Reprocessing and Preparation Handbook of Devices Ver 3.0 Sept 2018.pdf
Page 1
D-46343-2012
D-9107—2011
D-7323-2011
Handbook on the preparation of devices
and accessories
Version 3.0
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Visit ou ic of hygiene:
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on the to ger.com/hygie
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www.d
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2|
HANDBOOK ON THE PREPARATION OF DEVICES AND ACCESSORIES
Publisher:
Drägerwerk AG & Co. KGaA
Moislinger Allee 53–55
23558 Lübeck, Germany
www.draeger.com
Important information
Thanks to research and clinical experience, specialist
medical knowledge is subject to constant change.
The author of this book wanted to be sure that the opinions,
viewpoints and assumptions represented here, especially
those referring to applications and effects, correspond
to the current state of knowledge. However, this does not
absolve readers from their obligation to take responsibility
for clinical measures.
Status: September 2018
All rights to this book, especially the right to reproduction
and copying, lie with Drägerwerk AG & Co. KGaA. No
part of this book may be mechanically, electronically or
photographically reproduced without the prior written
consent of Drägerwerk AG & Co. KGaA.
Page 3
|3
Table of contents
1
Laws, standards and guidelines
5
2
Our contribution to hospital hygiene
5
3
Preparation process for reusable medical devices
6
3.2 Surface disinfection (for non-critical medical devices)
8
3.1 Classification of medical devices
3.3 Manual preparation
3.4 Mechanical cleaning and thermal disinfection
3.5 Sterilisation using a validated sterilisation process
4
5
6
7
8
9
10
11
12
6
8
8
8
Workplace anaesthesia
4.1 Fabius family
4.2 Perseus
4.3 Primus & Pallas
4.4 Zeus / Zeus IE
10
Workplace intensive-care
5.1 Evita family / Savina 300
5.2 Carina
18
Workplace neonatology
Accident & Emergency department
Patient monitoring
Workplace infrastructure
Further ward equipment
Lists of accessories
Notes
10
12
14
16
18
20
22
24
26
28
30
32
33
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HANDBOOK ON PREPARATION OF DEVICES AND ACCESSORIES |
PREFACE
Preface
The importance of hygiene in hospitals has continuously
grown in recent years. Dräger as a manufacturer in the
field of medical technology makes its contribution with
regard to the German Infection Protection Act.
In order to be able to prevent nosocomial infections
it is vital that the chain of infection be broken.
Alongside other measures, this can be achieved
through the correct preparation of medical devices.
The federal government has also recognised the importance
of hygiene standards, and with the change in the German
Infection Protection Act in 2011, they have tightened
up on the regulations regarding nosocomial infections.
Studies such as ‘Bakterielle Kontamination
manuell aufbereiteter EKG-Anschlussklemmen auf
Intensivtherapiestationen’ [Bacterial contamination
of manually prepared ECG electrodes on intensive
care wards] by Lestari, Ryll and Kramer (GMS Hygiene
and Infection Control 2013, Vol. 8) have, however,
shown that even supposedly clean medical devices
can be laden with germs.
The handbook provides orientation regarding the
relevant preparation of Dräger medical devices. It gives
users at every workplace an overview of preparation
of the individual components.
New in!
Further documents on the subject
of hygiene, e.g. the handbook
on preparation of anaesthesia
devices or preparation posters
for Dräger devices, are to be
found in our hygiene library at:
WWW.DRAEGER.COM/HYGIENE
Page 5
|5
1 Laws, standards and guidelines
In the preparation of medical devices, the following laws,
standards and guidelines should be observed:
– Council directive 93/42EEC (06/1993) concerning
medical devices
– DIN EN ISO 17664 Sterilisation of medical devices
– Information to be provided by the manufacturer on the
preparation of reusable medical devices (07/2004)
– German Commission for Hospital Hygiene and
Prevention of Infection (KRINKO) and Robert Koch
Institute (RKI) recommendation on preparation
of medical devices (10/2012)
– DIN EN ISO 15883 Cleaning/disinfecting devices (04/2014)
– DIN EN 285 Sterilisation (08/2009)
– German Society for Sterile Supply (DGSV) recommendation
on classification of medical devices (in accordance with
manufacturer’s specifications) (01/2013)
– Joint recommendation by the German Society of
Anaesthesiology and Intensive Care Medicine (DGAI)
and the German Society of Hospital Hygiene (DGKH)
on prevention of infection in anaesthesia ventilation through
use of respiratory-system filters (10/2010)
– Medical Devices Operator Ordinance (MPBetreibV) (2017)
2 Our contribution to hospital hygiene
Dräger sees itself as a system provider for medical devices
and thus also as a partner in everyday hospital operation.
The ultimate goal is to create maximum patient safety and
user safety – on the one hand through products and
solutions and on the other through services and our
expertise in the field of hygiene.
On the basis of the German Infection Protection Act,
each German land has prepared and issued an ‘Ordinance
on Hygiene and Prevention of Infection in Medical Facilities’
(MedHygVO). An emphasis of MedHygVO is the formation
of a hygiene commission with clearly defined members,
duties and obligations. One of the duties of the hygiene
commissions is the creation of hygiene plans. An important
component here is the creation of a workplace-related
hygiene plan.
Dräger supports you in the creation of hygiene plans and
preparation concepts concerning Dräger workplaces.
The basis for this is advice, taking into consideration
current legal specifications, principles, guidelines and
recommendations. The aim is to create a preparation
standard with defined disinfection measures and change
intervals with regard to the workplace, taking into
consideration device-specific accessories, patient-specific
accessories, compatibility, biocompatibility and material
compatibility. Dräger accompanies its work group in the
optimisation of in-house preparation processes through
analysis of the individual requirements and conditions, and
supports you in the creation and validation of new processes.
Please get in touch with us: www.draeger.com/hygiene.
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HANDBOOK ON PREPARATION OF DEVICES AND ACCESSORIES |
PREPARATION PROCESS FOR REUSABLE MEDICAL DEVICES
3 Preparation process for reusable medical devices
Information regarding cleaning, disinfection
and sterilisation of reusable medical devices and
accessories
3.1 CLASSIFICATION OF MEDICAL DEVICES
For preparation, the medical devices and their components
are divided up in accordance with the type of application
and the resultant risk:
1. Non-critical medical devices:
Surfaces accessible to the user and the patient,
e.g. Equipment surfaces, cables
2. Semi-critical medical device:
Parts conveying respiratory gas,
e.g. Breathing tubes, masks
3. Critical medical devices:
Penetrating skin or mucosa
NB
Adhere to national legal provisions, national and
international standards, guidelines and the applicable
hygiene regulations (Chap. 1) on preparation.
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|7
German Society for Sterile Supply (DGSV) flow diagram for classification of medical devices 2013
Medical device
Preparation taking into account the manufacturer’s
specifications (*1) by expert staff (*2)
Avoid contact with
broken skin?
Contact with mucosa
or pathologically
changed skin?
Skin or mucosa
penetration? (*3)
Yes
Yes
Yes
Non-critical
medical device
Semicritical
medical device
Critical medical device
Group A, B or C
Cleaning/disinfection
See
p. 2
Are cavities or hard-to-reach
parts available? (*6) and/or
Are the function and safety of the
medical-device-influencing effects
of preparation available? and/or
Is the number of preparation
cycles restricted?
Semicritical A
Without special
preparation requirements
Semicritical B
Yes
No
With more stringent
preparation requirements
Non-fixing preliminary
cleaning after use (*4)
Non-fixing preliminary
cleaning as necessary (*4)
Preferably mechanical
cleaning (preferably
alkaline) and thermal
disinfection
Preferably mechanical
cleaning (preferably
alkaline) and thermal
disinfection
Chemical disinfectants/
processes must be
bactericidal, fungicidal and
virucidal (DVV/RKI guideline)
Testing for cleanliness,
reliability, care
Testing for cleanliness,
reliability, care
Testing of technical/
functional safety
(functional inspection)
Testing of technical/
functional safety
(functional inspection)
Is the medical device
to be used sterilised?
Is the medical device
to be used sterilised
or in sterile areas
of the body?
No
Packaging (protection
against contamination/
dust protection [*5])
Yes
No
Packaging (sterile-barrier
system and where necessary
protective packaging)
Packaging (protection
against contamination/
dust protection [*5])
Sterilisation always
with humid heat
Labelling ‘Disinfected’
Labelling ‘Sterile’
Yes
Packaging (sterile-barrier
system and where necessary
protective packaging)
Sterilisation always
with humid heat
Labelling ‘Disinfected’
Labelling ‘Sterile’
D-19662-2015
Release document for use
Created on the basis of the Commission for Hospital Hygiene and Infection
Protection (KRINKO)/Federal Institute for Drugs and Medical Devices (BfArM)
recommendation regarding ‘Hygiene requirements in the preparation of medical
devices’ Federal Health Bulletin 2012; 55:1244–1310
© Copyright by
FA Qualität
January 2013
Fig. 1: German Society for Sterile Supply’s (DGSV) flow diagram on classification of medical devices; Central sterilisation 1/2013, p. 67
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HANDBOOK ON PREPARATION OF DEVICES AND ACCESSORIES |
PREPARATION PROCESS FOR REUSABLE MEDICAL DEVICES
3.2 SURFACE DISINFECTION
(FOR NON-CRITICAL MEDICAL DEVICES)
Manual cleaning with simultaneous disinfection of surfaces.
The processes and disinfectants for individual Dräger
devices are listed and described in the instructions for use.
Beyond this, the independent and ISO 17025-accredited
Dräger TestCenter has carried out over 20,000 tests on the
tolerability of all the common groups of disinfectants
involving the groups of materials used worldwide in medical
technology. Based on these test standards, for its devices
Dräger can recommend various disinfectants for preparation:
– Dismozon® pur/Dismozon® plus (Bode Chemie)
– Descogen® liquid/Descogen® liquid r.f.u. combined
with A-Wipes® (Antiseptic)
– Descogen® OxyWipes (Antiseptic)
– Perform® (Schülke & Mayr)
– Mikrozid® sensitive liquid combined with Mikrozid®
sensitive Wipes (Schülke & Mayr), (partially virucidal)
– Incidin® OxyWipe (Ecolab), (partially virucidal)
– Cleanisept® Wipes Maxi (Dr. Schumacher),
(partially virucidal)
At the time of validation (September 2018) these surface
disinfectants displayed material compatibility. Their range
of effects (as tested by the manufacturer) include: bacteria
(bactericidal), yeast fungi (levurocidal) and viruses (virucidal
or partially virucidal). With appropriate use of these agents
on surfaces of Dräger devices, material compatibility
is ensured and the requisite range of germs is covered.
Use of tested agents that are suitable for the entire workplace
for your Dräger devices increases patient and workplace
safety and protects your investments in medical technology.
3.3 MANUAL PREPARATION
Cleaning/disinfecting of reusable semi-critical
medical devices.
Carry out manual preparation in accordance with the
applicable instructions for use of the individual product.
3.4 MECHANICAL CLEANING AND THERMAL
DISINFECTION
Please carry out mechanical cleaning and thermal disinfection
on the (cleaning-disinfecting) devices in accordance with the
relevant instructions for use up to the requisite A0 value.
Hold time
Minutes
100
10
1
50
5
Seconds
6,000
600
60
3,000
300
Temperature
°C
70
80
90
80
90
A0 value
600
600
600
3,000
3,000
3.5 STERILISATION USING A VALIDATED
STERILISATION PROCESS
Carry out sterilisation in accordance with the relevant
instructions for use. According to RKI and DGSV
recommendations, the sterilisation of semi-critical medical
devices is optional – see DGSV flow diagram on p. 7.
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|9
Table of examples
DEVICES
Zeus family
Clarification
Surface disinfection
✓
Device can be
surface-disinfected
Manual preparation
/
Device cannot be
manually prepared
CDD
/
Device cannot be
prepared in the CDD
Sterilisation
Disposable accessories
Device cannot be
sterilised
If available, disposable
accessories are specified
Disposable accessories
/
DEVICE COMPONENTS
Respiratory system (APL valve)
Clarification
Respiratory system
Clarification
Surface disinfection
Manual preparation
CDD
Sterilisation
✓
✓
✓
✓
APL valve can be
surface-disinfected
✓
Respiratory system
can be surfacedisinfected
APL valve can be
manually prepared
APL valve can be
prepared in the CDD
Respiratory system
cannot be manually
prepared
Respiratory system
can be prepared in
the CDD
/
The table provides information on whether a device/device
component/accessory can be surface-disinfected, manually
prepared, prepared in the cleaning and disinfection device
(CDD) or sterilised (green tick) or not (red bar).
The applicable instructions for use remain unrestrictedly valid.
The handbook does not replace them.
✓
APL valve can be
sterilised
If available, disposable
accessories are specified
✓
Respiratory system
can be sterilised
If available, disposable
accessories are specified
This overview can be used to check and/or establish
in-house hospital hygiene guidelines and standards.
In-house hospital hygiene guidelines and standards
remain valid and are to take precedence.
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HANDBOOK ON PREPARATION OF DEVICES AND ACCESSORIES |
WORKPLACE ANAESTHESIA
4 Workplace anaesthesia
D-75695-2013
4.1 FABIUS FAMILY
This handbook does not replace the current instructions for use.
They remain fully valid.
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| 11
DEVICES
Manual preparation
CDD
Sterilisation
✓
/
/
/
✓
/
/
/
✓
/
/
/
✓
/
/
/
Surface disinfection
Manual preparation
CDD
Sterilisation
✓
✓
✓
✓
✓
✓
✓
✓
/
✓
✓
✓
/
✓
✓
✓
✓
✓
/
/
AGS particle filter, list of
accessories No. see p. 32
✓
✓
✓
/
AGS particle filter, list of
accessories No. see p. 32
✓
✓
/
/
Suction container, lid and silicone
connecting tube (no lid when
using VacuSmart/VacuSmart GEL)
Filter for suction list of
accessories No. see p. 32
✓
✓
✓
✓
/
✓
/
/
✓
Flow sensor: Spirolog
/
/
Fabius family
Infinity C500/C700
Infinity Delta/Delta XL/Kappa/
Gamma/GammaXL
Infinity M540/M500/PS250
Vamos gas monitor and Scio
gas module
Surface disinfection
✓
/
/
/
Disposable accessories
DEVICE COMPONENTS
COSY Compact respiratory
system (APL-valve)
Compact respiratory system (COSY)
Ventilator membrane
(roller membrane)
Ventilator lid
Anaesthetic gas suction AGS
(flow tubes)
Anaesthetic gas suction (AGS)
incl. Transfer tubes, without flow
tubes and filters
Bronchial suction vacuum
regulator/suction ejector
Flow sensor: SpiroLife
Vapor 2000
✓
✓
/
Surface disinfection
Manual preparation
/
/
CDD
Sterilisation
✓
✓
Disposable accessories
VacuSmart/VacuSmart GEL;
Suction tube with finger tap, list
of accessories No. see p. 32
DEVICE OPTIONS
✓
/
✓
/
/
/
✓
✓
✓
✓
/
✓
✓
✓
✓
✓
✓
✓
✓
/
/
/
✓
/
/
/
ECG cable/MultiMed master cable
✓
/
/
/
Temperature sensor
✓
✓
/
/
SpO2 Sensor
✓
/
/
/
Connecting cable sensor system
✓
/
/
/
Self Test Lung (MP02400)
(blue plastic cover)
✓
/
/
/
✓
✓
✓
✓
O2 Flowmeter
✓
/
/
/
CLIC adapter
CLIC soda lime cartridge
(contact surfaces)
Absorber pot with insert
(contact surfaces)
Silicone masks
Tube systems with breathing bag
and connectors (contact surfaces)
Water trap, WaterLock2/WaterLock
ID (contact surfaces)
Blood-pressure cuff and
blood-pressure tube
Self Test Lung (MP02400)
This handbook does not replace the current instructions for use.
They remain fully valid.
Disposable accessories
List of accessories No.
see p. 32
List of accessories No. see p. 32
List of accessories No.
see p. 32
List of accessories No.
see p. 32
available – see current lists
of accessories
available – see current lists
of accessories
available – see current lists
of accessories
available – see current lists
of accessories
available – see current lists
of accessories
Page 12
12 |
HANDBOOK ON PREPARATION OF DEVICES AND ACCESSORIES |
WORKPLACE ANAESTHESIA
D-6833-2011
4.2 PERSEUS
This handbook does not replace the current instructions for use.
They remain fully valid.
Page 13
| 13
DEVICES
Perseus
Infinity C500/C700
Infinity Delta/Delta XL/
Kappa/Gamma/GammaXL
Infinity M540/M500/PS250
Surface disinfection
Manual preparation
CDD
Sterilisation
✓
/
/
/
✓
/
/
/
✓
/
/
/
Surface disinfection
Manual preparation
CDD
Sterilisation
✓
✓
✓
✓
✓
/
/
/
Disposable accessories
DEVICE COMPONENTS
Respiratory system (APL valve)
Respiratory system
✓
✓
✓
✓
only outside
✓
/
✓
✓
/
/
/
Suction container, lid and
silicone connecting tube
(no lid when using
VacuSmart/VacuSmart GEL)
✓
✓
✓
✓
/
✓
/
/
✓
Flow sensor: Spirolog
/
/
TurboVent 2 ventilator unit
Bronchial suction
Suction ejector
Flow sensor: SpiroLife
Vapor 2000/3000
✓
✓
/
Surface disinfection
Manual preparation
/
/
CDD
Sterilisation
✓
✓
Disposable accessories
Filter for suction – see list
of accessories No. 9052629
VacuSmart/VacuSmart GEL;
Suction tube with finger tap,
see list of accessories
No. 9052629
DEVICE OPTIONS
Disposable accessories
✓
/
✓
/
/
/
✓
✓
✓
✓
/
✓
✓
✓
see list of accessories
No. 9052629
✓
✓
✓
✓
see list of accessories
No. 9052629
✓
/
/
/
see list of accessories
No. 9052629
✓
/
/
/
✓
/
/
/
Temperature sensor
✓
✓
/
/
SpO2 Sensor
✓
/
/
/
✓
/
/
/
✓
/
/
/
✓
✓
✓
✓
CLIC adapter
CLIC soda lime cartridge
(contact surfaces)
Absorber pot with insert
(contact surfaces)
Silicone masks
Tube systems with breathing
bag and connectors
(contact surfaces)
Water trap, WaterLock2/
WaterLock ID (contact surfaces)
Blood-pressure cuff and
blood-pressure tube
ECG cable/MultiMed
master cable
Connecting cable
sensor system
Self Test Lung (MP02400)
(blue plastic cover)
Self Test Lung (MP02400)
This handbook does not replace the current instructions for use.
They remain fully valid.
see list of accessories
No. 9052629
available – see current list
of accessories
available – see current list
of accessories
available – see current list
of accessories
available – see current list
of accessories
available – see current list
of accessories
Page 14
14 |
HANDBOOK ON PREPARATION OF DEVICES AND ACCESSORIES |
WORKPLACE ANAESTHESIA
D-18862-2010
4.3 PRIMUS & PALLAS
This handbook does not replace the current instructions for use.
They remain fully valid.
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| 15
DEVICES
Manual preparation
CDD
Sterilisation
✓
/
/
/
✓
/
/
/
✓
/
/
/
Surface disinfection
Manual preparation
CDD
Sterilisation
✓
✓
✓
✓
✓
✓
✓
✓
/
✓
✓
✓
✓
✓
/
/
✓
✓
✓
✓
✓
/
/
/
Suction container, lid and
silicone connecting tube
(no lid when using
VacuSmart/VacuSmart GEL)
/
✓
✓
✓
/
✓
/
/
✓
Flow sensor: Spirolog
/
/
Primus family
Infinity C500/C700
Infinity Delta/Delta XL/
Kappa/Gamma/GammaXL
Infinity M540/M500/PS250
Surface disinfection
✓
/
/
/
Disposable accessories
DEVICE COMPONENTS
Respiratory system (APL valve)
Respiratory system
Ventilator membrane
(roller membrane)
Anaesthetic gas suction
AGS (flow tubes)
Anaesthetic gas suction AGS
incl. Transfer tubes, without
flow tubes and filters
Bronchial suction
Suction ejector
Flow sensor: SpiroLife
Vapor 2000
✓
✓
/
Surface disinfection
Manual preparation
/
/
CDD
Sterilisation
✓
✓
Disposable accessories
AGS particle filter – see
list of accessories
No. 9039406
AGS particle filter – see
list of accessories
No. 9039406
Filter for suction – see list
of accessories
No. 9039406
VacuSmart/VacuSmart GEL;
Suction tube with finger tap,
see list of accessories
No. 9039406
DEVICE OPTIONS
Disposable accessories
✓
/
✓
/
/
/
✓
✓
✓
✓
/
✓
✓
✓
see list of accessories
No. 9039406
✓
✓
✓
✓
see list of accessories
No. 9039406
✓
/
/
/
see list of accessories
No. 9039406
✓
/
/
/
available – see current list
of accessories
✓
/
/
/
Temperature sensor
✓
✓
/
/
SpO2 Sensor
✓
/
/
/
✓
/
/
/
✓
✓
✓
✓
✓
/
/
/
CLIC adapter
CLIC soda lime cartridge
(contact surfaces)
Absorber pot with insert
(contact surfaces)
Silicone masks
Tube systems with breathing
bag and connectors
(contact surfaces)
Water trap, WaterLock2/
WaterLock ID
(contact surfaces)
Blood-pressure cuff and
blood-pressure tube
ECG cable/MultiMed
master cable
Connecting cable
sensor system
Self Test Lung (MP02400)
(blue plastic cover)
O2 Flowmeter
This handbook does not replace the current instructions for use.
They remain fully valid.
see list of accessories
No. 9039406
available – see current list
of accessories
available – see current list
of accessories
available – see current list
of accessories
available – see current list
of accessories
Page 16
16 |
HANDBOOK ON PREPARATION OF DEVICES AND ACCESSORIES |
WORKPLACE ANAESTHESIA
D-64716-2012
4.4 ZEUS / ZEUS IE
This handbook does not replace the current instructions for use.
They remain fully valid.
Page 17
| 17
DEVICES
Zeus family
Infinity C500/C700
Infinity Delta/Delta XL/
Kappa/Gamma/GammaXL
Infinity M540/M500/PS250
Surface disinfection
Manual preparation
CDD
Sterilisation
✓
/
/
/
✓
/
/
/
✓
/
/
/
Surface disinfection
Manual preparation
CDD
Sterilisation
✓
✓
✓
✓
✓
✓
✓
✓
only outside
✓
/
✓
/
/
✓
/
/
/
Disposable accessories
DEVICE COMPONENTS
Respiratory system (APL valve)
Respiratory system
TurboVent 2 ventilator unit
DIVA dosage module
Anaesthetic gas suction
AGS(flow tubes)
Anaesthetic gas suction AGS
incl. Transfer tubes, without
flow tubes and filters
Bronchial suction Vacuum
regulator/Suction ejector
Suction container, lid and
silicone connecting tube
(no lid when using
VacuSmart/VacuSmart GEL)
Flow sensor: SpiroLife
✓
/
✓
✓
/
/
✓
✓
✓
/
✓
✓
/
/
/
✓
✓
✓
/
✓
/
✓
Surface disinfection
Manual preparation
CDD
Sterilisation
✓
✓
Disposable accessories
see list of accessories
No. 9052018
Filter for suction – see list
of accessories
No. 9052018
VacuSmart/VacuSmart GEL;
Suction tube with finger tap,
see list of accessories
No. 9052018
DEVICE OPTIONS
Disposable accessories
✓
/
✓
/
/
/
✓
✓
✓
✓
/
✓
✓
✓
✓
✓
✓
✓
see list of accessories
No. 9052018
✓
/
/
/
see list of accessories
No. 9052018
✓
/
/
/
✓
/
/
/
Temperature sensor
✓
✓
/
/
SpO2 Sensor
✓
/
/
/
✓
/
/
/
✓
/
/
/
✓
/
/
/
CLIC adapter
CLIC soda lime cartridge
(contact surfaces)
Absorber pot with insert
(contact surfaces)
Silicone masks
Tube systems with breathing
bag and connectors
(contact surfaces)
Water trap, WaterLock2/
WaterLock ID
(contact surfaces)
Blood-pressure cuff and
blood-pressure tube
ECG cable/MultiMed
master cable
Connecting cable
sensor system
Self Test Lung (MP02400)
(blue plastic cover)
O2 Flowmeter
This handbook does not replace the current instructions for use.
They remain fully valid.
see list of accessories
No. 9052018
see list of accessories
No. 9052018
available – see current list
of accessories
available – see current list
of accessories
available – see current list
of accessories
available – see current list
of accessories
available – see current list
of accessories
Page 18
18 |
HANDBOOK ON PREPARATION OF DEVICES AND ACCESSORIES |
WORKPLACE INTENSIVE-CARE
5 Workplace intensive-care
MT-1899-2008
D-64714-2012
5.1 EVITA FAMILY/SAVINA 300
This handbook does not replace the current instructions for use.
They remain fully valid.
Page 19
| 19
DEVICES
Evita 2dura/4/XL
Savina 300/300 Select
Evita V300/V500
Surface disinfection
✓
✓
✓
Manual preparation
CDD
Sterilisation
/
/
/
/
/
/
/
/
/
✓
/
Surface disinfection
Manual preparation
CDD
Sterilisation
✓
✓
✓
✓
Expiratory valve
✓
✓
✓
✓
Flow sensor: SpiroLife
/
✓
Infinity C300/500
Disposable accessories
/
/
DEVICE COMPONENTS
Inspiratory valve
/
✓
/
✓
/
/
Surface disinfection
Manual preparation
CDD
Sterilisation
✓
/
/
/
/
✓
✓
✓
MR 850 humidifier
✓
/
/
/
Tube system simple
✓
✓
✓
✓
Tube system heated
✓
✓
✓
✓
Temperature sensor
✓
/
/
/
Tube-heater adapter
✓
/
/
/
/
✓
✓
✓
/
✓
✓
/
✓
/
/
/
/
✓
✓
✓
✓
✓
✓
✓
✓
/
/
/
✓
/
/
/
Self Test Lung (MP02400)
✓
✓
✓
✓
Closed catheter basket
✓
/
/
/
Flow sensor: Spirolog
Disposable accessories
List of accessories No.
see p. 32
DEVICE OPTIONS
CO2 sensor
CO2 cuvette
Silicone masks
NovaStarTS
Nebuliser:
Aeroneb basic device
Nebuliser:
Aeroneb chamber
Evita pneumat. nebuliser
PulmoVista 500
Self Test Lung (MP02400)
(blue plastic cover)
This handbook does not replace the current instructions for use.
They remain fully valid.
Disposable accessories
List of accessories No.
see p. 32
List of accessories No.
see p. 32
List of accessories No.
see p. 32
List of accessories No.
see p. 32
List of accessories No.
see p. 32
List of accessories No.
see p. 32
List of accessories No.
see p. 32
Page 20
20 |
HANDBOOK ON PREPARATION OF DEVICES AND ACCESSORIES |
WORKPLACE INTENSIVE-CARE
MT-8202-2005
5.2 CARINA
This handbook does not replace the current instructions for use.
They remain fully valid.
Page 21
| 21
DEVICES
Carina
Surface disinfection
Manual preparation
/
CDD
Sterilisation
Disposable accessories
✓
Surface disinfection
Manual preparation
CDD
Sterilisation
Disposable accessories
✓
✓
✓
✓
see list of accessories
No. 9038969
✓
✓
✓
✓
see list of accessories
No. 9038969
/
/
ACCESSORIES
Tube system simple (apart from
expiratory and disposable
expiratory leakage valve)
Tube system heated
(apart from expiratory and
disposable expiratory
leakage valve)
MR 850 humidifier
✓
Temperature sensor
/
/
/
✓
/
/
/
Tube-heater adapter
✓
/
/
/
/
✓
✓
✓
/
✓
✓
/
✓
/
/
/
/
✓
✓
✓
✓
Silicone masks
NovaStarTS
Nebuliser: Aeroneb basic device
Nebuliser:
Aeroneb chamber
PulmoVista 500
MX3001 oxygen monitor
Self Test Lung (MP02400)
(blue plastic cover)
Self Test Lung (MP02400)
Closed catheter basket
/
/
/
/
✓
✓
/
/
/
✓
✓
✓
✓
✓
/
/
/
/
This handbook does not replace the current instructions for use.
They remain fully valid.
/
see list of accessories
No. 9038969
see list of accessories
No. 9038969
see list of accessories
No. 9038969
see list of accessories
No. 9038969
Page 22
22 |
HANDBOOK ON PREPARATION OF DEVICES AND ACCESSORIES |
WORKPLACE NEONATOLOGY
D-43871-2015
6 Workplace neonatology
This handbook does not replace the current instructions for use.
They remain fully valid.
Page 23
| 23
DEVICES: REANIMATION UNIT
Resuscitaire
Babytherm 8004/8010
TI500/GT5400
Surface disinfection
✓
✓
✓
Manual preparation
/
/
/
CDD
/
/
/
Sterilisation
/
/
/
Disposable accessories
Surface disinfection
✓
✓
✓
✓
✓
Manual preparation
/
/
/
/
/
CDD
/
/
/
/
/
Sterilisation
/
/
/
/
/
Disposable accessories
Surface disinfection
✓
✓
✓
Manual preparation
/
/
/
CDD
/
/
/
Sterilisation
/
/
/
Disposable accessories
Surface disinfection
✓
✓
✓
Manual preparation
/
/
/
CDD
/
/
/
Sterilisation
/
/
/
Disposable accessories
Surface disinfection
✓
✓
✓
✓
✓
/
✓
✓
✓
✓
Manual preparation
✓
/
/
✓
✓
✓
/
/
/
✓
CDD
✓
/
/
✓
✓
/
/
/
/
✓
Sterilisation
✓
/
/
✓
✓
✓
/
/
/
✓
Disposable accessories
Surface disinfection
✓
/
✓
Manual preparation
/
✓
/
CDD
/
✓
/
Sterilisation
/
✓
/
Disposable accessories
see Dräger accessories catalogue
see Dräger accessories catalogue
✓
/
/
/
see lists of accessories Babylog
VN500 and Babylog 8000
Surface disinfection
Manual preparation
Disposable accessories
/
CDD
with approved textile
washing machine
Sterilisation
/
✓
/
/
/
/
✓
✓
✓
/
/
✓
/
/
✓
/
/
✓
✓
✓
✓
✓
/
/
/
DEVICES: HEAT THERAPY
Babyleo TN500
Isolette 8000 plus
Isolette C2000
Caleo
Babytherm WB 8000
DEVICES: RESPIRATION/MONITOR
Babylog 8000+
Babylog VN500
Infinity C500
DEVICES: LIGHT THERAPY
JM-103/JM-105 jaundice meter
PT4000 phototherapy
Bililux
DEVICE COMPONENTS
Tube ducts/Door sealing rings
Supporting arm
Iris diaphragms
Water tank
Expiratory valve
Neonatal flow sensor
MR 850 humidifier
Temperature sensor
Tube-heater adapter
MR 850 humidification chamber
see GA Isolette 8000
for Caleo, see GA
ACCESSORIES/DEVICES
Aeroneb
Aeroneb chamber
VarioLux light
SoundEar
FURTHER ACCESSORIES
DCA (positioning aids)
hoods
Gel mattress/SoftBed/
foam mattress
Babyflow
Flowmeter: DigiFlow
Skin temp. Probes
Hytrel reusable tube system/
silicone/ incl. tube heating
closed catheter basket
/
see Dräger accessories catalogue
see Dräger accessories catalogue
see Dräger accessories catalogue
Page 24
24 |
HANDBOOK ON PREPARATION OF DEVICES AND ACCESSORIES |
ACCIDENT & EMERGENCY DEPARTMENT
MT-5809-2008
7 Accident & Emergency department
This handbook does not replace the current instructions for use.
They remain fully valid.
Page 25
| 25
DEVICES
Oxylog 1000
Oxylog 2000
Oxylog 2000plus
Oxylog 3000
Oxylog 3000plus
Oxylog VE300
Surface disinfection
✓
✓
✓
✓
✓
Manual preparation
CDD
Sterilisation
/
/
/
/
/
/
/
/
/
/
Disposable accessories
/
/
/
/
/
✓
/
/
/
Surface disinfection
Manual preparation
CDD
Sterilisation
✓
✓
✓
✓
/
✓
✓
✓
/
✓
✓
/
✓
/
/
/
/
✓
✓
✓
✓
/
✓
✓
ACCESSORIES
Tube systems with
respiration valve incl.
Flow sensor
Silicone masks
NovaStarTS
Oxidem 3000
MR 100 (apart from disposable
oxygen reservoir)
Test lung incl. Mask elbow
This handbook does not replace the current instructions for use.
They remain fully valid.
Disposable accessories
see instructions for use for
the device
see list of accessories
No. 9038780
see list of accessories
No. 9038780