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Introduction

About this document

This Directions for use manual is a comprehensive guide designed to help you

understand the capabilities and operation of your Spot Vision Screener VS100. The

information in this manual includes all options available with the Spot Vision Screener.

The applicability of some sections of this manual depends on the configuration of your

particular device. Read this manual thoroughly before attempting to use the device.

The vision screener is a hand-held instrument with a video display on the rear of the unit

that provides subject visualization and alignment. Video display also provides user

interface functionality for data input and display. The vision screener provides visual and

audible cues to attract subject’s attention and gaze. The device provides a fast data

collect for easy evaluation of the most difficult pediatric subjects of limited compliance.

Each screening provides simultaneous binocular assessment of the subject’s refraction,

pupil size and gaze.

Intended use

The Spot Vision Screener is intended to produce optical images that can help identify

refractive errors and ocular misalignments by detecting special light reflexes from each

eye during screening. The Spot Vision Screener evaluates these light reflexes from the

retina to estimate refractive error. It also estimates pupil size, pupil distance and eye

gaze deviation. It is intended for use on subjects six months of age through adults.

Indications for use

The Spot Vision Screener is indicated for use by healthcare professionals or under the

direction of a healthcare professional to screen or evaluate individuals for potential

refractive errors associated with poor vision. This type of photoretinoscopy device is

intended to help the healthcare professional assess whether the subject should be

referred to an eye care specialist for further evaluation or simply be monitored at future

screenings. This screening is not intended to replace a full eye examination.

Contraindications

The Spot Vision Screener has no known contraindications.

Содержание Spot VS100

Страница 1: ...Welch Allyn Spot Vision Screener Model VS100 Directions For Use Software version 3 1 XX ...

Страница 2: ... copy of the software incorporated within this instrument as intended in the operation of the product in which it is embedded The software may not be copied decompiled reverse engineered disassembled or otherwise reduced to human perceivable form This is not a sale of the software or any copy of the software all right title and ownership of the software remains with Welch Allyn or its vendors This...

Страница 3: ... 19 Subject Information screen 19 To screen a subject 19 The Subject Results screen 22 To screen in monocular mode 23 Overview Conducting a mass screening 23 To delete records 24 Advanced settings on the vision screener 25 Before configuring network security 25 Connecting a device to the network 25 Printing 26 About importing and exporting 30 Custom banner 33 Web access 34 Vision screener criteria...

Страница 4: ...ess issues 40 Battery Issues 40 Restoring and restarting system messages 40 Screening tips 41 Screening Issues 41 Import Export Issues 42 Specifications 43 Guidance and manufacturer s declaration 45 Warranty 55 Service policy 57 Configuration options for the VS100 vision screener 59 iv Contents Welch Allyn Spot Vision Screener Model VS100 ...

Страница 5: ...eous binocular assessment of the subject s refraction pupil size and gaze Intended use The Spot Vision Screener is intended to produce optical images that can help identify refractive errors and ocular misalignments by detecting special light reflexes from each eye during screening The Spot Vision Screener evaluates these light reflexes from the retina to estimate refractive error It also estimate...

Страница 6: ...death Caution The caution statements in this manual identify conditions or practices that could result in damage to the equipment or other property or loss of data This definition applies to both yellow and black and white symbols Power symbols Rated power input DC Rechargeable battery Power on off USB DC power input port Center pin positive Miscellaneous symbols IPXO Not protected against the ing...

Страница 7: ... network in range No IP address assigned by the router Unknown network Cannot connect to configured network Sound off Sound on Continue Back Exit Print job in progress Shipping storing and environment symbols This way up Keep Dry Fragile Humidity limitation Temperature limit Atmospheric pressure limitation Directions For Use Introduction 3 ...

Страница 8: ...se as unsorted municipal waste Recyclable Separate collection of Electrical and Electronic Equipment Do not dispose as unsorted municipal waste Keep away from sunlight Lithium ion battery 4 Introduction Welch Allyn Spot Vision Screener Model VS100 ...

Страница 9: ...f the sound creates discomfort for the patient please mute the device in the settings Data and Performance WARNING Risk of data loss If a reboot is required during a system freeze data loss such as printer configuration and subject data can occur WARNING Use only accessories approved by Welch Allyn Visit www welchallyn com The use of any other accessories can result in inaccurate subject data can ...

Страница 10: ... the device For example a printer connected via USB must comply with IEC 60950 Connecting additional unapproved devices to the device might increase chassis or subject leakage currents WARNING Risk of electric shock No modification of this equipment is allowed Do not open the device or attempt repairs The device has no user serviceable internal parts Only perform routine cleaning and maintenance p...

Страница 11: ...ION Do not leave the device in excessive heat or in direct sunlight High temperatures can cause the device to malfunction CAUTION When plugging the DC power connector into the device do not force the power connector into the device Using force can damage the device and voids the warranty The power connector on the power supply easily inserts into the vision screener CAUTION Do not push or scratch ...

Страница 12: ...ARNING This device has not been tested for use in clinical environments near high frequency surgical equipment and magnetic resonance imaging Do not use this device in environments like these where electromagnetic disturbance is high WARNING This equipment system is intended for use under the supervision of healthcare professionals only This equipment system may cause radio interference or may dis...

Страница 13: ...tures Front and Rear Views of Vision Screener 1 2 3 4 5 6 3 8 9 10 11 12 13 7 No Feature 1 Ambient light sensor 2 LCD screen 3 Neck strap mount 4 USB port 5 Green LED Indicator Battery charging flashing or charged continuous 6 Tripod mount 7 Serial number label 8 AC power connector 9 Power button 10 Wrist strap mount 11 Ranger finder 9 ...

Страница 14: ...No Feature 12 Front glass 13 Speaker 10 Controls display window and connections Welch Allyn Spot Vision Screener Model VS100 ...

Страница 15: ...bjects by location or clear the queue 2 History Displays a list of subjects who have already been screened You can also sort subjects by location or clear the history 3 Tools Provides options to customize the vision screener 4 Start Displays the Subject Information screen so you can enter subject information before the screening 5 Battery Status Indicates the status of the battery or whether the v...

Страница 16: ...s are associated with this location Language Allows you to select the language that displays on the vision screener License Displays the License Update screen Network Allows you to connect the vision screener to a wireless network You can enter your network name select the security type and enter the password for your network From this menu you can view and change your TCP IP settings Printer Allo...

Страница 17: ... security PIN for your device If enabled a PIN is required whenever you start the device or upon waking it Web services Enables the Web server and web services API Directions For Use Controls display window and connections 13 ...

Страница 18: ...14 Controls display window and connections Welch Allyn Spot Vision Screener Model VS100 ...

Страница 19: ...e wrist strap as a means to carry the device it is not designed to carry the weight of the device Note Please do not discard the box and foam Damages incurred by shipping the device in non approved packing material voids the limited warranty See Warranty for details To turn on the vision screener To turn the vision screener on press and release the Power button After the start up process completes...

Страница 20: ...wer To activate the device tap the screen or press the Power button If the screen does not light up plug in the power cord and try again To charge the vision screener Turn on and charge the vision screener for 4 hours before first use When the battery reaches a very low level the screen displays a notice to insert the power cable If the power cable is not inserted the device automatically shuts do...

Страница 21: ...radio button next to the desired language By default the selected language is English 3 To return to the Tools screen touch the arrow in the upper right corner To set the system clock The system clock displays in the upper right hand corner of the Home screen If the vision screener has been in storage you might need to reset the system clock 1 From the Home screen select Tools and then Date Time 2...

Страница 22: ...18 Setting up the vision screener Welch Allyn Spot Vision Screener Model VS100 ...

Страница 23: ...at MMDDYYYY or DDMMYYYY or enter the age and touch Months or Years Eyewear prescription Allows you to select None or Glasses or Contacts If this field is left blank None is selected Gender Allows you to select Male or Female If this field is left blank no gender is specified OK Confirms any changes Go Begins the screening To screen a subject If the vision screener has a location specified the name...

Страница 24: ...ubject information When finished touch OK twice 10 To exit the Subject Results screen touch Home Results are saved automatically 11 If you encounter difficulty If you see a blue screen the vision screener is either too close or too far from the subject The vision screener also displays a prompt Move forward or backward as needed If the subject s pupils are too small the vision screener displays a ...

Страница 25: ...r Individual screening results are saved in the pdf subfolder A list of all the screening results is saved under the db subfolder Note Do not allow the device storage to become 100 full For best results when the device has accumulated 300 records delete all records from the vision screener Verify you have successfully exported all desired records to a USB drive before you select Clear All For more...

Страница 26: ...e Exam Recommended Results that are out of range are indicated in red The figure below outlines the Subject Results screen No Feature 1 Pupillary Distance 2 Pupil Size Indicator 3 Right Eye OD Left Eye OS 4 Complete refraction SE Spherical equivalent DS Sphere DC Cylinder Axis Axis 5 Screening Result 6 HOME 7 Cylinder Convention 8 Alignment Indicator Degree Horizontal Vertical 22 Screening subject...

Страница 27: ...ight eye OS subject s left eye 3 To repeat the process with the subject s other eye touch Mono from the Measurement Options menu Overview Conducting a mass screening If you set up a subject list ahead of time you can screen several individuals quickly without having to stop to add additional information Note For best results when the device has accumulated 300 records delete all records from the v...

Страница 28: ...8 Repeat steps 4 7 until you have screened all the subjects Once finished you can export the files to a USB 2 0 drive to easily scan the results on a computer Individual screening results are saved in the pdf subfolder A list of all the screening results is saved under the db subfolder To delete records CAUTION Verify you have successfully exported the records to a USB 2 0 drive before you touch C...

Страница 29: ...pe is not selected the connection to the wireless network is not secure and any information sent or received on this network is not necessarily confidential CAUTION Product security exploits can cause the device or device data to become unavailable or cause data security breaches Avoid inserting uncontrolled or unsecured USB drives into the USB port or connecting to a wireless network with incompl...

Страница 30: ...e network IP settings 1 Touch TCP IP The network address and settings display on the screen 2 To manually configure the network IP configuration touch Static When finished touch OK 3 Touch OK to save the changes and return to the previous screen Printing To print screening results you must connect the vision screener to a printer on a wireless network or connect to a printer using a USB cable Set ...

Страница 31: ...rs all you need to do is add the printer to the Available Printers screen and set it as the default printer If a default printer has already been set it displays first An icon next to each printer indicates the type of connection 1 If adding a USB printer connect the USB cable from the printer to the vision screener s USB port If adding a network connected wireless printer make sure the vision scr...

Страница 32: ...e USB cable from the printer to the vision screener s USB port If adding a network connected wireless printer make sure the vision screener has been added to the wireless network 2 Touch Tools and then touch Printer The Printers Available screen displays all the printers that have been saved on the vision screener 3 Touch Plus The Add Printer screen appears 4 Select the printer and touch the right...

Страница 33: ...format xxx xxx xxx xxx For example 192 123 100 001 Port Port numbers range from 0 to 65535 IPP The default port is 631 Raw Socket The default port is 9100 Resource Path Available when IPP is the selected protocol The maximum length is 40 characters For allowed characters see Hostname The default value is ipp print To add a printer manually If the vision screener cannot discover a printer you must ...

Страница 34: ...ange a particular setting touch the field To delete a printer touch Minus To set the printer as default touch Set as default 3 Touch X in the upper left corner of the screen to return to the previous screen To reset the printer system Resetting the printer system deletes all currently saved printers 1 On the Printers Available screen touch the Trash icon 2 A pop up appears touch Delete All current...

Страница 35: ...test results SpotSubjects db subfolder This is a template that you can use to create a subject list For more information see Create a subject list SpotCriteria import subfolder This file contains the Vision Screener criteria Before modifying the criteria see Vision screener criteria Note this folder also contains a SpotCriteria default file This file is not modifiable Importing exporting files Imp...

Страница 36: ...pdate it on your computer After you import the updated list into the vision screener the subject information displays in the queue When you select a subject and complete the screening the subject s information disappears from the queue and is added to the list of completed screenings in the SpotResults csv file Individual results appear in the pdf subfolder 1 After exporting the csv files to the U...

Страница 37: ... Export Once the USB device is detected Import and Export become available for selection and the USB symbol displays in the upper right black bar next to the wireless connectivity symbol The number of import files found appears on the screen Note Import is only available if the vision screener recognizes a valid import file If there are no files in the top level of the USB drive Import is not avai...

Страница 38: ... pdf folder Vision screener criteria Spot Vision Screener s criteria was developed in accord with the American Academy of Pediatric Ophthalmology and Strabismus AAPOS and American Academy of Pediatrics AAP recommendations for instrument based vision screening The criteria is age specific to assist with early detection of amblyopic risk factors in children WARNING Risk of false positive and false n...

Страница 39: ...the USB drive The file cannot be within a folder Once copied open the file 4 Make any desired changes using a spreadsheet or notepad program 5 Save file as a Comma Separated Value csv file Do not change the file name Eject the USB drive from your computer and insert into the vision screener 6 Touch Tools and then touch Import Export 7 Touch Import to import the updated criteria file 8 To verify th...

Страница 40: ...us menu touch the X in the upper left corner of the screen To lock unlock the vision screener 1 To lock the vision screener hold down the Power button 2 Touch Lock A Lock symbol appears on the screen 3 To unlock the vision screener touch A number screen appears 4 Enter the security PIN code To check the storage capacity If the storage capacity is 100 full the vision screener stops working until yo...

Страница 41: ... tested by qualified service personnel Clean on a routine basis according to your facility s protocols and standards or local regulations The following agents are compatible with the vision screener 70 percent isopropyl alcohol 10 percent chlorine bleach solution Note Disinfect according to your facility s protocols and standards or local regulations Cleaning with 70 percent isopropyl alcohol Wipe...

Страница 42: ...arged in 18 months charge the device overnight while the device is turned on before using For best results use and charge the vision screener regularly Disposing of electronic equipment This product and its components must be disposed of according to local laws and regulations Do not dispose of this product as unsorted municipal waste For more specific disposal or compliance information see www we...

Страница 43: ...al start up process Printer issues Check that your printer is turned on and has sufficient ink or toner 1 Verify the printer is set as the default printer 2 Print a test print page directly from the printer 3 After you confirm your printer is in proper working order verify the printer is on a local network by printing to the printer from a computer on the same local network 4 Verify the vision scr...

Страница 44: ...eener Restoring and restarting system messages Message Text Meaning Are you sure you want to delete the custom loaded criteria and restore system default criteria To save your custom criteria use the Export option in Import Export tool You have requested a restore to the factory default settings for the age based criteria settings If you select Restore current criteria settings are removed All sub...

Страница 45: ...ollow these steps to encourage the subject s pupils to dilate 1 Dim the lights if possible 2 Close blinds or curtains if possible 3 The subject s back should be positioned to the interfering light source 4 Avoid direct light into the subject s eyes from ambient light sources exterior light incandescent and halogen lights florescent light is the best testing environment if options are limited Scree...

Страница 46: ...nths or 10 years Subject Information Screen After exporting to a computer get an error message The file or directory is corrupted and unreadable Delete or move all the files and folders from the USB 2 0 drive and retry the export Importing Exporting files Message Export failed due to an internal error Data export failed Retry the export Importing Exporting files Message Unable to exclude personal ...

Страница 47: ...ed IPX0 and thus not protected from the ingress of water The vision screener is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide The vision screener is suitable for continuous operation The vision screener screens for vision issues across all age groups from 6 months to 100 years Welch Allyn suggests a battery replacement at an appoint...

Страница 48: ...essure 700 hPA to 1060 hPA Expected Battery Life 2 5 Years Under Normal Usage Screening capacity Screening results provide an output that is either in or out of range accompanied by the appropriate statement in the device output display Screening Complete or Complete Eye Exam Recommended The displayed message is intended to prompt the caregiver to assess whether the subject should be referred to a...

Страница 49: ...eflex Gaze Range 0 0 to 20 0 degrees in increments of 1 degree Nasal N or Temporal T 0 0 to 20 0 degrees in increments of 1 degree Inferior I or Superior S Accuracy 1 5 degrees Guidance and manufacturer s declaration EMC compliance Special precautions concerning electromagnetic compatibility EMC must be taken for all medical electrical equipment This device complies with IEC 60601 1 2 2014 All med...

Страница 50: ... might degrade if you don t maintain sufficient separation distance WARNING This device has not been tested for use in clinical environments near high frequency surgical equipment and magnetic resonance imaging Do not use this device in environments like these where electromagnetic disturbance is high Emissions and immunity information Electromagnetic emissions The device is intended for use in th...

Страница 51: ...loors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 2 kV Mains power quality should be that of a typical commercial or hospital environment 1 kV for input output lines 1 kV Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality...

Страница 52: ...lowing symbol Note1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people aField strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcas...

Страница 53: ...quency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Test sp...

Страница 54: ...of the FCC Rules Operation is subject to the following two conditions This device may not cause harmful interference This device must accept any interference received including interference that may cause undesired operation Note This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to Part 15 of FCC Rules These limits are designed to provide reas...

Страница 55: ... 15 407 UNII 802 11a Wi Fi 2 4 GHz 5 4 GHz FCC 15 247 DSS BT 2 1 FCC Part 15 Class B Canada RSS 210 802 11a b g n Wi Fi 2 4 GHz 5 8 GHz 5 2 GHz and 5 4 GHz ICES 003 Class B CSA C22 2 No 60950 RSS 210 BT 2 1 Europe Annex 3 2 2014 53 EU Radio Equipment Directive https eur lex europa eu legal content EN TXT uri celex 32014L0053 General radio compliance The wireless features of this device must be use...

Страница 56: ...ut power may be limited to 10 mW EIRP in the frequency range of 2454 2483 5 MHz For detailed information the end user should contact the national spectrum authority in France Norway Does not apply for the geographical area within a radius of 20 km from the center of Ny Ålesund Czech Welch Allyn tímto prohlašuje ze tento RLAN device je ve shodě se základními požadavky a dalšími příslušnými ustanove...

Страница 57: ...i Hawnhekk Welch Allyn jiddikjara li dan RLAN device jikkonforma mal htigijiet essenzjali u ma provvedimenti ohrajn relevanti li hemm fid Dirrettiva 2014 53 EC Portuguese Welch Allyn declara que este RLAN device está conforme com os requisitos essenciais e outras disposições da Directiva 2014 53 CE Slovak Welch Allyn týmto vyhlasuje ze RLAN device spĺňa základné požiadavky a všetky príslušné ustan...

Страница 58: ...54 Specifications Welch Allyn Spot Vision Screener Model VS100 ...

Страница 59: ...anty shall not apply to any damage or product failure determined by Welch Allyn to have been caused by misuse accident including shipping damage neglect improper maintenance modification or repair by someone other than Welch Allyn or one of its authorized service representatives 1 one Year Limited Warranty These express warranties are in lieu of any and all other warranties express or implied incl...

Страница 60: ...56 Warranty Welch Allyn Spot Vision Screener Model VS100 ...

Страница 61: ...rts orders a purchase order or credit card number For parts orders the required spare or replacement part numbers If your product requires warranty extended warranty or non warranty repair service please call the nearest Welch Allyn Technical Support Center first A representative will assist you troubleshooting the problem and will make every effort to solve it over the phone avoiding potential un...

Страница 62: ...58 Service policy Welch Allyn Spot Vision Screener Model VS100 ...

Страница 63: ...tion VS100S XXX Welch Allyn VS100 Spot Vision Screener with Carrying Case and 8 2 5m power cord VS100 XXX Welch Allyn VS100 Spot Vision Screener with wrist strap and 8 2 5m power cord Carrying Case not Included Indicates the appropriate country specific power cord 59 ...

Страница 64: ...Material No 728900 ...

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