GERATHERM 455713, Instructions For Use Manual

Page: 5 / 103

Instructions for Use
Diffustik / Variant PFTstik
Serial no.: xx|8|401|yyy and 2401xxxxx
Version: 8 | Release date: 16. August 2021 Page 5
9.2.2 Flow Unit ...................................................................................... 79
9.2.3 Ergoflow / Flow Sensor................................................................. 80
9.2.4 Shutter System ............................................................................. 81
9.2.4.1 Shutter-Cage or Shutter Block ..................................................... 81
9.2.4.2 Shutter-Drive ................................................................................ 82
10 Fault Indication and Repair .................................................. 83
11 Decommissioning / Disposal ............................................... 85
11.1 Expected Service Life ................................................................... 85
11.2 Decommissioning ......................................................................... 85
11.3 Disposal ....................................................................................... 85
11.3.1 Transport Packaging .................................................................... 85
11.3.2 Diffustik / Variant PFTstik .............................................................. 85
11.3.3 Infectious / Contaminated Single Use Items ................................. 86
12 Technical Specifications ...................................................... 87
12.1 Technical Data .............................................................................. 87
12.2 Installation and Operating Conditions ........................................... 89
12.3 Electrical Safety Concept .............................................................. 90
12.3.1 Variant Diffustik with Medical Device Cart and Isolation Transformer
..................................................................................................... 90
12.3.2 Variant PFTstik with Medical Device Cart and Isolation Transformer91
12.4 Electromagnetic Compatibility / EMC Guidelines .......................... 92
12.4.1 Emitted Interference Guideline and Manufacturer Declaration ....... 92
12.4.2 Interference Resistance for all ME Systems Guideline and
Manufacturer Declaration ............................................................. 93
12.4.3 Interference Resistance for Non-Life-Supporting ME Systems
Guideline and Manufacturer Declaration ....................................... 94
12.4.4 Recommended Safety Distances for Non-Life-Supporting ME
Systems ....................................................................................... 97
13 Safety of Product and Material ............................................ 98
14 Product Labeling / Type Label ............................................. 99
15 Warranty and Service ......................................................... 100
15.1 General Conditions ..................................................................... 100
15.2 Warranty Exemption ................................................................... 100
15.3 Packaging and Shipping ............................................................. 101
16 Authorised Specialist Retail Partner .................................. 102
Attachment – Declaration of Conformity ............................ 103