Baylis Medical NRG Transseptal Needle Instrucciones De Uso página 2

• 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 t o 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. STORAGE AND HANDLING INSTRUCTIONS
The NRG Transseptal Needle should be stored in a cool and dry place. Keep out of sunlight.
XII. TROUBLESHOOTING
The following table is provided to assist the user in diagnosing potential problems.
PROBLEM COMMENTS
Generator In order to successfully Ensure that all connections are made:
Error puncture tissue using - needle to connector cable
Messages RF energy, the entire - connector cable to generator
system must be - generator to power outlet
connected and all - generator to grounding pad
devices must be in good
working order. 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 In order to accurately Ensure that the following connections are made:
Pressure monitor pressure, the -needle to pressure transducer
Readings entire system must be -pressure transducer to monitoring system
properly connected and
• Ensure that the transducer is zeroed.
all devices must be in
• Ensure that the transducer is leveled with the phlebostatic axis
good working order.
• 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 and kinks in the Discard immediately
breaks or needle are a potential
kinks. cause of patient injury.
XIII. 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 bein g returned to Baylis Medical has
been cleaned, decontaminated and sterilized as indicated in the user instructions before returning it for warrantied service.
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TROUBLESHOOTING
XIV. LABELING AND SYMBOLS
Manufacturer
Non-pyrogenic
Sterile using ethylene oxide
Use By
Caution
Follow Instructions for Use
Model number
– D
XV. LIMITED WARRANTY ISPOSABLES AND
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 ACT ION, 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
Accessory Products
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 »). Les
générateurs compatibles avec l'aiguille transeptale NRG comprennent le RFP-100A (marquage CE) et le RFP-100 (sans marquage CE).
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order
of a physician.
Single Use – Do not reuse
Lot Number
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
Do Not Use if Packaging is Damaged
Keep Away from Sunlight
Keep Dry
A
CCESSORIES
The shelf life of the product
90 days from the shipment date
DMR NRG-1 3.3 (IFU) V-13.01 29-May-2020