36C26119Q0653-003.doc

Brand Name Item: WatchPat200U with Central Plus Essential/significant physical, functional, or performance characteristics.

· Records routine diagnostic device to detect sleep apnea and hypoxia, including central apneas

· Calculates the SDB clinical parameters such as AHI, EDI and ODI that utilize True Sleep Time and Complete Sleep Architecture (Deep, Light and REM)

· Provides complete sleep architecture for off-site monitoring and review

· Dimensions – maximum size 4 in x 2 in x 1 in

· Monitor and record parameters to detect sleep apnea

· Must be able to view the comprehensive detailed reports of the study on a PC

· Must be able to manually revise the automatically detected events that are on the reports

· Must have an LCD display screen

· Must have a built-in-self-diagnostic procedure to test that the device is working correctly before a night study

· Must include snoring and body position sensor for each device

· Must have error messages for:

(1) Low battery

(2) File error

(3) Probe errors

(4) Snore and Body Position sensor missing error

· Must include a carrying case

· Must be able to wear device around the wrist

· Must have a 10hr minimum recording time

· Must be able to at least measure PAT, pulse rate, oximetry, actigraphy

· Must have 3 consecutive nights of reporting time capacity

· Must have a minimum of 64 MB of storage capacity

· Must use a rechargeable battery

· Operating voltage: 3.3V

· Must be AASM/CMS compliant

1) Complete generic identification – Peripheral Arterial Tone with actigraphy

2) Applicable model/make/catalog number - WatchPAT200U

3) Manufacturer name – Itamar Medical