Preface; Contraindications; Non-Sterile; Warning - nContact CS-3000 Manual Del Usuario

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.

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 qualified medical
personnel trained in the use of electrocoagulation surgery. Failure 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 qualified personnel only (see information contained in "Customer Service /
Equipment Servicing").
o Interference produced by the operation of high-frequency surgical equipment may
adversely influence the operation of other electronic medical equipment such as
monitors and imaging systems.
o Never increase Power beyond what is minimally required without first 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 off 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 Indifferent Electrode is a key element in the safe
and effective use of electrosurgery, particularly in the prevention of patient burns.

Precautions

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.
o Make sure the patient is not in contact to earthed metal during the operation 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 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 Electrode at the same time, especially when operating the Model CS-3000
RF Generator. Superficial skin burns could occur.
o This equipment has been tested and found to comply with the limits for medical
devices to the IEC 60601-1-2:2015. 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 off
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 different outlets
•
Consult AtriCure, Inc. representatives for help
AtriCure, Inc.
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 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

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
LBL-2123 Rev. F
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.
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