Instructions for Use
NRG
®
Transseptal Needle
ENGLISH ................................................................................................................................................................................................................. 0
FRANÇAIS ............................................................................................................................................................................................................... 1
DEUTSCH ................................................................................................................................................................................................................ 3
NEDERLANDS ......................................................................................................................................................................................................... 5
ITALIANO ................................................................................................................................................................................................................ 6
ESPAÑOL ................................................................................................................................................................................................................ 8
PORTUGUÊS ..........................................................................................................................................................................................................10
SLOVENSKY ..........................................................................................................................................................................................................11
© Copyright Baylis Medical Company Inc., 2007-2016
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.
Patents pending and/or issued
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 Radiofrequency Puncture Generator is
contained in a separate manual that accompanies the Generator (entitled “BMC Radiofrequency Puncture Generator Instructions for Use”). Generators
compatible with the NRG Transseptal Needle include the RFP-100 or RFP-100A.
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.
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 radiofrequency 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. Always 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 handling 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
Thromboembolic episodes
Vessel perforation
Atrial Fibrillation
Myocardial Infarction
Vessel spasm
Sustained arrhythmias
Atrial Flutter
Hemorrhage
Vascular thrombosis
Perforation of the myocardium
Hematoma
Allergic reaction to contrast medium
Ventricular Tachycardia
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 Puncture 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
TM
Transseptal Guiding Sheath.
Disposable Indifferent (dispersive) Patch (DIP) electrode must meet or exceed IEC 60601-2-2 requirements for electrosurgical electrodes.
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
EU Authorized Representative:
Quality First International
20 Eversley Road, Bexhill-on-Sea, East Sussex
TN40 1HE, United Kingdom
Tel: +44-(20)-8-522-1937 Fax: +44-(20)-8-522-1937
1 of 7
DMR NRG 3.3 (IFU) V-11 23-Nov-2018
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 complications.
The NRG Transseptal Needle is supplied sterile. Use aseptic technique when opening the package and handling the product in the sterile field.
Thoroughly flush the NRG Transseptal Needle with heparinized saline solution prior to use.
A Transseptal Sheath and Dilator are usually inserted through the right femoral vein and are then advanced over a guidewire to be positioned into the superior
vena cava (SVC) under fluoroscopic guidance. The Baylis Medical TorFlex Transseptal Guiding Sheath is recommended for this purpose.
Insert the NRG Transseptal Needle through the sheath/dilator set until the tip of the needle is just within the dilator. Ensure the needle is free to twist and/or
rotate without resistance, as it is advanced to this position.
If using a pressure monitoring system, connect the NRG Transseptal Needle to it by joining its luer connector on the handle to a luer lock and rotating the
connector to ensure a secure connection.
Connect the NRG Transseptal Needle to the BMC Connector Cable. Make sure that the Connector Cable is plugged into the appropriate port on the BMC
Radiofrequency Puncture Generator. Be sure to carefully follow the Instructions for Use provided with the Generator and Cable.
Position the tip of the needle/sheath/dilator assembly so that the dilator is engaging the septum at the fossa ovalis under fluoroscopic guidance.
Deliver radiofrequency power via the BMC Radiofrequency Puncture Generator and advance the NRG Transseptal Needle through the septum into the left
atrium. Please refer to the Generator Instructions for Use before using the Generator.
NOTE: It is recommended that the user use the least amount of energy to achieve the desired puncture.
For RFP-100: A power setting of 10 Watts has been experimentally determined to be sufficient for successful puncture.
For RFP-100A: An initial RF setting between one (1) second on “PULSE” mode to two (2) seconds on “CONSTANT” mode has been shown to be sufficient
for successful puncture.
Radiofrequency power delivery can be terminated by pressing the RF ON/OFF button on the Generator if the timer has not expired.
Entry into the left atrium can be confirmed using fluoroscopy. Further confirmation can be obtained by either observing a left atrial pressure tracing, by
injecting a small amount of contrast media through the needle, or by aspiration of blood.
If septal puncture is not successful after five (5) radiofrequency power applications, it is advised that the user proceed with an alternate method for the
procedure.
Once successful puncture into the left atrium is confirmed, the NRG Transseptal Needle may be carefully advanced without any radiofrequency power.
The transseptal dilator can be advanced over the needle to enlarge the puncture.
Remove the NRG Transseptal Needle slowly.
Connections
(pg.07)
X.
CLEANING
AND
STERILIZATION
INSTRUCTIONS
The NRG Transseptal Needle is intended for single use only. Do not clean or re-sterilize the NRG Transseptal Needle.
XI.
TROUBLESHOOTING
The following table is provided to assist the user in diagnosing potential problems.
PROBLEM
COMMENTS
TROUBLESHOOTING
Generator
Error
Messages
In order to successfully
puncture tissue using
RF energy, the entire
system must be
connected and all
devices must be in good
working order.
Ensure that all connections are made:
- needle to connector cable
- connector cable to generator
- generator to power outlet
- generator to grounding pad
Visually inspect the needle or cable for damage. Immediately discard any damaged equipment. If
the problem persists discontinue use.
For error messages encountered while attempting radiofrequency puncture, refer to the operator’s
manual that accompanies the Generator.
Inaccurate
Pressure
Readings
In order to accurately
monitor pressure, the
entire system must be
properly connected and
all devices must be in
good working order.
Ensure that the following connections are made:
-needle to pressure transducer
-pressure transducer to monitoring system
Ensure that the transducer is zeroed.
Ensure that the transducer is leveled with the phlebostatic axis
Perform a ‘fast-flush test’ to determine the dynamic response.
Visually inspect the needle for any damage. If there are any breaks or kinks, discard immediately
Needle
breaks or
kinks.
Breaks and kinks in the
needle are a potential
cause of patient injury.
Discard immediately
XII.
CUSTOMER
SERVICE
AND
PRODUCT
RETURN
INFORMATION
If you have any problems with or questions about Baylis Medical Equipment contact our technical support personnel.
NOTES:
1. In order to return products you must have a return authorization number before shipping the products back to Baylis Medical Company.
2. Baylis Medical will not accept any piece of used equipment without a sterilization certificate. Ensure that any product being returned to Baylis Medical has
been cleaned, decontaminated and sterilized as indicated in the user instructions before returning it for warrantied service.
XIII.
LABELING AND SYMBOLS
Manufacturer
Caution:
Federal (U.S.A.) law restricts this device to sale by or on the order
of a physician.
EU Authorized Representative
Single Use – Do not reuse
Sterile using ethylene oxide
Lot Number
Use By
Only for EU member states:
Use of this symbol indicates that the product must be disposed of in a way
that complies with local and national regulations. For questions regarding
recycling of this device please contact your distributor
Caution
Do Not Use if Packaging is Damaged
Consult Instructions for Use
Keep Away from Sunlight
Model number
Non-pyrogenic
XIV.
LIMITED
WARRANTY
–
D
ISPOSABLES AND
A
CCESSORIES
Baylis Medical Company Inc. (BMC) warrants its Disposable and Accessory products against defects in materials and workmanship. BMC warrants that sterile
products will remain sterile for a period of time as shown on the label as long as the original package remains intact. Under this Limited Warranty, if any covered
product is proved to be defective in materials or workmanship, BMC will replace or repair, in its absolute and sole discretion, any such product, less any charges
to BMC for transportation and labor costs incidental to inspection, removal or restocking of product. The length of the warranty is: (i) for the Disposable products,
the shelf life of the product, and (ii) for the Accessory products, 90 days from shipment date. This limited warranty applies only to new original factory delivered
products that have been used for their normal and intended uses. BMC’s Limited Warranty shall not apply to BMC products which have been resterilized,
repaired, altered, or modified in any way and shall not apply to BMC products which have been improperly stored or improperly cleaned, installed, operated or
maintained contrary to BMC’s instructions.
DISCLAIMER AND LIMITATION OF LIABILITY
THE LIMITED WARRANTY ABOVE IS THE SOLE WARRANTY PROVIDED BY SELLER. SELLER DISCLAIMS ALL OTHER WARRANTIES,
WHETHER EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE.
THE REMEDY SET FORTH HEREIN SHALL BE THE EXCLUSIVE REMEDY FOR ANY WARRANTY CLAIM, AND ADDITIONAL DAMAGES,
INCLUDING CONSEQUENTIAL DAMAGES OR DAMAGES FOR BUSINESS INTERRUPTION OR LOSS OF PROFIT, REVENUE, MATERIALS,
ANTICIPATED SAVINGS, DATA, CONTRACT, GOODWILL OR THE LIKE (WHETHER DIRECT OR INDIRECT IN NATURE) OR FOR ANY OTHER FORM
OF INCIDENTAL, OR INDIRECT DAMAGES OF ANY KIND, SHALL NOT BE AVAILABLE. SELLER'S MAXIMUM CUMULATIVE LIABILITY RELATIVE TO
ALL OTHER CLAIMS AND LIABILITIES, INCLUDING OBLIGATIONS UNDER ANY INDEMNITY, WHETHER OR NOT INSURED, WILL NOT EXCEED THE
COST OF THE PRODUCT(S) GIVING RISE TO THE CLAIM OR LIABILITY. SELLER DISCLAIMS ALL LIABILITY RELATIVE TO GRATUITOUS
INFORMATION OR ASSISTANCE PROVIDED BY, BUT NOT REQUIRED OF SELLER HEREUNDER. ANY ACTION AGAINST SELLER MUST BE
BROUGHT WITHIN EIGHTEEN (18) MONTHS AFTER THE CAUSE OF ACTION ACCRUES. THESE DISCLAIMERS AND LIMITATIONS OF LIABILITY
WILL APPLY REGARDLESS OF ANY OTHER CONTRARY PROVISION HEREOF AND REGARDLESS OF THE FORM OF ACTION, WHETHER IN
CONTRACT, TORT (INCLUDING NEGLIGENCE AND STRICT LIABILITY) OR OTHERWISE, AND FURTHER WILL EXTEND TO THE BENEFIT OF
SELLER'S VENDORS, APPOINTED DISTRIBUTORS AND OTHER AUTHORIZED RESELLERS AS THIRD-PARTY BENEFICIARIES. EACH PROVISION
HEREOF WHICH PROVIDES FOR A LIMITATION OF LIABILITY, DISCLAIMER OF WARRANTY OR CONDITION OR EXCLUSION OF DAMAGES IS
SEVERABLE AND INDEPENDENT OF ANY OTHER PROVISION AND IS TO BE ENFORCED AS SUCH.
IN ANY CLAIM OR LAWSUIT FOR DAMAGES ARISING FROM ALLEGED BREACH OF WARRANTY, BREACH OF CONTRACT, NEGLIGENCE,
PRODUCT LIABILITY OR ANY OTHER LEGAL OR EQUITABLE THEORY, THE BUYER SPECIFICALLY AGREES THAT BMC SHALL NOT BE LIABLE
FOR DAMAGES OR FOR LOSS OF PROFITS, WHETHER FROM BUYER OR BUYER’S CUSTOMERS. BMC’S LIABILITY SHALL BE LIMITED TO THE
PURCHASE COST TO BUYER OF THE SPECIFIED GOODS SOLD BY BMC TO BUYER WHICH GIVE RISE TO THE CLAIM FOR LIABILITY.
No agent, employee or representative of Baylis Medical has the authority to bind the Company to any other warranty, affirmation or representation
concerning the product.
This warranty is valid only to the original purchaser of Baylis Medical products directly from a Baylis Medical authorized agent. The original purchaser
cannot transfer the warranty.
Use of any BMC product shall be deemed acceptance of the terms and conditions herein.
The warranty periods for Baylis Medical products are as follows:
Disposable Products
The shelf life of the product
Accessory Products
90 days from the shipment date
Français
Lire attentivement toutes les directives avant l’utilisation. Respecter toutes les contre-indications, avertissements et précautions indiqués dans ces directives.
Leur non-respect risque de causer des complications pour le patient.
AVERTISSEMENT : EN VERTU DE LA LOI FÉDÉRALE AMÉRICAINE, CE DISPOSITIF NE PEUT ÊTRE VENDU QUE PAR UN MÉDECIN OU SUR L’AVIS
D’UN MÉDECIN
I.
DESCRIPTION
DU
DISPOSITIF
NRG Transseptal Needle libère une énergie radiofréquence (RF) en mode monopolaire entre son électrode distale et une électrode indifférente de retour à
utilisation unique offerte sur le marché, laquelle doit être conforme aux normes IEC 60601-2-2. NRG Transseptal Needle s’insère dans une gaine transseptale/un
dispositif de dilatation; son extrémité proximale se branche au BMC Radiofrequency Puncture Generator par le BMC Connector Cable ; elle peut également
être connectée à un appareil de mesure de la pression externe au moyen d’un raccord Luer. Vous trouverez de l’information détaillée sur le BMC Radiofrequency
Puncture Generator dans le manuel distinct accompagnant le générateur (intitulé « Mode d’emploi du BMC Radiofrequency Puncture Generator »).
Générateurs compatibles avec NRG Transseptal needle comprennent la RFP-100 ou RFP-100A.
Les dimensions de NRG Transseptal Needle se trouvent sur l’étiquette du dispositif. L’extrémité distale de l’aiguille est dotée d’un orifice afin de faciliter l’injection
d’une solution de contraste et la surveillance des pressions cardiaques. Par ailleurs, l’extrémité active est spécialement conçue de façon à ne pas causer de
lésions aux tissus cardiaques lorsqu’il n’y a pas administration d’énergie RF.
II.
INDICATIONS
D’EMPLOI
NRG Transseptal Needle est utilisée pour créer une communication interauriculaire dans le cœur. Les indications secondaires comprennent la surveillance des
pressions intracardiaques, le prélèvement sanguin et la perfusion de solutions.