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Classifications for reprocessing
Classification of medical devices
The classification depends on the intended use of
the medical device. The risk of infection transmission
through the application of the product to the patient
without proper reprocessing is the basis of the
Spaulding classification.
Classification
Explanation
Non-critical
Components that come into con-
tact only with skin that is intact
Semi-critical
Components that carry breath-
ing gas or come into contact with
mucous membranes or patho-
logically altered skin
Critical
Components that penetrate skin
or mucous membranes or come
into contact with blood
Categorization and classification
The following classification is a recommendation
from Dräger.
Category
Classification
Part number
Pressure
Non-critical
See order list,
reducer
"Pressure reduc-
ers" on page 31
Connec-
Non-critical
See order list, "Con-
tion hose
nection hoses"
on page 31
Before reprocessing
The patient-specific accessories and consumables
must be removed from the device and, if necessary,
disassembled.
24
Reprocess the reusable products in accordance
with the instructions given in these instructions
for use.
Dispose of the disposable products.
Disassembly
Seal the inlet port and the outlet port with protec-
tion caps when the pressure reducer is not con-
nected.
Validated reprocessing procedures
Overview of the reprocessing procedures of the
components
Category
Surface
Manual
Machine
disinfec-
clean-
clean-
tion with
ing fol-
ing with
cleaning
lowed by
thermal
disinfec-
disinfec-
tion by
tion
immer-
sion
Pressure re-
Yes
No
No
ducer
Connection
Yes
No
No
hose
Surface disinfection with cleaning
Surface
Manufac-
Concentra-
disinfec-
turer
tion
tant
Dismozon
BODE Che-
1.6 %
plus
mie
Prerequisites:
–
The surface disinfectant has been prepared in
accordance with the manufacturer's instructions.
–
The manufacturer's instructions, e.g., regarding
shelf life or application conditions, are observed.
–
An uncontaminated, lint-free cloth soaked in sur-
face disinfectant is used for the cleaning surface
disinfection.
WARNING
Risk due to penetrating liquid
Penetrating liquid may cause the following:
–
Damage to the device
–
Device malfunctions
Ensure that no liquid penetrates the device.
Cleaning
1
Wipe off obvious soiling with a disposable cloth
Steam
soaked in surface disinfectant. Dispose of the
steril-
cloth.
ization
2
Wipe all surfaces. After that, there must no lon-
ger be any soiling visible.
Surface disinfection
3
Wipe cleaned surfaces again to visibly wet all
surfaces to be disinfected with surface disinfec-
No
tant.
4
Wait for the surface disinfectant contact time.
No
5
At the end of the contact time, moisten a new, un-
contaminated and lint-free cloth with water (at
least drinking water quality).
6
Wipe all surfaces until no remains of the surface
Contact
disinfectant, such as foam residues or streaks,
time
are visible.
7
Wait until the surfaces are dry.
15 min
8
Check the surfaces for visible damage and, if
necessary, replace the product.
Instructions for use SilverLine