GERATHERM Spirostik User manual

Spirostik
Serial numbers: xx|8|001|yyy and 2001xxxxx
Instructions for Use
Version: 6
Release date: 14. July 2021
Please read carefully and store in a place which is always accessible for future
consultation!

Version: 6
Release date:14. July 2021
Filename:TDOSPI0085R6
Language:English
Affected serial numbers: xx|8|001|yyy and 2001xxxxx
Software version: valid from 1.0.1
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
Spirostik
Serial no.: xx|8|001|yyy and 2001xxxxx
Version: 6 | Release date: 14. July 2021
Page 3
Table of Contents
1General Information ...............................................................6
1.1 Abbreviations.................................................................................. 7
1.2 Explanations................................................................................... 7
1.3 Symbols ......................................................................................... 9
1.4 Copyright...................................................................................... 12
1.5 Limitation of Liability ..................................................................... 12
2Conditions of Use ................................................................13
2.1 Intended Purpose......................................................................... 13
2.1.1 Indication...................................................................................... 14
2.1.2 Contraindication and Side Effect................................................... 15
2.1.2.1 Contraindications.......................................................................... 15
2.1.2.2 Side Effects .................................................................................. 16
2.1.3 Definition of the Groups of People ................................................ 17
2.2 Intended Use................................................................................ 18
2.2.1 Original Spare Parts / Accessories / Optional Expansions ............ 19
2.2.1.1 Original Spare Parts / Accessories................................................ 20
2.2.1.2 Optional Expansions..................................................................... 23
2.2.2 Consumable Items / Auxiliary Materials......................................... 25
3Safety in Handling ................................................................27
3.1 General Safety at Work and Personnel Qualification ..................... 28
3.2 The Technical State of Spirostik and System Construction........... 29
3.3 Operation / Servicing and Maintenance ........................................ 31
3.4 Electromagnetic Compatibility (EMC) ............................................ 32
3.5 Cleaning and Disinfection ............................................................. 33
4Structure and General Function of Spirostik .......................34
4.1 Hardware ..................................................................................... 34
4.1.1 Overview ...................................................................................... 34
4.1.2 Connectors / Interfaces of the Spirostik........................................ 35
4.1.2.1 Flow Sensor ................................................................................. 35
4.1.3 System Construction and Electrical Safety ................................... 35
4.1.3.1 Bluetooth / Computer / Printer Data Connection .......................... 38
4.1.3.2 Power Supply ............................................................................... 38
4.2 Technical Protection Measures..................................................... 38
4.3 Software....................................................................................... 39
5Transport, Storage and Assembly .......................................40
5.1 Transport to the Location of Use .................................................. 40

Instructions for Use
Spirostik
Serial no.: xx|8|001|yyy and 2001xxxxx
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Version: 6 | Release date: 14. July 2021
5.2 Storage ........................................................................................ 40
5.3 Assembly...................................................................................... 41
6Operation .............................................................................42
6.1 Initial Operating............................................................................. 42
6.1.1 Calibrate Spirostik / Set up funtional Operations........................... 42
6.2 Returning to Operation after Servicing / Cleaning Work ................ 43
7Operating Instructions .........................................................44
7.1 Checking for Worn Parts .............................................................. 44
7.2 Preparing the Device for Operation............................................... 45
7.3 Switching Spirostik On / Off.......................................................... 45
7.4 Inserting the Flow Sensor ............................................................. 46
7.5 Calibrating Spirostik...................................................................... 47
7.6 Using Spirostik / Carrying Out Measurements .............................. 48
7.7 Removing the Flow Sensor........................................................... 49
8Servicing / Maintenance ......................................................51
8.1 Duties of the Responsible Organisation ........................................ 51
8.2 Servicing / Maintenance by the User / Operator ........................... 52
8.2.1 Checking for Damage................................................................... 53
8.2.1.1 General......................................................................................... 53
8.2.1.2 Checking / Replacing the Handle ................................................. 54
9Cleaning and Disinfection ....................................................55
9.1 Single Use .................................................................................... 55
9.2 Disinfection................................................................................... 56
10 Fault Indication and Repair..................................................59
11 Decommissioning / Disposal ...............................................60
11.1 Expected Service Life ................................................................... 60
11.2 Removing from Operation............................................................. 60
11.3 Disposal ....................................................................................... 60
11.3.1 Transport Packaging .................................................................... 60
11.3.2 Spirostik ....................................................................................... 60
11.3.3 Infectious / Contaminated Single Use Items ................................. 61
12 Technical Specifications ......................................................62
12.1 Technical Data.............................................................................. 62
12.2 Installation and Operating Conditions ........................................... 64
12.3 Electrical Safety Concept.............................................................. 65
12.3.1 Spirostik with Medical Device Cart and Isolation Transformer ....... 65

Instructions for Use
Spirostik
Serial no.: xx|8|001|yyy and 2001xxxxx
Version: 6 | Release date: 14. July 2021
Page 5
12.3.2 Spirostik without Medical Device Cart and without Isolation
Transformer.................................................................................. 66
12.4 Electromagnetic Compatibility / EMC Guidelines .......................... 67
12.4.1 Emitted Interference Guideline and Manufacturer Declaration....... 67
12.4.2 Interference Resistance for all ME Systems Guideline and
Manufacturer Declaration ............................................................. 68
12.4.3 Interference Resistance for Non-Life-Supporting ME Systems
Guideline and Manufacturer Declaration ....................................... 69
12.4.4 Recommended Safety Distances for Non-Life-Supporting ME
Systems ....................................................................................... 71
13 Safety of Product and Material ............................................72
14 Product Labeling / Type Label.............................................73
15 Warranty and Service...........................................................74
15.1 General Conditions....................................................................... 74
15.2 Warranty Exemption ..................................................................... 74
15.3 Packaging and Shipping............................................................... 75
16 Authorised Specialist Retail Partner ....................................76
Attachment – Declaration of Conformity..............................77

Instructions for Use
Spirostik
Serial no.: xx|8|001|yyy and 2001xxxxx
Page 6
Version: 6 | Release date: 14. July 2021
Foreword
Thank you for purchasing a medical device from Geratherm®
Respiratory GmbH. Spirostik 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
Spirostik 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 Spirostik, 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 spirometric examinations.
The basic prerequisite for safe working with the Spirostik 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
Spirostik. 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!
Please refer to the separate IFU of the BLUE CHERRY®
software platform for pulmonary function diagnostics.

Instructions for Use
Spirostik
Serial no.: xx|8|001|yyy and 2001xxxxx
Version: 6 | Release date: 14. July 2021
Page 7
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
Spirostik
Serial no.: xx|8|001|yyy and 2001xxxxx
Page 8
Version: 6 | Release date: 14. July 2021
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 Spirostik.
Attention
Not observing this warning information may lead to faults or
malfunctions of the Spirostik or may indicate that something in
its environment may be damaged.

Instructions for Use
Spirostik
Serial no.: xx|8|001|yyy and 2001xxxxx
Version: 6 | Release date: 14. July 2021
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.
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.
Do not dispose of the device along with general
household waste!
It must be disposed of in a proper and correct manner
via the specialist retail partner. 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.

Instructions for Use
Spirostik
Serial no.: xx|8|001|yyy and 2001xxxxx
Page 10
Version: 6 | Release date: 14. July 2021
Symbol Explanation
For single use only!
This symbol does not refer to the Spirostik 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.
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.

Instructions for Use
Spirostik
Serial no.: xx|8|001|yyy and 2001xxxxx
Version: 6 | Release date: 14. July 2021
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Symbol Explanation
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.
Atmospheric pressure limitation
The product can be safely transported, stored or
operated within the permissible atmospheric pressure.

Instructions for Use
Spirostik
Serial no.: xx|8|001|yyy and 2001xxxxx
Page 12
Version: 6 | Release date: 14. July 2021
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
Spirostik
Serial no.: xx|8|001|yyy and 2001xxxxx
Version: 6 | Release date: 14. July 2021
Page 13
2Conditions of Use
Any other use of Spirostik which is not described in this IFU is
deemed improper use. The responsible organisation of
Spirostik 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
Spirostik is an electric medical device. It is a PC-connected
spirometer, intended to identify the static and dynamic lung
volume in pulmonary function testing in a clinical setting and by
established physicians.
Spirostik is designed for use in the mouth, nose, upper throat
area, trachea and lungs of the patient (definition see chap. 2.1.3
"Definition of the Groups of People”).
The standard version of the accompanying software permits
measurements for spirometry, flow / volume and MVV as well as
pre / post examinations and trend analysis.
Using Spirostik, you can also carry out the examination stated
below.
Examination Required option
Bronchoprovocation
Provocation
(Bronchial Provocation Software
403680)

Instructions for Use
Spirostik
Serial no.: xx|8|001|yyy and 2001xxxxx
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Version: 6 | Release date: 14. July 2021
You can find more information in:
•Spirometry IFU
for carrying out the examination
•BLUE CHERRY® IFU
for the general operation of the software and
carrying out the examination
2.1.1 Indication
With Spirostik, pulmonary function examinations can be carried
out for diagnosing, monitoring of process, screening and
assessing the severity of pulmonary diseases. In particular, this
includes:
Obstructive diseases
•Complaints such as dyspnea (shortness of breath) or
coughing when at rest as well as under stress
•Bronchial asthma
•Chronic obstructive pulmonary disease (COPD)
•Pulmonary emphysema
Restrictive diseases
•Interstitial lung diseases
•Pulmonary fibrosis
•Impairments of the chest
•Neuromuscular diseases
Allergy diagnosis

Instructions for Use
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Serial no.: xx|8|001|yyy and 2001xxxxx
Version: 6 | Release date: 14. July 2021
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2.1.2 Contraindication and Side Effect
2.1.2.1 Contraindications
The following contraindications apply for spirometric
examinations:
Contraindications Absolute Relative
Patients with a new (< 1 month old)
myocardial infarction
X X
Aneurysm of the ascending aorta
X X
Pulmonary embolism
X X
Tension pneumothorax
X
Acute internal bleeding
X
Recent eye operations
X
Recent thorax / abdominal operations
X
Hemoptysis
X
Acute diarrhea
X
Angina
X
Severe hypertension
(SBP > 200 mmHg, DBP > 120 mmHg)
X
Confusion / dementia
X
Infectious diseases
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: Miller MR, Crapo R. Hankinson J et al. 2005. General considerations
for lung function testing. Eur Respir J. 26:153–161.)

Instructions for Use
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Version: 6 | Release date: 14. July 2021
2.1.2.2 Side Effects
If there are no contraindications and the examination is carried
out in accordance with the descriptions in this IFU, side effects
rarely occur in pulmonary function examinations. These can be
described as follows:
Side effect / Frequency Rules of conduct
Side Effect / Frequency
Dizziness, syncope /
on a case-by-case basis.
Examinations should preferably be performed
in a sitting position and the patient should be
permanently observed during the examination.
Spontaneous
pneumomediastinum,
pneumopericardium and
subcutaneous emphysema
in spirometry /
in extremely rare cases.
Investigate any persistent dyspnea that occurs
after the examination.

Instructions for Use
Spirostik
Serial no.: xx|8|001|yyy and 2001xxxxx
Version: 6 | Release date: 14. July 2021
Page 17
2.1.3 Definition of the Groups of People
Groups of people named in this IFU are defined as follows:
Manufacturer
specifies all measures to ensure the safe and proper handling
and application of Spirostik. They are responsible for instructing
the operator in relation to this via the corresponding specialist
retail partner.
Responsible Organisation
is any natural or legal person who is responsible for the
operation of the health institution where Spirostik is used by
their employees (users).
User
is a medically trained specialist who is familiar with spirometry
examinations, who uses Spirostik on the patient after verifiable
instruction by the responsible organisation and / or is
responsible for rectifying faults to the Spirostik, as well as its
calibration.
Users must be aware of the clinical meaning and, for example,
be a physician, physician’s assistant, assistant or trained
maintenance personnel with basic electrical or mechanical
training. The user is able to identify, assess and, in the best
case, to avoid possible hazards when using Spirostik.
Trainee medical specialists must also be supervised in addition
to receiving training in how to use Spirostik.
Operator
is a person who has received instruction on cleaning Spirostik
by a medically trained specialist.
Patient
is a person undergoing medical treatment (check-up, initial
diagnosis as well as progress / treatment monitoring) to assess
their pulmonary function. The persons can be adults without an
age limitation as well as children form 4 years of age.
A requirement for carrying out the examination is the ability to
follow the instructions of the user.

Instructions for Use
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Serial no.: xx|8|001|yyy and 2001xxxxx
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Version: 6 | Release date: 14. July 2021
2.2 Intended Use
Spirostik can be operated independently as a non-stationary
device or in combination with all other Geratherm® Respiratory
GmbH products via the universal software BLUE CHERRY®.
(see chap. 4.1.3 “System Construction and Electrical Safety”)
In all cases, the Spirostik is only intended for use in closed,
pleasantly temperature-controlled (19 °C - 25 °C) rooms in a
clinical area.
In the respective room, there must be neither flammable or
explosive gases, nor magnetic fields (e.g. MRI).
The following applies in general: The installation of Spirostik is
only deemed safe and in line with intended use when this is
carried out in accordance with the details in chap. 12.2
“Installation and Operating Conditions”.
The responsible organisation must ensure that only medically
trained specialist personnel (see chap. 2.1.3 “Definition of the
Groups of People”) operates Spirostik. Personnel must
demonstrably have been given training in the function of
Spirostik. This also includes a complete study of this IFU.
The manufacturer has determined the expected service life (see
chap. 11.1 "Expected Service Life") and the maintenance work
required for this (see chap. 8 "Servicing / Maintenance").
The Spirostik may only be used for the duration of its service life
if the specifications are observed.
Any changes to Spirostik, in particular unauthorised
modifications, are prohibited.
The Spirostik is not intended for the control of vital physiological
parameters where the nature of the change could lead to
immediate danger to the patient, e.g. changes in heart function,
respiration or central nervous system activity.
Any other than the described use is deemed improper use.
The responsible organisation of Spirostik alone is liable for any
damage resulting from not adhering to these conditions.
Intended use also includes complying with all further information
and instructions in this IFU, without exception.

Instructions for Use
Spirostik
Serial no.: xx|8|001|yyy and 2001xxxxx
Version: 6 | Release date: 14. July 2021
Page 19
2.2.1 Original Spare Parts / Accessories / Optional Expansions
Intended use also includes using prescribed original spare parts,
accessories and expansions in constructing the system.
Only the components stated in the following are deemed tested
and approved, as products by the manufacturer of Spirostik.
The installation or use of other products can, under certain
circumstances, negatively change constructive prescribed
properties of Spirostik and, in the worst case, impair the safety
of the patient, user / operator and / or third parties.
The manufacturer assumes no liability for such consequences.
All warranty claims shall expire.
Possible danger to life.
Reason: Cross contamination. Therefore:
•
Do not use consumable articles with a limited life
span after their use-by date has expired!
Possible physical injury.
Reason:
Device damage as well as impurities /
contamination due to improper handling of
components.
Therefore:
•Protect separately stored components,
accessories and consumable items from
unauthorised access!
•Observe the storage conditions stipulated by the
manufacturer!
Attention
Electromagnetic compatibility (EMC) in accordance with
DIN EN 60601-1-2:2016-05; VDE 0750-1-2:2016-05; IEC 60601-1-
2:2014. See chap. 12.4 “Electromagnetic Compatibility / EMC
Guidelines”. Spirostik is suitable for use in all institutions including
those in residential areas and those which are directly connected to
the public supply network which also supplies buildings used for
residential purposes.

Instructions for Use
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Serial no.: xx|8|001|yyy and 2001xxxxx
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Version: 6 | Release date: 14. July 2021
2.2.1.1 Original Spare Parts / Accessories
The following components can be purchased via specialist retail
partners.
You will find:
•A list of specialist retail partners as an insert in this IFU
or in your medical device book, as well as the most
updated version at
www.geratherm-respiratory.com/login/
•Instructions on safe system construction in
chap. 4.1.3 of this IFU
•Further information on Ambistik in the
separate Ambistik IFU
Component Description / name Supply
scope in
units
Spirostik, Case
For safe and secure
transport of Spirostik.
For organised and
structured storage of
components and
accessories.
01 177882