Preface; Contraindications; Non-Sterile; Warning - nContact CS-3000 Mode D'emploi

CS-3000 RF Generator Unit Operator Manual

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 designed
specifically for use with nContact coagulation devices and accessories.

Contraindications

o The use of the nContact Model CS – 3000 RF Generator Unit, Coagulation 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 /
defibrillators (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 field. 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.
Carefully read all instructions before use.

Warning

o Handle RF Generator with care. Do not drop the RF Generator as this may damage
the console.
o The Coagulation Device, RF Generator, Cables, and Accessories have been tested
as a system and comply with the limits for medical devices to IEC 60601-1-2. Use of
another manufacturer's accessories may cause damage to the equipment or injury to
the patient.
o Use of radiofrequency energy in patients with internal or external pacemakers or ICDs
and monitoring equipment may require special consideration to ensure they do not
malfunction. The attending Cardiologist and/or the pacemaker/ICD manufacturer
should be consulted before electrocoagulation surgery.
o Hazardous electrical output. Failure of the high-frequency surgical equipment could
result in unintended increase of output powercausing tissue perforation or unintended
damage.
o Electric shock hazard. Do not remove the cover or back panel of the nContact RF
Generator Unit Model CS-3000. There are no user-serviceable parts inside
thegenerator. Refer servicing to qualified personnel only (see information contained in
"Customer Service / Equipment Servicing").
o Ensure the RF Generator is in Power Control and never change power based on
default settings without first inspecting the integrity and contact of the coagulation
device to avoid tissue perforation, unintended damage, or a non-transmural lesion.
o Care should be taken to ensure that the device is not in contact with tissue that is not
intended to be coagulated (e.g. vascular and nerve tissue), to avoid inadvertent tissue
damage.
o Radiofrequency surgery uses high-frequency energy output. Do not perform
procedures if flammable or explosive media are present. Non-flammable agents
should be used for cleaning and disinfection to avoid fire or explosion

Precautions

o The equipment generates, uses, and can radiate RF energy. Interference produced by
the operation of the RF Generator may adversely influence the operation of other
electronic medical equipment such as monitors and imaging systems.
o Make sure the patient is not in contact to earthed metal during the operation of the
CS-3000 RF Generator to avoid burns. 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 indifferent, dispersive electrode and
for proper insulation between the patient and any metallic surfaces.
o Ensure complete separation of the Indifferent, Dispersive Electrode and EKG
electrodes to prevent interference with patient monitoring equipment. Needle
monitoring electrodes are not recommended. Monitoring 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 specified below. The user should assure that the CS-3000 is used in such
an environment.
Emissions Test Compliance
RF Emissions
Group 1
CISPR 11
RF Emissions
Class A
CISPR 11
Harmonic Emissions
Class A
IEC 61000-3-2
Voltage
Fluctuations/ Flicker
Complies
Emissions
IEC 61000-3-3
AtriCure, Inc.
Electromagnetic Environment - Guidance
The CS-3000 RF Generator intentionally
transmits RF energy as its intended function.
Nearby electronic equipment may be affected.
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.
2021/09

Classification 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 –
Certified 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 flammable 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
English
LBL-2123 Rev. G
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