Emprint Ablation System with Thermosphere Technology

Transcription

1 Emprint Ablation System with Thermosphere Technology Specification Guide = FIELD CONTROL THERMAL CONTROL WAVELENGTH CONTROL THERMOSPHERE TM TECHNOLOGY

2 Product Information REF / SKU Product Length Unit of Sale CAGEN1 Emprint Ablation Generator with Thermosphere Technology 1 CART1 Emprint Ablation Cart 1 CA190RC1 Emprint Ablation Reusable Cable 190 cm 1 CAPUMP1 Emprint Ablation Pump 1 CA15L1 CA20L1 CA30L1 Short Percutaneous Antenna with Thermosphere Technology Large Spherical Ablation Zone Emprint Standard Percutaneous Antenna with Thermosphere Technology Large Spherical Ablation Zone Emprint Long Percutaneous Antenna with Thermosphere Technology Large Spherical Ablation Zone 15 cm 1 20 cm 1 30 cm 1 CAMSYS Emprint Ablation System with Thermosphere Technology 1 All specifications are nominal and subject to change without notice. A specification referred to as typical is within ±20% of a stated value at room temperature (77 degrees F 25 degrees C) and a nominal input power voltage.

3 Generator Specifications Enclosure Width: Depth: Height: Weight: Enclosure: Display: Performance Summary Maximum Output Power (measured at output port): Microwave Output Frequency: Modulation Type: Output Impedance: Power Supply Voltage Supply: Power Usage (typical): Fuse Rating: 300 mm (11.8 in.) 300 mm (11.8 in.) 90 mm (3.5 in.) Less than 4.5 kg (~10 lb) Aluminum white paint finish Super bright, white LED 7-segment numeric display W (+20%/-5%) 2.45 GHz +/-50 MHz Pulse width modulated continuous wave 50 Ω nominal VAC Hz 340VA 6.3 A, 5x20 mm, quick blow (F6.3AL250 V) Front Panel Connections Signal Output: RTP20 Port: Rear Panel Connections Mains Power: Footswitch: Protection Interlocks Amplifier Interlock Temperature: Environmental Sealing: Temperature Range: Relative Humidity: Atmospheric Pressure: Custom single coaxial (BMA) female and data connector Filtered IEC (maximum of 10 feet for mains power cable) 75 degrees C IP20 Operating: +10 to +30 degrees C Transport and Storage: -30 to +70 degrees C Operating: 20% to 80% (non-condensing) Transport and Storage: 10% to 90% (noncondensing) 66 kpa to 106 kpa Pump Specifications Enclosure Dimensions Width x Height x Depth: Weight: Enclosure: Power Supply Voltage Supply: Power Usage (typical): 184 x 159 x 146 mm (7.25 x 6.25 x 5.75 in.) kg (5.842 lb) Aluminum white paint finish VAC 50/60 Hz 35 VA Fuse Rating: 6.3 A, 5x20 mm, quick blow (F6.3AL250 V) Rear Panel Connections Mains Power Environmental Sealing: Temperature Range: Relative Humidity: Atmospheric Pressure Filtered IEC (maximum of 10 feet for mains power cable) IP20 Operating: +10 to +30 degrees C Transport and Storage: -30 to +70 degrees C Operating: 20% to 80% (non-condensing) Transport and Storage: 10% to 90% (noncondensing) 66 kpa to 106 kpa Electrical Safety Classifications as per IEC , the manufacturer describes the generator and pump as Type of protection against electric shock: Class 1 Degree of protection against electric shock (Generator only): Degree of protection against electric shock (Pump only): Mode of operation: Degree of safety in the presence of flammable anesthetic mixture with air, oxygen or nitrous oxide Degree of harmful ingress of water Type BF only Type BF only Continuous Not suitable for use IP20 (footswitch IPX8) Cable Specifications Cable Length x Diameter: 1900 mm x 14 mm (6 3 x 0.55 ) Weight: 500 g (1.10 lb) Power Handling: 100 W Material: Silicone/TEKBOND TB1723/GRILAMID LV-3H Connector Type: Custom with integrated microwave and data communication Sealing: IP20 Temperature Range: Operating: +10 to +30 degrees C; Storage: -20 to +80% (non-condensing) Relative Humidity: Operating: 20 to 80% (non-condensing) Atmospheric Pressure: 66 kpa to 106 kpa

4 Features Digital Displays The generator displays the Output Power (in Watts), the remote temperature probe temperature (in degrees Celsius only when a remote temperature probe is connected) and the remaining treatment duration time (in minutes and seconds - MM:SS). Remote Temperature Probe (RTP20) The remote-temperature-probe-connector port allows connection of the optional remote temperature probe (RTP20). When an RTP20 is attached to the generator, the remote-temperature-probe-temperature display shows the real-time measured temperature in degrees Celsius (C) in the range 00 to 99. The remotetemperature-probe-temperature display shows HI when the measured temperature is above 99 and LO when it is below 00. A RTP20 shutoff function for the remote temperature probe can be enabled by pressing the remotetemperature-probe-shutoff-enable button on the front panel. The switch will illuminate (green) to indicate that it is active. The default trip for the probe is 45 degrees C.This means that the generator will stop an activation when the temperature read by the remote temperature probe meets or exceeds 45 degrees C. Footswitch A footswitch is included with the system to allow the user to start and stop an ablation procedure while in the sterile field. System Cart A dedicated system cart is available for the Emprint ablation system. Microwave Output Power Set Point Control The adjustable output power levels in Watts (W). System power can be set from 5 to 100 W. Each Emprint antenna has a Device ID that places an upper limit on the generator power settings while connected. Display is used to adjust the power level in 5 W increments. Upper Limit = 100 W maximum Lower Limit = 0 W (to start energy delivery the power must be 5 W or greater) Treatment Time Display Treatment time can be set to a maximum of 10:00 (MM:SS), dependent upon the antenna attached, and is shown in the treatment-time display. Microwave START/ STOP Button Microwave power can be activated by pressing either the START/STOP button on the front panel or by depressing the footswitch. Reset Pressing the RESET button on the front of the generator will return the generator back to the default state (and clear errors). Integrated Microwave and Data Connector Port The output signal from the generator is provided from integrated microwave and data connector to the front panel. The reusable cable plugs directly into this port. Alert Bank Device TC Temperature Trip Activation Status Reflected Power Shutoff Antenna Not Identified Remote Temperature Probe (RTP20) Generator Error

5 Declaration of Conformity A declaration of conformity for generator is available upon request. EMC Microwave Interference with Other Devices The system is an intentional radiator at a frequency of MHz, which is the fundamental frequency range used to achieve desired tissue effect. Although the system meets all required electromagnetic compatibility (EMC) standards, the system may affect certain infrared (IR) devices, such as fire smoke detectors, particularly devices that use older IR technology. Prior to using the system at a facility, inform the appropriate personnel of the potential for IR interference and inquire about the technology used at the hospital for fires or other IR devices. Electromagnetic Compatibility (IEC ) Essential Performance Definition (IEC ) Essential performance The system shall be free from the display of incorrect numerical values associated with the therapy to be performed. Unallowable actions during system operation The temperature readout of the RTP must not flicker more than 2 degrees. The unit must not self-activate. Degradation of performance not allowed The power setting must equal the output power within ±20% Allowable degradation of performance The unit may shut off output power and stop the counter if an alarm is encountered.

6 COVIDIEN, COVIDIEN with logo, Covidien logo and positive results for life are U.S. and internationally registered trademarks of Covidien AG. Other brands are trademarks of a Covidien company Covidien US Longbow Drive Boulder, CO