TrueClear System Troubleshooting Guide May 2020

HysteroLux™ Fluid Management System Issue

Suggestion/Solution

Poor uterine distention

· Check inflow tubing for obstructions and/or kinks · Reposition hysteroscope to ensure that it is past the internal cervical os and is not touching the fundus · If SET PRESSURE is equal to INTRAUTERINE PRESSURE (IUP), consider increasing SET PRESSURE on pump · Consider closing or reducing outflow valve Inspect canister setup:

Tandem setup not flowing to next canister

Poor visualization

· Ensure suction source on system is securely connected and turned on · Confirm center vacuum port is attached to suction barb of lever suction or regulator suction · Ensure that tandem tubings are connected ONLY to tandem ports · Check that unused ports are closed · Ensure canister lids are secured and tight · Inspect canisters for cracks or holes · Ensure outflow and inflow valves on scope are fully open · Check that inflow and outflow tubings are not kinked · Outflow to gravity – ensure outflow tubing is placed under patient’s leg. If no return from outflow, reposition scope tip past internal os.

· Adjust focus on camera head

· Disengage camera from scope, clean optics on scope and camera · Increase SET PRESSURE on pump to increase flow rate No fluid flow after instrument recognition

· Ensure pump instrument recognition is complete and then "pump active" displays on screen · Reposition hysteroscope to ensure that it is past the internal cervical os and is not touching the fundus · Ensure fluid clamps are open on inflow tubing · Check that outflow valve is OPEN

Fluid deficit higher than anticipated by OR nursing team

· Verify scale was RESET after calibration · Ensure that ALL fluids are returning to scale · Avoid touching fluid bags to determine amount left in bag · Leave empty bags on hooks (one 3-liter bag weight = 80cc fluid) · Ensure canisters are NOT touching the legs of the roller base · Verify that tubings and/or power cords are not resting on top of the canisters Inspect canister setup:

Tandem setup not flowing to next canister

· Ensure suction source on system is securely connected and turned on · Confirm center vacuum port is attached to suction barb of lever suction or regulator suction · Ensure that tandem tubings are connected ONLY to tandem ports · Check that unused ports are closed · Ensure canister’s lids are secured and tight · Inspect canisters for cracks or holes

TruClear™ Elite and 5C Hysteroscopes – Set-up utilizing a pressure bag† Issue

Suggestion/Solution

Rapid outflow

Alter scope outflow by toggling outflow valve to 45 degrees to slow down outflow but still allow for continuous flow

No flow – uterine distention poor

· Ensure clamp on inflow tubing is open · Check for adequate pressure being applied from pressure bag/device · Ensure saline bag is not empty · Check inflow valve is in the OPEN position · Check for kinks in tubings · Ensure inflow tubing is connected and secure · Reposition hysteroscope to ensure that it is past the internal cervical OS and is not touching the fundus

Inadequate suction

· Check to make sure suction source is turned ON and produces adequate suction · Check canister lid and caps are secure and tight · Check filter is secure on center vacuum port · Inspect canisters for cracks or holes · Review all tubing connections to ensure properly attached and no kinks in tubings

Uterine distention collapses with tissue removal

Poor visualization

· Confirm suction level matches that of the suction requirement for the tissue shaver you are using as per the IFU

· Consider increasing pressure on pressure bag or increase height of pressure bag · Ensure shaver makes contact with tissue prior to and during tissue resection (footswitch engaged) · Ensure inflow and outflow valves are open · Check tubings are not kinked · Check for adequate pressure being applied from pressure bag/device · Check clamp on inflow tubing is open · Outflow to gravity – ensure outflow tubing is placed in downward position between patient’s legs · Reposition hysteroscope to ensure that it is past the internal os and is not touching the fundus · Ensure handpiece suction is ON · Consider increasing pressure on bag to increase flow rate · Check if scope is sticking to sheath during removal of sheath · Check if scope is bent

For full product information, please consult the products' Instructions For Use. © 2020 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. ™* Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. 05/2020 – US-UW-2000001 – [WF# 4036398]

Long Wharf Drive 555 New Haven, CT 06511

800.722.8772 508.261.8000

medtronic.com/truclear