[PMCF] RayPmcfCollector 

Customer Survey: Survey Link (Click)

[PMCF] RayPmcfCollector Field User Guide

Target Audience: Field and operations personnel responsible for PMCF data collection
Purpose: To provide instructions for properly running the program and understanding how collected data is protected
Applicable Version: RayPmcfCollector Initial Release

Program

RayPmcfCollector v1.0.0.0.zip  (Download)

After downloading the program, open the Properties of the ZIP file, check Unblock, click Apply, and then proceed with using the program.

1. Overview — What Is PMCF and Why Is It Collected?

PMCF (Post-Market Clinical Follow-up) is an ongoing activity conducted to verify that a medical device continues to perform as intended in real-world clinical settings after it has been placed on the market. Overseas regulatory authorities, including those under the EU MDR, require PMCF activities to be performed periodically, typically on an annual basis. Sample clinical images from actual clinical environments are required as supporting evidence.

RayPmcfCollector is a standalone application developed specifically for this purpose. In summary:

The program de-identifies images (removes personal information) stored on the acquisition PC and then uploads the de-identified images to the PMCF server.

💡 RayPmcfCollector is responsible only for data collection, de-identification, and upload. Viewing, downloading, and managing uploaded data are performed separately through the PMCF web portal.

2. Preparation Before Starting

Before starting data collection, please verify the following items.

3. Program Execution Flow (Startup Sequence)

When the program is launched, it proceeds in the following sequence:

3-1. Three Possible Device Verification Results

At Step [3], the program behaves as follows depending on the server verification result:

4. Consent Confirmation Screen — ⚠️ The Most Important Step

Immediately after the program starts, the Patient Consent Confirmation screen appears.

Proceed only after obtaining patient consent at the site.

4-1. Screen Layout

4-2. Signature Information (Simple Explanation for the Patient) 

4-3. Proceed / Exit

• The [Accept and Sign] button becomes enabled only after all required information in Section 4-2 has been completed.

• When [Accept and Sign] is clicked, the signed information is saved to iubenda, and the process continues. The program then proceeds to the main screen.

• If [Decline (Exit)] is clicked, or if consent is not provided, the program will exit.

5. Data Search

Use the filters at the top of the main screen to search for images to be collected.

5-1. Filters 

Use the filters at the top of the main screen to search for images to be collected.

After selecting the desired filters, click [Search]. The search results will be displayed in a table. 

5-2. Understanding the Results Table (Grid) 

Double-click a row in the table to view a larger preview of the representative thumbnail.

Search results are displayed in the following priority order: CT → Pano → Ceph → Patient, with up to 10 items per modality displayed. (It is normal for only a limited number of results to be shown at the site.)

Each time a search is performed, the search criteria and results are automatically recorded in a history file to help prevent duplicate data collection. (See Section 6-3 for the file location.)

6. Selection & Upload

6-1. Selecting Items

• Select the checkbox for each item you want to upload, or click [Select all] at the bottom to select all displayed items.

• The number of selected items is displayed at the bottom as “Selected N item(s)”.

• Once at least one item is selected, the [Upload selected ▲] button becomes enabled.

6-2. Upload Process

Click [Upload selected ▲] to open the PMCF Data Upload window. The selected data will then be processed automatically in the following sequence:

• The upload window displays a progress bar, percentage / number of processed items, and the message:
  “Packaging/de-identification runs automatically in the background, and uploaded data can be viewed/managed on the PMCF web portal.”

• When the process is complete, the [Close] button becomes available.

• If some items fail to upload, the following warning is displayed:
  “N of M series failed to upload. See log for details.”
  → Check the log as described in Section 6-3, then select the failed items and upload them again.

6-3. After Upload / File Locations

• Viewing, downloading, and long-term management of uploaded data are handled through the PMCF web portal (separate system), not through this program.

• Reference file locations:

  • Execution Log: C:\Ray\log\RayPmcfCollector_yyyyMMdd.log

  • Search History: search\search_yyyyMMdd.log in the program execution folder

7. How Is Patient Data Protected? (De-identification)

Before upload, personally identifiable information is automatically removed or masked. No additional action is required by the operator.

Key Points

✅ Exact patient names, chart numbers, dates of birth, and ages are not uploaded to the server.

✅ The partially masked patient name displayed on the screen (e.g., Kim○○) is shown only to help the operator distinguish between patients and is not transmitted.

✅ Patient-identifying information embedded in the DICOM files, including name, ID, and date of birth, is also modified or removed during de-identification.

8. Information Transmitted with the Images (Metadata)

In addition to the images, the following non-identifying metadata is transmitted. Any personally identifiable information is processed as described in Section 7 before transmission.

• Age range and gender

• Device serial number (SN)

• Imaging modality (CT / Pano / Ceph)

• Measurement data (overlay) and AI analysis results

9. Frequently Asked Questions / Troubleshooting (FAQ)