Emprint™ Ablation System

Emprint™ Ablation System
with Thermosphere™ Technology
Specification Guide
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FIELD
CONTROL
THERMAL
CONTROL
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WAVELENGTH
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THERMOSPHERE
TECHNOLOGY
TM
Product Information
REF / SKU
Product
Length
CAGEN1
Emprint™ Ablation Generator with Thermosphere™ Technology
1
CART1
Emprint™ Ablation Cart
1
CA190RC1
Emprint™ Ablation Reusable Cable
CAPUMP1
Emprint™ Ablation Pump
CA15L1
Short Percutaneous Antenna with Thermosphere™ Technology
Large Spherical Ablation Zone
15 cm
1
CA20L1
Emprint™ Standard Percutaneous Antenna with Thermosphere™ Technology
Large Spherical Ablation Zone
20 cm
1
CA30L1
Emprint™ Long Percutaneous Antenna with Thermosphere™ Technology
Large Spherical Ablation Zone
30 cm
1
CAMSYS
Emprint™ Ablation System with Thermosphere™ Technology
190 cm
Unit of Sale
1
1
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.
Generator Specifications
Enclosure
Front Panel Connections
Width:
300 mm (11.8 in.)
Depth:
300 mm (11.8 in.)
Height:
90 mm (3.5 in.)
Weight:
Enclosure:
Display:
Less than 4.5 kg (~10 lb)
Aluminum – white paint finish
Super bright, white LED 7-segment
numeric display
Performance Summary
Maximum Output Power
(measured at output port):
Microwave Output Frequency:
0-100 W (+20%/-5%)
Modulation Type:
Pulse width modulated continuous wave
Output Impedance:
50 Ω nominal
2.45 GHz +/-50 MHz
Power Supply
Voltage Supply:
100-240 VAC 50-60 Hz
Power Usage (typical):
340VA
Fuse Rating:
6.3 A, 5x20 mm, quick blow
(F6.3AL250 V)
Signal Output:
Custom single coaxial (BMA) female and data
connector
RTP20 Port:
Rear Panel Connections
Mains Power:
Filtered IEC (maximum of 10 feet for mains power
cable)
Footswitch:
Protection Interlocks
Amplifier Interlock
Temperature:
75 degrees C
Environmental
Sealing:
Temperature
Range:
Relative Humidity:
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)
Atmospheric
Pressure:
66 kPA to 106 kPA
Pump Specifications
Rear Panel Connections
Enclosure
Dimensions
Width x Height x Depth:
Weight:
184 x 159 x 146 mm
(7.25 x 6.25 x 5.75 in.)
2.650 kg (5.842 lb)
Enclosure:
Aluminum – white paint finish
Power Supply
Voltage Supply:
100-240 VAC 50/60 Hz
Power Usage (typical):
Fuse Rating:
35 VA
6.3 A, 5x20 mm, quick blow (F6.3AL250 V)
Mains Power
Filtered IEC
(maximum of 10 feet for mains power cable)
Environmental
Sealing:
IP20
Temperature Range:
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
Relative Humidity:
Atmospheric Pressure
Electrical Safety
Classifications as per IEC 60601-1, the manufacturer describes the generator and pump as
Type of protection against electric shock:
Class 1
Degree of protection against electric shock (Generator only):
Type BF only
Degree of protection against electric shock (Pump only):
Type BF only
Mode of operation:
Continuous
Degree of safety in the presence of flammable anesthetic mixture with air, oxygen or nitrous oxide
Not suitable for use
Degree of harmful ingress of water
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
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.
Alert Bank
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The reusable cable plugs directly into this port.
Device TC Temperature Trip
Activation Status
Reflected Power Shutoff
Antenna Not Identified
Remote Temperature Probe (RTP20)
Generator Error
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 2400 - 2500 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 60601-1-2)
Essential Performance Definition (IEC 60601-1-2)
• 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.
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U.S. and internationally registered trademarks of Covidien AG. Other brands are
trademarks of a Covidien company.
© 2014 Covidien. 3.14 US140119
5920 Longbow Drive
Boulder, CO
80301
800-255-8522
www.covidien.com