Bangalore, 7th November
2007:
Opto Circuits (India) Ltd. (OCI), India’s
leading manufacturer of medical diagnostics and interventional
products, today received Section 510(K) US FDA (United States
Food & Drug Administration) approval on two of its new
generation range of Pulse Oximeters. The latest certification
enables OCI to market its M30 and M34 Models of Pulse Oximeters
in the United States which is the largest market for these
products. A Pulse oximeter is a non-invasive diagnostic
device for detecting the pulse rate and percentage of hemoglobin
(Hb) that is saturated with arterial oxygen.
Mediaid, the 100 per cent subsidiary of OCI,
will begin marketing the product within the US. The global
market size for pulse oximeters is estimated to be around
US$800mn.
The M30 and M34 Models are already being
successfully marketed in Europe and Asian countries.
About Model 30 Pulse Oximeter:
This is a handheld oximeter designed for convenience
in spot checking and is ideal for the physician's office,
hospitals & clinics, diagnostic centres and home health
care. Model 30 has bright LED display visible in most lighting
conditions and comes with bar graph displays for Pulse Amplitude
& Perfusion Quality indication. The inbuilt rechargeable
Lithium Ion Battery runs the oximeter for approx. 18 hours.
About Model 34 Pulse Oximeter:
This is a handheld oximeter ideal for
most continuous monitoring applications. The salient features
of Model 34 are Bright LED display, Bar Graph, Audio / Visual
Alarms, Memory, Rechargeable Battery, USB & Infrared
Ports and Printer option. Tags patient readings automatically
with Patient number, the time and date of the reading, can
store 136 hours of information for a single patient, making
the device useful for treadmill and other long tests, can
be used in walk around test, storing more than 7200 data
for upto 20 consecutive patients, can be used for sleep
screening where data can be stored every 5 seconds for upto
to 18 hours. Enables data to be printed or transmitted to
a computer via the Infrared Port or the USB Port. Performs
approximately 24 hours of operation on a single rechargeable
Lithium Ion battery, (sleep mode).
