Dräger Fabius GS SW 3.n Bedienungsanleitung

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

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

118051

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