Baylis Medical NRG Transseptal Needle Instrucciones De Uso

Instructions for Use
®
NRG
ENGLISH .......................................................................................................................................................................................................................................... 1
FRANÇAIS ........................................................................................................................................................................................................................................ 1
DEUTSCH ......................................................................................................................................................................................................................................... 2
NEDERLANDS ................................................................................................................................................................................................................................. 3
ITALIANO ......................................................................................................................................................................................................................................... 4
ESPAÑOL ......................................................................................................................................................................................................................................... 5
PORTUGUÊS ................................................................................................................................................................................................................................... 6
SLOVENSKY .................................................................................................................................................................................................................................... 6
Baylis Medical Company Inc.
5959 Trans-Canada Highway
Montreal, Quebec, Canada, H4T 1A1
Tel: (514) 488-9801/ (800) 850-9801 Fax: (514) 488-7209
www.baylismedical.com
© Copyright Baylis Medical Company Inc., 2007-2019
The Baylis Medical logo, NRG and TorFlex are
trademarks and/or registered trademarks of Baylis Medical Company Inc.
in the United States of America and/or other countries.
English
Carefully read all instructions prior to use. Observe all contraindications, warnings and precautions noted in these instructions. Failure to do so may result in
patient complications.
CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN
I. DEVICE DESCRIPTION
The NRG Transseptal Needle delivers radiofrequency (RF) power in a monopolar mode between its distal electrode and a commercially available external
Disposable Indifferent (Dispersive) Patch (DIP) Electrode, which is in compliance with IEC 60601-2-2. The NRG Transseptal Needle is loaded through a
Transseptal Sheath/Dilator set, and is connected at its proximal end to the BMC Radiofrequency Puncture Generator via the BMC Connector Cable and
optionally to an external pressure monitoring system via a luer connection. Detailed information concerning the BMC Radiofre quency Puncture Generator is
contained in a separate manual that accompanies the Generator (entitled "BMC Radiofrequency Puncture Generator Instructions f or Use"). Generators
compatible with the NRG Transseptal Needle include the RFP-100A (CE marked) and the RFP-100 (not CE marked).
The dimensions for the NRG Transseptal Needle can be found on the device label. The distal end of the needle contains a hole to facilitate injection of contrast
solution and the monitoring of cardiac pressures. As well, the active tip is specially shaped to be atraumatic to the cardiac tissue unless RF energy is applied.
II. INDICATIONS FOR USE
The NRG Transseptal Needle is used to create an atrial septal defect in the heart. Secondary indications include monitoring intracardiac pressures, sampling
blood, and infusing solutions.
III. CONTRAINDICATIONS
The NRG Transseptal Needle is not recommended for use with any conditions that do not require cutting or coagulation of soft tissue.
IV. WARNINGS
• Only physicians with a thorough understanding of angiography and percutaneous interventional procedures should use this device.
Transseptal Needle
Patents pending and/or issued
• Do not alter this device in any way.
• The NRG Transseptal Needle is supplied STERILE using an ethylene oxide process. Do not use if the package is damaged.
• Laboratory staff and patients can undergo significant x-ray exposure during radiofrequency puncture procedures due to the continuous usage of fluoroscopic
imaging. This exposure can result in acute radiation injury as well as increased risk for somatic and genetic effects. Therefore, adequate measures must be
taken to minimize this exposure.
• The NRG Transseptal Needle is intended for single patient use only. Do not attempt to sterilize and reuse the needle. Reuse can cause the patient injury
and/or the communication of infectious disease(s) from one patient to another. Failure to do so may result in patient complications.
• The NRG Transseptal Needle must be used with the BMC Connector Cable. Attempts to use it with other connector cables can result in electrocution of the
patient and/or operator.
• For RFP-100: Do not attempt to puncture with an initial power setting of greater than 10 Watts. The initial attempt should be made with a setting of 10 Watts.
In subsequent punctures, the power setting can be increased, if necessary.
• The pressure transducer system used with the NRG Transseptal Needle must comply with the electrical safety requirements of IEC 60601. Failure to use
compliant pressure transducers may result in patient or operator injury.
V. PRECAUTIONS
• Do not attempt to use the NRG Transseptal Needle or ancillary equipment before thoroughly reading the accompanying Instructions for Use.
• Radiofrequency puncture procedures should be performed only by physicians thoroughly trained in the techniques of radiofr equency powered puncture in a
fully equipped catheterization laboratory.
• The sterile packaging should be visually inspected prior to use to detect any compromise. Ensure that the packaging has not been damaged. Do not use
the equipment if the packaging has been compromised.
• Visually inspect the needle prior to use. Do not use the needle if there is any damage.
• Do not use the NRG Transseptal Needle after the "Use By" date indicated on the label.
• The NRG Transseptal Needle is intended for use with only those devices listed in section VII "Equipment Required"
• Read and follow the manufacturer's instructions for use of the Disposable Indifferent (Dispersive) Patch (DIP) electrode. Al ways use DIP electrodes that
meet or exceed IEC 60601-2-2 requirements.
• Placement of the dispersive electrode on the thigh or hip could be associated with higher impedance.
• In order to prevent the risk of ignition make sure that flammable material is not present in the room during RF power application.
• Take precautions to limit the effects that the electromagnetic interference (EMI) produced by the Generator may have on the performance of other equipment.
Check the compatibility and safety of combinations of other physiological monitoring and electrical apparatus to be used on the patient in addition to the
Generator.
• Adequate filtering must be used to allow continuous monitoring of the surface electrocardiogram (ECG) during radiofrequency power applications.
• Careful needle manipulation must be performed to avoid cardiac damage, or tamponade. Needle advancement should be done under fluoroscopic guidance.
If resistance is encountered, DO NOT use excessive force to advance or withdraw the needle.
• Do not attempt to puncture until firm position of the active tip has been achieved against the atrial septum.
• It is not recommended to exceed five (5) radiofrequency power applications per NRG Transseptal Needle.
• Do not bend the NRG Transseptal Needle. Excessive bending or kinking of the needle shaft may damage the integrity of the needle and may cause patient
injury. Care must be taken when handling the needle.
• The Generator is capable of delivering significant electrical power. Patient or operator injury can result from improper han dling of the needle and DIP
electrode, particularly when operating the device.
• During power delivery, the patient should not be allowed to come in contact with ground metal surfaces.
• Apparent low power output or failure of the equipment to function properly at normal settings may indicate faulty application of the DIP electrode, failure to
an electrical lead, or poor tissue contact at the active tip. Check for obvious equipment defects or misapplication. Attempt to better position the tip of the
needle against the atrial septum. Only increase the power if low power output persists.
• Baylis Medical Company relies on the physician to determine, assess and communicate to each individual patient all foreseeable risks of the Baylis Medical
Radiofrequency Puncture System.
VI. ADVERSE EVENTS
Adverse events that may occur while using the Baylis Medical Radiofrequency Puncture System include:
Tamponade Sepsis/Infection
Vessel perforation Atrial Fibrillation
Vessel spasm Sustained arrhythmias
Hemorrhage Vascular thrombosis
Hematoma Allergic reaction to contrast medium
Pain and Tenderness Arteriovenous fistula
VII. EQUIPMENT REQUIRED
Intracardiac puncture procedures should be performed in a specialized clinical setting equipped with a fluoroscopy unit, radiographic table, physiologic recorder,
emergency equipment and instrumentation for gaining vascular access. Ancillary materials required to perform cardiac Punctur e include:
• BMC Radiofrequency Puncture Generator
• Baylis Connector Cable (RFP-102 or RFP-103 (model dependent for NRG Transseptal needle) for use with RFP-100 Generator, or RFX-BAY-TS for use
with RFP-100A Generator).
• Transseptal Sheath/Dilator kit, such as the Baylis Medical Company TorFlex
• Disposable Indifferent (dispersive) Patch (DIP) electrode must meet or exceed IEC 60601-2-2 requirements for electrosurgical electrodes.
VIII. INSPECTION PRIOR TO USE
Prior to use of the Baylis Medical Radiofrequency Puncture System, the individual components including the BMC Radiofrequency Puncture Generator, NRG
Transseptal Needle, and the BMC Connector Cable should be carefully examined for damage or defects, as should all equipment used in the procedure. Do
not use defective equipment.
IX. DIRECTIONS FOR USE
• All instructions for equipment required should be carefully read, understood, and followed. Failure to do so may result in c omplications.
• The NRG Transseptal Needle is supplied sterile. Use aseptic technique when opening the package and handling the product in the sterile field.
Thromboembolic episodes
Myocardial Infarction
Atrial Flutter
Perforation of the myocardium
Ventricular Tachycardia
TM Transseptal Guiding Sheath.