Dräger Fabius GS SW 3.n User manual

Reprocessing
Fabius family
Anesthesia workstation
Software 3.n
WARNING
To properly use this medical device,
read and comply with the instructions
for use and this supplement.

Contents
2Reprocessing Fabius family
Contents
Supplement to the instructions for use . . . . 3
Information about this document . . . . . . . . . 3
Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . 5
Safety information . . . . . . . . . . . . . . . . . . . . . . 6
Correct reprocessing . . . . . . . . . . . . . . . . . 6
Information on reprocessing. . . . . . . . . . . . . . . 7
Classifications for reprocessing . . . . . . . . . . . . 8
Classification of medical devices . . . . . . . . 8
Classification of device-specific
components . . . . . . . . . . . . . . . . . . . . . . . . 8
Before reprocessing . . . . . . . . . . . . . . . . . . . . . 9
Disassembling and removing patient-
specific accessories and consumables. . . . 9
Disassembling and removing device-
specific components . . . . . . . . . . . . . . . . . . 11
Validated reprocessing procedures . . . . . . . . . 17
Overview of the reprocessing
procedures of the components . . . . . . . . . . 17
Surface disinfection with cleaning. . . . . . . . 18
Machine cleaning with thermal
disinfection . . . . . . . . . . . . . . . . . . . . . . . . . 19
Positioning the components in the load
carrier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Performing reprocessing. . . . . . . . . . . . . . . 24
Storage and transport . . . . . . . . . . . . . . . . . 24
Other agents and reprocessing procedures . . . 25
Disinfectants . . . . . . . . . . . . . . . . . . . . . . . . 25
Reprocessing procedures. . . . . . . . . . . . . . 27
After reprocessing . . . . . . . . . . . . . . . . . . . . . . 28
Assembling and fitting device-specific
components . . . . . . . . . . . . . . . . . . . . . . . . 28
Preparation before next use of device . . . . . . . 35
Assembling and fitting patient-specific
accessories and consumables . . . . . . . . . . 35

Reprocessing Fabius family 3
English
Reprocessing Fabius family en English
Supplement to the instructions for use
Keep this supplement with the instructions for
use.
This supplement updates the information on
reprocessing the anesthesia machine in the
following chapters of all instructions for use and
supplements for the Fabius Family:
Information about this document
Trademarks
The following trademarks have been added or replace existing
trademarks.
Trademarks owned by Dräger
The following web page provides a list of the
countries in which the trademarks are registered:
www.draeger.com/trademarks
Trademarks owned by third-party
manufacturers
Instructions for use Part number Edition
Fabius Tiro SW 3.n 9054601 1 – 2014-06 and higher
Fabius GS premium SW 3.n 9054626 1 – 2014-06 and higher
Fabius MRI SW 3.n 9054649 1 – 2014-06 and higher
Fabius plus SW 3.n 9054673 1 – 2014-06 and higher
Fabius plus XL SW 3.n 9054695 1 – 2015-04 and higher
NOTE
The names of the chapters in the referenced doc-
uments may differ.
Trademark
WaterLock®
Trademark Trademark owner
Dismozon®BODE Chemie
Mikrobac®
neodisher
MediClean®
Dr. Weigert

English
4Reprocessing Fabius family
acryl-des®Schülke & Mayr
Mikrozid®
Perform®
Actichlor®Ecolab USA
Incidin®
Oxycide®
Sekusept®aktiv
BruTab 6S®Brulin
Dispatch®Clorox
Klorsept®Medentech
Descogen®Antiseptica
Oxygenon®
SteriMax®Aseptix
Cleanisept®Dr. Schumacher
Trademark Trademark owner

Reprocessing Fabius family 5
English
Reprocessing
Safety information
Correct reprocessing
WARNING
Risk due to improperly reprocessed products
Reusable products must be reprocessed, oth-
erwise there is an increased risk of infection.
– Follow the infection prevention policies
and reprocessing regulations of the
health-care facility.
– Follow the national infection prevention
policies and reprocessing regulations.
– Use validated procedures for reprocess-
ing.
– Reprocess reusable products after every
use.
– Follow the manufacturer's instructions for
cleaning agents, disinfectants, and repro-
cessing devices.
CAUTION
Risk due to faulty products
Signs of wear, e.g., cracks, deformation, discolor-
ation, or peeling, may occur with reprocessed
products.
Check the products for signs of wear. Replace
them if necessary.
WARNING
Risk of failure of flow measurement
Improper reprocessing and soiling, such as
deposits or particles, can damage the flow
sensor:
– No machine cleaning or disinfection of the
sensor insert
– No plasma sterilization or radiation steril-
ization
– No water jets, compressed air, brushes or
the like when cleaning the sensor insert
– No ultrasonic bath
– Clean and disinfect the flow sensor in ac-
cordance with the corresponding instruc-
tions for use.
– For disinfecting the flow sensor use only
clean disinfectant solutions.
WARNING
Risk of fire
Residual vapors of easily flammable disinfec-
tants (e.g., alcohols) and deposits that were
not removed during reprocessing can ignite
when the flow sensor is in use.
– Ensure particle-free cleaning and disinfec-
tion.
– After disinfection, allow the flow sensor to
air for at least 30 minutes.
– Before inserting the flow sensor check for
visible damage and soiling, such as resid-
ual mucus, medication aerosols, and parti-
cles.
– Replace flow sensors when damaged,
soiled, or not particlefree.