draeger_reprocessing_and_preparation_of_devices_gui.pdf
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D-8994-2011
D-91140-2013
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Reprocessing and preparation of devices
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REPROCESSING AND PREPARATION OF DEVICES
Issued by:
Drägerwerk AG & Co. KGaA
Moislinger Allee 53-55
23558 Lübeck, Germany
www.draeger.com
Important note
Due to research and clinical experiences, medical expersise is subject
to constant change. The author of this book took care to assure that
views, opinions and assumptions expressed herein correspond to the
current state of knowledge, especially those with regard to application
and effect. This, however, does not absolve the reader from the responsibility for clinical measures. (08/2015)
All rights for this book, especially the copyright, are reserved to
Drägerwerk AG & Co. KGaA. It is prohibited to reproduce or store
the book or parts of it mechanically, electronicaly or photographically,
without prior written approval by Drägerwerk AG & Co. KGaA.
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Table of contents
1 Laws, standards and guidelines
8
2 Preparation methods for reusable medical products
2.1 Classification of medical products
2.2 Surface disinfection (for uncritical medical products)
2.3 Manual disinfection
2.4 Mechanical cleaning and thermal disinfection
2.5 Sterilisation using validated sterilisation methods
9
9
10
11
11
11
3 Anaesthesia Workstations
3.1 Fabius family
3.2 Perseus A500
3.3 Primus family
3.4 Zeus IE
13
13
21
27
33
4 Intensive care ventilators
4.1 Evita family / Savina 300
4.2 Carina
39
39
45
5 Neonatal workplace
49
6 Oxylog family
57
7 Patient monitoring
61
8 Workplace infrastructure
67
9 Further ward equipment
73
10 Accessories list
78
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REPROCESSING AND PREPARATION OF DEVICES
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Introduction
The importance of hygiene in the hospital has continuously grown
within the past years. Dräger as a manufacturer of medical technology,
contributes to this infection protection act.
To prevent nosocomial infections, it is essential to break the chain of
infection which can be realised, amongst other measures, through the
correct preparation of medical products.
All over the world the meaning of infection prevention standards has
tightened the guidelines regarding nosocomial infections.
Studies as “Microbial contamination of manually reprocessed, ready to
use ECG lead wire in intensive care units” by Lestari, Ryll und Kramer
(GMS Hygiene and Infection Control 2013, Vol. 8 (1) have proven
that even allegedly clean medical products can be contaminated with
germs.
This handbook serves as orientation for the respective preparation of
medical products by Dräger. It provides the user with an overview on
the preparation of individual components for each workstation.
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REPROCESSING AND PREPARATION OF DEVICES
Table of examples
DEVICES
Surface disinfection
Zeus range
Explanations
✓
Device can be surface
disinfected
Manual disinfection
/
Device cannot be
prepared manually
DEVICES COMPONENTS
Surface disinfection
Breathing system (APL valve)
Explanations
Breathing system
Explanations
✓
APL valve can be surface
disinfected
Manual disinfection
✓
APL valve can be
prepared manually
✓
/
Breathing system can be
surface disinfected
Breathing system cannot
be manually prepared
The table provides information whether a device/device component/
accessory can be (green check) surface disinfected, manually
prepared, prepared in the washer-disinfector (WD) or sterilised
or not (red line).
The current Instructions for Use remain unconditionally valid and are
not replaced by this handbook.
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Washer disinfector
Sterilisation
/
/
Device cannot be
prepared in the washerdisinfector (WD)
Device cannot
be sterilised
Washer disinfector
Sterilisation
✓
✓
APL valve can be
prepared in the washerdisinfector
✓
Breathing system can be
prepared in the washer-
disinfector
APL valve can
be sterilised
Disposable accessories
If available, disposable
accessories are listed
Disposable accessories
If available, disposable
accessories are listed
✓
Breathing system can
be sterilised
If available, disposable
accessories are listed
This overview can be used to validate and/or define intrahospital
hygiene guidelines and standards. Intrahospital hygiene guidelines and
standards remain valid and have priority.
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REPROCESSING AND PREPARATION OF DEVICES |
LAWS, STANDARDS AND GUIDELINES
1 Laws, standards and guidelines
The following laws, standards and guidelines must be orbserved for
the preparation of medical products:
– Medical Device Directive 93/42 EEC (06/1993)
– DIN EN ISO 17664 Sterilization of medical devices – Information to
be provided by the manufacturer for the processing of resterilizable
medical devices (07/2004)
– DIN EN ISO 15883 Washer-disinfectors (04/2014)
– DIN EN 285 Sterilisation (08/2009)
– Recommandations by other relevant, local institutions
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2 Preparation methods for resusable medical
products
Information on cleaning, disinfection and sterilisation of
reusable medical products and accessories.
2.1 CLASSIFICATION OF MEDICAL PRODUCTS
To define the preparation method, the medical products and their
components are classified according to their application and the
resulting risk:
1. Uncritical medical products:
Surfaces (e.g. device surface, cables) accessible by user and
patient
2. Semicritical medical products:
Breathing gas bearing parts, e.g. breathing hoses, masks
3. Critical medical products:
penetrating skin or mucous membranes
Notice
National legal regulations, national and international standards,
guidelines and applicable hygiene guidelines (see Point 1) must be
observed during preparation.
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REPROCESSING AND PREPARATION OF DEVICES |
PREPARATION METHODS FOR REUSABLE MEDICAL PRODUCTS
2.2 S URFACE DISINFECTION
(FOR UNCRITICAL MEDICAL PRODUCTS)
Manual cleaning with simultaneous surface disinfection.
The independent and ISO 17025 accredited Dräger TestCenter has
performed over 20,000 tests on the compatibility of all common
disinfectant groups with regard to material groups of medical
technology used worldwide. Based on these studies, in Instructions
for Use dated before April 2015 for medical products which are
maufactured by Dräger, the specifications on surface disinfectants as
well as general recommendations on substance groups are replaced
by the following:
– Descogen liquid, Descogen liquid r.f.u. by Antiseptica
– Dismozon pur/Dismozon plus by Bode Chemie
– Mikrozid sensitive by Schülke
– Perform by Schülke
– Virkon by DuPont
– Actichlor plus by Ecolab
– Klorsept 17 by Medentech
– Oxycide by Ecolab USA
– BruTab 6S by Brulin
– Buraton by Schülke
These surface disinfectants have been material compatible at the
moment of validation (July 2015). Their manufacturer-tested
effectiveness covers bacteria (bactericidal), candida (yeasticidal) and
viruses (virucidal or limited virucidal). When using these products to its
intended use on surfaces of Dräger devices, the material compatibility
as well as the required germ spectrum are covered.
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Using tested agents which are suitable for the entire workstation for
your Dräger products improves the safety of your patient and
workstation and also protects your investment in medical technology.
2.3 MANUAL DISINFECTION
Cleaning/disinfection of reusable semicritical medical products.
Perform the manual disinfection according to the respective
Instructions of Use of the individual product.
2.4 MECHANICAL CLEANING AND THERMAL DISINFECTION
Perform the mechanical cleaning and thermal disinfection in
a washer-disinfector according to the respective Instructions for Use
until the required A0 value is reached.
Dwell time
minutes
Temperature
°C
A0 value
seconds
100
6.000
70
600
10
600
80
600
1
60
90
600
50
3.000
80
3.000
5
300
90
3.000
2.5 STERILISATION USING VALIDATED STERILISATION METHODS
Perform the sterilisation according to the respective Instructions for
Use.
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REPROCESSING AND PREPARATION OF DEVICES |
ANAESTHESIA WORKSTATIONS
NOTES
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3 Anaesthesia workstations
D-75695-2013
3.1 FABIUS FAMILY
This handbook does not replace the currently valid Instructions for Use
which remain valid, without restriction.
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REPROCESSING AND PREPARATION OF DEVICES |
ANAESTHESIA WORKSTATIONS
DEVICES
Surface disinfection
Manual disinfection
Fabius Family
✓
/
Infinity C500/C700
✓
/
✓
/
✓
/
✓
/
Infinity Delta/Delta XL/
Kappa/Gamma/GammaXL
Infinity M540/M500/PS250
Vamos Gas monitor and
Scio Gas module
This handbook does not replace the currently valid Instructions for Use
which remain valid, without restriction.
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Washer disinfector
Sterilisation
/
/
/
/
/
/
/
/
/
/
Disposable accessories
This handbook does not replace the currently valid Instructions for Use
which remain valid, without restriction.
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REPROCESSING AND PREPARATION OF DEVICES |
ANAESTHESIA WORKSTATIONS
DEVICE COMPONENTS
Compact breathing system
COSY
(APL valve)
Compact breathing system
COSY
Ventilator diaphragm
(Rolling diaphragm)
Surface disinfection
Manual disinfection
✓
✓
✓
✓
/
✓
Ventilator lid
/
✓
Vapor 2000/3000
✓
/
Anaesthetic gas suction AGS
(Flow tube)
✓
✓
Anaesthetic gas suction AGS
incl. transfer hoses
✓
✓
Bronchial suction vacuum
regulator/suction ejector
✓
✓
✓
✓
Suction container, lid and
silicone connecting hose
(lid omitted when using
VacuSmart/VacuSmart GEL)
Flow senor: Spirolife
/
✓
Flow sensor: Spirolog
/
✓
This handbook does not replace the currently valid Instructions for Use
which remain valid, without restriction.
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Washer disinfector
Sterilisation
✓
✓
✓
✓
✓
✓
✓
✓
/
/
/
/
✓
/
/
/
✓
✓
/
✓
/
/
Disposable accessories
Particle filter AGS
See current Accessories list
on page 78
Particle filter AGS
See current Accessories list
on page 78
Filter for suction
See current Accessories list
on page 78
VacuSmart/VacuSmart GEL;
Suction hose with Fingertip
See current Accessories list
on page 78
This handbook does not replace the currently valid Instructions for Use
which remain valid, without restriction.
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REPROCESSING AND PREPARATION OF DEVICES |
ANAESTHESIA WORKSTATIONS
DEVICE OPTIONS
Clic Sodalime
(Contact surface)
Absorber
(Contact surface)
Silicone masks
Hose systems with
breathing bag and connectors
(Contact surface)
Water trap, Waterlock2/
Waterlock ID
(Contact surface)
Blood pressure cuffs and
blood pressure hose
ECG cable /MultiMed
core cable
Temperature sensor
SpO2 sensor
Connection cable, sensors
Surface disinfection
Manual disinfection
✓
/
✓
✓
/
✓
✓
/
✓
/
✓
/
✓
/
✓
✓
✓
/
✓
/
Self Test lung (MP02400)
(blue plastic cover)
✓
/
Self Test lung (MP02400)
✓
✓
Flowmeter O2
✓
/
This handbook does not replace the currently valid Instructions for Use
which remain valid, without restriction.
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Washer disinfector
Sterilisation
Disposable accessories
See current Accessories list
on page 78 No. 9052629
✓
✓
✓
✓
✓
✓
✓
/
See current Accessories list
on page 78 No. 9052629
See current Accessories list
on page 78 No. 9052629
/
/
See current Accessories list
on page 78 No. 9052629
/
/
/
/
/
/
/
/
/
/
/
/
✓
✓
/
/
See current Accessories list
on page 78
See current Accessories list
on page 78
See current Accessories list
on page 78
See current Accessories list
on page 78
See current Accessories list
on page 78
This handbook does not replace the currently valid Instructions for Use
which remain valid, without restriction.
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REPROCESSING AND PREPARATION OF DEVICES |
ANAESTHESIA WORKSTATIONS
NOTES
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D-6833-2011
3.2 PERSEUS A500
This handbook does not replace the currently valid Instructions for Use
which remain valid, without restriction.
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REPROCESSING AND PREPARATION OF DEVICES |
ANAESTHESIA WORKSTATIONS
DEVICES
Surface disinfection
Manual disinfection
Perseus A500
✓
/
Infinity C500/C700
✓
/
✓
/
✓
/
Infinity Delta/Delta XL/
Kappa/Gamma/GammaXL
Infinity M540/M500/PS250
DEVICE COMPONENTS
Surface disinfection
Manual disinfection
Breathing system (APL valve)
✓
✓
Breathing system
✓
✓
Ventilator unit, TurboVent 2
only the outside
/
Vapor 2000/3000
✓
/
Bronchial suction
/suction ejector
✓
/
✓
✓
Suction container, lid and
silicone connecting hose
(lid omitted when using
VacuSmart/VacuSmart GEL)
Flow senor: Spirolife
/
✓
Flow sensor: Spirolog
/
✓
This handbook does not replace the currently valid Instructions for Use
which remain valid, without restriction.
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Washer disinfector
Sterilisation
/
/
/
/
/
/
/
/
Washer Disinfector
Sterilisation
✓
✓
✓
✓
/
✓
/
/
/
/
✓
✓
/
✓
/
/
Disposable accessories
Disposable accessories
Filter for suction
See current Accessories list
on page 78
VacuSmart/VacuSmart GEL;
Suction hose with Fingertip
See current Accessories list
on page 78
This handbook does not replace the currently valid Instructions for Use
which remain valid, without restriction.
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REPROCESSING AND PREPARATION OF DEVICES |
ANAESTHESIA WORKSTATIONS
DEVICE OPTIONS
Clic Sodalime
(Contact surface)
Absorber
(Contact surface)
Silicone masks
Hose systems with
breathing bag and connectors
(contact surface)
Water trap, Waterlock2/
Waterlock ID (Contact
surface)
Blood pressure cuffs and
blood pressure hose
ECG cable /MultiMed
core cable
Temperature sensor
SpO2 sensor
Connection cable, sensors
Surface disinfection
Manual disinfection
✓
/
✓
✓
/
✓
✓
/
✓
/
✓
/
✓
/
✓
✓
✓
/
✓
/
Self Test lung (MP02400)
(blue plastic cover)
✓
/
Self Test lung (MP02400)
✓
✓
This handbook does not replace the currently valid Instructions for Use
which remain valid, without restriction.
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Washer disinfector
Sterilisation
Disposable accessories
See current Accessories list
on page 78
✓
✓
✓
✓
✓
✓
✓
/
See current Accessories list
on page 78
See current Accessories list
on page 78
/
/
See current Accessories list
on page 78
/
/
/
/
/
/
/
/
/
/
/
/
✓
✓
See current Accessories list
on page 78
See current Accessories list
on page 78
See current Accessories list
on page 78
See current Accessories list
on page 78
See current Accessories list
on page 78
This handbook does not replace the currently valid Instructions for Use
which remain valid, without restriction.