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
Page 8
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.