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NeurOptics PLR-4000 Instructions For Use Manual

Pupillometer
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- 4000 Pupillometer
PLR
®
Instructions For Use

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Summary of Contents for NeurOptics PLR-4000

  • Page 1 - 4000 Pupillometer ® Instructions For Use...

  • Page 2: Table Of Contents

    The PLR-4000 Pupillometer is a handheld optical scanner which measures pupil size and pupil reactivity. The results obtained from the PLR-4000 scans are used for information only and are not to be used for clinical diagnostic purposes. The PLR-4000 should only be operated by properly trained clinical personnel, under the direction of a qualified physician.

  • Page 3: Warnings And Cautions

    Electromagnetic interference could disrupt the operation of the device. • The PLR-4000 is intended for use by trained clinical personnel, under the direction of a qualified physician. Federal Communications Commission Compliance This device complies with Part 15 of the Federal •...

  • Page 4: Getting Started

    Charging Station, and it will wake up automatically. • If the PLR-4000 does not turn on upon being placed in the Charging Station, the battery level may be too low for normal usage. The Charging Station indicator light should display a...

  • Page 5: Measuring Pupils

    If the PLR-4000 Pupillometer is not in the Charging Station, to conserve battery life it will: • Go into sleep mode after 4 minutes. To turn ON, touch the screen or push any button. • Power down after an additional 6 minutes.

  • Page 6: Set Measurement Protocol

    The Patient ID will now appear on the PLR-4000 touchscreen. Confirm the patient information is correct and select Accept (Ex. 16). The PLR-4000 will display the Patient ID and read Ready to Ex. 15 Scan (Ex.
  • Page 7 ID number, and which Protocol is active: For example, “Protocol1 (Pos. PLR)” = Positive Pulse Stimulus, “Protocol2 (Static)” = No Limit Stimulus, “Protocol3 (Inf)” = Extended. The screen should read “READY TO SCAN.” NeurOptics® PLR®-4000 Pupillometer System—Instructions for Use ©2023 NeurOptics, Inc.

  • Page 8: Video Replay

    Ex. 23 Ex. 24 screen before the measurement is initiated (Ex. 24). Once the green frame appears, release the button, holding the PLR-4000 in place for approximately three seconds until the results screen is displayed. Results Page for Positive Stimulus The results page for the Positive Stimulus (Ex.

  • Page 9: Browse Records

    To browse records by Patient ID, select the ID from the list or use the UP and DOWN arrows on the screen to browse additional IDs available in the list. The IDs of the most recent measurements taken on the PLR-4000 will appear at the top of the list. Ex. 29 •...

  • Page 10: Pupil Measurements - Special Considerations

    Delete Records Ex. 38 Ex. 37 To delete records off of the device memory of the PLR-4000, navigate to the Settings Menu and press Delete then select Yes to proceed to delete record (Ex. 39). Records on the device can be deleted for a specific Patient ID or All Records.

  • Page 11: Troubleshooting

    Press and hold the On/Off button on the side of the PLR-4000 for about 3 seconds. The PLR-4000 may occasionally require a System Reboot. To reboot, simply press and hold the On/Off button on the side of the PLR-4000 until it Ex.

  • Page 12: Handling, Cleaning And Maintenance

    (bleach) when cleaning equipment. If products containing sodium hypochlorite (bleach) are used to clean the LCD of the PLR-4000, the cleaning process should be followed by a second cleaning using a clean, soft, lint-free cloth and up to 70% IPA to ensure that all bleach residue is completely removed from the LCD.

  • Page 13: Ordering Information

    Determination of a product defect or mislabeling will be made by NeurOptics, which determination will be final. Products will not be accepted for credit if they have been in the possession of the customer for more than 30 days.

  • Page 14: International Symbol Definition

    Standard: ISO 15223-1 Indicates a medical device that has not been Non-sterile Symbol Reference No: 5.2.7 subjected to a sterilization process NeurOptics® PLR®-4000 Pupillometer System—Instructions for Use ©2023 NeurOptics, Inc.
  • Page 15 Indicates that the original medical device information has undergone a translation Standard: ISO 15223-1 Translation which supplements or replaces the original Symbol Reference No: 5.7.8 information NeurOptics® PLR®-4000 Pupillometer System—Instructions for Use ©2023 NeurOptics, Inc.

  • Page 16: Wireless Printing Range And Frequency

    Up to 100 cm Wireless Printing low energy operation frequency 2.4 GHz 9223 Research Drive Irvine, CA 92618 | USA p: 949.250.9792 Toll Free North America: 866.99.PUPIL info@NeurOptics.com NeurOptics.com NeurOptics® PLR®-4000 Pupillometer System—Instructions for Use ©2023 NeurOptics, Inc. PLR-4000 IFU Rev A (HOMA-BZERFJ)

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