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Circulatory Support Systems

Breethe OXY-1 System Instructions for Use and Reference Manual Rev M Oct 2020

Instructions for Use and Reference Manual

68 Pages

TABLE OF CONTENTS  USER RESPONSIBILITY...  3 ABOUT THIS MANUAL...  4 Instructions for Use...  4 Indications & Intended Users...  4 Contraindications...  4 SYMBOLS...  5 WARNINGS & CAUTIONS...  TECHNICAL SPECIFICATIONS ... 0 GLOSSARY OF TERMS... 12 1... XY-1 SYSTEM DESCRIPTION... 4 1... Theory of Operation... 17 1... Special Functions...  19 2... XY-1 SYSTEM OPERATING INSTRUCTIONS ... 0 2... Adjusting Parameters ... 20 2... Display Icons & Description ... 4 2... Installing PLU Disposable into Pump Driver...  26 3... LARMS & TROUBLESHOOTING... 27 3... Alarm Definitions, Conditions and Actions...  27 3... Alarm Troubleshooting ... 29 4... PERATING THE EMERGENCY PUMP DRIVE (E-DRIVE)... 2 4... Emergency Drive Initial Set-Up ... 2 4... Transferring PLU Disposable to E-Drive...  33 4... Manually Powering The E-Drive... 3 4... Transferring PLU Disposable from E-Drive to new Pump Driver... 34 5... NITIAL EQUIPMENT SET-UP...  35 5... Initial Equipment Set Up / Contents ... 5 5... Installation Checkout Procedures... 7 6... LU DISPOSABLE SET-UP & PRIMING PROCEDURE... 8 6... Required Equipment... 9 6... PLU Disposable Kit Contents... 39 6... Priming Kit Set-Up... 0 6... Priming Process (Blood Tubing) ...  41 6... PLU Disposable De-Airin...  42 6... Pump Circulation De-Airing ... 2 7... RE-USE CHECKOUT PRIOR TO PATIENT USE... 43 7... Connecting Gas Tubing...  43 7... Pre-Use Checks (Before Placing on Patient)... 44 8... ONNECTING TO PATIENT & INITIATION OF THERAPY ... 46 8... Presenting Primed PLU Disposable to Surgical Team in Sterile Field... 47 8... Adjust Blood Flow to Target Flow Set Point ...  47  9... ONITORING & ONGOING MAINTENANCE...  48 9... Ongoing Monitoring During Therapy...  48 9... Sighing Function... 0 9... PLU Disposable Change-Out Procedure... 51 9... Troubleshooting Common Problems During Therapy... 3 10... ISCONTINUATION/TERMINATION OF THERAPY... 54 10... Terminating Therapy... 54 10... Disposal of Single Use PLU...  54 11... LEANING & DISINFECTION... 55 11... Cleaning Touchscreen ... 55 11... Cleaning and Disinfection After Each Use... 6 12... UMP & OXYGENATOR PERFORMANCE DATA...  57 12... Pump Hydraulic Performance...  57 12... Transmembrane Pressure... 57 12... Oxygen Transfer Rate (Internal & External Gas Mode) ... 8 12... CO2 Transfer (Internal & External Gas Mode) ... 8 13... XPORTING DATA... 9 14... ERVICE & PERIODIC MAINTENANCE ... 60 14... Service & Repair - Guidance ...  60 APPENDIX A: ELECTROMAGNETIC RISKS... 1 APPENDIX B: ELECTRICAL SAFETY TESTS ... 4 Leakage Current ...  64 APPENDIX C: COMPLIANCE TESTING & STANDARDS ... 65 APPENDIX D: OXY-1 PART NUMBERS ...  66 APPENDIX E: OPERATOR ASSISTANCE ... 66  6  Breethe
File Type: PDF
File Size: 14 MB
File Name: Breethe OXY-1 System Instructions for Use and Reference Manual Rev M Oct 2020.pdf

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