idmed NeuroLight Portable Pupillometer Manufactured User Manual

idmed NeuroLight Portable Pupillometer Manufactured

Product Information

The NeuroLight is a portable video pupillometer manufactured by IDMED. It is designed to assess the neurologic conditions of conscious, unconscious, or sedated patients by measuring the pupil of the patient and the patients’ pupils variation (Pupil Light Reflex – PLR) following a light stimulation.

Key Features:

• Measures the average diameter of a patient’s pupil to an accuracy of +/- 0.1 mm (simulated pupil of 3 mm diameter)
• Generates a white light stimulation with an intensity of 320 lux +/- 10% and a duration of 1 sec +/- 0.1 sec
• Provides reliable, accurate, and reproducible measurements to evaluate the neurologic conditions

The NeuroLight is intended for use by qualified medical personnel only, including state registered Nurses, Anaesthetists, and Doctors. It can be used in a hospital or healthcare facility (operating room, recovery or critical care) to monitor pupil size and reactivity. There is no limitation for use regarding patient gender, but the patient must be at least 2 years old.

Product Usage Instructions

1. Read the entire user manual carefully before operating the NeuroLight.
2. Ensure that the NeuroLight is properly set up according to the instructions provided in the manual.
3. Before using the NeuroLight, clean and check the device as described in the specific cleaning and checking procedures mentioned in the manual.
4. Position the eyecup of the NeuroLight on the patient’s eye.
5. Initiate the measurement by activating the white light stimulation.
6. Observe and record the patient’s pupil size at rest, as well as its minimal/maximal size, latency to constriction, and percentage dilation during the light stimulation.
7. Interpret the measurement results obtained with the NeuroLight by clinically appraising them and comparing them to other clinical signs observed.
8. Keep the operating manual with the NeuroLight for maintenance and repair purposes.

If you require further information or support, please contact IDMED, the manufacturer of the NeuroLight, via their website WWW.IDMED.FR, or by post using the following address:

SAFETY MEASURES
Telephone: +33 (0)4.91.11.87.84

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.

Intended Use
The NeuroLight is a portable video pupillometer which enables to measure:

• the pupil of the patient
• the patients’ pupil variation (Pupil Light Reflex – PLR) following a light

Indication for use
The NeuroLight is used to assess the neurologic conditions of conscious, unconscious, or sedated patients. It measures quickly and simply the pupil of the patient. The NeuroLight measures patient pupil size at rest as well as its minimal/maximal size, latency to constriction, and percentage dilation during light stimulation. There is one part of the NeuroLight that is or may be applied to the patient: the eyecup.

Expected technical 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 Performances
The NeuroLight provides reliable, accurate, and reproducible measurements to be used as supplementary data to evaluate neurologic conditions thanks to the pupillary light reflex.

Clinical Benefit
The clinical benefit of NeuroLight is to provide an objective evaluation of the Pupillary Light Reflex.

Important information about the use of NeuroLight
The NeuroLight compact video pupillometer is designed to be used by an authorized health professional (anesthetist, ophthalmologist, or state registered nurse – anesthetist nurse) who has received special training in its use. The system and all the associated parameters are designed to be used in the general population – conscious, unconscious, or sedated patients in a hospital or health care facility (operating room, recovery, or critical care) to monitor pupil size and reactivity. There is no limitation for use regarding patient gender. Regarding the age, the patient must be at least 2 years old. 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

For further information please contact IDMED, the manufacturer of the NeuroLight via their website WWW.IDMED.FR or by post to the following address: IDMED Hôtel Technoptic 2 rue M.DONADILLE 13013 MARSEILLE FRANCE Telephone: +33 (0)4.91.11.87.84

SAFETY MEASURES

INTRODUCTION

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.

Warnings Explosion risk: do not use the NeuroLight in a flammable atmosphere or in places where flammable anesthetic 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.
• To prevent electromagnetic disturbance, keep a minimum separation from RF communication equipment of 30cm.
• Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
• Any hardware or software modifications to the device are prohibited.
• Use of accessories, transducers, and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
• The use of the NeuroLight should not result in any significant pressure of its eye cup on the patient’s face but only putting it in contact. If too much pressure is applied, light marks or red patches may appear on the skin in the contact area due to pressure points. They should remain limited and not related to an injury.

Caution

• Read the complete manual carefully before using the NeuroLight. NeuroLight should be handled with medical gloves.
• 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 sterilization 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 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, to avoid any risk of corneal dryness, the use of the device on the patient (open eye) should not exceed 60 seconds continuously. 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.
• 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 by 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.

Symbols definition

• Symbols are on the labels
• Symbols on NeuroLight screen

• Reliability of the measure: Poor
• Reliability of the measure: Good
• Reliability of the measure: Average

GENERAL DESCRIPTION

Overview of the NeuroLight and its accessories

Display screen

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 the pupil size and reactivity (photomotor reflex) of a patient. The QPi score can help for a quick read of the measures (see p14-15).

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.

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.

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.

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”, “time” and “format” of the date as desired. By pressing the icon , 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, at the end of the measurement, a pop-up window appears allowing the user to identify the eye used thanks to the following indications: Right, Left.

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 the 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 be filled automatically. If not, get closer to the module and press the following icon

USING THE NEUROLOGIST

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 Or Create a patient file by reading a barcode identifying a

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. It is important when measuring a very small pupil to position the NeuroLight so that the white spots (reflections of the infra-red diodes) do not deform the detected pupil contour. If this is the case reposition the NeuroLight or position it differently.

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 is 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 measuring 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 select 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 analyzed 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 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 mode used.

If the reliability of the measure is poor ( ) the user has to do the measure again. If the reliability of the measure is average ( ), the user must ensure that the measurement is clinically relevant. 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 us to save and send the data to the configured receiver module.

The results displayed are:

• QPi Score (between 0 and 5)
• Pupil size before stimulation (Diameter in mm)
• Variation percentage (Var. in %): (Var%=(Abs(Variation(mm))/size (mm))*100)
• A commentary on reactivity level
• Selected eye for the measurement
• Reliability of the measure

When pressing the icon, more information appears:

• Results control curve with the following markers:
  • Duration of the flash (light blue area)
  • Size of the pupil (blue horizontal line)
  • Maximum variation in pupil size (black horizontal line)
• Maximum variation in pupil size in mm
• Constriction Velocity (speed in mm/s)
• Latency of constriction (latency in ms)

The QPi is the score allowing a quick interpretation of the photomotor reflex of patients. It simply differentiates, on a scale of 0 to 5, the reactivity of the photomotor reflex. It comes with a color code of 3 levels (red, orange, green) and a commentary to facilitate interpretation.

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

NOTE : If a data transfer mode is active, the following icon is displayed on the screen. It allows to sending of 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 to access comparison and historical data.

Left eye / right eye comparison page
This page allows us to compare the measures performed on each eye (within a maximum of 2 minutes between the two measurements): QPi score, baseline sizes, photomotor reflex ampli- tude and reliability of the measurement.

When pressing the icon , more information appears:

Results control curve for each eye (red curve for right eye and blue curve for left eye) with the following markers:

• Duration of the flash (light blue area)
• Size of the pupil (blue horizontal line)
• Maximum variation in pupil size (black horizontal line)

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 the last 24 hours or the last 3 hours. It also displays the evolution of the variations in pupil size and of the QPi score for the same file.

Selecting a patient registration file
The measurement folder or patient file enables to saving 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.

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 authorized 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

The NeuroLight indicates the battery charge level using icons

The battery has a 6-month warranty

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

Battery recharging and maintenance
The battery can be recharged using an 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 of the current level of charge.

NOTE : 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.

Charging in progress
Charging station indicator No maintenance is required for the NeuroLight battery but it is recommended to change it every two years. Only qualified technicians trained by IDMED or IDMED personnel are authorized to carry out repairs or maintenance operations on the battery.

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. 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.
Examples of recommended products :

• Septalkan from the manufacturer
• Clinell® Universal Spray from the manufacturer Gama Healthcare
• CLEANISEPT from the manufacturer Schumacher.
• Mikrozid Sensitive Liquid from the manufacturer Schülke &Mayr
• Incidin™ OxyWipe from the manufacturer Ecolab

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.

APPENDIX 1

Troubleshooting

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

The device will not turn ON, or turn OFF by itself

After a few seconds

| Charge the battery by positioning the device on the charger (See «Battery and battery charging chapter»)
The LED charge indicator will not illuminate while charging the device| Remove and reposition the device on its charger.
The video image is blurred| Check the cleanliness

(see « Cleaning / Disinfection»)

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

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 appliance components, contact a company specializing in the recycling of electronic appliances. Electronic goods that have not been selectively sorted are potentially dangerous to 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 anesthetic 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.

• Temperature10°C to +40°C
• Humidity35% to 90% (without condensation)
• Pressure 700hPa to 1060 hPa

Technical specifications

Safety

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

EMC Emission

Group 1

| The NeuroLight uses RF energy only for internal functions. Therefore RF emissions are very low and should not disturb other nearby devices.
RF Emissions CISPR 11
Harmonics IEC 61000-3-2| Class B| The NeuroLight must be used in a professional healthcare facility environment
Voltage fluctuations| Class A
and flicker IEC 61000-3-3| Compliant| The NeuroLight can be connected to the public mains network

EMC Immunity

__

__

Phenomenon

| __

Basic EMC standard

| Professional healthcare facility environment Immunity Test Levels| __

Compliance levels

| __

EMC

Instructions/Precautions

---|---|---|---|---
__

ELECTROSTATIC DISCHARGE (ESD)

| __

IEC 61000-4-2

| ± 8 kV contact| ± 8 kV contact| __

To reduce ESD, the device must be used in a 35% humidity environment or more

± 2 kV, ± 4 kV,

± 8 kV,

± 15 kV air

| ± 2 kV, ± 4 kV,

± 8 kV air

| | | | Use of this equipment adjacent to or
__

Radiated RF EM Fields

| __

IEC 61000-4-3

| 3 V/m

80 MHz – 2,7

GHz

80 % AM at

1 kHz

| 3 V/m

80 MHz – 2,7

GHz

80 % AM at

1 kHz

| stacked with other equipment should

be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating

| | | | normally
Proximity fields from RF wireless communications equipment| __

IEC 61000-4-3

| Complies to table 9 of IEC 60601-1-2

(2014)

| Complies to table 9 of IEC 60601-1-2

(2014)

| To prevent electromagnetic disturbance, keep a minimum separation from RF communication equipment of 30cm
__

Electrical    fast transients/bursts

| __

IEC 61000-4-4

| __

± 2 kV

100 kHz repetition frequency

| __

± 2 kV

100 kHz repetition frequency

| The NeuroLight may temporarily not display results during transient electromagnetic disturbances such as the use of an electrosurgery device. In that case, the NeuroLight will maintain the safety of the patient and the user.
---|---|---|---|---
Surges Line-to-line| IEC 61000-4-5| __

± 0,5 kV, ± 1 kV

| __

± 0,5 kV, ± 1 kV

| Mains power quality should be that of a typical residential, commercial, or hospital environment.
Surges Line-to-ground| IEC 61000-4-5| ± 0,5 kV, ± 1 kV,

± 2 kV

| ± 0,5 kV, ± 1 kV, ± 2 kV| Mains power quality should be that of a typical residential, commercial, or hospital environment.
__

__

Conducted disturbances induced by RF fields

| __

__

__

IEC 61000-4-6

| 3 V

0,15 MHz –

80 MHz

6 V in ISM

bands between 0,15 MHz and

80 MHz

80 % AM at

1 kHz

| 3 V

0,15 MHz –

80 MHz

6 V in ISM

bands between 0,15 MHz and

80 MHz

80 % AM at

1 kHz

| __

__

To prevent electromagnetic disturbance, keep a minimum separation from RF communication equipment of 30cm

RATED    power frequency magnetic fields| IEC 61000-4-8| 30 A/m

50 Hz or 60 Hz

| 30 A/m

50 Hz or 60 Hz

| Mains power quality should be that of a typical residential, commercial, or hospital environment
__

__

__

__

Voltage dips

| __

__

__

IEC 61000-4-11

| 0 % UT;

0,5 cycle

At 0°, 45°, 90°,

135°, 180°, 225°,

270° and 315°

| 0 % UT;

0,5 cycle

At 0°, 45°, 90°,

135°, 180°, 225°,

270° and 315°

| __

__

__

Mains power quality should be that of a typical residential, commercial, or hospital environment.

0 % UT;

1 cycle and

70 % UT; 25/30

cycles Single phase:

at 0°

| 0 % UT;

1 cycle and

70 % UT; 25/30

cycles Single phase:

at 0°

Voltage interruptions| IEC 61000-4-11| | | Mains power quality should be that of a typical residential, commercial, or hospital environment.

Measurements

• Measurement system by video camera and in-built data processor
• Measurement range: 1 to 9 mm (pupil diameter)
• Accuracy 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 the data collection system)
  • Frequency band : [2400 – 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: 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)

APPENDIX 3: ACCESSORIES
The NeuroLight (reference: NL-MU) can be delivered with several accessories. Here is the list of the main accessories with their names and IDMED references.

Medical accessories of the NeuroLight

Other accessories

(dilatation)

NL-WDT| Wireless receiver for PC for data transfer
IDM-GTW| HL7 gateway for pupillometers

References

• IDMED, une technologie innovante, des résultats plus sûrs.

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