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
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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
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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.

Instructions for Use
Ergostik Blueflow
Serial no.: xx|8|201|yyy and 2203xxxxx
Version: 6 | Release date: 02 August 2022
Page 11
Symbol Explanation
0494
Conformity mark
This symbol indicates conformity with health, safety and
environmental protection standards for products sold
within the European Economic Area (EEA). The
additional four-digit number identifies the Notified Body
involved in the conformity evaluation procedure of this
product. In this case 0494 identifies SLG Prüf- und
Zertifizierungs GmbH as Notified Body.
Caution, non-ionizing electromagnetic radiation
Precautions must be taken to avoid an unexpected
effect of non-ionizing radiation.
General warning symbol
Warning of a hazardous area.
Fragile, handle with care
The package contains a product that must be handled
with appropriate care to prevent damage during
transport and storage.
Keep away from rain
The package contains a product that must be protected
from moisture during transport and storage.
Temperature limitation
The product can be safely transported, stored or
operated within the specified temperature range.
Humidity limitation
The product can be safely transported, stored or
operated within the specified humidity range.

Instructions for Use
Ergostik Blueflow
Serial no.: xx|8|201|yyy and 2203xxxxx
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Version: 6 | Release date: 02 August 2022
Symbol Explanation
Atmospheric pressure limitation
The product can be safely transported, stored or
operated within the permissible atmospheric pressure.

Instructions for Use
Ergostik Blueflow
Serial no.: xx|8|201|yyy and 2203xxxxx
Version: 6 | Release date: 02 August 2022
Page 13
1.4 Copyright
The manufacturer reserves all rights to this document and the
information contained therein. No part of this document or the
information contained herein may be reproduced or transmitted
without the written consent of the manufacturer. All information
or brand names of a third party contained in this document are
subject to the copyright of that third party.
1.5 Limitation of Liability
The manufacturer emphasises the creation of accompanying
documents for his products. Despite careful checking, errors or
inaccuracies in this document version cannot be completely
ruled out. The liability of the manufacturer for direct or indirect
damages arising in connection with the present documentation
is excluded to the extent permitted by law. Technical or content
information in this document is subject to change at any time
and without notice. Should any questions arise, please contact
your authorised specialist retailer or the manufacturer directly.

Instructions for Use
Ergostik Blueflow
Serial no.: xx|8|201|yyy and 2203xxxxx
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Version: 6 | Release date: 02 August 2022
2Conditions of Use
Any other use of Ergostik Blueflow which is not described in
this IFU is deemed improper use. The responsible
organisation of Ergostik Blueflow alone is liable for any direct
or indirect damage resulting from not adhering to these
conditions. They are then solely responsible for the fulfillment
of the basic requirements of the medical device and assumes
complete product liability for the whole system.
2.1 Intended Purpose
The medical device Ergostik Blueflow is a PC-based measuring
device used to determine physical exercise tolerance by
measuring gas exchange. The interaction of heart, circulation,
respiration and metabolism is analyzed during defined physical
stress. The test person is subjected to a load on an ergometer.
Heart rate, respiratory rate, respiratory minute volume, oxygen
uptake and carbon dioxide output are recorded continuously.
The Ergostik Blueflow is intended for use in clinical and office
settings and can be operated both stationary and mobile.

Instructions for Use
Ergostik Blueflow
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Version: 6 | Release date: 02 August 2022
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Examination Required option
Bronchoprovokation
Provokation ( 403680)
Resting Energy Expenditure /
Resting Metabolic Rate
REE ( 526143)
You can find more information in:
•IFU Spirometry
for carrying out the examination
•IFU BLUE CHERRY®
for the general operation of the software and carrying
out the examination

Instructions for Use
Ergostik Blueflow
Serial no.: xx|8|201|yyy and 2203xxxxx
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Version: 6 | Release date: 02 August 2022
2.1.1 Indication
The Ergostik Blueflow can be used for cardio-pulmonary
(exercise) tests for diagnosis, follow-up, screening and severity
assessment of pulmonary diseases. These include in particular:
Evaluation of exercise intolerance
Unexplained dyspnea
Evaluation of patients with cardiovascular diseases
Evaluation of patients with respiratory diseases
•Chronic obstructive pulmonary disease
•Interstitial lung disease
•Chronic pulmonary vascular disease
•Cystic fibrosis
•Exercise-induced bronchospasm
Preoperative assessment
•Preoperative assessment for lung cancer resection
surgery
•Surgery to reduce lung volume
•Evaluation for lung or heart-lung transplantation
•Preoperative evaluation of other procedures
•Prescription of pulmonary rehabilitation exercises
Prescription of pulmonary rehabilitation exercises
Assessment of the impairment / disability

Instructions for Use
Ergostik Blueflow
Serial no.: xx|8|201|yyy and 2203xxxxx
Version: 6 | Release date: 02 August 2022
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2.1.2 Contraindication and Side Effect
2.1.2.1 Contraindications
The following contraindications apply to ergometric
examinations:
Contraindications Absolute Relative
Acute myocardial infarction (3–5 days)
X
Unstable angina
X
Uncontrolled arrhythmias
X
Syncope
X
Active endocarditis
X
Acute myocarditis or pericarditis
X
Symptomatic severe aortic stenosis
X
Uncontrolled heart failure
X
Acute pulmonary embolus or pulmonary infarction
X
Thrombosis of lower extremities
X
Suspected dissecting aneurysm
X
Uncontrolled asthma
X
Pulmonary edema
X
Respiratory failure
X
Room air desaturation at rest <= 85 %
X
Acute noncardiopulmonary disorder that may affect
exercise performance or be aggravated by exercise
X
Mental impairment leading to inability to cooperate
X X
Left main coronary stenosis or its equivalent
X
Moderate stenotic valvular heart disease
X
Severe untreated arterial hypertension at rest
(200 mm Hg systolic, 120 mm Hg diastolic)
X
Tachyarrhythmias or bradyarrhythmias
X

Instructions for Use
Ergostik Blueflow
Serial no.: xx|8|201|yyy and 2203xxxxx
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Version: 6 | Release date: 02 August 2022
High-degree atrioventricular block
X
Hypertrophic cardiomyopathy
X
Significant pulmonary hypertension
X
Advanced or complicated pregnancy
X
Electrolyte abnormalities
X
Orthopedic impairment that compromises exercise
performance
X
As the transitions between absolute and relative
contraindication can be fluid in the
assessment, the assertion of
a physician should be regarded as binding.
(Source: American Thoracic Society, American College of Chest Physicians.
ATS/ACCP Statement on cardiopulmonary exercise testing. 2003. Am J Respir
Crit Care Med. 167:211–277.)
The following contraindications apply to spirometry
examinations:
Contraindications
Due to increases in myocardial demand or changes in blood pressure
•Acute myocardial infarction within 1 week
•Systemic hypotension or severe hypertension
•Significant atrial / ventricular arrhythmia
•Noncompensated heart failure
•Uncontrolled pulmonary hypertension
•Acute cor pulmonale
•Clinically unstable pulmonary embolism
• History of syncope related to forced expiration / cough
Due to increases in intracranial / intraocular pressure
•Cerebral aneurysm
•Brain surgery within 4 weeks
•Recent concussion with continuing symptoms
• Eye surgery within 1 week
Due to increases in sinus and middle ear pressures

Instructions for Use
Ergostik Blueflow
Serial no.: xx|8|201|yyy and 2203xxxxx
Version: 6 | Release date: 02 August 2022
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Contraindications
•
Sinus surgery or middle ear surgery or infection within 1 week
Due to increases in intrathoracic and intraabdominal pressure
•Presence of pneumothorax
•Thoracic surgery within 4 weeks
•Abdominal surgery within 4 weeks
•
Late-term pregnancy
Infection control issues
•Active or suspected transmissible respiratory or systemic infection,
including tuberculosis
•Physical conditions predisposing to transmission of infections, such
as hemoptysis,
• significant secretions, or oral lesions or oral bleeding
Spirometry should be discontinued if the patient experiences
pain during the maneuver. Relative contraindications do not
preclude spirometry but should be considered when ordering
spirometry. The decision to conduct spirometry is determined
by the ordering healthcare professional on the basis of their
evaluation of the risks and benefits of spirometry for the
particular patient. Potential contraindications should be
included in the request form for spirometry.
(Source: Graham, B. L. et al. 2019. Standardization of Spirometry 2019
Update. Am J Respir Crit Care Med Vol 200, Iss 8, pp e70–e88.)

Instructions for Use
Ergostik Blueflow
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Version: 6 | Release date: 02 August 2022
2.1.2.2 Side Effects
If there are no contraindications and the examination is carried
out in accordance with the descriptions in the IFU, cardio-
pulmonary exercise testing is a safe examination, but in rare
cases (1 per 10,000 examinations) serious cardiac incidents and
death (2-5 per 100,000 examinations) can occur. Therefore, the
following safety measures must be observed when conducting
cardio-pulmonary exercise tests:
•Presence of a physician for timely detection and
assessment of termination criteria (see table below)
•Presence of emergency equipment (defibrillator,
emergency medication)
•Availability of emergency medically trained personnel for
assistance
The following side effects may also occur:
Side effect / Frequency Rules of conduct
Exhaustion / Frequent
Stopping the exercise after medical
assessment.
Shortness of breath /
Frequent
Stopping the exercise after medical
assessment.
Chest pain / Frequent
Stopping the exercise after medical
assessment, monitoring of the patient for
cardiac events and, if necessary, treatment of
these.
Cardiac arrhythmias /
Frequent
Stopping the exercise after medical
assessment, monitoring of the patient for
cardiac incidents and treatment of these if
necessary.
Bronchospasm / Rare
Stopping the exercise after medical
assessment, monitoring of the patient after the
examination and administration of a
bronchodilator if necessary.