NeurOptics NPi-200 Instructions For Use Manual
Pupillometer
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Table of Contents
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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. 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.
NeurOptics® NPI®-200 Pupillometer System-Instructions for Use © 2022 NeurOptics, Inc.
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Ordering Information ........................................................................ 9
Appendix A
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Appendix B
3
3
Appendix C
4
5
Appendix D
6
7
(EMR) Flowsheet Integration .......................................................11
7
Appendix E
7
International Symbol Definition ................................................12
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NPi®-200 Pupillometer
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Summary of Contents for NeurOptics NPi-200
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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
9223 Research Drive station. There are no user serviceable parts. Irvine, CA 92618 • 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. To turn ON, touch the screen, push any button, or place in the Charging Station. -
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. 11). The NPi-200 will display the patient ID number and read “Ready to scan” (Ex. 12). Ex. 11 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. 16). Once the green circle appears, release the button, holding the NPi-200 in place for approximately three seconds until the result screen is displayed. -
Page 6: Pupil Measurements - Special Considerations
Pupillometer Resolution Threshold: Change in Pupil Size The NPi-200 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 7: Trend For Changes
Yes. Rebooting the NPi-200 Pupillometer As with any electronic device, the NPi-200 Pupillometer may occasionally require a System Reboot. To reboot the NPi-200 Pupillometer, simply press and hold the button on the device until the Pupillometer powers ON. -
Page 8: Cleaning And Maintenance
Isopropyl alcohol (IPA)-based cleaning solutions, in formula concentrations up to 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 9: Customer Service
(bleach) when cleaning equipment. If products containing sodium hypochlorite (bleach) are used to clean the LCD of the NPi-200 Pupillometer, the cleaning process should be followed by a second cleaning solution with up to 70% IPA solution to ensure that all bleach residue is completely removed from the LCD using a clean, soft, lint-free cloth. -
Page 10: Pupillary Measurement Parameters
Determination of a product defect or mislabeling will be made by NeurOptics, which determination will be final. Products will not be accepted for replacement or credit if they have been in the possession of the customer for more than 30 days. -
Page 11: Bluetooth® And Radio Frequency Identification Device (Rfid) Broadcast Range And Frequency
SmartGuard Reader © 2022 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. -
Page 12: International Symbol Definition
Symbol Reference No: 5.1.6 medical device can be identified Indicates the manufacturer’s Standard: ISO 15223-1 Batch Code batch code so that the batch or Symbol Reference No: 5.1.5 lot can be identified. NeurOptics® NPI®-200 Pupillometer System—Instructions for Use © 2022 NeurOptics, Inc. - Page 13 European Union Consult instructions for Standard: ISO 15223-1 Indicates the need for the user use or consult electronic to consult the instructions for use Symbol Reference No: 5.4.3 instructions for use NeurOptics® NPI®-200 Pupillometer System—Instructions for Use © 2022 NeurOptics, Inc.
- Page 14 Standard: IEC 60417-5140 area that include RF transmitters or that intentionally apply RF electromagnetic energy for diagnosis or treatment 9223 Research Drive Irvine, CA 92618 p: 949.250.9792 Toll Free North America: 866.99.PUPIL info@NeurOptics.com NeurOptics.com NPi2 IFU Rev M (HOMA-956RTQ)
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