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.

English
6Reprocessing Fabius family
Information on reprocessing
Follow the national infection prevention policies
and reprocessing regulations.
Follow the infection prevention policies and
reprocessing regulations of the health-care facility
(e.g., concerning the reprocessing cycles).
CAUTION
Risk of patient injury due to failure of accessories
Disposable products have been designed, tested
and manufactured exclusively for single use. Re-
use, reprocessing or sterilization can result in fail-
ure of accessories and injury to the patient.
Do not reuse, reprocess, or sterilize disposable
products.

Reprocessing Fabius family 7
English
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 of device-specific components
Observe the instructions for use for the
components.
The following classification is a recommendation
from Dräger.
Critical
The device does not contain any components
classified as critical.
Non-critical
– Device surface including screen
– Trolley and holders
– Removable parts of the main device
Semi-critical
– Compact breathing system
–Housing
– Inspiratory valve
– Expiratory valve
– APL valve
– Exhaust port
– Rigid breathing bag arm (option)
– Flexible breathing bag arm (option)
– Absorber container and absorber insert
– Ventilator
– Ventilator lid
– Piston diaphragm
– Ventilator hose
– Screw cap for O2sensor housing
Classification Explanation
Non-critical Components that come into contact only with skin that is intact
Semi-critical Components that carry breathing gas or come into contact with mucous mem-
branes or pathologically altered skin
Critical Components that penetrate skin or mucous membranes or come into contact with
blood

English
8Reprocessing Fabius family
Before reprocessing
Observe before disassembly
1Switch off the device and all devices connected
to it.
2Disconnect all power plugs.
Disassembling and removing patient-specific accessories and consumables
The patient-specific accessories and consumables
must be removed from the device and, if necessary,
disassembled.
Reusable products:
If the reusable product has its own instructions
for use, perform reprocessing in accordance
with the separate instructions for use.
If no separate instructions for use are available
for the reusable product, perform reprocessing
in accordance with the instructions in this
supplement.
Disposable products:
Dispose of the disposable products.
Removing patient-specific accessories and
consumables
Remove the following accessories:
– Sample line
– Filter (option, not shown)
– Breathing hoses
– Breathing bag
Removing the sample line
Disconnect the sample line (A) from the water
trap (B) on the patient-gas measurement
module and on the Y-piece (C) and dispose of it.
Observe the instructions for use of the patient-
gas measurement module.
133
C
A
B
E
D

Reprocessing Fabius family 9
English
Removing the filter (option)
Remove the filter from the nozzle on the Y-piece
(C), the inspiratory port, or the expiratory port.
Removing the breathing hoses
Remove the breathing hoses (D) from the ports
on the compact breathing system.
Removing the breathing bag
Remove the breathing bag (E) and the hose.
WARNING
Risk of infection
Breathing gas which may contain infectious
agents flows through the sample line.
– If no bacteria filter is used between the
sample line and the patient, the sample
lines must not be reused and must be re-
placed after each patient.
– Observe the replacement interval of the
water trap.
CAUTION
Material damage due to disinfectants
When the sample line is disinfected and residue
of the agent remains in the sample line, this resi-
due can get into the water trap and the patient-gas
measurement module later. This may result in
faulty measurements.
Sample lines are disposable products. Dispos-
able products must not be disinfected.
049
CAUTION
Risk of insufficient ventilation due to damaged
breathing hoses
The breathing hoses can be damaged if not re-
moved properly.
Ambient air can enter the breathing gas or breath-
ing gas can escape as a result of leakages.
If the coil reinforcement of a breathing hose is
damaged, there is risk of kinking or occlusion.
– Attach or disconnect breathing hoses only at
the connection sleeves.
– Check the breathing hoses for damage before
each use.
– Do not use damaged breathing hoses.

English
10 Reprocessing Fabius family
Disassembling and removing device-specific components
The device-specific components must be removed
from the device and, if necessary, disassembled.
Remove the following accessories:
– Hoses and cables
–O2sensor
–CO2absorber
– CLIC adapter
– Breathing bag arm
– Exhaust port
– Flow sensor
– Compact breathing system
– Valve plate and sealing ring of the inspiratory
valve and expiratory valve
– APL valve
– Ventilator parts
– Anesthetic gas receiving system
Removing the hoses and cables
Before removing the compact breathing system,
the following hoses and cables must be removed
from the respective connectors on the breathing
system:
1Disconnect the pressure measuring line (A).
2Disconnect the flow sensor cable (B).
3Disconnect the PEEP/PMAX hose (C).
4Disconnect the APL bypass hose (D).
5Disconnect the O2sensor cable with the O2
sensor (E).
6Screw off the fresh-gas hose (F).
7Remove the ventilator hose (G) from the
connector on the compact breathing system
and from the connector on the device.
Disassembling the O2sensor
1Unscrew the screw cap (A) from the O2sensor
(B).
The O2sensor capsule (C) remains in the O2
sensor or is disposed of in accordance with
regulations.
117
B
A
C
D
E
118051
G
F
G
C
B
A