MEDAP WISTA SP 1070 User manual

OPERATING INSTRUCTIONS
SURGICAL ASPIRATOR
MEDAP-TWISTA SP 1070
GA 5752 1555 DE 28

GA 5752 1555 DE 28
2
Subject to technical modification!
Illustrations and technical specifications may vary slightly from those in these Operating
Instructions as a result of ongoing product development.
V28 2021-02
4

GA 5752 1555 DE 28 3
Table of contents
Table of contents
1 Introduction ..............................................................................................................................................6
1.1 Foreword ....................................................................................................................................................6
1.2 How to use these operating instructions ....................................................................................................6
1.2.1 Abbreviations ............................................................................................................................... 6
1.2.2 Symbols ....................................................................................................................................... 6
1.2.2.1 Cross-references ....................................................................................................... 6
1.2.2.2 Actions and responses .............................................................................................. 6
1.2.3 Definitions .................................................................................................................................... 7
1.2.3.1 Design of safety notes ............................................................................................... 7
1.2.3.2 Structure of notes ...................................................................................................... 7
1.2.4 Symbols used .............................................................................................................................. 7
1.2.5 Disposal ....................................................................................................................................... 9
1.2.5.1 Packing...................................................................................................................... 9
1.2.5.2 ATMOS products ....................................................................................................... 9
1.2.6 Used electrical devices ................................................................................................................ 9
1.3 Overview ..................................................................................................................................................10
1.3.1 Overview of TWISTA SP 1070 ................................................................................................... 10
1.4 Basic requirements................................................................................................................................... 11
1.4.1 Use in accordance with the intended purpose ........................................................................... 11
1.4.2 Applicable standards.................................................................................................................. 11
1.4.3 Intended purpose ....................................................................................................................... 11
1.4.3.1 For use in cardiac surgery and surgery of the central nervous system (CNS) ........ 12
1.4.4 Versions ..................................................................................................................................... 12
1.4.5 Interface description................................................................................................................... 13
1.4.5.1 Hydrophobic bacterial and viral filter ....................................................................... 13
1.4.5.2 Vacuum connection tube ......................................................................................... 13
1.4.5.3 Septic fluid jar including septic fluid jar cap ............................................................. 13
1.4.5.4 Suction tube............................................................................................................. 14
1.4.5.5 Utensil...................................................................................................................... 14
1.4.5.6 Rinsing fluid jar ........................................................................................................ 14
1.4.5.7 Bacterial filter paper................................................................................................. 14
1.4.5.8 Application sets ....................................................................................................... 15
1.4.5.9 Switch valve............................................................................................................. 15
1.4.5.10 Equipotential bonding cable .................................................................................... 15
2 Safety notes............................................................................................................................................16
2.1 General safety notes ................................................................................................................................ 16
2.2 Product safety notes.................................................................................................................................17
3 Initial operation.......................................................................................................................................19
3.1 General.....................................................................................................................................................19

GA 5752 1555 DE 28
4
Table of contents
3.2 Scope of delivery...................................................................................................................................... 19
3.3 Mounting the stand................................................................................................................................... 20
3.4 Mounting the tube holder..........................................................................................................................23
3.5 Mounting the foot switch...........................................................................................................................23
3.6 Overflow protection device/tube connector .............................................................................................. 23
3.6.1 Mounting the mechanical overflow protection device (REF 5752 1775).................................... 24
3.6.1.1 Inserting the overflow protection device .................................................................. 24
3.6.2 Mounting the hydrophobic bacterial and viral filter (REF 5752 1783) in the mechanical overflow
protection device (REF 5752 1775) ........................................................................................... 25
3.6.3 Inserting the tube connector ...................................................................................................... 25
3.7 Mounting point for rail clamp (REF 5752 2048)........................................................................................ 26
3.8 Mounting the switch valve (REF 5752 2049)............................................................................................ 27
3.9 Mounting the tubes................................................................................................................................... 27
3.9.1 Mounting the tube to the overflow protection device.................................................................. 28
3.9.2 Mounting the tube to the tube connector ................................................................................... 28
3.9.3 Tube connection of overflow protection device with septic fluid jar cap (REF 5750 0390) ........ 29
3.9.4 Tube connection of overflow protection device with septic fluid jar cap (REF 5750 5362) ........ 29
3.9.5 Tube connection of overflow protection device with septic fluid jar cap (REF 5752 5432) ........ 30
3.9.6 Tube connection for vacuum shift (REF 5752 2049).................................................................. 30
3.10 Connecting/disconnecting the mains cable..............................................................................................31
4 Operation ................................................................................................................................................33
4.1 Functional test..........................................................................................................................................33
4.2 Suction .....................................................................................................................................................33
4.2.1 Switching on the aspirator.......................................................................................................... 35
4.2.2 Setting the vacuum level............................................................................................................ 35
4.2.3 Operating the footswitch ............................................................................................................ 36
4.2.4 Setting the vacuum shift............................................................................................................. 36
4.3 Replacing the bacterial filter paper........................................................................................................... 36
5 Taking the unit out of operation............................................................................................................ 38
5.1 Completing the aspiration process...........................................................................................................38
5.2 Emptying the septic fluid jar ..................................................................................................................... 38
5.3 Disassembly.............................................................................................................................................39
5.3.1 Detaching tubes ......................................................................................................................... 39
5.3.2 Removing the overflow protection device .................................................................................. 39
6 Cleaning and disinfection...................................................................................................................... 40
6.1 Cleaning ...................................................................................................................................................40
6.1.1 General ...................................................................................................................................... 40
6.1.2 General ...................................................................................................................................... 41
6.1.3 Cleaning procedure.................................................................................................................... 42
6.2 Disinfection...............................................................................................................................................42
6.2.1 General ...................................................................................................................................... 42

GA 5752 1555 DE 28 5
Table of contents
6.2.2 Suitable disinfectants ................................................................................................................. 43
6.2.3 Disinfection procedure ............................................................................................................... 43
6.2.4 Disinfection procedures ............................................................................................................. 43
7 Maintenance............................................................................................................................................45
7.1 General.....................................................................................................................................................45
7.2 Period tests ..............................................................................................................................................45
7.3 Visual and functional inspections ............................................................................................................. 45
7.4 Malfunctions and troubleshooting.............................................................................................................46
7.5 Replace mains fuse..................................................................................................................................47
7.6 Repairs.....................................................................................................................................................49
7.7 Type plate................................................................................................................................................. 49
7.8 Spare parts...............................................................................................................................................49
7.9 Sending in the device...............................................................................................................................50
8 Technical specifications ........................................................................................................................51
8.1 General.....................................................................................................................................................51
8.2 Ambient conditions...................................................................................................................................51
8.3 Technical specifications............................................................................................................................ 51
8.3.1 TWISTA SP 1070 230 V 50 / 60 Hz ........................................................................................... 51
8.3.2 TWISTA SP 1070 127 V 60 Hz .................................................................................................. 52
8.4 Dimensions and weight ............................................................................................................................ 52
8.5 Vacuum depending on altitude ................................................................................................................. 52
8.6 Electromagnetic compatibility (EMC) ....................................................................................................... 52
8.6.1 Electromagnetic emissions ........................................................................................................ 52
8.6.2 Resistance to electromagnetic interference............................................................................... 53
8.6.3 Resistance to electromagnetic interference, non-life-sustaining equipment.............................. 54
8.6.4 Recommended separation distances......................................................................................... 55
9 Approved accessories...........................................................................................................................57
9.1 Accessories..............................................................................................................................................57
9.2 TWISTA SP 1070 .....................................................................................................................................58
9.3 Application sets ........................................................................................................................................58
9.4 Consumables ...........................................................................................................................................58

Introduction
Foreword
6GA 5752 1555 DE 28
1
1 Introduction
1.1 Foreword
Your facility has selected the leading-edge medical technology made by ATMOS. We sincerely
appreciate the trust you have placed in us.
1.2 How to use these operating instructions
These operating instructions are provided to familiarise you with the features of this ATMOS
product. They are subdivided into several chapters.
Please note:
• Please read these operating instructions carefully and completely before using the product for
the first time.
• Always proceed in accordance with the information contained herein.
• Store these operating instructions in a location near the product.
1.2.1 Abbreviations
EN European standard
EEC European Economic Community
1.2.2 Symbols
1.2.2.1 Cross-references
References to other pages in these operating instructions are identified with a double arrow
symbol ‘’.
1.2.2.2 Actions and responses
The „“ symbol identifies an action taken by the user while the „“ symbol identifies the reaction
that this will induce in the system.
Example:
Turn on the light switch.
Lamp lights up.

Introduction
How to use these operating instructions
GA 5752 1555 DE 28 7
1
1.2.3 Definitions
1.2.3.1 Design of safety notes
Pictogram Descriptor Text
DANGER!
Indicates a direct and immediate risk to
persons which may be fatal or result in
most serious injury.
The text for the safety note
describes the type of risk and
how to avert it.
WARNING!
Indicates a potential risk to persons or
property which may result in health hazard
or grave property damage.
CAUTION!
Indicates a potential risk to property which
may result in property damage.
Tab. 1: Design of safety notes
1.2.3.2 Structure of notes
Notes not referring to personal injury or property damage are structured as follows:
Pictogram Descriptor Reference to
NOTE Supplementary assistance or further useful information
without potential injury to persons or property damage is
described in the text of the note.
ENVIRONMENT Information regarding proper disposal.
Tab. 2: Structure of notes
1.2.4 Symbols used
Symbols Identification
4
Labelling for products which were developed and are marketed in
compliance with the Medical Devices Directive 93/42/EEC. Class Is, Im, IIa,
IIb and III products are also marked with the identifying number for the
notified body.
Identification of devices incorporating a Type BF applied part as defined in
the IEC 60601-1 standard.
Degree of protection against electrical shock.
Labelling in compliance with the ISO 15223-1 standard.
Symbol for ‘Serial number’.

Introduction
How to use these operating instructions
8GA 5752 1555 DE 28
1
Symbols Identification
Labelling in compliance with the ISO 15223-1 standard.
Symbol for ‘Product number’.
Symbol for ‘Follow Operating Instructions’.
Labelling in compliance with the ISO 15223-1 standard.
Symbol for ‘Name and address of the manufacturer as well as date of
manufacture’.
Labelling in compliance with the ISO 15223-1 standard.
Symbol for ‘Date of manufacture’.
Labelling as per EC Directive 2002/96/EC (Directive on Waste Electrical and
Electronic Equipment).
Symbol for ‘Do not dispose of at the municipal collection points for used
electrical equipment’.
Labelling as per IEC 60529 standard.
Symbol for ‘Protection against dripping water’.
Symbol for foot switch --> Stand-by operation.
The appliance can be transferred to standby mode using the foot switch.
Labelling in compliance with the IEC 60601-1 standard.
Symbol for ‘On’.
Labelling in compliance with the IEC 60601-1 standard.
Symbol for ‘Off’.
Labelling in compliance with the IEC 60417-1 standard.
Symbol for ‘Microfuse’.
Packaging label.
Symbol for ‘Keep dry’.
Packaging label.
Symbol for ‘Fragile! Handle with care’.

Introduction
How to use these operating instructions
GA 5752 1555 DE 28 9
1
Symbols Identification
Packaging label.
Symbol for ‘Top’.
Labelling in compliance with the ISO 15223-1 standard.
Symbol for ‘Temperature limitations’.
Labelling in compliance with the ISO 15223-1 standard.
Symbol for ‘Relative humidity’.
Labelling in compliance with the ISO 15223-1 standard.
Symbol for ‘Atmospheric pressure’.
Labelling in compliance with the IEC 60601-1 standard.
Symbol for ’Potential equalisation’.
Tab. 3: Symbols
1.2.5 Disposal
1.2.5.1 Packing
The packing is made of materials compatible with the environment. ATMOS will dispose of the
packing materials upon request.
1.2.5.2 ATMOS products
ATMOS will take back used products or those which are no longer in service.
Please contact your ATMOS representative for more detailed information.
1.2.6 Used electrical devices
Within the European Economic Community
This product is governed by EC Directive 2002/96/EC (Directive on Waste Electrical and
Electronic Equipment). This product has not been registered for use in private households.
Disposal at municipal collection points for used electrical equipment is not authorised. Please
contact your ATMOS representative for more detailed information on correct and legal disposal.
Outside the European Economic Community
When disposing of this product, ensure compliance with the applicable national regulations on
the handling and disposal of used electrical equipment.

Introduction
Overview
10 GA 5752 1555 DE 28
1
1.3 Overview
1.3.1 Overview of TWISTA SP 1070
-1,0
-0,8
-0,6 -0,4
-0,2
0
200
400
600
750
mmHg
bar
TWISTA SILENT
POWER 1070
2
2
3
3
4
4
1
1
5
5
7
7
9
9
1
1
3
3
1
1
2
2
5
5
8
8
1
1
0
0
1
1
1
1
1
1
6
6
1
1
4
4
Fig. 1: Overview of TWISTA SP 1070
1 Aspirator basic equipment
2 Control panel
3 Vacuum gauge
4 Control light foot switch
5 ON switch
6 Power control light
7 OFF switch
8 Regulating knob
9 Push bar
10 Tube holder
11 Equipment rail
12 Bacterial filter cap
13 Foot switch
14 Tube connector
15 Mains cable