medicap Precise 6000 MI Gebrauchsanweisung Seite 46

1 Introduction
1.1 Abbreviations
MD Medical Device
MDR Medical Device Regulation (2017/745)
ME Medical electrical equipment
1.2 How to use the Instructions for Use
Importance of the This Instructions for Use is part of the accompanying documents and therefore an
Instruction for Use essential part of the device. It contains all necessary instructions for operating the
device in accordance with Regulation (EU) 2017/745, Annex I: General safety and
performance requirements, Chapter III: Requirements regarding the information
supplied with the device.
The Instruction for Use must be read thoroughly before the device is put into operation.
The device may only be used by persons who have demonstrably been instructed in
its proper use.
Illustrations The illustrations used in the documents may differ from the original.
Changes Changes to the documents are made as new editions or supplementary sheets. In
general, the following applies: Subject to change.
Reproduction Reproduction, even in part, is only permitted with written approval.
1.3 Significance of warnings and notes
Warning
The signal word "Warning" alerts the user to a potentially hazardous situation which, if not avoided,
could result in death or serious injury.
Caution
The signal word "Caution" draws the user's attention to the fact that in case of failure to observe
this warning may result in personal injury, serious injury or damage to the device.
Note
The signal word "Note" draws the user's attention to the fact that the following effects are to be
expected in case of non-observance:
- Damage to the device may occur.
- Desired functions do not run or do not run correctly.
1.4 Brief description
The Précise 6000 Oxygen concentrator is an electronic device that is used to enrich the breathing air with
oxygen during oxygen inhalation therapy at home and in practices. The Précise 6000 MI / MSI generates
molecular oxygen that can be negatively ionised in the device.
Oxygen for medical purposes is a highly effective medicine. Oxygen inhalation therapy should therefore only be
carried out after a thorough medical examination.
The difference between the Précise 6000 MI and Précise MSI is the maximum flow rate:
Précise 6000 MI: 5 l/min
Précise 6000 MSI: 6 l/min
Précise 6000 MS / Précise 6000 MSI Rev.D 2024-10 46