AtriCure nContact CS-3000 User manual

CS-3000 RF Generator Unit Operator Manual
AtriCure, Inc.
IFU-0022.A2021/04
Page 1 / 12
nContact Coagulation System Radiofrequency (RF) Generator Unit - Model CS-3000
2797
AtriCure Incorporated
7555 Innovation Way
Mason, Ohio 45040 USA
Customer Service:
1-866-349-2342 (toll free)
1-513-755-4100 (phone)
Caution: Federal (US) law restricts this device to sale by or on the order of a physician.
Disclaimer AtriCure reserves the right to change its products and services at any time to incorporate the
latest technological developments. This Manual is subject to change without notice.
Although this Manual has been prepared with every precaution to ensure accuracy, AtriCure
assumes no liability for damages resulting from the application or use of this information.
Trademarks nContact and the nContact logo are trademarks of AtriCure, Inc.
IFU-0022.A

CS-3000 RF Generator Unit Operator Manual
AtriCure, Inc.
IFU-0022.A2021/04
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Table of Contents
Preface.................................................................................................................................................................................................... 3
Indications ............................................................................................................................................................................................... 3
Contraindications .................................................................................................................................................................................... 3
Non-Sterile .............................................................................................................................................................................................. 3
Warning................................................................................................................................................................................................... 3
Precautions ............................................................................................................................................................................................. 3
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions............................................................................................... 3
Classication in accordance with EN 60601-1........................................................................................................................................ 3
Guidance & Manufacturer’s Declaration– Electromagnetic Immunity..................................................................................................... 4
Glossary of Terms ................................................................................................................................................................................... 5
Symbols and Icons.................................................................................................................................................................................. 6
Chapter 1 Introduction................................................................................................................................................................................. 6
Overview ................................................................................................................................................................................................. 6
Product Description................................................................................................................................................................................. 6
Figure 1. Power Output versus Impedance Load .............................................................................................................................. 6
Figure 2. Voltage versus Impedance Load ........................................................................................................................................ 6
Figure 3. Delivered Power versus Set Power .................................................................................................................................... 6
Generator Operating Modes ................................................................................................................................................................... 6
System Components Supplied with the Generator ................................................................................................................................. 7
Components Not Supplied with the Generator........................................................................................................................................ 7
CS-3000 RF Generator User Interface ................................................................................................................................................... 7
Figure 4. Generator Front Panel – Key Features .............................................................................................................................. 8
Figure 5. CSK Type Devices, CSK-2000 Cable and RF Generator Setup ........................................................................................ 8
Figure 6A. CDK Type Devices, CSK-2000, CSK-2030 with over molded yoke and RF Generator Setup......................................... 8
Figure 6B. CDK Type Devices, CSK-2000, CSK-2030 with enclosure box and RF Generator Setup............................................... 8
Figure 7. Generator Back Panel – Key Features............................................................................................................................... 8
Chapter 2 Setup and Operation................................................................................................................................................................... 8
Generator Setup and Operation.............................................................................................................................................................. 8
Chapter 3 Cleaning...................................................................................................................................................................................... 9
Chapter 4 Technical Specications and Safety Inspection.......................................................................................................................... 9
Device Specications.............................................................................................................................................................................. 9
Environmental Specications.................................................................................................................................................................. 9
Periodic Inspections ................................................................................................................................................................................ 9
Chapter 5 Product Specications .............................................................................................................................................................. 10
Operational Conditions & Front Panel Displays .................................................................................................................................... 10
Figure 8. RF Generator Front Panel Display at “Power On”............................................................................................................ 10
Figure 9. RF Generator Front Panel Display at “Standby Mode”..................................................................................................... 10
Figure 10. RF Generator Front Panel Display Entering “Power Control Mode”............................................................................... 10
Figure 11. RF Generator Front Panel Display in “Power Control \ Ready State”............................................................................. 10
Figure 12. Sample Display in “RF ON” State with a Device Attached .............................................................................................. 10
Figure 13. Front Panel Display in “RF ON” with Resistivity Active................................................................................................... 10
Figure 14. RF Generator Cycle Complete, Returns to Power Control “Ready” State...................................................................... 10
Figure 15. User Terminates Energy Cycle – Generator Returns to “User Request” State................................................................11
Figure 16. Generator Enters “Diagnostic Evaluation Mode” .............................................................................................................11
Warning and Fault States – Error Conditions.........................................................................................................................................11
Figure 17. ERROR “Imp Limit” – Impedance Exceeds Threshold .....................................................................................................11
Figure 18. ERROR “RF E󰀨 Limit” – System Error..............................................................................................................................11
Chapter 6 Troubleshooting .........................................................................................................................................................................11
Figure 19. Generator Modes, States and Operational Flow .............................................................................................................11
Table 1 – List of Troubleshooting Symptoms & Actions ........................................................................................................................ 12
Chapter 7 Customer Service / Equipment Servicing/ Warranty................................................................................................................. 12
WARRANTIES ...................................................................................................................................................................................... 12
Limitation on Liability ........................................................................................................................................................................ 12
DISCLAIMER ........................................................................................................................................................................................ 12

CS-3000 RF Generator Unit Operator Manual
AtriCure, Inc.
IFU-0022.A2021/04
Page 3 / 12
Preface
The nContact Model CS – 3000 Radiofrequency Generator Unit is used to transmit
radiofrequency (RF) energy for localized tissue heating resulting in tissue coagulation.
The unit operates in Power Control and Diagnostic Evaluation modes and is de-
signed specically for use with nContact coagulation devices and accessories.
Indications
For use only with nContact Coagulation Devices, RF Coagulation Cable, and
Sensing Cable.
Contraindications
o The use of the nContact Model CS – 3000 RF Generator Unit, Coagula-
tion Device and accessories is contraindicated when, in the judgment of
the physician, surgical electrocoagulation procedures using RF energy
would be contrary to the best interests of the patient.
o Use in the presence of internal or external pacemakers or internal
cardioverter / debrillators (ICDs) and monitoring equipment may require
special considerations.
Non-Sterile
The nContact Model CS – 3000 Radiofrequency Generator Unit is provided
non-sterile and is not intended to be used within the sterile eld. Do not sterilize the
CS-3000 RF Generator with any sterilization method or the CS-3000 RF Generator
may be damaged. Follow cleaning instruction in chapter 3 to clean CS-3000 RF
Generator.
Warning
o Carefully read all instructions before use.
o Use of radiofrequency energy in patients with internal or external
pacemakers or ICDs and monitoring equipment may require special
consideration. The attending Cardiologist and/or the pacemaker/ICD
manufacturer should be consulted before electrocoagulation surgery.
o Hazardous electrical output. This equipment is for use only by qualied
medical personnel trained in the use of electrocoagulation surgery. Fail-
ure of the high-frequency surgical equipment could result in unintended
increase of output power.
o Electric shock hazard. Do not remove the cover of the nContact RF
Generator Unit Model CS-3000. There are no user-serviceable parts
inside the generator. Refer servicing to qualied personnel only (see
information contained in “Customer Service / Equipment Servicing”).
o Interference produced by the operation of high-frequency surgical equip-
ment may adversely inuence the operation of other electronic medical
equipment such as monitors and imaging systems.
o Never increase Power beyond what is minimally required without rst
inspecting the integrity and contact of the coagulating device.
o Care should be taken to ensure that the device is not in contact with
tissue that is not going to be coagulated (e.g. vascular and nerve tissue),
to avoid inadvertent tissue damage.
o Avoid contact between the Coagulation Device and other surgical
instruments, staples or other objects while coagulating. Inadvertent
contact with objects while coagulating could lead to conduction of RF
energy or heat and unintentional coagulation of tissues in contact with
those objects.
o Burns to the physician’s hands are possible if an RF activated device
electrode comes into contact with a metal instrument or surface.
o The Coagulation Devices and RF Coagulation Cable are provided
sterile and are intended for single patient use only. Do not reprocess or
reuse. Reuse can cause patient injury and the transmission of infectious
disease(s) from one patient to another.
o The coils on the distal end of the Coagulation Device must be kept
clean of coagulum during surgery to avoid loss of power. Do not clean
coagulum o󰀨 the electrode of the device with an abrasive cleaner or
electrosurgical tip cleaner. The electrodes could be damaged, resulting
in device failure.
o The use and proper placement of an Indi󰀨erent Electrode is a key
element in the safe and e󰀨ective use of electrosurgery, particularly in the
prevention of patient burns.
Precautions
o Radiofrequency surgery uses high-frequency energy output. Do not
perform procedures if ammable or explosive media are present.
Non-ammable agents should be used for cleaning and disinfection.
o Make sure the patient is not in contact to earthed metal during the oper-
ation of the CS-3000 RF Generator. Always use appropriate insulation
between the patient and metal surfaces that may connect to earthed
ground. Follow the manufacturer’s directions for the placement of the
indi󰀨erent, dispersive electrode and for proper insulation between the
patient and any metallic surfaces.
o Maintain safe handling techniques during electrocoagulation due to
electric elds and hot metallic surfaces.
o Do not touch the electrode surface of the Coagulation Device and the
Indi󰀨erent, Dispersive Electrode at the same time, especially when
operating the Model CS-3000 RF Generator. Supercial skin burns
could occur.
o This equipment has been tested and found to comply with the limits
for medical devices to the IEC 60601-1-2:20151. These limits are
designed to provide reasonable protection against harmful interference.
This equipment generates, uses, and can radiate RF energy and, if
not installed and used in accordance with the instructions, may cause
harmful interference to other devices in the vicinity. However, there is no
guarantee that interference will not occur. If this equipment does cause
harmful interference to other devices, which can be determined by
turning the equipment o󰀨 and on, the operator is encouraged to correct
the interference by:
• Relocating or moving the equipment
• Increase the separation distance between the equipment
• Connect the equipment into di󰀨erent outlets
• Consult AtriCure, Inc. representatives for help
o The Coagulation Device, RF Generator, Cables and Accessories have
been tested as a system. Use of another manufacturer’s accessories
may cause damage to the equipment or injury to the patient.
o The use of accessory equipment not listed in this operator’s manual as
complying with the equivalent safety requirements of this CS-3000 RF
Generator may lead to a reduced level of safety. Accessory equipment
connected to the CS-3000 RF Generator must be in compliance with
IEC-60601-1 requirements. Anyone who connects additional equipment
to the CS-3000 RF Generator is responsible for compliance with the
requirements of industry standard IEC 60601-1-1. If in doubt, consult
the technical service at AtriCure, Inc.
o While the distal portion of the Coagulation Device is designed to be
malleable to conform to the anatomy of the area to be coagulated,
excessive or rough shaping of the device may damage its internal
components. Care should be taken when handling the distal end of the
device near the electrode with surgical instruments – do not squeeze or
clamp the electrode.
o Inspect the Coagulation Device, RF Coagulation Cable, and packaging
before use. If any breach of the packaging is found, the sterility of the
product cannot be guaranteed, and the product should not be used.
o Ensure complete separation of the Indi󰀨erent, Dispersive Electrode
and EKG electrodes to prevent interference with patient monitoring
equipment. Needle monitoring electrodes are not recommended. Mon-
itoring systems incorporating high frequency current-limiting devices are
recommended.
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The Model CS-3000 RF Generator is intended for use in the electromagnetic
environment specied below. The user should assure that the CS-3000 is used
in such an environment
Emissions Test Compliance Electromagnetic Environment -
Guidance
RF Emissions
CISPR 11 Group 1
The CS-3000 RF Generator intentionally
transmits RF energy as its intended
function. Nearby electronic equipment
may be a󰀨ected.
RF Emissions
CISPR 11 Class A
The CS-3000 RF Generator is suitable
for use in all establishments other than
domestic and those directly connected
to public low-voltage power supply
network that supplies buildings used for
domestic purposes.
Harmonic Emissions
IEC 61000-3-2 Class A
Voltage Fluctuations/
Flicker Emissions
IEC 61000-3-3
Complies
Classication in accordance with EN 60601-1
Safety Met Labs Mark Information
CLASS 8750 01 – MEDICAL ELECTRICAL EQUIPMENT/SYSTEMS
CLASS 8750 81 – MEDICAL ELECTRICAL EQUIPMENT/SYSTEMS –
Certied to US Standards
Radio Frequency Ablation Device, Model nContact CS-3000, rated: 100-240V~
50-60Hz 250VA
1. Type of protection against electric shock: Class 1
2. Degree of protection against electric shock: Type CF
3. Degree of protection against ingress of water: IPX1
4. Equipment not suitable for use in presence of a ammable anesthetic
mixture with air or with oxygen or nitrous oxide
5. Mode of operation: Intermittent
Environmental Conditions: Normal: 10-40°C, 30-75% rH. 700-1050mb

CS-3000 RF Generator Unit Operator Manual
AtriCure, Inc.
IFU-0022.A2021/04
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Guidance & Manufacturer’s Declaration– Electromagnetic Immunity
Product complies with the requirements of directive 93/42/EEC.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment -Guidance
Electrostatic Discharge
(ESD)
IEC 61000-4-2
± 2 kV, ± 4 kV, ± 8 kV Contact for
conductive parts
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV Air
Discharge for insulated parts
± 8 kV CD
± 15 kV AD
Floors should be wood, concrete or ceramic tile.
If oors are covered with synthetic material, the
relative humidity should be at least 30%.
Electrical Fast Transient
/ Burst
IEC 61000-4-4
± 2 kV @ 100 kHz repetition
frequency for power supply lines
± 2 kV @ 100 kHz repetition
frequency for input/output lines
± 2 kV @ 100 kHz repetition
frequency for power supply lines
± 2 kV @ 100 kHz repetition
frequency for input/output lines
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
Power inputs
± 0,5 kV, ± 1 kV Line-to-Line
± 0,5 kV, ± 1 kV, ± 2 kV Line-to-
Ground
Signal input/outputs:
± 2 kV Line-to-Ground
Power inputs
± 0,5 kV, ± 1 kV Line-to-Line
± 0,5 kV, ± 1 kV, ± 2 kV Line-to-
Ground
Signal input/outputs:
± 2 kV Line-to-Ground
Mains power quality should be that of a typical
commercial or hospital environment.
Conducted RF
IEC 61000-4-6
0,15 MHz – 80 MHz
3V, 80 % AM at 1 kHz
ISM bands between
0,15 MHz and 80 MHz
6V, 80 % AM at 1 kHz
0,15 MHz – 80 MHz
3V, 80 % AM at 1 kHz
ISM bands between
0,15 MHz and 80 MHz
6V, 80 % AM at 1 kHz
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage Dips, short
interruptions and voltage
variations on power supply
input lines
IEC 61000-4-11
Voltage Dips:
0 % Vt ; 0,5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and
315° phase angles
0 % Vt ; 1 cycle and
70 % Vt ; 25/30 cycles
Single phase: at 0°
Voltage interruptions:
0 % Vt ; 250/300 cycle
Voltage Dips:
0 % Vt ; 0,5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and
315° phase angles
0 % Vt ; 1 cycle and
70 % Vt ; 25/30 cycles
Single phase: at 0°
Voltage interruptions:
0 % Vt; 250/300 cycle
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the CS-3000 RF Generator requires continued
operation during power mains interruptions, it is
recommended that the CS-3000 RF Generator be
powered from an uninterruptible power supply or a
battery.
Power Frequency
(50/60 Hz) Magnetic eld
IEC 61000-4-8
30 A/m
50 Hz or 60 Hz
30 A/m
50 Hz or 60 Hz
Power frequency magnetic elds should be at
levels characteristic of a typical location in a typical
commercial or hospital environment.
NOTE: Vt is the ac mains voltage prior to application of the test level.
Immunity test Band (MHz) Wireless Service
Immunity
Test Lev-
el (V/m)
Compliance Test Level (V/m)
Immunity from Radiated
RF EM Fields including
proximity elds from RF
wireless communications
equipment
IEC 61000-4-3
150 kHz to 80 MHz General < 3 < 3
80 MHz – 2,7 GHz General 3 3
380 –390 TETRA 400 27 27
430 – 470 GMRS 460, FRS 460 28 28
704 – 787 LTE Band 13, 1 9 9
800 – 960
GSM 800/900, TETRA 800,
iDEN 820, CDMA 850,
LTE Band 5
28 28
1,700 – 1,990
GSM 1800; CDMA 1900;
GSM 1900; DECT;
LTE Band 1, 3, 4, 25; UMTS
28 28
2,400 – 2,570
Bluetooth, WLAN,
802.11 b/g/n, RFID 2450,
LTE Band 7
28 28
5,100 – 5,800 WLAN 802.11 a/n 9 9

CS-3000 RF Generator Unit Operator Manual
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IFU-0022.A2021/04
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Portable and mobile RF communications equipment should be used no closer to any part of the CS-3000 RF Generator including cables, than the recommended separation
distance calculated from the equation:
d=6/E×√P Where:
• d is the separation in meters
• P is the maximum output power rating of the transmitter
in watts (W) according to the Service
• E is the Compliance Test Level indicated above.
Interference may occur in the vicinity of equipment marked with the following symbol:
a) Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an elec-
tromagnetic site survey should be considered. If the measured eld strength in the location in which the ASU System or any of its components are used exceeds
the applicable RF compliance level above, the ASU System should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating components or the entire ASU System.
b) Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the CS-3000 RF Generator
The CS-3000 RF Generator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the
CS-3000 RF Generator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the CS-3000 RF Generator as recommended below, according to the maximum output power of the communications equipment.
Rated Maximum
Output Power of
Transmitter (W)
Separation Distance According to Frequency of Transmitter (m)
150 kHz to 80 MHz
d = 1.2√P
80 MHz to 800 MHz
d = 1.2√P
800 MHz to 2.5 GHz
d = 2.3√P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance ‘d’ in meters (m) can be estimated using the equation applica-
ble to the frequency of the transmitter, where ‘P’ is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is a󰀨ected by absorption and reection from structures, objects and people.
Glossary of Terms
Electrocoagulation Surgical procedures in which high-frequency electric current is used to coagulate tissues.
Coagulation Electrode The metal conductor in the coagulation device used to transmit RF energy to tissue.
Indi󰀨erent, Dispersive
Electrode
Commonly referred to as the “return electrode” or “patient electrode” or “ground pad.” Large surface area ground used to complete the circuit
of the electrical current. Usually placed on the patient’s back or thigh, the Indi󰀨erent, Dispersive Electrode is connected to the generator at
the Indi󰀨erent Connector.

CS-3000 RF Generator Unit Operator Manual
AtriCure, Inc.
IFU-0022.A2021/04
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Symbols and Icons
Manufacturer Catalog Number
VAC Vacuum RF Radiofrequency
Keep Upright Perfusion
Equipotentiality Con-
nection
Debrillation Proof Type
CF Applied Part
Indi󰀨erent, Dispersive
Electrode Caution
Caution: Electrical Shock
Hazard Footswitch Connection
WWatts Non-ionizing Radiation

Time ΩOhms
Follow Instructions for
Use sSeconds
Serial Number Alarm Volume Control
~ Alternating Current Neutral Electrode Isolated
from Earth
+Control Buttons to In-
crease Power or Time 0AC Power Switch OFF
-Control Buttons to De-
crease Power or Time lAC Power Switch ON
Protective Earth Terminal OC Measurement Out of
Range
Separate Collection for
Electrical Equipment per
WEEE Directive
2797
Product complies with the
requirements of directive
93/42/EEC
EC REP
Authorized Represen-
tative Dangerous Voltage
104°F
(50°C)
50°F
(10°C)
Operating temperature
range
140°
F
(60°C)
-30°F
(-34°C)
Storage temperature
range
75%
30%
%
Operating humidity range
85%
30%
%
Storage humidity range
1060 mbar
700 mbar
Operating pressure range Storage pressure range
NON
STERILE
Non-Sterile Non-ionizing electromag-
netic radiation
Federal (US) law restricts this device to sale by or on the order of a
physician.
Chapter 1 Introduction
Overview
The nContact Model CS-3000 RF Generator Unit transmits a high-frequency alter-
nating current through a coagulation device to coagulate soft tissue. The RF current
induces ionic agitation in the tissue causing molecular friction and producing heat.
Thus, the heat is generated in the tissue and not in the device.
As the temperature in the tissue increases, tissue coagulation occurs leading to cell
necrosis. The tissue temperature and volume of coagulated tissue are a󰀨ected by
the amount of Power delivered, the surface area of coagulation device contacting
the tissue, and the duration of energy delivery.
The generator operates in either the Power Control or Diagnostic Evaluation
mode. When operating in Power Control mode, set the desired duration and Power
level. The generator will transmit Power at the set point for the Time set by the
operator. Power may be adjusted manually throughout the treatment to tailor the
coagulation process but caution should be used when deviating from the recom-
mended, pre-set power settings.
Product Description
The nContact Model CS-3000 RF Generator Unit is an electrosurgical generator that
transmits RF current at a frequency of 480 kHz. The generator transmits up to 100
watts (W) of Power (+/- 20%), depending on the coagulation device connected. While
the RF Energy is delivered, Power, Impedance, and Time are continually measured
and updated on the generator display.
Figure 1 shows the Power versus Impedance curves at set power levels of 100 Watts
and 50 Watts. The RF Generator operates between 30 and 500 ohms. The RF
Generator produces constant power along the operational impedance range. Figure 2
shows the relationship between Voltage and Impedance. Figure 3 shows the relation-
ship between Set Power and Delivered Power at an impedance of 275 ohms.
Power & Voltage Output Diagrams
Figure 1. Power Output versus Impedance Load
Figure 2. Voltage versus Impedance Load
Figure 3. Delivered Power versus Set Power
Generator Operating Modes
1. Standby mode – The generator is idle; no energy is delivered, no measure-
ments are performed. The software version is identied.
2. Ready Power Control mode – The generator detects the type of coagulation
device connected and determines initial Power and Time set points according-
ly. These preset Power and Time levels can be adjusted by the operator.
3. RF ON Power Control mode – The generator transmits a constant Power level
until the elapsed Time equals the set point or an error is detected.
4. Diagnostic Evaluation Mode – RF energy is NOT transmitted to the coagu-
lation device during this mode. Measurements of resistivity are taken from
electrodes on a separate accessory device (not yet available) to indicate the
extent of coagulation necrosis.

CS-3000 RF Generator Unit Operator Manual
AtriCure, Inc.
IFU-0022.A2021/04
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System Components Supplied with the Generator
Components provided with the nContact Model CS-3000 RF Generator Unit include:
o 1 US Line power cable (US version only)
o 1 EU Line power cable (EU version only)
o 1 UK Line power cable (EU version only)
o 1 Footswitch (pedal)
o 2 Operator Manuals
o 2 Fuses – LittleFuse 2183-15, Time Delay (Slo -Blo), Rated at 3.15A, 250VAC
Components Not Supplied with the Generator
Accessories provided separately by AtriCure, Inc. for use with the CS-3000 RF
Generator Unit and complying with the limits for medical devices to the IEC 60601-1
standards include:
o EPI-Sense® Coagulation Devices with sensing capabilities (Single Use,
Sterile) – Packaged Kit Models that may be used with the RF Generator
are: CDK-1413. Refer to device Instructions for Use (IFU) for operation
and disposal.
o RF Coagulation Cable (Single Use, Sterile) – Model CS-2000 Refer to
CSK-2000 cable Instructions for Use (IFU) for operation and disposal.
• Note: Packaged Kit Model CSK-2000 contains the Model CS-2000
Cable
o Sensing Cable Assembly (Multiple Use, Non-Sterile) – Model CS-2030
Refer to CSK-2030 cable Instructions for Use (IFU) for operation.
• Note: Packaged Kit Model CSK-2030 contains the Model CS-2030
Cable
Accessories required for use with the Model CS-3000 RF Generator unit but not pro-
vided with CS-3000 RF Generator but with Coagulation Devices include:
o Patient Return Electrode (e.g. Indi󰀨erent, Dispersive Electrode), surface
area of 21 square inches (136cm2), equivalent to Covidien Valleylab
Polyhesive Reference Number E7506.
CS-3000 RF Generator User Interface
Figure 4. Generator Front Panel – Key Features
The front panel of the generator provides connections for the Coagulation Device
Cable CSK-2000 (9), the Indi󰀨erent, Electrode (10), a Footswitch (11), and con-
nector for CSK-2030 Sensing Cable (12). The Front Panel incorporates push-
buttons to set Power (2), Set Time (3), change the operating Mode (4), and turn
the RF energy transmission on and o󰀨 (1). The graphical display (5) shows the
Operating Mode, Power, Time, Impedance, and Percent Change in Impedance
during Power Control Mode. LEDs indicate when the generator is in Standby
Mode (6), if an Error (7) has been detected, or when RF energy is transmitted (8).
Front Control Panel
Power Set (2)
Power is displayed in Watts (W). In Power Control mode, the Power Set point is
the power level that will be transmitted to the coagulation device. The power set
point is determined by the specic coagulation device and will automatically register
once the coagulation device is connected. Refer to the Instructions For Use of the
devices for the pre-set power and time. The maximum power allowed depends
on the connected coagulation device. Power delivery may be adjusted while RF
is activated by depressing the Power up or down pushbuttons to set the power in
1-Watt increments.
NOTE: If a coagulation device is not connected or identied, then Power will be
set to 4 W and the maximum power will be limited to 50 W.
Actual Power (5)
The actual Power transmitted through the coagulation device replaces the set point
in the graphic display once RF energy is activated. In Power Control mode, the
Actual Power is adjusted to the set point but is also controlled to account for tissue
response that is detected by changes in impedance.
Impedance (5)
Impedance (resistance between the coagulation device and the indi󰀨erent,
dispersive electrode) is measured by the generator and displayed in ohms (Ω). A
bar graph shows the change in impedance between the initiation of RF energy
(baseline) and throughout tissue coagulation (test). As conductivity decreases,
impedance increases. During coagulation of tissue, when the temperature of the
tissue increases above 100ºC causing tissue desiccation, the impedance increases
markedly. This creates an insulating barrier. The generator rapidly decreases Power
if the impedance increases rapidly and terminates RF energy transmission if the
impedance increases above 500Ω.
Time Set (3)
Time is preset when a coagulation device is connected and identied by the genera-
tor. The Time set point determines the duration of energy delivery unless an error is
detected or the operator manually terminates the transmission of RF energy. Using
the up and down arrows, Time is set in 1 second increments between 0 and 150
seconds.
Elapsed Time (5)
Elapsed time of the energy delivery replaces the Time Set value on the graphic
display once RF energy is activated.
Error Indicator (7)
The Error LED Indicator illuminates when the system encounters an internal condi-
tion precluding operation of the generator. This may include a self-test failure, an
incorrect connection or setting, excess heating warning, or a fault in the system.
The generator will not deliver power when the Error LED is illuminated (see Chapter
6: Troubleshooting).
Mode Button (4)
The Mode button is used to adjust the operating mode between Standby, Power
Control, and Diagnostic Evaluation. Pressing the Mode button during the applica-
tion of RF energy will be ignored by the system.
RF ON/OFF Button (1)
The RF ON/OFF button works in parallel with the Footswitch (see Footswitch
description). During Power Control Mode, the RF ON/OFF button controls the
operation of the RF generator by initiating or terminating RF energy.
RF ON/OFF Indicator (8)
The RF ON/OFF indicator lights up when RF energy is being transmitted. RF
energy transmission includes the periodic delivery of energy to measure impedance,
even when the RF generator has not been activated. However, when RF energy
is being transmitted at the power capable of causing coagulation, the RF ON/OFF
indicator light is constantly illuminated.
Connections
Front Panel Connectors
The Footswitch, RF Coagulation Cable for the Device, Indi󰀨erent, Dispersive Elec-
trode connectors allow interfacing with accessory devices.
Footswitch (11)
Depress the footswitch to begin delivering RF energy. To terminate the energy
delivery and reset the Time during operation, depress the footswitch again.
Indi󰀨erent, Dispersive Electrode (10)
The indi󰀨erent, dispersive electrode provides a path for the electrical current
through the patient and back to the generator. It is important to properly attach the
indi󰀨erent, dispersive electrode to the patient per manufacturer’s instructions (see
“Setup and Operation”). The indi󰀨erent, dispersive electrode is for single use only.
Sensing Cable Connection (12)
The Sensing Cable Interface (Generator ‘diagnostic’ port) allows the connection of
the sensing electrodes from the EPi-Sense device to the external EP Sensing (EKG)
equipment, with the use of the CSK-2030 cable.
RF Coagulation Cable for the Device (9)
AtriCure manufactures the coagulation devices and RF coagulation cable for exclu-
sive use with the Model CS-3000 RF Generator Unit. Refer to the two Figures (5 &
6) below, for the appropriate setup.

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CSK Type Devices, CSK-2000 Cable and RF Generator Setup
Refer to the drawing below for the appropriate setup of the CSK devices with the
CSK-2000 cable and the CS-3000 generator.
Figure 5. CSK Type Devices, CSK-2000 Cable and RF Generator Setup
CDK Type Devices, CSK-2030, CSK-2000 Cable and RF Generator Setup
Refer to the drawing below for the appropriate setup of the CDK devices with the
CSK-2000 cable, CSK-2030 cable and the CS-3000 generator.
Figure 6A. CDK Type Devices, CSK-2000, CSK-2030 with over molded
yoke and RF Generator Setup
Figure 6B. CDK Type Devices, CSK-2000, CSK-2030 with enclosure
box and RF Generator Setup
D1 = Distal Electrode 1 = Shrouded Pin #1; P1 = Proximal Electrode 1 = Shrouded Pin #3;
D2 = Distal Electrode 2 = Shrouded Pin #2; P2 = Proximal Electrode 2 = Shrouded Pin #4
CAUTION: Ensure that the EP Sensing (EKG) equipment comply with IEC
60601-2-25 for protection from high frequency surgical interference.
Back Panel Connectors
Figure 7. Generator Back Panel – Key Features
Power Switch (13)
Switch that powers the generator on and o󰀨.
AC Power Connector (14)
Connector for the AC line power cable.
Grounding Stud (15)
Used as a ground equalization for safety and testing.
Data Connector (16)
USB or Serial communication connector to a host computer for data display and
archival purposes.
Alarm Volume Control (17)
Knob for modifying the volume of the generator alarm. Rotate the knob clockwise to
increase the volume.
Chapter 2 Setup and Operation
Generator Setup and Operation
Preparing the Patient – Attaching the Indi󰀨erent, Dispersive Electrode
Prepare the patient for electrosurgery following standard protocol. Ensure patient’s
entire body, including extremities, is insulated against contact with grounded metal
parts. Closely follow instructions for the coagulation device and manufacturer direc-
tions for the indi󰀨erent, dispersive electrode.
CAUTION: Failure to achieve good skin contact by the entire adhesive surface
of the indi󰀨erent, dispersive electrode could result in a patient burn or poor electrical
performance from the coagulation device. Note: Patient Return Electrode (e.g. Indif-
ferent, Dispersive Electrode), surface area of 21 square inches (136cm2), equivalent
to Covidien Valleylab Polyhesive Reference Number E7506 is recommended.
Setting up the CS-3000 RF Generator
1. Connect the supplied power cord into back mains receptacle of the CS-3000
RF Generator.
2. Plug the CS-3000 RF Generator power cord into an outlet.
3. On the back of the CS-3000, activate the mains switch and turn the RF
Generator on.
4. Turning on the generator (switch on rear of generator) causes the system
to enter Standby mode where no measurements or settings are possible.
The nContact logo and the software version number are displayed in the
message window; the Standby LED is illuminated.
5. Press the Mode button to perform a self-test and check system functionality
before transitioning to Power Control mode. Subsequent depressing of the
Mode button will toggle between Power Control and Diagnostic Evaluation
modes.
NOTE: If an Error is detected, the red Error LED will illuminate,and a Message
will display in the Graphic Display. Cycle the CS-3000 main power o󰀨 and on so
the RF Generator passes through self-test. (see Chapter 6: Troubleshooting).
CS-3000 Operation in Power Control Mode
When the RF Generator enters Power Control mode, the initial Power is set to 4 W
and Time is set to 0 until a Coagulation Device is connected via the RF coagulation
cable to the receptacle in the generator.
Connect a coagulation device to the appropriate receptacle (blue) of the cable then
connect the cable (black) to the receptacle on the RF generator so the pre-set Pow-
er and Time values are displayed. Refer to the instruction for use of the coagulation
devices for the appropriate pre-set power and time settings.

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1. The Power level is automatically pre-set by the manufacturer at the recom-
mended level for the connected coagulation device; however, the Power level
may be adjusted by the user to a di󰀨erent setting, if desired.
2. The Time set point is automatically pre-set by the manufacturer for the
connected coagulation device at the recommended treatment duration
setting, however, the Time set point may be adjusted by the user to a di󰀨erent
duration if desired.
3. Connect the indi󰀨erent, dispersive electrode to the appropriate receptacle on
the RF generator.
4. Make sure the indi󰀨erent, dispersive electrode is adequately attached to the
patient’s back or thigh.
5. Insert the footswitch connector into the receptacle on the front panel.
6. Prepare the patient for electrosurgery following standard protocol.
7. Position the coagulation device. Depress and release the footswitch once or
press the RF ON/OFF button on the front panel. The CS-3000 operates as
an “Intermittent” generator so depressing and releasing the footswitch once
will turn the generator ON. Standing on the footswitch may cause unwanted
termination of the RF Generator.
8. Once the RF ON/OFF button or the footswitch is depressed and released,
the generator enters the RF ON State and transmits RF energy to the coag-
ulation device. If the generator needs to be terminated during operation, the
RF ON/OFF button or the footswitch may be depressed and released again.
The CS-3000 is an “Intermittent” generator so depressing and releasing the
footswitch once will turn the generator OFF. Standing on the footswitch may
cause unwanted initiation of the RF Generator.
9. Proper placement of the coagulation device and appropriate generator set-
tings are essential to electrocoagulation. Monitor the Impedance measure-
ments on the front panel graphic display to assist in the coagulation process.
10. At any point in the procedure, the setting for the Power delivery may be
adjusted. Time may only be adjusted while RF energy is not transmitted.
11. The generator automatically stops delivering energy once it has Timed out
(completed the pre-set cycle) and enters Ready state. To stop the RF deliv-
ery before the cycle duration expires, depress and release the footswitch, or
the RF ON/OFF button on the front panel. When the generator is re-started,
the unit re-sets to the previous set Time and Power settings.
CAUTION: Depress and release the footswitch once to turn the RF
Generator ON or OFF. Do not stand on the footswitch because it may cause
unwanted activation or termination.
NOTE: If the coagulation device must be repositioned, depress and release
the footswitch or RF ON/OFF button to terminate energy delivery. To restart the
generator, depress and release the footswitch or the RF ON/OFF button again.
NOTE: If the impedance rises above 500Ω, the generator stops delivering RF
and transitions back to Ready state.
Chapter 3 Cleaning
NOTE: Do not spray or pour liquids directly on the unit.
NOTE: The unit and/or accessories cannot be sterilized.
WARNING: Ensure Isopropyl Alcohol (IPA) is completely dry before oper-
ating the unit.
CAUTION:Avoid caustic or abrasive cleaners
Guidelines
The following guidelines are recommended for cleaning the unit. It is the user’s
responsibility to qualify any deviations from these processing methods.
1. Disconnect the unit or cart from the outlet before cleaning.
2. If the unit and/or accessories are contaminated with blood or other body
uids, they shall be cleaned before the contamination can dry (within two
hours of contamination).
3. The outer surfaces of the unit and/or accessories shall be cleaned with
70% -90% Isopropyl alcohol (IPA) wipes for a minimum of two minutes.
Do not allow uids to enter the chassis.
4. Pay attention to all areas where uids or soil may gather, such as under/
around the handles or any tight crevices/ grooves.
5. Dry the unit and/or accessories with a dry, white lint-free cloth.
6. Conduct a nal conrmation of the cleaning process by visually inspecting
the white cloth for remaining soil.
7. If soil remains on the white cloth, repeat steps 3 through 6.
After cleaning is complete, turn the unit on to perform Power On Self-Test (POST). If
any errors are received, contact AtriCure to begin return process.
Chapter 4 Technical Specications and Safety Inspection
Device Specications
1. Class I Equipment
2. Debrillation Proof Type CF Applied Part. The recovery time for the CS-3000
RF Generator to be fully operational after exposure to debrillation voltages
is 5 seconds.
3. Generator meets IPX1 Requirements for protection against uid ingress
4. Not Suitable for Flammable Anesthetics
5. Intermittent Operation – The Duty Cycle for Transmitting RF Energy at Maxi-
mum Power (100 Watts, +/-20%) is 150 Seconds ON and 10 Seconds OFF.
6. Uses LittelFuse 2183.15, Time Delay (Slo Blo) Fuse Rated at 3.15 A, 250VAC.
CAUTION: Only replace fuses with the LittleFuse 2183.15, Time Delay (Slo
Blo) Fuse Rated at 3.15 A, 250VAC
Environmental Specications
Operating Conditions
Temperature 10°C to 40°C, 50°F to 104°F
Humidity 30 % RH to 75 % RH, non-condensing
Atmospheric pressure 700 to 1060 millibar
Storage & Shipping Conditions
Temperature -34°C to 60°C, -30°F to 140°F
Humidity 30% RH to 85% RF, non-condensing
Atmospheric pressure 500 to 1060 millibar
NOTE: Gradually return the RF Generator to operational conditions after storage
or shipping and stabilize for one hour before use.
Periodic Inspections
Periodic safety inspections of the generator and attached accessories should be
performed by persons who, based on their training, knowledge, and practical expe-
rience, are capable of adequately testing and assessing the safety and functionality
of the generator.
Visual Inspection
1. Instruction manual present.
2. Labels, cautions, or warnings placed correctly and in all required locations
3. No apparent external mechanical damage to the generator, connectors,
accessories, or wiring.
Operating Test
1. Self-test diagnostic upon start-up, includes self-calibration of measurement
circuitry.
2. Footswitch operation.
3. Front control panel; keys and displays.
WARNING: If testing reveals a defect that could harm the patient, employ-
ees, or third parties, the generator should not be used until it has been properly
repaired or serviced. The operator must immediately notify the appropriate author-
ities of the defect.

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Chapter 5 Product Specications
Operational Conditions & Front Panel Displays
Figure 8. RF Generator Front Panel Display at “Power On”
Turning POWER ON to the generator transitions the generator to “Standby” mode.
Figure 9. RF Generator Front Panel Display at “Standby Mode”
Entering STANDBY MODE activates the “Standby” LED (“Error” LED and “RF ON/
OFF” LEDs remain o󰀨). The nContact logo & “software version” are displayed.
Figure 10. RF Generator Front Panel Display Entering “Power Control
Mode”
From Standby, when the user presses the “MODE” button, the generator passes a
self-test. If the self-diagnostic tests don’t detect an Error code, the generator then
enters POWER CONTROL MODE (in this mode, the RF ON/OFF LED is blinking).
As displayed in the drawing above, the impedance measurement is Open Circuit
(OC) because the device and the indi󰀨erent electrode is not connected. The
generator Power is set to 4 W and Time is set to 0.
Figure 11. RF Generator Front Panel Display in “Power Control \
Ready State”
From POWER CONTROL MODE the generator enters a Ready State.
Note: An indi󰀨erent electrode and coagulation device are connected to the
generator and placed on the patient.
“RF ON/OFF” LED is not activated, but will be blinking.
When the user attaches a device, the generator detects device type and presets
information.
Refer to the Instructions for Use of the coagulation devices for the pre-set power
and time.
Figure 12. Sample Display in “RF ON” State with a Device Attached
POWER CONTROL \ RF ON State for Devices
In this mode, the user presses “RF ON/OFF” to activate and transmit RF energy
to the coagulation device. The “RF ON/OFF” LED is activated. Power is preset
for the coagulation devices. The cycle Time (e.g. 56 s) is displayed in lower right
corner and counts up to the set value.
Impedance is measured and the value displayed in the lower left (e.g. 105 Ω).
Impedance is graphed (in the right “Test” bar) against the baseline value mea-
sured at initiation of RF. The baseline value is also displayed above the graph
and in the left “Baseline” bar.
The percent change in impedance from baseline is displayed on the right (e.g.
↓25%) with an arrow (↑ or↓) to indicate whether the change in value was an
increase or a decrease.
During RF application, an audible tone will sound every second for a 200 millisec-
ond pulse.
Figure 13. Front Panel Display in “RF ON” with Resistivity Active
POWER CONTROL \ RF ON with Resistivity Active, Device & Indi󰀨erent,
Dispersive Electrode Attached
“RF ON/OFF” is transmitted to the device and the “RF ON/OFF” LED is activated.
Measured impedance is displayed (120) but not graphed.
Resistivity is measured and graphed (“Test”) against the “Baseline” value (300 Ω/cm).
Percent change in resistivity is displayed on the right (e.g. ↑ 20%)
Power transmitted at 50 W
Time (33 sec) counts up to set point
Figure 14. RF Generator Cycle Complete, Returns to Power Control
“Ready” State
When the RF cycle is complete upon reaching preset time, generator returns to
the POWER CONTROL MODE Ready State.
“RF ON/OFF” terminates when Time equals set point, and LED turns o󰀨.
“Time Limit” message is displayed in the upper right.
Parameters display for 3 seconds, then reset to preset values.
Final Impedance is measured (80 Ω) and displayed in lower left and is graphed
against the “baseline” value (100 Ω).
Final Percent change in impedance is displayed (↓ 20%).
Final Power transmitted shown (50W).
Time at Termination of RF energy is displayed (90 s).

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Figure 15. User Terminates Energy Cycle – Generator Returns to
“User Request” State
When user presses RF ON/OFF button to terminate RF transmission, generator
returns to the POWER CONTROL MODE User Request State and “RF ON/
OFF” LED turns o󰀨.
“User Request” message is displayed in the upper right.
Both device and indi󰀨erent, dispersive electrode remain connected.
Parameters display for 3 seconds then reset to preset values.
Final Impedance measured (90 Ω) is displayed and graphed against baseline
value (100 Ω).
Final Percent change in impedance is displayed (e.g. ↓ 10%).
Final Power transmitted is shown on the left (50 W).
Time at User Termination of RF energy is displayed (41 s).
Figure 16. Generator Enters “Diagnostic Evaluation Mode”
To enter the Diagnostic Mode from the POWER CONTROL - Ready State, user
presses the MODE button.
RF energy is inactive and the “RF ON/OFF” LED is o󰀨.
User connects an accessory device (not yet available), presses “RF ON/OFF” to
set the baseline resistivity value.
Measured resistivity (300 Ω/cm) is displayed and graphed against baseline (250 Ω/cm).
Final Percent change in resistivity is displayed (↑ 20% indicating an increase).
Warning and Fault States – Error Conditions
Figure 17. ERROR “Imp Limit” – Impedance Exceeds Threshold
This error (warning) occurs when Impedance exceeds the threshold limit, caus-
ing termination of RF energy transmission.
“Imp Limit” message displays in upper right and Error LED illuminates.
For warnings, parameters display for 3 seconds or until the warning is corrected.
Once the warning is corrected then the parameters reset to the preset values.
Final Impedance (765 Ω) is displayed and graphed against the baseline (100 Ω).
Final Percent change in impedance is displayed (↑ 665%).
Final Power transmitted shown (50 W).
Time at User Termination of RF energy (34 s) displayed.
When this warning occurs, an audible tone will sound three times for 1.5 seconds
with 450 milliseconds between tones
Figure 18. ERROR “RF E󰀨 Limit” – System Error
This error (fault) occurs when there is a conict with hardware or software, causing
termination of RF energy transmission.
All faults that are not recoverable will be displayed with the appropriate message and
will require cycling of the main power switch so the generator passes through self-test.
“RF E󰀨 Limit” message is displayed and the Error LED illuminates. (E󰀨 = E󰀩ciency).
Parameters display until the generator is Powered OFF, then Powered ON so that the
generator performs its start-up diagnostic self tests.
Final Impedance (90 Ω) displays and is graphed against baseline (100 Ω).
Final Percent change in impedance is displayed (e.g. ↓ 10%).
Final Power transmitted is shown (50 W).
Time at User Termination of RF energy (22 s) is displayed.
When this fault occurs, an audible tone will sound continuously until the generator is
turned o󰀨.
Chapter 6 Troubleshooting
The following owchart illustrates a user decision tree to assist in operation of the
generator and troubleshooting.
Figure 19. Generator Modes, States and Operational Flow
WARNING: Do not open the back panel of the RF Generator. This may
cause serious injury and damage to the unit. It will void the warranty. When
problems cannot be resolved by the directions in this troubleshooting section,
contact AtriCure, Inc. for additional service and repair information

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Table 1 provides a list of symptoms which may occur during routine operation of the
RF Generator. If you encounter a problem that is not listed here, contact AtriCure, Inc.
Table 1 – List of Troubleshooting Symptoms & Actions
Symptom Action
No displays or indicators when the RF
Generator is turned on
• Be sure the generator is plugged into a
working electrical outlet.
• Check power switch on back of generator.
• Unplug and check the fuse on the rear
panel. Fuses should only be replaced with
LittleFuse 2183.15, Time Delay (Slo Blo)
rated at 3.15A, 250VAC.
IMP LIMIT warning, indicating imped-
ance out of range
• Check connections to coagulation device
and indi󰀨erent, dispersive electrode.
• Ensure device is properly placed on tissue
site.
• Check position of indi󰀨erent, dispersive
electrode on patient’s back or thigh.
• If problem persists, replace the coagulation
device and indi󰀨erent, dispersive electrode.
Error LED indicator illuminates and one
of the following Fault messages appears
in Message window:
RF EFF LIMIT
ROM CRC FAILURE
RAM FAILURE
TIMER FAILURE
+48 VOLT SUPPLY FAIL
-12 VOLT SUPPLY FAIL
+12 VOLT SUPPLY FAIL
+5 VOLT SUPPLY FAIL
IMPEDANCE TEST FAIL
RF POWER TOO HIGH WHEN OFF
RF POWER TOO HIGH WHEN ON
RESISTIVITY FAILED
MEASURED POWER CALCULATED
POWER
FAN FAULT
GROUND FLOAT ON A/D
CAL VOLTAGE ON A/D
AMBIENT TEMP FAIL
• Power unit OFF, then Power ON again.
• Allow generator to run through normal start-
up self-diagnostics.
• If generator returns to Error state and the
problem persists, contact your AtriCure, Inc.
representative.
Error LED indicator shows a button is
stuck and one of the following Fault
messages appears:
RF ON BUTTON STUCK
MODE BUTTON STUCK
POWER/TEMP UP BUTTON STUCK
POWER/TEMP DOWN BUTTON
STUCK
TIME UP BUTTON STUCK
TIME DOWN BUTTON STUCK
• Depress and release the indicated button to
determine if the button remains stuck.
• Power unit OFF, then Power ON again.
• Allow generator to run through normal start-
up self-diagnostics.
• If generator returns to Error state and the
problem persists, contact your AtriCure, Inc.
representative.
RF power does not turn on when
footswitch is depressed
• Verify the footswitch is connected to the
front panel of the generator
• Ensure Time is not set to 0.
• Ensure IMP LIMIT error is not detected -
impedance should be within 30 – 500Ω.
• Ensure a coagulation device is connected to
the generator
• Ensure the indi󰀨erent, dispersive electrode
is attached to the patient and connected to
the generator
• Check the footswitch by unplugging its cable
from the generator, placing a thumb over
the foot pedal connector then depressing
the pedal. If the footswitch is functioning
properly, air should be expelled through the
connector as the footswitch is depressed.
RF interferes with ultrasound and other
equipment
• Ensure the cables from the electrodes do
not cross the cables from the ultrasound
probe or other equipment.
• Changing settings on the ultrasound may
alleviate image interference.
Impedance is greater than 500 Ω at the
beginning of RF power delivery
• Ensure the indi󰀨erent, dispersive electrode
is properly attached.
• Check all connections.
• Clean o󰀨 any coagulum from the coagula-
tion device.
• Ensure device is properly placed on tissue
site.
Impedance is less than 30 Ω at the
beginning of RF power delivery
• Reposition the coagulating device
Chapter 7 Customer Service / Equipment Servicing/ Warranty
AtriCure, Inc. is dedicated to providing service and support to its customers. If there
are any questions concerning the use of the nContact Coagulation system, please
contact Customer Service at:
AtriCure Incorporated
7555 Innovation Way
Mason, Ohio 45040 USA
Customer Service:
1-866-349-2342 (toll free)
1-513-755-4100 (phone)
EC REP
AtriCure Europe B.V.
De Entree 260
1101 EE Amsterdam
The Netherlands
[phone]
[email protected]
WARRANTIES
Limitation on Liability
This warranty and the rights and obligations hereunder shall be construed under and gov-
erned by the laws of the State of Ohio, U.S.A.
AtriCure, Inc. warrants this product to be free from defects in material and workmanship
under normal use and preventive maintenance for the respective warranty period shown
below. AtriCure’s obligation under this warranty is limited to the repair or replacement, at
its option, of any product, or part thereof, which has been returned to AtriCure, Inc. or its
Distributor within the applicable time period shown below and which examination disclosed,
to AtriCure’s satisfaction, to be defective. This warranty does not apply to any product, or
part thereof, that has been: (1) adversely a󰀨ected due to use with devices manufactured
or distributed by parties not authorized by AtriCure, Inc. (2) repaired or altered outside Atr-
iCure’s factory in a way so as to, in AtriCure’s judgment, a󰀨ect its stability or reliability, (3)
subjected to improper use, negligence or accident, or (4) used other than in accordance
with the design and use parameters, instructions and guidelines for the product or with
functional, operational or environmental standards for similar products generally accepted
in the industry. AtriCure has no control over the operation, inspection, maintenance
or use of its products after sale, lease or transfer, and has no control of the selection
of Customer’s patients.
AtriCure’s products are warranted for the following periods after shipment to the original
purchaser:
nContact RF Generator ................................................... One (1) Year
Footswitch ....................................................................... One (1) Year
Grounded Electrical Cords .............................................. One (1) Year
Sensing Cable ................................................................. One (1) Year
THIS WARRANTY IS IN LIEU OF AND EXCLUDES ALL OTHER WARRANTIES NOT
EXPRESSLY SET FORTH HEREIN,WHETHER EXPRESSED OR IMPLIED BY OPER-
ATION OF LAW OR OTHERWISE, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE, AND
OF ALL OTHER OBLIGATIONS OR LIABILITIES ON THE PART OF ATRICURE, INC.,
AND IS A PURCHASER’S EXCLUSIVE REMEDY. IN NO EVENT SHALL ATRICURE, INC.
BE LIABLE FOR SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES INCLUDING,
WITHOUT LIMITATION, DAMAGES RESULTING FROM LOSS OF USE, PROFITS, BUSI-
NESS OR GOODWILL.
AtriCure, Inc. neither assumes nor authorizes any other person to assume for it any other
liability in connection with the sale or use of any of AtriCure Inc. products. There are no war-
ranties that extend beyond the terms presented unless an extended warranty is purchased
before the original warranty expires. No agent, employee or representative of AtriCure
has any authority to change any of the foregoing or assume or bind AtriCure to any
additional liability or responsibility. AtriCure, Inc. reserves the right to make changes to
products built and/or sold by them at any time without incurring any obligation to make the
same or similar changes on products previously built and/or sold by them.
DISCLAIMER
Users assume responsibility for approving the acceptable condition of this product before it
is used, and for ensuring that the product is only used in the manner described in these in-
structions for use. Under no circumstances will AtriCure, Inc. be responsible for any inciden-
tal, special or consequential loss, damage, or expense, which is the result of the deliberate
misuse of this product, including any loss, damage, or expense which is related to personal
injury or damage to property.