Thermedx FluidSmart Operation Manual

Fluid management system

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Fluid Management System

FluidSmart

Operation Manual

Thermedx

, LLC - 31200 Solon Rd., Unit #1, Solon, Ohio 44139 USA

Toll-Free Phone: 1.888.542.9276

Local Phone: 440.542.0883

International Phone: 011.1.440.542.0883

www.Thermedx.com

1 |

P a g e

Part Number - 00824 Revision K, DCO 2017-0074

, LLC

Table of Contents

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Summary of Contents for Thermedx FluidSmart

Page 1 , LLC - 31200 Solon Rd., Unit #1, Solon, Ohio 44139 USA Toll-Free Phone: 1.888.542.9276 Local Phone: 440.542.0883 International Phone: 011.1.440.542.0883 www.Thermedx.com P a g e Part Number - 00824 Revision K, DCO 2017-0074 © 2017 Thermedx ® , LLC...
Page 2 , LLC. The Thermedx ® and FluidSmart ® names and logos are trademarks of Thermedx ® , LLC. The symbol ® indicates the trademark is registered in the U. S. Patent and Trademark Office and certain other countries. Every effort has been made to ensure that the information in this manual is accurate and details provided are correct at the time of printing.
Page 3: Table Of Contents
Section 10 – Troubleshooting Guide ................34 Section 11 – Specifications ................... 37 Section 12 – Part Numbers ................... 38 Section 13 – Symbols ....................39 P a g e Part Number - 00824 Revision K, DCO 2017-0074 © 2017 Thermedx , LLC ®...
Page 4: Section 1 - About This Manual
Read the entire Operation Manual before using the product. Failure to properly follow warnings, cautions, and instructions could result in death or serious injury to the patient. P a g e Part Number - 00824 Revision K, DCO 2017-0074 © 2017 Thermedx , LLC ®...
Page 5: Section 2 - Description
Fluid Bag Touch-Screen Hook(s) Canister Ring Door Stand Storage Basket P a g e Part Number - 00824 Revision K, DCO 2017-0074 © 2017 Thermedx , LLC ®...
Page 6 Set-points in grey Real-time values Change Canisters Help Information Note - Displayed values represent readings at the device. They may not represent in-cavity conditions. P a g e Part Number - 00824 Revision K, DCO 2017-0074 © 2017 Thermedx , LLC ®...
Page 7: Section 3 - Indications For Use
Knee, Shoulder and Small Joint Distention: The use of this device is contraindicated for use in patients with:  Ankylosis  Inflammation or bacterial contamination P a g e Part Number - 00824 Revision K, DCO 2017-0074 © 2017 Thermedx , LLC ®...
Page 8: Section 4 - Principle Of Operation
Section 4 – Principle of Operation  The FluidSmart ® uses a peristaltic pump to pressurize fluids from fluid bags hanging on either side of the unit.  Fluid is conducted through a warming mechanism that uses infrared lamps to warm the irrigation fluids on demand to a specified set temperature, generally approximating body temperature.
Page 9: Section 5 - Important Safety Information
 Do not operate the FluidSmart ® in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. The risk of explosion exists if the FluidSmart is operated in ® a potentially explosive environment. ...
Page 10 It is critical to closely monitor the input and outflow of the distending liquid. 10 | P a g e Part Number - 00824 Revision K, DCO 2017-0074 © 2017 Thermedx , LLC ®...
Page 11 This build-up of fluid can lead to post-operative swellings and pathological changes in patients. It is therefore of the utmost importance that the surgeon monitors both the FluidSmart ® and the patient closely during the procedure.
Page 12 Physical injury to the patient, user, and/or an adverse effect on the device or its performance may occur if these cautions are not followed: General  Do not use the FluidSmart ® if equipment or disposable tubing set malfunction is evident. ...
Page 13: Section 6 - Assembly And Setup Instructions
Section 6 – Assembly and Setup Instructions This device must be assembled and tested by authorized Thermedx ® personnel, an authorized distributor of Thermedx ® , or a qualified person prior to placing the device into service. The following steps describe how to assemble and perform preliminary setup of the product.
Page 14 Plug in canister ring and secondary display (optional) to ports in lower rear of main unit. Install power cord. 14 | P a g e Part Number - 00824 Revision K, DCO 2017-0074 © 2017 Thermedx , LLC ®...
Page 15 The Electrical Safety Check must be performed and documented at least once per year, or according to institutional policy. The degree of protection against electric shock: Type BF Applied Part. 15 | P a g e Part Number - 00824 Revision K, DCO 2017-0074 © 2017 Thermedx , LLC ®...
Page 16 The date, time, and sound level can be adjusted in the settings screen, accessible with the Gear Icon. 16 | P a g e Part Number - 00824 Revision K, DCO 2017-0074 © 2017 Thermedx , LLC ®...
Page 17 The Edit button allows the facility information to be edited. 17 | P a g e Part Number - 00824 Revision K, DCO 2017-0074 © 2017 Thermedx , LLC ®...
Page 18: Section 7 - Operating Instructions
Section 7 – Operating Instructions The FluidSmart ® touch-screen provides step-by-step setup instructions. Arrows allow the user to Experienced users not needing step-by-step move forward and back through the steps. instructions may select Skip Instructions Insert cartridge into slot as shown.
Page 19 Do not remove cartridge from unit during operation. If removed and re-installed, unit may fail to read actual fluid pressure accurately. Cartridge is filling. 19 | P a g e Part Number - 00824 Revision K, DCO 2017-0074 © 2017 Thermedx , LLC ®...
Page 20 When procedure is over press procedure. Doing so will freeze the deficit measurement and display a summary of the system performance. 20 | P a g e Part Number - 00824 Revision K, DCO 2017-0074 © 2017 Thermedx , LLC ®...
Page 21 Fluid returned (output) 230 ml Fluid deficit: 0 ml End Time: 15:20 If the printer runs out of paper, replace the paper. 21 | P a g e Part Number - 00824 Revision K, DCO 2017-0074 © 2017 Thermedx , LLC ®...
Page 22 Do Not resume suction yet. Allow movement or vibration of canister ring caused by changing canisters and/or reconnecting vacuum and/or suction lines to dissipate. 22 | P a g e Part Number - 00824 Revision K, DCO 2017-0074 © 2017 Thermedx , LLC ®...
Page 23 Notification will extinguish once pressure is reduced. 23 | P a g e Part Number - 00824 Revision K, DCO 2017-0074 © 2017 Thermedx , LLC ®...
Page 24 Close button to return to the run screen. Main Help Menu No or Low Flow Deficit Too High 24 | P a g e Part Number - 00824 Revision K, DCO 2017-0074 © 2017 Thermedx , LLC ®...
Page 25 Tissue Removal System Suction Set-up – single canister Suction Set-up – multiple canister No Heat 25 | P a g e Part Number - 00824 Revision K, DCO 2017-0074 © 2017 Thermedx , LLC ®...
Page 26 Deficit Too Low Interactive Run Screen Change Fluid Type Ureteroscopy Only DDITIONAL ETTINGS 26 | P a g e Part Number - 00824 Revision K, DCO 2017-0074 © 2017 Thermedx , LLC ®...
Page 27 Alarm and bag chime sound level Alarm and bag chime sound level can be adjusted by selecting the Adjustment Icon 27 | P a g e Part Number - 00824 Revision K, DCO 2017-0074 © 2017 Thermedx , LLC ®...
Page 28 Deficit has exceeded maximum limit. This varies by procedure. Collect fluids to lower deficit or end case. 28 | P a g e Part Number - 00824 Revision K, DCO 2017-0074 © 2017 Thermedx , LLC ®...
Page 29 Ensure tubing is fully inserted into bubble detector. Check for bubbles in bubble detector. If problem persists, call for support. Device requires re-calibration. Call for support. 29 | P a g e Part Number - 00824 Revision K, DCO 2017-0074 © 2017 Thermedx , LLC ®...
Page 30 High fluid deficit may affect patient safety. Press the notification to confirm deficit set- point increase during specific procedures. 30 | P a g e Part Number - 00824 Revision K, DCO 2017-0074 © 2017 Thermedx , LLC ®...
Page 31: Section 8 - Maintenance
 Thermedx recommends the unit be calibrated annually. The customer is responsible for ® coordinating calibration with your distributor or Thermedx ® 31 | P a g e Part Number - 00824 Revision K, DCO 2017-0074 ©...
Page 32: Section 9 - Limited Product Warranty
NOT apply if Thermedx determines in its sole and absolute discretion that any of the following ® have occurred: (i) The Product(s) is not used or maintained in accordance with Thermedx ’s Device Operation Manual, written instructions, and/or labeling; (ii) Any unauthorized modifications, repairs, service, alterations or other work have been performed on such Product(s), other than ®...
Page 33 ; (iv) The alleged defect results in whole or in ® part from the use of components, accessories, parts or supplies not furnished by Thermedx ; or (v) more than thirty (30) days has passed since the End-User Customer first learned of the defect.
Page 34: Section 10 - Troubleshooting Guide
Section 10 – Troubleshooting Guide This device contains no user serviceable parts. All service must be performed by an authorized representative of Thermedx ® UGGESTIONS OLUTIONS “ ” HERE CALL FOR SUPPORT IS INDICATED PLEASE CALL YOUR DISTRIBUTOR OR ESCRIPTION ®...
Page 35 Ensure there is only one bag of fluid hanging on each hook. total fluid volume If problem persists call for support.  readout is incorrect 35 | P a g e Part Number - 00824 Revision K, DCO 2017-0074 © 2017 Thermedx , LLC ®...
Page 36 Ensure proper valve is chosen: i.e. procedure pressure setting elevated in disposable tubing Ureteroscopy and “General Urology” valve is installed. 36 | P a g e Part Number - 00824 Revision K, DCO 2017-0074 © 2017 Thermedx , LLC ®...
Page 37: Section 11 - Specifications
WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601-1, IEC/EN 60601-1, CAN/CSA C22.2 No. 601.1 47LG (P2000 only) 37 | P a g e Part Number - 00824 Revision K, DCO 2017-0074 © 2017 Thermedx , LLC ®...
Page 38: Section 12 - Part Numbers
LL0002 – Luer Lock Set Single Lumen LL0004 – Tubing Set – Single Lumen Inflow with Dual Outflow LL0006 – Urology Set 38 | P a g e Part Number - 00824 Revision K, DCO 2017-0074 © 2017 Thermedx , LLC ®...
Page 39: Section 13 - Symbols
Temperature limitation 0°C Manufacturer Use by Protective Earth [Ground] Humidity Limits    Fragile Keep Dry Do Not Reuse 39 | P a g e Part Number - 00824 Revision K, DCO 2017-0074 © 2017 Thermedx , LLC ®...

This manual is also suitable for:

P2000 W2100