DPT - Elcam Medical
DPT - Elcam Medical
DPT - Elcam Medical
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<strong>DPT</strong><br />
D i s p o s a b l e P r e s s u r e T r a n s d u c e r<br />
www.elcam-medical.com
<strong>DPT</strong><br />
D i s p o s a b l e P r e s s u r e Tr a n s d u c e r<br />
<strong>Elcam</strong> <strong>Medical</strong> <strong>DPT</strong> is indicated for pressure sensing during<br />
clinically invasive procedures without interfering with the<br />
patient’s blood flow and/or blood pressure. The sensor is in fluid<br />
communication with different body fluids. By hydraulic connection<br />
the pressure is transferred to the sensing unit, which translates it to<br />
an electrical signal.<br />
For single use only.<br />
Benefits<br />
• Improved accuracy<br />
• Improved luer locks - utilizing <strong>Elcam</strong> <strong>Medical</strong>’s “ramp lock” patent<br />
for excellent connectivity<br />
• Clear and visible fluid path - easy to de-bubble and flush<br />
• Both female and male configurations<br />
Applications<br />
• Cardiac catheterization<br />
• Radiology and special procedures<br />
• Intracranial pressure monitoring<br />
• Intrauterine pressure monitoring<br />
• Compartmental (intramuscular) pressure<br />
monitoring<br />
Available configuration<br />
Male/ Male: Both ports are male luer with rotating lock-nuts.<br />
Female/ Male: A female luer at the cable entrance side & a male<br />
luer with a rotating lock-nut, on the other side.<br />
Technical specifications<br />
Sensitivity 5µV/V/mmHg ±1%<br />
Zero offset Max offset 30 mmHg<br />
Sterilization EtO sterilization compatible<br />
Shelf life 3 years from assembly date<br />
Regulatory Information<br />
• Quality System Requirements: <strong>Elcam</strong> <strong>Medical</strong><br />
manufactures in a clean room environment (Class<br />
100.000, according to former federal standard 209E, and<br />
class 8 according to current ISO 14644).<br />
• U.S Regulations: Production, warehousing, documentation<br />
and traceability meet Quality Systems Regulation, Title 21<br />
Code of Federal Regulations Part 820.<br />
• International Standards: <strong>Elcam</strong>’s Quality management<br />
System is ISO 9001 (2000) and ISO 13485 (2003) certified.<br />
• Biocompatibility Requirements: All fluid path components<br />
materials meet biological requirements according to ISO<br />
10993-1, under ‘External communicating device, Blood<br />
path - indirect, Contact duration: Prolonged’.<br />
The sensor cover and the cable, which may contact<br />
patient’s skin, passed skin irritation and cytotoxicity tests<br />
according to ISO 10993-1 standard.<br />
<strong>Elcam</strong> <strong>Medical</strong> <strong>DPT</strong> complies with the following international standards:<br />
ANSI/AAMI BP22-1994<br />
IEC 60601-1, IEC 60601-2-34<br />
The <strong>DPT</strong> is available only as an OEM product.<br />
Head Office / Manufacturer<br />
<strong>Elcam</strong> <strong>Medical</strong><br />
BarAm 13860<br />
Israel<br />
Tel: 972-4-698-8120/1/2<br />
Fax: 972-4-698-0777<br />
sales@elcam.co.il<br />
www.elcam-medical.com<br />
USA<br />
<strong>Elcam</strong> <strong>Medical</strong> INC.<br />
2 University Plaza, Suite 620<br />
07601 Hackensack, NJ<br />
Tel: +1 201 4571120<br />
Fax: +1 201 4571125<br />
info@elcam-medical.com<br />
www.elcam-medical.com<br />
Europe<br />
MedNet GmbH<br />
Borkstrasse 10<br />
48163 Muenster Germany<br />
Tel: +49 (0) 251 32266 0<br />
Fax: +49 (0) 251 32266 22<br />
info@medneteurope.com<br />
www.medneteurope.com<br />
China<br />
<strong>Elcam</strong> China Office<br />
Room 25B, Building B, No. 1118 of Changshou Rd.,<br />
Shanghai 200042, China<br />
上 海 市 长 寿 路 1118 号 悦 达 国 际 大 厦 B 幢 25B 室 ,200042<br />
Tel: +86 2152375561<br />
Fax: +86 2152375562<br />
johnliu02@126.com<br />
ISO 13485<br />
ISO 9001<br />
REV-2, 02/2009
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