NPi®-300 Pupillometer
Regulatory Class: Medical Device
Introduction: The NeurOptics® NPi®-300 Pupillometer offers clinicians quantitative infrared technology to objectively and accurately measure and trend pupil size and reactivity in their critically ill patients. The NPi-300 provides a comfortable ergonomic design, incorporated barcode scanner, wireless charging, and easy-to-read touchscreen LCD and graphics.
Indications for Use: The NPi-300 Pupillometer is a handheld optical scanner which measures pupil size and pupil reactivity in patients requiring neurological pupil examinations. The results obtained from the NPi-300 scans are used for information only and are not to be used for clinical diagnostic purposes. The NPi-300 should only be operated by properly trained clinical personnel, under the direction of a qualified physician.
Contraindication: Avoid use when the orbit structure is damaged, or surrounding soft tissue is edematous or has an open lesion.
Special Precaution:
- Use of the NPi-300 Pupillometer – The NPi-300 is intended for use by trained clinical personnel, under the direction of a qualified physician.
- If a problem is recognized while operating the device, the device must be removed from use and referred to qualified personnel for servicing. Do not use the device if damage to the housing or internal optical components is apparent. Using an inoperative device may result in inaccurate readings.
- Electric shock hazard – Do not open the device or the charging station. There are no user serviceable parts.
- The battery in the NPi-300 is only replaceable by a qualified NeurOptics’ service technician. Contact NeurOptics if you suspect an inoperable battery.
- Use only the NeurOptics NPi-300 Charging Station for charging the NPi-300.
- Risk of fire or chemical burn – This device and its components may present a risk of fire or chemical burn if mistreated. Do not disassemble, expose to heat above 100°C, incinerate, or dispose of in fire.
- Store and use the NPi-300 System in ambient environments with non-condensing humidity levels only. Using the NPi-300 with condensation on optical surfaces may result in inaccurate readings.
- The SmartGuard is NOT a sterile product. It is not intended to be cleaned between measurements. If the SmartGuard appears soiled or if the clinician becomes concerned about product cleanliness, the SmartGuard should be discarded and replaced before using the NPi-300 on a patient.
Presentation/ Packaging: Npi 300 Pupillometer: Box of 1’s; Smartguard (box of 24’s)
For more information, please see full product information.
