Use Instructions

PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 30 of 101
• IEC 60601-1 Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential
Performance
• IEC 60601-1-2 Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and
Essential Performance – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests
3.1.4. DIS – Dark Imaging Sheet
• ISO 11135:2014 Sterilization of Health Care Products -Ethylene Oxide –
Requirements for the
development, validation and routine control of a sterilization process for medical devices
3.1.5. DIB – Dark Imaging Box
Not Applicable.
3.1.6. CCD – Contact Charging Device
• IEC 60601-1 Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential
Performance
• IEC 60601-1-2 Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and
Essential Performance – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests
3.1.7. PSC – Protective Storage Cradle
• ISO 17664:2017 Processing of Health Care Products – Information to be Provided by the Medical Device
Manufacturer for the processing of Medical Devices
• ISO 17665-1:2006 Sterilization of Health Care Products – Moist Heat – Part 1: Requirements for the
Development, Validation and Routine Control of a Sterilization Process for Medical Devices
3.2. Classification
In accordance with 21 CFR PART 312 INVESTIGATIONAL NEW DRUG APPLICATION
, an IND was submitted
to the FDA to approve PD G 506 A drug use in clinical trial SBI-CIP 20-002.
In accordance with Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications a CTA was
submitted to Health Canada to approve PD G 506 A drug use in clinical trial SBI-CIP 20-002.
In accordance with Guidance Document Applications for Medical Device Investigational Testing
Authorizations an ITA was submitted to Health Canada to approve Eagle V1.2 Imaging System use in
clinical trial SBI-CIP 20-002.
The Handheld Fluorescence Camera is intended for use only by qualified investigators in accordance with
SBI-CIP-20-002.
The Handheld Fluorescence Camera is classified as “IP67” for fluid ingress, and has protection against
exposure to liquids.