Specifications

Table of contents
1 System description…………………………………………………………………… 1
2 Indications for use…………………………………………………………………… 6
3 Contraindications……………………………………………………………………..6
4 Warnings…………………………………………………………………………….. 6
5 Precautions………………………………………………………………………….. 8
6 OAS component storage and handling……………………………………….. 9
7 Adverse events……………………………………………………………………… 10
8 Clinical study summary…………………………………………………………… 11
9 Equipment, set up, and test………………………………………………………. 21
10 OAS directions for use………………………………………………………….. 28
11 Specifications……………………………………………………………………….. 35
12 OAS Pump declaration of conformity…………………………………………... 37
13 EMC declaration……………………………………………………………………. 37
Appendix A – OAS Troubleshooting……………………………………………. 38
Appendix B – Maximum orbit and resulting lumen diameter……………………….. 44
Appendix C – Orbit performance………………………………………………………. 45