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
Page 4
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