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Dräger Infinity Delta Series - Classification of Device-Specific Components; Classification of Medical Devices; Classifications for Reprocessing

Dräger Infinity Delta Series
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Supplement for Infinity Delta Series Software
80 Supplement – Infinity
®
Delta Series Software VF10.1
Classifications for reprocessing
Classification of medical devices
Medical devices and their components are classified according to the way they are used and the resulting
risk.
Classification of device-specific components
Observe the instructions for use for the components.
The following classification is a recommendation from Dräger.
Non-critical
Delta series monitors
Semi-critical A
–N/A
Semi-critical B
–N/A
Critical
–N/A
Classification Explanation
Non-critical Components that come only into contact with skin that is intact
Semi-critical (A, B) Components that carry breathing gas or come into contact with mucous
membranes or pathologically altered skin
Critical (A, B, C) Components that penetrate skin or mucous membranes or come into contact with
blood

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