GERATHERM Ambistik User manual

Ambistik
Serial numbers: xx|4500|004|yyy
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: TDOAMB0034R6
Language: English
Affected serial numbers:xx|4500|004|yyy
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

Instructions for Use
Ambistik
Serial no.: xx|4500|004|yyy
Version: 6 | Release date: 14. July 2021
Page 3
Table of Contents
1General Information ...............................................................5
1.1 Abbreviations.................................................................................. 6
1.2 Explanations................................................................................... 7
1.3 Symbols ......................................................................................... 8
1.4 Copyright...................................................................................... 11
1.5 Limitation of Liability ..................................................................... 11
2Conditions of Use ................................................................12
2.1 Intended Purpose......................................................................... 12
2.1.1 Definition of the Groups of People ................................................ 13
2.2 Intended Use................................................................................ 14
2.2.1 Original Spare Parts / Accessories / Optional Expansions ............ 15
2.2.1.1 Original Spare Parts / Accessories................................................ 16
2.2.2 Auxiliary Materials ......................................................................... 17
3Safety in Handling ................................................................18
3.1 General Safety at Work and Personnel Qualification ..................... 19
3.2 Storage Conditions stipulated by the Manufacturer ...................... 20
3.3 The Technical State of Ambistik and System Construction........... 20
3.4 Operation / Servicing and Maintenance ........................................ 22
3.5 Electromagnetic Compatibility (EMC) ............................................ 24
3.6 Cleaning and Disinfection ............................................................. 25
4Structure and General Function of Ambistik........................26
4.1 Hardware ..................................................................................... 26
4.1.1 Overview ...................................................................................... 26
4.1.2 System Construction and Electrical Safety ................................... 27
4.1.2.1 Bluetooth / Computer / Printer Data Connection .......................... 29
4.2 Technical Protection Measures..................................................... 30
4.3 Software....................................................................................... 30
5Transport, Storage and Assembly .......................................31
5.1 Transport to the Location of Use .................................................. 31
5.2 Storage ........................................................................................ 31
5.3 Assembly...................................................................................... 32
6Operation .............................................................................33
6.1 System Overview.......................................................................... 34
6.2 Recommissioning ......................................................................... 34
7Operating Instructions .........................................................35
7.1 Checking for Worn Parts .............................................................. 35

Instructions for Use
Ambistik
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Version: 6 | Release date: 14. July 2021
7.2 Initial Operating............................................................................. 36
8Servicing / Maintenance ......................................................37
8.1 Duties of the responsible Operator ............................................... 37
9Cleaning and Disinfection ....................................................38
9.1 Disinfection................................................................................... 38
10 Fault Indication and Repair..................................................41
11 Decommissioning / Disposal ...............................................43
11.1 Expected Service Life ................................................................... 43
11.2 Disposal ....................................................................................... 43
11.2.1 Transport packaging .................................................................... 43
11.2.2 Ambistik ....................................................................................... 43
12 Technical Specifications ......................................................44
12.1 Technical Data.............................................................................. 44
12.2 Installation and Operating Conditions ........................................... 46
12.3 Electrical Safety Concept.............................................................. 47
12.3.1 Ambistik with Medical Device Cart and Isolation Transformer ....... 47
12.3.2 Ambistik without Medical Device Cart and without Isolation
Transformer.................................................................................. 48
12.4 Electromagnetic Compatibility / EMC Guidelines .......................... 49
12.4.1Emitted Interference Guideline and Manufacturer Declaration....... 49
12.4.2 Interference Resistance for all ME Systems Guideline and
Manufacturer Declaration ............................................................. 50
12.4.3 Interference Resistance for Non-Life-Supporting ME Systems
Guideline and Manufacturer Declaration ....................................... 51
12.4.4 Recommended Safety Distances for Non-Life-Supporting ME
Systems ....................................................................................... 53
13 Safety of Product and Material ............................................54
14 Product Labeling / Type Label.............................................55
15 Warranty and Service...........................................................56
15.1 General Conditions....................................................................... 56
15.2 Warranty Exemption ..................................................................... 56
15.3 Packaging and Shipping............................................................... 57
16 Authorised Specialist Retail Partner ....................................58
Attachment – Declaration of Conformity..............................59

Instructions for Use
Ambistik
Serial no.: xx|4500|004|yyy
Version: 6 | Release date: 14. July 2021
Page 5
Foreword
Thank you for purchasing a medical device from Geratherm®
Respiratory GmbH. Ambistik is a 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
Ambistik fulfills the regulatory requirements for medical devices
(class I).
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 Ambistik, 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 Ambistik 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
Ambistik. 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.
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/.

Instructions for Use
Ambistik
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Version: 6 | Release date: 14. July 2021
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)

Instructions for Use
Ambistik
Serial no.: xx|4500|004|yyy
Version: 6 | Release date: 14. July 2021
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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).
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 Ambistik.
Attention
Not observing this warning information may lead to faults or
malfunctions of the Ambistik or may indicate that something in
its environment may be damaged.

Instructions for Use
Ambistik
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Version: 6 | Release date: 14. July 2021
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!
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.
Serial number
This symbol identifies the serial number given by the
manufacturer.
Catalog number
This symbol identifies the catalog number given by the
manufacturer.

Instructions for Use
Ambistik
Serial no.: xx|4500|004|yyy
Version: 6 | Release date: 14. July 2021
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Symbol Explanation
Manufacturer
This symbol identifies the manufacturer of a product.
Date of manufacture
This symbol indicates the date on which a product is
manufactured.
Conformity mark
This symbol indicates conformity with health, safety and
environmental protection standards for products sold
within the European Economic Area (EEA).
Caution, non-ionizing electromagnetic radiation
Precautions must be taken to avoid an unexpected
effect of non-ionizing radiation.
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.

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Version: 6 | Release date: 14. July 2021
Symbol Explanation
Atmospheric pressure limitation
The product can be safely transported, stored or
operated within the permissible atmospheric pressure.

Instructions for Use
Ambistik
Serial no.: xx|4500|004|yyy
Version: 6 | Release date: 14. July 2021
Page 11
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
Ambistik
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Version: 6 | Release date: 14. July 2021
2Conditions of Use
Any other use of Ambistik which is not described in this IFU is
deemed improper use. The responsible organisation of
Ambistik 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 Ambistik is a PC-based measuring device
which is used to determine the environmental conditions.
As an accessory to our products in the field of spirometry and
spiroergometry, the Ambistik is intended to enable automatic
recording of ambient conditions.
When breathing, air is inhaled at room conditions.
As such, the volumes of air inhaled increase due to an increase
in body temperature, as well as an increase in air humidity up to
the point of saturation. In order to balance out this effect, the
volumes inhaled are multiplied within the software with the BTPS
factor (Body Temperature Pressure Saturated).
This factor is calculated by using the ambient conditions for
temperature, air pressure and air humidity.
As such, the software has to detect the actual ambient
conditions during the measurement process.
So the user is saved from having to input values manually, and in
order to minimise any potential errors resulting from information
being input incorrectly, Ambistik automatically transfers these
parameters to the software via the USB interface.
The Ambistik consists of a case with integrated electronics, as
well as sensors for temperature, air humidity and pressure.
The Ambistik is always supplied with other Geratherm®
Respiratory lung function devices, as well as the BLUE
CHERRY® software.

Instructions for Use
Ambistik
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Version: 6 | Release date: 14. July 2021
Page 13
You can find more information in:
•BLUE CHERRY® IFU for the general operation of the
software and carrying out the examination
2.1.1 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 Ambistik. They are responsible for instructing
the users 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 Ambistik is used by their
employees (users / operators).
User
is a medically trained specialist who is familiar with lung function
examinations, who uses Ambistik after verifiable instruction by
the responsible organisation and / or is responsible for rectifying
faults to the Ambistik.
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 Ambistik.
Trainee medical specialists must also be supervised in addition
to receiving training in how to use Ambistik.
Operator
is a person who has received instruction on cleaning Ambistik 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.

Instructions for Use
Ambistik
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2.2 Intended Use
Ambistik 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. 4.1.2 “System Construction and Electrical Safety”)
In all cases, the Ambistik 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 Ambistik 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. 2.1.1 “Definition of the
Groups of People”) operates Ambistik. Personnel must
demonstrably have been given training in the function of
Ambistik. 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 Ambistik may only be used for the duration of its service life
if the specifications are observed.
Any changes to Ambistik, in particular unauthorised
modifications, are prohibited.
Any other than the described use is deemed improper use.
The responsible organisation of Ambistik 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
Ambistik
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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 Ambistik.
The installation or use of other products can, under certain
circumstances, negatively change constructive prescribed
properties of Ambistik 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.
(see also chap. 15.2 “Warranty Exemption“)
Attention
Electromagnetic compatibility (EMC) in accordance with
DIN EN 60601-1-2:2006-10; VDE 0750-1-2:2006-10; IEC 60601-1-
2:2001 + A1:2004. See chap. 12.4 “Electromagnetic Compatibility /
EMC Guidelines”. Ambistik 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.

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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 materials from
unauthorised access!
• Observe the storage conditions stipulated by the
manufacturer!
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. 4.1.2 of this IFU
•Further information on Ambistik in the separate Ambistik
IFU

Instructions for Use
Ambistik
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Version: 6 | Release date: 14. July 2021
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Component Description / name Supply
scope in
units
Ambistik
USB 2.0 ambient
conditions module for
accurate online BTPS
conditions.
Continuous measurement
of ambient temperature,
pressure and humidity.
Runs on modular and
intuitive Windows based
diagnostic software
platform for pulmonary
function BLUE
CHERRY®.
01 884000
[old:40.300]
USB Docking Station
For USB based devices
(1.5 m)
01 652725
[old:40.300-01]
2.2.2 Auxiliary Materials
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/
Component Description / name
Disinfectant
For wipe disinfection,
alcoholic quick-acting
Bacillol Tissues (BODE Chemie GmbH)
 SprayIn (Dr. Deppe GmbH)
depending
on provider

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Version: 6 | Release date: 14. July 2021
3Safety in Handling
Ambistik has been designed and built in accordance with the
state of technology and its recognised safety and technical
regulations.
In spite of this, dangers of injury to operators / users, patients
and third parties as well as damage to Ambistik or other
materials may occur if this is:
• Not used in accordance with the conditions of intended
use.
• Not operated in a technically flawless state.
• Operated by untrained or uninstructed personnel.
• Maintained or serviced improperly.
In order for Ambistik or the complete system to be
operated in accordance with its intended use, the safety
information and procedures in this IFU must be
understood.
Ensure that these are followed!
Otherwise, in the worst case, death or severe injuries
are the consequence resulting from the risks
described in more detail in the respective chapters!
Therefore:
•
Read this IFU manual carefully and in its
entirety before using the Ambistik. Keep it in
close proximity to the medical device for later
reference and make it accessible to the user /
operator at all times!
•Also observe the safety information of all other
accompanying documents of the complete
system!
•If you have any questions, ask your authorised
specialist retail partner!

Instructions for Use
Ambistik
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Version: 6 | Release date: 14. July 2021
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3.1 General Safety at Work and Personnel Qualification
Possible danger to life.
Reason:
Not complying with health and safety
regulations. Ignoring essential preventive measures.
Therefore:
•Always comply with general national regulations
on accident prevention! Instruct users /
operators accordingly!
• Safety and warning information on Ambistik may
not be altered or removed! Have missing or not
readable information replaced immediately!
•When working with auxiliary materials, always
observe the safety information from the
respective manufacturer! Wear suitable
protective clothing!
Reason:
Electric shock. False diagnosis.
Triggering Ambistik malfunctions. Unqualified
personnel can discover sources of fault too late or
even cause them.
Therefore:
• Only use officially trained users!
•All maintenance and servicing work may only be
performed by specialised personnel who have
been authorised by the manufacturer!

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3.2 Storage Conditions stipulated by the Manufacturer
Possible physical injury.
Reason:
Device damage as well as
impurities
/
contamination due to improper handling
of components.
Therefore:
•Observe the storage conditions stipulated by the
manufacturer!
Reason:
Measurement error due to leakage caused by
incorrect assembly of components.
Therefore:
• Carefully observe the assembly instructions!
3.3 The Technical State of Ambistik and System Construction
Possible danger to life.
Reason:
Electric shock. Cross-contamination.
Misdiagnosis caused by measurement error.
Therefore:
• Do not overstress Ambistik! Use with care!
•Do not modify or use product Ambistik or
complete system contrary to the respective
manufacturer's specification!
• Only use the USB connection cable / docking
station supplied by manufacturer within the
scope of delivery and available as a spare part,
which is always part of the medical device!
•Under no circumstances use or connect any
devices, systems, equipment and other products
that are not part of the complete system! This
also includes only components approved by the
manufacturer such as Bluetooth dongle,
(rechargeable) batteries, battery chargers,
(connection) cables and computers that are not
permitted by the manufacturer.
See chap. 12 "Technical Specifications"!