Common use of Functions and Features Clause in Contracts

Functions and Features. 2.01 Non-invasively read and display result in units of mg/dl of total serum bilirubin. 2.02 [*] with a standard error of TBD. 2.03 Optical radiation output will not cause retinal burn. Device shall not exceed the optical radiation Threshold Limit Values (TLV's) as determined by the American Conference of Governmental Industrial Hygenists for light, near infrared radiation or UV radiation. 2.04 Two second total measurement time measured from when trigger is engaged until reading is displayed. 2.05 User calibration at power up. Calibration good for 5 (maybe 3) applications after which device requires another calibration and a replacement of disposable tip. 2.06 [*], including calibration. Automatic time-out between measurements 2 minutes. 2.07 Does not require any input such as age, etc. of patient before displaying a reading. 2.08 Simple, easy to follow user prompts and messages. 2.09 Battery backed up, time, date and last reading by primary battery. 1). Battery life between charges [*] tests/shift. 2). Low battery LCD icon. 3). When battery is at lowest device activation level, the device will not take a measurement, will emit the invalid tone, and will display three dashes. 4). Last reading maintained until device is turned off or recalibrated. 2.10 Field upgradeable and serviceable by trained technicians or hospital bio-meds, and trained personnel. 1). Connectors 2). Battery 3). E-prom 4). Light source 2.11 Failure rate of less than [*]. 1). FMECA 2). MTBF 3). Hazards analysis [*] Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commission. 2.12 Mean time to troubleshoot and repair in field to be less than 30 minutes, without factory intervention. 2.13 [*] 2.14 Have built in error messages, test point, diagnostic features for minimal downtime in troubleshooting device failures, using off-the-shelf test fixtures. 2.15 Can be used by end user with no special training required. 2.16 Operator and service manual.