NeurOptics NPi-200 Instructions For Use Manual

NeurOptics NPi-200 Instructions For Use Manual

Pupillometer
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NPi
-200
®
Pupillometer
Instructions for Use
Introduction
The NeurOptics® NPi®-200 Pupillometer offers clinicians quantitative infrared
technology to objectively and accurately measure and trend pupil size and
reactivity in their critically ill patients with neuronal injuries in an advanced
design. The NeurOptics NPi-200 Pupillometer is designed to upload into any
hospital electronic medical record (EMR) system using the SmartGuard® Reader by
Omnikey®. The NPi-200 provides a comfortable ergonomic design, easy-to-read
touchscreen LCD and graphics, simple patient identification (ID) number entry
and trending capabilities customized to the clinician preference.
Indications for Use
NPi-200 Pupillometer is a handheld optical scanner which measures pupil size and pupil reactivity in patients requiring
neurological pupil examinations. The results obtained from the Pupillometer scans are used for information only and are
not to be used for clinical diagnostic purposes. The NPi-200 Pupillometer should only be operated by properly trained
clinical personnel, under the direction of a qualified physician.
Contraindications
Avoid use when the orbit structure is damaged, or surrounding soft tissue is edematous or has an open lesion.

Table of Contents

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NeurOptics® NPi®-200 Pupillometer System-Instructions for Use © 2018 NeurOptics, Inc.
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Appendix A
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Appendix B
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Appendix C
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NPi®-200 Pupillometer
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Summary of Contents for NeurOptics NPi-200

  • Page 1: Table Of Contents

    The results obtained from the Pupillometer scans are used for information only and are not to be used for clinical diagnostic purposes. The NPi-200 Pupillometer should only be operated by properly trained clinical personnel, under the direction of a qualified physician.
  • Page 2: Warnings And Cautions

    18101 Von Karman Avenue, Suite 1940 station. There are no user serviceable parts. Irvine, CA 92612, USA • The battery in the NPi-200 Pupillometer is only replaceable by a p: 949.250.9792 qualified service technician. Contact NeurOptics if you suspect Toll Free North America: 866.99.PUPIL an inoperable battery.
  • Page 3: Getting Started

    When not in use, the NPi-200 will remain powered ON when seated in the NPi-200 Charging Station. If the NPi-200 is not in the Charging Station, to conserve battery life the Pupillometer will: • Go into sleep mode after 5 minutes. Touch the screen to turn ON.
  • Page 4: Scan The Patient Id

    The patient ID will now appear on the NPi-200 touchscreen. Confirm the patient information is correct and select Accept (Ex. 12). Ex. 12 The NPi-200 will display the patient ID number and read “Ready to scan” (Ex. 13). Ex. 13 Manual Entry of the Patient ID Press Manual Entry.
  • Page 5: Measure Pupils

    Press and hold either the RIGHT or LEFT button until the eye is centered on the touchscreen and the display shows a green circle around the pupil (Ex. 17). Once the green circle appears, release the button, holding the NPi-200 in place for approximately three seconds, making sure the patient maintains an open eye position.
  • Page 6: Pupil Measurement Considerations

    A difference in NPi between Right and Left pupils of ≥ 0.7 may also be considered an abnormal pupil reading Upload into EMR The NPi-200 is designed to integrate into all hospital Electronic Medical Record (EMR) systems by interfacing through the hospital information technology (IT) infrastructure using the NeurOptics SmartGuard Reader. Please contact your IT department to identify the next steps required to integrate the NPi-200 into your hospital EMR system.
  • Page 7: Power Down

    Isopropyl alcohol (IPA)-based cleaning solutions, in formula concentrations up to 70% IPA (70% IPA), are recommended for use in cleaning the NPi-200 Pupillometer and NPi-200 Charging Station. Do not use chemicals that can damage the pupillometer and charging station surface. Some chemicals can weaken or damage plastic parts and may cause instruments to not operate as intended.
  • Page 8 DO NOT use products containing sodium hypochlorite (bleach) to clean the gold connector blades located on the bottom of the NPi-200 Pupillometer handle, and the gold connector pins located in the base of the NPi-200 Charging Station. NeurOptics® NPi®-200 Pupillometer System—Instructions for Use © 2018 NeurOptics, Inc.
  • Page 9: Ordering Information

    If products containing sodium hypochlorite (bleach) are used to clean the gold connector blades located on the bottom of the NPi-200 Pupillometer and the gold connector pins located in the base of the NPi-200 Charging Station, the cleaning process should be followed by a second cleaning using 70% IPA solution to ensure that all residue is completely removed from the device in order to minimize damage to the gold connector pins and blades.
  • Page 10: Technical Specifications

    SmartGuard Reader © 2018 NeurOptics, Inc. NeurOptics, NPi, Neurological Pupil index, SmartGuard, and SmartGuard Reader are all trademarks of NeurOptics, Inc. Bluetooth is a registered trademark of Bluetooth SIG, Inc. Socket is a registered trademark of Socket Mobile, Inc., and Omnikey is a registered trademark of HID Global Corporation/ASSA ABLOY AB.

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