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PPE Specification
Labeling Specification
Spec for Railway IFU
VII.
Instructions for Use
Preparation
1.
Select an appropriately sized vessel dilator. Refer to Table 1 and to the product labeling for recommended guiding catheter and guidewire compatibility.
2.
Remove the vessel dilator and components from the packaging using aseptic technique.
3.
Inspect the system contents for any signs of damage; do not use if any damage is present.
4.
Using a 5 or 10 cc syringe and an appropriately sized flushing needle (recommended 27 gauge for the 0.021" dilator and 21 gauge for the 0.035" dilator) filled with a sterile heparinized
saline or similar isotonic solution, flush both the distal and proximal segments of the dilator by inserting the needle gently into the wire port and flushing in both the distal and proximal
directions.
CAUTION: Failure to flush the device prior to use may result in air embolism.
5.
Soak the distal 25 cm of the vessel dilator in sterile heparinized saline or similar isotonic solution to activate the hydrophilic coating. If using a hydrophilic access wire, soak the wire as well
to activate the coating.
6.
Use a syringe filled with heparinized saline or similar isotonic solution to flush the access needle (Introcan Safety
Recommended Procedure
1.
Prepare the selected, compatible sized guiding catheter per appropriate IFU. Load the distal tip of the guiding catheter over the proximal end of the vessel dilator. Refer to Table 1 for
recommended product compatibility information.
2.
Advance the guiding catheter over the proximal end of the vessel dilator until the tip of the guiding catheter is approximately 5 cm proximal to the wire port of the vessel dilator.
3.
Use a surgical scalpel to make a superficial skin nick at the skin puncture site. Introduce either the Introcan Safety
accepted medical technique for vascular access.
4.
Gently insert the soft end of the mini-guidewire through the needle or IV cannula into the radial artery, manipulating cautiously to prevent entry into the side branches or sub-intimal space.
If strong resistance is met during advancement of the guidewire, discontinue movement and determine the cause of resistance before proceeding.
5.
Hold the mini-guidewire in place and withdraw the needle.
CAUTION: After withdrawal of the Introcan Safety
attempt to re-insert the needle into the patient or replace the protective guard.
6.
Load the distal tip of the vessel dilator over the mini-guidewire, with the wire port oriented upwards, and advance it into the vessel. The dilator may be advanced until the wire port is
within approximately 3 cm of the puncture site. DO NOT advance the vessel dilator wire port into the vessel. Hold the dilator near the tip to prevent slippage or buckling at the skin. It is
recommended to use gauze soaked with heparinized saline or similar isotonic solution to enhance wetting of the hydrophilic coating and ease insertion of the dilator. As the dilator is
advanced, bend it slightly to allow the proximal end of the access wire to exit from the dilator wire port (Refer to Figure 5).
7.
Withdraw the mini-guidewire through the vessel dilator wire port (Refer to Figure 6). If resistance is encountered when removing the mini-guidewire and the cause of the resistance
cannot be determined and corrected, discontinue the procedure and withdraw the vessel dilator and mini-guidewire together. If wire will be reinserted for any reason, wipe with moistened
gauze and immerse in heparinized saline solution or similar isotonic solution until further use.
While fixing the proximal end of the dilator, advance the guiding catheter through the skin and subcutaneous tissue into the vessel (Refer to Figure 7).
8.
Note: It is important to maintain the fixed position of the vessel dilator, as forward motion of the dilator may cause vascular complications.
a.
When using a 100 cm guiding catheter – advance the guiding catheter until the hub is advanced to Marker A (the more proximal marker). This indicates that the tip of the 100
cm guiding catheter is near the taper transition of the vessel dilator. Note: Do not advance the guiding catheter any farther over the vessel dilator when Marker A is visible at the
guiding catheter hub (Refer to Figures 8 and 9). Moving the guiding catheter hub beyond this marker may cause the tip of the guiding catheter to advance beyond the transition
to the dilator tip, increasing the potential for vascular complications.
b.
When using a 90 cm guiding catheter – advance the guiding catheter until the hub is advanced to Marker B (the more distal marker). This indicates that the tip of the 90 cm
guiding catheter is near the taper transition of the vessel dilator.
Note: DO NOT advance the guiding catheter any farther over the vessel dilator when Marker B is visible at the guiding catheter hub (Refer to Figures 8 and 9). Moving the
guiding catheter hub beyond this marker may cause the tip of the guiding catheter to advance beyond the transition to the dilator tip, increasing the potential for vascular
complications.
9.
Remove the vessel dilator by withdrawing it through the guiding catheter while maintaining the position of the guiding catheter (Refer to Figure 10). If the dilator will be reinserted for any
reason, wipe with moistened gauze, flush and immerse in heparinized saline solution or similar isotonic solution until use.
10. Administer appropriate medications through the hub of the guiding catheter to minimize potential complications, patient discomfort and vasospasm during catheterization.
11. A sheathless guiding catheter access in the target vessel has been achieved. If required, vessel angiography can be performed by injecting contrast. An interventional 0.035" J-wire or other
0.035" wire per operator' s preference may be inserted into the guiding catheter and advanced to enable tracking of the guiding catheter over the interventional wire to the target site.
12. If additional support is desired while advancing the guiding catheter through the vasculature, insert the 0.035" guidewire (if not already in place) and insert the 0.035" compatible dilator
over the wire into the guiding catheter up to the appropriate proximal marker as referenced in step 8 above. Under fluoroscopic guidance, advance the dilator and guiding catheter over the
guidewire to an area up to, but not beyond, the subclavian artery. Remove the dilator and wire, then reinsert the wire in the guiding catheter and proceed to the target site.
CAUTION: The dilator must be tracked over a guidewire at all times and alignment between the dilator and guiding catheter per Step 8 must be maintained; failure to
do so may result in vascular complications.
CAUTION: If extreme tortuosity or strong resistance is encountered during advancement or withdrawal of the catheter, discontinue movement and determine the
cause of resistance before proceeding. If the cause of resistance cannot be determined, withdraw the entire system.
CAUTION: Do not advance the dilator beyond the subclavian artery. Further advancement may cause vascular complications (refer to Complications section).
13. If exchange of the guiding catheter is necessary:
a.
Refer to the Warnings section. Failure to follow the instructions may lead to loss of access.
b.
Ensure that a 0.035" interventional guidewire of at least 260 cm length is in place to maintain access, and remove the guiding catheter. Manually apply gentle pressure at the
puncture site.
c.
Load the new guiding catheter over the 0.035" compatible vessel dilator to the appropriate proximal marker as referenced in step 8 above.
Load the 0.035" vessel dilator and guiding catheter over the 0.035" wire together (Refer to Figure 11).
d.
e.
Insert the dilator and guiding catheter combination into the vessel while fixing the proximal end of the 0.035" wire.
f.
As described in the steps above, the dilator may be removed once access of the new guiding catheter is achieved, or it may be used to support the guiding catheter during
advancement. If used for advancement, once the dilator and guiding catheter reach the desired position up to, but not beyond, the subclavian artery, remove the dilator and wire,
then reinsert the wire in the guiding catheter and proceed to the target site.
14. Dispose of all used devices in accordance with hospital policy for bio-hazardous materials.
Note: By using compatible dilators and guiding catheters, the guiding catheter can be upsized as needed for the procedure. Refer to Table 1 for dilator and recommended guiding catheter
compatibility.
VIII.
DISCLAIMER OF WARRANTY AND LIMITATIONS OF REMEDY
THERE IS NO EXPRESS OR IMPLIED WARRANTY, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, ON THE
CORDIS PRODUCT(S) DESCRIBED IN THIS PUBLICATION. UNDER NO CIRCUMSTANCES SHALL CORDIS BE LIABLE FOR ANY DIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES OTHER
THAN AS EXPRESSLY PROVIDED BY SPECIFIC LAW. NO PERSON HAS THE AUTHORITY TO BIND CORDIS TO ANY REPRESENTATION OR WARRANTY EXCEPT AS SPECIFICALLY SET FORTH
HEREIN.
Descriptions or specifications in Cordis printed matter, including this publication, are meant solely to generally describe the product at the time of manufacture and do not constitute any express warranties.
Cordis Corporation will not be responsible for any direct, incidental, or consequential damages resulting from reuse of the product.
®
*Introcan Safety
IV Catheter is a registered Trademark of B. Braun Medical Inc.
**Ethiodol and Lipiodol are Trademarks of Guerbet S.A.
For patent information on Cordis products please visit www.cordis.com
Français
STÉRILE. Stérilisé à l'oxyde d'éthylène. Apyrogène. Réservé à un usage unique. Ne pas restériliser.
Mise en garde : La loi fédérale des États-Unis limite la vente de ce dispositif aux médecins ou sur ordonnance médicale.
I.
Composants / description
Le système d'accès sans gaine RAILWAY
comprend un dilatateur vasculaire compatible avec un guide de 0,53 mm (0,021"), un dilatateur vasculaire compatible avec un guide de 0,88 mm (0,035"), un mini-guide de 0,53 mm (0,021"), un
cathéter IV (comprenant une canule IV et une aiguille) et une aiguille non couverte. L'aiguille non couverte n' e st pas incluse avec les références catalogue dont le mini-guide de 0,53 mm (0,021")
est hydrophile.
Remarque : La taille du dilatateur doit être compatible avec la taille du guide et du cathéter-guide. Consulter le Tableau 1 et l' é tiquetage du produit pour prendre connaissance des informations sur la compatibilité
recommandée entre le guide et le cathéter-guide.
Références
catalogue
RW5ADTH
Hydrophile
RW5ADTB
Non couvert
RW5VBTH
Hydrophile
RW5VBTB
Non couvert
RW6ADTH
Hydrophile
RW6ADTB
Non couvert
RW6VBTH
Hydrophile
RW6VBTB
Non couvert
RW7VBTH
Hydrophile
RW7VBTB
Non couvert
Concernant la compatibilité du cathéter-guide : les dilatateurs ont été optimisés pour s'adapter aux cathéters Cordis VISTA BRITE TIP
1
dimensions ne sont pas optimisées à des fins de compatibilité avec d'autres cathéters-guides. Consulter les dimensions dans le Tableau 1.
Dilatateurs vasculaires
Les dilatateurs vasculaires possèdent un revêtement lubrifiant hydrophile et facilitent la pénétration par voie percutanée d'un cathéter-guide en assurant une transition atraumatique en douceur
depuis la peau à travers le tissu sous-cutané et jusque dans le vaisseau. Consulter la Figure 1 pour plus de détails concernant les dilatateurs.
Le revêtement hydrophile couvre la partie distale du dilatateur vasculaire sur 20 cm. Le revêtement hydrophile doit être activé en immergeant l' e xtrémité distale du dilatateur vasculaire dans une solution saline avant
utilisation du dilatateur. Consulter les instructions de préparation du dispositif à la section Préparation.
Un orifice de guide situé à proximité de l' e xtrémité distale facilite le retrait du mini-guide. Consulter le Tableau 1 pour prendre connaissance des informations sur la compatibilité du guide.
Les deux dilatateurs vasculaires sont équipés de deux marqueurs proximaux, libellés A et B sur la Figure 1. Le marqueur A (marqueur le plus proximal) sert de référence positionnelle lors de l'utilisation d'un cathéter-guide
compatible de 100 cm. Le marqueur B (marqueur le plus distal) sert de référence positionnelle lors de l'utilisation d'un cathéter-guide compatible de 90 cm.
Aiguille de cathéter IV
Une aiguille d'introduction Cathéter IV* Introcan Safety
l'introduction du mini-guide dans le vaisseau cible. Consulter la Figure 2 pour plus de détails concernant le cathéter IV. Rincer l'aiguille en suivant les instructions fournies à la section Préparation. Il
®
IV Catheter* or bare needle and activation of the safety clip (where applicable), dispose of the needle. Do not
™
est un système d'accès par voie radiale sans gaine compatible avec les cathéters-guides de 5F, 6F et 7F de 90 cm et 100 cm de long. Le système
Tableau 1 : Matrice du produit et compatibilités recommandées
Dilatateur
Compatibilité de cathéter-guide
Guide
vasculaire
recommandée
5F, gris
6F, vert
7F, orange
®
est fournie afin de faciliter la pénétration initiale dans l'artère. Lorsque l'aiguille est retirée, la canule IV reste en place afin de faciliter
(et diamètre interne)
1
®
5F Cordis ADROIT
(1,47 mm [0,058"])
0,53 mm (0,021") et 0,88 mm (0,035")
®
5F Cordis VISTA BRITE TIP
(1,41 mm [0,056"])
0,53 mm (0,021") et 0,88 mm (0,035")
®
6F Cordis ADROIT
(1,82 mm [0,072"])
0,53 mm (0,021") et 0,88 mm (0,035")
®
6F Cordis VISTA BRITE TIP
(1,77 mm [0,070"])
0,53 mm (0,021") et 0,88 mm (0,035")
®
7F Cordis VISTA BRITE TIP
(1,97 mm [0,078"])
0,53 mm (0,021") et 0,88 mm (0,035")
Released: 03 Dec 2019
Release Level: 4. Production
®
IV Catheter* needle or bare needle) prior to use.
®
IV Catheter* needle or bare needle into the patient' s vessel using
Compatibilité de guide
Dimensions du diamètre externe
(2 dilatateurs)
®
®
ou Cordis ADROIT
(voir liste dans le Tableau 1) ; leurs
100322810 | Rev:5
CO: 100539666
du dilatateur
1,45 mm / 0,057"
1,41 mm / 0,056"
1,80 mm / 0,071"
1,77 mm / 0,070"
1,97 mm / 0,078"
7
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