DARC PhotographerAndDeviceCertificationProtocol SM Konan 30may2019

Photographer and Device
CERTIFICATION PROTOCOL
Specular Microscopy (SM), Konan Device:
Non-Contact Specular Microscope
with Network Features
Contents
1. Introduction .........................................................................................................................................................2
2. DARC Study Forms Registration for DARC Certifications .................................................................................2
3. Photographer Certification ..................................................................................................................................3
4. Device Certification .............................................................................................................................................3
5. SM Device and System Requirements ...............................................................................................................3
6. Complete Photographer Certification / Get Grandfathered ................................................................................4
7. Export and Upload Overview ..............................................................................................................................5
8. File Format Accepted by DARC for SM Image Export .......................................................................................5
9. Technique: SM Images .......................................................................................................................................6
10. Enter Photographer’s Details to De-Identify Patient SM Images........................................................................6
11. DARC Required SM Protocol: Central Cornea Field ..........................................................................................7
12. Acquiring the Konan Required SM Images ........................................................................................................8
13. Exporting Patient Visit Data for Upload to DARC .............................................................................................11
14. Label Certification Image Submissions for Upload ...........................................................................................13
15. Confirm an SM Image Folder(s) is Ready for Upload to DARC .......................................................................14
16. Browser Specific DARC Upload Information ....................................................................................................15
17. Upload Certification Image Folder(s) to DARC .................................................................................................16
18. Receive and Print Certification Documents ......................................................................................................18
19. Maintain Photographer Certification .................................................................................................................19
20. Maintain SM Device Certification ......................................................................................................................19
21. Contact DARC ..................................................................................................................................................19
22. DARC help & Support Documents....................................................................................................................19
Appendix A: Optional DARC Photographer and Imaging Device Certification Site Checklists ................................20
DARCsite.darconline.com ~ [email protected]
Digital Angiography Reading Center, 111 Great Neck Road, Suite 300, Great Neck, NY 11021
Phone: +1+212-935-3039 ~ Fax: +1+855-268-1155
1. Introduction
This document describes how to obtain DARC photographer and device certification to perform
specular microscopy endothelial cell imaging using a DARC and sponsor approved Konan non-
contact specular microscope (SM) for use in a clinical trial. It also describes the steps to submit the
certification images to DARC and how to maintain your photographer and device certification with DARC.
2. DARC Study Forms Registration for DARC Certifications

DARC Study Forms is DARC’s site management database. This database gives your site access to
study related Handbooks, support documents, study tutorials, copies of study-specific certificates, and
an area to keep your site information current with DARC.
Register Devices and Personnel for Certification:
Upon sponsor request, DARC emails the designated site study coordinator(s) a registration request to
complete information in the DARC Study Forms database on a per study basis. Each photographer
seeking certification, and each digital imaging device to be certified by DARC, must be registered in
DARC Study Forms.
DARC requires the site location (where the SM device is located), the photographer name(s) and
email(s) who are seeking certification, and the SM device specifications (device serial number,
software and version number) to be registered for certification purposes.
From your DARC Clinical Site Portal homepage at DARCsite.darconline.com, click on DARC Study
Forms and then click on link “Site Information/Details” to update your site’s information at any time
during certification or study participation (bookmark your log in homepage).
It is your site’s responsibility to keep your study related personnel and contact information correct and
current with DARC to receive emails and to maintain your certifications for the duration of the study.
DARC Photographer and Device Certification Protocol, SM Konan eff. 30may2019 Page 2 of 20
3. Photographer Certification
Each photographer who will perform SM imaging in the study must be registered with and certified by
DARC for that imaging type. Photographers who are not currently DARC-certified should not perform
study subject imaging. After they are certified, photographers may perform study subject images
beginning on the effective date of certification.
DARC Photographer Certification Submission Review Process:

The photographer must demonstrate the ability to perform the required images on a Non-Contact
Specular Microscope (SM) device with acceptable quality to be granted certification. DARC reviews
the images for quality.
DARC emails certification reviews to the photographer and the site study coordinator(s). If the
images are acceptable, then the photographer is certified. If the images are unacceptable, then
DARC will explain why and request additional images to complete certification. At any time in the
process, the photographer may request additional help from DARC to achieve certification.
4. Device Certification
Each imaging device used in the study must be registered with and certified by DARC for that study
imaging type. It is not required that the imaging device you use to take photographer certification
images be DARC certified already. DARC will review the photographer certification images from
an uncertified device as one of the requirements to certify it. DARC emails a study-specific
certificate for the device upon receipt of acceptable photographer certification images.
The device must be approved by DARC through the certification process. DARC cannot certify and
imaging device that has not been approved for use by the appropriate regulatory agency.
An imaging device that is not currently DARC certified should not be used to perform study subject
imaging. After it is certified the imaging device may be used to perform study subject imaging on the
effective date of certification.
When deciding which imaging device(s) to certify for use in a study, be aware that DARC requires
you to follow all study subjects on the same device for the duration of the study whenever
possible. If you cannot avoid a change, refer to section 20. Maintain SM Device Certification.
To issue an imaging device certification, DARC requires complete hardware and software information,
receipt of a minimum number of acceptable quality images taken on the imaging device (equivalent to
certify a photographer).
5. SM Device and System Requirements

SM Konan Device:
Network-able non-contact specular microscopy (SM) Konan device approved by DARC.
Approved SM Konan CellChek devices with current vendor software:
NSPC, NSP-7700, NSP-8800, NSP-9900
If your SM device is not listed here, please see section 21. Contact DARC.
Computer Specifications:
Windows 8 or above is the preferred operating system on the computer used to upload images.
Your local Windows user (log in) account must have full administrative read/write privileges to the
local disk C:\.
SM Device and Operating Requirements (continued)
Internet:
A hardwired high-speed internet connection should be used to upload image folders to DARC;
a wireless connection is not reliable to upload a large amount of data.
Internet Browser Programs:

Preferred programs are the current supported version of Google Chrome, Firefox, or Microsoft Edge.
DARC does not recommend using Microsoft Internet Explorer. iPhone and Safari not supported.
Java and DARCsend Installation:

All images must be acquired digitally and uploaded to DARC using DARCsend, DARC’s secure
online upload program. DARC does not accept film media, CD-ROM, DVD-ROM, USB thumb drive, or
paper printouts.
Installation of the most current version of Java is required on the computer being used for DARCsend.
The first time you log in to DARCsite.darconline.com to upload images, you will be prompted to install
DARCsend. Steps to install DARCsend are described in the document “DARCsend Installation”
which can be printed from DARCsite.darconline.com; click DARC help and select from the list of
Support Documents.
6. Complete Photographer Certification / Get Grandfathered

Submission of all acceptable images as per the SM DARC Imaging Protocol of two patients, both eyes
(3 images per eye, 6 images per patient) are required for DARC to certify a photographer. All
photographer certification images must be captured and submitted to DARC as per the specifications in
this document to be considered for certification.
Images submitted for certification must have been taken within the past six (6) months.
Only submit your best images for certification and do not batch-submit them, but rather upload them as
soon as you have an acceptable set. Do not analyze, alter or manipulate the images that you are
exporting and submitting to DARC.
Images required to be submitted based on the photographer’s DARC certification status:
Currently DARC certified for SM imaging protocol on the Konan device:

✓ None: Upon completion of DARC study-specific registration forms (see section 2) DARC will verify
the photographer’s status as currently certified and issue a study-specific certificate.
Previously DARC certified for SM imaging protocol on the Konan device, or currently certified
for SM imaging protocol on other device:
 SM Konan: All scans per section 11. DARC Required SM Protocol: Central Cornea Field
New photographer / never DARC certified:

 SM Konan: All scans per section 11. DARC Required SM Protocol: Central Cornea Field
7. Export and Upload Overview
All certification images are considered source documents and must be saved in your imaging device
database following your site’s standard protocol. You will upload a de-identified copy of the images to
DARC. CD-ROM, DVD-ROM, USB thumb drive, or paper printouts are not accepted
All patient images must be de-identified in accordance with established Good Clinical Practice (GCP)
and Health Insurance Portability and Accountability Act (HIPAA) guidelines. DARC will delete and not
review any images received with patient information including the patient’s name, clinic ID number,
clinical unit number, or date of birth.
Create and upload de-identified copies of the certification images as described in this overview:
1. “Enter Patient Information”: complete the fields to de-identify patient details and replace with the
photographer’s information for SM certification submission
2. Take the required certification SM protocol images
3. Back up the database before exporting the data
4. Export all the SM images for each patient’s visit separately following the detailed instructions in
this document
5. Using the same computer, Log in to the DARC web portal at DARCsite.darconline.com and click on
Certification Upload
6. Verify each certification folder name and complete the online upload form required during that
process and then upload the certification submission folder(s) to DARC
7. Confirm successful uploads by checking your DARCsend\Logs folder (after uploading, your
DARCsend\Send folder should be empty)
8. After you receive an email from DARC confirming receipt of the uploaded images, delete uploaded
image files from your DARCsend\Backup folder
8. File Format Accepted by DARC for SM Image Export

For instructions on how to export a de-identified copy of the SM images captured for certification in a file
format approved by DARC, follow the detailed instructions in this document and refer to your device user
manual. If needed, ask your imaging device vendor, or 21. Contact DARC, for technical support specific
to your device and software version.
Each folder for upload should contain all the SM images for one patient’s visit (6 images per
set, for each patient’s visit). DARC cannot accept multiple procedure types (such as FA and SM),
or multiple patients’ visit images, in the same folder. Each patient’s visit image set must be exported
into a separate folder for upload to DARC.
SM Device REQUIRED File Format for SM Image Export
Konan CellChek device One (1) zipped (compressed) folder per patient, renamed using
with current software version the appropriate photographer certification labeling format that
NSPC contains:
NSP-7700 • one (1) patient’s right eye (OD) and left eye (OS) images
NSP-8800 (6 total images per set)
NSP-9900 • one (1) Microsoft access .mdb file
9. Technique: SM Images
Refer to section 12. Acquiring the Konan Required SM Images for image quality during image acquisition.
DARC support: For further support on SM or photographer imaging technique, please see
section 21. Contact DARC.
10. Enter Photographer’s Details to De-Identify Patient SM Images

All patient records must be de-identified. Any images sent to DARC containing the patient’s
name cannot be used and will result in a query. DARC will delete and not review any images
received with patient’s information including the patient’s name, clinic ID number, clinical unit
number, or date of birth.
• Start the software by clicking on the CellChek icon on the desktop.
• The Home screen appears.
• Click on the Enter Patient Information icon circled below:
The Enter Patient Information screen will open.
Enter Photographer’s Details to De-Identify Patient SM Images (continued)
All patient records must be de-identified. Enter the required Patient Information as shown
below. Do not use any dashes ( – ) or other special characters in the Patient ID, First Name, and
Last Name fields.
De-Identifying Patient Data for Photographer Certification Upload:

What to enter in your SM device software
SM Field SM Device Patient Field Input
First Name (forename or given) and Last Name (surname or family)
Patient ID
of the photographer who performed the images
First Name (forename or given) and Last Name (surname or family)
First Name
of the photographer who performed the images
SMKonanCert When submitting more than one image set for review,
Last Name
number consecutively (example: SMKonanCert1, SMKonanCert2, etc.)
Gender Always select “Male”
DOB Always enter “01/01/1900”
Operator
Doctor Leave blank
Comment
11. DARC Required SM Protocol: Central Cornea Field
Submission of all acceptable images of two patients, both eyes (3 images per eye,
6 images per patient) are required for DARC to certify a photographer.
EYE FIELD Required SM Images (6 total per set)

Right Eye Central Three (3) images of the Central Cornea
Left Eye Central Three (3) images of the Central Cornea
Suitable Patients: The certification patient can be a patient on whom the SM image is being
performed for normal clinical purposes. The SM images submitted for certification cannot be from
subjects currently in a DARC clinical study. Patients imaged for certification should have relatively
normal corneas.
12. Acquiring the Konan Required SM Images
When the required information has been entered, click on the camera icon.
The Image Capture screen will come up.
Note: Perform specular microscopy imaging prior to dilation, and prior to contact tonometry
and angiography. Do not analyze images.
• Position the patient at the specular microscope.
• The patient’s body and head should be straight and aligned, with the chin pressed down on the
chinrest and forehead all the way up against the forehead rest.
• It is not critical to have the eye centered in the circle, but the better it is centered (move patient’s
head slightly to the left or right to achieve this) the faster the image will be taken.
• The patient’s head can be raised or lowered using the manual chinrest positioning knob
(CellChek XL), or, in the case of the CellChek SL, through the on screen UP/DOWN buttons
(not shown here).
The target location should be central by default. If for some reason it is not, select central target location.
If you are using the CellChek XL, the patient’s position on the chinrest will determine which eye is being
imaged. This will be shown on the anterior image. Start with right eye.
Acquiring the Konan Required SM Images (continued)
A good tear film will improve image quality. Have the patient blink repeatedly and administer artificial
tears prior to imaging. Coach the patient prior to imaging, telling them that they will see a central green
target light. At some point a red light will start to flash off to one side. They should ignore this and try to
look right at the green light.
Check that the device is in AUTO mode. In the vast majority of cases the camera will capture images
automatically. If it does not, see manual imaging instructions below.
Have the patient blink a few times. Press the camera button. Have the patient blink a couple more times
and then open wide, stay still, and look at the green light without blinking. The Specular Image screen
will appear.
If the image is acceptable, press the green button

to prepare the camera for the next image.
If the image is unacceptable, press the red button

to delete the image and prepare the camera for the next image.
Acquiring the Konan Required SM Images (continued)
Image Quality: If images are not of high quality, then more images should be taken. Only submit the
best images which fulfill the protocol.
• Good: The entire image can be graded with confidence.

• Fair: At least half of the image can be graded with confidence.
• Poor or Non-gradable: Less than 25% of the image can be graded with confidence.
Take three (3) acceptable images of each eye per section 11. DARC Required SM Protocol: Central
Cornea Field. If you are using the CellChek XL model, you will need to move the patient’s chin to the
other side of the chinrest to change eyes.
After all six (6) images have been taken, and before letting the patient leave the device, carefully
review all images to ensure that they are of sufficient quality for DARC analysis. If any of the
images are not of sufficient quality, repeat the images.
When you are satisfied, press the Home button in the bottom right of the screen and the patient
may leave.
Manual imaging: Click on the arrow above AUTO, and then set the depth of focus manually using the
UP/DOWN arrows. Use a nominal value that is approximately one tenth of the corneal pachymetry value
as starting point. Take an image.
• If the number is too high, you will be focusing inside the anterior chamber and the image will
have a dark band on the left. Decrease the number by 5-10 and retry.
• If the number is too low, you will be focusing inside the stroma and the image will have a light
band on the right. Increase the number by 5-10 and retry.
Troubleshooting: If you have problems getting a good image, have the patient blink, or use artificial
tears, and try again. If this doesn’t help, consider checking the patient’s positioning is as described
above, turning off room lights, and closing any blinds (if possible). If all of this fails, please contact
Konan Medical technical support at +1+949-576-2200 or [email protected].
If you have a patient with phakic or multifocal IOLs that are causing multiple reflections,
position the patient, have them look slightly off the target, click on the IOL-ICL button,
click LED OFF, tell the patient not to move and click the camera button. Do not use the green arrows.
13. Exporting Patient Visit Data for Upload to DARC
Before exporting data to the DARC Export desktop folder, back up the database. Do not modify or
run any analysis on the images before exporting the files.
13.1. Backing up the Database
Click on the Tools icon on the Home screen. The Tools screen opens.
Click on the BACKUP button.
The Backup screen opens.
Select FULL BACKUP
The destination will have been preset to a Backup flashdrive. Select Save.
13.2. Exporting to a Temporary DARC Export Desktop Folder
Do not modify or run any analysis on the images before exporting the files.
1. Create a NEW FOLDER on the Konan device desktop and rename it following the required study
certification folder labeling format per the table in section 14. Label Certification Image Submissions
for Upload.
2. Click on the Tools icon on the Home screen. The Tools screen opens.
3. Click on the EXPORT IMPORT DATA button. The Export / Import screen appears.
Exporting to a Temporary DARC Export Desktop Folder (continued)
4. The source database is preset.
5. Set the Destination path:

a. Click on the SELECT button to the right of the Destination field
b. Select patient’s folder that you made in step #1 renamed with the photographer’s
information and click Open
c. Enter the file name “SMKonanCert” and click Open
d. Click YES in the Destination pop-up box “This file doesn’t exist” to create the file
6. Use CTL + Left-Click to select ALL the image data for this patient’s visit that you want to export.
The image data should now be highlighted blue.
Note: A patient visit with a set of six images will be saved in three separate records.
DARC cannot accept multiple procedure types (such as FA and SM), or multiple patients’ visit
images, in the same folder. Each patient’s visit image set must be exported into a separate folder
for upload to DARC.
7. Click the Copy button at the bottom of the screen:

This will export all the selected images taken for that patient’s visit, both right eye (OD) and
left eye (OS), into the folder.
8. Close the CellChek software and open the patient’s visit image folder on your desktop.
a. Confirm that an .mdb file and a CCD_patient_info folder are in the desktop folder
b. Drag the .mdb file into the CCD_patient_info folder
c. Zip (compress) the CCD_patient_info folder
d. Delete the original file folder, keeping only the newly created zipped folder
9. Copy the properly labeled desktop folder (containing the zipped folder) into your DARCsend/Send
folder. Each folder for upload should contain all the SM images for one patient’s visit.
14. Label Certification Image Submissions for Upload
Follow the labeling format below to prepare the SM submission folders for upload to DARC by
labeling each certification image folder with the photographer’s information.
You must label all certification submissions using the instructions in this document. Submitting images
that are not exported and de-identified to DARC protocol, or not correctly labeled to DARC protocol, will
result in delays in the certification review process.
Labeling Format for Certification Submissions:
Do not use any dashes ( – ) or other special characters in the folder label.
DARC cannot accept multiple procedure types (such as OCT-A and FA), or multiple patient’s
visit scans, in the same folder. Each patient’s visit image set must be exported and uploaded to
DARC separately.
Rename the New Folder using this format:
Photographer certification folder labeling format:

Photographer’sFirstNameLastName+SM+Konan+Cert+DateOfImaging
First Name (forename or given) and Last Name (surname or family) of

Photographer
the photographer who performed the images
Procedure type (SM) SM for specular microscopy images
Device name Konan
Cert for certification images
when submitting more than one certification set for review in one upload,
Submission number
number each folder consecutively (example: cert1, cert2, etc.)
Date certification images

must be format DDmmmYEAR
were taken
Photographer SM Certification JohnLennonSMKonanCert131may2019

folder label examples:
JohnLennonSMKonanCert205jun2019
15. Confirm an SM Image Folder(s) is Ready for Upload to DARC
After following the instructions in section 13. Exporting Patient Visit Data for Upload to DARC,
confirm that the properly labeled photographer certification visit image folder (containing the
zipped folder) is in your DARCsend\Send folder and is ready for upload to DARC:
On the drive selected during installation, double-click on the folder DARCsend
Inside the “DARCsend” folder are four sub-folders:

Backup, Config, Logs, and Send
• Confirm the folder(s) you will rename using the certification

labeling format are in the DARCsend\Send folder as shown below.
New folder containing one (1) patient’s visit SM images
New Folder
New Folder(2)
Follow the steps in the next section to upload the

patient visit image folder(s) to DARC.
16. Browser Specific DARC Upload Information
Preferred programs are the current supported version of Google Chrome, Firefox, or Microsoft Edge.
DARC does not recommend using Microsoft Internet Explorer.
Using any browser, you may receive

this warning pop-up, “Do you want to
run this application?”
• You must click Run
Checking the box, “Do not show this

again for apps from the publisher and
location above” will hide this warning
pop-up so it does not appear each time
the program loads
Each time you upload to DARC:
iPhone and Safari not supported
Internet Explorer DARC does not recommend using Microsoft Internet Explorer
Chrome buttons display in the lower left of the page, as shown here below
• Click Keep:
example
A second button appears, also in the lower left

• Click on button to run the java program: example
Firefox does not display additional buttons
Microsoft Edge button displays in the lower center of the page, as shown here below
• Click Open:
example
17. Upload Certification Image Folder(s) to DARC
First, confirm the images were prepared correctly for upload following the instructions in sections:
13. Exporting Patient Visit Data for Upload to DARC
14. Label Certification Image Submissions for Upload
15. Confirm an SM Image Folder(s) is Ready for Upload to DARC
Now you are ready to upload images to DARC. While logged in at DARCsite.darconline.com (using your
individual user account to access your DARC homepage):
Click on Certification Upload. This will load the Java image upload application.
Depending on the browser you are using, you may see additional pop-ups
requesting your validation.
After a short delay while the program checks your DARCSend\Send

folder, you will see a screen that will show you a list of all the folders you
are going to upload.
JohnLennonSMKonanCert131may2019
To begin, click on Verify for any of the image folder(s) to confirm

the information in the label is correct before uploading.
Upload Certification Image Folder(s) to DARC (continued)
After you click on Verify you will see a screen that will lead you through the verification process:
• If your folder was labeled correctly (following the required photographer certification format in
section 14. Label Certification Image Submissions for Upload) the fields will be prepopulated.
• If your folder for upload was labeled incorrectly, click on the edit icon to the
right of that field and edit the information on this form so the images can be
correctly identified by DARC.
SM
Joh
31may2019
nLe
nno
nS
MK
ona
nCe
rt10
After all the information is correct, click on Save and the image folder will then show on the screen
as Ready to upload. If you want 5oct
to start over or cancel, click on Cancel.
201
8
Click on Begin Upload. The remaining unverified images/folder(s) will stay in the DARCSend\Send
folder until you complete this process for those images.
• You will see your “Upload is in progress… please wait.”
• Then you will see a confirmation notification, “Upload Complete”.
17.1. Confirm Successful Uploads to DARC in your DARCsend\Logs Folder
After you upload the images, confirm what you successfully uploaded to DARC. Go to the folder
“C:\DARCsend\Logs” on the computer you used to upload the images. This folder contains log files
of the date, start and end time of upload, and names of all files successfully uploaded during each
session.
“Total Files to Upload” must show the same number of files as “Files Successfully Uploaded”
to confirm your upload was complete.
If all files were not uploaded, begin the upload process again. If all files are still not uploaded,
21. Contact DARC for support.
17.2. Notify DARC of Your Certification Submission

Email [email protected] when you upload the images: It is helpful to email
DARC about all certification uploads. In your email, include your site identification (Study Site number
or DARC Site Identification “D” Number), and the number and type of submissions. Explain if it is for
certification or recertification.
DARC will email a detailed certification review of each submission to the site study coordinator(s) and
photographer within up to five (5) business days of receipt of the images and notification email.
Incorrectly exported, or incorrectly labeled images, will cause delays in the review process.
17.3. Delete Uploaded Image Files from your DARCsend\Backup Folder

The DARCsend program automatically removes all uploaded files from the Send folder and moves
them into the “C:\DARCsend\Backup” folder at the end of the upload process.
After each upload session has been completed, open the “C\DARCsend\Send” folder to
confirm it is empty.
After you receive an email from DARC confirming receipt of the uploaded images, you can delete
the folders inside the “C:\DARCsend\Backup” folder. If you prefer, you may leave them there as part
of your back-up process but be aware this will take up increasing space on your local C drive.
18. Receive and Print Certification Documents

After the photographer fulfills the DARC certification requirements, DARC will email the study
coordinator(s) and photographer registered in DARC Study Forms a study-specific and procedure-
specific SM photographer certificate.
After your site completes imaging device certification requirements, DARC emails the study
coordinator(s) entered in DARC Study Forms a study-specific and image-procedure-specific imaging
device certificate.
Print and file the emailed documents in your study specific site binder. To print additional copies from
DARCsite.darconline.com: click on DARC Study Forms, then click the link “Online Study Registration
Forms and Certification Documents” and select the document.
19. Maintain Photographer Certification
DARC photographer certifications are issued on a per-procedure basis and are valid for twelve (12)
months from the date issued. The DARC database will reset the 12-month clock each time a
photographer performs that image type in a study and submits it correctly in the DARC imaging database.
DARC will email the photographer and study coordinator(s) sixty (60) days and thirty (30) days prior to
the certification expiring and provide instructions about how to maintain the certification as current.
After twelve (12) months of inactivity the photographer and study coordinator(s) will receive an email
notification of the certification expiration. At that time, the photographer’s certification status changes
to “previously certified” for that DARC image procedure type. The photographer should not perform
study subject imaging until they are recertified by submitting certifications per section 6. Complete
Photographer Certification / Get Grandfathered.
20. Maintain SM Device Certification

DARC issues a certificate for each registered SM device that meets image quality acceptance per
photographer certification submissions. DARC Test Eye images are not a required part of this process.
Failure to report changes to your DARC-registered SM device prior to using it for a study visit
may result in un-useable data and in a protocol deviation. Always report changes to your DARC-
registered SM device on a high priority basis.
You must email information about any scheduled or unscheduled repairs, upgrades, or other changes to
your DARC-certified SM imaging device to [email protected] and include your site
identification (Study Site Number or DARC Site Identification “D” Number), or submit a DARC help ticket.
DARC will email you the steps to keep your site’s imaging system certification current based on the
changes reported and will email confirmation of maintenance of certification at the end of the process
which you must file in your site study binder.
If your site obtains a new SM device during the course of a study, you must register it with DARC prior to
using it to perform study subject imaging or this may result in protocol deviations. If possible, contact
DARC in advance of the purchase to be sure it meets DARC certification requirements.
21. Contact DARC

If you need help with certification, contact DARC by phone, email, or DARC help ticket:
111 Great Neck Road, Suite 300, Great Neck, NY 11021

DARC
Phone: +1+212-935-3039 ~ Fax: +1+855-268-1155
Digital Angiography
[email protected]
Reading Center
DARCsite.darconline.com
22. DARC help & Support Documents

DARC help is an online site help system. Click DARC help on your
DARCsite.darconline.com homepage and follow the steps to either
download a Support Document or Submit a Help Ticket. You will be
directed to the appropriate DARC staff member based on your specific
request. DARC’s response time will be within 1-3 business days,
depending on how you complete your request.
Appendix A: Optional DARC Photographer and Imaging Device Certification
Site Checklists
PHOTOGRAPHER CERTIFICATION
These steps must be completed by each photographer seeking certification for a study.
□ Log in at DARCsite.darconline.com, click on DARC Study Forms and register each photographer
for the study.
□ Take the required images for certification based on your current certification status with DARC.
Submit your best work as you obtain it for timely evaluation and feedback from DARC.
□ Export certification submissions per the instructions in this document, “DARC Photographer and
Device Certification Protocol SM, Konan”.
□ Label certification images using certification-labeling protocol in this document, “DARC

Photographer and Device Certification Protocol SM, Konan”.
□ Upload certification images to DARC: Log in to the DARC web portal at DARCsite.darconline.com
and click on Certification Upload.
□ Notify DARC of your photographer certification submission by emailing [email protected].
□ Upon receiving the email from DARC, file the photographer certification document in your site
study binder.
IMAGING DEVICE CERTIFICATION

These steps must be completed once for your site to certify an imaging device. Also follow these steps
if you have hardware or software changes to your DARC certified imaging device.
□ Log in at DARCsite.darconline.com, click on DARC Study Forms and register each imaging device
for the study.
□ Submit images from each imaging device via photographer certification submissions, or per the
separate document “Certify a New or Upgraded Imaging System or Device” if your photographers
are already DARC-certified.
□ Notify DARC of your imaging device submission by emailing [email protected].
□ Upon receiving the email from DARC, file the imaging device certification document in your site
study binder.

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Photographer and Device

2. DARC Study Forms Registration for DARC Certifications

Register Devices and Personnel for Certification:

DARC Photographer Certification Submission Review Process:

5. SM Device and System Requirements

Internet Browser Programs:

Java and DARCsend Installation:

6. Complete Photographer Certification / Get Grandfathered

Images required to be submitted based on the photographer’s DARC certification status:

Currently DARC certified for SM imaging protocol on the Konan device:

New photographer / never DARC certified:

8. File Format Accepted by DARC for SM Image Export

SM Device REQUIRED File Format for SM Image Export

10. Enter Photographer’s Details to De-Identify Patient SM Images

The Enter Patient Information screen will open.

De-Identifying Patient Data for Photographer Certification Upload:

11. DARC Required SM Protocol: Central Cornea Field

EYE FIELD Required SM Images (6 total per set)

The Image Capture screen will come up.

• Position the patient at the specular microscope.

If the image is acceptable, press the green button

If the image is unacceptable, press the red button

• Good: The entire image can be graded with confidence.

13.1. Backing up the Database

Click on the BACKUP button.

The Backup screen opens.

Select FULL BACKUP

13.2. Exporting to a Temporary DARC Export Desktop Folder

4. The source database is preset.

5. Set the Destination path:

7. Click the Copy button at the bottom of the screen:

Labeling Format for Certification Submissions:

Rename the New Folder using this format:

Photographer certification folder labeling format:

First Name (forename or given) and Last Name (surname or family) of

Procedure type (SM) SM for specular microscopy images

Device name Konan

Cert for certification images

Date certification images

Photographer SM Certification JohnLennonSMKonanCert131may2019

On the drive selected during installation, double-click on the folder DARCsend

Inside the “DARCsend” folder are four sub-folders:

• Confirm the folder(s) you will rename using the certification

New folder containing one (1) patient’s visit SM images

Follow the steps in the next section to upload the

Using any browser, you may receive

Checking the box, “Do not show this

Each time you upload to DARC:

iPhone and Safari not supported

A second button appears, also in the lower left

Firefox does not display additional buttons

After a short delay while the program checks your DARCSend\Send

To begin, click on Verify for any of the image folder(s) to confirm

• You will see your “Upload is in progress… please wait.”

• Then you will see a confirmation notification, “Upload Complete”.

17.2. Notify DARC of Your Certification Submission

17.3. Delete Uploaded Image Files from your DARCsend\Backup Folder

18. Receive and Print Certification Documents

20. Maintain SM Device Certification