USER MANUAL NeuroLight

About this manual

This operating manual contains all the information necessary to set up and use the portable pupillometer NeuroLight manufactured by IDMED. It also describes the specific cleaning and checking procedures that you may need to perform. This manual is intended for use by qualified medical personnel only (state registered Nurses, Anaesthetists and Doctors).

Keep this operating manual with the NeuroLight. It serves as a maintenance and repair manual.

Read the safety information in this manual carefully before using the NeuroLight.

Indications of use

The NeuroLight is a portable video pupillometer. It measures in a quick and simple way the pupil of the patient. Simultaneously to measuring the size, it can also measure the reactivity of the pupil following a flash of light.

It provides the user with reliable, accurate and reproducible measurements. The NeuroLight measures patient pupil size at rest as well as its minimal/maximal size, latency to constriction and percentage dilation during a light stimulation. There is one part of the NeuroLight that is or may be applied to the patient: the eyecup.

Expected performance

The following features are the essential performance characteristics of the NeuroLight:

• Measure the average diameter of a patient's pupil to an accuracy of +/- 0.1 mm (simulated pupil of 3 mm diameter).
• Generate a white light stimulation with an intensity of 320 lux +/- 10%, and a duration of 1 sec +/- 0.1 sec.

Clinical Benefits

The clinical benefits of the NeuroLight are:

• Accurate anisocoria detection.
• A reproducible and quantitative measurement of the photomotor reflex (Pupil Light Reflex) in neurological assessment.

Important information about the use of NeuroLight

The NeuroLight compact video pupillometer is designed to be used by an authorised health professional (anaesthetist, ophthalmologist or state registered nurse - anaesthetist nurse) who has received special training in its use. The system and all the associated parameters are designed for use on adult and paediatric patients in a hospital or health establishment to monitor pupil size and reactivity.

The NeuroLight measurement results on pupil size and reactivity can be used to complete the neurological assessment of the patient.

The interpretation of the results obtained with the NeuroLight must always be clinically appraised and compared to other clinical signs observed.

The NeuroLight conforms to the European directive covering medical devices and to the regulations in force in the country of distribution.

I SAFETY MEASURES

INTRODUCTION

The user must read carefully the whole manual before operating the NeuroLight.

WARNING, CAUTION, REMARK

All parts of this manual contain warning, caution, and remark statements about the NeuroLight.

• WARNING statements give important information that, if ignored, could lead directly to personal injury or death.
• CAUTION statements give important information that, if ignored, could lead directly to equipment damage, erroneous data or cancelled procedure and indirectly to personal injury.
• REMARK statements provide useful information for a function or a procedure.

EXPLANATION OF SYMBOLS

The symbols that may appear on the NeuroLight display are compiled and explained at the end of this chapter.

Any serious incident occurring in connection with the device must be notified to the manufacturer and to the competent authority of the Member State or country in which the user and the patient are established.

I.1 Warnings

• Explosion risk: do not use the NeuroLight in a flammable atmosphere or in places where flammable anaesthetic products may accumulate.
• The NeuroLight is not designed to operate in the environment of a SCANNER, M.R.I or any other appliance creating powerful magnetic fields.
• Never use the NeuroLight in the vicinity of short-wave or micro-wave therapy appliances.
• Before use, check the device, display and cable for damage. Never use the unit if any defect or damage is found.
• After taking any measurements, check the patient's complete eyelid closure to protect the eye from dryness and cornea alteration.
• In order to prevent electromagnetic disturbance, keep minimum separation from RF communication equipment of 30cm.

I.2 Caution

• Read the complete manual carefully before using the NeuroLight.
• Do not autoclave the NeuroLight or any of its components or accessories other than the eyecup.
• Never submerge the appliance or any of its components in liquid, or spray it or clean it with liquid.
• The NeuroLight and its components are not compatible with sterilisation processes by gas, radiation (gamma or other), baths, steam or heat.
• Follow the instructions for cleaning and disinfecting the NeuroLight given in the “Cleaning and Disinfection" chapter.
• The NeuroLight contains a lithium-ion battery. The NeuroLight battery must never in any circumstances be removed, modified or replaced. Any intervention on the battery presents a risk of combustion or explosion; only a qualified technician or from the IDMED company is competent to intervene.
• After a long period of non-use (storage), recharge the battery of the NeuroLight for at least 4 hours before use. If the NeuroLight does not start when the device is picked up (motion detection), the NeuroLight must not be used and must imperatively undergo maintenance operations.
• Only qualified biomedical technicians are qualified to do repairs and maintenance, after obtaining permission from IDMED.
• It should be noted that in all cases, in order to avoid any risk of corneal dryness, the use of the device on the patient (open eye) should not exceed 60 seconds continuously. In order to avoid any risk of corneal or retinal damage, the number of measurements performed on a single patient should not exceed 10 per hour.
• The user of NeuroLight must take care not to be in contact with any other electrical appliances when using the NeuroLight.
• Use only the accessories/components supplied by IDMED.
• In order to prevent electrostatic shock, the device must be used in an electrostatic limited environment. (see Environment section)
• Notice on Electromagnetic Compatibility (EMC): 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 interferences may result.
• The equipment has been tested and found to comply with the norm IEC60601–1–2 for medical electrical equipment.
• These limits provide reasonable protection against electromagnetic interferences when operated in the intended environments (e.g. hospitals).
• Known contraindications to use the NeuroLight: orbit structure damaged, surrounding soft tissue oedematous, abraded skin.

I.3 Symbols definition

Symbols are on the labels:

II GENERAL DESCRIPTION

Overview of the NeuroLight and its accessories

Device Image Description: The image shows the NeuroLight device, a handheld unit with a display screen at the front and an eyecup at the end. Arrows point to the 'Display screen' and 'Eyecup'.

Display screen

Screen Description: The screen displays patient information (Patient 1), battery charge level, a video image of an eye with a detected pupil (green surface), the real-time measured value (e.g., 6.72 mm), time and date, and a 'Main menu' button.

Touch Screen

The NeuroLight is designed in such a way that all controls are accessible with a simple touch of a symbol or icon. The touch screen is designed to work even if the operator is wearing gloves for the examination.

Note: The normal time to press the screen is approximately 1 to 60 seconds. Do not stay in contact with the screen for more than 1 minute.

General Use

The NeuroLight measures pupil size and reactivity (photomotor reflex) of a patient.

Fitting the positioning eyecup

The NeuroLight has a silicone eyecup so it can be positioned on the patient's face. Before each use, the operator must clean this part. For more information about cleaning, refer to the "CLEANING AND DISINFECTION" chapter. This eyecup is the only part in contact with the patient. The eyecup is to be placed on the NeuroLight by simply pushing it onto the black lens.

Diagram Description: An illustration shows the silicone eyecup being attached to the front of the NeuroLight device.

Installation and positioning of the NeuroLight

To obtain accurate measurements the NeuroLight must be positioned correctly on the filmed eye of the patient. The black silicone eyecup on the NeuroLight must be in contact with the upper and lower part of the eye socket bone without pressing. In this way there will never be any pressure on the eye-ball itself. It should never be in contact with the patient's eye. The operator must hold the device vertically and firmly to prevent any movements while filming.

Diagram Description: An illustration shows the correct positioning of the NeuroLight device against a patient's eye socket.

Turning the device ON/OFF

The NeuroLight switches on automatically when the device is held in the hand (movement detection).

Note: the device switches off automatically if it is not used for 2 minutes or if it is repositioned on its charging station.

Patient Files / Measurements identification

The NeuroLight has a barcode reader. Activation of the red light beam for reading barcodes identifying the patient is done by pressing and holding the dedicated button and directing the light beam towards the barcode.

Diagram Description: An illustration shows a barcode being scanned by the NeuroLight device.

When a label is read, it creates a file with the label encoded ID number or retrieves an existing file created by a previous scan of that same label.

The NeuroLight has also 20 pre-set files numbered 1 to 20. If there is no barcode scanning, the user will either choose one of those files or create additional files numbered 21 and above to save the measurement results.

Settings Menu

Setting date and time

The NeuroLight contains a clock that is set at the factory. The operator can update the date and time of the NeuroLight. To access the time setting and date change menu proceed as follows:

• Select the menu "settings" by pressing the following icon ⚙️.
• Then select this icon ?. Use the navigation arrows ⬆️⬇️ to adjust the "date", the "time" and "format" of the date as desired. By pressing the "Home" button ?, the changes will be automatically validated.

Changing the language

If necessary, the operator can change the language of the NeuroLight. To access the menu for changing the language, follow the procedure below:

• Select the "Settings” menu by pressing the following icon ⚙️.
• Then use the navigation arrows ⬆️⬇️ to select the desired "language".

Right Eye/ Left Eye Indicator

In the Flash mode, it is possible to identify the eye being filmed during measurement. A pop-up window appears at the end of the measurement allowing the user to identify the eye used with the following icons L R .

Transport Mode

The operator can set the NeuroLight to "transport mode." This mode switches off the unit for transport or storage. It prevents the unit from switching on every time a motion is detected.

To access the "transport mode", follow the procedure below:

• Select the "Settings" menu by pressing the following icon ⚙️.
• Then select the transport mode by pressing ?.

To deactivate the transport mode, position the device on its charging station. The device will automatically switch on when it is removed from the station.

Data transfer / Communication

The user can select the mode and the data destination.

To access the data transfer menu, follow the steps below:

• Select settings menu by pressing on ⚙️.
• Then select data transfer by pressing on ?.
• Using the arrows ⬆️⬇️ select the transfer mode (PC/HL7).
• Connect your receiver module; on PC (ref: NL-WDT) or HL7 (ref: IDM-GTW).
• Validate your choice by pressing on ✔️.

Note: When activating the data transfer, the user must be at less than 1m (3ft) away from the receiver.

When pairing, the type and identification (ID) at the bottom left of the screen must fill automatically. If not, get closer of the module and press again the following icon ✔️.

III USING THE NEUROLIGHT

Create or select a patient's file

It is strongly advised to create a patient's file or select an existing one to be able to save the measurements.

To select an existing patient's file:

• Press the icon “Patient File” ? and select the correct file with the left or right arrow ⬅️➡️.
• Or Scan the patient's barcode that was previously used to create the file.

To create a new patient's file:

• Press the icon “Patient File” ? and select the icon “New patient's file” ➕. Numbering starts at 21.
• Or Create a patient file by reading a barcode identifying a patient.

Taking a measurement

Positioning of the device and detection of the pupil

Positioning the device on the patient's face is an important step to obtain reliable measurements (see: Installation and positioning).

If the patient is conscious, ask him/her to keep his/her head straight, open the filmed eye wide and look straight ahead without blinking. The other eye is closed.

If the patient is unconscious or not able to cooperate, the operator may need to raise and/or lower the patient's eyelids so that the pupil measured by the NeuroLight appears completely unobstructed.

The patient's pupil should be centered on the screen and totally in green color. Only the pupil will be colored in the image displayed by the NeuroLight. If this is not the case, reposition or position differently the NeuroLight.

Diagram Description: Three examples of pupil detection are shown: "NO White spots deform the pupil", "YES Correct positioning and detection of the pupil", and "NO Poor pupil detection".

When the pupillometer is ready for a measure the following icon ✅ will appear at the bottom right of the video image.

Note: when the pupil detection is not correct, the red icon ❌ will appear at the bottom right of the video image. The pupillometer does not detect the pupil in the video image. Do not move the NeuroLight when taking measurements.

Taking a measurement

Once the device correctly positioned, the NeuroLight displays the green icon ✅ when the pupil is detected. It is necessary to ensure that the size of the pupil is stable before taking the measurement.

Start taking the measurement by pressing continuously on the main button ▶️ until the countdown at the bottom right corner of the screen reaches 0.

A beep will indicate the start and end of the measurement period. In “Flash” mode, at the end of the measurement, the user can record the patient's eye used for the measurement (right or left).

Bilateral Pupil Exam: If a measurement on the other eye is done within 2 minutes of the first one, a comparison chart of the bilateral pupil exam will be displayed.

Hold function

It is possible to freeze the analysed image of the pupil by putting the NeuroLight on pause. To pause press on the video image. It freezes the pupil size and the image. Press again on ⏸️ to deactivate the pause mode.

Display of the results

The NeuroLight displays the results of the measurement of the eye that has been filmed. The results and measurements displayed depend on the protocol used. It is important to control the quality of the displayed curve and to verify that measurement values are not artefacts. For example, the horizontal blue and black lines show respectively the pupil size baseline (size of the pupil before stimulation) and the smallest size of the pupil during the measurements (maximum pupil variation). The lines must be appended to the curve and not to an isolated point (artefact).

Example of a result: The screen shows pupil size (6.90 mm), amplitude of the reflex (41.0%, -2.85 mm), speed and latency of reflex (Vel.: 5.55 mm/s, Lat.: 205 ms), and a commentary on reactivity (VERY GOOD). It also shows the control curve of the pupillary reflex and options to select left/right eye or save/delete results.

After each measurement, results can be saved or deleted. These measurements will be recorded in the current folder.

Press the 'Save' icon ? to validate and keep the results.

Press the 'Delete' icon ?️ to delete the results.

Note: If a data transfer mode is active, the following icon ? is displayed on the screen. It allows to save and send the data to the configured receiver module.

The results displayed are:

• Results control curve with the following markers:
  • Duration of the flash (light blue area)
  • Baseline diameter of the pupil (blue horizontal line)
  • Maximum variation in pupil size (black horizontal line)
• Diameter baseline before stimulation (Base in mm)
• Variation percentage (Var. in %):
  • (Var%=(Abs(Variation(mm))/Base(mm))*100)
• Maximal size variation of the pupil (value in mm in brackets)
• Constriction Velocity (speed in mm/s)
• Latency of constriction (latency in ms)
• A commentary on reactivity level
• Selected eye for the measurement

Quantitative and qualitative scale of the photomotor reflex (5 levels, 3 colours) to determine commentary on pupil reactivity level.

The quantitative and qualitative scale of the photomotor reflex and resulting commentary are based on the amplitude of the reflex (value in %). They are only indicative and must be corroborated with other physiological indicators commonly used.

Review saved files / Trend charts

Press the icon “patient's file” ?, select a file with the left/right arrow ⬅️➡️ and access results with "show records" ?.

Diagram Description: Shows icons for File selection, Show records, Delete records, Create new patient's file, Barcode reading, and Home page.

Note: If a data transfer mode is active, the following icon ? is displayed on the screen. It allows send all the patient's data to the configured receiver module.

Comparison and trend monitoring

The display of the recordings is done through 2 pages.

Press on the icons L and R to access comparison and historical data.

Left eye / right eye comparison page

This page displays the measurement performed for one eye together with the measurement performed for the other eye, if both measurements are taken within 2 minutes.

Diagram Description: Shows a comparison screen with data for the right eye (Base: 3.60 mm, Var: 30.0%) and the left eye (Base: 2.90 mm, Var: 28.0%). It includes pupil reaction curves and a comparison of baseline sizes and photomotor reflex amplitude, noting an anisocoria of 0.7mm.

Trending

On the patient selection page press the “Trend” icon ?. This page allows you to visualize the evolution of the diameters of both eyes over time. It also displays the evolution of the variations in pupil size for the same file over time.

Diagram Description: Shows graphs for 'Diameter' and 'Variation' over time, with a note that right eye values are in red, and blue for the left eye.

Selecting a patient registration file

The measurement's folder or patient's file enables to save a set of measurements of the same patient in a single file. The selection of the file can be done very simply by scanning the identification bar code of the electrode used for patient stimulation. Thus by identifying the patient, the NeuroLight is positioned on the patient's file.

Alternatively the user can select the patient's file manually by selecting the «registration folder» icon ?.

Once positioned in the «registration folder» menu, the user can select the desired patient's file by using the navigation arrows ⬆️⬇️.

IV PREVENTIVE MAINTENANCE, CLEANING AND DISINFECTION

Preventive maintenance

To be sure of maintaining the performance level, we strongly recommend having the appliance checked every two years on the following points:

• Check the casing, the screen and the labels for damage.
• Check the quality of the filmed image (sharpness and contrast).
• Check the cleanliness of the lens.
• Check the battery charging process.
• Check the absolute values measured.
• Check the light stimulation.
• Battery replacement.

The lifetime of the NeuroLight, under the required conditions of use and maintenance, is 5 years (2 years for accessories).

Caution: Only technicians trained by IDMED are authorised to carry out repairs or maintenance operations.

Battery and battery charging

Battery

The NeuroLight contains a rechargeable Lithium-Ion battery. It is fitted with thermal protection and protection against short-circuits.

Battery specifications

• 2900 mA/h (or higher)
• Nominal value 3.7 V (3.6- 4.2 V)
• Contains a thermal protection system (overheating).
• Contains a short-circuit protection system.

The NeuroLight indicates the battery charge level using icons:

• ? Charge level OK
• ? Intermediate battery charge level
• ? Discharged battery symbol. If this symbol appears the NeuroLight must be recharged immediately (Battery red).

The battery has a 6-month warranty.

Note: Only qualified technicians trained by IDMED or IDMED personnel are authorised to carry out repairs or maintenance operations on the battery.

Battery recharging and maintenance

The battery can be recharged using IDMED wireless charger (ref: STA-W2). The complete charge time is about 10 hours. Charger specifications are given in the “power supply” paragraph under the “Technical Specifications” section.

The battery can be recharged regardless the current level of charge.

To recharge the battery, place the unit on its charging station.

Caution: if the indicator light is orange ⚠️, Remove and reposition the NeuroLight on the charging station.

Diagram Description: Shows the charging station indicator and an arrow indicating 'Charging in progress'.

Cleaning and Disinfection

Caution: Do not autoclave the NeuroLight or any of its components or accessories except for the eyecup.

Under no circumstances should the NeuroLight or any of its components or accessories other than the eyecup, be in direct contact, immersed, sprayed or filled with any liquid.

In order to avoid inadvertently changing the settings of the device, we advise you to put it in transport mode before cleaning it.

The NeuroLight, its parts and accessories are non-sterile. In no circumstances should the NeuroLight be sterilized.

The surface of the NeuroLight has to be cleaned with a lint-free cloth moistened with a quaternary ammonium disinfectant, 70% isopropyl alcohol or a cold decontamination solution (e.g. ANIOS). Before using any of these solutions, refer to the manufacturer's documentation and carry out a test on a small area.

Example of recommended products:

• Incidin™ OxyWipe from the manufacturer Ecolab Inc.
• Septalkan from the manufacturer Alkapharm.
• Clinell® Universal Spray from the manufacturer Gama Healthcare Ltd.
• Cleanisept from the manufacturer Dr. Schumacher.
• Mikrozid® Sensitive Liquid from the manufacturer Schülke &Mayr GmbH.

Please check with your local authorized distributor or the manufacturer which products are available and approved in your country.

The eyecup, the only part in contact with the patient, will be removed from the NeuroLight and cleaned in the same way as the NeuroLight and then put back in place on the clean NeuroLight. It can also be cleaned by autoclaving (maximum temperature 135°C). The eyecup can withstand 50 autoclave washing cycles. Any alteration, degradation or modification of the eyecup must lead to its replacement.

The eyecup must be cleaned or changed between each patient. The NeuroLight must be cleaned and disinfected between each patient. Low-level disinfection is usually sufficient.

The lens should always be free of stains or scratches to avoid the risk of distorting the measurements made. It should be cleaned with a lint-free cloth and wiped carefully to avoid any stains or reflections.

V APPENDIX 1

Troubleshooting

The table below is a list of possible malfunctions as well as the solution to be implemented for their resolution.

Note: All other malfunctions must be handled by the manufacturer (IDMED) or by qualified biomedical technicians trained by IDMED and authorised to carry out repairs or maintenance operations on the NeuroLight.

VI APPENDIX 2

End of life equipment / Recycling

In order to protect the environment, it is mandatory to hand over your worn out system to a collecting body capable of processing appliances containing electronic components and Lithium-Ion accumulators.

For the disposal or recycling of the appliance components, contact a company specialising in the recycling of electronic appliances. Electronic goods that have not been selectively sorted are potentially dangerous for the environment.

Packaging materials should be disposed of or recycled according to the regulations in force.

Specification and warranty

Environment

Storage and expedition

The NeuroLight and its accessories should be stored or transported within the limits of the following conditions. These conditions apply to storage and transport situations excluding operation.

• Temperature: 10°C to +50°C
• Humidity: 15% to 95% (without condensation)
• Pressure: 500hPa to 1060 hPa

The original factory packaging should be used for storage and transport. Protect the NeuroLight from sudden temperature changes that could cause condensation.

Operating environment

Reminders:

• Explosion risk: do not use the NeuroLight in a flammable atmosphere or in places where flammable anaesthetic products could concentrate.
• The NeuroLight is not designed to operate in the environment of a SCANNER, M.RI or any other appliance creating powerful magnetic fields.

The NeuroLight is designed to operate in complete safety in the following conditions. Any situation outside those described is likely to affect the reliability of the appliance.

• Temperature: 10°C to +40°C
• Humidity: 35% to 90% (without condensation)
• Pressure: 700hPa to 1060 hPa

Technical specifications

Safety

• Eyecup (part in contact with the patient). Latex free.
• Compliant with European regulation 2017/745.
• Visible and infrared lighting conforms to IEC 62471 safety standards.
• CE marking (certifying body 0459 LNE/G-Med) – Class 2a.
• Compliant with standard IEC 60601–1. Class II equipment. / Continuous mode of operation.
• EMC: IEC 60601-1-2.

EMC Emission

EMC Immunity

Measurements

• Measurement system by video camera and in-built data processor.
• Measurement range: 1 to 9 mm (pupil diameter).
• Accuracy 0.1 mm or 5%, resolution 0.01 mm (pupil size).
• Measurement and image acquisition frequency 60 images/s.

Data transfer

• Data transfer via Bluetooth (depending on data collection system)
• Frequency band : [2400 - 2483.5] MHz
• Maximum output power: 8 dBm.

Light Stimulation

• Duration 1 second.
• Intensity fixed at 320 Lux (precision +/-10%).

Measurements management

• Folder creation by barcode reading.
• Number of recordable measurements: approx. 10000.

Power Supply

• 3,7V DC Lithium-Ion battery 2900 mAh or above (with in-built thermal and short-circuit protection), autonomy approx. one week in normal use (20 measurements per day).
• IDMED STA-W2 charging base:
  • Qi standards compliant 5W min.
  • AC adapter ref. PWR5_1, 5V / 1.3 A min. Compliant IEC60601–1.
  • Input: 100-240V, 50-60 Hz, 160-80 mA.
  • Output: 5V DC / 1400 mA.

Weight

• 280 g (approx.).

Warranty

• Length of the warranty: 2 years (except battery warranty: 6 months).

VII APPENDIX 3: ACCESSORIES

The NeuroLight (reference : NL-MU) can be delivered with a number of accessories. Here is the list of the main accessories with their names and IDMED references.

Medical accessories of the NeuroLight

Other accessories