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Part Number - 00824 Revision K, DCO 2017-0074

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Thermedx

Fluid Management System

SN: 20100005

SW: 20.4-7298fa37

P2000 TEST

31200 SOLON RD

SOLON OH 44139

4405420883

Date: 28-Dec-2016

Start time: 14:58

Procedure ACL Reconstruction
Tubing Set Luer Lock

Heating disabled

Average temp. 19.5°C
Average pressure: 29 mmHg

Fluid pumped (input) 230 ml
Fluid returned (output) 230 ml

Fluid deficit: 0 ml

End Time: 15:20

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Summary of Contents for FluidSmart

Page 1: ...017 0074 2017 Thermedx LLC 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 ...

Page 2: ...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 The company reserves the right to modify the equipment shown For further information please call your local representative 2017 Thermedx LLC All rights reserved The products described are covered by one or more Pa...

Page 3: ...ations for Use 7 Section 4 Principle of Operation 8 Section 5 Important Safety Information 9 Section 6 Assembly and Setup Instructions 13 Section 7 Operating Instructions 18 Section 8 Maintenance 31 Section 9 Limited Product Warranty 32 Section 10 Troubleshooting Guide 34 Section 11 Specifications 37 Section 12 Part Numbers 38 Section 13 Symbols 39 ...

Page 4: ...low warnings cautions and instructions could result in death or serious injury to the patient This Operation Manual describes the setup and use of the system including the suction canister ring and optional secondary display This Operation Manual is intended for use by individuals trained in the healthcare and biomedical professions WARNING Read the entire Operation Manual before using the product...

Page 5: ...ring allow the processor to monitor fluid levels pumped to and suctioned from the surgical site Disposable Tubing Sets Several versions of the disposable tubing sets are available The LL0002 is an inflow tubing set used for endoscopic procedures with maximum fluid pressures up to 150 mmHg The LL0004 is an inflow and outflow tubing set used for endoscopic procedures with maximum pressures up to 150...

Page 6: ...re details The Run screen provides real time values for Temperature Temp Pressure Deficit if enabled Volume and Flow Set point values can be changed simply by pressing the adjustment buttons Note Displayed values represent readings at the device They may not represent in cavity conditions Date Time Change Canisters Help Bag indicators Set points in grey Real time values Information Mute ...

Page 7: ...ynecology urology and orthopedic disciplines CONTRAINDICATIONS General Usage Not for use with blood products including platelets cryo precipitates or granulocyte suspensions Use of this device for distention is contraindicated whenever endoscopy is contraindicated See the Operation Manual of your endoscope for absolute and relative contraindications Knee Shoulder and Small Joint Distention The use...

Page 8: ... point temperature the IR lamp power is calculated The warming process is adjusted as needed based on feedback from temperature sensors Temperature measurements displayed by the system are readings of fluid temperature at the exit of the warming mechanism These readings do not account for temperature losses as fluid passes through the disposable tubing Fluid volume instilled inflow and fluid defic...

Page 9: ...disconnection Use only with a dedicated properly grounded 120 volt 20 amp receptacle for P2000 model or 240 volt 10 amp receptacle for W2100 model Risk of electric shock exists if the equipment is not connected to a properly grounded receptacle The tubing must be properly placed in the Bubble Detector Failure to do so may result in failure of the device to operate properly While the warming cartri...

Page 10: ...ssories used and that the fluid manufacturer s instructions for use are followed Be sure to strictly monitor evaluate and manage fluid deficit and or absorption levels as appropriate for the selected procedure to prevent potential complications e g fluid overload etc o Observe the patient for electrolyte imbalances e g hyponatremia hypervolemia etc and symptoms of other fluid complications particu...

Page 11: ...and may produce dilutional hyponatremia TUR syndrome of water overload Shoulder Knee and Small Joint Distention o Monitor and assess patient for signs and symptoms of potential arthroscopic complications associated with fluid distention media for the particular procedure which may include fluid extravasation neuropraxia compartment syndrome vascular injuries and tachycardia together with airway co...

Page 12: ...ctrolytic irrigation fluids 0 9 sodium chloride and lactated ringer s with monopolar electrocautery probes Federal law U S A restricts this device to sale by or on the order of a physician General Distention Pressure values shown on the touch screen and secondary display are system pressures not surgical cavity pressures For procedures where monitoring of cavity pressure is required it is recommen...

Page 13: ...the product Read through the instructions completely prior to setting up the device Components Checklist Wheeled base with storage basket Support pole with threaded fasteners Main unit with power cord Canister ring with hanger pin Alignment tool Allen wrench Secondary display Optional accessory Assemble support pole and canister ring using hanger pin Tighten 1 locking screw with alignment tool Ins...

Page 14: ...r of wheeled base The main unit is seated on the support pole when the pins protruding from the base align with the holes in the bottom of the main unit Attach with 4 threaded fasteners and lock washers The preferred lifting method is one hand on the top handle and one under the recess on the back of the unit Plug in canister ring and secondary display optional to ports in lower rear of main unit ...

Page 15: ...titutional procedure These include but are not limited to leakage current high pot and ground bond test WARNING Grounding reliability can only be achieved when the power cord is connected to a properly grounded receptacle Risk of electric shock exists if the equipment is not connected to a properly grounded receptacle and can result in death or serious injury to the patient or user The Electrical ...

Page 16: ...corner to the On position The product will power on and display a splash screen A startup screen showing the facility information will appear while the software loads The system will prompt the user for a facility name and address if one is not entered Enter information by touching an empty field and using the on screen keyboard to fill it in Dismiss the keyboard with the yellow down button then p...

Page 17: ...ate and time can be adjusted using the appropriate increment buttons Alarm and bag chime sound level can be adjusted by selecting the Adjustment Icon Save changes to exit or press the back button to cancel changes The Edit button allows the facility information to be edited ...

Page 18: ...ing step by step instructions may select Skip Instructions Insert cartridge into slot as shown Push until seated Press Step by step instructions to proceed Open pump Place tube in opening Close pump When complete press Right Arrow to proceed Insert tubing into bubble detector Push until seated Close door When complete press Right Arrow to proceed Prepare fluid bags 1 5 liters Close clamps spike ba...

Page 19: ... at bottom of screen When complete press Right Arrow to proceed to Procedure Selection Select 1 Discipline 2 Tube set Procedure 3 Confirm selection Once Choices are confirmed press the Right Arrow Follow on screen instructions and select Press here to start prime Do not remove cartridge from unit during operation If removed and re installed unit may fail to read actual fluid pressure accurately Ca...

Page 20: ...oints Use toggle buttons to enable or disable features Press the gear icon to access additional settings see below Pump will start stop reverse and change speed as required to maintain selected pressure Press STOP to stop the pump Pressing STOP does not stop deficit measurement The flow icon indicates pump is running When procedure is over press END procedure Doing so will freeze the deficit measu...

Page 21: ...e procedure Thermedx Fluid Management System SN 20100005 SW 20 4 7298fa37 P2000 TEST 31200 SOLON RD SOLON OH 44139 4405420883 Date 28 Dec 2016 Start time 14 58 Procedure ACL Reconstruction Tubing Set Luer Lock Heating disabled Average temp 19 5 C Average pressure 29 mmHg Fluid pumped input 230 ml Fluid returned output 230 ml Fluid deficit 0 ml End Time 15 20 If the printer runs out of paper replac...

Page 22: ...inimize bouncing on hooks Canister Changes Suspend fluid collection by disconnecting or clamping suction source Failure to do so will result in error in the displayed deficit volumes Note Fluid inflow may continue Select Change suction cans Remove add or replace canisters tissue collection accessories or additional suction lines as needed Re connect vacuum and or suction lines Do Not resume suctio...

Page 23: ...tioning and deficit volume will decrease as fluid returns to canisters MISCELLANEOUS Low Bags When a bag s volume drops below 30 the bag indicator background turns red When volume drops below 20 a tone sounds User should prepare more bags to continue past remaining volume If bags run dry a Fluid not Flowing message will display and the unit will continue to pump in an attempt to maintain pressure ...

Page 24: ...vision K DCO 2017 0074 2017 Thermedx LLC Help Menu Selecting the Question mark icon brings up the help menu Users may select a topic or press the Close button to return to the run screen Main Help Menu No or Low Flow Deficit Too High ...

Page 25: ...25 P a g e Part Number 00824 Revision K DCO 2017 0074 2017 Thermedx LLC Tissue Removal System Suction Set up single canister Suction Set up multiple canister No Heat ...

Page 26: ...26 P a g e Part Number 00824 Revision K DCO 2017 0074 2017 Thermedx LLC Deficit Too Low Interactive Run Screen Change Fluid Type Ureteroscopy Only ADDITIONAL SETTINGS ...

Page 27: ...e limit for the selected procedure Note False positives can occur during periods of high flow such as when filling cavities or when removing the scope from a cavity without closing inflow valve Print Summary User may Print a summary of pertinent case information such as current volume and deficit Volume Deficit snapshot 14 58 Fluid pumped input 30 ml Fluid returned output 30 ml Fluid deficit 0 ml ...

Page 28: ...l not warm until temperature has dropped below limit Temperature has exceeded 46 degrees C Wait for fluid to cool system will then continue operation Temperature has exceeded 46 degrees C and secondary temperature protection means have engaged Replace tube set and reboot system to continue Pressure has exceeded set point by 10 or 12mm Hg whichever is greater This can be caused by abrupt changes in...

Page 29: ...remove cartridge from unit during operation If removed and re installed unit may fail to read actual fluid pressure accurately A new cartridge must be installed in device If a procedure has been started use the end procedure button to return to setup screens then press error message to dismiss Proceed through screens to re prime new cartridge or Stop vibrations If problem persists call for support...

Page 30: ...e indicating pressure set point is elevated normally above 75mm Hg A proper relief valve will be required in these circumstances See Help Menu for specific instructions During some procedures the pressure can be increased to potentially unsafe levels Press the notification to confirm fluid pressure set point increase during specific procedures High fluid deficit may affect patient safety Press the...

Page 31: ...ents water and a soft cloth To disinfect external surfaces use a 10 bleach distilled water solution or a quaternary ammonium disinfectant The FluidSmart should be visually inspected for damage before each use If there is apparent damage for example from a fall or rough handling the unit should be inspected and approved by qualified personnel before returning to service Thermedx recommends the unit...

Page 32: ...HE PRODUCTS COVERED HEREBY INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE ALL OF WHICH ARE HEREBY DISCLAIMED BY THERMEDX NO EMPLOYEE AGENT OR REPRESENTATIVE OF THERMEDX IS AUTHORIZED TO MAKE ANY REPRESENTATION OR WARRANTY ON BEHALF OF THERMEDX EXCEPT FOR THERMEDX S PRESIDENT OR EXECUTIVE VICE PRESIDENT IN WRITING THERMEDX WILL NOT BE LIAB...

Page 33: ...se neglect improper maintenance accident or the negligence of any party other than Thermedx 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: ...eck to make sure inflow and outflow valves are open Check for occluded scope If flow is present but low increase pressure setting If problem persists call for support Hysteroscopic tissue removal system troubleshooting To increase distention increase pressure or reduce suction by adjusting regulator If no regulator is available open an extra port on a suction canister to reduce suction To increase...

Page 35: ... sets is placed on canister ring after pressing Run Calculations will be affected and deficit will be low if a Bladder is evacuated after pressing Run b A canister is added after pressing Run without using the Change Suction Cans button c Inflow line is emptied at the end of the procedure Pressure is erratic or not read Replace Disposable Tubing Set and follow on screen set up procedures Do not re...

Page 36: ...STOMERS OUTSIDE THE US PLEASE CALL YOUR DISTRIBUTOR OR THERMEDX AT 011 1 440 542 0883 Relief valve is leaking on disposable tubing set Ensure relief valve is properly installed into valve body Press relief valve back into position If relief valve is absent replace Disposable Tubing Set Ensure proper valve is chosen i e procedure pressure setting elevated in Ureteroscopy and General Urology valve i...

Page 37: ...igation bag capacity 1 5 liters per hook 1 bag per hook Suction canister capacity 3 liters maximum per canister Up to four 4 suction canisters can be accommodated Fluid measurement accuracy 250ml or 10 of fluid pumped whichever is greater This device is not manufactured using natural rubber latex components P2000 Electrical 120VAC 60 Hz 16A requires dedicated 20A outlet W2100 Electrical 240VAC 50 ...

Page 38: ...art Numbers Base Unit P2000 Fluid Management System with deficit monitoring W2100 Fluid Management System with deficit monitoring 240V international model Disposable Tubing Sets LL0002 Luer Lock Set Single Lumen LL0004 Tubing Set Single Lumen Inflow with Dual Outflow LL0006 Urology Set ...

Page 39: ... Water Attention see instructions for use Catalog Number Type BF Applied Part Serial Number Sterilized using ethylene oxide LOT Batch Code Do not use if package is damaged Date of Manufacture 0 C 40 C Temperature limitation Manufacturer Use by Protective Earth Ground 25 95 Humidity Limits Fragile Keep Dry Do Not Reuse ...

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