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