Hologic Fluent Pro

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Hologic, Inc.

250 Campus Drive

Marlborough, MA 01752 USA

1-800-422-9892

www.hologic.com

Patents: http://hologic.com/patentinformation

MAN-11714-001 Rev. 001

09/2024

Main Page

Table of Contents5
Introduction to System, Warnings and Precautions13
Important Operator/User Notes13
Trademark Notice13
Manufacturer13
Indications for Use13
Intended Users13
Intended Use Environment13
Patient Target Group13
Contraindications13
Important User Notes13
Essential Performance14
Warnings and Precautions14
Definitions14
List of Warnings and Precautions14
System Introduction15
Introduction to the Fluent Pro Fluid Management System15
Shipping Contents16
System Components16
Figure 1: Front View of System16
Figure 2: Rear View of System17
Figure 3: System Launch Screen18
Figure 4: System Settings Screen19
Figure 5: System Setup Screen19
Figure 6: System Confirmation Screen20
Figure 7: Procedure Screen20
Figure 8: 360° Handle22
Fluent Pro Procedure Kit Components23
Figure 9A: Carton Components23
Figure 9B: Tray Components23
Figure 9C: Waste Bag23
Procedure Setup25
Moving the System27
Positioning the System27
Figure 10: Unlock Wheels27
Figure 11: Positioning the System27
Connecting the Power Cord28
Locking the Wheels28
Figure 12: Lock Wheels28
Turning on the Fluent Pro Fluid Management System29
Configure System Settings (Required for Initial Setup)29
Figure 13A: Power Button29
Figure 13B: Launch Screen29
Figure 14: Settings Screen29
Setup System30
Setup Screen30
Figure 15: Launch Screen30
Figure 16: Setup Screen30
Hang Fluid Bag31
Unpack the Fluent Pro Procedure Kit31
Figure 17: Setup Step Detected Screen31
Figure 18: Hang Fluid Bag31
Figure 19A: Carton and Tray32
Figure 19B: Carton, Tray and Waste Bag32
Figure 20: Waste Bag32
Figure 21: Peel Back Sterile Cover32
Hang Waste Bag33
Figure 22A: Out-Flopak Connections33
Figure 22B: In-Flopak Connections33
Figure 23: Hang Waste Bag33
Install In-Flopak34
Figure 24A: Depress In-Flopak Lever34
Figure 24B: Slide In-Flopak over Shaft34
Figure 25: Clamp Tubing and Spike Fluid Bag34
Install Out-Flopak35
Figure 26A: Depress Out-Flopak Lever35
Figure 26B: Slide Out-Flopak over Shaft35
Figure 27: Connect UBD Suction Connector35
Figure 28: Connect Waste Bag Connector36
Figure 29: Setup Screen with All Setup Steps Detected36
Figure 30: Confirmation Screen37
Figure 31: Confirmation Screen with Steps Complete37
Priming the System38
Figure 32: Initial Prime Screen38
Figure 33: Unclamp Fluid Bag38
Figure 34: Open Inflow Stopcock and Unclamp Inflow Tubing39
Figure 35: Direct Priming Fluid into UBD39
Figure 36: Initial Prime Screen40
Figure 37: Air Purge Screen40
Priming Pause41
Figure 38: Hysteroscope Calibration Screen41
Figure 39: End Priming Screen41
Figure 40: Priming Paused Screen42
Figure 41: Priming Complete Screen42
How to Reprime43
Connecting the Myosure Tissue Device (TRD)43
Figure 42: Procedure Screen43
Figure 43: Reprime Screen43
During Procedure45
Adjusting the Deficit47
Figure 44: Procedure Screen47
Zeroing the Deficit48
Adjusting Thei48
Figure 45: Change Deficit Limit Screen48
Adjusting the Suction49
Performing the Procedure49
Figure 46: Connecting the Myosure TRD49
Figure 47: Change Scope Screen50
Figure 48: Ready to Prime Screen51
Figure 49: Priming Complete Screen51
Ending the Procedure52
Figure 50: Procedure End Confirmation Screen52
Figure 51: Recovering Fluid Screen52
Last Procedure Data53
Replacing Components54
Adding the Fluid Bag54
Figure 52: Last Procedure Data Screen54
Waste Bag55
Figure 53: Remove Waste Bag Connector55
Figure 54: Screw Waste Bag Cap Onto Waste Bag56
Figure 55: Remove Full Waste Bag56
Figure 56: Install Waste Bag Connector56
Tissue Trap57
Figure 57: Open Tissue Trap Canister Lid57
After Procedure59
Disassembly and Disposal61
Yo Sure Tissue Removal Device Athology61
Figure 58: Disconnecting the Myosure TRD61
Dispose of Waste Materials62
Figure 59: Remove Waste Bag Connector62
Figure 60: Screw Waste Bag Cap Onto Waste Bag62
Disassemble the63
Under -Buttocks Drape Hysteroscope63
Fluent Pro I N -Flo Pak63
Figure 61: Remove Full Waste Bag63
Figure 62: Disconnect UBD63
Shutdown and 4.2 Cleaning the Fluentp64
Fluent Pro out -Flo Pak64
Fluid Management System64
Storing the System64
Troubleshooting67
Help69
Help Screen Menu69
Figure 63: Help Icon Location69
Figure 64: Help Screen Menu69
Help with Setup70
Riming70
Figure 65A: Setup Help Menu70
Figure 66: Priming Help Screen70
Figure 65B: Additional Setup Help Menu70
Help During the71
Figure 67: Procedure Running Help Screen71
Figure 68: Procedure End Help Screen71
Troubleshooting72
Uction72
Figure 69: System Restarted Screen72
Loss of Suction 5.3.3 Inadequate S 5.3.4 Poor Visibility73
Poor Uterine73
Tissue Resection73
Fluid Deficit Difficulty73
System Frozen74
Limit75
Table 1: Real-Time Display, Notifications and Troubleshooting75
Table 2: Real-Time Display, Alerts and Troubleshooting76
Figure 70: System Fault Screen77
Table 3: Real-Time Display, System Faults78
Supplementary Information79
Annual Inspection81
Scale Calibration Check81
Figure 71: Scale Calibration Check Overview Screen81
Figure 72: Scale Calibration Check, Part 1 Screen82
Figure 73: Scale Calibration Check, Scales Zeroed Screen82
Figure 74: Scale Calibration Check, Part 2 Screen83
Alibration Check84
Figure 75: Pressure Calibration Check Overview Screen84
Figure 76: Pressure Calibration Check Steps, Part 184
Figure 77: Pressure Calibration Check Steps, Part 285
Figure 78: Begin Purge for Pressure Calibration Check85
Figure 79: Stop Purge for Pressure Calibration Check86
Figure 80: Performing Pressure Calibration Check86
Technical Specifications87
Table 4: Technical Specifications87
Power Cord Safety88
Electromagnetic Compatibility88
Table 5: Electromagnetic Emissions Guidance88
Table 6: Electromagnetic Immunity Guidance89
Emissions Guidance and M Immunity Guidance and M Separation Distances91
Table 7: Guidance and Manufacturer's Declaration - Electromagnetic Immunity91
Table 8: Recommended Separation Distances91
Console Disposal92
Procedure Kit Storage92
Procedure Kit Disposal92
Disposables Anda92
Ccessories92
Information92
Table 9: Disposables and Accessories92
Figure 81: Preventative Maintenance Due Date93
Warranty Information93
Nformation94
Complaints R 6.9.5 Contacting H 6.10 Symbol Glossary94
Eporting94
Ologic Technical Support94
Table 10: Symbols94
Glossary96

Hologic Fluent Pro - Page 98

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