Baylis Medical DuoMode RFX-BAY-DUO-100A Instrucciones De Uso página 2

Switching the DuoMode Cable
6. To connect the puncture device to the Diagnostic Equipment, press the rocker
switch down towards the Mapping symbol.
7. To connect the puncture device to the RF Puncture Generator, press the rocker
switch down towards the Generator symbol.
Do not activate RF delivery on the generator while the switch is set to the
Mapping setting.
Do not change the rocker switch position while RF is being delivered.
Disconnecting the DuoMode Cable
8. To disconnect the puncture device from the RFP Connector Cable, follow the
RFP Connector Cable Instructions for Use.
9. To disconnect the RFP Connector Cable from the DuoMode cable, follow the
RFP Connector Cable Instructions for Use.
10. To disconnect the Generator Connector from the generator, while firmly holding
the Generator Connector housing, gently pull the Generator Connector straight
out of the isolated patient connector socket on the Generator.
11. To disconnect the Diagnostic Equipment, grasp the Diagnostic Equipment
Connector firmly and gently pull it straight out of the socket.
XI. CLEANING AND STERILIZATION INSTRUCTIONS
The DuoMode cable is a non-body contact device and therefore is NOT sterile and
CANNOT be sterilized. If cleaning is necessary, the surface of the DuoMode cable
can be cleaned with a damp low lint cloth with non-abrasive detergent dissolved in
water. Dry the surface after wiping down. Do not spray or pour liquids directly on the
DuoMode Cable.
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 per user instructions before returning
it for warrantied service.
XIII. TROUBLESHOOTING
The following table is provided to assist the user in diagnosing potential problems.
PROBLEM COMMENTS
Generator In order to successfully
Alert
puncture tissue using
Messages
radiofrequency energy,
the entire system must
be connected and all
devices must be in
good working order.
DuoMode
The connectors are
Cable does designed to connect in
not fit into the a specific way for safety
Isolated reasons. If the
connector "keys" are
Patient
Connector out of line, the
connectors won't fit
on the front
panel of the together
generator
XIV. LABELING AND SYMBOLS
Manufacturer
Consult Instructions for Use
Model number
Do Not Use if Packaging is
Damaged
EU Authorized Representative
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order
of a physician.
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
LIMITED WARRANTY – Disposables and Accessories
XV.
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
Page 2 of 13
TROUBLESHOOTING
Ensure that all connections are made:
- puncture device to connector cable
- connector cable to DuoMode cable
- DuoMode cable to generator
- generator to power outlet
- generator to grounding pad
Visually inspect the catheter/wire or cable for
damage. Immediately discard any damaged
equipment. If the problem persists discontinue
use.
For error/alert messages encountered while
attempting puncture, refer to the operator's
manual that accompanies the Generator. If
errors persist, attach a new connector cable. If
this solves the problem, discard the damaged
connector cable.
Check that the connector keys are lined up in
the proper orientation.
Ensure that the connectors are clean and
unobstructed.
Caution
Lot Number
Keep Away From Sunlight
Keep Dry
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
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
Lisez attentivement le mode d'emploi avant d'utiliser le produit. Respectez toutes les
contre-indications, mises en garde et précautions qui y sont indiquées, sans quoi vous
risqueriez de causer du tort au patient.
Avertissement : La loi fédérale (États-Unis) limite la vente de ces dispositifs à un
médecin ou sur prescription médicale.
I. DESCRIPTION DU DISPOSITIF
Le câble DuoMode réutilisable est un câble de rallonge pour les dispositifs de
ponctions par radiofréquence (RF) approuvés par Baylis Médicale, le Baylis Medical
Company Radiofrequency Puncture Generator (RFP-100A) et l'équipement
diagnostique.
Le manuel accompagnant le générateur (mode d'emploi du générateur RFP-100A)
donne de plus amples renseignements sur ce générateur. De plus, les manuels
accompagnant les dispositifs de ponctions RF contiennent des renseignements
détaillés sur ces dispositifs.
Le câble DuoMode comporte un connecteur de quatre broches sur un câble qui
s'enclenche dans le générateur RFP ainsi qu'un connecteur ou port de dispositif de
ponctions acceptant d'autres câbles connecteurs RFP de Baylis permettant la
connexion au dispositif de ponctions. Le câble de connexion DuoMode est aussi muni
d'un connecteur pour équipement diagnostique qui est une broche protégée de 2 mm.
II. INDICATIONS
Le câble DuoMode est conçu pour servir de câble de rallonge pour les dispositifs de
ponctions par radiofréquence de Baylis Médicale, le Baylis Medical Company
Radiofrequency Puncture Generator et l'équipement diagnostique.
III. CONTRE-INDICATIONS
Il n'est pas recommandé d'utiliser le câble DuoMode pour un usage avec d'autres
générateurs RF.
IV. MISES EN GARDE

Le câble DuoMode est un dispositif réutilisable. Un nettoyage inapproprié du
dispositif pourrait causer des lésions aux patients ou transmettre des maladies
infectieuses d'un patient à un autre.

Le câble DuoMode doit être utilisé exclusivement avec des générateurs de
ponctions par RF et des dispositifs de ponctions RF de Baylis. Tenter de l'utiliser
avec d'autres générateurs et dispositifs RF pourrait causer des blessures
électriques graves au patient ou à l'opérateur.

Le personnel de laboratoire et les patients peuvent être fortement exposés à
des rayons X pendant les manipulations de ponction par radiofréquence en
raison de l'utilisation continue de la radioscopie. Cette exposition peut entraîner
un mal des rayons aigu et un risque élevé d'effets somatiques et génétiques.
C'est pourquoi il faut prendre des mesures adéquates pour réduire l'exposition
aux rayons au minimum.
V. PRÉCAUTIONS

Ne tentez pas d'utiliser le câble DuoMode ni de l'équipement auxiliaire avant
d'avoir lu attentivement le mode d'emploi connexe.
DMR RFX-BAY-DUO 3.3 (RFX-BAY-DUO-100A) V-2 07-Mar-2018
NEGLIGENCE AND STRICT LIABILITY)
The shelf life of the product
90 days from the shipment date
OR