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General compliance and standards

The RetinaVue 100 Imager complies with the following standards:

IEC 60601-1:2005/A1:2012 (EN 60601-1:2006/A1:2013)

IEC 60601-1-2 : 2014 (EN 60601-1-2 : 2015)

ISO 15004-1

：

2006

ISO 15004-2

：

2007

ISO 10940

：

2009

ISO 10993-1 : 2009

Directive 2002/96/EC-WEEE:
Disposal of noncontaminated electrical and electronic equipment

This product and its accessories must be disposed of according to local laws and

regulations. Do not dispose of this product as unsorted municipal waste. Prepare this

product for reuse or separate collection as specified by Directive 2002/96/EC of the

European Parliament and the Council of the European Union on Waste Electronic and

Electrical Equipment (WEEE). If this product is contaminated, this directive does not

apply.

For more specific disposal or compliance information, see www.welchallyn.com/weee,

or contact Welch Allyn Customer Service at +44 207 365 6780.

General radio compliance

The wireless features of this device must be used in strict accordance with the

manufacturer’s instructions as described in the user documentation that comes with the

product.

Federal Communications Commission (FCC)

This device complies with part 15 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.

Содержание RetinaVue 100 Imager

Страница 1: ...Welch Allyn RetinaVue 100 Imager Directions for use Software version 6 XX...

Страница 2: ...tes of America copyright laws and international treaty provisions applicable worldwide Under such laws the licensee is entitled to use the copy of the software incorporated with this instrument as int...

Страница 3: ...from the RetinaVue Network Customer Portal wireless only 31 Create a new patient on the RetinaVue 100 Imager camera wireless and USB 37 Select a patient from the patient list wireless and USB 40 Revi...

Страница 4: ...83 Update the RetinaVue 100 Imager software to version 6 XX and above USB and wireless 97 Viewing or changing the RetinaVue 100 Imager settings 100 RetinaVue 100 Imager Accessories 106 Warranty 109 i...

Страница 5: ...nt 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 Consult directions for use DFU A copy o...

Страница 6: ...ssion 2AFB3WA WEC100 IC ID Industry Canada identification number The equivalent governing body to the FCC in the United States 21375 WAWEC100 CAN ICES 3 B NMB 3 B Australian Communications and Media A...

Страница 7: ...Degree of protection provided by enclosure IP code Battery charge level indicators Device is running on battery and charge is between 75 and 100 percent Device is running on battery and charge is belo...

Страница 8: ...4 Symbols Welch Allyn RetinaVue 100 Imager...

Страница 9: ...for use that pertain to your use of the device Specific warnings and cautions are also found throughout this manual Failure to understand and observe any warning statement in this manual could lead to...

Страница 10: ...illator or electrocautery devices CAUTION This device is not protected against the ingress of water and should not be used in the presence of liquids which may enter the device CAUTION Results deleted...

Страница 11: ...onsult the cleaning agent and germicidal cleaner agent manufacturer instructions for their proper use and germicidal efficacy prior to their use CAUTION Only use the cleaning or germicidal cleaner age...

Страница 12: ...ions on changing the power management options and for identifying the Always On USB port 2 RetinaVue 100 Imager device Digital hand held eye fundus camera used to record digital photographs of the fun...

Страница 13: ...ess of charging When the device is not docked the LED is off 7 LCD touchscreen 3 5 color HD LCD touchscreen Displays information for charging testing and adjustments to the device 8 Home button Press...

Страница 14: ...10 Introduction Welch Allyn RetinaVue 100 Imager...

Страница 15: ...items are included Number Item Description 1 RetinaVue 100 Imager device Digital hand held eye fundus camera used to record digital photographs of the fundus of the human eye and surrounding area 2 D...

Страница 16: ...ct pins on the device and the docking station Install the battery replace the battery Set the RetinaVue 100 Imager on a flat clean surface with the LED display facing down WARNING Personal injury risk...

Страница 17: ...s procedure only applies to battery replacement Remove the existing battery from the battery compartment and insert the new replacement battery into the battery compartment Match the polarity of the b...

Страница 18: ...s The eye cup works on the patient s left and right eye Set up the eye cup for a patient exam 1 Remove the lens cap from the RetinaVue 100 Imager 2 Slide the eye cup over the bezel on the RetinaVue 10...

Страница 19: ...aVue 100 Imager must be held level and in line with your patient s eye There are two recommended techniques to properly hold the RetinaVue 100 Imager for a quick and successful retinal exam Telescope...

Страница 20: ...100 Imager Guide Patient End Hand Hold the patient end of the RetinaVue 100 Imager with just the thumb and forefinger Use the small and ring finger to steady the RetinaVue 100 Imager by anchoring them...

Страница 21: ...B cable into the wall adapter plug and then plug the wall adapter into an AC outlet or plug the USB cable into the Always On USB port on a computer a Plug the USB cable into the wall adapter plug and...

Страница 22: ...tact pins of the docking station charger and reseat the RetinaVue 100 Imager into the docking station Charging is impacted if the pins are not properly touching Note The removal of the plug from the s...

Страница 23: ...ning battery Press to power up the RetinaVue 100 Imager As the device is powering up the RetinaVue 100 Imager displays the Welch Allyn logo If your facility has chosen to use a Device access code or a...

Страница 24: ...Note For the USB workflow the RetinaVue 100 Imager must be connected to a computer running the RetinaVue Network software requires additional software to transfer exams Note To change the connectivity...

Страница 25: ...camera setup wizard screen appears Note The USB or Wi Fi camera setup only needs to be completed once unless a change to the connectivity workflow is desired 2 Touch RetinaVue Network Wi Fi to select...

Страница 26: ...upported See the the Device radio section for further information If you don t see the network name in your list it might be a hidden network Select Other and enter the network name See the Troublesho...

Страница 27: ...Portal select Manage Devices wireless only and click Next 11 Click Add Device 12 On your RetinaVue 100 Imager camera touch Next to generate a Device Registration Code 13 On the RetinaVue Network Custo...

Страница 28: ...tinaVue Network Customer Portal as it appears on the RetinaVue 100 Imager device installation screen including the dash Note The code expires after 30 minutes 14 On the RetinaVue Network Customer Port...

Страница 29: ...amera and the RetinaVue Network Customer Portal support from 4 to 6 digits in the Device Access Code Note Setting the Device Access Code before first use provides additional security features in the R...

Страница 30: ...oaded The camera will require this code on next encounter 18 Optional If multiple clinics were selected at the RetinaVue Network Customer Portal use the drop down menu to select the primary clinic whe...

Страница 31: ...ptional If a Device Access Code was set at the RetinaVue Network Customer Portal enter the Device Access Code on the RetinaVue 100 Imager and touch OK Directions for use Using the RetinaVue 100 Imager...

Страница 32: ...ings on the RetinaVue 100 Imager Home screen 2 Touch Clinic States 3 Use the drop down menu to select a clinic 4 Touch Back to return to the Settings screen 5 Touch Home to return to the RetinaVue 100...

Страница 33: ...up for Multi State use 4 Touch Multi State The switch changes from Off to On 5 Touch States to select between 2 and 6 States for the clinic Touch More to see additional States and to proceed to OK wh...

Страница 34: ...Note For each exam performed in multi state use select the state where the exam was performed Touch OK to confirm 30 Using the RetinaVue 100 Imager Welch Allyn RetinaVue 100 Imager...

Страница 35: ...t wireless only from the RetinaVue Network Customer Portal Welcome screen and then click Next 2 Use the drop down menu to select a clinic The Schedule a Patient screen appears for your clinic 3 Comple...

Страница 36: ...nd click Search Any previous patients of your clinic within the RetinaVue Network meeting any of the search parameters appear on the Patients Search screen 4 Ensure that the RetinaVue 100 Imager camer...

Страница 37: ...6 Touch OK to start a new exam The Pre acquisition screen appears Directions for use Using the RetinaVue 100 Imager 33...

Страница 38: ...etinaVue Network Customer Portal wireless only 1 Select View Scheduled Patients wireless only from the RetinaVue Network Customer Portal Welcome screen and then click Next The View Scheduled Patients...

Страница 39: ...rk Customer Portal without submitting an exam for over read wireless only 1 Select Schedule a Patient wireless only from the RetinaVue Network Customer Portal Welcome screen and then click Next 2 Use...

Страница 40: ...ents screen appears 5 Ensure that the RetinaVue Imager camera is powered on and connected to a secure Wi Fi network Touch Patients The Patients screen appears 36 Using the RetinaVue 100 Imager Welch A...

Страница 41: ...new exam to practice with a demo patient without submitting the exam for over read on the RetinaVue Network Customer Portal 9 Refer to the section Perform an eye exam using the Auto exam mode for ins...

Страница 42: ...less Touch to refresh the patient list from the RetinaVue Network Customer Portal Scheduled Patients list 2 Touch New patient The New Patient screen appears Required fields are noted with a red asteri...

Страница 43: ...nter the patient s Date of Birth Touch within the DOB Gender field to launch the on screen keyboard and to enter the patient s Date of Birth Touch OK 6 Enter the patient s gender using the radio butto...

Страница 44: ...Select a patient from the patient list wireless and USB 1 From from the Home screen touch Patients The Patients screen appears Wireless workflow images shown 2 Touch the Patient s name to view a summa...

Страница 45: ...re wireless only to view the second Patient summary screen with additional Referring Physician and Diabetes type required fields 4 Touch OK to start a new exam The Pre acquisition screen appears Direc...

Страница 46: ...B workflow 1 From the Home screen touch Review The patient s Review screen appears 2 Touch on a patient s information to review the patient demographics and to view images associated with a patient 3...

Страница 47: ...4 After the review is complete touch Back to return to the Review screen and then touch Home to return to the Home screen Directions for use Using the RetinaVue 100 Imager 43...

Страница 48: ...of 40 Acceptable quality yellow If the image is of good enough quality it is likely to be read by a specialist Range of 20 39 Unacceptable quality red If the image is lacking in quality it is highly u...

Страница 49: ...mage capture order of the right and left eye Navigation to the image Inspection screen In addition to the automatic features manual capture manual focus adjustment and manual flash brightness adjustme...

Страница 50: ...required to obtain an image Available manual features include Focus adjustment values range from 1 to 1 Flash brightness adjustment values range from 2 to 2 Sequential image capture order of the righ...

Страница 51: ...t specific time intervals Note The best image quality is obtained while the diamond is at the beginning smallest size Note The diamond will reset to its smallest size each time the view moves out of t...

Страница 52: ...etinaVue 100 Imager can be used on patients with cataracts and other eye opacities the use of the RetinaVue 100 Imager may result in a lower quality image due to the increased reflection of the flash...

Страница 53: ...capture the highest quality image see the Technique guide and the Training video that came with the RetinaVue 100 Imager 1 Press the power button Note To conserve power the RetinaVue 100 Imager enter...

Страница 54: ...ue forward to compress the eye cup against the examined eye WARNING Clean and disinfect the eye cup after each patient to avoid the risk of cross contamination 6 Direct the patient to focus on the gre...

Страница 55: ...image on the LCD touchscreen This is your initial target 8 Guide the green circle on the RetinaVue 100 Imager LCD touchscreen towards the initial target by slowly moving the RetinaVue 100 Imager towar...

Страница 56: ...eep the RetinaVue 100 Imager in line Slightly adjust the RetinaVue 100 Imager away from any shadows that appear 11 Move the patient end of the RetinaVue 100 Imager toward the bubble 12 Align the bubbl...

Страница 57: ...s left eye L1 and wait at least 1 minute before repeating the steps until the second image is automatically captured Optional If the 2 image Macula Optic Disc center exam setup is selected in Advanced...

Страница 58: ...touch and then touch to create a new patient or touch on an existing patient s name from within the Patients screen to select that patient In the USB workflow touch Save to save the exam images In th...

Страница 59: ...Directions for use Using the RetinaVue 100 Imager 55...

Страница 60: ...tion screen appears 4 If this is the last image in the sequence touch Accept on the Image inspection screen and navigate to the Exam summary screen If an image is missing in the 1 image Macula centere...

Страница 61: ...mode 1 From the Home screen touch Exam The Pre acquisition screen appears 2 Touch MANUAL to enter Image acquisition mode and begin the exam of the patient s eye The Exam acquisition screen appears Di...

Страница 62: ...hscreen This is your initial target 7 Guide the green circle on the RetinaVue 100 Imager LCD touchscreen towards the initial target by slowly moving the RetinaVue 100 Imager towards the eye 8 Once the...

Страница 63: ...visibly worn distorted or contaminated should be replaced immediately To correct an error follow these instructions or contact Welch Allyn Technical Support www welchallyn com service Troubleshooting...

Страница 64: ...hat it is in the forward position Reinsert SD card to ensure the card is seated correctly The space left in the SD card is not enough Please replace the SD card Replace the SD card with a formatted SD...

Страница 65: ...the computer If the low battery message continues to display after the camera is docked in the docking station for several hours and while it is plugged into a USB port of your computer plug the USB...

Страница 66: ...d if the pins are not properly touching Ensure that the contact pins of the camera are touching the contact pins of the docking station charger If necessary reseat the camera into the docking station...

Страница 67: ...aVue Network Server Message Error connecting to the network using the supplied credentials Ensure that Wi Fi is connected Touch Settings Touch Wi Fi Ensure that a network name appears If no name appea...

Страница 68: ...u are attempting to connect with is a Wi Fi hot spot or has one of the following security types EAP PSK pre shared key using a passphrase EAP PEAP enterprise PEAP using a username and password There i...

Страница 69: ...e entered Touch Settings Touch Wi Fi Select a network name from the list enter your Username and Password and check the Remember this connection checkbox Every time you reboot the camera it will conne...

Страница 70: ...t to the RetinaVue Network Server Check your network connection If your saved exam does not appear in the Review list then it was successfully submitted to the RetinaVue Network Server Check the View...

Страница 71: ...ng OK and save new images for the exam Deleting pending exams from the Restore factory defaults menu Problem Solution In the event that you have an active Wi Fi connection and unsent exams on the Reti...

Страница 72: ...een appears press and hold the Home button for approximately 10 seconds Touch Confirm at the dialogue screen prompt Reset all the settings to defaults Note The reset process typically takes a few minu...

Страница 73: ...glutaraldehyde based disinfectants CAUTION Do not use bleach solutions of any kind when cleaning metal electrical contacts They will damage the docking station charger and the device Note Clean on a...

Страница 74: ...station charger Follow the manufacturers recommendations Approved cleaning agents Use only the following approved cleaning agents on the RetinaVue 100 Imager eye cup and docking station charger 70 per...

Страница 75: ...xels LCD Monitor 3 5 inch Full Color TFT LCD Image Format Encrypted JPEG DICOM Interface Micro USB File Transfer Docking station micro USB cable to PC running RetinaVue Network requires additional sof...

Страница 76: ...ions Temperature 10 C to 55 C Relative humidity 10 to 95 Atmospheric pressure 700 hPa to 1060 hPa Transportation environment Criterion Environmental conditions Temperature 40 C to 70 C Relative humidi...

Страница 77: ...DQPSK DBPSK 802 11g 64 QAM 16 QAM QPSK BPSK 802 11n BPSK QPSK 16 QAM 64 QAM Host interface USB 2 0 Encryption WPA2 WPA2 PSK WPA2 Enterprise EAP PEAP IEEE 802 11i Channel availability 2 4GHz Ch 1 11 U...

Страница 78: ...ons be sure the correct country in which the access point is installed is selected This product can be used with the following restriction s Norway Does not apply for the geographical area within a ra...

Страница 79: ...rliament and the Council of the European Union on Waste Electronic and Electrical Equipment WEEE If this product is contaminated this directive does not apply For more specific disposal or compliance...

Страница 80: ...by unauthorized modification of the devices included with this Welch Allyn product or the substitution or attachment of connecting cables and equipment other than specified by Welch Allyn The correct...

Страница 81: ...la s n zk m v konem je v souladu se z kladn mi po adavky a dal mi p slu n mi ustanoven mi sm rnice 2014 53 ES Danish Medimaging Integrated Solution Inc MiiS erkl rer herved at denne lavt str m transmi...

Страница 82: ...tento vysiela s n zkym v konom je v s lade so z kladn mi po iadavkami a al mi pr slu n mi ustanoveniami smernice 2014 53 ES Slovene S tem Medimaging Integrated Solution Inc MiiS izjavlja da je ta nizk...

Страница 83: ...arious agencies including FCC 47 CFR 15 247 and R TTE Directive 1995 5 EC The transmitter is excluded from the EMC requirements of 60601 1 2 but should be considered when addressing possible interfere...

Страница 84: ...d strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equi...

Страница 85: ...o 80 MHz d 1 17 80 MHz to 800 MHz d 1 17 800 MHz to 2 7 GHz d 2 23 0 01 0 11667 0 11667 0 23333 0 1 0 36894 0 36894 0 73785 1 1 1667 1 1667 2 3333 10 3 6894 3 6894 7 3785 100 11 667 11 667 23 3333 For...

Страница 86: ...82 General compliance and standards Welch Allyn RetinaVue 100 Imager...

Страница 87: ...as Item Area 1 Device status 2 Content Device Status Area The Device Status Area located at the top of the Home screen displays the Battery condition Estimated battery capacity is displayed in a charg...

Страница 88: ...created on the RetinaVue 100 Imager or transferred from the RetinaVue Network requires additional software Exam The Exam workflow provides a guided approach to image capture To maintain consistent and...

Страница 89: ...mation Training Provides demonstrations and interactive training exercises on the RetinaVue 100 Imager Short video clips and interactive training help you practice the three key steps necessary to mas...

Страница 90: ...to navigate to the first scene within the training section Step back to previous scene Touch to navigate to the previous scene within the training section Home Displays the RetinaVue 100 Imager workf...

Страница 91: ...the next step in a sequence of steps Image acquisition navigation Navigates to the image acquisition position within the prescribed sequence Provides a visual representation of the prescribed sequent...

Страница 92: ...ons The primary navigation area is located at the bottom of the RetinaVue 100 Imager screen In addition the Advance to next screen button navigates to an image The button is located on the same line a...

Страница 93: ...ANUAL switches to advanced image capture options 3 Image Order skips to the next image in the sequence 6 Next skips to the next image acquisition within a prescribed image acquisition sequence or navi...

Страница 94: ...ial captured image is saved Touch Discard then touch Yes at the dialogue Do you wish to discard this image to discard the image Alternatively touch No at the dialogue screen to return to the Post acqu...

Страница 95: ...images shown Touch Good quality green to view that image Image accepted good quality Quality scores of 40 Touch Acceptable quality yellow to view that image Image accepted quality OK Quality scores ra...

Страница 96: ...en Wireless only Touch Submit to accept and send all images and to return to the Home screen If an image is missing touch Override to access the Submit or Save button and to submit or save a single im...

Страница 97: ...Review Touch on a patient s name The Exam summary screen appears for that patient Touch Good quality green Acceptable quality yellow or Unacceptable quality red to view the image Touch Patient to revi...

Страница 98: ...e screen Power down the RetinaVue 100 Imager 1 Press 2 A dialogue box appears with three options Power Off Sleep Cancel 3 Touch one of the options The RetinaVue 100 Imager will power off go into Sleep...

Страница 99: ...ue 100 Imager out of Sleep mode use any of these methods 1 Touch the power button 2 Touch the LCD touchscreen 3 Press the Home button Note Lifting or moving the RetinaVue 100 Imager also brings the Re...

Страница 100: ...h the LCD touchscreen or 3 press the Home button Note Lifting or moving the RetinaVue 100 Imager also brings the RetinaVue 100 Imager out of Sleep mode 2 After performing one of the options the Retina...

Страница 101: ...00 Imager containing the SD card that you plan to update Alternatively you can use a blank formatted 8GB to 32GB SD Card to transfer the downloaded software update to the RetinaVue 100 Imager 1 Ensure...

Страница 102: ...uch About to view the software version 13 Touch OK Update the RetinaVue 100 Imager connection settings USB and wireless Complete the following steps to update or change USB or wireless connection sett...

Страница 103: ...ard Remove the SD Card reformat it on a PC Repeat the steps to perform the update again Update extraction file error If the RetinaVue 100 Imager displays the failed update error message Update file ex...

Страница 104: ...te Continent and Location Use the radio buttons to select the 24 hour or 12 hour format Touch Back to return to the Settings screen Touch Date Touch up or down to adjust the day month and year in the...

Страница 105: ...Network Information Touch Network Information to view the wireless radio Wi Fi MAC address IP address Netmask address or Broadcast address Touch Back to return to the Settings screen Touch Home to ret...

Страница 106: ...ovides additional security features in the RetinaVue 100 Imager to prevent unintended access to patient information by unauthorized individuals Note See First time RetinaVue 100 Imager camera registra...

Страница 107: ...s screen 9 Touch Home to return to the RetinaVue 100 Imager Home screen Reset the Device access code USB only Note See the Troubleshooting section if you cannot recall your RetinaVue 100 Imager access...

Страница 108: ...e and need to erase the code 1 Remove the RetinaVue 100 Imager from the docking station charger 2 If the RetinaVue 100 Imager is set with a Device access code in addition to the Advanced settings code...

Страница 109: ...naVue 100 Imager Home screen without using an Advanced setting code 9 Touch OK to accept the code and touch OK again at the confirmation screen 10 Touch Back to return to the Settings screen 11 Touch...

Страница 110: ...l adapter for Welch AllynRetinaVue 100 Imager 100 240 V 50 60 Hz IEC Plug Type C EU 106509 Power supply wall adapter for Welch Allyn RetinaVue 100 Imager 100 240 V 50 60 Hz IEC Plug Type G UK 106530 P...

Страница 111: ...100 Imager 3 years S1 RV100 1P Welch Allyn Partners in Care Comprehensive Partnership Program Premium Service for RetinaVue 100 Imager 1 year S1 RV100 2P Welch Allyn Partners in Care Comprehensive Par...

Страница 112: ...108 Appendix Welch Allyn RetinaVue 100 Imager...

Страница 113: ...2 use or maintenance contrary to labeled instructions 3 alteration or repair by anyone not authorized by Welch Allyn and 4 accidents Shipping cost to return a device to a Welch Allyn Service center is...

Страница 114: ......

Страница 115: ......

Страница 116: ...Material No 411492...

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