here - Neuroptics
Contents
1. 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 pressing the up arrow key for 3 continuous seconds until a beep is heard or by placing the device into the charging station V2P IFU 01 Revision C July 1 2015 28 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 Pupillometer sys tem as sterilization may damage the device To clean the surfaces of the NeurOptics Pupillometer eye cup or charging station use a soft lint free wipe with a quaternary disinfectant or isopropyl alco hol IPA 50 IPA 50 water DO NOT immerse or drip liquids on to the Pupillometer or charging sta tion 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 Pupillometer 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 batte2. er via an infrared port IrDA The NeurOptics VIP 200 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 patient identification ID numbers The Pupillometer is powered by a 3 7 volt rechargeable lithium ion battery Pupillary data sampled at 30fps and for a total duration of 2 seconds is used in the calculation and the final display shows the average and standard devi ation of the pupil size during the 2 seconds of measurement in Light Off mode Under Variable mode pupil diameter is measured under three dif ferent background light conditions Scotopic light off Low Mesopic 0 3 lux and High Mesopic 3 lux The NeurOptics system includes a Pupillometer a rechargeable battery two reusable eye cups and a charging station Options are listed in Appen dix B and can be ordered separately Features e The NeurOptics VIP 200 Pupillometer has been designed to be a lightweight device with a small footprint e To compensate for pupillary unrest the device tracks and averages pupillary information for approximately two seconds 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 V2P IFU 01 Revision C July 1 2015 Section 2 Unpacking and Setup International Plu
3. thermal printer Optional See separate owners manual for instruc tions Model NEUR PRTS455 V2P IFU 01 Revision C July 1 2015 36 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 statuto ry 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 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 i
4. which eye OD or OS was meas ured The short menu bar at the bottom of the results page can be activated with a press of the down arrow key vw Three options are available To PLAY the pupil video of the measurement Light Off mode only To PRINT the current record see the Printing the Records section below To DELETE the current rec ord 4 amp The results page in Variable mode Figure 3 6 shows the diameter of the pupil DIA and the standard deviation std of pupil diameter measured dur ing the scan at three different light levels Scoptic Light Off Low Mesopic 0 3 lux and High Mesopic 3 lux It also includes the ID num ber of the subject if set the date and time of the measurement and finally which eye OD or OS was meas ured Low Mesopic simulates lighting condi tions such as moon illumination driv ing at night outside of urban areas or a dimly lit room High Mesopic simu lates conditions such as moderate night streetlights or early twilight Revision C July 1 2015 22 Patient Identification ID number To enable recall of patient data a Patient ID number may be entered be fore initiating a scan Assigning a Patient ID number is optional Measure ments can be taken without assigning a Patient ID number To assign an ID number from the default measurement screen press the down arrow on the keypad and select the ID bracelet icon by pressing the SELECT key once th
5. 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 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 Pu pillometer 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
6. 9 The patient record currently displayed in the results window Figure 3 5 and 3 6 can be printed by activating the short menu bar at the bottom of the results page Figure 3 5 and 3 6 and the 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 a few seconds for a single record to print During printing hold the Pupillometer directly in front of the IR infrared window 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 eye diame ter std date and time If you want to print a measurement other than the last measurement taken refer to the Browsing Records to View and Print section V2P IFU 01 Revision C July 1 2015 24 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 rec ords Consult the printer s instruction manual for specific printer op eration instructions V2P IFU 01 Revi
7. Ready phase Figure 3 4 Revision C Keep the Pupillometer in position Phase 3 When the OS or OD scan button is released then the actual pupil recording is initiated Keep the Pupillometer firmly on the subject s eye for the entire duration of the recording which lasts 2 seconds approx 12 seconds in Variable mode Do not move or remove the device while the bracket is visible Once the measure ment is complete the bracket will disappear and the result will be displayed At this point the device can be removed from the eye This is called the Measurement phase July 1 2015 19 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 patient s eye should be wide open with minimal blinking While the measurement is being recorded hold the Pupillometer as still as possible against the orbital rim minimizing any tilting until the results are displayed on the screen Refer to Figure 3 3A At the end of the Measurement phase the scan results will display almost imme diately If the analysis fails the Pupillometer displays an error message Pupil Not Detected Refer to Troubleshooting Section in Appendix A When the measurement for the fir
8. specifically permitted under U S Copyright law without the prior writ ten consent of the Company NeurOptics and VIP are trademarks of NeurOptics Inc Seiko is a trademark of Seiko Instruments Inc EMC Notice NeurOptics VIP 200 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 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 series of digital images to obtain a measurement of the diame ter of a human pupil It should only be operated by properly trained clinical per sonnel under the direction of a qualified physician The results obtained from the pupillometer scans are used for information
9. 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 directional keypad Figure 3 1 Each icon in the Menu Bar corresponds to a different function of the Pupillome ter Notice that the key in the center of the keypad labeled with a solid circle is the SELECT key Figure 3 1 V2P IFU 01 Revision C July 1 2015 17 To activate the main Menu Bar press the down arrow key W Press OS or OD to start a new Scan ID 0 Fress OS or OD to start a new Scan oFf20 2008 12 12 ws ID 0 NEUrR jPTrics oFf2o 2008 12 12 k W EUF ae Figure 3 2A Figure 3 2B To exit the Menu Bar or any submenu see the next Section for an expla nation and list of submen us and return to the de fault measurement screen press OD or OS Once the Menu Bar has been activated by pressing the down arrow the icon which is high lighted will have a square frame drawn around it To highlight a different icon use the left or right arrow keys on the keypad lt 4 gt Once the desired icon has been high lighted press the SELECT key on the keypad to select that V2P IFU 01 Revision C July 1 2015 18 Initiating the SCAN A measurement can only be taken from the default measurement screen Figure 3 2A To return to
10. Instruction Manual NeurQOptics VIP 200 Variable Pupillometer From Pupil to Expert Precision Guaranteed V2P IFU 01 Revision C July 1 2015 2 Equipment Symbols Symbol Source Compliance A Symbol 03 02 IEC 60878 ATTENTION consult ACCOMPANYING DOCUMENTS Symbol 5333 IEC 60417 TYPE BF equipment Symbol 02 03 IEC 60878 ES 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 EE Symbol 01 01 IEC 60878 Ndicates ON Power Symbol 5008 IEC 60417 Symbol 01 02 IEC 60878 Indicates OFF Power Indicates Intermittent Use Indicates Non sterile Serial Number Model Number Lot Number V2P IFU 01 Revision C July 1 2015 Table of Contents NOUCOS ronnen E din suena nirenetdanaenateamnaseaen 4 ICTY ATOM ANON oine E E A EE AEN 5 Section 1 INO GUCHON sisena aaa a ii 8 Section 2 Unpacking amp SOUP ieventcrsszecascsscdscansasinebiledetoerataresevesdecwiatecenedlentes 9 COACHING PENETAN DEA AAN caput AA EE T T ATE 9 Atacning INC EyecUp masmeenedranana aaa aS 10 Connecting the Charging Station c ccccececcssssssssessessessessssssssssseaseasees 11 Charging the Pupillometer cccccssssescescessssssssssssssssscessessessssssssassaseasess 12 Section 3 USING the Device scsssssssssescecescessesssssssssssecsesessessessssassaseaseess 14 Powering On and Menu Navi
11. S NEUR PRTCBUS Seiko US Printer Cable 49006 Seiko Printer Paper NEUR CASE 02 NeurOptics Pupillometer Carrying Case For more information please contact NeurOptics or visit www NeurOptics com NEUR PTICS Distributed by NeurOptics Inc US Customer Service 18101 Von Karman Blvd Suite 1940 Irvine CA 92612 USA Tel 949 250 9792 or 866 99 PUPIL Toll Free North America Fax 949 250 9796 info NeurOptics com V2P IFU 01 Revision C July 1 2015 33 Appendix C Clinical Phenomena Affecting Pupillary Measurement Pupillary Unrest The pupil is always in motion due to a phenomenon referred to as Pupillary Unrest Pupillary Noise or Hippus The magnitude of this motion can be as large as 0 5 mm in amplitude Therefore the presence of pupillary unrest limits the accuracy of single snap shot measurements of pupil size The NeurOptics VIP 200 Pupillometer is designed to mitigate the effects of pupillary unrest on pupil size measurements by collecting data over an approximate two second period The Pupillometer reports the average detect ed pupil size over this period as well as the standard deviation 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 us
12. at icon is highlighted To enter a new ID press SELECT on the first menu selection New ID Figure 3 7 and a 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 Numbers or letters can be selected by navigating over the keyboard using the directional keypad and pressing the 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 displayed key board once the new ID is completed The results of the patient s next scan will be stored under this ID number Cur IGs1 Mew ILC Figure 3 8 Figure 3 7 In case other ID numbers are included 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 The desired Patient ID number can be selected by using the directional keypad arrow up and arrow down and then pressing SELECT This function is useful if you need to immediately re enter a Patient ID already in the memory without the necessity of typing it again V2P IFU 01 Revision C July 1 2015 23 Printing the Records 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
13. dicated by the bat tery icon on the LCD screen of the device The arrow in Figure 2 4 points to the LED on the front of the charging station which when lit indi cates that the charging station is powered up cor rectly 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 indicates 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 6 When correctly installed the eye cup on the Pu pillometer should be facing the rear of the docking station with the keypad and screen towards the front as shown in Figure 2 4 This will orient the Figure 2 4 terminals on the Pupillometer with the terminals in the base of the docking station and enable a posi tive connection Note IF THE LIGHTNING BOLT superimposed over Fress 05 or OD the battery icon IS NOT VISIBLE on the LCD to start a new Scan screen of the device THE DEVICE IS NOT ID 0 CHARGING Figure 2 5 NEUR PTICS ere 7 Figure 2 5 V2P IFU 01 Revision C July 1 2015 13 CAUTION Do not try to pull the device up out of the charging station without first rotating it forward to release F
14. ed 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 Pupillometer utilizes the NeurOptics VIP Vertex Invariant Pupillometry technology which reduces or eliminates the impact of vertex distance on pupillometry measurements Usui Shiro and Stark Lawrence Sensory and Motor Mechanisms Interact to Control Amplitude of Pupil Noise Vision Research 1978 18 505 07 Migliori ME and Gladstone GJ Determination of the normal range of exophthalmometry for black and white adults American Journal of Ophthalmology 1984 98 438 42 V2P IFU 01 Revision C July 1 2015 34 Appendix D Specifications NeurOptics Pupillometer Model VIP 200 Variable Input Human pupil size varying from 1 mm 9mm Measurement Output The instrument provides data on pupil size Average pupil aperture and standard deviation Characteristic Accuracy 0 1mm Type of protection against electric shock See Battery Charger Class II Degree of protection Pupillometer Eyecup Type BF Applied Part provided against Electric Shock protection Classification of the equipment against in Ordinary equipment gress of liquids D
15. egree of safety of appli cation in the presence of 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 Temperature Range 18 C 65 F to 30 C 86 F Operating Environment Relative Humidity 20 to 70 RH Non condensing at all times The equipment is not an AP or APG category equip ment Temperature 0 C 32 F to 75 C 167 F Transportation and Sto rage Environment Relative Humidity 10 to 95 RH Non condensing at all times With Headrest 7 5 191 mm x 2 65 67 mm x 4 65 118 mm Dimensions Without Headrest 7 5 191 mm x 2 65 67 mm x 3 65 93 mm Classification Class 1 LED product per IEC 60825 V2P IFU 01 Revision C July 1 2015 35 Accessories NeurOptics Charging Station Model VIP CHG 01 Degree of protection Type B Applied Equipment against Electric Shock 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 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
16. 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 V2P IFU 01 Revision C July 1 2015 11 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 pa tient refer to Section 4 Figure 2 2B Connecting the Charging Station Connect the NeurOptics medi cal grade 6 volt power supply included with your system to the center plug in the charging sta tion as shown in Figure 2 3 Connect the power supply to a suitable AC outlet After a sec ond you should see a blue LED illuminate 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 Neu 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 V2P IFU 01 Revision C July 1 2015 12 Charging the Pupillometer Install the Pupillometer battery into the Pupillome ter see Section 4 The battery must be fully charged prior to first use This may take up to four hours The battery status is in
17. g Adapter Charging Station Optional Spare Battery Optional a 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 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 V2P IFU 01 Revision C July 1 2015 10 Attaching the Eyecup 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
18. gation ccccccsssccsessesessessssssssssssesseases 14 Taking a Measurement ccceccessescssssssseseessecsesssscssssnsesscsenssnsssesacsansseess 16 Paten IDO NUMDO oiii O 22 PANUNG INE ROCONI S conira r E T actmesilesustpinaienun iets 23 Browsing Records to View and PYING cccccccesesessessssseessesseasessseeeeees 25 Momi ODVOD Seleena a A abe ds ci 26 Section 4 Cleaning and Maintenance cccccccscssssessessesessssstssssssseaseasees 28 CIO GIANG rete aa a naaa 28 Changing the Battery e ananannnnenennnnnenenennenrnnnnnenunnnnrnrnnnnnunnnnrnrennnnernnnennas 28 Panter Maintenant anneanne E A ERNS 29 Appendices Appendix A Troubleshooting cccccceccesccssetsesssssessssscnsssssseseasesssssatesens 30 Appendix B Contact amp Ordering Information cccctetetseeesstsetsetseseeeees 32 Appendix C Phenomena Affecting Pupillary Measurement 0006 33 Appendix D SNOCIICANONS 522 vesacsiessdesd cis sent srvndsthaesveateaecede edi nteebetaets 34 Warranty amp Returned Goods Policy ccccscsssessessescessssssssssessesseesessesssaseaseasens 36 V2P IFU 01 Revision C July 1 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
19. igure 2 6 V2P IFU 01 Revision C July 1 2015 14 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 60 minutes of in activity 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 until a beep is heard or by placing the Pupillometer into the charging station Taking a Measurement Patient and Environment Preparation The following preparations will help to optimize the assessment of pupil size Before initiating the measurement scan turn off or reduce over head lighting to ensure that the room is darkened Be sure to dark adapt the subject for 3 minutes or more in case of strong lighting before the measurement Instruct the patient 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 Ask the patient 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 patient s eyelid open with your fi
20. n 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 FOR A PARTIC ULAR 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 V2P IFU 01 Revision C July 1 2015
21. nger 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 It may be helpful for the operator to be at the same level as the patient when performing the scan to minimize tilting If necessary both patient and operator can sit down facing each other during targeting and measurement Be aware that in Variable mode the measurement lasts approxi mately 12 seconds V2P IFU 01 Revision C July 1 2015 15 Good alignment Poor alignment Poor alignment tilting is mini device is tilted device is tilted mized Figure 3 3A Pressing the OD or OS button activates the Targeting phase Press and hold down the OD or OS 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 Figure 3 3B Figure 3 3B V2P IFU 01 Revision C July 1 2015 16 Section 3 Using the Device Powering on and Menu Navigation The unit will turn on automatically when inserted into the charging station or when the battery is installed If the unit is not on press and hold the up arrow A for three seconds until a beep is heard or insert the device into the charging station Insert the battery and make sure it is fully charged before first usage refer to Section 4 After the system has booted
22. not turn on Battery will not charge Pupil not de tected error message after measurement attempt Pupil not de tected error message after measurement attempt Pupil not de tected error message after measurement attempt V2P 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 correct ly Too much blinking or heavy makeup Device removed from eye before measure ment phase completed Revision C Use only power supply provid ed 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 the IFU and that a lightning bolt symbol is displayed on the bat tery icon Hold device at a 90 degree angle to patient s face Make sure subject s eye is centered on the screen Gently hold patient s eye open with your finger during meas urement Don t remove device from eye until measurement results are displayed on the screen July 1 2015 31 issue Po
23. only and are not to be used for any diagnostic process Regulatory Notice Federal law restricts the sale of this device except by or on order of a physician V2P IFU 01 Revision C July 1 2015 Classification Type of Equipment Medical Equipment Class 1 886 1700 Trade names NeurOptics VIP 200 Pupillometer Manufactured by NeurOptics Inc 18101 Von Karman Blvd Suite 1940 Irvine California 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 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 V2P IFU 01 Revision C July 1 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
24. ows you to Dim the LCD backlight illumination Press the SELECT key to toggle between different backlight illumination levels and then press OD or OS to save and exit Change the Pupillometer date and time If selected the numeric keyboard 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 di rectional keypad of the Pupillometer Figure 3 1 Press SELECT to save the new set tings for the date and repeat the same steps for setting the time whose keyboard is automatically displayed after date has been set Note that time is in 24 hour for mat i e from 00 00 to 23 59 Toggle between Light Off and Vari able modes Press the SELECT key to toggle between the two modes In the Vari able mode the eye is exposed to a se quence of three consecutive light back grounds simulating Scotopic Low Mesopic and High Mesopic viewing conditions The duration of the measurement is approxi mately 12 seconds Revision C July 1 2015 27 gt gt 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 Only the last measurement taken is saved in memory and available for playback Note Video is only saved in the Light Off mode and not in the Variable mode
25. ry com partment Figure 4 1 V2P IFU 01 Revision C July 1 2015 29 Place the Pupillometer into the charging station to charge the battery until the battery status light on the LCD shows green indicating a full charge 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 19 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 D During charging a lightning bolt is overlaid on a blue battery icon a completely charged battery is shown with a lightning bolt overlaid on 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 V2P IFU 01 Revision C July 1 2015 30 Appendix A Troubleshooting Issue Possible Reason Solution Device will not turn on Device will not turn on Device will not turn on Device will
26. sion C July 1 2015 25 Browsing Records to View and Print You can browse retrieve and print data from previous measurements To do this select the folder icon in the main Menu Bar In the Browse catalog window Figure 3 11 you can select which patient to browse and print You can decide to browse all records in memory All Records Figure 3 11 or a specific patient ID number Enter Patient ID Figure 3 11 For your convenience the Browse catalog lists all the most re cent patient ID numbers so that you can select directly from the catalog with out having to re enter the Patient ID using option Enter Patient ID Browse catalog All records corresponding to the ID specified in the Browse catalog win dow will be displayed as in Figure 3 5 and 3 6 You can review each single record using the right and left arrow keys in the directional keypad Figure i 3 1 Each time a record is displayed in EF Enter Patient IC the LCD you can decide to print it by f i selecting the printer icon on the menu bar located at the bottom of the record display Figure 3 11 V2P IFU 01 Revision C July 1 2015 26 Menu Options The Main Menu bar provides a few more functions Settings If this icon is selected in the Main Menu the Settings window will be dis played in the LCD Figure 3 12 setings g Backlight 100 Change Date Time Light Off Figure 3 12 V2P IFU 01 This window all
27. specified in Appendix B Use of another battery may present a risk of fire or explosion Dispose of battery promptly Keep away from children V2P IFU 01 Revision C July 1 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 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 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 NOT submerge the device or pour cleaning liquids over or into the device DO NOT use acetone to clean any surface of the Pupillometer or charging station V2P IFU 01 Revision C July 1 2015 Section 1 Introduction The NeurOptics VIP 200 Pupillometer is a handheld optical scanner which captures and analyzes a series of digital images to obtain measure ment of the diameter of a human pupil The system acquires images using a self contained infrared illumination source and a digital camera It analyz es the captured image data and displays a summary of the measurement in the LCD window Data may also be printed out on an optional thermal print
28. ssible Reason Solution Pupil measure ment will not The same reasons initiate after re and solutions as lease of the OD discussed above or OS key apply here Pupillometer held too far away from printer or not in line of sight Pupillometer must be held in di Record will not of IR window of print rect line of sight of IR window of print er printer See instructions in 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 measurement not successfully Perform and complete a pupil completed and video successful measurement Play Video will not not present in video back before taking a new play memory scan or turning device off Enter key on Patient ID num screen keyboard not Select and press Enter on ber is not dis pressed after enter screen keyboard after entering played ing Patient ID patient ID number V2P IFU 01 Revision C July 1 2015 32 Appendix B Contact amp Ordering Information The following options and accessories can be ordered from NeurOptics VIP 200 Variable NeurOptics Pupillometer US NEUR PWR1 01 Pupillometer Charger Power Supply US VIP CHG 01 NeurOptics Pupillometer Charging Station BATPUP 01 NeurOptics Pupillometer Rechargeable Battery NEUR 2059 01 NeurOptics Pupillometer Eye Cup NEUR PRTS445 Seiko Printer NEUR PRTPSUS Seiko Printer Power Supply U
29. st eye is complete return to the default meas urement screen by pressing OD or OS then press the other scan button OD or OS and proceed with the measurement of the second eye If the patient s eyelid is closed or droopy instruct the patient to open his her eyes as widely as possible or use your fingers to keep the eyelid open If the patient 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 measurement results are displayed on the LCD screen At that point the Pupillometer can be removed from the patient s eye When the scan s is complete the results screen will display a scanned image with a green circle showing the pupil boundary Figure 3 5 WARNING If the green pupil boundary circle is NOT centered on the pupil perimeter during the Targeting phase do not release the scan OD or OS button Also verify that the pupil boundary is cir cled in the result display If the green circle is not nicely cen tered around the perimeter of the eye the scan is not valid and must be repeated V2P IFU 01 Revision C July 1 2015 Figure 3 5 Figure 3 6 V2P IFU 01 21 The results page in Light Off mode Figure 3 5 shows the diameter of the pupil Dia and the standard deviation std of pupil diameter measured dur ing the scan It also includes the ID number of the subject the date and time of the measurement and finally
30. the default measurement screen from any other window menu or submenu press OD or OS on the keypad To initiate a new scan from the default measurement screen press OD right eye or OS left eye on the keypad depending on which eye is going to be measured Note The OD or OS keys will initiate a scan from the default measurement screen only Figure 3 2A If the OD or OS 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 V2P IFU 01 Revision C July 1 2015 Pupil Measurement A pupil measurement is divided into three distinct phases Figure 3 4 Hold down the OS or OD Button Phase 1 Either the OS or the OD scan button is pressed Video is enabled and displayed in the Pu pillometer LCD screen The user is required to hold the OS or OD scan but ton down position the Pupillometer on the subjec s eye and center the sub ject s pupil in the center of the field of view This is called the Targeting phase V2P IFU 01 ROLEN ARONNE g B Button when ready Phase 2 The Pupil lometer automatical ly detects the pupil The pupil is marked with a green circle drawn around its perimeter Release the button when ready to initiate the actual measurement i e once the green circle appears around the pupil This is called the
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