GERATHERM Ergostik Blueflow User manual

Ergostik Blueflow
Serial numbers: xx|8|201|yyy and 2203xxxxx
Instruction for Use
Version: 6
Release date: 02 August 2022
Please read carefully and store in a place which is always accessible for future
consultation!

Version: 6
Release date: 02 August 2022
File name:TDOERG0135R6
Language:English
Affected serial numbers: xx|8|201|yyy and 2203xxxxx
Software version: valid from 1.1.0
Geratherm® Respiratory GmbH
Kasernenstraße 4
97688 Bad Kissingen, GERMANY
Tel.: [phone]
Fax: [phone]
[e-mail]
www.geratherm-respiratory.com
EUDAMED SRN:
DE-MF-000006818 © Geratherm® Respiratory GmbH
0494

Instructions for Use
Ergostik Blueflow
Serial no.: xx|8|201|yyy and 2203xxxxx
Version: 6 | Release date: 02 August 2022
Page 3
Table of Contents
1General Information ...............................................................6
1.1 Abbreviations.................................................................................. 7
1.2 Explanations................................................................................... 7
1.3 Symbols ......................................................................................... 9
1.4 Copyright...................................................................................... 13
1.5 Limitation of Liability ..................................................................... 13
2Conditions of Use ................................................................14
2.1 Intended Purpose......................................................................... 14
2.1.1 Indication...................................................................................... 16
2.1.2 Contraindication and Side Effect................................................... 17
2.1.2.1 Contraindications.......................................................................... 17
2.1.2.2 Side Effects .................................................................................. 20
2.1.3 Definition of the Groups of People ................................................ 22
2.2 Intended Use................................................................................ 23
2.2.1 Original Spare Parts / Accessories / optional Expansions ............. 25
2.2.1.1 Original Spare Parts / Accessories................................................ 26
2.2.1.2 Optional Expansions..................................................................... 30
2.2.2 Consumable Items / Auxilary Materials ......................................... 35
3Safety in Handling ................................................................37
3.1 General Safety at Work and Personnel Qualification ..................... 38
3.2 The Technical State of Ergostik Blueflow and System Construction39
3.3 Operation / Servicing and Maintenance ........................................ 41
3.4 Electromagnetic Compatibility (EMC) ............................................ 42
3.5 Cleaning and Disinfection ............................................................. 43
4Structure and General Function of Ergostik Blueflow..........45
4.1 Hardware ..................................................................................... 45
4.1.1 Overview ...................................................................................... 45
4.1.2 Connections / Interfaces of the Ergostik Blueflow ......................... 46
4.1.2.1 Ergostik Device and Connections ................................................. 46
4.1.2.2 Sensors ........................................................................................ 47
4.1.2.3 Pressure Reducer......................................................................... 48
4.1.3 System Construction and Electrical Safety ................................... 48
4.1.3.1 Data Connection .......................................................................... 50
4.1.3.2 Equipment Cart with Isolating Transformer ................................... 50
4.1.3.3 Power Supply ............................................................................... 51
4.2 Technical Protection Measures..................................................... 51
4.3 Software....................................................................................... 51

Instructions for Use
Ergostik Blueflow
Serial no.: xx|8|201|yyy and 2203xxxxx
Page 4
Version: 6 | Release date: 02 August 2022
5Transport, Storage and Assembly .......................................53
5.1 Transport to the Location of Use .................................................. 53
5.2 Storage ........................................................................................ 53
5.3 Assembly...................................................................................... 54
6Operation .............................................................................55
6.1 Initial Operating............................................................................. 55
6.2 Recommissioning after Servicing / Cleaning Work ........................ 55
6.2.1 Assembly Calibration Tube ........................................................... 56
6.2.2 Power Supply and PC-Connection............................................... 58
7Operating Instructions .........................................................59
7.1 Checking for Worn Parts .............................................................. 59
7.1.1 Minifilter / Permapure Check ........................................................ 59
7.2 Establishing Operational Readiness.............................................. 60
7.3 Switching Ergostik Blueflow On / Off ............................................ 60
7.4 Inserting the Flow Sensor ............................................................. 61
7.4.1 Assembly Face Mask.................................................................... 62
7.4.2 Assembly Blueflow Mouthpiece .................................................... 63
7.5 Calibrating Ergostik Blueflow ........................................................ 64
7.6 Using Ergostik Blueflow / Performing Measurements.................... 64
7.7 Exchange of Disposable Products / Disinfection........................... 67
7.7.1 Noseclip / Blueflow Disposable / Exercise Mask Adapter Blueflow67
7.7.2 Mask ............................................................................................ 68
8Servicing / Maintenance ......................................................69
8.1 Duties of the Responsible Organisation ........................................ 69
8.2 Servicing / Maintenance by the User / Operator ........................... 70
8.2.1 Checking / Exchanging of Tubes and Cables ............................... 71
9Cleaning and Disinfection ....................................................72
9.1 Single Use .................................................................................... 73
9.2 Disinfection................................................................................... 73
9.2.1 Ergostik Blueflow.......................................................................... 76
9.2.2 Blueflow Flow Sensor- / Blueclip Removal.................................... 76
9.2.3 Removing the Silicone Mask / Adapter ......................................... 77
10 Fault Indication and Repair..................................................78
11 Decommissioning / Disposal ...............................................81
11.1 Expected Service Life ................................................................... 81
11.2 Decommissioning ......................................................................... 81
11.3 Disposal ....................................................................................... 81

Instructions for Use
Ergostik Blueflow
Serial no.: xx|8|201|yyy and 2203xxxxx
Version: 6 | Release date: 02 August 2022
Page 5
11.3.1 Transport Packaging .................................................................... 81
11.3.2 Ergostik Blueflow.......................................................................... 81
11.3.3 Infectious / Contaminated Single Use Items ................................. 82
12 Technical Specifications ......................................................83
12.1 Technical Data.............................................................................. 83
12.2 Installation and Operating Conditions ........................................... 85
12.3 Electrical Safety Concept.............................................................. 86
12.3.1 Ergostik Blueflow with Medical Device Cart and Isolation Transformer
..................................................................................................... 86
12.3.2 Ergostik Blueflow without Medical Device Cart and without Isolation
Transformer.................................................................................. 87
12.4 Electromagnetic Compatibility / EMC Guidelines .......................... 88
12.4.1 Emitted Interference Guideline and Manufacturer Declaration....... 88
12.4.2 Interference Resistance for all ME Systems Guideline and
Manufacturer Declaration ............................................................. 89
12.4.3 Interference Resistance for None-Life-Supporting ME Systems
Guideline and Manufacturer Declaration ....................................... 90
12.4.4 Recommended Safety Distances for Non-Life-Supporting ME
Systems ....................................................................................... 93
13 Safety of Product and Material ............................................94
14 Product Labeling / Type Label.............................................95
15 Warranty and Service...........................................................96
15.1 General Conditions....................................................................... 96
15.2 Warranty Exemption ..................................................................... 96
15.3 Packaging and Shipping............................................................... 97
16 Authorised Specialist Retail Partner ....................................98
Attachment – Declaration of Conformity..............................99