Nonin’s EQUANOX Neonatal/Pediatric Cerebral/Somatic Oxygen Saturation Sensor Now Available in U.S.

June 13th, 2012 Editors Anesthesiology, Cardiac Surgery, Critical Care, Pediatrics

Nonin Medical is releasing in the U.S. its EQUANOX Advance Model 8004CB Series neonatal/pediatric (<40 Kg) oxygen saturation sensor for use with the EQUANOX Advance Model 7600 Oximetry System.

The company touts its patent-pending Dynamic Compensation algorithm that makes the sensor the only cerebral/somatic oxygen saturation sensor capable of automatically compensating for pediatric brain-tissue-development.

More details on the features from the announcement:

The EQUANOX Advance 8004CB and 8004CB-NA (non-adhesive) Neonatal/Pediatric Sensors, along with the Model 7600 Oximetry System, provide additional advantages including:

Cerebral and Somatic Monitoring – Up to four channels displayed on one screen for monitoring oxygen saturation in the brain and somatic sites on the body, including kidney and liver sites

Patented Dual-Light Emitters and Detectors with Four Wavelength Accuracy – The first and only device that utilizes a dual-light emitting and detecting sensor architecture, which has been shown to more effectively target the cerebral cortex, eliminating surface artifacts that interfere with measurement accuracy(1)

Absolute Accuracy – Assures accurate measure of tissue saturation at a point in time, not just relative or trending accuracy of changes

Consistency and Reliability – Rapid, reliable response to change without signal instability and interruptions from ambient electrical and light interferences

Portability and Connectivity – Lightweight, durable monitor with long battery life and pole-mounting capability for continually monitoring patients during intra-hospital transport. Data output available via Bluetooth® wireless technology or RS232 connection. Interfaces with Philips® VueLink (through Philips IntelliVue® Monitor), Philips CompuRecord Anesthesia Information System, Spectrum Medical VIPER Independent Data Management System and Sorin Perfusion Data Management System.

Press release: Nonin Medical, Inc. Announces U.S. Market Release of EQUANOX™ Advance Model 8004CB Series Sensor for Neonatal, Pediatric Patients

Product page: EQUANOX System

Upcoming conferences

october

18octallday19alldayWorld Congress on Polycystic Ovarian Syndrome and Fertility, 2018Abu Dhabi, UAE

18octallday19alldayManaging Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an InspectionMinneapolis, MN, USA

Event Details

Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time consuming, and often lead to more serious financial consequences. Over 80% of FDA Inspection target observations for lack of compliance in these areas.

By attending this seminar, you will discover:

How to overcome one of the biggest obstacles device manufacturers face
How the FDA expects you to develop and implement proper handling of complaints reportable or non-reportable, product complaint handling and documentation
How and when to file Medical Device Reports (MDR), effective and appropriate communication with the appropriate regulatory agencies in the event of a recall.
How to conduct a correction and removal actions to avoid a recall crisis, including required recordkeeping, expectation from FDA and other regulatory agencies in the event of a recall and key factors in implementing and maintaining compliance with the regulations and real life experiences of FDA.

**New course materials have been added, updated content will include:

Creating Standard Operating Systems (SOPs) for Post-Market Quality Systems and
What to expect from the changes in ORA with Inspection Structure Realignment

This Seminar will have you stop spinning your wheels with nonessential activities, and leave you with a comprehensive learning package that only Rita Hoffman, a former FDA CDRH Recall Branch Chief with experience across the device, drug and veterinary industries can provide.

Spend one and a half days in an interactive course led by Ms. Rita Hoffman, Former FDA CDRH Recall Branch Chief with over 36 years with FDA and leading Industry Expert, who will provide the participants with tools to minimize risk of regulatory enforcement actions.

Time

october 18 (Thursday) - 19 (Friday)

Organizer

Compliance Online 80068SEM

Learn More

Calendar GoogleCal

18octallday19allday18th Global Ophthalmology, Optometry and Glaucoma Conference, 2018Helsinki, Finland

18octallday19alldayBiology and Pathology of Infectious Disease Conference, 2018Helsinki, Finland

18octallday19allday14th Global Biomarkers Summit, 2018Amsterdam, Netherlands

22octallday23alldayInternational Conference on Breast Cancer, 2013Vancouver, British Columbia, Canada