NeurOptics VIP-300 Getting Started

Page 1

VIP®-300

Pupillometer

Instructions for Use

Introduction

The NeurOptics® VIP®-300 Pupillometer offers clinicians quantitative infrared technology to objectively and accurately measure pupil size in an advanced design. The system acquires images using self contained infrared and visible illumination sources and a digital camera. It analyzes the captured image data and displays a summary of the measurement in the LCD window. The NeurOptics VIP-300 Pupillometer uses a menu driven graphical user interface (GUI), with a color touchscreen LCD screen for data display. A keypad completes the user interface and enables manual entry of individual patient identification (ID).

Indications for Use

The VIP-300 Pupillometer is a handheld optical scanner which measures pupil size at different background illuminations. The results obtained from the Pupillometer scans are used for information only and are not to be used for clinical diagnostic purposes. It should only be operated by properly trained clinical personnel, under the direction of a qualified physician.

VIP®-300 Pupillometer

Contraindications

Avoid use when the orbit structure is damaged, or surrounding soft tissue is edematous or has an open lesion.

Table of Contents

Warnings and Cautions ..................................................... 2

Classification ...................................................................... 2

Patents, Copyright and Trademark Notice ........................ 2

Getting Started .................................................................. 3

Power Up ........................................................................... 3

Enter a new Patient ID ....................................................... 4

Set Measurement Protocol ................................................ 5

Measure Pupils .................................................................. 5

Browse Records ................................................................ 6

Power Down ...................................................................... 6

Troubleshooting ................................................................. 6

Cleaning and Maintenance ............................................... 7

Ordering Information ......................................................... 8

Customer Service .............................................................. 9

Appendix A

Technical Specifications ................................................ 9

Appendix B

Bluetooth® Broadcast Range and Frequency ..............10

Appendix C

International Symbol Definition .....................................10

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Warnings and Cautions

Warnings

Warnings and Cautions appear throughout this manual where they are relevant. The Warnings and Cautions listed here apply generally any time you operate the device.

• Use of the Pupillometer - The Pupillometer 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. 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 VIP®-300 Pupillometer is only replaceable by a qualified ser vice technician. Contact NeurOptics if you suspect an inoperable battery.

• Use only the NeurOptics VIP®-300 Charging Station for charging the Pupillometer.

• 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.

Cautions

The following cautions apply when cleaning the device or when sterilizing device accessories.

• The internal components of the Pupillometer are not compatible with sterilization techniques, such as ETO, Steam Sterilization, Heat Sterilization and Gamma.

• DO NOT submerge the device or pour cleaning liquids over or into the device.

• DO NOT use acetone to clean any surface of the Pupillometer or Charging Station.

Electromechanical Compatibility (EMC) Notice

This device generates, uses, and can radiate radio frequency energy. If not set up and used in accordance with the instructions in this manual, electromagnetic interference may result. The equipment has been tested and found to comply with the limits set forth in EN60601-1-2 for Medical Products. These limits provide reasonable protection against electromagnetic interference when operated in the intended use environments (e.g. hospitals, research laboratories).

Magnetic Resonance Imaging (MRI) Notice

This device contains components whose operation can be affected by intense electromagnetic fields. Do not operate the device in a MRI environment or in the vicinity of high-frequency surgical diathermy equipment, defibrillators, or short-wave therapy equipment. Electromagnetic interference could disrupt the operation of the device.

Bluetooth® Notice

Do not attempt to pair the VIP-300 Pupillometer with the NeurOptics® Antimicrobial Barcode Scanner by Socket® while simultaneously using another barcode scanner in close proximity.

Classification

Type of Equipment: Medical Equipment, Class 1 886.1700

Trade name: NeurOptics®VIP®-300 Pupillometer

Manufactured by:

NeurOptics, Inc.

23041 Avenida de la Carlota, Suite 100 Laguna Hills, CA 92653 | USA p: 949.250.9792 Toll Free North America: 866.99.PUPIL [email protected]

NeurOptics.com

Patents, Copyright and Trademark Notice

This work is protected under Title 17 of the U.S. Code and is the sole property of NeurOptics, Inc. (the Company). No part of this document may be copied or otherwise reproduced, or stored in any electronic information retrieval system, except as specif ically permitted under U.S. Copyright law, without the prior written consent of the Company.

Pupillometers:

Pat. No. 6116736 Pat. No. 6260968 Pat. No. 6820979 Pat. No. 7147327 Pat. No. 7670002 Pat. No. 8235526 Pat. No. 8393734 Pat. No. 7967442 Pat. No. 8534840

Federal Communications Commission Compliance

This device complies with Part 15 of the Federal Communications Commission (FCC) Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference , and (2) this device must accept any interference received, including interference which may cause undesired operation.

Pat. No. 9198570 Canadian Pat. No. 2368232 Other Patents Pending

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Getting Started

Safety Information

• Please review the following safety information prior to operating the device.

• Please read the Operating Instructions fully before attempting to use the Pupillometer. Attempting to operate the

device without fully understanding its features and functions may result in unsafe operating conditions and/or inaccurate results.

• If you have a question regarding the installation, set up,

operation, or maintenance of the device, please contact NeurOptics.

Unpacking the Pupillometer

The NeurOptics VIP®-300 Pupillometer is packaged with the following components (Ex. 1):

• VIP-300 Pupillometer

• VIP®-300 Charging Station

• Eye Cups (2)

• VIP®-300 Power Supply Adaptor

• VIP®-300 Instructions for Use

Ex. 1

Power Up

Initial Set-up

Connect the VIP-300 Pupillometer Power Supply to the VIP-300 Charging Station and plug into a power outlet. The green light at the base of the Charging Station will indicate power has been established (Ex. 2).

Place the VIP-300 into its Charging Station. After powering on, the touchscreen will display a blue battery icon indicating the VIP-300 is charging. The battery icon will turn green when fully charged (Ex. 3).

To modify the date and time, from the main screen, select the Settings icon and then select Set Date and Set Time (Ex. 4). Follow the prompts to input the proper date and time using 24 hour time configuration and select Accept.

Turning On the VIP-300

When not in use, the VIP-300 should be kept in the Charging Station. If the VIP-300 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.

• Power down after 30 minutes. Press and hold the Up arrow to turn on (red circle Ex. 5).

To get to home screen:

• Press LEFT or RIGHT Button (green circles)

Ex. 2

Ex. 3

Ex. 4

Ex. 5

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Enter a new Patient ID

Patient ID is reported in the main screen (Ex. 3) and it enables recall of patient data. To assign a new Patient ID, from the main screen select icon and then select either Barcode Scanner or Manual ID to indicate the patient ID entry method to be used (Ex. 6). In case other ID numbers are included in the VIP®-300 database stored in memory, these will be listed in the same window (e.g. ID=123ABC , Ex. 6) and they can be immediately re-entered.

Pairing the VIP-300 to the NeurOptics Antimicrobial Barcode Scanner

Connect the NeurOptics Antimicrobial Barcode Scanner and Charging Cradle to the power supply and plug into a power outlet (Ex. 7). Turn on the Barcode Scanner until an audible beep is heard and a blue light on the device flashes. Position the Barcode Scanner next to the VIP-300.

On the VIP-300, select Barcode Scanner. The VIP-300 will display successfully paired, the touchscreen will prompt when the device is ready to scan the patient ID barcode (Ex. 9).

“Connecting...”

on the touchscreen (Ex. 8). Once

Ex. 6

Ex. 7

The patient ID will now appear on the VIP-300 touchscreen. Conf irm the patient information is correct and select Accept (Ex. 10).

The VIP-300 will display the patient ID number and read

“Ready to scan”

(Ex. 11).

Manual Entry of the Patient ID

Press Manual Entry. Using the touchscreen, press the Patient ID. Select Shift to toggle from alpha to numeric as required. When the patient ID number has been manually entered, check for accuracy and press Enter (Ex. 12 & 13).

Ex. 8

Ex. 12

Ex. 9

Ex. 10

Ex. 11

Ex. 13

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Set Measurement Protocol

From the main screen, select the Settings icon and then the top left icon to toggle between Light Off and Variable modes (Ex. 14).

In the Variable mode, the eye is exposed to a sequence of three consecutive light backgrounds simulating Scotopic, Low Mesopic and High Mesopic viewing conditions and the duration of the measurement is approximately 12 seconds. During Scotopic, the background is off. Low Mesopic (approx. 0.3 lux), simulates lighting conditions such as moon illumination, driving at night outside of urban areas, or a dimly lit room. High Mesopic (approx. 3 lux) simulates conditions such as moderate night streetlights or early twilight. Patient should be dark adapted prior to taking a measurement in variable mode

The Light Off mode is approximately 2 seconds and there is no light background.

The VIP-300 should not be used without the eye cup positioned correctly (Ex. 15). It is very important that the eye cup be correctly fitted. A snug fit helps reduce the possibility of stray light entering the eye while the scans are taking place. The eye cup has a tab in the rim, which fits into the indentation in the lens shield of the Pupillometer. Position the tab in the eye cup rim into the indent in the lens shield and press into place. The tabs on either side of the lens shield should also snap into the holes on either side of the eye cup.

Ex. 14

Ex. 15

Measure Pupils

Position the VIP-300 with the eye cup at a right angle to the patient’s axis of vision, minimizing any tilting of the device (Ex. 16).

Press and hold either the OD or OS button until the eye is centered on the touchscreen and the display shows a circle around the pupil (Ex. 17). Once the circle appears (green for OD and yellow for OS), release the button, holding the VIP-300 in place for approximately 2 seconds for Light Off mode or 12 seconds for Variable mode, making sure the patient maintains an open eye position.

When the pupil measurement is complete, pupil data are analyzed and then results finally displayed. If the measurement was affected by a tracking problem (e.g. excessive blinks) then results are reported as NA.

The results page in Light Off mode (Ex. 18) shows the diameter of the pupil in bold and (in parenthesis and smaller font) the standard deviation of pupil diameter measured during the scan. It also includes the ID number of the subject, the date and time of the measurement and, finally, which eye, (OD or OS) was measured.

Ex. 16

Ex. 17

Ex. 18

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Measure Pupils (cont.)

From the results page, you may select the Video icon to view the video playback of the scan. Records can also be deleted using Delete icon or printed using a Bluetooth printer using the Print icon . Contact NeurOptics® for information about the printer.

The results page in Variable mode (Ex. 19) shows the diameter and the standard deviation of pupil diameter measured during the scan at the three different light levels.

Browse Records

To browse, retrieve and print data from previous measurements select icon from the main screen. In the browse records menu (Ex. 20) select All Records to browse all records in memory, or Specify Patient ID if only one specific patient needs to be retrieved. All the most recent patient IDs are reported in the browse records catalog so that it is possible to select directly from the catalog without having to re-enter the Patient ID using option Specify Patient ID (e.g. ID=123ABC , Ex. 20).

Rebooting the VIP-300 Pupillometer

Ex. 19

Ex. 20

As with any electronic device, the VIP-300 Pupillometer may occasionally require a System Reboot. To reboot the VIP-300 Pupillometer, simply press and hold the button on the device until the Pupillometer powers ON.

Power Down

To turn the VIP-300 off, select the from the main screen and confirm Ye s .

Troubleshooting

Issue Possible Reason Solution

1. Device will not turn on Using incorrect power supply Use only power supply provided with Pupillometer. Check label on power supply

2. Pupil measurement will not

initiate after release of the OD or OS key

Power cord is not fully plugged into the wall or the charging station

Battery completely discharged Charge the battery by positioning the Pupillometer

Too much blinking Gently hold patient’s eye open with your finger

Device not held correctly Hold device at a 90-degree angle to patient’s

Check connections

into the charger

during measurement

face. Make sure patient’s eye is centered on the screen

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Cleaning and Maintenance

ALWAYS handle the VIP-300 Pupillometer and VIP-300 Charging Station with care because sensitive metal, glass, plastic and electronic components are contained inside. The VIP-300 Pupillometer and VIP-300 Charging Station can be damaged if dropped, or if they come in contact with liquid.

The VIP-300 Pupillometer and VIP-300 Charging Station do not require any regularly scheduled maintenance. If the VIP-300 Pupillometer and VIP-300 Charging Station are not working properly, or are believed to have been damaged, immediately contact NeurOptics Customer Service at Toll Free North America: 866.99.PUPIL (866-997-8745), international: +1-949-250-9792, or email: [email protected].

Cleaning the VIP-300 Pupillometer and VIP-300 Charging Station

Isopropyl alcohol (IPA)-based cleaning solutions, in formula concentrations up to 70% IPA (70% IPA), are recommended for use in cleaning the VIP-300 Pupillometer and VIP-300 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. Use all cleaning products per manufacturer’s instructions, being careful to squeeze out excess liquid prior to wiping the pupillometer and charging station and do not use an oversaturated cloth.

Wipe all exposed surfaces. Follow the cleaner’s manufacturer instructions as to the time required to leave the solution on the device surface.

• DO NOT allow any other cleaner other than 70% IPA to contact the gold connector blades located on the bottom of the VIP-300 Pupillometer handle, and the gold connector pins located in the base of the VIP-300 Charging Station.

• DO NOT use an oversaturated cloth. Be sure to squeeze out excess liquid prior to wiping the VIP-300 Pupillometer or the VIP-300 Charging Station.

• DO NOT allow the cleaner to collect on the instrument.

• DO NOT use any hard, abrasive or pointed objects to clean any part of the VIP-300 Pupillometer or VIP-300

Charging Station.

• DO NOT immerse the VIP-300 Pupillometer or the VIP-300 Charging Station in liquid, or attempt to sterilize the product, as damage to the electronic and optical componentry could occur.

Drying and Inspection Following Cleaning

Confirm the VIP-300 Pupillometer is thoroughly dry before placing in the VIP-300 Charging Station to charge. Once thoroughly dry, place the VIP-300 Pupillometer into the VIP-300 Charging Station and plug in the VIP-300 Power Supply to the back of the charging station to power ON.

• DO NOT place the VIP-300 Pupillometer into the VIP-300 Charging Station until all components are completely dry.

• DO NOT reconnect the VIP-300 Power Supply to the VIP-300 Charging Station until all components are completely dry.

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Cleaning Considerations: Gold Connector Pins and Blades

In instances where there is concern of exposure to highly resistant bacteria or viruses (ie: Clostridium difficile, or “C. diff”), we understand that hospital protocols may require use of cleaning solutions containing sodium hypochlorite (bleach) when cleaning equipment. Please be aware solutions containing sodium hypochlorite (bleach) will corrode the gold connector blades located on the bottom of the VIP-300 Pupillometer handle (Figure 21), and the gold connector pins located in the base of the VIP-300 Charging Station (Figure 22.)

VIP-300 Pupillometer

Gold Connector Blades

Figure 21- Gold Connector Blades

• DO NOT use products containing sodium hypochlorite (bleach) to clean the gold connector blades located on the bottom of the VIP-300 Pupillometer handle, and the gold connector pins located in the base of the VIP-300 Charging Station

VIP-300 Pupillometer

Gold Connector Pins

Figure 22- Gold Connector Pins

If products containing sodium hypochlorite (bleach) are used to clean the gold connector blades located on the bottom of the VIP-300 Pupillometer and the gold connector pins located in the base of the VIP-300 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.

Cleaning Considerations: Pupillometer Liquid Crystal Display (LCD)

For best protection of the liquid crystal display (LCD), use a clean, soft, lint-free cloth and 70% IPA cleaning solution to clean the pupillometer optics.

In instances where there is concern of exposure to highly resistant bacteria or viruses (ie: Clostridium difficile, or “C. diff”), we understand that hospital protocols may require use of cleaning solutions containing sodium hypochlorite (bleach) when cleaning equipment. If products containing sodium hypochlorite (bleach) are used to clean the LCD of the VIP-300 Pupillometer, the cleaning process should be followed by a second cleaning solution with a 70% IPA solution to ensure that all bleach residue is completely removed from the LCD using a clean, soft, lint-free cloth.

Ordering Information

VIP-300 VIP-300 Pupillometer

NEUR-2059-01 Eye Cup

BCS-CC-01 NeurOptics® Antimicrobial Barcode Scanner by Socket®

NEUR-PRTS445-BT Seiko printer

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Customer Service

For technical support, or if you have a question about your order, please contact NeurOptics Customer Service.

Toll Free North America: 866.99.PUPIL (866 - 997-8745) | email: [email protected]

p: 949.250.9792

| International +1-949-250-9792, or

Returned Goods Policy

Products must be returned in unopened packages, with manufacturer’s seals intact, to be accepted for replacement or credit, unless returned due to a complaint of product defect or mislabeling. 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

Appendix A—Technical Specifications

Parameter

Measurement Characteristics

Degree of protection against electric shock

Classification of the equipment against ingress of liquids

Degree of safety of application in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide

Mode of Operation On Demand battery operation

Power Supply

Battery 3.6V 11.70 Wh 3350 mAh/hour Li: Ion Cell

Operating Environment

Description

Input= Human pupil sizing varying from 1 mm–9 mm

Mean and standard deviation of pupil diameter at different background illuminations

Accuracy: +/- 0.03 mm

Pupillometer is double insulated (Class II protection)

Ordinary equipment

The equipment is not an AP or APG category equipment

Input: 100-240 VAC +/- 8%

Output: 6V, 2.8 Amps

Temperature Range: 18° C (65 F) to 30° C (86° F)

Relative Humidity: 20% to 70% RH. Non condensing at all times

Transportation and storage environment

Dimensions

Weight 320 grams +/- 10 grams

Classification Class 1 LED product per IEC 60825

Temperature Range: 0° C (32° F) to 75° C (167° F)

Relative Humidity: 10% to 95% RH. Non-condensing at all times

With eye cup = 7.5” H, 3.5” W, 4.5” D

Without eye cup = 7.5” H, 3.5” W, 3.5” D

Page 10

Appendix B— Bluetooth® Broadcast Range and Frequency

Broadcast Function

Bluetooth Barcode Scanner to/from VIP-300 Pupillometer

© 2019 NeurOptics, Inc. NeurOptics and V IP-300 are all tra demar ks of NeurOptics , Inc. Bluetooth is a registered trademark of Bluetooth SIG, Inc. Socket is a regis tered t rademark of Socket Mo bile, I nc.

Range Frequency

Up to 100 yards depending on environment 2.45 GHz

Appendix C— International Symbol Definition

Symbol

Source/Compliance

Standard: ISO 15223-1 Symbol Reference No: 5.4.4

Standard: IEC 60417 Symbol Reference No: 5333

Title of Symbol Description of Symbol

Indicates that the instructions for use contain important cautionary information such as

Caution

Type BF Applied Part

warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.

To identify a type BF applied part complying with IEC 60601-1.

NON

STERILE

Standard: IEC 60417 Symbol Reference No: 5840

Standard: IEC 60417, Symbol Reference No: 5010

Section 1.1 of Chapter I of Annex IX to Directive 93/42/EEC. U.S. 21 CRF 801.5(c.)

Standard: ISO 15223-1 Symbol Reference No: 5.4.4

Standard: ISO 15223-1 Symbol Reference No:

5.1.7

Type B Applied Part

“ON”/ “OFF” (Power)

Intermittent Use

Non-sterile. Single patient use only

Serial Number

To identify a type B applied part complying with IEC 60601-1.

To indicate electronic power connection or disconnection to internal battery supply.

To indicate use to be Transient or intermittent with contact to intact skin with duration less than 60 minutes.

Indicates a medical device that has not been subjected to a sterilization process. Intended for single patient use.

Indicates the manufacturer’s

serial number so that a specic medical device can be identied.

REF

Standard: ISO 15223-1 Symbol Reference No: 5.1.6

Catalog Number

Indicates the manufacturer’s catalog number so that the

medical device can be identied.

Page 11

0123

LOT

Appendix C— International Symbol Definition (cont.)

Standard: ISO 15223-1 Symbol Reference No: 5.1.5

BS EN 50419 Article 11(2) of the European Community Directive 2002/96/EC (WEEE) 2006/66/EC

U.S. 40 CRF 273.2 European Community Directive Article 21 of 2006/66/EC

Standard: ISO 15223-1 Symbol Reference No: 5.1.1

Batch Code

Crossed Out Trash Can

Recycle. Battery contains Lithium.

Manufacturer

Indicates the manufacturer’s batch code so that the batch or

lot can be identied.

Identies product that is subject

to the European Union’s Waste Electrical and Electronic Equipment (WEEE) 2012/19/EU Directive for recycling of electronic equipment. The black bar underneath the bin indicates goods that were placed on the market after 13 August 2005.

Dispose of according to local procedures for products containing lithium Ion batteries and products containing lithium perchlorate.

Indicates the medical device

manufacturer, as dened in EU

Directives 90/385/EEC, 93/42/ EEC and 98/79/EC

REP

European Medical Devices Directive 93/42/EEC of 14 June 1993 (as amended by Directive 2007/47/EC) as described in Article 17 of the Directive

Standard: ISO 15223-1 Symbol Reference No: 5.1.2

Conformité Européene or European Conformity

with Identication of Notied Body

Authorized representative in the European Community

Indicates manufacturer declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation.

Indicates that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation and that the product is listed through TUV SUD as the

Notied Body

Indicates the authorized representative in the European Community.

23041 Avenida de la Carlota, Suite 1 00

Laguna Hills, CA 9265 3 | USA

Toll Free North A merica: 866.99.PUPIL

p: 949.250.9792

[email protected]

NeurOptics.com

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