5 Connecting the Footswitch to the Controller Rear...

Страница 7: ... 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 6 16 Table 8 1 System Specifications 8 1 Table 8 2 Environmental Specifications 8 5 Table 8 3 Error Codes 8 7 ...

Страница 8: ......

Страница 9: ...e 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 XPTM Cardiac Ablation System is operated in conjunction with commercially available external Disposable Indifferent Dispersive Patch DIP Electrodes which are in complia...

Страница 10: ...RF power deliveries is automatically counted for the physician The XP APM provides RF filtering to allow continuous electrogram recording during RF power delivery via the catheter tip electrode The XP APM allows for safe use of either standard or special high power EPT ablation catheters Safety Features The System s built in safety features include automatic shutoff for the following conditions If...

Страница 11: ...rature Control The Temperature Control mode is only compatible with Catheter T and allows selection of a desired catheter tip temperature The maximum amount of power to be delivered by the Catheter must be selected for both control modes Power Control or Temperature Control If insufficient power is selected for the Temperature Control mode the desired catheter tip temperature temperature setpoint ...

Страница 12: ...Operator s Manual 1 4 Figure 1 1 System Installation Diagram ...

Страница 13: ...le Model 703 Quick Connect 9 Pole Quadripolar Adapter Cable Model 654 APM Extension Cable 10ft Optional Model 653 Quick Connect 6 Pole 3ft APM to EGM Instrument Cable THERMISTOR CATHETER WITH QUICK CONNECT NONTHERMISTOR CATHETER WITH QUICK CONNECT 6 PIN QC OUT PINS OUT THERMISTOR NONTHERMISTOR CATHETER PIN CONNECTS Model 822T Quick Connect XP APM Switch Box EPT 1000 XP CARDIAC ABLATION CONTROLLER ...

Страница 14: ......

Страница 15: ...a typically chronic drug refractory atrial fibrillation Contraindications Use of the device is contraindicated for patients with active systemic infection Use of the device in patients with implanted permanent leads of an implantable device of any kind Patients with implanted mitral tricuspid artificial valve Pregnant women Presence of tumors or clots in atrium and or ventricules The retrograde tr...

Страница 16: ......

Страница 17: ...nimize this exposure Careful consideration must therefore be given for the use of the device in pregnant women Patients undergoing AV nodal modification or ablation of septal accessory pathways are at risk for inadvertent AV block It is advisable to use lower initial power in such patients and to monitor anterior conduction closely during RF power delivery Pacemakers and implantable cardioverter d...

Страница 18: ... unprotected male pin connectors must exercise extreme caution during device set up to prevent patient or operator injury Unused pins should be secured so that they do not inadvertantly touch other equipment or surfaces Never insert pins into mains outlets or into any equipment other than systems providing patient electrical isolation in accordance with IEC 601 The APM output labeled recorder must...

Страница 19: ...r any long term effects of lesions in proximity to the specialized conduction system or coronary vasculature are unknown Furthermore the risk benefit in asymptomatic patients has not been studied Read and follow the Disposable Indifferent Dispersive Patch DIP Electrode manufacturer s instructions for use the use of DIP Electrodes which meet or exceed ANSI AAMI HF 18 requirements is required Placem...

Страница 20: ...ery endocarditis pericarditis pericardial pleural effusion pleurisy hemoptysis hemorrhage pulmonary edema embolus vessel thrombus valve damage infection catheter entrapment skin burns pseudoaneurysm cardiac respiratory arrest sinoatrial SA node damage atrioventricular AV node damage phrenic nerve damage aspiration atrial septal defect ruptured chordae tendineae femoral artery thrombus aortic punct...

Страница 21: ...nd accessories carefully and inspect for damage 2 Notify the carrier immediately if the shipment carton is damaged 3 Verify that the items listed above are received Call EPT for Service If there are any discrepancies notify EPT Telephone Number 408 895 3500 4 Read Section 6 Operational Sequence in this Manual very carefully and follow the installation and setup instructions Repackaging the Control...

Страница 22: ......

Страница 23: ...ntroller s status and or report error conditions This section describes the operator controls on the front panel shown in Figure 5 1 Figure 5 1 Controller Front Panel TEMPERATURE C IMPEDANCE TIME S COUNTER CLEAR RF POWER CONTROL ISOLATED PATIENT CONNECTOR CONTROL POWER TEMP CALIBRATION MAINS POWER W Power Panel Temperature Panel Impedance Panel Time Panel Control Panel Calibration Panel Counter Pa...

Страница 24: ...r Control mode while using a Catheter T pressing the CONTROL Button see Figure 5 2 changes the control mode to Power Control as indicated by the flashing green POWER LED If a Catheter Non T or no Catheter is connected then the Controller automatically switches to the Power Control mode when initially powered on as indicated by the flashing green POWER LED Note POWER TIME and TEMPERATURE setpoints ...

Страница 25: ...of a desired catheter tip temperature The maximum amount of power to be delivered by the Catheter from a value of 0 W to a maximum of either 50 or 100 W depending on catheter type must also be selected in the Temperature Control mode see Table 5 1 If insufficient power is selected the desired catheter tip temperature may not be achieved Catheters are designed to transmit three distinct quantities ...

Страница 26: ...ing the actual power output the Catheter delivers to the tissue In the Power Control mode the Controller adjusts its output to maintain the measured power at the power setpoint and in the Temperature Control mode the Controller adjusts its output to maintain the measured temperature at the temperature setpoint In the Temperature Control mode measured power may be lower than the power setpoint valu...

Страница 27: ...put on page 6 9 Note Access to greater than 50 W of power requires the use of appropriately coded special high power catheters and the XP APM TEMPERATURE Panel TEMPERATURE Display The TEMPERATURE Display see Figure 5 4 shows the temperature setpoint desired catheter tip temperature in degrees Centigrade This feature is only available if a Catheter T is connected to the Controller Figure 5 4 TEMPER...

Страница 28: ...mperature is below 20 C the message LO displays If the measured temperature is above 120 C the message HI displays In DONE operational mode When RF power is discontinued the last measured value of temperature is shown on the display flashing at 1 second intervals Catheter T Power Control Mode In READY mode display reading is 85 C In ON or CALIBRATE operational modes display indicates measured cath...

Страница 29: ... Buttons select the temperature that the Controller attempts to achieve during RF power delivery In Temperature Control mode the Controller automatically adjusts power within the user selected upper power limit to achieve the desired catheter tip temperature In Power Control mode the Controller automatically decreases RF power to the Catheter if this value of user selected upper temperature limit ...

Страница 30: ...nd 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 When either the CALIBRATION or RF POWER CONTROL Buttons are depressed the Controller returns to the READY mode and the IMPEDANCE Display returns to three dashes Figure 5 5 IMPEDANCE Display IMPE...

Страница 31: ...ime or the Footswitch is released stopping RF power delivery If RF power delivery is stopped before the preset maximum duration has been reached actual duration of RF power delivery is displayed flashing at 1 second intervals TIME Buttons The POWER increase decrease Buttons select the maximum duration of each RF power delivery The range of times available is 1 to 120 seconds in increments of one N...

Страница 32: ...POWER CONTROL Button see Figure 5 8 controls the three operational modes of the Controller READY mode This mode allows the ablation parameters to be adjusted ON mode This mode is the Controllers state during the delivery of RF power DONE mode This mode defines the system state after cessation of RF power delivery Note This button can also be used for exiting the CALIBRATION or Error modes and retu...

Страница 33: ...ol Panel RF Power Control Button Light CALIBRATION Panel CALIBRATION Button Pressing the CALIBRATION Button see Figure 5 9 places the Controller into the CALIBRATION mode which performs the following functions Approximately 1 Joule of energy is delivered to the tissue which is used to make a single measurement of tissue impedance This value is continuously displayed on the front panel The catheter...

Страница 34: ...calibration signal automatically discontinues if the RF POWER CONTROL Button or the Footswitch is pressed Figure 5 9 CALIBRATION Panel and Button LED CALIBRATION Calibration Panel Calibration Button Calibration LED Isolated Patient Connector The ISOLATED PATIENT CONNECTOR see Figure 5 1 provides for connection of the XP APM to the Controller The connector has a screw on locking mechanism for secur...

Страница 35: ...SHOCK HAZARD 100 120V 3A 50 60 Hz 220 240V 1 6A 50 60 Hz AUX MAINS T3A 250V T1 6A 250V 2X 100 120V 1A 50 60 Hz 220 240V 500mA 50 60 Hz T1A 250V T500mA 250V 2X Power Switch Analog Outputs Power Cord Mains Fuse Holder Fuse Holders 2 Footswitch Cable Connector Volume Control Knob Serial Port Auxiliary Power Outlet Ground Stud CAUTION THE TOTAL SYSTEM CHASSIS RISK CURRENT SHOULD NOT EXCEED 100µ µ µ µA...

Страница 36: ...impedance during delivery of RF power Temperature Analog Output TEMPERATURE This output port is active only when a Catheter T is in use It 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 Catheter T measured catheter tip temperature during delivery of RF po...

Страница 37: ... the knob to determine if the volume level has been adjusted too low Serial Port This port is labeled RS 232 It provides for computer interface to EPT approved accessory computers only Auxiliary Power Outlet This outlet is labeled Auxiliary Power Outlet It provides for future optional EP Technologies approved accessories only Ground Stud Protective Earth Ground stud chassis ground ...

Страница 38: ...s for safe use of either standard or special high power EPT ablation catheters The XP APM passes RF energy at 500 kHz from the Controller to the patient via the catheter and one or two DIP Electrodes The maximum power delivered depends on the configuration of the attached catheter The XP APM detects the presence of a special high power catheter and enables the Controller to deliver RF power up to ...

Страница 39: ...h Quick Connect CATHETER Front Panel Top View CARDIAC ABLATION SYSTEM XP AUTOMATIC PERSONALITY MODULE CATHETER RECORDER EP Technologies Inc X 2 Side Panel ELECTRODES INDIFFERENT INDIFFERENT ELECTRODES EPT 1000 XP APM FOR USE WITH EP TECHNOLOGIES CARDIAC ABLATION SYSTEM ONLY RECORDER ...

Страница 40: ......

Страница 41: ...T CONNECTOR socket on the Controller front panel by carefully lining up the connector pins with the socket Push the connector firmly into the socket then secure in place by rotating the locking ring in a clockwise direction 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 F...

Страница 42: ...le to connect the XP APM to optional recording equipment see Figure 6 2 b Plug in the Quick Connect fitting from the XP APM EGM Interconnect Cable into the connector located on the XP APM side panel labeled RECORDER and plug the opposite end of this cable into isolated recorder inputs Note Ensure that the pins are not bent or broken and that the monitoring connectors are securely in place Unused p...

Страница 43: ...he XP APM front panel see Figure 6 4 as follows a Read the manufacturer s manual before installing the DIP Electrode pads b Gently push each DIP Electrode fitting straight and firmly into place c To disconnect a DIP Electrode grasp the DIP Electrode fitting and gently pull it out from the XP APM Indifferent Electrode receptacle Precaution Do not disconnect a DIP Electrode Connector by pulling on i...

Страница 44: ...ocations are the upper arm or left flank area Avoid scar tissue bony prominence adipose tissue or any areas where fluid may pool Shave clean and dry the application site as needed Check for wrinkles or folds when applying the pad as these decrease conductivity Note RF output ceases to the patient if more than 1 A flows through either of the DIP Electrodes Figure 6 4 Connecting the Disposable Indif...

Страница 45: ...120V 3A 50 60 Hz 220 240V 1 6A 50 60 Hz AUX MAINS T3A250V T1 6A250V 2X 100 120V 1A 50 60 Hz 220 240V 500mA 50 60 Hz T1A 250V T500mA 250V 2X CAUTION THE TOTAL SYSTEM CHASSIS RISK CURRENT SHOULD NOT EXCEED 100 µ µ µ µA ATTENTION LE COURANT DE TISQUE TOTAL ADMISSIBLE AU CHASSIS NE DOIT PAS DEPASSER 100 µ µ µ µA AUX FUSES Footswitch Footswitch Cable Connector 11 The System is now ready to record elect...

Страница 46: ...ted after completion of a successful Controller self test Ready mode is indicated by a flashing RF POWER CONTROL Button on the Controller front panel TEMPERATURE IMPEDANCE TIME and COUNTER Displays are continuously lit Values displayed when the Controller is first initialized are zero in the POWER TIME and COUNTER Displays and dashes in the IMPEDANCE Display Refer to Figure 5 1 for the location of...

Страница 47: ...l Modes Catheter T Connected When the Controller is in either the ON or CALIBRATE operational modes the TEMPERATURE Display indicates LO if the measured temperature is less than 20 C HI if temperature is greater than 120 C otherwise it shows the measured temperature see Figure 6 7 Figure 6 7 Ready Mode Initialization Catheter T Connected Measured Temperatur Reading C TEMPERATURE Catheter Non T or ...

Страница 48: ...This generates a minimum to full scale 0 0 to 1 0 volt continuous square wave calibration signal which is sent continuously and simultaneously to each of the analog outputs until the CALIBRATION Button is pressed again or until the RF POWER CONTROL Button is pressed Figure 6 9 Calibrating the Controller Analog Outputs Calibration Button COUNTER CLEAR RF POWER CONTROL CALIBRATION MAINS 5 With the C...

Страница 49: ...etpoint is equal to or greater than the amount of power necessary to achieve the desired catheter tip temperature then the Controller supplies the appropriate amount of power to achieve the temperature setpoint The Controller only supplies as much RF power as necessary to achieve the desired catheter tip temperature If the RF power setpoint is less than the amount of power required to achieve the ...

Страница 50: ...ures involving automatic temperature control it is recommended that the operator initially select a lower set temperature range from 55 C to 70 C The operator should consider a lower initial set temperature to avoid excessive thermal damage to tissue or collateral damage to adjacent tissue not intended for ablation particularly in areas where high blood flow and correspondingly high convective coo...

Страница 51: ...htly greater rate than it does when the Controller is in the READY mode Selecting Temperature When Using the Catheter T in POWER Control Mode If a Catheter T is connected to the Controller an upper temperature limit can be selected The Controller automatically decreases RF power to the Catheter if this value of temperature is exceeded in the Power Control mode To select the temperature setpoint fo...

Страница 52: ...he desired duration depress and hold the appropriate TIME Button down 4 Release the TIME Button when the TIME Display shows the appropriate duration When the selected value is programmed into the Controller control circuit Note The value can be changed at any time during the READY mode by depressing the TIME Button increase or TIME Button decrease Clearing the Counter Important Always clear the Co...

Страница 53: ...ring a clinical procedure the Volume Control Knob may be rotated fully counter clockwise to its lowest setting Note At the minimum setting the tone may NOT be audible during RF power delivery Figure 6 10 Adjusting Audio Control RF POWER ANALOG OUTPUT SPEAKER FOOT SWITCH RS 232 IMPEDANCE TEMPERATURE SPARE VOLUME Volume Control Knob To increase the volume of the audio signal turn the Volume Control ...

Страница 54: ... The Audible tone sounds during RF power delivery Note If the Controller is in the Temperature Control mode and the measured temperature is outside the range of 31o C to 43o C the Controller does not deliver RF power and an E07 error code message displays When RF power is delivered to the Catheter the displays function as follows RF POWER CONTROL BUTTON Light This light illuminates and remains lit...

Страница 55: ...atheter tip temperature If the measured temperature is outside the range of 31 C to 43 C the Controller does not deliver RF power In ON operational mode If the temperature is within 20 C 120 C range the measured temperature displays If the measured temperature is below 20 C the message LO displays If the measured temperature is above 120 C the message HI displays Catheter T Power Control Mode In R...

Страница 56: ... Reading Typical Impedance 80 to 150 Ω Normal operating condition Normal RF power delivery Display shows measured impedance Low Impedance1 50 Ω If accessing up to 50 W of RF power Controller automatically shuts off RF power Display flashes LO 25 Ω If accessing up to 100 W of RF power Controller automatically shuts off RF power Display flashes LO High Impedance2 300 Ω N A Controller automatically s...

Страница 57: ... time as follows When the RF POWER CONTROL Button is pressed or the Footswitch is depressed this display changes from the user selected time limit to 0 seconds and begins to count up to the user selected value When the preset duration has elapsed the RF power automatically shuts OFF The user selected value remains flashing on the TIME Display If the RF POWER CONTROL Button is pressed during delive...

Страница 58: ...orward from its neutral position the tip curves proportionately up to a maximum of 270 degrees in one direction depending upon the curve option selected Pulling the Steering Lever back causes the tip to deflect in the opposite direction To prevent over stressing the tip the Steering Lever movement is limited by the handle design 4 When crossing the aortic valve with the ablation catheter it is rec...

Страница 59: ...tor temperature sensing component and has associated electrical leads designed to monitor and or control temperature at the endocardial surface during the ablation procedure Turning the RF Power Delivery OFF RF power delivery ceases by user intervention or certain operating conditions listing in the next section Possible Causes of RF Power Delivery Interruption To discontinue RF power delivery dur...

Страница 60: ...the last measured impedance value remains flashing on the IMPEDANCE Display alternating with the appropriate HI or LO message If RF power delivery ceases due to an error the last measured impedance value remains flashing on the IMPEDANCE Display alternating with the appropriate error code See Table 8 3 for a listing of error codes In any of the above cases when either the RF POWER CONTROL Button o...

Страница 61: ... The outer surfaces of the Controller and its accessories may be cleaned with a mild soapy solution If disinfecting is required isopropyl alcohol may be used to clean the outer surfaces Precaution Do not immerse the Controller or its accessories in any liquid Avoid caustic or abrasive cleaners Replacing the Fuses Replacing the Main Fuse 1 Before replacing a fuse in the Controller disconnect the ma...

Страница 62: ...re 5 10 3 Use a slotted screwdriver to rotate the fuse holder counter clockwise 1 8th of a turn The fuse holder pops out approximately 6 mm 1 4 inch 4 Remove the fuse holder and the fuse 5 Insert the new fuse in the fuse holder and reinsert it into the housing Call EPT for Service If there appears to be a problem with the Controller please contact EPT for instructions on returning the Controller t...

Страница 63: ...g Fuse Rating 3 A 50 60 Hz 100 120 VAC Auxiliary Power 100 120 VAC Model 800XP Current Rating Fuse Rating 1 A 50 60 Hz 100 120 VAC Power Length Cord 10 ft Footswitch Cable Length 10 ft Connector to Controller Polarized Patient Cable to High Power Automatic Personality Module Length Connector 10 ft Multi pin Polarized Connector High Power Automatic Personality Module Dimensions Height Width Depth W...

Страница 64: ...Hz High Power Disconnect Mechanism RF output ceases to the patient if more than 1 A flows in either INDIFFERENT ELECTRODE Controller RF Power Outputs 50 W maximum into a minimum impedance of 50 Ω within a 1 A current limit 100 W maximum into a minimum impedance of 25 Ω within a 2 A current limit Maximum RF power output based on catheter type used and control mode Impedance Measures 50 Ω and above ...

Страница 65: ...r With Catheter Non T Connected Controller displays Normal Operating Condition With Controller in the Temperature Control or Power Control Modes Controller measures 20 to 120 C Outside of Normal Operating Range Controller displays LO or HI Dimensions Height Width Depth Weight 8 20 cm 13 33 cm 21 53 cm 23 lb 10 4 kg Time 0 to 120 seconds in increments of 1 second Counter 0 to 99 RF power deliveries...

Страница 66: ...ts 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 Impedance 0 1 volt corresponds to 0 300 Ω continuous square wave Temperature 0 1 volt corresponds to 20 120 C continuous square wave ...

Страница 67: ...ification 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 500 to 1060 millibar Operating Temperature 10 C to 40 C Relative humidity 30 to 75 non condensing Atmospheric pressure 700 to 1060 millibar ...

Страница 68: ...sually high or low tissue impedance the System limits the maximum power A graph which depicts the maximum output power of the System as a function of tissue impedance is shown in Figure 8 1 Note Only the maximum power is affected If the power setting is less than the maximum power available the System delivers the set power value Figure 8 1 Output Power vs Tissue Impedance 20 40 60 80 100 120 140 ...

Страница 69: ...perature outside the range of 31o C to 43o C E08 Upper temperature limit cutoff exceeded for more than 4 0 seconds E09 Upper temperature limit cutoff exceeded for the second time E01 E03 Error Codes If error codes E01 E03 are observed it is recommended that the ablation be attempted again Call EPT for Service If the error code displays again notify EPT for service Telephone Number 408 895 3500 E06...

Страница 70: ... Decrease Protective Earth Ground Defibrillator Proof Type Equipment Variability Clock Time Switch Timer Dangerous Voltage Attention Consult Accompanying Documents Non Ionizing Radiation Loudspeaker Fuse Counter Calibration Clear Indifferent Dispersive Patch Electrode Radio Frequency Power On Off Equipotentiality 000 M Explosion Hazard AP ...

Страница 71: ...ness for intended use with respect to such instrument Disclaimer and Exclusion of Other Warranties There are no warranties of any kind which extend beyond the description of the warranties above EPT disclaims and excludes all warranties whether expressed or implied of merchantability of fitness for a particular use or purpose Limitation of Liability for Damages In any claim or lawsuit for damages ...

Страница 72: ......

Страница 73: ...ng analog outputs 6 8 calibration panel button 5 11 illustration 5 12 catheter maximum power output 5 3 naming conventions v Catheter T temperature selection 6 10 6 11 catheter tip temperature selection 6 10 connecting DIP electrodes 6 3 footswitch 6 5 power cord 6 1 quick connect instrument cable 6 3 recorder equipment 6 2 XP APM patient cable 6 1 XP APM EGM interconnect cable 6 2 contraindicatio...

Страница 74: ...1 2 safety 1 2 user selectable parameters 1 2 footswitch cable connector 5 14 connecting 6 5 description 5 16 front panel calibration panel 5 11 control panel 5 2 5 10 illustration 5 1 impedance panel 5 7 isolated patient connector 5 12 mains display 5 12 power panel 5 4 RF power control panel 5 10 temperature panel 5 5 time panel 5 9 fuse holders description 5 14 fuses location of 5 13 replacing ...

Страница 75: ...ains fuse holder 5 14 power cord 5 14 power switch 5 13 serial port 5 15 volume control knob 5 15 repackaging the system 4 1 RF power control panel button light 5 10 illustration 5 11 status 6 14 RF power delivery causes of interruption 6 19 control display 6 17 counter display 6 17 impedance display readings 6 16 temperature display readings 6 15 time display 6 17 turning off RF power 6 19 turnin...

Страница 76: ...ompatibility 1 3 temperature display readings Catheter Non T connected 6 7 temperature panel display readings Catheter Non T connected 5 6 Catheter T connected 5 6 temperature panel display 5 5 illustration 5 5 readings 5 6 temperature increase button 5 7 time control selection 6 12 time panel display 5 9 illustration 5 9 readings 6 17 time buttons 5 9 transaortic approach warnings 3 1 unpacking t...

Страница 77: ...i ...

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