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

Instructions for Use
Ergostik Blueflow
Serial no.: xx|8|201|yyy and 2203xxxxx
Page 6
Version: 6 | Release date: 02 August 2022
Foreword
Thank you for purchasing a medical device from Geratherm®
Respiratory GmbH. Ergostik Blueflow is part of our product
family with solutions for cardiopulmonary function diagnostics
which are operated using the common software platform
BLUE CHERRY®. This means that you have the option of
optimising the working processes in your practice using the
networked application of further products from Geratherm®
Respiratory GmbH, and to benefit from the simple use of our
products.
1General Information
All our medical devices are manufactured and tested in
accordance with certified quality standards. This means that
Ergostik Blueflow fulfills the regulatory requirements for medical
devices (class IIa).
This IFU is a component of the product in accordance with DIN
EN ISO 60601-1. It should make it easier to familiarise yourself
with Ergostik Blueflow, as well as give you instructions about its
intended use and safe operation.
This IFU has been written for healthcare professionals who are
qualified to perform cardiopulmonary exercise tests.
The basic prerequisite for safe working with the Ergostik
Blueflow is to follow all the safety instructions given.
In addition to the notes in this IFU, the local accident prevention
regulations and the national industrial safety regulations apply.
Read this IFU carefully and in its entirety before using Ergostik
Blueflow. For future reference, keep them in the immediate
vicinity of the medical device, ready at hand for the user /
operator and accessible at all times!

Instructions for Use
Ergostik Blueflow
Serial no.: xx|8|201|yyy and 2203xxxxx
Version: 6 | Release date: 02 August 2022
Page 7
Please refer to the separate IFU of the BLUE CHERRY®
software platform for pulmonary function diagnostics.
If, in spite of careful reading of this IFU, you require more
information, please contact your specialist retail partner on site.
You can obtain the contact details via a form provided by the
manufacturer at www.geratherm-respiratory.com/login/.
1.1 Abbreviations
The following simplified style of writing and abbreviations are
used hereinafter to make this IFU easier to read.
Instructions for Use IFU
Geratherm® Respiratory GmbH Manufacturer
Medical specialist personnel User(s)
Personnel instructed in cleaning/
maintenance work Operator(s)
1.2 Explanations
For the safety of your patients, for your personal safety and to
avoid damage to property, observe the meaning of the following
explanations of symbols. These are divided into hazard levels.
If several severity levels occur at the same time, the warning note
for the highest level is always used.
The safety instructions are presented in accordance with DIN
ISO 3864 following ANSI Z535.4 (American National Standards
Institute).

Instructions for Use
Ergostik Blueflow
Serial no.: xx|8|201|yyy and 2203xxxxx
Page 8
Version: 6 | Release date: 02 August 2022
Indicates a directly hazardous situation.
Not observing and not avoiding the situation will lead to
death or severe injuries. The signal word DANGER is
only used for extreme situations.
Indicates a possibly hazardous situation.
Not observing and not avoiding the situation may lead to
death or severe injuries.
Indicates a possibly hazardous situation.
Not observing and not avoiding the situation may lead to
minor or moderate injuries.
Indicates places in the IFU which are relevant to the current
topic but do not present any danger, or which simplify your
handling of the Ergostik Blueflow.
Attention
Not observing this warning information may lead to faults or
malfunctions of the Ergostik Blueflow or may indicate that
something in its environment may be damaged.

Instructions for Use
Ergostik Blueflow
Serial no.: xx|8|201|yyy and 2203xxxxx
Version: 6 | Release date: 02 August 2022
Page 9
1.3 Symbols
Symbols displayed in this IFU, on the medical device itself and/or
on its packaging are standardised symbols.
Symbol Explanation
Follow the instructions for use!
Applied part from type BF corresponding to
DIN EN 60601-1
The applied part is in direct contact with the patient
(BF: Body Floating). In order to comply with the limit
value for the patient leakage current, the applied part is
insulated from earth.
Device of protection class II
(safety measure against touching)
Protection by double or reinforced insulation
For the prevention of electric shock.
Only use indoors!
IP20
Protection type (safe environmental conditions)
IP2x: Protection of enclosure against ingress of solid
foreign objects with a diameter greater than or equal to
12.5 mm and access to hazardous parts with finger.
IPx0: No protection of enclosure against harmful ingress
of water.

Instructions for Use
Ergostik Blueflow
Serial no.: xx|8|201|yyy and 2203xxxxx
Page 10
Version: 6 | Release date: 02 August 2022
Symbol Explanation
Do not dispose of the device along with general
household waste!
It must be disposed of in a proper and correct manner
via the distributor. By marking a device with this symbol,
the manufacturer also declares that he fulfills all the
requirements of the law on the distribution, return and
environmentally friendly disposal of electrical and
electronic devices. (Rechargeable) batteries must be
taken to a central collection point for used batteries or to
the manufacturer.
For single use only!
This symbol does not refer to the Ergostik Blueflow itself,
but to the consumable items used in connection with it.
This is applied to the respective packaging and must be
observed.
Batch number
This symbol identifies the batch or lot code given by the
manufacturer. The code is placed adjacent to the
symbol.
Serial number
This symbol identifies the serial number given by the
manufacturer.
Catalog number
This symbol identifies the catalog number given by the
manufacturer.
Manufacturer
This symbol identifies the manufacturer of a product.
Date of manufacture
This symbol indicates the date on which a product is
manufactured.