Use Instructions

PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 2 of 101
Contents
1. Introduction .......................................................................................................................................... 6
i. CSS – Custom Sterile Sleeve .................................................................................................................. 6
ii. ECH – External Communication Hub ..................................................................................................... 6
iii. DIS – Dark Imaging Sheet ...................................................................................................................... 6
iv. DIB – Dark Imaging Box ......................................................................................................................... 6
v. CCD – Contact Charging Device ............................................................................................................ 6
vi. PSC – Protective Storage Cradle ........................................................................................................... 7
1.1. Intended Use/Indications for use – Eagle V1.2 Imaging System ................................................ 7
1.2. Intended Use/indication for use – PD G 506 A ............................................................................ 7
1.3. Clinical Need ................................................................................................................................. 7
1.4. Principles of Operation ................................................................................................................ 7
1.4.1. ALA and Protoporphyrin (PpIX) Production ........................................................................ 8
1.4.2. Fluorescence Imaging ........................................................................................................... 9
1.1. Regulatory Information .............................................................................................................. 12
1.2. Terminology Used ...................................................................................................................... 13
2. Eagle V1.2 Imaging System Contents ................................................................................................. 14
2.1. HCF – Handheld Fluorescence Camera ...................................................................................... 17
2.1.1. HFC Optical Head ................................................................................................................ 17
2.2. Accessories and Consumables ................................................................................................... 19
2.2.1. CSS – Custom Sterile Sleeve ............................................................................................... 19
2.2.2. ECH – External Communication Hub .................................................................................. 20
2.
2.3. DIS – Dark Imaging Sheet ................................................................................................... 23
2.2.4. DIB – Dark Imaging Box ...................................................................................................... 24
2.2.5. CCD – Contact Charging Device .......................................................................................... 26
2.2.6. PSC – Protective Storage Cradle......................................................................................... 28
3. Safety Information ............................................................................................................................. 29
3.1. Certifications .............................................................................................................................. 29
3.1.1. HFC – Handheld Fluorescence Camera .............................................................................. 29
3.1.2. CSS – Custom Sterile Sleeve ............................................................................................... 29
3.1.3. ECH – External Communications Hub ................................................................................ 29
3.1.4. DIS – Dark Imaging Sheet ................................................................................................... 30
3.1.5. DIB – Dark Imaging Box ...................................................................................................... 30