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400100 Spot Handheld Screener Instructions - Good
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1. ENSKENLJ Figure 8 6 Subject Screen On the subject screen Figure 9 confirm all data is correct To change or add information simply select the desired field If the DOB age is missing or incomplete the date of birth box will be highlighted red Simply touch the red box to add edit the age data You can also select whether or not the subject has a vision prescription for glasses or contacts After all information is confirmed select the continue icon to begin the capture process SMITH123 18m Robert Smith zd None Figure 9 7 Eyewear Confirmation Screen If you selected that a subject has a vision prescription on the subject screen you will be asked if the subject is currently wearing their prescription Simply select Yes or No The screening will then begin P N 20079 Rev A Page 11 Screening a Subject When all information is entered position yourself about 1 meter from the subject as shown below Figure 10 Figure 10 Check the lighting in your environment per the instructions on page 6 and then position yourself appropriately Have the subject sit cradle Spot in your left hand and hold the right handle Prior to screening hold the nose of Spot pointing down Begin the screening by slowly rotating Spot upward to meet both of the subject s eyes Adjust your distance to the subject until both eyes are clear on the screen A blue screen indicates you are too close or too far from t
2. 6kV contact 2 kV high voltage power line Differential mode 1 kV Common mode 2kV 596 UT gt 95 dip of UT for 0 5 cycle 40 UT gt 60 dip of UT 70 UT gt 30 dip of UT lt 5 UT gt 95 dip of UT for 5 seconds for 5 cycle for 25 cycle Non conforming This unit is sensitive to ESD and may require resetting 2 kV high voltage power line Differential mode 1 kV Common mode 2kV 596 UT gt 95 dip of UT for 0 5 cycle 40 UT gt 60 dip of UT 70 UT gt 30 dip of UT lt 5 UT gt 95 dip of UT for 5 seconds for 5 cycle for 25 cycle The floor should be in wood concrete or ceramic tile If the floor is covered with synthetic material relative humidity should be at least 3096 The quality of the power supply should be that one of a typical commercial or clinical environment The quality of the power supply should be that one of a typical commercial or clinical environment The quality of the power supply should be that one of a typical commercial or clinical environment If the user requests a continuous functioning during power supply interruptions it is recommended a backup power supply unit UPS or battery Power frequency magnetic fields should have characteristic levels of a typical commercial or clinical environment Immunity Radio Frequency Guidance Spot is manufactured to work in the electromagnetic environment specified below The operator or user should ma
3. Show Hide Figure 24 P N 20079 Rev A Page 23 Data Format The changes to this configuration will show either formatted or raw refractive values on the Subject Results screen If Formatted version is chosen Spot will round the refractive results to the nearest quarter diopter You can toggle between the formatted and raw versions on the results screen by touching the data boxes of either eye Thesettings here indicate which version is shown by default on the Subject Results screen Cylinder Convention The changes to this configuration will show either positive or negative cylinder convention on the Subject Results screen You can toggle the between positive and negative on the results screen by tapping on the CYL icon between the data fields Please note that the Axis will shift by 90 The settings here indicate which version is shown by default on the Subject Results screen Measurements After a screening is complete Spot will present eye measurements on the screen and on the printed certificate Selecting Hide will prevent Spot from showing these measurements on the screen The data will be saved to the database on Spot and can be recalled later NOTE If you select Hide Measurements the device will automatically hide the recommendation as well Recommendation Spot will inform you if a subject is in or out of range and if a full comprehensive eye exam should be recommended Selecting Hide will prevent Spot from making a
4. Spot is manufactured to work in an electromagnetic environment in which the radiated RF disturbances are controlled The operator or user of the device could prevent electromagnetic interferences by assuring a minimal distance between the portable or mobile RF communication devices transmitter and the device as recommended in the chart below in respect of the output maximum power of the radio communication devices Output maximum frequency Separation distance at the transmitter Output maximum frequency m m nominal power of the transmitter W from 150kHz to 80MHz from 80MHz to 800MHz from 800MHz to 2 5GHz D 1 2 x OP D 1 2 x OP D 2 3x OP For the transmitter with output maximum nominal power not reported above the separation distance d in meters can be calculated using the applicable equation at the frequency of the transmitter where P is the output maximum nominal power of the transmitter in Watts specified by the transmitter manufacturer Notes 1 At 80 MHz and 800 MHz it is applicable the higher frequency range 2 This line guide could not be applicable in every circumstance The electromagnetic propagation is affected by the absorption and the reflection of structures people or objects Specifications Dimensions in 82 x 634 x 434 LxWxH Weight Ibs 2 55 Operating Temperatures C 10 to 40 Operating Humidity 30 to 75 Relative Humidity non condensing Storage Shipping Temperatures C Oto 50 Storage Shi
5. building power receptacle outlet is ungrounded then the Spot shall only be used with the internal battery power until replacement parts become available The operator shall not touch accessible conductive parts ac dc adaptor output connector camera power input connector and USB port and the subject simultaneously Screening Environment For the best screening results be sure to screen in a proper subdued lighting environment Take care to eliminate sunlight and or incandescent light Florescent light is acceptable but note that the subject s pupil size will be affected by light in the room and will decrease your chances of a successful screening Subject s pupils should be greater than 5mm for best results P N 20079 Rev A NOTE A minimum pupil size of 4mm is required for screening to occur and may be difficult to achieve in a room with any light source Subject s pupils should be greater than 5mm in size for best results Best screening environment minimal fluorescent light Figure 3 Page 6 Getting Started Charging Spot Spot contains a rechargeable battery for mobile use To charge the battery first connect the provided AC power cord to the provided power supply charger Tilt Spot forward and find the power connector port O then gently insert the AC power connector as seen below DO NOT force the AC power connector into the AC power port on Spot It should easily insert Forceful insertion can ca
6. following information and features If Spot is connected to a network the network name and IP address will be visible in the lower left corner as seen in Figure 5 above Start To begin the screening process select the Start function the blue Spot logo This will allow you to enter subject information find queued subjects begin the capture process and review and print screening results Records The records section will allow you to view already screened subjects complete records and select individual records to review results select queued subjects from a list to begin the screening capture process and delete all records from Spot Tools The tools section allows you to customize Spot to meet your specific needs From Tools you will be able to set things such as the date amp time set up a printer amp print a test page connect to a wireless network enable a security pin review screening criteria set the measurement formats recalibrate your touchscreen import export data and view the software version currently running on your Spot device P N 20079 RevA Page 9 Subject Data Entry To begin screening select the Start function blue Spot logo from the main menu Using the onscreen keyboard Figure 6 enter subject information as outlined below P N 20079 Rev A yy r LAJ J VV f agggBDBH zi E3J d DES Figure 6 Subject ID Optional If you use an ID number for the subject you are scre
7. records Custom Banner PediaVision offers the ability to add a custom banner to the bottom of the printable reports Banner files must be named banner png and be no larger than 1MB The banner image must be 1376 x 240 pixels or it will not fit on the printout Place the banner png file on the root top directory level of the USB then place the USB in the Spot The import file option will highlight select Import To verify that the file was imported successfully either screen a new subject or select a completed record and print the certificate Ensure the new banner has been properly inserted on the bottom of the printable report Viewing Criteria Criteria To view the current age based criteria on your device select Criteria from the tools menu A table will be displayed that shows the current criteria used to compute the screening results To change the criteria please see the Import Export section for details on how to update the Spot Criteria file Results Configuration Results To change how results are displayed on the Results Window after a screening select the Results option from the Tools Menu You will be presented with a Results Options screen from which you can customize your Results Figure 24 When a selection is made the changes will take effect immediately for the next screening Data Format C Raw i Formatted Cylinder Convention Positive 8 Negative Measurements e Shaw j Hide Recommendation
8. screen black Simply touch the screen to bring the application back To delete ALL records from Spot go to the Records screen and touch the trash canicon This will bring up the Delete All Records screen Be sure you have correctly exported any desired data to a USB drive then select Delete All Records You can also turn the capture sound on and off by pressing the V icon in the bottom left corner of the capture scree Spot has several keyboard layouts to provide all characters you may need while screening Simply select the shift key or the special character keys to switch back and forth The best way to know if your Spot is connected to a wireless network is to go to the Main Menu and see if you see your network name and IP address are in the lower left corner Spot requires a minimum pupil size of 4mm for screening to occur and this may be difficult to achieve in a room with any light source Subject s pupils should be greater than 5mm in size for best results To power off Spot press the power button for about 2 seconds A confirmation screen will appear to confirm shutdown of the device Do not power off Spot during a screening Instead exit the screening by selecting the e then power down the device normally Holding down the EJ button on any input screen will delete all data from the field Page 8 Figure 5 User Operation Main Menu When Spot is powered on the main menu screen Figure 5 will appear with the
9. the screen along with the current printer status as shown in Figure 22 HP Deskjet 3000 J310 series Driver HP Deskjet 3000 j310 Series Location socket HPF70077 local Figure 22 NOTE If you are having a problem with your printer or a job is stuck in the queue select the reset button to clear the print job and reset the printer Import amp Export Import Export Importing and Exporting files to and from Spot is quick and easy Simply insert a USB storage device into the USB port on Spot refer to Page 4 Terminology for USB port location From the Tools menu select Import Export and you will be directed to the Import Export screen Figure 23 When a USB device has been detected the Import and Export buttons will be available to select The Import button will only become available if Spot recognizes a valid import file on the USB drive P N 20079 Rev A Page 20 Please insert a USB drive Figure 23 NOTE If the buttons do not highlight within 5 seconds of inserting the USB drive remove the USB insert it into your PC and delete all files from the drive If you are importing a file be sure to put the import file back on the USB drive before continuing Export To export data from Spot select the Export button You will be asked whether or not to exclude personal data The Exclude Personal Data function will export a single Comma Separated Values csv file with all screening data except the subject s firs
10. Network section Figure 17 of the Tools Menu The current network settings are displayed on the screen To add or edit any of the fields see instructions below If they are correct select to be returned to the Tools menu n spot d Security Type WPA Current Network i 400845 spot 192 168 1 104 Figure 17 P N 20079 Rev A Page 16 To add change the network name SSID touch the SSID Name field and the keyboard will appear Enter the SSID and select the ok button to save your changes and return the previous screen To add select the security type just touch the Security Type field Select the appropriate security type and you will be returned to the Network screen To add change the passphrase password touch the Passphrase button and the edit screen will appear with a keyboard This is only available with the security field is set to WEP or WPA Enter the Passphrase and select the Ok button to save your changes and return the previous screen The Ok button on the network screen will be darkened and available to select if any changes have been made Select Ok to apply all changes made to the network settings Figure 17 NOTE If you do not select ok changes will not be applied You can enable or disable the wireless capabilities on Spot by selecting the pe or On Off button from the network menu After changes have been applied you can select to return to the Tool
11. Spot Instructions for Use MODEL VS100 SOFTWARE VERSION 1 1 51 VISION SCREENING P N 20079 REVA Table of Contents VISION SCREENING P N 20079 Rev A Welcome to Spot ccscccccccccssccccsccccsscccsccccsscccscsccsscccecsccescccessccesccoees 3 Iber drei n E RE 3 Product Registration ecce esee eee ee ee eee eee eee eee eee eene tees eee een nn 3 Basic ODerU DOT o cies cot E EE EOE ae SERE EUREN ERE E 4 PUT enia 4 past gmera C dI Busse dis dS EDDE tema Ec IDIOMS 5 EEODnralI5s a eve eee ene ten ere rT ETE Eee ee 5 NIN TN ER P 6 Doreenmie eh GAYA 1a 2 All eosdem soe eee canny nee te MEUM MUS 6 Getting SONIC assis Stee sesso 7 Chgreins T senno eI UNUM antem uires CU DUM EIUS T Powenng opot On and CUTE onam and quee tincta Ret pA COE RE 7 NTA ST SEE Dee asc din Ier REN e eeeens tena NU NUS M MM M 7 Oa Neck rap NND N 8 e E e N EE A EEE E 8 User OCR AON isi codo m nrinn a nE ENEA UUeUS 9 PT IAE TRENTINO RR OE 9 SUDIBCE DH BUD esce rede coevas oe Un OSEE ade In eq NEUE 10 SCPOSHITIS a couscous smtistet ise OR Ghi UA UI Me ee 12 IOBOGU OE SCPEBITTIBureatimie anna tiit titus E 13 Views Ene TS GS e ascen Ius mpi ue A uec o 14 TOOLS E 15 Geruns Ene Taro dad DI6Esecendessionticuq ima dime aT OmU e RUNE 16 Wireless Network COHFTIBUPSt LlODL aces conr rak
12. W4015 760F NC BK Input Voltage 85 264VAC 100 240VAC Nominal Input Frequency 47 63 Hz Input Current 1A rms Efficiency Avg Efficiency 86 496 115VAC 85 796 230VAC Environmental Protection This device contains Lithium ion cells Please contact PediaVision for proper disposal instructions at end of life EMC Information This device complies with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 this device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation NOTE Changes or modifications not expressly approved by the party responsible for compliance could void the user s authority to operate the equipment This equipment has been tested and found to comply with the limits for a Class A digital devices pursuant to Part 15 of the FCC Rules This medical device equipment is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instruction manual may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference t
13. acked with other equipment If adjacent or stacked use is necessary the equipment or system should be observed to verify normal operation in the configuration in which it will be used EMC Table Emission Guidance The Pediavision Spot is intended for use in the electromagnetic environment specified below The operator or the user of Spot should assure that it is used in such an environment RF Emission Cispr 11 Spot must emit electromagnetic energy in order to perform its intended function Nearby electronic equipment may be affected RF Emission Cispr 11 Class A Spot is suitable for use in all establishments other than domestic and those directly Harmonic Emission IEC 61000 3 2 Class A Compliant connected to the public low voltage power supplies building used for domestic purposes Voltage Fluctuation flicker Emission IEC Compliant 61000 3 3 P N 20079 Rev A Page 31 Immunity Guidance Spot is manufactured to work in the electromagnetic environment specified below The operator or user should make sure it is used within those environmental conditions Immunity Test Test level EN 60601 1 2 Conformity Level Electromagnetic environment guide Electrostatic Discharge ESD EN 61000 4 2 Electrical Fast Transient Burst EN 601000 4 4 Surge EN 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines EN 61000 4 11 Magnetic field at power frequency EN 61000 4 8 8kV air
14. ance For more information on troubleshooting or error messages visit pediavision com refer to the last page of this manual for additional contact information Wireless Issues If you encounter problems connecting to a wireless network first ensure all network settings are entered correctly If the settings are correct try turning Spot off then back on Oftenit will help initiate the connection to the network with a restart For more information on troubleshooting or error messages visit pediavision com refer to the last page of this manual for additional contact information P N 20079 Rev A Page 28 Technical Description General Spot model VS100 will be referred to as Spot below The external power supply charger supplied is a Class equipment and the Spot is also a Class equipment when connected to the external power supply charger Spot is internally powered by equipment battery when not connected to the external power supply charger Protection against electric shock no applied part Spot is rated IPXO and thus not protected from the ingress of water Spot does not require sterilization or disinfection DO NOT use cleaners that contain organic solvents to clean Spot s housing or front glass For stubborn dirt try using a soft cloth with a small amount of water or a non abrasive cleaner Spot is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxid
15. arry or support the weight of Spot Display Care Spot has an all in one 5 LCD Display and touchscreen To ensure long lasting functionality and performance please be aware of the following 1 DONOT push or scratch display surface with anything stiff or rigid 2 DO NOT spill liquids on the display Please wipe off drops of liquid like saliva and water on LCD panel surface immediately Front Glass Care Spot uses a piece of optical glass with a special coating If dirt or fingerprints are visible use a soft cloth to wipe clean For stubborn dirt try using the provided cleaning cloth with a small amount of water or a non abrasive cleaner P N 20079 Rev A Page 5 Warnings Changes or modifications not expressly approved by PediaVision could void the user s authority to operate the equipment The supplied cord set is to be used Replacement or substitution may only be done with a CSA or UL approved hospital grade power supply charger cord set The supplied power supply charger may not be substituted and shall only be replaced by an approved unit supplied by PediaVision Interconnection of this medical device with other medical devices medical used systems or non medical devices shall be evaluated to the requirements of CSA IEC 60601 1 1 in the end use application This equipment is ESD sensitive do not touch connector pins during use If the power cord or external power supply becomes damaged or its integrity is suspect or the
16. e Spot is suitable for continuous operation Spot is a breakthrough device that quickly and easily detects vision issues across all age groups starting at 6 months Spot helps ensure children have an opportunity to reach their full potential Designed to work as easily with toddlers as with teenagers Spot provides reliable data in seconds With Spot educators healthcare professionals and charitable organizations can now confidently assess eyesight for all ages Spot is powered by sophisticated technology that quickly detects the indication of the following vision issues Near sightedness myopia Far sightedness hyperopia Unequal refractive power anisometropia Blurred vision eye structure problem astigmatism Pupil size deviations anisocoria Eye misalignment strabismus In just seconds Spot provides a comprehensive reliable analysis that enables informed decision making about the need for care with a vision specialist Pediavision suggests a battery replacement at an appointed Pediavision repair facility every 2 5 years at the owner s expense Spot regular maintenance consists of wiping dust or dirt off the surface as needed The USB port shall only be used for software download upload via a USB key and shall not be cable connected to any other device P N 20079 Rev A Page 29 The power supply charger supplied with Spot has the following characteristics International Power Corporation Elpac Power Systems Model M
17. e disposed of i for EU member countries in accordance with WEEE Directive on Waste Electrical and Electronic Equipment or ii for all other countries in accordance with local disposal and recycling laws ESD Protection Mark USB software updates only E P N 20079 Rev A Page 35 DC power input port center pin positive Battery Status Level Indicator Graphics Display Icon Connected to the wireless network Graphics Display Icon No wireless network in range Graphics Display Icon No IP address assigned by the router Graphics Display Icon Unknown network Graphics Display Icon Cannot connect to configured network Graphics Display Icon Sound Off Graphics Display Icon Sound On Graphics Display Icon Continue Icon Back Icon Exit to Previous Screen or Main Menu 9jejej s ale 99 0 9 B i P N 20079 Rev A Page 36 Print Job in Progress Limited Warranty PediaVision provides the following limited warranty for Equipment PediaVision provides a limited repair or replacement warranty and agrees and warrants only that Equipment Equipment means the medical device outlined in this document model number VS100 Spot will be fit for its intended purpose and without material defect in workmanship and materials for the one 1 year period following delivery date Equipment shall not be considered defective if it is a different color than shown in PediaVision s materials and no warranty is made relating to co
18. ening enter it here If not you may leave this field blank and proceed to the next entry by selecting ok or the continue icon You may also use the ID field to search for records you previously imported onto Spot Simply type the queued subjects ID number case sensitive and touch the continue icon You will skip the rest of the input screens and go straight to the Subject Confirmation screen If you don t see the character you need select the Bl icon for additional keyboards First Name Optional The next screen will ask you for the subject s First Name After entry select ok or the continue icon Last Name Optional The next screen will ask you for the subject s Last Name After entry select ok or the continue icon c Gender Optional The next screen will ask you to select the subject s Gender Figure 7 After you make your selection you will be moved to the DOB screen or select the continue icon C uU u Male Female Figure 7 Page 10 5 Date of Birth Age Required On the final entry screen you will be asked to enter the subject s date of birth DOB or age in months and or years Figure 8 For the DOB use the format MM DD YY f entering an age simply enter the number of months years or a combination of both Example 3 Years and 4 months would be 3y4m After entry select e ok or the continue icon O Date of Birth J 21 nud na a Mimi mim don
19. et 3000 J310 series Driver HP Deskjet 3000 j310 Series Location socket HP46C505 local Figure 21 On the Add Printer Details screen you can change the displayed name of your printer by touching the Name field To select a printer driver touch the Driver field and you will be presented with a list of available drivers Use the search function at the top of the driver list to narrow down the number of visible drivers P N 20079 Rev A Page 19 NOTE The list of print drivers represents all printers supported by Spot The Location is the network location of the printer and is automatically given a local name by Spot To select a custom TCP IP address location of the printer touch the Location field and enter a new location as socket XxX XXX XXX XXX where XXX XXX XXX XXX is the TCP IP address of the printer When all printer settings are complete and valid the Save button will be dark grey Touch the Save button to save all settings or at any time press the exit icon to return to the previous screen without making changes NOTE It may take several minutes after hitting save for the changes to take affect When your printer settings have been saved the Print Test Page will be dark grey Press the Print Test Page button to test the printer configuration A print icon will appear in the menu bar indicating the job is processing Also the number of jobs in the print queue will show up in the Jobs box at the top of
20. he results screen will appear at the end of the screening process Figure 14 Results that are out of range are indicated Robert Smitty 0 SD in red The screener user will make the TP a final recommendation regarding a follow e o up exam with an eye care professional E 0 25 ra 0 25 0 50 0 75 164 0 25 0 00 On the Results screen you can toggle the results data between raw and formatted results by touching the values in the box under the eyes You can also toggle between positive and negative cylinder conventions by selecting the Y label found between the boxes At any time you can select to close this screen and return to the main menu or select the continue icon for additional options Figure 14 From the Results Menu screen Figure 15 you can print the screening results certificate re screen the current subject switch to monocular mode or return to the Main Menu Figure 15 P N 20079 Rev A Page 14 Tools The tools menu will allow you to customize and configure Spot The main tools menu gives you the following options Date Time Network Printer Import Export a Criteria Security Touchscreen P N 20079 Rev A This section displays Spot s firmware version software application version and serial number Also displayed is a quick reference of important Spot features This section allows you to set the current date and time for your device The Network sectio
21. he subject NOTE Keeping Spot even on axis with the subject s eyes will promote quicker results and help ensure you are not capturing other objects Position yourself with one foot in front of the other and slowly lean forward and back until the spinning icon appears indicating you are in range Figure 11 Hold the device steady until the screening process is complete Figure 11 You can also turn the capture sound on and off by pressing the Y icon in the bottom left corner of the capture screen P N 20079 Rev A Page 12 NOTE Do not power off Spot during a screening Instead exit the screening by selecting the then power down the device normally If you are unable to capture the subject or select the exit icon from the screening process you will be presented with a Screening Options menu Figure 12 From here you can try to Re Screen subject again switch to Monocular screening mode Flag the subject as unscreened or return to the Main Menu Selecting the exit icon amp will return you to the subject information screen Figure 12 Monocular Screening In monocular mode you will be given the option Figure 13 to choose which eye to screen Simply touch the side of the screen that corresponds with the eye you would like to screen When complete you can repeat the process with the other eye by choosing Monocular from the Results Menu Figure 13 P N 20079 Rev A Page 13 Viewing the Results T
22. inter select the printer from the list and press the Delete BE button A popup will appear asking you to confirm deletion of the printer To restore the printing system to factory defaults press the trash can W button A popup will appear asking you to confirm restoring the printing system to factory This will remove all current printer configurations and reinstall the default Spot printer You can exit this screen at any time by selecting exit icon 9 which will return you to the Tools menu P N 20079 Rev A Page 18 Adding a Printer When you select the Add amp button from the Printer Screen Figure 19 you are directed to the Add Printer screen Figure 20 where you can add a network ready printer If the Printer is discovered on the network it will show up in the list If you wish to add this printer to Spot select it from the list and press the continue icon 9 If the network printer you want does not show on the list then select Add New Printer and press the continue icon Confirm the settings and press the Save button es Officejet 6000 E609n 474935 tety Deskjet 3050A 61 senes 205CE 01 Na Orvver Figure 20 Adding Editing or Viewing Print Configuration When you select the Edit EM button or you select to add a printer from the Add printer screen you are directed to the Add Printer Details Screen Figure 21 The default Spot printer information will be populated which can be edited if needed HP Deskj
23. ke sure it is used within those environmental conditions Immunity Test Test level EN 60601 1 2 Conformity Level Electromagnetic environment guide Conducted RF EN 61000 4 6 Radiated RF EN 61000 4 3 Surge EN 61000 4 5 3 Veff from 150kHz to 80MHz 3 V m from 80MHz to 2 5GHz Differential mode 1 kV Common mode 2kV 3 Veff from 150kHz to 80MHz 3 V m from 80MHz to 2 5GHz Differential mode 1 kV Common mode 2kV The portable and mobile devices with RF communication shouldn t be used near any part of the device including cables except when they follow the recommended safety distance for separation calculated with the equation applicable to the frequency of the transmitter Recommended safety distance for separation D 1 2 x VP from 150kHz to 80MHz D 1 2 x JP from 80MHz to 800MHz D 2 3 x VP from 800MHz to 2 5GHz Where P is the nominal maximum power of the transmitter output expressed in Watts W as specified by the transmitter manufacturer and d is the recommended separation distance expressed in meters m The field intensity of the fixed RF transmitters as checked in an electromagnetic investigation of the locus should be less than the conformity level for each range of frequency It is possible to have interference near devices marked with the symbol P N 20079 Rev A 2 Page 32 Recommended separation distance between portable or mobile devices for radio communication and the device
24. lor All requests for warranty work are subject to Equipment inspection at PediaVision contracted facilities End User must ship the Equipment for inspection to PediaVision s dedicated warranty and repair facility at User s expense Misuse improper usage and or handling dropping improper repairs improper maintenance and care or accidental abusive or negligent treatment of the Equipment will invalidate PediaVision s warranty PediaVision shall not be responsible after delivery of the Equipment to End User for maintenance or support of the Equipment only for warranty services This warranty is not a guarantee that the Equipment will not through use or handling develop wear tear and mechanical breakdown from time to time the repair of which is the sole responsibility of the End User if beyond the stated warranty period or excluded from warranty coverage for the reasons stated hereinabove If a returned item of Equipment is evaluated and found defective and the warranty for such Equipment is in force PediaVision will bear the cost of shipping the repaired or replacement Equipment to End User otherwise all shipping costs will be borne solely by the End User No statement remark or representation of any employee or representative of PediaVision may vary this limited warranty unless in writing and signed by an officer of PediaVision This warranty shall be void if User loads or uses any software programs or applications on Equipment other than the sof
25. n allows you to connect Spot to a wireless network You can manually enter your network name SSID select the security type and enter the passphrase for your network From this page you can view and change your TCP IP settings This section allows you to configure a network printer and print a test page It also lets you view printer status This section enables you to import and export using an inserted USB storage device Here you can view the age based criteria settings used for exam recommendations This section allows you to configure how data is displayed on the Results screen when a screening is complete This section allows you to set a security PIN for your device This section allows you to calibrate the touchscreen on your device Page 15 Setting the Date and Time Date Time From the Tools menu select the Date Time icon The currently set date and time will be visible as seen in Figure 16 If itis correct select to return to the Tools menu 07 28 pm DATE 6 7 2012 Figure 16 To change the time touch the time field and the keypad will appear After you enter the correct time select the ok button to save your changes and return the previous screen Alternatively select the button to cancel changes and return to the previous screen Repeat these steps to reset the date field Wireless Network Configuration Network To connect Spot to a wireless network you will need to access the
26. o radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Connect the equipment into an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio TV technician for help P N 20079 Rev A Page 30 Electromagnetic Compatibility This product conforms to the EMC standard IEC 60601 1 2 2007 MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the accompanying documents Connectors should not be touched and connections should not be made to these connectors unless ESD precautionary procedures are used Provided ESD connector covers shall be installed when the connector is not in use dies ESD protection mark may be used in lieu of protective covers Portable and mobile RF communications equipment can effect medical electrical equipment The use of accessories and cables other than those supplied with the instrument exception for cables sold by the manufacturer of the equipment as replacement parts may result in increase emission or decrease immunity of the equipment or system The equipment or system should not be used adjacent to or st
27. onfig folder Here you will find a file called SpotSubjects csv The file will contain 6 columns It is imperative that you do not change any of the column headings Only add information to the columns as shown below 1 Subject ID You can use any combination of alpha numeric characters and symbols This field is also used for the subject lookup feature To quickly look up queued subjects the best combination is Alphanumeric characters only 2 First Name Enter the first name Use any combination of alpha characters 3 Last Name Enter the last name Use any combination of alpha characters 4 Date of Birth Enter the data of birth in the format MM DD YY or YYYY You may also enter the age of the subject in years months or a combination of both Example a subject that is 2 years and 10 months old would be entered 2Y10M Use numeric and alpha characters 5 Gender Enter Male or M or Female or F Alpha characters only Leaving the field blank will default to Male when importing 6 Eyewear Enter None Glasses or Contacts Leaving the field blank will result in None as the default when importing P N 20079 Rev A Page 22 After updating the import file ensure you save it as a Comma Separated Values csv file and that the file name is SpotSubjects csv Follow the import procedures to load the file onto Spot To verify that the file was imported successfully go to the Records menu and select Queue to view the new
28. or subjects of incomplete screenings that still require screening The maximum storage capacity of Spot is 3000 completed screenings Complete g o Dick Smith 11 11 11 11 37 pm g a1 Dick Smith 11 11 11 11 36 pm B an Diet Smith 11 11 11 11 26 pm B a Dick Smith 11 11 11 11 25 pm g o Dick Smith 11 11 11 11 24 pm 27a BILL JONES 11 11 11 11 19 pm 1 7 of 24 Records Figure 28 P N 20079 Rev A Page 26 result was out of range based on criteria at time of screening 15 Red square indicates a subject that has been screened and at least one a Green indicates the subject has been screened and all readings were within the range based on the criteria at time of screening Subjects with no color indicate the subject has not yet been screened If you select a previously screened complete subject the final results page will be displayed If you selected a queued subject you will be directed to the Subject Information screen to verify the data and start a new screening Deleting Subject Records To delete all records on Spot select the trash can icon located on the bottom left corner of the Records screen Figure 28 All subject data will be deleted permanently so ensure you have exported any data you wish to save with the Import Export function located in the Tools menu Once you select the trash can icon the Delete All Records screen will appear To remove all subject records select Delete All Records othe
29. ose to center as possible a stylus is a useful tool for calibrating the touchscreen After all 5 targets have been touched move to Step 2 NOTE If you do not touch the first target within 15 seconds the calibration will be cancelled Please select first crosshair within 15 seconds to begin Figure 26 Step 2 A series of 5 confirmation targets will appear one after the other starting in the upper left hand corner again Figure 27 Simply touch the crosshairs without going outside the circle surrounding each target and the calibration will be complete P N 20079 Rev A Page 25 Please confirm calibration within 115 seconds to save new values Figure 27 NOTE If you touch outside the confirmation circle for the targets the calibration will be cancelled and the previous settings will be used Web Access When connected to a wireless network Spot gives you the ability to view the PDF reports and the SpotResults csv file from a Web Browser Internet Explorer Firefox Safari etc on another PC on the same network To access the webserver on Spot simply open your web browser and enter Spot s IP address in the address bar The Username is spot and the default password is 0000 If you have enabled security on your device the password will be your PIN code Records On the Records page Figure 28 you can view previously screened subjects Complete tab as well as any queued subject data Queue tab that was previously imported
30. otsensri toe nre eet eret PEE nieve oHd Sin Eo bna 16 Printer coni ura easain serm n MEO mI cU 18 PEYOTE ERDO gcse canvas cee NOIPERERIEEEHEERE RHEINE i 20 VIBUIDE GEILGBIOLe s ente ueneno uelle mM DIU MU MUI 23 Results Configuration aoctor ttu ues casebecdesicscatectcatanransseses HOv ilie SR IE rE eI EEUU 23 IA MR ERRT S 24 Touchscreen LIO RC UH O CRT RR 25 NI CT PC ar EE EE A E EA 26 RECOS RT E E E 26 Deleting Subject ReCOLOS csset raseces ia eot tribe Date bI iem paco dde mtu QU 27 Basic Troubleshooting ecce eee e eee eee eene eese ee eene 28 Technical Description 000000000000000000000000002ec00eseccosececceseccoseecceseecceeeecse 29 Environmental Protection ccccsssccccccsssccccssccccccssceccccsscscccsccscccesscscccees 30 EMCAnDnEOPINOEIOI edere E Heec ERR DIEM RED 30 klectromagnetic Compatibilty oisein mt esca uie mA 31 Iu A E a c 31 DSDOCITIGSEIORIE E A UIN MOON EU DER IE E UTILE ee 33 Me Bea ab UNE E 34 SYDE iene Lococo sce 35 Limited Warranty ss csssnsecsseccawsccecestscsncensessscveceseeisvansdeesavesecensecsacceesassndss 37 Contacting PediaVision ssscccccccssscccccccssscccccccssscecccccessccccccceess 38 Welcome to Spot Welcome to the PediaVision VS100 vision screener otherwise known as Spot This instructions for Use document will help you learn to navigate Spot so you can make
31. pping Humidity 0 to 75 Relative Humidity non condensing Storage Shipping Atmospheric Pressure 800 hPA to 1060 hPA Expected Battery Life 2 5 Years Under Normal Usage P N 20079 RevA Page 33 Measurements Refraction Spherical Equivalent Range Accuracy Cylindrical Range Accuracy Cylindrical Axis Range Accuracy Pupil size Range Accuracy Pupil distance Range Accuracy Time per measurement Measuring distance Fixation target Measurement principal P N 20079 Rev A 7 50D to 7 50D in 0 25D increments 3 50D to 3 50D 0 50D 7 50D to lt 3 50D 1 00D gt 3 50D to 6 00D 1 00D 0 00D to 3 00D in 0 25D increments 0 00D to 1 50D 0 50D gt 1 50D to 3 00D 1 00D 1 to 180 degrees in 1 degree increments 5 degrees for cylinder values gt 0 5D 4 0 mm to 9 0 mm in 0 1 mm increments 0 1mm 35mm to 80 mm in 1 mm increments 1mm 1s 1mzz5cm Random visual pattern and audible sound Optical reflex Page 34 Symbols DC Power IPX0 Ingress protection Battery inside not user replaceable Battery charging flashing charged continuous Power On Off ejau emm o Q Non ionizing electromagnetic radiation Refer to instruction manual 9 This symbol is applicable for EC member countries only To avoid potential negative consequences for the environment and possibly human health this instrument should b
32. rap Mount Serial Number Label Range Finder Front Glass Speaker Figure 2 NOTE The USB port shall only be used for software installations and import export of data via a USB flash drive It shall not be cable connected to any other device P N 20079 Rev A Page4 Basic Camera Care 1 Spotisa precision instrument DO NOT drop it or subject it to physical shock 2 Spot is NOT waterproof If you accidentally drop it into liquid or liquid is spilled on it please promptly contact PediaVision Customer Service If minor water droplets are found on Spot please wipe them off with a soft dry cloth 3 DO NOT leave Spot in excessive heat such as in a car or in direct sunlight High temperatures can cause Spot to malfunction 4 Spot contains precision electronic circuitry Never attempt to disassemble Spot yourself This will void any warranty 5 DO NOT use cleaners that contain organic solvents to clean Spot s body or front glass For stubborn dirt use the provided cleaning cloth with a small amount of water or a non abrasive cleaner If you have any questions about proper cleaning procedures please contact PediaVision Customer Service 6 When plugging the AC power connector into Spot be sure NOT to force the power connector into the Spot device as this may cause damage not covered under warranty 7 The safety wrist strap on Spot is intended to assist in the event the device slips or is dropped It is not to be used to c
33. recommendation on the Results Screen or Printed Reports Security Securi ty Spot gives you the ability to add a layer of security to your device through the use of a PIN code To enable the use of the PIN code select Security from the tools menu You will be asked if you would like to use a security pin code If you select this option Spot will ask you to enter a 4 digit pin code and then re enter the same pin to confirm Security will then be enabled To disable simply uncheck Use Security Pin Code and you will be asked to confirm by entering your PIN To lock the screen simply press and hold the power button for 2 seconds until the power off popup appears Spot will ask you if you would like to Power Off Lock or Cancel Select Lock and your Spot will be locked If you let Spot sit idle for more then five minutes or power off Spot with Security enabled you will be prompted to enter your pin before you can use Spot Figure 25 P N 20079 Rev A Page 24 LJ 4 5 6 j K1 iL icm f B Figure 25 Touchscreen Calibration The Spot touchscreen can be calibrated by selecting Touchscreen from the tools menu You will be asked to confirm whether or not you want to calibrate the screen If you select Calibrate it is a simple two step process to complete calibration Step 1 A series of 5 crosshairs will appear one after the other starting in the upper left hand corner Figure 26 Simply touch each target as cl
34. reports P N 20079 Rev A Page 21 Spot Criteria The easiest way to modify the current criteria being used on the Spot is to first export the current criteria file This gives you a copy of the current criteria file located in the config folder After the export is complete insert the USB in your PC and go to the USB drive folder on your PC Select the Spot folder that you just exported then select the config folder Here you will find a file called SpotCriteria csv Make a copy of the criteria file and paste it into the main directory of the USB drive root or top directory level Make any desired changes using Microsoft Excel or similar then save the file as a Comma Separated Values csv file Ensure the file is still called SpotcCriteria csv Remove the USB drive from your PC and insert it into Spot Go to the Tools menu then Import Export Select the Import option to import the updated criteria file To check to see if the file was imported successfully go to the Tools menu then to Criteria and review the new criteria settings Spot Subjects Spot gives you the ability to be ahead of the game with the Subject import function The easiest way to import subjects is to first export the subject from Spot This gives you a template to use for the import file After the export is complete insert the USB into your PC and go to the USB drive on your PC Select the Spot folder that you just exported then select the c
35. rwise select Cancel to return to the Records menu and no data will be removed NOTE Regularly deleting the records will ensure you always have enough storage space on Spot P N 20079 Rev A Page 27 Basic Troubleshooting System Restart To power cycle Spot simply press and release the power button After confirming shutdown Spot will turn itself off After the screen is black wait 30 seconds and then press the power button to turn Spot back on System Freeze In the event the Spot locks up and is unresponsive to touch you will need to perform a hard system reset To reset Spot press the power button If the Power Off window appears select the Power Off button to shutdown the device If not press and hold the power button until the screen goes black Release the power button Wait about 1 minute then perform the normal start up process NOTE This may cause some data loss ex printer configuration and subject data Printer Issues First always check that your printer is turned on and has sufficient ink You can usually do this by printing a test print page directly from the printer After you confirm your printer is in proper working order ensure the printer is on a local network by printing to the printer from a PC on the same local network If all of the above are in working order then try restarting Spot as stated under System Restart If issues continue please contact Pediavision Customer Service for further assist
36. s menu or select TCP IP Figure 18 to view advanced network settings From here you can view your current TCP IP address as assigned by your network or for more advanced network configurations you can select Static to manually configure your network address and settings Also available on this screen is the MAC Address of your Spot Ww DHCP IP Address 192 168 1 147 Netmask 255 255 255 0 Gateway 192 168 1 1 DNS 1 192 168 1 1 DNS 2 255 255 255 255 Figure 18 P N 20079 Rev A Page 17 Printer Configuration ea Printer When you select the Printer icon from the Tools menu you will be presented with a list of available printers on your network on the Printer Tools Screen Figure 19 NOTE Spot will search your network for available printers For this feature to function properly Spot will need to be connected to a wireless network before adding a printer Es Figure 19 To select or change a default printer find the desired printer in the list highlight it by touching it once then touch the Set as Default button To add a printer to your list pressing the Add Ell button will take you to the Add Printer screen See Adding a Printer on Page 19 e To configure a printer view the printer status or print a test page select the printer from the list then press the Edit El button This will take you to the Printer Details Screen See Adding Editing or Viewing Print Configurations e To remove a pr
37. t name last name and DOB To exclude personal information press the Exclude Personal Data label on the screen and an X will appear next to the label Select the Export button and do not remove the USB drive until the export is complete Spot will indicate Export Successful when the export completes and it is then safe to remove the USB drive If the USB is withdrawn prior to the export being complete incomplete or corrupted data may be the result This may cause problems with both Spot and your USB drive If you do not select the exclude personal data option Spot will export the following information 1 PDF s of all completed subject screenings located in the current folder 2 Spot Results file located in the current folder 2 Spot Criteria file located in the config folder 3 Spot Subjects Template file located in the config folder 4 Spot s Complete database file located in the db folder NOTE When data is exported to Spot a new folder will be created on the USB drive The folder will be in the format of Spot SerialNumber YYYYMMDD HHMMSS All export data will be put into this folder Import All files must be located in the root or top directory of the USB drive not in a folder and must have the correct naming convention for Spot to recognize it for import With Spot s import function you can import an updated Criteria file an upcoming subjects file or a custom banner for the screening
38. the most of your screening experiences Box Contents Remove Spot and the accessories box from the packaging In addition to the items listed Figure 1 you will Accessory box contents find a Cleaning Cloth and Velcro Cable Straps in the accessories box NOTE Please do not discard the box and foam Damages incurred by shipping Spot in non approved packing e Power Charger material will void the limited warranty Power Cord see page 37 for warranty details e Safety Wrist Strap User s Guide If you have a Spot carrying case place Quality checklist the foam from the shipping box inside the carrying case for safer Figure 1 transport Product Registration IMPORTANT Before you begin to use Spot it needs to be registered with PediaVision To register your device please go to pediavision com register and provide some basic information This will keep you in tune with the latest software updates and support services as well as ensure warranty coverage P N 20079 Rev A Page 3 Basic Operation This section explains preparatory steps before you start screening with Spot and basic operation Terminology USB Port dedicated for software l Ambient updates only Light Sensor LCD Screen Neck Strap Mount Neck Strap Mount e USB Port AC Power Connector lt rz Battery Charge Green LED Indicator Power Button Tripod Mount Safety Wrist St
39. tware installed and licensed to User by PediaVision This warranty shall be void if PediaVision finds that Equipment has been opened or the hardware has been altered in any way All warranty claims must be made in writing addressed to PediaVision within the warranty period Pediavision does not warrant accessories P N 20079 Rev A Page 37 Contacting PediaVision If you have questions about Spot PediaVision Support is available Monday Friday 9 00 am 5 30 pm ET excluding holidays Visit us online anytime at pediavision com email your questions or call during normal business hours Email Customer Service Sales General Information Phone Customer Service Operator Address PediaVision Holdings LLC 200 Waymont Court Suite 122 Lake Mary FL 32746 USA P N 20079 Rev A support pediavision com sales pediavision com info pediavision com 888 514 7338 x 102 888 514 7338 x 100 VISION SCREENING Page 38
40. use damage to Spot and potentially void the limited warranty Finally plug the power cable into an available AC outlet When the battery charge indicator green LED is steady no further charging is required Figure 4 Spot will also run directly off the AC power source Powering Spot On and Off To power on Spot press and release the power button The system will take approximately 30 seconds to complete its start up process When complete you will be on the Main Menu with the blue Spot logo To power off Spot hold the power button for about 2 seconds A confirmation screen will Green LED appear to confirm shutdown of the device dicia Flashing Charging Steady Fully Charged Wrist Strap Figure 4 Use the included wrist strap as extra precaution to help prevent damage to Spot if it slips from your hands Attach the wrist strap to the pin located under the handle DO NOT carry Spot by the wrist strap The wrist strap is an extra precaution but does not guarantee damage will be prevented if dropped P N 20079 Rev A Page 7 Optional Neck Strap PediaVision offers an optional neck strap to assist during extended usage The neck strap connects to the two tabs located below the display on Spot Please contact PediaVision Customer Service to order a neck strap Helpful Hints P N 20079 Rev A When there is no activity on Spot the device will automatically dim the screen and then turn the
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