NeurOptics VIP-300 User manual

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.

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

VIP®-300

Pupillometer

Instructions for Use

VIP®-300 Pupillometer

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 service 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

info@NeurOptics.com

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 specifically 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

Pat. No. 9198570

Canadian Pat. No. 2368232

Other Patents Pending

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.

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

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. 1

Ex. 2

Ex. 3

Ex. 4

Ex. 5

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

“Connecting...”

on the touchscreen (Ex. 8). Once

successfully paired, the touchscreen will prompt when the

device is ready to scan the patient ID barcode (Ex. 9).

The patient ID will now appear on the VIP-300 touchscreen. Confirm 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. 6

Ex. 12

Ex. 11

Ex. 8

Ex. 7

Ex. 9

Ex. 10

Ex. 13

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.

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. 14

Ex. 18

Ex. 17

Ex. 16

Ex. 15

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

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 Yes.

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

Power cord is not fully plugged into

the wall or the charging station

Check connections

Battery completely discharged Charge the battery by positioning the Pupillometer

into the charger

2. Pupil measurement will not

initiate after release of the

OD or OS key

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

during measurement

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

face. Make sure patient’s eye is centered on

the screen

Ex. 19

Ex. 20

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: Support@NeurOptics.com.

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.

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.)

• 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

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

Figure 21- Gold Connector Blades Figure 22- Gold Connector Pins

Gold

Connector

Blades

Gold

Connector

Pins

VIP-300 Pupillometer VIP-300 Pupillometer

Appendix A—Technical Specifications

Parameter Description

Measurement Characteristics

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

Degree of protection

against electric shock Pupillometer is double insulated (Class II protection)

Classification of the equipment

against ingress of liquids Ordinary equipment

Degree of safety of application

in the presence of flammable

anesthetic mixture with air or

with oxygen or nitrous oxide

The equipment is not an AP or APG category equipment

Mode of Operation On Demand battery operation

Power Supply Input: 100-240 VAC +/- 8%

Output: 6V, 2.8 Amps

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

Operating Environment 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

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

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

Dimensions With eye cup = 7.5” H, 3.5” W, 4.5” D

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

Weight 320 grams +/- 10 grams

Classification Class 1 LED product per IEC 60825

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) |p: 949.250.9792 |International +1-949-250-9792, or

email: Support@neuroptics.com

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 B—Bluetooth®Broadcast Range and Frequency

Broadcast Function Range Frequency

Bluetooth Barcode Scanner to/from

VIP-300 Pupillometer

Up to 100 yards depending on environment 2.45 GHz

Socket is a registered trademark of Socket Mobile, Inc.

Appendix C— International Symbol Definition

NON

STERILE

Source/Compliance

Symbol Title of Symbol Description of Symbol

Standard: ISO 15223-1

Symbol Reference No: 5.4.4 Caution

Indicates that the instructions

for use contain important

cautionary information such as

warnings and precautions that

cannot, for a variety of reasons,

be presented on the medical

device itself.

Standard: IEC 60417

Symbol Reference No: 5333 Type BF Applied Part To identify a type BF applied part

complying with IEC 60601-1.

Standard: IEC 60417

Symbol Reference No: 5840 Type B Applied Part To identify a type B applied part

complying with IEC 60601-1.

Standard: IEC 60417,

Symbol Reference No: 5010 “ON”/ “OFF” (Power)

To indicate electronic power

connection or disconnection

to internal battery supply.

Section 1.1 of Chapter I

of Annex IX to Directive

93/42/EEC.

U.S. 21 CRF 801.5(c.)

Intermittent Use

To indicate use to be Transient

or intermittent with contact to

intact skin with duration less

than 60 minutes.

Standard: ISO 15223-1

Symbol Reference No: 5.4.4

Non-sterile. Single

patient use only

Indicates a medical device that

has not been subjected to a

sterilization process. Intended

for single patient use.

Standard: ISO 15223-1

Symbol Reference No:

5.1.7

Serial Number 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

Indicates the manufacturer’s

catalog number so that the

medical device can be identied.

Catalog Number

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