Welch Allyn RetinaVue™ 700 Imager Directions for use Software version 1.
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iii Contents Symbols .......................................................................... 1 Introduction .................................................................... 5 Intended use .................................................................................. 5 About warnings and cautions ......................................................... 5 General warnings, cautions, and notes .......................................... 6 Controls and connectors ...................................
iv Contents Welch Allyn RetinaVue™ 700 Imager Search for a patient in the Scheduled Patients list on the RetinaVue 700 Imager (wireless) ................................................................... 75 Search for a patient in the Saved exams list on the RetinaVue 700 Imager (wireless) .......................................................................... 77 Delete an image during an eye exam .......................................... 80 Delete a patient from the RetinaVue 700 Imager ...........
1 Symbols Documentation symbols For information on the origin of these symbols, visit http://www.welchallyn.com/ symbolsglossary for the Welch Allyn symbols glossary. WARNING The warning statements in this manual identify conditions or practices that could lead to illness, injury, or death. Warning symbols will appear with a grey background in a black and white document.
2 Symbols Welch Allyn RetinaVue™ 700 Imager Fuse Rechargeable battery Connectivity symbols USB Wireless Wireless radio symbols Non-ionizing electromagnetic radiation Wireless signal strength • • • • • Best (4 bars) Good (3 bars) Fair (2 bars) Weak (1 bar) No signal (no bars) FCC ID The identification number assigned by the Federal Communication Commission IC ID Industry Canada identification number.
Directions for use Symbols 3 Separate collection of Electrical and Electronic Equipment. Do not dispose as unsorted municipal waste.
4 Symbols Welch Allyn RetinaVue™ 700 Imager Manufacturer Call for maintenance Process indicator for activities like connecting to network or connecting to computer 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 below 75 percent. Device is running on battery and charge is below 50 percent. Device is running on battery and charge is below 25 percent. Device is connected to a power supply.
5 Introduction Intended use The RetinaVue 700 Imager (RV700) is a high-resolution ophthalmic camera used to acquire, save and transmit digital images of the human eye. Anterior and posterior ocular structures such as the surface of the eye, cornea, and fundus including retina, macula and optic disc can be imaged. It is a prescription use only medical device. No sterility requirements apply to this product.
6 Introduction Welch Allyn RetinaVue™ 700 Imager General warnings, cautions, and notes WARNING Exposure to the RetinaVue 700 Imager flash, in rare cases, may contribute to migraines or temporary visual disturbances, particularly in patients with a history of light sensitivity or migraines. Multiple flashes per eye in a single exam may increase the likelihood of occurrence. WARNING Clean and disinfect the face cup after each patient to avoid the risk of crosscontamination.
Directions for use Introduction CAUTION This device needs to be installed and put into service according to the EMC information provided herein. CAUTION Portable and mobile RF communications equipment can affect the RetinaVue 700 Imager performance. CAUTION Input overload can occur in proximity to defibrillator 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.
8 Introduction Welch Allyn RetinaVue™ 700 Imager CAUTION Do not use the device adjacent to or stacked with other equipment. If the device is used adjacent or stacked with other equipment, the device should be observed to verify normal operation in the configuration in which it will be used. CAUTION Do not submerge the device in liquid or allow liquid to enter the interior of the device. CAUTION Do not use automatic cleansing machines or sterilization.
Directions for use Introduction Controls and connectors No. 1 Feature Description Power button • • • Push button to turn the device on and off. Push button to bring the device out of Sleep mode. Push button to launch a dialogue box with three options: ○ Power down ○ Sleep ○ Cancel 2 LCD touchscreen 6” color LCD touchscreen with a 16x9 aspect ratio. Displays information for charging, testing, and adjustments to the device.
10 Introduction Welch Allyn RetinaVue™ 700 Imager Bottom No. Feature Description 5 Face cup Blocks ambient light during testing 6 (Optional) Pedestal mounting Pedestal mounting well and attachment slot 7 Battery cover Covers the battery compartment Note The two service ports under the battery cover are for factory use only and are not for customer use.
11 First time set up of the RetinaVue 700 Imager Use the following topics when setting up the RetinaVue 700 Imager for the first time. View images saved to the RetinaVue 700 Imager on the LCD touchscreen. The images saved on the RetinaVue 700 Imager are encrypted. To view the images on the PC, install the RetinaVue Network software application. For information on the RetinaVue Network Software visit www.RetinaVue.com. Unpack the system The RetinaVue 700 Imager device is packaged with the following items.
12 First time set up of the RetinaVue 700 Imager Number Item Welch Allyn RetinaVue™ 700 Imager Description structures such as the cornea, lens and fundus including retina, macula and optic disc. 2 USB cable Connects the device to a computer or laptop to transfer results. 3 Wall adapter plug and AC power cord Connects the device to the wall adapter plug for AC charging. Match to region-specific AC wall outlet.
Directions for use First time set up of the RetinaVue 700 Imager 13 WARNING Personal injury risk. Improper handling of the battery can lead to heat generation, smoke, explosion, or fire. Do not short-circuit, crush, incinerate, or disassemble the battery. Never dispose of batteries in refuse containers. Always recycle batteries according to national or local regulations. WARNING Use only Welch Allyn approved accessories, and use them according to the manufacturer’s directions for use.
14 First time set up of the RetinaVue 700 Imager 5. Note Welch Allyn RetinaVue™ 700 Imager Tighten the screw at the edge of the battery cover. Do not over-tighten the screw. Connect the power supply to the RetinaVue 700 Imager 1. Locate the power connector charging port on the RetinaVue 700 Imager and plug the power supply connector plug into the RetinaVue 700 Imager. CAUTION The power supply connector easily inserts into the RetinaVue 700 Imager.
Directions for use First time set up of the RetinaVue 700 Imager 15 Startup Power The Power button, located on the upper-left corner of the RetinaVue 700 Imager, performs multiple functions: • • • powers up the RetinaVue 700 Imager wakes the RetinaVue 700 Imager from Sleep mode opens a dialogue screen with controls to power down, enter Sleep mode, or to cancel and return to the prior screen, depending on the option you choose Power up the RetinaVue 700 Imager The RetinaVue 700 Imager runs a brief diagn
16 First time set up of the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager As the device is powering up, the RetinaVue 700 Imager displays the Welch Allyn logo. 2. If this is the first time set up, select your preferred language from the dropdown list and then touch Next. 3. Touch 4. Touch (up) or (down) to enter, or adjust, the Hour, Minute (Min), Continent, and Location. Touch Next. Note Use the radio buttons to select the 24-hour or 12-hour format. 5.
Directions for use First time set up of the RetinaVue 700 Imager 17
18 First time set up of the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager First time selection of USB connectivity workflow 1. Touch RetinaVue Network - USB to select the USB workflow and touch Next. 2. Touch OK at the Setup completed screen and follow the touchscreen instructions to connect the camera to a computer.
Directions for use First time set up of the RetinaVue 700 Imager 19 Before you begin 1. Power on the RetinaVue 700 Imager and touch Practice on the main Patients screen. 2. See the Practice mode topic for further instructions. 3. Practice with interactive feedback from the integrated RetinaVue 700 Imager Practice mode. Set up the RetinaVue 700 Imager 1. Note 2. Note Power on the computer and the RetinaVue 700 Imager. If prompted to log in to Windows enter your Windows credentials.
20 First time set up of the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager Start a new exam 1. Have the patient sit in a dark room for 5 minutes to dilate their pupils. 2. Click New Exam in the RetinaVue Network software application. 3. Complete all required fields. Required fields are highlighted in red. 4. Click NEXT to save the patient information. A message appears indicating the patient has been added to the camera. Click OK.
Directions for use 5. First time set up of the RetinaVue 700 Imager 21 Disconnect the RetinaVue 700 Imager from the computer and USB cable. CAUTION Do not disconnect the RetinaVue 700 Imager from the USB cable while the RetinaVue Network software application is transferring data. Data may be lost. The process status icon appears while data is being transferred. 6. The new patient appears on the RetinaVue 700 Imager main Patients screen. 7. Select the patient from the Patients list. 8.
22 First time set up of the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager
Directions for use First time set up of the RetinaVue 700 Imager 23 Acquire images 1. To proceed with the default Exam protocol, touch START. a. (Optional) If creating the exam on the camera, touch (Settings) 2W or touch within the currently displayed exam protocol to launch the Exam protocol selection dialog box and to select the desired Exam protocol. Select the new protocol at the dialog screen prompt: "Which type of eye exam do you want to capture?" R L Touch OK. 2.
24 3. First time set up of the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager Instruct the patient to look at the green fixation light inside the RetinaVue 700 Imager. A message appears on the LCD touchscreen: "Aim and center camera" as the camera is entering the live preview mode. WARNING Clean and disinfect the face cup after each patient to avoid the risk of cross-contamination. 4. Keep the RetinaVue 700 Imager in line. 5.
Directions for use 8. First time set up of the RetinaVue 700 Imager 25 • If the image is of good quality (scores of 40 +) likely to be read. • If the image is of good enough quality (range of 20 — 39) it is likely to be read. • If the image is lacking in quality (range of 0 — 19) highly unlikely to be read. If the quality indicator is green or yellow, touch corner. , it is very , , it is (next) in the bottom right If the quality indicator is red, touch (Discard) in the bottom left corner.
26 First time set up of the RetinaVue 700 Imager Note Welch Allyn RetinaVue™ 700 Imager If the exam does not transfer or if a syncing error message appears in the RetinaVue Network software application, see the Troubleshooting topic for further information.
Directions for use First time set up of the RetinaVue 700 Imager 27 Transfer exam images 1. Connect the RetinaVue 700 Imager to the computer with a USB cable. 2. Ensure that the camera remains powered on until the exams are transferred to the RetinaVue Network software application. 3. In the RetinaVue Network software application, click Incomplete Exams. A list of patients with incomplete exams appears on the Incomplete Exams screen. Select your patient and click Next. 4.
28 First time set up of the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager Review the images and then click Next again. 5. From the Exam Workflow Complete screen, click Submit Exam. 6. Once the exam has been submitted, a message appears indicating the exam was successfully submitted. Click OK.
Directions for use First time set up of the RetinaVue 700 Imager 29 View New Reports - RetinaVue Network Customer Portal Once images are submitted from the computer running the RetinaVue Network software application and the images are evaluated, a new report is available on the RetinaVue Network Customer Portal. 1. Log in to the RetinaVue Network Customer Portal. The Welcome screen appears. 2. Select View New Diagnostic Reports and click Next.
30 First time set up of the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager The New Diagnostic Reports screen appears. 3. Select your patient and click View to view report.
Directions for use First time set up of the RetinaVue 700 Imager 31 First time selection of Wi-Fi connectivity workflow Note The Wi-Fi camera setup only needs to be completed once unless a change to the connectivity workflow is desired. 1. Touch RetinaVue Network - Wi-Fi to select the wireless workflow and touch Next. 2. From the list of available networks, touch on the Wi-Fi connection that you want to connect to. Note *Wi-Fi network names shown here are examples.
32 First time set up of the RetinaVue 700 Imager During Wi-Fi communication, the RetinaVue 700 Imager supports the use of the following secure authentication types: WPA2-PSK and WPA2 Enterprise. 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 Troubleshooting section for further information. Note 3.
Directions for use Note First time set up of the RetinaVue 700 Imager 33 If prompted, click I agree to accept the End User License Agreement on the RetinaVue Network Customer Portal. 7. On the RetinaVue Network Customer Portal, select Manage Devices (wireless only) and click Next. 8. Click Add Device.
34 First time set up of the RetinaVue 700 Imager 9. Welch Allyn RetinaVue™ 700 Imager On your RetinaVue 700 Imager, touch Next to generate a Device Registration Code. 10. On the RetinaVue Network Customer Portal, enter the Device Registration Code from the RetinaVue 700 Imager and then click Enter. Note *The Device Registration Code shown here is an example.
Directions for use Note First time set up of the RetinaVue 700 Imager 35 a. (Optional) Test the WiFi and EMR connection by sending images to a test server. This mode is not intended to be used for patient exams. b. (Optional) To select multiple clinics where the RetinaVue 700 Imager will be used at, select each clinic by clicking the check box next to the clinic name. c.
36 First time set up of the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager 13. (Optional) If a Device Access Code was selected at the RetinaVue Network Customer Portal, touch OK at the dialogue: A new device access code has been downloaded. The camera will require this code on next encounter. 14. (Optional) If multiple clinics were selected at the RetinaVue Network Customer Portal, use the drop-down menu to select the primary clinic where exams will be performed and then touch Next. 15.
Directions for use First time set up of the RetinaVue 700 Imager 37 About the Auto and Manual Exam modes Auto Mode Auto Mode is the default image capture mode.
38 First time set up of the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager Manual mode contains advanced image capture options. Note A manual touch of the capture button is required to obtain an image.
Directions for use First time set up of the RetinaVue 700 Imager 39 About image quality scores Good quality green (Inspection screen) Good quality green (Exam summary screen) If the image is of good quality, it is very likely to be read. (Scores of 40 +) Acceptable quality yellow Acceptable quality yellow (Inspection screen) (Exam summary screen) If the image is of good enough quality, it is likely to be read.
40 First time set up of the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager About Exam protocols Available Exam protocols include: • • • 60 ° Macula centered 60 ° Optic disc centered Anterior white light Macula centered imaging: Evaluate and document the central retina and macula for clinical signs of Diabetic Retinopathy.
Directions for use First time set up of the RetinaVue 700 Imager 41 Optic disc centered imaging: Evaluate and document the optic disc for clinical signs of glaucoma. 60 ° Optic disc centered Anterior white imaging: Evaluate and document anterior ocular structures like lids, lashes, and cornea.
42 First time set up of the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager Anterior white light CAUTION Failure to install the face cup spacer plate before a patient anterior image exam may result in unacceptable image quality or failure to capture an image. CAUTION Failure to remove the face cup spacer plate before a patient 60 ° Macula centered or 60 ° Optic disc centered exam may result in unacceptable image quality or failure to capture an image.
Directions for use Note First time set up of the RetinaVue 700 Imager 43 If a patient has been scheduled from the RetinaVue Network Customer Portal in wireless mode, no changes can made to the Exam protocol once the administrator has locked the protocols. Face cup The face cup blocks ambient light during testing and covers both of the patient's eye sockets to allow them to best focus on the green fixation light.
44 First time set up of the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager attach the face cup spacer plate to the RetinaVue 700 Imager , and then attach the face cup to the spacer plate. CAUTION Failure to install the face cup spacer plate before a patient anterior image exam may result in unacceptable image quality or failure to capture an image. 2.
Directions for use First time set up of the RetinaVue 700 Imager 45 removing the face cup spacer plate from the RetinaVue 700 Imager CAUTION Failure to remove the face cup spacer plate before for a patient 60 ° Macula centered or 60 ° Optic disc centered exam may result in unacceptable image quality or failure to capture an image. Remove the face cup spacer plate for a patient a 60 ° Macula centered or 60 ° Optic disc centered exam 1.
46 2. First time set up of the RetinaVue 700 Imager From the Pre Acquisition screen, touch Welch Allyn RetinaVue™ 700 Imager (Settings) or touch within the 2W to launch the Exam protocol selection dialog current exam protocol box and to select either the 60 ° Macula centered or 60 ° Optic disc centered Exam protocol. R 3. L Touch the 60 ° Macula centered or 60 ° Optic disc centered protocol button and touch OK at the prompt.
47 Using the RetinaVue 700 Imager The following topics describe using the RetinaVue 700 Imager for exams, creating new patients, deleting exams and reviewing exams. Perform an eye exam (wireless workflow) • • • • • Note To ensure that the patient's pupils sufficiently dilate to 3 mm, adjust the room lighting to the lowest possible level. If necessary, have the patient sit in a dark room for 5 minutes to dilate their pupils.
48 Using the RetinaVue 700 Imager • Welch Allyn RetinaVue™ 700 Imager Approach the patient from directly in front of the examined eyes and firmly press the face cup against the patient's forehead and nose. Ask the patient to focus on the fixation light. • Note 1. For additional information about techniques to capture the highest quality image, see the Technique guide that came with the RetinaVue 700 Imager. Press the power button.
Directions for use Using the RetinaVue 700 Imager 49 a. Touch to search for a patient with an existing exam within the Scheduled patients or Saved exams list. b. Touch to refresh the patient list from the RetinaVue Network Customer Portal Scheduled Patients list. 3. Touch within the Patient's Last name, First name, or Middle initial entry box to launch the on-screen keyboard. 4. Enter the patient's last name and first name. (Middle initial is optional.) 5. Enter the patient's DOB (Date of Birth).
50 9. Using the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager Enter the patient's Diabetes type using the drop-down menu to select Type I, Type II, None, or Unspecified. 10. Once all the required fields are complete, touch Exam to open a new exam. Optionally, to save the patient information without starting an exam, touch Save. 11. To proceed with the default Exam protocol, touch START.
Directions for use a. Using the RetinaVue 700 Imager 51 (Optional) If creating the exam on the camera, touch (Settings) 2W or touch within the currently displayed exam protocol launch the Exam protocol selection. R L to Touch OK. Note If a patient has been scheduled from the RetinaVue Network Customer Portal in wireless mode, no changes can made to the Exam protocol once the administrator has locked the protocols. 12.
52 Using the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager WARNING Clean and disinfect the face cup after each patient to avoid the risk of cross-contamination. 14. Keep the RetinaVue 700 Imager in line. 15. While the camera is locating the eye and self-adjusting to capture the best image, the "Keep camera steady and in place" message appears on the LCD touchscreen for each eye along with an animation. 16.
Directions for use 18. Touch Using the RetinaVue 700 Imager 53 to review the displayed image on the Inspection mode screen. Images with a red X ( ) and low score denote low quality images. Touch to navigate back to the Inspection mode screen. Touch (trash) to dispose of an image and to begin a capture of another image. Touch OK at the dialog prompt "Do you wish to discard this image and acquire again?". The Live acquisition screen appears. 19.
54 Using the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager Perform an eye exam (USB workflow) • • Note To ensure that the patient's pupils sufficiently dilate to 3 mm, adjust the room lighting to the lowest possible level. If necessary, have the patient sit in a dark room for 5 minutes to dilate their pupils.
Directions for use Using the RetinaVue 700 Imager 55 Note To conserve power, the RetinaVue 700 Imager enters Sleep mode if it remains idle for the time set during set up. (Sleep mode settings include 2, 5, 7, 10 minutes, and Never). Touch the LCD screen or press the power button to wake up the RetinaVue 700 Imager from Sleep mode. Note Unless Never is selected, the RetinaVue 700 Imager powers down after 10 minutes of inactivity in Sleep mode. Press the power button to activate the RetinaVue 700 Imager.
56 Using the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager 5. Enter the patient's DOB (Date of Birth). (Touch within the DOB field to launch the on-screen keyboard and to enter the patient's Date of Birth.) 6. Enter the patient's gender using the drop-down menu to select Male, Female, Unknown, or Other. 7. Enter the patient's ID. 8. Once all the required fields are complete, touch Exam to open a new exam. The Pre-acquisition screen appears. 9.
Directions for use Using the RetinaVue 700 Imager 57 Touch OK. 10. Approach the patient from directly in front of the examined eyes and firmly press the facecup of the RetinaVue 700 Imager against the patient's forehead and nose. A message appears on the LCD touchscreen: "Getting ready to aim and center camera" as the camera is entering the live preview mode. 11. Instruct the patient to look at the green fixation light inside the RetinaVue 700 Imager.
58 Using the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager WARNING Clean and disinfect the face cup after each patient to avoid the risk of cross-contamination. 12. Keep the RetinaVue 700 Imager in line. 13. While the camera is locating the eye and self-adjusting to capture the best image, the "Keep camera steady and in place" message appears on the LCD touchscreen for each eye along with an animation. 14.
Directions for use Using the RetinaVue 700 Imager 59 Images with a red X ( ) and low score denote low quality images. Touch to navigate back to the Inspection mode screen. Touch (trash) to dispose of an image and to begin a capture of another image. Touch OK at the dialog prompt "Do you wish to discard this image and acquire again?". The Live acquisition screen appears. 17. Touch (Next) after all images are automatically captured. 18.
60 Using the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager Perform a manual image capture while in Auto exam mode 1. From the Pre Acquisition screen, touch MANUAL. 2. Select the desired manual Exam protocol from the Exam protocol selection screen.
Directions for use Using the RetinaVue 700 Imager 61 Note To adjust settings before capturing an image, see the topic About the Auto and Manual Exam modes for additional information about using advanced image capture options (such as Focus adjustment, Flash brightness adjustment, or X-axis and Y-axis adjustment). 3. (image capture) to manually capture an image of the right or left Touch eye. (Right eye manual capture shown.) An audible tone alerts you that the image has been captured.
62 Using the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager 2. The Patient summary screen appears. Required fields are noted with a red asterisk. 3. Touch within the patient's last name or first name field to launch the onscreen keyboard. Enter the patient's last name and first name. (Middle initial is optional.) 4. Enter the patient's DOB (Date of Birth). (Touch within the DOB field to launch the on-screen keyboard and to enter the patient's Date of Birth.) 5.
Directions for use 8. Using the RetinaVue 700 Imager 63 Refer to Perform an eye exam for instructions on performing exams and acquiring images. Create a new patient on the RetinaVue 700 Imager (wireless) to create a new patient. (Wireless 1. From the main Patients screen, touch workflow images shown) 2. The Patient summary screen appears. Required fields are noted with a red asterisk.
64 Using the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager 3. Touch within the patient's last name or first name field to launch the onscreen keyboard. Enter the patient's last name and first name. (Middle initial is optional.) 4. Enter the patient's DOB (Date of Birth). (Touch within the DOB field to launch the on-screen keyboard and to enter the patient's Date of Birth.) 5. Enter the patient's gender using the drop-down menu to select Male, Female, Unknown, or Other. 6.
Directions for use Using the RetinaVue 700 Imager 65 The Pre-acquisition screen appears. 10. Refer to Perform an eye exam for instructions on performing exams and acquiring images.
66 Using the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager Select or change a clinic on the RetinaVue 700 Imager (wireless only) (Navigation Menu) from the main Patients screen. 1. Touch 2. Touch Settings. 3. Touch Clinic / States. Note With saved exams on the camera, switching a clinic is not permitted. Either save or delete the exam to switch clinics. Note If the "Wi-Fi connection not available." message appears, see the Troubleshooting section. 4.
Directions for use Using the RetinaVue 700 Imager 67 Select or change a Multi-State clinic on the RetinaVue 700 Imager (wireless only) (Navigation Menu) from the main Patients screen. 1. Touch 2. Touch Settings 3. Touch Clinic / States. 4. If multiple clinics are set up, use the drop-down menu to select the clinic you would like to set up for Multi-State use. 5. Touch Multi-State. The switch changes from Off to On.
68 Using the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager 6. Touch States to select between 2 and 6 States for the clinic. Touch More to see additional States and to proceed to OK when the desired number of States are selected. 7. Touch OK to return to the Clinic/State Settings screen. 8. Touch Note (Back) to return to the main Patients screen. For each exam performed in multi-state use, select the state where the exam was performed. Touch OK to confirm.
Directions for use Using the RetinaVue 700 Imager 69 Schedule a patient from the RetinaVue Network Customer Portal (wireless only) 1. Select Schedule a Patient (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. Complete the required fields and click Schedule Patient.
70 Using the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager Note Required fields contain a red asterisk. Required fields include: MRN, First and Last Name, Date of Birth, Gender, and Referring Provider. Optional Risk factor fields include: None, Diabetes Type, Obesity, Pregnant, Smoker, High Cholesterol, and High Blood Pressure.
Directions for use Using the RetinaVue 700 Imager 71 7. Touch Exam to start a new exam. The Pre-acquisition screen appears. 8. Refer to Perform an eye exam for instructions on performing exams and acquiring images. Delete a patient scheduled from the RetinaVue Network Customer Portal (wireless only) 1. From the Patient summary screen, touch Delete. A patient scheduled from the RetinaVue Network Customer Portal is also deleted from the Scheduled patient's list.
72 Using the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager 2. To confirm that the patient deleted at the RetinaVue 700 Imager is deleted at the RetinaVue Network Customer Portal, log in and select View Scheduled Patients (wireless only) from the Welcome screen and then click Next. 3. Use the drop-down menu to select a clinic and then confirm that the patient no longer appears in scheduled patients list. View Scheduled Patients on the RetinaVue Network Customer Portal (wireless only) 1.
Directions for use Using the RetinaVue 700 Imager 73 The View Scheduled Patients screen appears. 2. Note Use the drop-down menu to select a clinic and then view scheduled patients. Scheduled patients appear as Scheduled in the Status column. If the patient's exam has been completed the patient record appears as Submitted until the patient's report is returned. Schedule a Demo patient from the RetinaVue Network Customer Portal without submitting an exam for over-read (wireless only) 1.
74 2. Using the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager Use the drop-down menu to select a clinic. The Schedule a Patient screen appears for your clinic. 3. Click Create Demo Patient, complete all required fields, and then click Schedule Patient.
Directions for use Using the RetinaVue 700 Imager 75 4. The View Scheduled Patients screen appears. 5. Ensure that the RetinaVue 700 camera is powered on and connected to a secure Wi-Fi network. Touch Patients. The Patients screen appears. 6. Touch on Patient, Demo to select the Demo Patient. The Patient Summary screen appears. 7. Touch OK to start a new exam to practice with a demo patient without submitting the exam for over-read on the RetinaVue Network Customer Portal. 8.
76 Using the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager 2. Search for Scheduled patients downloaded to the RetinaVue 700 Imager from the RetinaVue Network Customer Portal (the Patients list search). 3. Touch OK to launch the on-screen keyboard and begin typing the patient's last name, first name, or Patient ID (MRN #) into the entry field box and then touch OK on the on-screen keyboard. The Patients list search screen appears.
Directions for use 4. Using the RetinaVue 700 Imager 77 Touch on a patient's name or ID to select that patient. Selected patients are highlighted in color. The Patient summary screen appears. Note Patient information is not editable for patients created on the RetinaVue Network Customer Portal. 5. Refer to Perform an eye exam for instructions on performing exams and acquiring images. Search for a patient in the Saved exams list on the RetinaVue 700 Imager (wireless) 1.
78 Using the RetinaVue 700 Imager 2. Note 3. Welch Allyn RetinaVue™ 700 Imager Touch Saved exams to search for patients in the Saved exams list of patients already contained on the camera and then touch OK to launch the on-screen keyboard. Patients in the Saved Exams list already have completed or partially completed exams. Begin typing the patient's last name, first name, or Patient ID (MRN #) into the Search entry field and then touch OK on the on-screen keyboard.
Directions for use Using the RetinaVue 700 Imager 79 4. Touch on a patient's name or ID to select that patient. The Exam summary screen appears. 5. From the Exam summary screen, exams can be deleted or submitted.
80 Using the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager Delete an image during an eye exam 1. From the Post Acquisition screen, touch to review the current image on the Inspection mode screen. , it is very • If the image is of good quality (scores of 40 +) likely to be read. • If the image is of good enough quality (range of 20 — 39) it is likely to be read. • If the image is lacking in quality (range of 0 — 19) highly unlikely to be read.
Directions for use a. Using the RetinaVue 700 Imager From the Image Inspection screen, touch to navigate back to the Post Acquisition screen. (Right eye Image Inspection screen shown). From the Post Acquisition screen, touch again to discard unsaved images. Touch OK at the "Discard unsaved images and patient data?" dialog prompt. The home Patients screen appears. b. From the Image Inspection screen, touch (trash) to dispose of an image and to begin a capture of another image.
82 Using the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager Touch OK at the dialog prompt "Do you wish to discard this image and acquire again?". The Acquisition screen appears. 3. Capture the remaining images and touch 4. (Wireless option). When the image capture is complete and the images contain a green or yellow quality acceptance check mark, proceed to the Exam summary screen and touch Save or Submit. Note 5. (Next) to complete the exam.
Directions for use Using the RetinaVue 700 Imager 83 • Touch Save to save exam to the device for further review or editing. The Exam Saved dialog appears. • Touch Complete and connect the USB cable to transfer the exam by USB cable to the RetinaVue Network Software application for a submission from software application on the computer to the RetinaVue Network Customer Portal for a reading. Delete a patient from the RetinaVue 700 Imager 1.
84 Using the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager Touch OK at the prompt: "Are you sure you want to delete the patient file?". 3. (Optionally), from the main Patients screen, touch (Wireless workflow images shown) to search for a patient. 4. Search for Scheduled patients downloaded to the RetinaVue 700 Imager from the RetinaVue Network Customer Portal (the Patients list search).
Directions for use 5. Using the RetinaVue 700 Imager 85 Touch OK to launch the on-screen keyboard and begin typing the patient's last name, first name, or Patient ID (MRN #) into the entry field box and then touch OK on the on-screen keyboard.
86 Using the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager screen appears depending on the option chosen. 6. Note 7. Note Touch on a patient's name or ID to select that patient. The Exam summary screen appears. Patient information is not editable for patients created on the RetinaVue Network Customer Portal. Touch (delete) to remove a patient from the RetinaVue 700 Imager.
Directions for use Using the RetinaVue 700 Imager 87 Delete a patient and exam from the RetinaVue 700 Imager to search for a patient. (Wireless 1. From the main Patients screen, Touch workflow images shown) 2. Search for patients from the Scheduled patients/Saved exams list of patients already contained on the RetinaVue 700 Imager. 3.
88 Using the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager The Saved/Submitted(Wi-FI) or the Saved/Completed (USB) list screen appears. 4. For Saved exams, touch on a patient's name or ID to select that patient. The Exam summary screen appears.
Directions for use 5. Using the RetinaVue 700 Imager 89 Touch (delete) to remove the patient and the exam from the RetinaVue 700 Imager. Touch OK at the screen dialog: "Are you sure you want to delete this patient's information and exam?".
90 Using the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager Capture additional images using the same protocol 1. From the Post Acquisition screen, touch (Missing Image) to capture an additional image using the existing protocol. • 2. If the image has a yellow or blue information message, observe the tips to capture another image to improve the image quality of the new image.
Directions for use • Touch (add optional) to capture an additional image using the existing protocol. The "Get ready to aim and center" and the Pre Acquisition screens appear. As the new images are captured by the RetinaVue 700 Imager , the new image icon (Next) appears in place of the image capture icon. Touch after all images are captured. • (Wireless option).Touch Save to save the exam to the device or touch Submit to send the exam to the RetinaVue Network for a reading. (USB option).
92 Using the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager The patient's Review screen appears. 2. 3. Touch on a patient's information to review the patient demographics and to view images associated with a patient. Any images which have not been sent for overread appear on the Exam summary screen. 4. After the review is complete, touch Save to save any changes or touch Complete to sent for overread using USB. 5.
Directions for use Using the RetinaVue 700 Imager 93 Review (Wi-Fi workflow) 1. From the main Patients screen touch Review. The patient's Review screen appears. 2. 3. Touch on a patient's information to review the patient demographics and to view images associated with a patient. Any images which have not been sent for overread appear on the Exam summary screen.
94 Using the RetinaVue 700 Imager 4. 5. Welch Allyn RetinaVue™ 700 Imager After the review is complete, touch Save to save any changes or touch Submit to sent for overread using Wi-Fi. From the patient's Review screen, click on the following icons for additional status messages: - Waiting to upload - submitted - report available Note 6. Once exam has been viewed on the RetinaVue Network customer portal it will be deleted from the device. Touch (Back) to return to the main Patients screen.
Directions for use Using the RetinaVue 700 Imager 95 Update the RetinaVue 700 Imager software Note (USB only) Patient list changes will only be made to the RetinaVue 700 Imager after the USB cable is reattached and connected to a computer running the RetinaVue Network software application. Note (USB only) DICOM files will be available to theRetinaVue Network once the RetinaVue 700 Imager is reattached and connected to a computer running the RetinaVue Network software application.
96 Using the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager Note (In this example, "DATA (E:)".) Note Use a safe eject method when ejecting the RetinaVue 700 Imager to ensure a complete software transfer to the RetinaVue 700 Imager . (Options include rightclicking on the Start Menu > Open File Explorer> rightclick on EXAM , click Eject. Or, click on the Taskbar> Show hidden icons > click Safely Remove Hardware and Eject Media> click Eject RetinaVue Imager.
Directions for use Note Using the RetinaVue 700 Imager 97 The RetinaVue 700 Imager boots up normally after a successful software update, however if a software update fails, the RetinaVue 700 Imager displays a failed update error message. Power loss during software update: • If a power loss occurs during the software update or if there are hardware issues, the RetinaVue 700 Imager posts a blank screen. Remove the battery, reinstall it, and restart RetinaVue 700 Imager.
98 Using the RetinaVue 700 Imager Welch Allyn RetinaVue™ 700 Imager
99 Controls RetinaVue 700 Imager main Patient screen The RetinaVue 700 Imager main Patients screen includes the following areas: Item Area 1 Device status 2 Patients list or Content Area 3 Navigation 1. Device Status Area The Device Status Area, located at the top of the main Patients screen, displays the: • Device Model • Clinic Name (if in Wi-Fi workflow and the clinic is selected at the RetinaVue Network customer portal). The clinic text indicates which clinic is selected. • Time.
100 Controls Welch Allyn RetinaVue™ 700 Imager • Connection status. The icons indicate which connection type, if any, is currently active. Icon Connection type Wireless signal strength • Battery condition. Percentage of charge is displayed. In the Live Preview, Exam Summary and Review screens, the Device Status Area displays: • • • • • Patient Icon and Patient name. The format of the Patient name is last name, first name, and middle initial.
Directions for use • • • 101 Patients: Presents a list of patients created on the RetinaVue 700 Imager or transferred from the RetinaVue Network (requires Wi-Fi connection to the RetinaVue Network or an additional software application). Review: Presents images and exams from a list of patients contained on the RetinaVue 700 Imager. Settings.
102 Controls ○ • – Disable Flash – Disable Second Start – Enable Second Start Export log Settings.
Directions for use Controls 103 3. Navigation Area In the Wi-Fi workflow, the Navigation Area, located at the bottom of the main Patients screen, displays the: • Navigation menu. Touch and then touch Patients to navigate to the Patients menu, touch Review to navigate to the Review menu, touch Settings to navigate to the Settings menu, touch Practice to navigate to the Practice menu. (See Content Area or Patients list for further details). • Search.
104 Controls Welch Allyn RetinaVue™ 700 Imager Item Area 1 Device status colored blue 2 Single patient "Exam, Practice" 3 Navigation — touch Patients, Review, or Exit Practice mode 1. From the main Patients screen, touch 2. Touch Practice to enter Practice mode. Touch OK at the prompt: "You are about to enter practice mode. This is not a place to capture a real exam." The Practice mode screen appears. 3.
Directions for use Controls 105 4. Touch Exam. 5. On the LCD touchscreen, the camera prompts to "Aim and center the camera" until the images for each eye are captured. 6. An audible tone alerts you that the images have been captured. The acquired images appear on the LCD touchscreen for review after a few seconds. 7. Touch to review the current image on the Inspection mode screen. 8. Touch (Next) after all images are automatically captured.
106 Controls 9. Touch Save. Welch Allyn RetinaVue™ 700 Imager 10. When you complete your practice experience, touch and then touch Exit. 11. Touch OK at the prompt: "Are you sure you want to exit practice mode?" to leave Practice mode and to return to the main Patients screen.
Directions for use Controls 107 Viewing or changing the RetinaVue 700 Imager settings To view or change the settings, touch Patients screen. (Navigation Menu) from the main Touch Settings and then modify the settings as desired. In the Wi-Fi workflow: • Touch Wi-Fi Off/On. ○ • Touch "OFF" or "ON" to turn the wireless radio off or on. Touch Wi-Fi to view or reset available Wi-Fi networks. The list of available wireless networks in range appears.
108 Controls Welch Allyn RetinaVue™ 700 Imager Subnet mask 244.244.244.1 Gateway 10.20.244.1 Version 2.00.02 SSID (Your Network) Access Point MAC B2:DE:31:OC:32:B2 RSSI -70 Touch • • • Touch . The Wi-Fi Radio settings screen appears. See "Troubleshooting" for more information on updating Wi-Fi Radio settings. Touch Clinic / States. Up to 6 States may be selected for a clinic. ○ Touch Multi-State. The switch changes from Off to On. ○ Touch States.
Directions for use Controls 109 Enable Second Start at the prompt: "Select what will be displaying on screen • • during an automatic acquisition." Touch (Back) to return to the Settings screen. Export Log. Exports logs into a viewable zip file . Touch OK at the prompt: "The log files were exported. Using a USB cable, plug the device in to the computer to copy the exported logs. When finished copying the file, unplug the device from the computer.
110 Controls ○ Welch Allyn RetinaVue™ 700 Imager Touch Date and time. – Touch (up) or (down) to adjust the hour, minute, Continent, and Location. Use the radio buttons to select the 24-hour or 12-hour format. Touch Settings screen. ○ Touch Advanced settings. – Device access code. Set the Device access numeric code, retype the code to confirm, and touch OK to return to the Advanced settings screen. (USB only) – Advanced settings code.
Directions for use Regulatory Information. Touch Regulatory Information to (Back) to return to the view Regulatory Information. Touch Settings screen. ○ Open Source information. Touch Open Source information to view this open source information message: "This product may contain software known as “free” or “open source” software (FOSS). Welch Allyn uses and supports the use of FOSS. We believe that FOSS makes our products more robust and secure, and gives us and our customers greater flexibility.
112 Controls 2. A dialogue box appears with three options: 3. Welch Allyn RetinaVue™ 700 Imager • Power down • Sleep • Cancel Touch Sleep. The RetinaVue 700 enters Sleep mode. Exit sleep mode 1. Note 2. Press or touch the LCD touchscreen. Lifting or moving the RetinaVue 700 Imager also brings the RetinaVue 700 Imager out of Sleep mode. After performing one of the options, the RetinaVue 700 Imager will awaken from Sleep mode, or return to the prior screen.
Directions for use Controls 113 Use the radio buttons to select the 24-hour or 12-hour format. Note 4. Touch (up) or MM/YY format. 5. Touch (down) to adjust the day, month, and year in the DD/ (Back) to return to the Settings screen. Set the Device access code at the RetinaVue 700 Imager (USB only) Note Setting the Device access code before first use provides additional security features in the RetinaVue 700 Imager to prevent unintended access to patient information by unauthorized individuals.
114 Controls Welch Allyn RetinaVue™ 700 Imager Reset the Device access code (USB only) See the Troubleshooting section if you cannot recall your RetinaVue 700 Imager access code and need to erase the access code. Note 1. If you are not already logged in, enter the existing access code for the RetinaVue 700 Imager. 2. Touch Settings on the RetinaVue 700 Imager main Patients screen. 3. Touch Advanced settings. 4. Touch Device access code. 5. Touch Reset to clear the existing access codes. 6.
Directions for use 7. Controls 115 Use the touchscreen numeric keypad to enter a code into the Advanced settings code field and then retype the same code into the Advanced settings code (retype) field. Note The Advanced settings code password can contain a minimum of 1-digit and a maximum of 18-digits. Characters are only numeric from 0 through 9.
116 Controls Welch Allyn RetinaVue™ 700 Imager
117 Troubleshooting CAUTION A defective device should not be used. A device with parts which may be broken or missing, 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.
118 Troubleshooting Welch Allyn RetinaVue™ 700 Imager Problem Solution Partial blink Ask the patient to keep his or her eye open. Dark semi-circle on top Move the patient side of the camera down and away from dark semi-circle. Dirty lens Clean the lens with an appropriate cleaning cloth.
Directions for use Troubleshooting 119 Information messages Information message/problem Solution Dirty lens Clean the camera lens with the recommended cleaner such as Thorlabs Inc. found in the topic Cleaning the RetinaVue 700 lens Small pupil To ensure that the patient's pupils sufficiently dilate to at least 3.0 mm diameter, adjust the room lighting to the lowest possible level. If necessary, have the patient sit in a dark room for 5 minutes to dilate their pupils.
120 Troubleshooting Information message/problem Welch Allyn RetinaVue™ 700 Imager Solution to the power supply to charge the battery. The battery level is too low to acquire any image. Connect the camera to the power supply to charge the battery. Please recharge now. There are unsubmitted exams that need to be sent so your patients can be diagnosed. See the Review topic for further information on submitting exams. Error message/problem Solution Error connecting to the network.
Directions for use Troubleshooting Problem Solution Problem Solution 121 Battery is not installed. Camera will not charge. Install the battery and check to ensure The power indicator LED light on the camera that the connector pins on the battery blinks between green and amber when charging. and the device are properly seated. Wireless connectivity Problem Solution Cannot connect to the network. Ensure that the signal strength is sufficient.
122 Troubleshooting Problem Welch Allyn RetinaVue™ 700 Imager Solution - Fair (2 bars) - Weak (1 bar) Cannot connect to the RetinaVue Network Server. Ensure that Wi-Fi is connected. Touch Settings. Message: Error connecting to the network using the supplied credentials. Touch Wi-Fi. Ensure that a network name appears. If no name appears, then select a network name again, enter a Username and Password and touch OK.
Directions for use Problem Troubleshooting 123 Solution SSID Your Network Access Point MAC B2:DE:31:OC: 32:B2 RSSI -70 Message: Failure to connect to the portal. Unable Follow all steps for connecting to to delete patient information. RetinaVue Network Server. Clinic network does not appear in the Wi-Fi list. Ensure that your network meets the supported credentials type.
124 Troubleshooting Welch Allyn RetinaVue™ 700 Imager Problem Solution Camera does not connect to the network. Ensure that correct network credentials are used. For PSK, ensure that the correct Username and Password are 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 connect to the network automatically.
Directions for use Troubleshooting Problem Solution Patient List is empty. Follow all steps for connecting to RetinaVue Network Server. Touch list. Exam was not sent to the RetinaVue Network Server. 125 to refresh the scheduled patients Follow all steps for connecting to RetinaVue Network Server. To view or change the settings, touch (Navigation Menu) from the main Patients screen. Touch Review.
126 Troubleshooting Problem Welch Allyn RetinaVue™ 700 Imager Solution Server. Check the "View New Diagnostic Reports" area on the RetinaVue Network Customer Portal. Select your clinic name from the dropdown menu. Find your patient and check the Report column. A "Submitted" status confirms that the exam was successfully received by the RetinaVue Network Server.
127 Maintenance Clean and disinfect CAUTION Never submerge the RetinaVue 700 Imager in water or any other liquid. CAUTION Never use abrasive cleaning agents, thinners or benzene for cleaning and never immerse the instrument in water or other cleaning liquids. CAUTION Never insert a sharp object into the device or any open surface on the RetinaVue 700 Imager. CAUTION Do not use unapproved cleaning or disinfection agents. Use of these agents may cause damage to components.
128 Maintenance Welch Allyn RetinaVue™ 700 Imager The RetinaVue 700 Imager has been tested to verify that it is compatible with the approved cleaning agents. Cleaning the RetinaVue 700 Imager lens Wipe the surface of the lens with a cleaning cloth or a lens cleaning tissue such as Thorlabs Inc.. Avoid touching the lens except when cleaning is required. Cleaning the RetinaVue 700 Imager and face cup Power off the RetinaVue 700 Imager before cleaning it.
129 Specifications Specifications Field of View 60 degrees ±5% horizontal 45 degrees ±5% vertical Pupil size 3.0 mm (minimum) Working distance 19 - 21 mm from objective lens to cornea Dimensions Width: 6.6 inches (167 mm) Height: 4.2 inches (106 mm) Length without adapter spacer: 11.4 inches (290.2 mm) Length with adapter spacer: 12 inches (305.4 mm) Weight 2.
130 Specifications Captures Welch Allyn RetinaVue™ 700 Imager Auto capture and Manual capture Anterior image Camera Resolution 2048 x 1536 pixels LCD Monitor 6 inch Full Color TFT-LCD Image Format DICOM compliant Interface Micro USB File Transfer Wired Wireless File Storage USB to PC by micro USB cable to PC running RetinaVue Network (requires additional software) WPA2, FIPS certification to Welch Allyn server Integrated storage Ability to save a minimum of 2000 images (500 standard exams, bo
Directions for use Operating Time Specifications 131 3 hours at 5 minutes working mode. Once set, the device enters Sleep mode if idle for the set time of 2, 5, 7, or 10 minutes. Unless Never is selected, the RetinaVue 700 Imager powers down after 10 minutes of inactivity in Sleep mode. Charging Time 5 hours to full charge via 3A @12V 3 hours to full charge the empty 2-cell battery via 3A@12V DC adapter in power off. 5 hours to full charge the empty 4-cell battery via 3A@12V DC adapter in power off.
132 Specifications Welch Allyn RetinaVue™ 700 Imager Device lifetime The lifetime of the device is five (5) years. The manufacture date of the device can be found on the device labels. Welch Allyn will service RetinaVue 700 Imager devices that are within their lifetime. Firmware updates and support may require an annual subscription service after the initial one (1) year warranty period. The expected battery life is at least one (1) year.
133 Device radio The RetinaVue 700 Imager's radio operates on 802.11 networks. Feature Descritption Regulatory Domain Support FCC (Americas, Parts of Asia, and Middle East) ETSI (Europe, Middle East, Africa, and Parts of Asia) MIC (Japan) (formerly TELEC) KC (Korea) (formerly KCC) 2.4 GHz Frequency Bands ETSI: 2.4 GHz to 2.483 GHz MIC: 2.4 GHz to 2.495 GHz FCC: 2.4 GHz to 2.483 GHz KC: 2.
134 Device radio Feature Welch Allyn RetinaVue™ 700 Imager Descritption 5.725 GHz to 5.825 GHz 5 GHz Operating Channels ETSI: 19 non-overlapping MIC: 19 non-overlapping FCC: 24 non-overlapping KC: WLAN standard IEEE802.11a/b/g/n, Wi-Fi compliant Data Rate 802.11a: 54, 48, 36, 24, 18, 12, 9, 6 Mbps OFDM 802.11b: 11, 5.5, 2, 1 Mbps DSSS 802.11g: 54, 48, 36, 24, 18, 12, 9, 6 Mbps OFDM 802.11n: HT20 MCS0~7, OFDM Modulation BPSK @ 1, 6, 6.5, 7.2 and 9 Mbps QPSK @ 2, 12, 13, 14.4,18, 19.5 and 21.
Directions for use Feature Device radio 135 Descritption New Zealand maintains a Mutual Recognition Agreement (MRA) with Australia. To ensure compliance with local regulations, 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 radius of 20 km from the center of Ny-Ålesund. France - Outdoor use is limited to 10 mW EIRP within the band 2454 to 2483.5 MHz.
136 Device radio Welch Allyn RetinaVue™ 700 Imager
137 General compliance and standards The RetinaVue 700 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 ISO/EN 14971 IEC/EN 62304+AC IEC 62366 EN 1041 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.
138 General compliance and standards Welch Allyn RetinaVue™ 700 Imager 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.
Directions for use General compliance and standards 139 Innovation, Science and Economic Development Canada (ISED) – Canada Statement: This device complies with ISED license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.
140 General compliance and standards Welch Allyn RetinaVue™ 700 Imager (ii) le gain maximal d’antenne permis pour les dispositifs utilisant les bandes 5250-5350 MHz et 5470-5725 MHz doit se conformer à la limite de e.i.r.p. (iii) le gain maximal d’antenne permis (pour les dispositifs utilisant la bande 5725-5825 MHz) doit se conformer à la limite de e.i.r.p. spécifiée pour l’exploitation point à point et non point à point, selon le cas.
Directions for use General compliance and standards 141 Estonian Käesolevaga Medimaging Integrated Solution Inc. (MiiS) teatab, et see väikese võimsusega saatja on vastavus olulistele nõuetele ja teistele asjakohastele sätetele direktiivi 2014/53/ EÜ Finnish Näin ollen Medimaging Integrated Solution Inc.
142 General compliance and standards Welch Allyn RetinaVue™ 700 Imager 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 (EN 60601-1-2 : 2015). • All medical electrical equipment must be installed and put into service in accordance with the EMC information provided in this Directions for use.
Directions for use General compliance and standards 143 Electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The customer or user of the device should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 Group 1 The device uses RF energy only for its internal function.
144 General compliance and standards Welch Allyn RetinaVue™ 700 Imager Electromagnetic immunity ±0.5 kV, ±1 kV, ±2 kV ±2 kV Line-to-ground Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 0 % UT; 0.5 cycle 0 % UT; 0.
Directions for use General compliance and standards 145 Electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
146 General compliance and standards Welch Allyn RetinaVue™ 700 Imager Electromagnetic immunity bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Recommended separation distances between portable and mobile RF communications equipment and the device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Directions for use General compliance and standards 147 Test specifications for enclosure port immunity to RF wireless communications equipment 745 217 Hz 780 810 800 - 960 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 Pulse modulation b 18 Hz 2 0.3 28 1700 - 1990 GSM 1800; Pulse CDMA 1900; modulation b GSM 1900; 217 Hz DECT; LTE Band 1, 3, 4, 25; UMTS 2 0.3 28 2450 2400 - 2570 Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 2 0.3 28 5240 5100 - 5800 WLAN 802.
148 General compliance and standards Welch Allyn RetinaVue™ 700 Imager
149 RetinaVue 700 Imager Accessories Pedestal stand Part number Description 107145 RetinaVue 700 Imager Pedestal stand Miscellaneous items Part number Description RV700-B RetinaVue 700 Imager with lithium-ion battery and US plug 106145 RetinaVue 700 Imager neck strap 106146 RetinaVue 700 Imager wrist strap 107142 Battery (standard capacity) for RetinaVue 700 Imager; Lithium-Ion 3200mAh 107143 Battery (high capacity) for RetinaVue 700 Imager; Lithium-Ion 6400mAh 107144 Battery charger for R
150 RetinaVue 700 Imager Accessories Welch Allyn RetinaVue™ 700 Imager Part number Description 107181 Replacement USB Cable for RetinaVue 700 Imager 728139 RetinaVue 700 Battery cover 723481 Laptop for RetinaVue Network 723671 Lens cloth 729097 RetinaVue 700 Imager Spacer, Anterior Imaging Applied parts Part number Description 107146 Reusable Face Cup for RetinaVue 700 Imager: Qty.
Directions for use RetinaVue 700 Imager Accessories Part number Description 728142 RetinaVue 700 Imager Quick start guide 728143 RetinaVue 700 Imager Patient education poster Carry Case Part number Description 107200 RetinaVue 700 Imager Premium carry case with shoulder strap 151
152 RetinaVue 700 Imager Accessories Welch Allyn RetinaVue™ 700 Imager
153 Warranty Welch Allyn warrants the product to be free of defects in material and workmanship and to perform in accordance with manufacturer's specifications for the period of one year from the date of purchase from Welch Allyn or its authorized distributors or agents. The warranty period shall start on the date of purchase.
Material No.
