NeurOptics NPi-300 Instructions For Use Manual

NeurOptics NPi-300 Instructions For Use Manual

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- 300 Pupillometer
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Instructions For Use

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Summary of Contents for NeurOptics NPi-300

  • Page 1 - 300 Pupillometer ® Instructions For Use...
  • Page 2: Table Of Contents

    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.
  • Page 3: Warnings And Cautions

    MRI environment or in the vicinity of high- frequency surgical diathermy equipment, defibrillators, • Use of the NPi-300 Pupillometer – The NPi-300 is intended for use by trained clinical personnel, under the or short-wave therapy equipment. Electromagnetic direction of a qualified physician.
  • Page 4: Getting Started

    Initial Set-Up Ex. 1 • To set up the NPi-300 for first-time use, please refer to the Power Up section below, ensuring the NPi-300 is fully charged and Date/Time are set accurately prior to use. Power Up Charging the NPi-300 Pupillometer •...
  • Page 5 If the NPi-300 Pupillometer is not in the Charging Station, to conserve battery life it will: • Go into sleep mode after 5 minutes. To turn ON, touch the screen or push any button. • Power down after 20 minutes.
  • Page 6: Associate Smartguard With Patient Id

    Select Manual ID. Using the touchscreen or keypad, enter the alpha or numeric Patient ID and select (Ex. 19). Confirm the patient information on the screen is correct and select Accept (Ex. 17). The NPi-300 will display the Patient ID and read Ready to Scan (Ex. 18). Ex. 19 2.
  • Page 7: Trend For Changes

    Repeat the scan procedure for the patient’s other eye to complete the bilateral pupil exam. When the bilateral pupil exam is complete, the NPi-300 measurement results will be displayed in green for the Right eye and in yellow for the Left eye.
  • Page 8 The NPi-300 also offers both quantitative (NPi Summary Table) and graphical (NPi/Size Trending Graph) summaries of all pupil measurements taken on any patient’s SmartGuard that is attached to the NPi-300: NPi Summary Table The NPi Summary Table (Ex. 30) provides a quantitative summary from the attached SmartGuard of the number of Right and Left Eye NPi Measurements in the following categories: NPi ≥...
  • Page 9: Pupil Measurements - Special Considerations

    Pupillometer Resolution Threshold: Change in Pupil Size The NPi-300 Pupillometer’s minimum measurement threshold for detecting a change in pupil size is 0.03 mm (30 microns). In the event a change in pupil size is < 0.03 mm, the pupillometer will not be able to measure a change in pupil size, and it will display an NPi of 0.
  • Page 10: Npi-300 Pupillometer Navigation Guide

    Ex. 38 Ex. 37 Delete Records To delete records off of the device memory of the NPi-300 (does not disable or delete records off of the attached SmartGuard), navigate to the Settings Menu and press Delete then select Yes to proceed to delete record (Ex.
  • Page 11: Troubleshooting

    Contact NeurOptics for additional information. Ex. 43 System Information Select System (Ex. 43) to view the NPi-300’s system information, displaying the Serial Number, Software Application, and Firmware versions of the device. Troubleshooting Issue Possible Reason Solution 1.
  • Page 12: Handling, Cleaning And Maintenance

    Isopropyl alcohol (IPA)-based cleaning solutions, in formula concentrations up to 70% IPA, are recommended for use in cleaning the NPi-300 and Charging Station. Do not use chemicals that can damage the NPi-300 and Charging Station surface. Some chemicals can weaken or damage plastic parts and may cause instruments to not operate as intended.
  • Page 13: Customer Service

    Customer Service For technical support, or if you have a question regarding your product or order, please contact NeurOptics Toll Free North America: Customer Service at 866.99.PUPIL (866-997-8745), international: +1-949-250-9792, or email: Info@NeurOptics.com. Ordering Information NPi-300-SYS NPi®-300 Pupillometer System SG-200 SmartGuard®...
  • Page 14: Technical Specifications

    Broadcast Function Range Frequency RFID memory card in SmartGuard to/from Up to 2 centimeters 13.56 MHz NPi-300 Pupillometer RFID memory card in SmartGuard to/from Up to 2 centimeters 13.56 MHz SmartGuard Reader NeurOptics® NPi®-300 Pupillometer System—Instructions for Use ©2021 NeurOptics, Inc.
  • Page 15: Npi-300 Pupillometer Display Limits For Electronic Medical Record (Emr) Flowsheet Integration

    Appendix D – NPi-300 Pupillometer Display Limits for Electronic Medical Record (EMR) Flowsheet Integration The following low and high display limits are included to inform hospital staff of the specific parameter display limits for consideration in the development of neurological parameter flow sheets.
  • Page 16 9223 Research Drive Irvine, CA 92618 | USA p: 949.250.9792 Toll Free North America: 866.99.PUPIL info@NeurOptics.com NeurOptics.com NeurOptics® NPi®-300 Pupillometer System—Instructions for Use ©2021 NeurOptics, Inc. NPi-300 IFU Rev F (HOMA-BCLLVU)

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