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1. US VIP CHG 01 NeurOptics Pupillometer Charging Station BATPUP 01 NeurOptics Pupillometer Rechargeable Battery NEUR 2059 01 NeurOptics Pupillometer Eye Cup NEUR PRTE 30 Seiko Printer 49005 1 Seiko Printer Cover 49005 2 Seiko Printer Power Supply US 49006 Seiko Printer Paper NEUR CASE 02 NeurOptics Pupillometer Carrying Case For more information please contact NeurOptics or visit www NeurOptics com NEUR lt PTICS Distributed by NeurOptics Inc US Customer Service NeurOptics Inc 2082 Michelson Drive Suite 450 Irvine CA 92612 USA Tel 949 250 9792 or 866 99 PUPIL No America Toll Free Fax 949 250 9796 info NeurOptics com PL2 IFU 01 Revision D May 10 2010 38 Appendix C Clinical Phenomena Affecting Pupillary Measurement Vertex Variation The distance of the corneal apex to the first optical surface of an instrument is referred to as the vertex distance Natural biological variation in the general population results in an anatomical vertex distance range of approximately 12 mm For modern pupillometers which are used in close proximity to the eye this 12 mm variation can account for a significant fraction of the object distance to the eye Therefore the projected scale of a pupillometer which has not been adjusted for vertex distance may result in a significant measurement error of pupil size To compensate for potential differences in vertex distances the NeurOptics Pupillome
2. The pupillometer should not be used without the eye cup positioned correctly 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 indenta tion in the lens shield of the Pupillometer Position the tab in the eye cup rim into the in dent 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 Figure 2 2A The flexible contoured eye cup fits onto the Pupillometer as shown in Fig ure 2 2A The eye cup is reusable To clean the eye cup follow the instruc tions under Cleaning and Maintenance To replace it or to order additional eye cups call the number given in Appendix B and request part number NEUR 2059 01 PL2 IFU 01 Revision D May 10 2010 17 CAUTION Do not touch the lens when fitting or removing the cup Damage to the lens may result When the eye cup is correctly posi tioned the contour of the eye cup should be aligned horizontally as shown in figure 2 2B Always clean the eye cup before taking measurements on each sub Figure 2 2B ject refer to Section 4 Connecting the Charging Station Connect the NeurOptics medical grade 4 2 volt power supply included with your system to the center plug in the charging station as shown in Figur
3. 3 83 mm x 3 5 89 mm Weight 356 g 10g Classification Class 1 LED product per IEC 60825 PL2 IFU 01 Revision D May 10 2010 40 Accessories NeurOptics Charging Station Model VIP CHG 01 Degree of protection Type B Applied Equipment Type of protection against Class Il Battery Charger electric shock Classification of the Ordinary equipment equipment against ingress Degree of safety of appli The equipment is not an AP or APG category equip cation in the presence ofa ment flammable anesthetic mix ture with air or with oxy gen or nitrous oxide Mode of Operation Continuous operation Power Supply Input 100 240 VAC 8 Output 6V 2 8 Amps Power Line Frequency 50 60 Hz Seiko thermal printer Optional See separate owners manual for instruc tions Model NEUR PRTE 30 PL2 IFU 01 Revision D May 10 2010 41 Warranty A Standard Limited Warranty NeurOptics the Manufacturer warrants to the original end user purchaser the Purchaser that the enclosed product Product purchased by the Pur chaser at the time of delivery to the Purchaser shall be substantially free from defects in material and workmanship The Manufacturer makes no warranty express implied or statu tory for Products that are modified except as expressly contemplated herein or subjected to unusual physical stress misuse improper operation neglect improper testing use in combi nation with other products
4. ODIONSE SRE RE RE AR eo 29 Section 4 Cleaning and Maintenance EE AA EE P baal E A at E E S 31 Changing the BAUME rs ne tenons 31 Printer Maimtenant o csscau accsacenepansanstaas acnatecataustacs teen calouabedstens Atelaue decades toe 32 Section 5 Downloading and Viewing Records on an External Computer 33 Appendices Appendix A Troubleshooting cccsssssssssesssssessessessessassassscsssenssssassseenees 35 Appendix B Contact amp Ordering Information ccccccccsesetstsesstsessseeseeeees 37 Appendix C Phenomena Affecting Pupillary Measurement 38 Appendix D Specifications 39 PL2 IFU 01 Revision D May 10 2010 Terms WARNINGS Identify conditions or practices that could result in serious adverse reactions or potential safety haz ards CAUTIONS Identify conditions or practices that could result in damage to the device or other equipment NOTES Identify supplemental information to help you better understand how the device works 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 pers
5. and for a maximum total duration of 23 sec onds is used in the calculation of a number of different pupillary variables that are displayed at the end of each single measurement The NeurOptics system includes a pupillometer a rechargeable battery two reusable eye cups and a charging station Options are listed in Appendix B and can be ordered separately Features e The NeurOptics PLR 2000 Pupillometer has been designed to be a lightweight device with a small footprint e The device has the capacity to store approximately 3000 measure ments e The optional Seiko thermal printer enables hard copy printing of re sults PL2 IFU 01 Revision D May 10 2010 Section 2 Unpacking and Setup International Plug Adapter Charging Station Optional gt Spare Battery Optional Eye Cups Power Supply Figure 2 1 Unpacking The NeurOptics system is housed in a protective hard shell case Included with your system are e The pupillometer e Lithium ion battery e Two eye cups e Medical grade power supply for the charging station e The charging station Please check the contents of your case Figure 2 1 when delivered If anything is damaged or missing please contact NeurOptics at once at 1 949 250 9792 DO NOT ATTEMPT TO USE A DAMAGED DEVICE The Pupillometer may not function correctly if it has been damaged or tampered with PL2 IFU 01 Revision D May 10 2010 10 Attaching the eye cup
6. five different sets of settings for the light stimulation in memory Each set of settings is associated to a different protocol number 1 to 5 that can be selected and thus retrieved without having to reenter again all the values by pressing the left or right arrow keys on the keypad To save and exit the current setting press the RIGHT or LEFT key So for example to define a new protocol select the corresponding number 1 to 5 then set all the light stimulation values and exit To only retrieve a prede fined protocol simply select the corresponding number and exit This option enables the continuous pupil recording All the other options Cox gt for setting the light stimulation are automatically disabled Menu Options cont Play Video If this icon is selected from the main menu a video of the latest valid scan will be played back on the pupillometer LCD Power Off This icon is for turning the device off The Pupillometer will ask you for confir mation before performing this operation The device can be powered back on by placing the device into the charging station or pressing the up arrow key for 3 continuous seconds PL2 IFU 01 Revision D May 10 2010 31 Section 4 Cleaning amp Maintenance Cleaning The NeurOptics Pupillometer and charging station are non sterile products DO NOT attempt to sterilize any part of the NeurOptics pupillome ter system as sterilization may damage the device To clea
7. is selected see Settings then pupil di ameter is tracked and then saved for a total maximum duration of 10 minutes Light stimulation is not allowed and the pupil waveform is not analyzed Con tinuous pupil recording is initiated as in a normal measurement Phase 3 see Figure 3 4 and terminated by pressing again the RIGHT or LEFT key During this continuous acquisition the user can define and insert time markers in the pupil record by pressing the directional keypad Each of the five possible keys in the directional keypad are associated to five different colors and the corresponding time marker displayed with a vertical line superimposed on the pupil plot This can be useful for associating external events i e emotional or cognitive stimulation with the diameter and behavior of the pupil during the acquisition The result page simply reports the whole pupil waveform and the lines corre sponding to the time markers Figure 3 6 Pressing the SELECT key the user can magnify those portions of the pupil waveform corresponding to the time markers Different and consecutive portions can be magnified by pressing the SELECT key again Printing and video are not allowed for continuous pupil measurements Four different vertical lines represent the time markers inserted by the user during the acquisition with a press of a key in the directional keypad Keys in the keypad and the corresponding time markers in the pupil waveform are rep
8. or components other than those for which the Products were de Signed or use in any manner or medical procedure for which the Products are not indicated If the Product is opened up by anyone other than an authorized service technician of NeurOp tics the warranty shall be void B Remedy Purchaser s exclusive remedy and the Manufacturer s sole liability for breach of the foregoing warranty shall be at the Manufacturer s sole option and election to replace the Product or credit Purchaser for the net amount actually paid for any such Product provided that i the Manufacturer is notified in writing within one 1 year after Purchaser s receipt of the Product that such Product failed to conform including a detailed explanation in English of any alleged nonconformity ii such Product is returned to the Manufacturer within one 1 year after Purchaser s receipt of the Product as designated by the Manufacturer and iii the Manu facturer is reasonably satisfied that the claimed nonconformities actually exist Except as ex pressly provided in this paragraph Purchaser shall not have the right to return Products to the Manufacturer without the Manufacturer s prior written consent C Exclusion of Other Warranties EXCEPT FOR THE LIMITED WARRANTY PROVIDED IN A ABOVE NEUROPTICS GRANTS NO OTHER WARRANTIES OR CONDITIONS EX PRESS OR IMPLIED AND MANUFACTURER SPECIFICALLY DISCLAIMS THE IMPLIED WARRANTIES AND CONDITIONS OF MERCHANTABILITY AND FITNESS F
9. s NMEUIR PTIcCS s M E UF sPTics Figure 3 2A Figure 3 2B To exit the Menu Bar or Once the Menu Bar has been any submenu see the activated by pressing the down next Section for an expla arrow the icon which is high nation and list of sub lighted will have a square menus and return to the frame drawn around it To default measurement highlight a different icon use screen press the LEFT the left or right arrow keys on or RIGHT key the keypad gt Once the desired icon has been high lighted press the SELECT key on the keypad to select that icon PL2 IFU 01 Revision D May 10 2010 16 Note In order to conserve battery power while outside of the charging station the Pupillometer will go into sleep mode after 3 minutes of inactivity The device will turn itself off after 1 hour of inactivity When in sleep mode outside of the charging station the Pupillometer LCD backlight will be turned off and can be turned back on with a quick press and release of any button of the keypad If the device is turned off it can be turned back on by pressing and holding the up arrow key on the keypad for 3 seconds Taking a Measurement Subject and Environment Preparation These are few general instructions e Instruct the subject to focus on a small target object for example a wall chart or a dim flashing light that is at least 10 or more feet 3 meters away with the eye that is not being tested e A
10. Appendix B Indications for use Used for measuring a dilated or non dilated pupil Contraindications Avoid use when the orbit structure is damaged or surrounding soft tissue has an open lesion or edema Safety Information Please review the following safety information prior to operating the device 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 mainte nance of the device contact NeurOptics as shown in Appendix B PL2 IFU 01 Revision D May 10 2010 Table of Contents NOTICE a a ata eae te aa ee 4 oalet TON MA NON Bisse tai Ro ich cialis tars ut 5 Section T MTOdUCUON nisreen E ETOT 8 Foal S oE E ed E E EO 8 Section 2 Unpacking amp Setup WINDACKING En ne Ne ENE EENE 9 Attaching the EVOCHDE nm onmunadnnisnatann 10 Connecting the Charging Station 11 Charging the Pupillometer 12 Section 3 Using the Device Powering On and Menu Navigation cccccceecsssssesssssssesssssssssssesesessen 14 Taking a Measurement ai kien aie a Ne onu 16 CONUNUCUS PUN FGCOMAING seirinin 24 Supject ID NOD OF need enennbiee 25 Pining the Records sien Bis ena NS nd 26 Browsing Records to View and Print 28 Menu
11. Instruction Manual NeurOptics PLR 2000 Pupillometer PL2 IFU 01 Revision D May 10 2010 Source Compliance Symbol 03 02 IEC 60878 ATTENTION consult ACCOMPANYING DOCUMENTS Symbol 5333 IEC 60417 TYPE BF equipment Symbol 02 03 IEC 60878 Symbol 02 02 IEC 60878 TYPE B equipment Symbol 5032 IEC 60417 This symbol indicates the equipment is Symbol 01 14 IEC 60878 suitable for alternating current Symbol 5008 IEC 60417 Symbol 01 02 IEC 60878 Indicates OFF Power Indicates Intermittent Use Indicates Non sterile Indicates Keep Dry Serial Number Model Number Lot Number PL2 IFU 01 Revision D May 10 2010 Copyright and Trademark Notice Copyright 2010 NeurOptics California 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 writ ten consent of the Company NeurOptics and PLR 2000 are trademarks of NeurOptics Inc Seiko is a trademark of Seiko Instruments Inc EMC Notice The NeurOptics PLR 2000 Pupillometer 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 equip ment has been te
12. OR A PAR TICULAR PURPOSE NEUROPTICS NEITHER ASSUMES NOR AUTHORIZES ANY OTHER PERSON TO ASSUME ANY OTHER LIABILITIES ARISING OUT OF OR IN CONNECTION WITH THE SALE OR USE OF ANY PRODUCT 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 thirty 30 days PL2 IFU 01 Revision D May 10 2010
13. While the Download Records key is high lighted press and release the SELECT key A text message reading WinCE would like to send the following file to your computer via a wireless link File R_20091019 1227 dat for example Do you want to accept this file Hint Data are all encrypted and contained in a file named with the date and time of the moment of the download and extension dat For example R_20080909 1030 dat is a file downloaded on September 9th 2008 at 10 30 After pressing Yes the next text message on the computer screen will read Your computer is receiving a file or folder transfer The pupillometer should be held in place until the downloading is complete Upon completion a text message will read The files were received successfully from WinCE Once the file has been downloaded into the computer locate the file and save it in a convenient location in the computer file system To view all records in the file insert the iDecoder disk provided by NeurOptics and execute the applica tion iDecoder exe Figure 5 1 Use the Load button to open the file and browse through all records using the Next or Prev button Finally the entire file contents can be exported and saved as an ASCII file by pressing the Save ASCII button The intent of the ASCII file is to allow the user to read the re cords outside the iDecoder viewer using Notepad or WordPad or to write a personalized pr
14. cleaning the device or when sterilizing device accessories The internal components of the Pupillometer are not compatible with steriliza tion 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 charger PL2 IFU 01 Revision D May 10 2010 Section 1 Introduction The NeurOptics PLR 2000 Pupillometer is a handheld optical scanner It stimulates the eye with a flash of light and captures and analyzes a rapid sequence of digital images to obtain a temporal measurement of the diame ter of ahuman pupil The onset intensity and duration of the light stimulus can be set by the user The system acquires images using a self contained infrared illumination source and a digital camera It analyzes the captured image data and displays a summary of the measurement in the LCD win dow Data may also be printed out on an optional thermal printer or downloaded to an external computer via an infrared port IrDA The NeurOptics PLR 2000 Pupillometer uses a menu driven graphical user interface GUI with a color LCD screen for data display A keypad completes the user interface and enables manual entry of individual subject identification ID numbers and other information The Pupillometer is powered by a 4 2 volt rechargeable lithium ion battery Pupillary data sampled at 32fps
15. ct s next scans will be stored under this ID number CUr 1 J Mew IC Figure 3 8 Figure 3 7 In case other ID numbers are present in the Pupillometer database stored in memory these will be listed in the same window for example in Figure 3 7 see ID 1 and ID 0 These IDs can be selected by using the directional key pad arrow up and arrow down and then pressing SELECT This function is useful if you need to immediately re enter a Subject ID already in the memory without the necessity of typing it again PL2 IFU 01 Revision D May 10 2010 Printing the Records a Attach the power supply to the printer as shown in Figure 3 9 Turn the printer on and the green light will illuminate Figure 3 9 The subject record currently displayed in the results window Figure 3 5 can be printed by activating the short menu bar at the bottom of the results page Figure 3 5 with a press of the down arrow key and then selecting the printer icon The range of the IrDA transceiver on the Pupillometer is less than one meter If the Pupillometer is too far away from the printer not pointed directly at the printer IR window see Figure 3 10 or if the printer is not turned on the error message Print Failed will be reported in the LCD of the Pupillometer If the connection is successful and printing has been completed a Print Done message will appear It will take only few seconds for a single record to print During p
16. e 2 3 Connect the power supply to a suitable AC outlet After a second you should see a blue LED illumi nate on the plug of the power supply and a green LED on the front of the charging sta tion The other 2 plugs in the back of the charging station are for NeurOptics use only eut 4 Rourea s Warning ONLY use NeurOptics Part number NEUR PWR1 01 power supply with the NeurOptics Charging Station The device may be dam aged if an incorrect power supply is used PL2 IFU 01 Revision D May 10 2010 12 Charging the Pupillometer Install the Pupillometer battery into the Pupillome ter see Section 4 The battery must be fully A charged prior to first use This may take up to four hours The battery status is indicated by the bat tery icon on the LCD screen of the device The arrow in Figure 2 4 points to the green LED on the front of the charging station which when lit indicates that the charging station is powered up correctly When placing the pupillometer into the charging station the pupillometer should be inserted at a 90 degree angle straight down until a click is heard The battery icon in the LCD screen will show a lightning bolt symbol indicating that the device is properly connected to the charging sta tion When removing the pupillometer from the charg ing station do not pull straight up First rotate the device forward and once it releases then pull it up See Figure 2 5 When correct
17. e IFU and that a lightning bolt symbol is displayed on the bat tery icon Hold device at a 90 degree angle to subject s face Make sure subject s eye is centered on the screen Gently hold subject s eye open with your finger during meas urement May 10 2010 36 NS Possible Reason DE Pupillometer held too far away from the IrDA transceiver port The IrDA port must be held in Record will not or not in line of sight direct line of sight of infrared port download of IR window in the pupillometer Pupillometer held too far away from printer Printer must be held in direct line or not in line of sight of sight of the infrared port in the Record will not of IR window of pupillometer See instructions in print printer IFU Measurement to print Record will not is not shown in the Browse to find record to print print active screen then follow instructions in IFU Pupil video record Video will not not present in mem Perform and complete a pupil play ory measurement Enter key on Subject ID num screen keyboard not Select and press Enter on ber is not dis pressed after enter screen keyboard after entering played ing Subject ID subjectID number PL2 IFU 01 Revision D May 10 2010 37 Appendix B Contact amp Ordering Information The following options and accessories can be ordered from NeurOptics PLR 2000 NeurOptics Pupillometer US NEUR PWR1 01 Pupillometer Charger Power Supply
18. entification code of the subject measured for example 0 in Figure 3 5 which eye was measured Left in the example and the date and time of the measurement Remember that if variables are displayed in red then the measurement was affected by a blink or a similar artifact that occurred during the period of the pupillary light reflex In this case the measurement data should not be trusted and the measurement should be repeated e The intensity onset and duration of the light stimulation In the example shown in Figure 3 5 the light stimulation intensity P was 180 micro Watts with a DC background level of 0 micro Watts The onset of the light stimu lation S was at 0 seconds for a total duration D of 0 802 seconds The onset and duration of the light stimulation is also represented by two yellow vertical lines superimposed over the pupil plot e INIT and END represent the diameter of the pupil before the reflex INIT 3 0 mm in this example and just at the peak of the reflex END 2 3 mm respectively They are given in millimeters and are represented by two horizontal gray lines superimposed over the pupil plot Figure 3 5 The variable DELTA is the amount of the constriction INIT END INIT as a percent e LAT is the latency and it represents the time of the onset of the reflex It is PL2 IFU 01 Revision D May 10 2010 22 given in seconds for example 0 22 second in the example and is repre sented by a vertical green line s
19. fic ID number Enter ID Figure 3 11 For your convenience the Browse catalog lists all the most recent ID numbers For ex ample ID 0 in Figure 3 11 so that you can select directly from the catalog with out having to re enter the ID using the option Enter ID All records corresponding to the ID specified in the Browse catalog window will be displayed as in Figure 3 5 You can review each single record using the right and left arrow keys on the directional keypad Figure 3 1 Each time a record is displayed in the LCD you can decide to print it by selecting the printer icon on the menu bar located at the bottom of the record display PL2 IFU 01 Revision D May 10 2010 29 Menu Options The main menu bar provides a few more functions Gi X Settings The settings window is enabled when the nut and bolt icon is selected in the main menu bar This window allows you to Dim the LCD backlight illumination Press the two keys to toggle between different backlight illumination levels and then press RIGHT or LEFT to save and exit Change the Pupillometer date and time If selected the numeric key board will be displayed on the LCD Figure 3 8 The current date and time will be reported on the top of the keyboard These setting can be changed by pressing Clear and re entering the correct settings using the directional keypad of the Pupillometer Figure 3 1 Select Enter on the LCD to save the new se
20. ly installed the eye cup on the Pupil lometer should be facing the rear of the docking Figure 2 4 station with the keypad and screen towards the front as shown in Figure 2 4 This will orient the terminals on the Pupillometer with the terminals in the base of the docking station and enable a posi tive connection PL2 IFU 01 Revision D May 10 2010 13 CAUTION Do not try to pull the device up out of the charging station without first rotating it forward to release Figure 2 5 PL2 IFU 01 Revision D May 10 2010 14 Section 3 Using the Device Powering On the Device and Menu Navi gation Insert the battery and make sure it is fully charged before first usage refer to Section 4 After the system has booted up which takes a few seconds the default measurement screen will display as shown in Figure 3 2A The main menu bar is displayed at the bottom of the default measurement screen and can be activated Figure 3 2B by pressing the down arrow of the direc tional keypad Figure 3 1 Each icon in the Menu Bar corresponds to a different function of the Pupillometer Notice that the key in the center of the keypad la beled with a solid circle is the SE LECT key Figure 3 1 PL2 IFU 01 Revision D May 10 2010 15 To activate the main menu bar press the down arrow key V Press Left or Right to start a new Scan Press Left or Right to start a new Scan ID 0 o9 20 ID 0 agran
21. meter into the Charging Station to charge the battery During charging a lightning bolt is overlaid on a blue battery icon a completely charged battery is shown with a lightning bolt overlaid on a full green battery icon when the device is kept in the charger Note Using the device when it is in red battery status is strongly discouraged Batteries should be recycled or disposed of in accordance with local ordi nances in force in your area Printer Maintenance The optional Seiko thermal printer is shipped with its own user s manual Please refer to it for instructions as to loading paper general use and safety PL2 IFU 01 Revision D May 10 2010 33 Section 5 Downloading and viewing re cords on an external computer All measurement data contained in the Pupillometer s memory can be downloaded to an external Windows based computer or laptop The download is initiated by selecting the red down arrow Download Records icon in the Browse Records sub menu Figure 3 10 Highlight the Download Records key in the Browse Records sub menu by using the up or down keys on the di rectional keypad and then press SELECT The downloading process is similar to that for printing records see Section Printing the Records This time the infrared window on top of the device should be pointed towards the infrared transceiver port in the external computer or any IrDA infrared USB adapter that can be found on the market
22. n the surfaces of the NeurOptics Pupillometer eye cup or charging station use a soft lint free wipe with a quaternary disin fectant or isopropyl alcohol IPA 50 IPA 50 water DO NOT immerse or drip liquids on to the Pupillometer or charging station DO NOT use acetone to clean any surface of the Pupillometer or charger The LCD window should be cleaned using a soft lint free wipe and IPA Clean the lens with lens cleaning solution and a lint free cloth Changing the Battery To maximize available battery reserve it is recommended that the Pupillom eter be stored in the connected charging station when not in use Lav A To change the battery open the housing compartment by pressing down to release the catch and pull ing outward Figure 4 1 Insert the battery with the terminals as indi cated on the label in the battery compartment Figure 4 1 PL2 IFU 01 Revision D May 10 2010 32 A battery status icon is visible on the main LCD screen which changes shape and color as the battery is depleted When the Pupillometer has a full charge the battery status icon is shown as fully green As the charge decreases the area inside the icon reduces and will eventually change into yellow D A severely depleted battery is displayed by the level indicator being reduced to the very bottom and the color changes to red A text message will appear which reads Please charge device C Place the Pupillo
23. ogram to access this file and incorporate its contents into a pre ferred computational or statistical platform NeurOptics can provide a Matlab script for this PL2 IFU 01 Revision D May 10 2010 34 OK pes Load Print Save ASCII Switch View Figure 5 1 PL2 IFU 01 Revision D May 10 2010 35 Appendix A Troubleshooting Issue Possible Reason Solution Device will not turn on Device will not turn on Device will not turn on Device will not turn on Battery will not charge Pupil measure ment will not initiate after release of the RIGHT or LEFT key Pupil measure ment will not initiate after release of the RIGHT or PL2 IFU 01 Using incorrect power supply Power cord is not fully plugged into the wall or the charging station Battery not installed correctly in device Battery completely dis charged Device is not placed in charging station cor rectly Device not held cor rectly Too much blinking or heavy makeup Revision D Use only power supply pro vided with pupillometer Check label on power supply Check connections Remove and replace following instructions in Instructions for Use IFU Verify that battery is installed correctly into the device Charge the battery by position ing the pupillometer into the charger see instructions in IFU Make sure to push device straight down into the charging station following instructions in th
24. onnel for servicing Using an inoperative device may result in inaccurate readings Electric shock hazard Do not open the device or the docking sta tion There are no user serviceable parts Refer all servicing to an authorized service technician Opening up the device will void the warranty Use only the specified lithium ion rechargeable battery P N BATPUP 01 in the Pupillometer Use only power adapters which are shipped with the NeurOptics Pupil lometer system Using unauthorized parts will void the warranty Use only the NeurOptics charging station for charging Pupillometer batteries Risk of fire or chemical burn The battery used in this device may present a risk of fire or chemical burn if mistreated Do not disassem ble heat above 100 degrees C incinerate or dispose of in fire Risk of fire or explosion Replace the Pupillometer battery with battery specified in Appendix B Use of another battery may present a risk of fire or explosion Dispose of battery promptly Keep away from children PL2 IFU 01 Revision D May 10 2010 Cautions The following cautions apply any time you work with the device A battery that is fully drained i e void of any charge may cause dam age to the device and should be replaced Be careful when removing the eyecup to ensure that you do not dam age the lens Make sure that you do not rotate the lens when fitting or removing the eyecup The following cautions apply when
25. open his her eyes as widely as possible or use your fingers to keep the eyelid open If the subject is wearing heavy eye makeup which may interfere with the scan hold the eyelid open as widely as possible The scan is complete when the message Capture Done is displayed on the LCD screen At that point the Pupillometer can be removed from the subject s eye When the analysis is complete the results screen will display as shown in Fig ure 3 5 WARNING If critical part s of the measurement are affected by a tracking problem e g blinks then results are all displayed in red font In this case the measurement results are not valid and should not be relied upon and the measurement should be repeated If the blink can be recovered by the analysis algorithm then measure ment results can still be evaluated and they are not displayed in red In this case the blink will be reported in the graph with a darker line connecting the two extremities of the blink PL2 IFU 01 Revision D May 10 2010 21 Time of 75 recovery after constriction Average dilation velocity Pupil diameter before and after light reflex Duration of light stimulation Figure 3 5 The results page shows a plot of the entire pupil waveform and reports the in formation listed below the portion of the pupil waveform corresponding to pe riod of stimulation can be magnified by pressing the SELECT key on the key pad e ID the id
26. qual to the background level then there will be no pupil reflex All of the dynamic variables described in Figure 3 5 are omitted Instead the mean and standard deviation of the pupil diameter evaluated over the entire duration of the experiment are provided in the results page PL2 IFU 01 Revision D May 10 2010 23 The short menu bar at the bottom of the results page can be activated with a press of the down arrow key v Three options are available S PLAY the pupil video of the measurement a to PRINT the current record see section below sd J A to DELETE the current record Note In case of a dark reflex measurement that is when the background illumi nation level DC is higher than the light stimulation intensity P and thus the eye is stimulated with a decrease or negative step of light the pupil responds with a dilation instead of a constriction In this case the variables ACV MCV and T75 are not reported in the result page The vari able INIT and END represents the diameter before the negative steps of light INIT and at the end of the corresponding dilation movement END INIT will be smaller than END If a blink occurred during or after the nega tive light stimulation then all variables will be reported in red PL2 IFU 01 Revision D May 10 2010 24 Continuous pupil recording The pupillometer allows acquisition of pupil diameter for a continuous and pro longed period of time If this option
27. r LEFT on the keypad depending on which eye is going to be measured Note The RIGHT or LEFT keys will initiate a scan from the default measurement screen only Figure 3 2A If the RIGHT or LEFT key is pressed during any other system mode the pupillometer will not initiate a new scan but in stead will return to the default measurement screen This is similar to the ESC escape key on a computer PL2 IFU 01 Revision D May 10 2010 19 Pupil Measurement A pupil measurement is divided into three distinct phases Figure 3 4 Hold down the LEFT Button Phase 1 Either the RIGHT or the LEFT scan button is pressed Video is enabled and dis played in the Pupil lometer LCD screen The user is required to hold the RIGHT or LEFT scan button down position the Pupillometer on the subject s eye and center the subject s pupil in the center of the field of view indi cated by the blue rectangular This is called the Targeting phase PL2 IFU 01 Release the LEFT Button when ready Phase 2 The Pupil lometer automati cally detects the pupil The pupil is marked with a green circle drawn around its perimeter Re lease the button when ready to initi ate the actual meas urement i e once the green circle ap pears around the pupil This is called the Ready phase Figure 3 4 Revision D Keep the Pupillometer in position Press LEFT again to abort Phase 3 When the RIGHT or LEFT scan but
28. resented with the same color Zs Eye blinks are easily discernable they are usually characterized by an abrupt drop of pupil tracking 4 ec The directional keypad is mapped into five different colors Orr Figure 3 6 PL2 IFU 01 Revision D May 10 2010 Subject Identification ID number To enable recall of subject data a Subject ID number may be entered before initiating a scan Assigning a Subject ID number is optional If not entered the new measurement will be associated to the latest and current ID which is al ways indicated in the default measurement screen Figure 3 2A To assign a new ID number or to change it select the ID bracelet icon on the main menu bar in the default measurement screen To enter a new ID press SELECT on the first menu selection New ID Figure 3 7 and the complete keyboard will be displayed in the screen Figure 3 8 Any combination of lower and upper case letters and numbers can be used to create a new ID up to a maximum of 9 digits or letters Numbers or letters can be se lected by navigating over the keyboard using the directional keypad and press ing SELECT on the Pupillometer keypad to select the current character or number or symbol In order to shift between lower and upper case letters and numbers select the Shift key Figure 3 8 Press the Enter key on the dis played keyboard once the new ID is completed The results of the subje
29. rinting hold the Pupillometer directly in front of the IR infrared win dow of the thermal printer as shown in Figure 3 10 A wireless connection is established with the printer through direct line of sight The printout is a text summary of the results page If you want to print a measurement other than the last measurement taken refer to the Browsing Records to View and Print section PL2 IFU 01 Revision D May 10 2010 27 Figure 3 10 Note The system will only print a record when data is displayed on the screen i e after a measurement or when browsing records Consult the printer s instruction manual for specific printer operating instructions PL2 IFU 01 Revision D May 10 2010 28 Browsing records to view and print Previous measurements can be browsed retrieved and printed selecting the folder icon in the main menu from the default measurement screen Browse catalog All Records The red down arrow icon option in the browse records menu Figure 3 11 serves to download Enter ID all records saved in the Pupillome ters memory to an external com puter via infrared IrDA Please refer to the Downloading and viewing records in an external computer section Download Records Figure 3 11 In the Browse catalog window Figure 3 11 you can select which subject to browse and print You can decide to browse all records in memory All Re cords Figure 3 11 or a speci
30. sk the subject to keep his head straight and both eyes wide open during both targeting and measurement In some cases if target ing becomes a problem it may be necessary to gently hold the subject s eye open with your finger e The operator should position the instrument at a right angle to the subject s axis of vision and any tilting of the instrument should be minimized Figure 3 3A e t may be helpful for the operator to be at the same level as the subject when performing the scan to minimize tilting If neces sary both subject and operator can sit down facing each other during targeting and measurement PL2 IFU 01 Revision D May 10 2010 17 Good alignment tilting is mini mized Figure 3 3B PL2 IFU 01 Poor alignment Poor alignment device is tilted device is tilted Figure 3 3A Pressing the RIGHT or LEFT button activates the Targeting phase Press and hold down the RIGHT or LEFT button and keep the Pupillom eter snugly up to the subject s eye During this phase a video image of the eye is displayed in the LCD win dow The subject s pupil must be centered within the field of view Figure 3 3B Revision D May 10 2010 18 Initiating the SCAN A measurement can only be taken from the measurement screen Figure 3 2A To return to the main menu screen from any other window menu or submenu press RIGHT or LEFT on the keypad To initiate a new scan from the measure ment screen press RIGHT o
31. sted 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 described in this manual 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 Intended Use Notice The NeurOptics Pupillometer is a handheld optical scanner which captures and analyzes a digital video of the human pupil responding to light stimulation It should only be operated by properly trained personnel The results obtained from the pupillometer scans are used for information only and are not to be used for any diagnostic process PL2 IFU 01 Revision D May 10 2010 Regulatory Notice Federal law restricts the sale of this device except by or on order of a physician Classification Type of Equipment Medical Equipment Class 1 886 1700 Trade names NeurOptics PLR 2000 Pupillometer Manufactured by NeurOptics Inc 2082 Michelson Drive Suite 450 Irvine CA 92612 USA If you have a question regarding this product please contact NeurOptics at one of the numbers given in
32. ter utilizes the NeurOptics VIP Vertex Invariant Pu pillometry technology which reduces or eliminates the impact of vertex dis tance on pupillometry measurements PL2 IFU 01 Revision D May 10 2010 Appendix D Specifications 39 NeurOptics Pupillometer Model PLR 2000 Measurement Human pupil size varying from 1 mm uk 9mm Characteristic Max and Min diameter latency aver age and maximum constriction veloc ity average dilation velocity time to 75 recovery Accuracy 0 1mm Type of protection See Battery Charger Class Il Degree of protection Pupillometer Eyecup Type BF Applied Part provided against Electric Shock protection Classification of the Ordinary equipment equipment against in gress of liquids Degree of safety of appli The equipment is not an AP or APG category equip cation in the presence of ment a flammable anesthetic mixture with air or with oxygen or nitrous oxide Mode of Operation On Demand battery operation Power Supply 4 2V 1800mAmp hour Li lon Cell battery 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 Sto Temperature 0 C 32 F to 75 C 167 F rage Environment Relative Humidity 10 to 95 RH Non condensing at all times Dimensions With Eyecup 8 3 211 mm x 1 3 83 mm x 4 5 114 mm Without Eyecup 7 5 191 mm x 1
33. ton is released the actual pupil recording is initiated Keep the Pupil lometer firmly on the subject s eye for the entire duration of the recording Do not move or remove the device during this period of time If you need to abort the measurement then press the RIGHT or LEFT button again Once the measurement is complete a message Capture Done will be displayed at the bottom of the screen At this point the device can be removed from the eye This is called the Meas urement phase May 10 2010 20 If no pupil is found and detected in the field of view during the Targeting Phase the Pupillometer will not transition to the next Ready Phase and the pupil scan cannot be initiated The Targeting and Measurement phases take a few seconds depending on the duration of the Targeting phase during which time the subject s eye should be wide open with no blinking While the measurement is being recorded hold the Pupillometer as still as possible against the orbital rim minimizing any tilting until the message Capture Done is displayed on the screen Refer to Figure 3 3A WARNING If the green pupil boundary circle is NOT centered on the pupil perimeter during the Targeting phase do not release the scan RIGHT or LEFT button At the end of the Measurement phase the scan results will display almost imme diately If the subject s eyelid is closed or droopy instruct the subject to
34. ttings for the date and repeat the same steps for set ting the time whose keyboard is automatically displayed after date has been set Note that time is in 24 hour format i e from 00 00 to 23 59 stimulation and its duration Once an option has been se a lected to change the corresponding value press the left or right arrow keys on the keypad to toggle back and forth between different possible values Il TT These two options allow you to change the onset of the light US These three options allow you to change 1 the dura Ht tion of the measurement from a minimum of 2 7 sec onds to a maximum of 23 seconds 2 the level of the stimulating light expressed in microwatts for a maximum light strength of 180 u W and 3 the background light illumination In case of a dark reflex the background illumination can set higher than the pulse strength in this case the duration of the stimulation must be at least one sec In case of a static measurement background can be set equal to the strength of the pulse and the first two options are automatically disabled Remember that the onset of the light stimulation must be at least three sec onds before the end of the measurement Any erroneous settings of the light stimulation for example a pulse duration shorter than one second in case of a dark reflex will be automatically prevented by the software PL2 IFU 01 Revision D May 10 2010 30 This option allows you to save
35. uperimposed over the pupil plot e ACV and MCV are the average and the maximum constriction velocity and they are given in millimeters second respectively The negative sign is to differentiate the constriction from the opposite pupillary movement that is dilation Both velocities refer to the constricting movement of the pupil diameter responding to the flash of light e ADV is the dilation velocity given in millimeters second and represents the average pupillary velocity when after having reached the peak of the constriction the pupil tends to recover and to dilate back to its initial resting size Pupillary recovery after a light reflex constriction is usually character ized by an initial and more rapid phase followed by a much slower converg ing movement The dilation velocity reported here refers to the initial and stronger recovery and is indicated in the graph see example in Figure 3 5 by a green line fit to the corresponding dilation phase of the pupil profile If a blink occurred during the dilation this variable might not be displayed e 175 is the total time taken by the pupil to recover 75 of the initial resting pupil size after it reached the peak of constriction It is given in seconds 0 80 in the example and is represented by a vertical blue line superim posed on the pupil plot Figure 3 5 If a blink occurred during the dilation this variable might not be displayed Note If the level of the light stimulation is e
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