Classifications For Reprocessing; Reprocessing Procedures; Disinfectants - Dräger DigiFlow Instrucciones De Uso

Safety information
WARNING
Risk due to inappropriately reprocessed
products
Reusable products must be reprocessed,
otherwise there is an increased risk of infection.
– Observe the hygiene regulations and
reprocessing regulations of the healthcare
facility.
– Observe national hygiene regulations and
reprocessing regulations.
– Use validated procedures for reprocessing.
– Reprocess reusable products after every
use.
– Observe the manufacturer's instructions for
cleaning agents, disinfectants, and
reprocessing devices.
WARNING
Risk due to faulty products
Signs of wear, e.g., cracks, deformation, discol-
oration, or peeling, may occur with reprocessed
products.
Check the products for signs of wear and re-
place them if necessary.
Instructions for use DigiFlow

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 Explanation
Non-critical Components that come only into
contact with skin that is intact
Semi-critical Components that carry breathing
(A, B) gas or come into contact with
mucous membranes or
pathologically altered skin
Critical (A, B, Components that penetrate skin
C) or mucous membranes or come
into contact with blood
Classification DigiFlow
The following classification is a recommendation
from Dräger.
Non-critical

Reprocessing procedures

Validated reprocessing procedures
At the time of product-specific validation, the
following reprocessing procedures showed good
material compatibility and effectiveness:
Procedure Surface disinfection with
cleaning
Agent Dismozon pur
Manufacturer Bode Chemie
Concentration 1.5 %
Contact time
The effectiveness of the listed reprocessing
procedures has been validated by independent
laboratories that are certified to the standard
ISO 17025.

Disinfectants

Use disinfectants that are nationally approved and
are suitable for the particular reprocessing
procedure.
Surface disinfectant
At the time of the test, the surface disinfectants listed
in the following table showed good material
compatibility. They can be used in addition to the
surface disinfectants listed in the section "Validated
reprocessing procedures".
The manufacturers of the surface disinfectants have
verified at least the following spectra of activity:
– Bactericidal
– Yeasticidal
– Virucidal or virucidal against enveloped viruses
Observe the specifications of the surface disinfectant
manufacturers.
Other surface disinfectants are used at one's own
risk.
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