Instructions for use DigiFlow
25
English
Safety information
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 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:
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.
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.
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
Procedure
Surface disinfection with
cleaning
Agent
Dismozon pur
Buraton 10 F
Manufacturer
Bode Chemie
Schülke &
Mayr
Concentration
1.5 %
1 %
Contact time
15 min
30 min
Содержание DigiFlow
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