Instructions for Use
Contents
1. Figure 3 12 or a specific SEE al Records patient ID number Enter ID Figure 3 12 For convenience the Browse catalog lists the 100 most recent patient ID numbers so that the opera Enter ID tor can select directly from the catalog without hav ing to re enter the Patient ID using option Enter Patient ID All records corresponding to the ID specified in the Browse catalog window will be displayed as in Figure 3 5 Review of each single record is possi ble using the right and left arrow keys in the direc tional keypad Figure 3 1 Each time a record is displayed in the LCD the record can be printed by selecting the printer icon on the menu bar located at Figure 3 12 the bottom of the record display NPi IFU 01 Revision June 29 2015 29 This window allows the user to Enable w or disable wo the printout of the pupil graph Press the SELECT key to toggle between these two options if print of pupil graph is disabled wo then only the pupil variables will be printed and printing is faster Test the white visible LEDs When this option is selected the four white LEDs are briefly flashed This test should be repeated regular ly to ensure that the pupil light stimulation is fully functional The four white LEDs are also flashed every time the device is turned on see page 16 Dim the LCD backlight illumination Press the SELECT key to toggle between different backlight illuminati2. 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 one hour of inac tivity 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 NPi IFU 01 Revision June 29 2015 15 To activate the main menu bar press the down arrow key w Press Left or Right to start a new Scan Fress Left or Right to start a new Scan ID 0 ID 0 1 1 Es DOH 2008 UUS JEU So ON 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 submen lighted will have a square us and return to the de frame drawn around it To fault measurement highlight a different icon use screen press the LEFT the left or right arrow keys on or RIGHT key on the key the key lt pad pad Once the desired icon has been highlighted press the SELECT key on the keypad to select that icon NPi IFU 01 Revision June 29 2015 16 or placing the device into the charging station Every time the device i
3. with green is to remember that both words have the letter R NPi IFU 01 Revision June 29 2015 17 Poor alignment Poor alignment Good alignment device is tilted device is tilted Figure 3 3A Pressing the RIGHT or LEFT button activates the Targeting phase see next Section Press and hold down the RIGHT or LEFT button and keep the Pupillometer snugly up to the patient s eye During this phase a video image of the eye is displayed in the LCD window The patient s pupil must be centered within the field of view within the blue rectan gle Figure 3 3B Revision June 29 2015 18 Initiating the SCAN A measurement can only be taken from the default measurement screen Figure 3 2A To return to the default measurement screen from any other window menu or submenu press RIGHT or LEFT on the keypad To initiate a new scan from the measurement screen press RIGHT or 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 meas urement 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 instead will return to the default measurement screen This is similar to the ESC escape key on a computer NPi IFU 01 Revision June 29 2015 19 Pupil measurement A pupil measurement is divided into three distinct p
4. Instruction Manual NeurOptics NPi 100 Pupillometer NPi IFU 01 Revision June 29 2015 Symbol Source Compliance ATTENTION consult ACCOMPANYING Symbol 03 02 IEC 60878 DOCUMENTS g 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 5007 IEC 60417 ae Symbol 01 01 IEC 60878 Ndicates ON Power Symbol 5008 IEC 60417 Symbol 01 02 IEC 60878 Indicates OFF Power Indicates Intermittent Use e Indicates Non sterile Serial Number Model Number Lot Number NPi IFU 01 Revision June 29 2015 Table of Contents NOTICE a a os 4 SAC RMIOIMA NON ed one il eines 5 Section 1 INOQUCHON ere Ro Mantes 8 Section 2 Unpacking amp Setup 9 Cnam hd bonne 9 Atlaching tne TACAQIOSE iranien nnii 10 Connecting the Charging Station 11 Charging the Pupillomete r ccccsssscscescessssssssssssssssssessessesssssssassaseasess 12 Section 3 Using the Device Powering On and Menu Navigation 14 Taking a Measurement 16 Paten JO NUMMDL nant anodin dns 25 PANUNG INO RKOCONIS nn hier lande 26 Browsing Records to View and Print 28 MENVODIONS Nc a ne date 29 Section 4 Cleaning and Maintenance CIGARE RS a ne a on 31 Changing the Battery sn nee 31 Panter Maintenant anina none a E A RAN 32 Appendices Appendix A Troub
5. The device will not be able to scan the eye unless the headrest is attached The headrest has a tab in the rim which fits into the indenta tion in the lens shield of the Pu pillometer Position the tab in the headrest rim into the indent in the lens shield and press into place The tabs on either side of the lens shield should also snap into the holes on either side of the headrest The headrest fits onto the Pupillometer as shown in Figure 2 2A The headrest is disposable and it should be changed for each patient for hy gienic reasons To order additional headrests call the number given in Appendix B and request part number NPi100 HR WARNING Pupil measurements are not enabled when the headrest is not properly fitted onto the Pupillometer NPi IFU 01 Revision June 29 2015 11 CAUTION Do not touch the lens when fitting or removing the headrest Damage to the lens may result When the headrest is correctly posi tioned the contour of the headrest should be aligned as shown in Figure 2 2B Connect the NeurOptics medical grade 6 volt power supply included with your system to the center plug in the charging station as shown in Fig ure 2 3 Connect the power supply to a suitable AC outlet After a second you should see a blue LED illuminate on the plug of the power supply and a green LED on the front of the charg ing station The other 2 plugs in the back of the charging station are for N
6. icon on the top right corner of the default measurement screen to the left of the battery icon Figure 3 6 Note Measurements can be taken in any order left right or right left but they must be taken less than one minute apart and they must both be valid measurements The date and time of the pair corresponds to the latest measurement in the pair The text color of date and time and ID indicates which was the latest pupil measured in the pair in the example above Figure 3 6 it was the left pupil and consequently the ID and date and time are displayed in yellow at the top of the screen NPi IFU 01 Revision June 29 2015 24 Patient Identification ID number To enable recall of patient data a Patient ID number may be entered before initiating a scan Assigning a Patient ID number is optional If not entered the new measurement will be associated with the latest and current ID which is always indicated on the default measurement screen Figure 3 2A The Pupil lometer will list the last 100 ID s entered To assign a new ID number or to change it select the ID bracelet icon on the main menu bar in the default meas urement screen 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 to PLAY the video of the latest measurement af to PRINT the current record see section below KN to DELETE the current record In the case
7. of paired measurements the corre sponding video will play the two pupils in sync and side by side in the same window Figure 3 7 This dual video is aligned such that the center of the two pupils is at the same height The extent of the two pupil diameters is indicated by horizontal lines of different colors and they serve to better visualize differences in size between the two pupils The video can be stopped SELECT key on the keypad and advanced one frame forward or back ward using the right or left arrow keys on the key pad 2 0 MS A vertical bar will scroll from left to right over the Playing two pupil graphs as the dual video progresses in time see the plot at the bottom Figure 3 7 Figure 3 7 To Only the last measurement s video can be played enter anew ID press SE back Once the device has been turned off the last LECT on the first menu video is not accessible NPi IFU 01 Revision June 29 2015 25 option New ID Figure 3 8 and the complete keyboard will be displayed in the screen Figure 3 9 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 let ters Numbers or letters can be selected through the touch screen interface by pressing the corresponding character or number displayed on the screen Also characters can be input by navigating over the keyboard using the direc tional Keypad and pressing SELECT on the Pupillome
8. 191 mm x 2 65 67 mm x 4 65 118 mm Without Headrest 7 5 191 mm x 2 65 67 mm x 3 65 93 mm Classification Class 1 LED product per IEC 60825 NPi IFU 01 Revision June 29 2015 38 Accessories NeurOptics Charging Station Model NPi 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 of liquids Degree of safety of appli The equipment is not an AP or APG category equip cation in the presence of a 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 Power Line Frequency 50 60 Hz Seiko thermal printer Optional See separate owners manual for Model NEUR PRTE445 instructions 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 NPi IFU 01 Revision June 29 2015 NPi IFU 01 Revision 39 June 29 2015
9. 2015 WARNING 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 patient s eye should be wide open with no blinking While the measurement is being recorded hold the Pupillometer as still as possible minimizing any tilting until the measurement results are 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 as shown in Figure 3 5A Press the Select button to change to the graph view as shown in Figure 3 5B If the patient s eyelid is closed or droopy the patient should be instructed to open his her eyes as widely as possible or the operator can use his her fingers to keep the eyelid open If the patient is wear ing heavy eye makeup which may interfere with the scan hold the eyelid open as widely as possible ID 100 2012 05 21 11 29 46 _ 2012 05 21 11 29 46 0 02 0 05 0 02 mm 0 05 mm Figure 3 5A Figure 3 5B NPi IFU 01 Revision June 29 2015 21 If the init
10. 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 NPi IFU 01 Revision June 29 2015 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 NPi 100 Pupillometer Manufactured by NeurOptics Inc 18101 Von Karman Avenue Suite 1940 Irvine CA 92612 USA If you have a question regarding this product please contact NeurOptics at one of the numbers given in 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
11. OT submerge the device or pour cleaning liquids over or into the device DO NOT use acetone to clean any surface of the pupillometer or charging station NPi IFU 01 Revision June 29 2015 Section 1 Introduction The NeurOptics NPi 100 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 system acquires images using a self contained infrared illumination source and a digital video camera It analyzes the cap tured image data and displays a summary of the measurement in the LCD window Data may also be printed out on an optional thermal printer The NeurOptics NPi 100 Pupillometer uses a menu driven graphical user interface GUI with a color LCD screen for data display A keypad com pletes the user interface and enables manual entry of individual subject identification ID numbers and other information The Pupillometer is powered by a 3 7 volt rechargeable lithium ion battery Pupillary data sampled at 32fps and for a total duration of 2 7 seconds 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 and a charging station and power supply The Pupillometer must also be used with the headrest Options are li
12. als on the Pupillometer with the terminals in the base of the charging station and enable a correct electrical connection Press Left or Right The arrow indicates the charging status light for to start a new Scan the Pupillometer ID 9267 Note IF THE LIGHTNING BOLT superimposed over the battery icon IS NOT VISIBLE while placed in the charging station THE DEVICE IS NOT CHARG ING Figure 2 5 Figure 2 5 NPi IFU 01 Revision June 29 2015 13 CAUTION Do not try to pull the device up out of the charging station without first rotating it forward to release Section 3 Us ing the Device Figure 26 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 by holding the up arrow key down for a few seconds or placing the device into the charging station which takes a NPi IFU 01 Revision June 29 2015 14 dew 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 Y of the direc tional keypad of the Pupillometer Figure 3 1 Each icon in the menu bar corre sponds to a different function of the Pupil lometer Notice that the key in the center of the keypad labeled with a solid circle isthe SELECT key Figure 3 1
13. eurOptics use only Figure 2 3 WARNING Use ONLY NeurOptics Part number NEUR PWR1 01 power sup ply with the NeurOptics Charging Station The Pupillometer may be damaged if an incorrect power supply is used NPi IFU 01 Revision June 29 2015 12 Charging the Pupillometer Install the Pupillometer battery into the Pupil lometer see Section 4 The battery must be fully charged prior to first use This may take up to four hours The battery status is indicated by the battery 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 blue lightning bolt symbol indicating that the device is properly connected to the charging station When removing the Pupillometer from the charg ing station do not pull straight up First rotate the A device forward and once it releases then pull it up See Figure 2 6 When the Pupillometer is properly positioned in the charging station for charging the headrest on the Pupillometer should be facing the rear of the charging station with the keypad and screen to wards the front as shown in Figure 2 4 This will orient the termin
14. hanges shape and color as the battery is depleted When the Pupillometer has a full charge the battery status icon is shown as fully green i As the charge decreases the area inside the icon reduces and will eventually change into yellow 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 Place the Pupillometer 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 indicated with a lightning bolt overlaid on a green battery icon when the device is kept in the charger See Fig ure 2 5 Note Using the device when it is in red battery status is strongly discour aged Batteries should be recycled or disposed of in accordance with lo cal ordinances 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 NPi IFU 01 Revision June 29 2015 Appendix A Troubleshooting 33 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 Targeting phase will not initiate after pressing the RIGHT or LEFT key Pupil measurement
15. hases Figure 3 4 Keep the Pupillometer in position Press LEFT again to abort Hold down the LEFT Button Release the LEFT Button when ready Phase 1 Either the RIGHT or the LEFT Phase 2 The Pupil lometer automatical Phase 3 When the RIGHT or LEFT scan button is released the actual pupil recording is initiated Keep the Pupil lometer firmly on the pa tient s eye for the entire duration of the recording which lasts 2 7 seconds scan button is pressed Video is enabled and dis played in the Pupil lometer LCD screen The user is required ly detects the pupil The pupil is marked with a green circle drawn around its perimeter The oper ator can now release to hold the RIGHT or LEFT scan button down position the Pupillometer on the the button when ready to initiate the actual measurement i e once the green Do not move or remove the device during this period of time If you need to abort the meas urement then press the RIGHT or LEFT button patient s eye and center the patient s pupil in the center of circle appears around the pupil This is called the the blue rectangle in Ready phase again Once the meas the field of view This urement is complete the is called the Target results will appear on the ing phase LCD screen At this point the device can be re moved from the eye This is called the Meas urement phase Figure 3 4 NPi IFU 01 Revision June 29
16. ial part of the measurement was affected by a tracking problem e g blinks then measurement results are all displayed in red font on the results screen In this case the measurement results are not valid and should not be relied upon and the meas urement should be repeated If pupil data can be recovered by the analysis algorithm then measurement results can still be evalu ated 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 Figure 3 5C The results screen reports a number of pupillary variables ID the identification code of the patient measured for example 0 in Figure 3 5A which eye was measured and the date and time of the meas urement NPi is the Neurological Pupil in dex and it measures the level of the pupillary light reaction per the NeurOptics NPi algorithm The between 0 and 5 and ed value ranges can be trend 1 An NPi E value equal to or above 3 indicates Fiaure 3 5C that the intensity of the pupil response falls within gn the range of a NeurOptics normal population Within this range in a given patient NPi values closer to 3 are weaker than NPi values closer to 5 Look for trends up or down 2 An NPi value below 3 indicates weaker responses compared to the NPi IFU 01 Revision June 29 2015 22 NeurOptics normal population 3 If dashes a
17. ice 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 NPi IFU 01 Revision June 29 2015 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 headrest to ensure that you do not dam age the lens Make sure that you do not rotate the lens when fitting or removing the headrest The following cautions apply when 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 Gam ma DO N
18. leshooting sccsccescescessetsessesssssssscsssssssasessesssssseasees 33 Appendix B Contact amp Ordering Information 35 Appendix C Phenomena Affecting Pupillary Measurement 36 Appendix D SNOCIICANONS srs32 vesaciieesdasd ots sents svncsbhaes ventsancede debi neterabesesets 37 Accessories and Returned Goods Policy 38 NPi IFU 01 Revision June 29 2015 4 Copyright and Trademark Notice Copyright 2015 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 NPi 100 are trademarks of NeurOptics Inc Seiko is a trademark of Seiko Instruments Inc EMC Notice NeurOptics NPi 100 Pupillometer device generates uses and can radiate radio frequency energy If not set up and used in accordance with the instruc tions in this manual electromagnetic interference may result The equipment has been tested and found to comply with the limits set forth in EN60601 1 2 for Medical Products These limits provide reasonable protection against electro magnetic interference when operated in the intended use environments e g hospitals research laboratories described in this manual MRI
19. on levels and then press RIGHT or LEFT to save and exit Change the Pupillometer date and time If selected the numeric keyboard will be displayed on the LCD Figure 3 9 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 cor rect settings using the directional keypad of the Pupillometer Figure 3 1 Select Enter on the LCD to save the new settings for the date and repeat the same steps for setting the time whose keyboard is automatically dis played after date has been set Note that time is in 24 hour format i e from 00 00 to 23 59 Daylight saving time needs to be set manually Enable or disable the pairing display feature When pairing is ena bled this icon is displayed in the default measurement screen to the left of the battery icon Warning If one of the four white LEDs stops working the device should not be used as this will affect measurement results Contact NeurOptics Customer Service immediately for assistance NPi IFU 01 Revision June 29 2015 30 gt Play Video Video of the latest measurement either a single one or a pair in case pairing was enabled and two last measurements could be paired can be played also from the default measurement screen selecting this icon in the main menu bar Power Off This icon is for turning the device off The Pupillometer will ask you for confir mation befo
20. 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 NPi IFU 01 Revision June 29 2015 6 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 personnel for servicing Using an inoperative device may result in inaccurate readings Electric shock hazard Do not open the device or the charging sta tion There are no user serviceable parts Refer all servicing to a NeurOptics authorized serv
21. re performing this operation The device can be powered back on by pressing the up arrow key for 3 continuous seconds or by placing the device into the charging station NPi IFU 01 Revision June 29 2015 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 Neu rOptics Pupil lometer system as sterilization may damage the device To clean the surfaces of the NeurOptics Pupillometer or charging station use a soft lint free wipe with a quaternary disinfectant 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 charging station 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 Pupillome ter be stored in the connected charging station when not in use 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 indicat ed on the label in the battery com partment Figure 4 1 NPi IFU 01 Revision June 29 2015 32 A battery status icon is visible on the main LCD screen which c
22. re reported the pupil response did not follow typical light reflex behavior as defined by the NeurOptics algorithm and all the other variables are also reported with dashes This might be due to a nonre sponsive pupil or a response smaller than the optical capacity of the de vice or other measurement factors The operator should repeat the meas urement and check the presence of a response by zooming in on the pupil profile by pressing the SELECT key on the keypad Zooming is recom mended for very small pupils whose response may be difficult to see on the main results screen If a blink occurred anywhere during the measurement NPi is reported as bink MAX represents the maximum pupil diameter before constriction MAX 3 54 mm in this example right pupil MIN is the pupil diameter at the peak of constriction MIN 2 48 mm in this example Both are reported in millimeters The variable CH is the percent of the change MAX MIN MAX as a percent LAT is the latency and it represents the time of the onset of the con striction It is given in seconds for example 0 25 seconds in Figure 3 5A CV and MCV are the average and the maximum constriction velocity and they are given in millimeters second respectively in the example 2 92 mm s and 3 69 mm s Both velocities CV and MCV refer to the con stricting movement of the pupil diameter responding to the flash of light DV is the dilation velocity given in millimeter
23. rint Record will not print Video will not play Patient ID number is not displayed NPi IFU 01 Device not held correctly Device was removed from the eye too earl Excessive blinking Excessive movement of user s hand or patients head Pupillometer held too far away from printer or not in line of sight of IR window of printer Measurement to print is not shown in the active screen Pupil video record not present in memory Enter key on screen keyboard not pressed after entering Patient ID Revision Hold device at a 90 degree angle to patient s face Make sure patient s eye is centered on the screen Hold device in place during the meas urement phase until a text message on the screen reads Measurement Done Gently hold the patient s eyelid open and repeat the measurement Repeat the measurement Printer must be held in direct line of sight of the infrared port in the pupillometer See instructions in IFU Browse to find record to print then follow instructions in IFU Perform and complete a pupil measure ment Select and press Enter on screen key board after entering patient ID number June 29 2015 35 Appendix B Contact amp Ordering Information The following options and accessories can be ordered from NeurOptics NPi 100 NEUR PWR1 BL NPi CHG 01 BATPUP 01 NPi100 HR NEUR PRTS445 NEUR PRTPSUS NEUR PRTCBUS 49006 NEUR CASE 02 NEUR 2020 01 NeurOptic
24. s Pupillometer US Pupillometer Charging Station Power Supply US NeurOptics Pupillometer Charging Station NeurOptics Pupillometer Rechargeable Battery NeurOptics Pupillometer Headrests 24 pack box Seiko Printer Seiko Printer Power Supply US Seiko US Printer Cable Seiko Printer Paper NeurOptics Pupillometer Carrying Case NPi Touch Screen Stylus For more information please contact NeurOptics or visit www NeurOptics com NEUR lt PTICS Distributed by NeurOptics Inc US Customer Service 18101 Von Karman Avenue Suite 1940 Irvine CA 92612 USA Tel 1 949 250 9792 or 866 99 PUPIL Fax 1 949 250 9796 info NeurOptics com NeurOptics com NPi IFU 01 Revision June 29 2015 36 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
25. s second and repre sents 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 1 05 mm s in the example Figure 3 5A Note If a variable could not be measured for example if no pupillary movement is detected after light stimulus then its value is reported with dashes When in doubt repeat measurement and watch the video playback Correlate findings with a proper neuro assess ment and in the context of any drugs that have been administered to the patient NPi IFU 01 Revision June 29 2015 23 Pairing of measurements Two consecutive measurements taken on two different pupils left and right within a period of 1 minute apart are paired which means that they are dis played together in the same results screens as indicated in Figure 3 6 A third column representing the difference between the two measurements is added Pairing is a display feature intended to facilitate the comparisons between the two eyes Pairing is the default and preferred setting To disable pairing refer to the instructions for Settings on page 29 Note the two pupil graphs at the bottom of the results screen that are overlapped on the same plot in order to facilitate comparisons Remember that the green plot is for the right pupil and the yellow plot is for the left pupil The pairing feature is indicated with the double folders
26. s turned on the four white LEDs will flash briefly Taking a Measurement Patient and environment preparation Below are a few general instructions e Ifthe patient is awake and conscious ask the patient to keep his head straight and both eyes wide open during both targeting and measurement Instruct the patient to look straight or to focus with the eye that is not being tested on an object in the distance e When the patient is not awake or in those cases when targeting becomes a problem it may be necessary to manually and gently hold the patient s eyelid open e The operator should position the instrument at a right angle to the patient 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 patient when performing the scan to minimize tilting If necessary and feasible both patient and operator can sit down facing each other during targeting and measurement Results Screen Note The results of a measurement of the right pupil are reported in the left column and the results of the left pupil in the right column Figure 3 5A This is to maintain consistency with the apparent ori entation of the patient s two eyes with respect to the operator s point of view The results of the two eyes are also differentiated by color green for the right pupil and yellow for the left pupil A helpful mnemonic rule to associate right
27. sted in Appendix B and can be or dered separately Features e The NeurOptics NPi 100 Pupillometer has been designed to be a lightweight device with a small footprint e The device has the capacity to store approximately 3 000 measure ments e The optional Seiko thermal printer enables hard copy printing of re sults NPi IFU 01 Revision June 29 2015 Section 2 Unpacking and Setup International Plug Charging Station Adapter Optional FL p _ n Spare Battery Optional Touch Screen Stylus Charging Station 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 Medical grade power supply for the charging station e The charging station e Touch Screen Stylus 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 NPi IFU 01 Revision June 29 2015 10 Attaching the Headrest The Pupillometer should not be used without the headrest positioned correct ly Figure 2 2A It is very important that the headrest be correctly fitted It helps the correct and firm posi tioning of the Pupillometer in front of the patient s eye
28. ter 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 9 You must press the Enter key on the displayed keyboard once the new ID entry is com pleted The results of the patient s next scans will be stored under f this ID number le IES New ID a Figure 3 8 Figure 3 9 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 8 see IDs 3 2 and 1 These IDs can be selected by using the directional key pad arrow up and arrow down and then pressing SELECT This function is useful for immediately re entering a Patient ID already in memory without the necessity of typing it again Printing the Records Attach the power supply to the printer as shown in Figure 3 10 Turn the printer on and the green light will illuminate The patient record currently displayed in the results window 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 NPi IFU 01 Revision June 29 2015 26 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 11 or if the printer is not turned on
29. the NeurOptics Pupillometer utilizes the NeurOptics VIP Vertex Invariant Pu pillometry technology which reduces or eliminates the impact of vertex distance on pupillometry measurements NPi IFU 01 Revision June 29 2015 Appendix D Specifications 37 NeurOptics Pupillometer Model NPi 100 Measurement Human pupil size varying from 1 mm oat 9mm Characteristic NPi Neurological Pupil index Max and Min diameter latency aver age and maximum constriction veloci ty average dilation velocity Accuracy 0 03mm Type of protection See Battery Charger Class Il against electric shock Degree of protection Pupillometer Headrest Type BF Applied Part provid against Electric Shock ed 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 3 7V 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 me Relative Humidity 10 to 95 RH Non condensing at all times Dimensions With Headrest 7 5
30. 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 Figure 3 10 message will appear It will take only few seconds for a single record to print During printing hold the Pupillometer directly in front of the IR infrared win dow of the thermal printer as shown in Figure 3 11 A wireless connection is established with the printer through direct line of sight The printout is a text summary of the results page For printing a measurement other than the last measurement taken refer to the Browsing Records to View and Print sec tion NPi IFU 01 Revision June 29 2015 27 Note The sys tem will only print a record when data is displayed on the screen i e after Figure 3 11 a measurement or when browsing records Consult the printer s instruction manual for specific printer opera tion instructions Menu Options The main menu bar provides a few more functions NPi IFU 01 Revision June 29 2015 28 Browsing records to view and print Previous measurements can be browsed retrieved and printed by selecting the folder icon in the main menu from the default measurement screen g In the Browse catalog window Figure 3 12 it is possible to select which patient to browse and Browse Single Record print One option available is to browse all records in memory All Records
31. will not initiate after release of the RIGHT or LEFT ke NPi 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 correctly The headrest is not mounted on the pupillometer Too much blinking or heavy makeup Revision Use only power supply provided with pupillometer Check label on power supply Check connections Remove and replace following instruc tions in Instructions for Use IFU Verify that battery is installed correctly into the device Charge the battery by positioning the pupillometer into the charger see instructions in IFU Make sure to push device straight down into the charging station follow ing instructions in the IFU and that a lightning bolt symbol is displayed on the battery icon Make sure to properly attach the head rest as indicated in the IFU Gently hold patient s eye open with your finger during measurement June 29 2015 34 Issue Possible Reason Solution _ _ Pupil measurement will not initiate after release of the RIGHT or LEFT key The variables are displayed in red font on the measure ment results screen The variables are displayed in red font on the measure ment results screen The variables are displayed in red font on the measure ment results screen Record will not p
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