AtriCure nContact CS-3000 Скачать руководство пользователя страница 6

CS-3000 RF Generator Unit Operator Manual

AtriCure, Inc.

IFU-0022.A

2021/04

Page 6 / 12

Symbols and Icons

Manufacturer

Catalog Number

VAC

Vacuum

RF

Radiofrequency

Keep Upright

Perfusion

Equipotentiality Con-

nection

Defibrillation Proof Type 

CF Applied Part

Indifferent, Dispersive 

Electrode

Caution

Caution: Electrical Shock 

Hazard

Footswitch Connection

W

Watts

Non-ionizing Radiation

Time

Ohms

Follow Instructions for 

Use

s

Seconds

Serial Number

Alarm Volume Control

~

Alternating Current

Neutral Electrode Isolated 

from Earth

+

Control Buttons to In-

crease Power or Time

0

AC Power Switch OFF

-

Control Buttons to De-

crease Power or Time

l

AC 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 affected 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 identified.

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.

Содержание nContact CS-3000

Страница 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...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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...

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