AtriCure nContact CS-3000 Operator'S Manual Download Page 4

CS-3000 RF Generator Unit Operator Manual

AtriCure, Inc.

IFU-0022.A

2021/04

Page 4 / 12

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 floors 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 % V

; 0,5 cycle

At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 

315° phase angles

0 % V

; 1 cycle and

70 % V

; 25/30 cycles

Single phase: at 0°

Voltage interruptions:

0 % V

; 250/300 cycle 

Voltage Dips:

0 % V

; 0,5 cycle

At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 

315° phase angles

0 % V

; 1 cycle and

70 % V

; 25/30 cycles

Single phase: at 0°

Voltage interruptions:

0 % V

t

; 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 field

 

IEC 61000-4-8

30 A/m

50 Hz or 60 Hz

30 A/m

50 Hz or 60 Hz

Power frequency magnetic fields should be at 

levels characteristic of a typical location in a typical 

commercial or hospital environment.

NOTE: V

t

 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 fields 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

Summary of Contents for nContact CS-3000

Page 1: ...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 applica...

Page 2: ... and Operation 8 Generator Setup and Operation 8 Chapter 3 Cleaning 9 Chapter 4 Technical Specifications and Safety Inspection 9 Device Specifications 9 Environmental Specifications 9 Periodic Inspections 9 Chapter 5 Product Specifications 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 ...

Page 3: ...connect to earthed ground Follow the manufacturer s directions for the placement of the indifferent dispersive electrode and for proper insulation between the patient and any metallic surfaces o Maintain safe handling techniques during electrocoagulation due to electric fields and hot metallic surfaces o Do not touch the electrode surface of the Coagulation Device and the Indifferent Dispersive El...

Page 4: ...ality 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 31...

Page 5: ...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 Transmit...

Page 6: ...e 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 s...

Page 7: ...in impedance Impedance 5 Impedance resistance between the coagulation device and the indifferent 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 ...

Page 8: ...e coagulation device and manufacturer direc tions for the indifferent dispersive electrode CAUTION Failure to achieve good skin contact by the entire adhesive surface of the indifferent 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 13...

Page 9: ...G 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 bl...

Page 10: ...nd 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 ...

Page 11: ...rected 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 b...

Page 12: ...ng 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 31 20 7005560 ear atricure com WARRANTIES Limitation on Liability This warranty and the rights and obligations hereund...

Reviews: