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  9. Moller Liposat Pro User manual

Moller Liposat Pro User manual

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INSTRUCTIONS FOR USE
en
Liposat® Pro
Liposat® Pro plus
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 onthe last page. Möller Medical GmbH reserves the right to make changes to the technology, functions,
specifications, design and information at any time and without prior notification.
Liposat® Pro
Liposat® Pro plus
Contents
Page 4 of 58
Contents
1General safety information...........................................................................................7
1.1 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
1.2 Explanation of the format conventions used...........................................................11
1.3 Manufacturer’s responsibility ..................................................................................11
1.4 Operator's duty of care...........................................................................................12
1.5 Warning notices .....................................................................................................13
1.6 Non-product-related additional equipment..............................................................13
1.7 Single use..............................................................................................................13
1.8 Declaration on DEHP.............................................................................................14
1.9 Precautionary measures ........................................................................................14
1.10 Target group (users)...............................................................................................14
2Intended use................................................................................................................15
2.1 Proper use .............................................................................................................15
2.1.1 Intended use of the Liposat® Pro .....................................................................15
2.1.2 Intended use of the Liposat® Pro plus..............................................................15
2.2 Contraindications ...................................................................................................15
2.3 Complications.........................................................................................................16
2.4 Essential performance features..............................................................................16
2.5 Combination with other products............................................................................16
3Product description ....................................................................................................17
3.1 Design....................................................................................................................17
3.2 Liposat®Pro devices..............................................................................................18
3.2.1 Liposat® Pro.....................................................................................................18
3.2.2 Liposat®Pro plus.............................................................................................18
3.3 Footswitch..............................................................................................................18
3.4 Tubing sets ............................................................................................................19
Liposat® Pro
Liposat® Pro plus
Contents
Page 5 of 58
4Setup and commissioning..........................................................................................20
4.1 Transport and storage information..........................................................................20
4.2 Unpacking the device and checking the delivered items.........................................20
4.3 Suitable operating environment..............................................................................21
4.4 Use with defibrillation and RF surgical devices.......................................................21
4.5 Setting up the Liposat® Pro/Pro plus.......................................................................22
4.5.1 Inserting the tube sets.....................................................................................22
4.5.1.1 Insert TLA Tubing Liposat® Pro/power (Liposat®Pro)...............................23
4.5.1.2 Inserting a tubing set in the Liposat®Pro plus ..........................................25
4.5.1.2.1 Insert FAT Tubing Liposat®Pro plus (Liposat®Pro plus).......................26
4.5.1.2.2 Insert TLA Tubing Liposat®Pro plus (Liposat®Pro plus).......................28
4.6 Disassembly...........................................................................................................29
4.6.1 Removing the tube sets...................................................................................29
4.6.1.1 Remove TLA Tubing Liposat® Pro/power (Liposat®Pro)...........................29
4.6.1.2 Removing the tube set from the Liposat®Pro plus ...................................30
4.6.1.2.1 Remove TLA Tubing Liposat®Pro plus (Liposat®Pro plus)...................30
4.6.1.2.2 Remove FAT Tubing Liposat®Pro plus (Liposat®Pro plus)...................30
5Application and operation ..........................................................................................31
5.1 Switching on and off...............................................................................................31
5.2 Screen description: Start screen ............................................................................32
5.3 Operation...............................................................................................................33
5.3.1 Increase and decrease....................................................................................33
5.3.2 Screen description: Main menu.......................................................................33
5.3.2.1 Set brightness..........................................................................................34
5.3.2.2 Priming flow rate ......................................................................................34
5.3.2.3 Sound level..............................................................................................34
5.3.2.4 Service menu...........................................................................................34
5.3.2.5 Manufacturer information .........................................................................34
5.3.2.6 Factory settings........................................................................................34
5.3.3 Venting a tubing set ........................................................................................35
5.3.3.1 Priming.....................................................................................................35
5.3.4 Target volume.................................................................................................35
5.3.5 Flow rate.........................................................................................................36
5.3.5.1 Operating mode .......................................................................................36
5.3.6 Start/Stop........................................................................................................37
5.4 Example of infiltration.............................................................................................38
Liposat® Pro
Liposat® Pro plus
Page 6 of 58
6Cleaning and care .......................................................................................................40
6.1 Cleaning and disinfection .......................................................................................40
6.2 Maintenance ..........................................................................................................42
7Help in the event of a fault..........................................................................................43
8Service.........................................................................................................................45
8.1 Software update.....................................................................................................46
9Periodic safety checks................................................................................................48
10 Disposal.......................................................................................................................49
11 Annex...........................................................................................................................50
11.1 Technical data........................................................................................................50
11.2 General data..........................................................................................................51
12 Electromagnetic compatibility....................................................................................52
12.1 Electromagnetic emissions.....................................................................................52
12.2 Electromagnetic immunity ......................................................................................53
12.3 Recommended safety distances ............................................................................55
13 Accessories.................................................................................................................56
Liposat® Pro
Liposat® Pro plus
General safety information
Page 7 of 58
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.
1.1.1 Symbols in the instructions for use
Caution
Information or help
Non-ionising electromagnetic radiation
1.1.2 Symbols on the device
Consult instructions for use
Article number
Medical device
Unique identifier of a medical device
Serial number (the first 4 digits indicate the year and month of man-
ufacture in YYMM format)
Manufacturer
Alternating current
Return and disposal as per the WEEE Directive
Compliant with ANSI/AAMI ES 60601-1
CAN/CSA 22.2 No. 60601-1-6A:11
CAN/CSA 22.2 No. 60601-1:14
Liposat® Pro
Liposat® Pro plus
General safety information
Page 8 of 58
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
Plus (add / increase)
Minus (minus / decrease)
Target volume
Start
Prime (Rinse)
Reset
Reset to factory settings
Liposat® Pro
Liposat® Pro plus
General safety information
Page 9 of 58
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
Device information
Existing connection