Konica Minolta mKDR Xpress Operation page 154

Mobile X-ray Unit
Operation
B-2
Ensure trusted content:
Restrict software or firmware updates to authenticated code.
Detect, respond, recover:
Watch for on-screen warnings of possible virus infections.

Respond by scanning for and removing possible virus infections.

Recover from possible virus infections by having up to date backups of

your host computer.
REQUIRED STRATEGIES BY THE MEDICAL DEVICE MANUFACTURER
/ SOFTWARE MANUFACTURER
We affirm our commitment to providing you with validated software updates and
patches as needed throughout the life cycle of the medical device to continue
to assure its continued safety and effectiveness.
Please promptly apply software updates and patches provided by us and never
use image management software supplied by anyone else. Our development
process utilizes the CISCO AMP protection. We are constantly scanning our
development computers for malware. We hope you are doing the same.
A summary of our integrity controls:
Our development computers are constantly being scanned for malware,

and our supplier for anti-virus software automatically updates the
software continuously as new threats are revealed.
We perform daily backups to our external hard drives. The backups are

in another place.
During software development we disconnect from the Internet to prevent

external attacks.
Our development process utilizes the CISCO AMP protection.

Copies of software updates we will be sending you are individually

scanned for malware.
CONCLUSION
It is our JOINT responsibility to ensure your medical image software and image
collection is safe and secure. We must both do our parts.
Appendix B