Y-CLICK - Elcam Medical

Y-CLICK
Y Connector for PTCA Application
Product Specifications
Can be used with automatic contrast media injectors employing a flow rate of up to 15cc per
second and setting pressure of up to 600 psi.
Compatible with any angiography device that goes through 9fr or
smaller guide catheters.
Compatible with 0.014” – 0.038”
diameter guide wires.
Male luer is designed according
to ISO 594-1 & 2.
Regulatory information
Quality system requirements:
Elcam Medical manufactures in a clean
room environment (Class 100.000, according to
federal standard 209E and Class 8, according to ISO
14644).
U.S. regulations:
Production, warehousing, documentation and traceability meet Quality Systems
Regulation, Title 21 Code of Federal Regulations Part 820.
International standards:
Elcam’s Quality Management System is ISO
13485 (2003) and ISO 9001 (2000) certified.
Biocompatibility requirements:
All “Y-Click” components meet biological
requirements according to ISO 10993-1,
under ‘blood contact, indirect, limited contact
duration’.
Regulatory Status:
510(k) Cleared (#K060759)
CE Mark approved
Elcam is a Leading OEM Provider of High
Quality Medical Devices
Elcam, the leading OEM producer of stopcocks and manifolds, is also an
innovator with a number of technologically advanced devices for interventional
cardiology, radiology, anesthesia, and critical care. Elcam provides solutions
for over 300 companies throughout the world.
Y-CLICK
Y C o n n e c t o r f o r P T C A A p p l i c a t i o n
Head Office / Manufacturer
Elcam Medical
BarAm 13860
Israel
Tel: 972-4-698-8120/1/2
Fax: 972-4-698-0777
sales@elcam.co.il
www.elcam-medical.com
USA
Elcam Medical INC.
2 University Plaza, Suite 620
07601 Hackensack, NJ
Tel: +1 201 4571120
Fax: +1 201 4571125
info@elcam-medical.com
www.elcam-medical.com
Europe
MedNet GmbH
Borkstrasse 10
48163 Muenster Germany
Tel: +49 (0) 251 32266 0
Fax: +49 (0) 251 32266 22
info@medneteurope.com
www.medneteurope.com
China
Elcam China Office
Room 25B, Building B, No. 1118 of Changshou Rd.,
Shanghai 200042, China
Tel: +86 2152375561
Fax: +86 2152375562
johnliu02@126.com
0483
ISO 13485
ISO 9001
REV-2, 01/2009
www.elcam-medical.com

Y-CLICK
Y Connector for PTCA Application
Introduction
Elcam’s new Y-Click connector provides an easy-to-use hemostatic
device for both diagnostic and interventional procedures.
Mechanism
Open position
2 clicks in
The Y-Click consists of two channels; a straight
primary channel which contains the silicone
rubber sealing gasket that opens to accept
the catheter or guide wire, and an angled
secondary channel that attaches to a manifold
for pressure monitoring, contrast injection
and flushing or to automatic contrast media
injectors. The Y-Click prevents back-bleeding
while the balloon catheter / guide wire is inserted
into the guiding catheter, and provides easy manipulation
during placement while securing catheter’s position.
Revolutionary New Design
The ergonomically designed Y-Click significantly reduces the blood loss during
interventional procedures using a three stage valve: open, semi-open and closed positions.
With the easy-to-use lever you can use Y-Click in the following positions:
• Open: For insertion of guide wire / catheter
• Semi-open: Allows for maneuverability with minimal friction while preventing back bleeding
• Closed: Seals around the catheter or wire prevents blood loss still allowing maneuverability of guide
wires and small diameter catheters
Lever holds the product at the open position
Semi-Open position
Closed position
Single click
Provides Convenience
at device insertion and
removal stage
Used when you want to manipulate the catheter with
no blood loss
• Easier Catheter maneuverability
• No blood loss
Single click to close
Press Lever - the product returns
to closed position
Unique Advantages
Self closing mechanism
During injection of contrast media, if the device is in semi-open
position, its mechanism will shut itself before leakage occurs
through the proximal side. The device, then, will move to
‘closed’ position.
Insertion of catheters
1
Push cup for 2 clicks and
leave in open position
2
Insert Catheter
One-Handed Operation
Compared to current devices on the market which
use either a Tuohy-Borst valve or simple open/close
mechanism, Elcam’s Y-Click allows the operator total
control over the manipulation of catheters and wires
without concern of bleedback.
The Y-Click utilizes a one hand operation both for opening
the device by pushing the valve or closing the device by
pressing on the lever with one’s thumb.
3
Single click lever to lock