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Moller Liposat Pro Instructions For Use Manual

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Summary of Contents for Moller Liposat Pro

  • Page 1 ® Liposat ® Liposat Pro plus...
  • Page 3 IMPORTANT READ CAREFULLY BEFORE USE KEEP THESE INSTRUCTIONS FOR FUTURE CONSULTATION © Möller Medical GmbH All rights reserved. No part of this documentation may be reproduced or translated in any way whatsoever without prior written approval from Möller Medical GmbH. The status of the information, specifications and figures in these instructions for use is indicated by the version number on the last page.
  • Page 5 ® Liposat ® Liposat Pro plus Contents Contents General safety information ...................7 Explanation of the safety symbols used..............7 1.1.1 Symbols in the instructions for use ..............7 1.1.2 Symbols on the device ..................7 1.1.3 Symbols in the screen ..................8 1.1.4 Additional symbols on the retail packaging ............10 Explanation of the format conventions used ............
  • Page 6 ® Liposat ® Liposat Pro plus Contents Setup and commissioning ..................20 Transport and storage information ................20 Unpacking the device and checking the delivered items ......... 20 Suitable operating environment ................21 Use with defibrillation and RF surgical devices ............21 ®...
  • Page 7 ® Liposat ® Liposat Pro plus Cleaning and care ....................... 40 Cleaning and disinfection ..................40 Maintenance ......................42 Help in the event of a fault ..................43 Service ......................... 45 Software update ..................... 46 Periodic safety checks ....................48 10 Disposal ........................
  • Page 8 ® Liposat ® Liposat Pro plus General safety information 1 General safety information 1.1 Explanation of the safety symbols used Important information is indicated visually in these instructions for use. This information is a prerequisite for preventing hazards to patients and operating personnel, as well as for avoiding damages or malfunctioning of the device.
  • Page 9 ® Liposat ® Liposat Pro plus General safety information Standby switch Standby switched on Standby switched off Input / Output (for energy and signals) USB host Applied part Type B Footswitch Direction of rotation: clockwise 1.1.3 Symbols in the screen Accept / Confirm Reject Back...
  • Page 10 ® Liposat ® Liposat Pro plus General safety information Rotor signal No rotor signal No rotor function Inserting the tubing set Front panel open Main menu Rotate screen Service menu Volume / sound Deactivate sound Sound by pressing a button Signal volume on starting and stopping the pump Brightness Fault / error...
  • Page 11 ® Liposat ® Liposat Pro plus General safety information 1.1.4 Additional symbols on the retail packaging Packaging unit Production lot number, batch Expiry date (YYYY-MM-DD) Date of manufacture (YYYY-MM-DD) Sales partner Store away from sunlight Store in a dry place Air humidity limitation Temperature limitation Stacking limit, do not store more than 3 packs high...
  • Page 12 ® Liposat ® Liposat Pro plus General safety information Single sterile barrier system with protective outer packaging Single sterile barrier system with protective inner packaging Sterilised using ethylene oxide Contains or presence of phthalates Attention: Under US Federal law, this device may be only sold to a physician or ordered by a physician.
  • Page 13 ® Liposat ® Liposat Pro plus General safety information 1.4 Operator's duty of care The operator is responsible for the proper operation of the medical devices. In line with the German Medical Device Operator Ordinance (MPBetreibV), the user must perform a wide range of duties and also assume responsibility when handling medical devices within the ®...
  • Page 14 ® Liposat ® Liposat Pro plus General safety information 1.5 Warning notices • The devices must not be modified. • No liquids must be allowed to penetrate the current-conducting parts of the devices. • Disconnect the power cable before cleaning. •...
  • Page 15 ® Liposat ® Liposat Pro plus General safety information 1.8 Declaration on DEHP ® The Liposat Pro devices do not contain di(2-ethylhexyl) or phthalates (DEHP). 1.9 Precautionary measures • The application results vary depending on the patient’s age, site of intervention and the surgeon’s experience.
  • Page 16 ® Liposat ® Liposat Pro plus Intended use 2 Intended use Proper use ® 2.1.1 Intended use of the Liposat ® The Liposat Pro is a peristaltic pump used both for medical indications, including those ac- companied by a change in fatty tissue, and for aesthetic body shaping. ®...
  • Page 17 ® Liposat ® Liposat Pro plus Intended use 2.3 Complications • Volume losses (blood, lymph, tissue fluid etc.) can occur intra- and postoperatively with use of this product and may negatively affect the patient’s haemodynamic situation. Vol- ume substitution must thus be considered by the user. •...
  • Page 18 ® Liposat ® Liposat Pro plus Product description 3 Product description 3.1 Design Figure 3: Figure 3: ® ® Front view Liposat Pro plus Front view Liposat Figure 3: ® Back view Liposat Pro/Pro plus Name Name Front panel Footswitch Rotor Cable marker, blue Threading loop...
  • Page 19 ® Liposat ® Liposat Pro plus Product description ® 3.2 Liposat Pro devices ® 3.2.1 Liposat ® The Liposat Pro assists you with the infiltration of sterile liquids such as TLA solutions into patients. ® 3.2.2 Liposat Pro plus ® The Liposat Pro assists you with the infiltration of endogenous tissues and sterile liquids such as TLA solutions into patients.
  • Page 20 ® Liposat ® Liposat Pro plus Product description ® ® Liposat /Vibrasat footswitch (3-pedal) No. Designation Down button On/Off button Up button Figure 5: Table 2: Symbols for inserting the tubing set ® ® Liposat /Vibrasat footswitch (3-pedal) By pressing the middle button (On/Off button) of the footswitch, the pump can be started and stopped.
  • Page 21 ® Liposat ® Liposat Pro plus Setup and commissioning 4 Setup and commissioning 4.1 Transport and storage information The following safety information must be observed when transporting the devices. This pre- vents damage to the devices and other property. • Make sure that the box is not damaged on delivery to you.
  • Page 22 ® Liposat ® Liposat Pro plus Setup and commissioning 4.3 Suitable operating environment ® The Liposat Pro/Pro plus are suitable for environments in the following areas: • Professional healthcare facilities with specific requirements Clinics (rooms in A+E, hospital rooms, intensive care, operating theatres, except for in the proximity of active facilities of RF surgery devices or outside of the RF-shielded room for magnetic resonance imaging, first aid facilities).
  • Page 23 ® Liposat ® Liposat Pro plus Setup and commissioning ® 4.5 Setting up the Liposat Pro/Pro plus ® Prepare the Liposat Pro/Pro plus prior to initial use as per the instructions for use (see chapter 6.1). 1. Remove the corresponding unit from the packaging. 2.
  • Page 24 ® Liposat ® Liposat Pro plus Setup and commissioning ® ® 4.5.1.1 Insert TLA Tubing Liposat Pro/power (Liposat Pro) The tumescent pump “Liposat Pro” may only be used with the following tubing set: ® • ® REF 00002251 "TLA Tubing Liposat Pro/power"...
  • Page 25 ® Liposat ® Liposat Pro plus Setup and commissioning • Insert the tubing so that it can be optimally picked up by the rotor. • Press and hold the Insert tube set button. The rotor turns and takes up the tubing set. Alternative: Turn the rotor to the right by hand.
  • Page 26 ® Liposat ® Liposat Pro plus Setup and commissioning • Screw the two Luer-Lock connectors to- gether. Figure 13: Connect tubing 1 with 2 • Close the front window. ➔ The tubing set is fully assembled. Left: Spike (infiltration medium) Right: Luer (infiltration option) Figure 14:...
  • Page 27 ® Liposat ® Liposat Pro plus Setup and commissioning ® ® 4.5.1.2.1 Insert FAT Tubing Liposat Pro plus (Liposat Pro plus) • Open the front cover of the pump. • The rotor automatically rotates into a suitable position for inserting the tubing set. Figure 15: Front view with open cover •...
  • Page 28 ® Liposat ® Liposat Pro plus Setup and commissioning • Insert the tubing so that it can be optimally picked up by the rotor. • Press and hold the Insert tube set button. The rotor turns and takes up the tubing set. ➔...
  • Page 29 ® Liposat ® Liposat Pro plus Setup and commissioning ® ® 4.5.1.2.2 Insert TLA Tubing Liposat Pro plus (Liposat Pro plus) ® A "TLA Tubing Liposat Pro plus" (REF 00003997) was used for the following instructions. 1. Open the front cover of the pump. 2.
  • Page 30 ® Liposat ® Liposat Pro plus Setup and commissioning 4.6 Disassembly 4.6.1 Removing the tube sets ® ® 4.6.1.1 Remove TLA Tubing Liposat Pro/power (Liposat Pro) • Close the hose clamps. Figure 22: Close hose clamps 1. Remove the left tubing end from the left tube clamp. 2.
  • Page 31 ® Liposat ® Liposat Pro plus Setup and commissioning ® 4.6.1.2 Removing the tube set from the Liposat Pro plus ® ® 4.6.1.2.1 Remove TLA Tubing Liposat Pro plus (Liposat Pro plus) ➔ Same procedure as in chapter 4.6.1.1Fehler! Verweisquelle konnte nicht gefunden werden.. ®...
  • Page 32 ® Liposat ® Liposat Pro plus Application and operation 5 Application and operation • All handling of a device requires precise knowledge and compliance with these instructions for use. • The devices may only be used by specialist staff. • ®...
  • Page 33 ® Liposat ® Liposat Pro plus Application and operation 5.2 Screen description: Start screen Figure 26: Start screen display No. Name Description Infiltration time Time from start of infiltration to now Progress indicator Infiltration volume (3) in relation to target volume (4) Infiltration volume Volume pumped Volume pumped until pumping pauses automatically.
  • Page 34 ® Liposat ® Liposat Pro plus Application and operation 5.3 Operation ® The Liposat Pro/Pro plus offer various operating options: • Manually via the touch screen • With the foot via the footswitch 5.3.1 Increase and decrease • Pressing once changes the value by one level at a time. •...
  • Page 35 ® Liposat ® Liposat Pro plus Application and operation 5.3.2.1 Set brightness • With + and - (in 5% increments, from 10–100) • Rotate the screen if the Vertical Mounting Kit is to be used. • When the screen is turned, the logo illumination goes out. 5.3.2.2 Priming flow rate •...
  • Page 36 ® Liposat ® Liposat Pro plus Application and operation 5.3.3 Venting a tubing set The tubing set must be bled, ... • ... before an infiltration option is applied. • ... if air bubbles are visible in the tubing set. •...
  • Page 37 ® Liposat ® Liposat Pro plus Application and operation 5.3.5 Flow rate Before each use, check the Flow rate setting in the Start screen. Set the flow rate (ml/min) of the pumps using the Plus or Minus button. Incre- Buttons Flow rate (ml/min) ments ®...
  • Page 38 ® Liposat ® Liposat Pro plus Application and operation 5.3.6 Start/Stop To start the pump, the front window must be closed. The pump can be started and stopped in 3 ways: • Start/Stop button on the screen • Progress bar on the screen •...
  • Page 39 ® Liposat ® Liposat Pro plus Application and operation 5.4 Example of infiltration ® Likewise applies to theLiposat Pro/Pro plus. Switch on the unit • Switch on the unit (chapter 5.1). Inserting the tubing set • Insert the appropriate tubing set into the pump. ®...
  • Page 40 ® Liposat ® Liposat Pro plus Application and operation About 40% of the target volume has already been delivered. Indicated by the filled bar (progress indicator). 1,700 ml were delivered. There is still ~60% to be delivered until the target volume is reached. The set target volume is 4,000 ml.
  • Page 41 ® Liposat ® Liposat Pro plus Cleaning and care 6 Cleaning and care 6.1 Cleaning and disinfection • No moisture must be allowed to enter the device. • Before cleaning and disinfecting the device surfaces, disconnect the mains plug. • Use a lint-free, soft cloth for cleaning and disinfecting.
  • Page 42 ® Liposat ® Liposat Pro plus Cleaning and care Rotor Removal Press and hold the grey button on the rotor. Pull the rotor off the motor shaft. Figure 29: Remove rotor Pull the tube clamp off the pins. Figure 30: Remove tube clamp Clean the inside of the pump.
  • Page 43 ® Liposat ® Liposat Pro plus Cleaning and care 6.2 Maintenance ® ® The Liposat Pro or Liposat Pro plus will remind you of the pending date for a technical safety check during the booting process. ® The service, upgrade or modification of the Liposat Pro/Pro plus must only be performed by Möller Medical GmbH or by a facility specifically authorised to do so by the manufacturer.
  • Page 44 ® Liposat ® Liposat Pro plus Help in the event of a fault 7 Help in the event of a fault ® The Liposat Pro/Pro plus must not be opened by the user! This chapter describes certain problems which may occur in conjunction with the devices. The devices must always be turned off when connecting and disconnecting plug connections.
  • Page 45 ® Liposat ® Liposat Pro plus Help in the event of a fault Problem Solution • Set flow rate does not comply The delivered quantity is recorded and evaluated via the with actual delivered pump rotor speed. quantity. If the set quantity does not correspond to the delivered quantity, this may be due to the following causes;...
  • Page 46 ® Liposat ® Liposat Pro plus Service 8 Service • Before disposal or return, the devices must be disinfected using a suitable disinfection procedure in order to exclude a possible risk of infection. • Consumable materials should be disposed of in accordance with hygiene guidelines.
  • Page 47 ® Liposat ® Liposat Pro plus Service 8.1 Software update • Observe the order of the update. Deviations can result in the software update being cancelled or unsuccessful. • Note that the USB port blocker key may break if used incorrectly. Explanation of symbols used Standby switch Main menu...
  • Page 48 ® Liposat ® Liposat Pro plus Service 13. Plug in the mains plug. 14. The Start screen is displayed. 15. Call up the device information in the main menu and check whether the software ver- sion displayed there is correct. 16.
  • Page 49 ® Liposat ® Liposat Pro plus Periodic safety checks 9 Periodic safety checks ® The Liposat Pro/Pro plus must not be opened by the user! Perform safety checks (SC) as per the German Medical Devices Operator Ordinance (MPBetreibV) at least every 12 months.
  • Page 50 ® Liposat ® Liposat Pro plus Disposal 10 Disposal This device includes materials which must be disposed of in an environ- mentally friendly manner. The European Directive 2012/19/EU on waste electrical and electronic equipment (WEEE2) applies to these devices. They thus bear the symbol with a crossed out bin on the rating plate. Return reprocessed devices which are no longer used to Möller Medical GmbH.
  • Page 51 ® Liposat ® Liposat Pro plus Annex 11 Annex 11.1 Technical data Article number ® Catalogue number Liposat REF 00003977 ® Catalogue number Liposat Pro plus REF 00003974 Dimensions ® Liposat Pro/Pro plus 275 mm x 210 mm x 350 mm (width x height x depth) Weight ®...
  • Page 52 ® Liposat ® Liposat Pro plus Annex 11.2 General data Transport and storage information Temperature -10 °C to +50 °C Air humidity < 90% relative humidity Width x height x depth: Dimensions with packaging 336 mm x 280 mm x 362 mm Store the packaged devices in a dry place.
  • Page 53 ® Liposat ® Liposat Pro plus Electromagnetic compatibility 12 Electromagnetic compatibility 12.1 Electromagnetic emissions ® The Liposat Pro/Pro plus are suitable for use in the stated electromagnetic environment. The ® customer and/or operator of the Liposat Pro/Pro plus must ensure that the devices are used in the electromagnetic environment described below.
  • Page 54 ® Liposat ® Liposat Pro plus Electromagnetic compatibility 12.2 Electromagnetic immunity IEC 60601 - testing Electromagnetic environment Immunity test Level of conformity level - guidelines Floors should be wood, con- ±8 kV contact dis- ±8 kV contact dis- crete or ceramic tile. If floors Discharge of static charge charge...
  • Page 55 ® Liposat ® Liposat Pro plus Electromagnetic compatibility IEC 60601 - testing Electromagnetic environment Immunity test Level of conformity level - guidelines Magnetic fields of the supply Magnetic field in frequency should conform power supply fre- with the typical values found 30 A/m 30 A/m quency (50/60 Hz)
  • Page 56 ® Liposat ® Liposat Pro plus Electromagnetic compatibility Electromagnetic IEC 60601 - test- Level of con- immunity test- Electromagnetic environment - guidelines ing level formity ing/standard Portable and mobile radio transmitting de- vices, including the cables, should be used 150 kHz to ®...
  • Page 57 ® Liposat ® Liposat Pro plus Accessories 13 Accessories Sterile consumables ® For Liposat Pro: ® TLA Tubing Liposat Pro/power Catalogue no.: 00002251 (Pack of 10 in a box) ® For Liposat Pro plus: ® TLA Tubing Liposat Pro plus Catalogue no.: 00003997 (Pack of 10 in a box) ®...
  • Page 58 ® Liposat ® Liposat Pro plus Accessories ® ® Liposat /Vibrasat footswitch (3-pedal, 2 m cable length) Catalogue no.: 93003517 ® ® Liposat /Vibrasat footswitch (3-pedal, 5 m cable length) Catalogue no.: 00003981 ® Vertical mounting kit for Liposat Pro/Pro plus ➔...
  • Page 59 Revision status: 2023-05 V01 Software version: 101.00.13 Catalogue number of Instructions for use REF 93007492 Möller Medical GmbH Wasserkuppenstrasse 29-31 36043 Fulda, Germany Tel. +49 (0) 661 / 94 19 5 – 0 Fax +49 (0) 661 / 94 19 5 – 850 www.moeller-medical.com info@moeller-medical.com The instructions for use are part of the product.

This manual is also suitable for:

Liposat pro plus