GERATHERM Ambistik PFT User manual

Ambistik PFT /
Ambistik CPET
Serial numbers: 2024xxxxx / 2025xxxxx
Instructions for Use
Version: 1
Release date: 31 January 2022
Please read carefully and store in a place which is always accessible for future
consultation!

Version: 1
Release date:31 January 2022
Filename: TDOAM2004R1
Language: English
Affected serial numbers:2024xxxxx / 2025xxxxx
Software version: valid from 1.2.0
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 PFT-CPET
Serial no.: 2024xxxxx / 2025xxxxx
Version: 1 | Release date: 31 January 2022
Page 3
Table of Contents
1General Information ...............................................................6
1.1 Abbreviations.................................................................................. 7
1.2 Explanations................................................................................... 8
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 Definition of the Groups of People ................................................ 14
2.2 Intended Use................................................................................ 15
2.2.1 Original Spare Parts / Accessories / Optional Expansions ............ 16
2.2.1.1 Original Spare Parts / Accessories................................................ 17
2.2.2 Auxiliary Materials ......................................................................... 19
3Safety in Handling ................................................................20
3.1 General Safety at Work and Personnel Qualification ..................... 21
3.2 Storage Conditions stipulated by the Manufacturer ...................... 22
3.3 The Technical State of Ambistik PFT / Ambistik CPET and System
Construction................................................................................. 22
3.4 Operation / Servicing and Maintenance ........................................ 24
3.5 Electromagnetic Compatibility (EMC) ............................................ 27
3.6 Cleaning and Disinfection ............................................................. 28
4Structure and General Function of Ambistik PFT / Ambistik
CPET ....................................................................................29
4.1 Hardware ..................................................................................... 29
4.1.1 Overview ...................................................................................... 29
4.1.2 LEDs for Status Indication ............................................................ 30
4.1.2.1 Function test ................................................................................ 30
4.1.2.2 Warm-up phase ........................................................................... 30
4.1.2.3 Measuring mode .......................................................................... 31
4.1.2.4 Error display ................................................................................. 33
4.1.3 System Construction and Electrical Safety ................................... 35
4.1.3.1 Bluetooth / Computer / Printer Data Connection .......................... 37
4.2 Technical Protection Measures..................................................... 38
4.3 Software....................................................................................... 38
5Transport, Storage and Assembly .......................................39
5.1 Transport to the Location of Use .................................................. 39

Instructions for Use
Ambistik PFT-CPET
Serial no: 2024xxxxx / 2025xxxxx
Page 4
Version: 1 | Release date: 31 January 2022
5.2 Storage ........................................................................................ 39
5.3 Assembly...................................................................................... 40
6Operation .............................................................................41
6.1 System Overview.......................................................................... 42
6.2 Recommissioning ......................................................................... 43
7Operating Instructions .........................................................44
7.1 Checking for Worn Parts .............................................................. 44
7.2 Initial Operating............................................................................. 45
7.2.1 Additionally for Ambistik CPET...................................................... 46
8Servicing / Maintenance ......................................................47
8.1 Duties of the responsible Operator ............................................... 47
9Cleaning and Disinfection ....................................................48
9.1 Disinfection................................................................................... 48
10 Fault Indication and Repair..................................................50
11 Decommissioning / Disposal ...............................................53
11.1 Expected Service Life ................................................................... 53
11.2 Disposal ....................................................................................... 53
11.2.1 Transport packaging .................................................................... 53
11.2.2 Ambistik PFT / Ambistik CPET...................................................... 53
12 Technical Specifications ......................................................54
12.1 Technical Data.............................................................................. 54
12.2 Installation and Operating Conditions ........................................... 56
12.3 Electrical Safety Concept.............................................................. 57
12.3.1 Ambistik PFT / Ambistik CPET with Medical Device Cart and Isolation
Transformer.................................................................................. 57
12.3.2 Ambistik PFT / Ambistik CPET without Medical Device Cart and
without Isolation Transformer........................................................ 58
12.4 Electromagnetic Compatibility / EMC Guidelines .......................... 59
12.4.1 Emitted Interference Guideline and Manufacturer Declaration....... 59
12.4.2 Interference Resistance for all ME Systems Guideline and
Manufacturer Declaration ............................................................. 60
12.4.3 Interference Resistance for Non-Life-Supporting ME Systems
Guideline and Manufacturer Declaration ....................................... 61
12.4.4 Recommended Safety Distances for Non-Life-Supporting ME
Systems ....................................................................................... 63
13 Safety of Product and Material ............................................64

Instructions for Use
Ambistik PFT-CPET
Serial no.: 2024xxxxx / 2025xxxxx
Version: 1 | Release date: 31 January 2022
Page 5
14 Product Labeling / Type Label.............................................65
15 Warranty and Service...........................................................67
15.1 General Conditions....................................................................... 67
15.2 Warranty Exemption ..................................................................... 67
15.3 Packaging and Shipping............................................................... 68
16 Authorised Specialist Retail Partner ....................................69
Attachment – Declaration of Conformity..............................70

Instructions for Use
Ambistik PFT-CPET
Serial no: 2024xxxxx / 2025xxxxx
Page 6
Version: 1 | Release date: 31 January 2022
Foreword
Thank you for purchasing a medical device from Geratherm®
Respiratory GmbH. Ambistik PFT / Ambistik CPET 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 PFT / Ambistik CPET 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 PFT / Ambistik CPET, 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 PFT /
Ambistik CPET 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 PFT / Ambistik CPET. 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
Ambistik PFT-CPET
Serial no.: 2024xxxxx / 2025xxxxx
Version: 1 | Release date: 31 January 2022
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)

Instructions for Use
Ambistik PFT-CPET
Serial no: 2024xxxxx / 2025xxxxx
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Version: 1 | Release date: 31 January 2022
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 PFT / Ambistik CPET.
Attention
Not observing this warning information may lead to faults or
malfunctions of the Ambistik PFT / Ambistik CPET or may
indicate that something in its environment may be damaged.

Instructions for Use
Ambistik PFT-CPET
Serial no.: 2024xxxxx / 2025xxxxx
Version: 1 | Release date: 31 January 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!
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 PFT-CPET
Serial no: 2024xxxxx / 2025xxxxx
Page 10
Version: 1 | Release date: 31 January 2022
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-ionising electromagnetic radiation
Precautions must be taken to avoid an unexpected
effect of non-ionising 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.

Instructions for Use
Ambistik PFT-CPET
Serial no.: 2024xxxxx / 2025xxxxx
Version: 1 | Release date: 31 January 2022
Page 11
Symbol Explanation
Atmospheric pressure limitation
The product can be safely transported, stored or
operated within the permissible atmospheric pressure.

Instructions for Use
Ambistik PFT-CPET
Serial no: 2024xxxxx / 2025xxxxx
Page 12
Version: 1 | Release date: 31 January 2022
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 PFT-CPET
Serial no.: 2024xxxxx / 2025xxxxx
Version: 1 | Release date: 31 January 2022
Page 13
2Conditions of Use
Any other use of Ambistik PFT / Ambistik CPET which is not
described in this IFU is deemed improper use. The
responsible organisation of Ambistik PFT / Ambistik CPET
alone is liable for any direct or indirect damage resulting from
not adhering to these conditions (see chap. 2.1.1 “Definition
of the Groups of People”). 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 PFT / Ambistik CPET is a PC-
based measuring device used to determine environmental
conditions: temperature, air humidity and pressure. From these
measured values the so-called BTPS factor (Body Temperature
Pressure Saturated) is calculated, which ensures standardised
measurement results by multiplication with the inhaled volume.
As an accessory for all products that measure air volumes, the
Ambistik PFT / Ambistik CPET is intended to enable the
automatic recording of ambient conditions.
The Ambistik CPET also contains a CO
2
sensor to correctly take
into account the CO2content of the ambient air in CPET
applications.
You can find more information in:
•BLUE CHERRY® IFU for the general operation of the
software and carrying out the examination

Instructions for Use
Ambistik PFT-CPET
Serial no: 2024xxxxx / 2025xxxxx
Page 14
Version: 1 | Release date: 31 January 2022
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 PFT / Ambistik CPET. They are
responsible for instructing the users in relation to this via the
corresponding specialist retailer’s partner.
Responsible Organisation
is any natural or legal person who is responsible for the
operation of the health institution where Ambistik PFT / Ambistik
CPET is used by their employees (users / operators).
User
is a medically trained specialist who is familiar with lung function
examinations, who uses Ambistik PFT / Ambistik CPET after
verifiable instruction by the responsible organisation and / or is
responsible for rectifying faults to the Ambistik PFT / Ambistik
CPET.
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 PFT /
Ambistik CPET. Trainee medical specialists must also be
supervised in addition to receiving training in how to use
Ambistik PFT / Ambistik CPET.
Operator
is a person who has received instruction on cleaning Ambistik
PFT / Ambistik CPET 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 PFT-CPET
Serial no.: 2024xxxxx / 2025xxxxx
Version: 1 | Release date: 31 January 2022
Page 15
2.2 Intended Use
Ambistik PFT / Ambistik CPET 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 Ambistik PFT / Ambistik CPET 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 PFT
/ Ambistik CPET 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 ensuring that only medically
trained specialist personnel (see chap. 2.1.1 “Definition of the
Groups of People”) operates Ambistik PFT / Ambistik CPET.
These personnel must demonstrably have been given training in
the function of Ambistik PFT / Ambistik CPET. 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 PFT / Ambistik CPET may only be used for the
duration of its service life if the specifications are observed.
Any changes to Ambistik PFT / Ambistik CPET, in particular
unauthorised modifications, are prohibited.
Any other than the described use is deemed improper use.
The responsible organisation of Ambistik PFT / Ambistik CPET
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 PFT-CPET
Serial no: 2024xxxxx / 2025xxxxx
Page 16
Version: 1 | Release date: 31 January 2022
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 PFT
/ Ambistik CPET.
The installation or use of other products can, under certain
circumstances, negatively change constructive prescribed
properties of Ambistik PFT / Ambistik CPET 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
EN 61000-6-1:2007 / EN 6100-6-3:2007+A1:2011+A11 /
AC:2012. Ambistik PFT / Ambistik CPET
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
Ambistik PFT-CPET
Serial no.: 2024xxxxx / 2025xxxxx
Version: 1 | Release date: 31 January 2022
Page 17
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. 4.1.3 of this IFU
•Further information on Ambistik in the separate
Ambistik IFU

Instructions for Use
Ambistik PFT-CPET
Serial no: 2024xxxxx / 2025xxxxx
Page 18
Version: 1 | Release date: 31 January 2022
Component Description / name Supply
scope in
units
Ambistik
PFT
Supply
scope in
units
Ambistik
CPET
Ambistik PFT
01 - 654063
Ambistik CPET
- 01 493425
USB cable type-A to
type-C
01 01 104080
BLUE CHERRY® Media
Pack
Modular and intuitive
Windows based
diagnostic software
platform for
pulmonary function
01 01 598197
[old:10.500]

Instructions for Use
Ambistik PFT-CPET
Serial no.: 2024xxxxx / 2025xxxxx
Version: 1 | Release date: 31 January 2022
Page 19
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

Instructions for Use
Ambistik PFT-CPET
Serial no: 2024xxxxx / 2025xxxxx
Page 20
Version: 1 | Release date: 31 January 2022
3Safety in Handling
Ambistik PFT / Ambistik CPET 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 PFT / Ambistik
CPET 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 PFT / Ambistik CPET or the total
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 PFT /
Ambistik CPET. 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 total system!
•If you have any questions, ask your authorised
specialist retail partner!