ECG lead wires

RFQ Description

Dear ECG cables and lead wires manufacturer.My name is Ben Shenkar and I am business development manager for Cardicell Ltd.We are now looking for an outsourcing partner to supply us a whole range of lead wires for our flagship ECG device that is due to be launched towards August 09 and receive FDA and CE clearance on December 09.Please review the attached sketch and specifications below and let me know if you are able to provide a relevant quote-lead wires - specifications1.Background1.1GeneralCardicell is a medical device start up in the cardiac telemedicine field. We are currently in the design and development phase. 1.2Product descriptionE-Nova is an ECG monitoring device that functions as an event recorder recording ECG signals by 3 embedded electrodes. Additionally, the E-nova may utilize standard 10 lead wires in order to record 12 lead ECG.1.3. Commercial forecast for E-Nova-August 2009 - Samples available-December 2009 - CE and FDA 510(K) device approval and beginning of mass production-2010 - 10K units p.a-2011 - 25K units p.a -2012 - 100K units p.a2.Required solutionsWe are interested in companies that manufacture conventional lead wires andelectrodes snaps (for the 12 leads ECG recording).2.1 Custom designed ECG lead wire assemblyThe lead wires will be assembled in several configurations suitable for the different ECG monitoring methods offered by the E-Nova device. 2.1.1 Specifications-Patient side - connected to color coded snap electrodes -FDA & CE approved (including compliance with EC53).-Device side - bonded and connected to plug connector -dimensionsoThickness: 1-1.5 mmoLength (excel sheet will be provided upon request):Bonded section- 30-80 cmLength of lead snap to bonded section- 6.5-20cm-Configurations:o3, 5, 10 wiresI look forward to your quote Please Dont hesitate and contact me via the contact details below if any clarifications are requiredRegards, Ben ecg, lead wires, medical cable ECG lead wires,reusable ecg electrodes