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| 1

D-91140-2013

D-8994-2011

Reprocessing and preparation of devices


2 |

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.


| 3

Table of contents

1 Laws, standards and guidelines 8

2 Preparation methods for reusable medical products 9

2.1 Classification of medical products 9

2.2 Surface disinfection (for uncritical medical products) 10

2.3 Manual disinfection 11

2.4 Mechanical cleaning and thermal disinfection 11

2.5 Sterilisation using validated sterilisation methods 11

3 Anaesthesia Workstations 13

3.1 Fabius family 13

3.2 Perseus A500 21

3.3 Primus family 27

3.4 Zeus IE 33

4 Intensive care ventilators 39

4.1 Evita family / Savina 300 39

4.2 Carina 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


4 | REPROCESSING AND PREPARATION OF DEVICES


| 5

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.


6 |

REPROCESSING AND PREPARATION OF DEVICES

Table of examples

DEVICES

Surface disinfection Manual disinfection

Zeus range ✓ /

Explanations

Device can be surface

disinfected

Device cannot be

prepared manually

DEVICES COMPONENTS

Surface disinfection Manual disinfection

Breathing system (APL valve) ✓ ✓

Explanations

APL valve can be surface

disinfected

APL valve can be

prepared manually

Breathing system ✓ /

Explanations

Breathing system can be Breathing system cannot

surface disinfected 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.


| 7

Washer disinfector Sterilisation Disposable accessories

Device cannot be

prepared in the washerdisinfector

(WD)

/ /

Device cannot

be sterilised

If available, disposable

accessories are listed

Washer disinfector Sterilisation Disposable accessories

✓ ✓

APL valve can be

prepared in the washerdisinfector

APL valve can

be sterilised

✓ ✓

Breathing system can be

prepared in the washerdisinfector

Breathing system can

be sterilised

If available, disposable

accessories are listed

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.


8 | 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


| 9

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.


10 |

REPROCESSING AND PREPARATION OF DEVICES |

PREPARATION METHODS FOR REUSABLE MEDICAL PRODUCTS

2.2 SURFACE 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.


| 11

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 Temperature A0 value

minutes seconds °C

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.


12 | REPROCESSING AND PREPARATION OF DEVICES |

ANAESTHESIA WORKSTATIONS

NOTES


| 13

3 Anaesthesia workstations

3.1 FABIUS FAMILY

D-75695-2013

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


14 | 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.


| 15

Washer disinfector Sterilisation Disposable accessories

/ /

/ /

/ /

/ /

/ /

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


16 |

REPROCESSING AND PREPARATION OF DEVICES |

ANAESTHESIA WORKSTATIONS

DEVICE COMPONENTS

Surface disinfection Manual disinfection

Compact breathing system

COSY



(APL valve)

Compact breathing system

COSY

✓ ✓

Ventilator diaphragm

(Rolling diaphragm)

/ ✓

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.


| 17

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.


18 |

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.


| 19

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.


20 | REPROCESSING AND PREPARATION OF DEVICES |

ANAESTHESIA WORKSTATIONS

NOTES


| 21

3.2 PERSEUS A500

D-6833-2011

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


22 | 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.


| 23

Washer disinfector Sterilisation Disposable accessories

/ /

/ /

/ /

/ /

Washer Disinfector Sterilisation 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.


24 | 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.


| 25

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.


26 | REPROCESSING AND PREPARATION OF DEVICES |

ANAESTHESIA WORKSTATIONS

NOTES


| 27

3.3 PRIMUS FAMILY

D-18862-2010

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


28 | REPROCESSING AND PREPARATION OF DEVICES |

ANAESTHESIA WORKSTATIONS

DEVICES

Surface disinfection

Manual disinfection

Primus range ✓ /

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 diaphragm

(Rolling diaphragm)

/ ✓

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.


| 29

Washer disinfector Sterilisation Disposable accessories

/ /

/ /

/ /

/ /

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.


30 | 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) ✓ ✓

Flowmeter O2 ✓ /

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


| 31

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.


32 | REPROCESSING AND PREPARATION OF DEVICES |

ANAESTHESIA WORKSTATIONS

NOTES


| 33

3.4 ZEUS IE

D-12334-2009

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


34 |

REPROCESSING AND PREPARATION OF DEVICES |

ANAESTHESIA WORKSTATIONS

DEVICES

Surface disinfection

Manual disinfection

Zeus IE ✓ /

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 ✓ ✓

DIVA metering modules ✓ /

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.


| 35

Washer disinfector Sterilisation Disposable accessories

/ /

/ /

/ /

/ /

Washer disinfector Sterilisation Disposable accessories





/ /

/ /

/ /

/ /

/ /



/ ✓

/ /

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.


36 | 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)

✓ /

Flowmeter O2 ✓ /

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


| 37

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.


38 | REPROCESSING AND PREPARATION OF DEVICES |

ANAESTHESIA WORKSTATIONS

NOTES


| 39

4 Intensive care ventilators

4.1 EVITA FAMILY / SAVINA 300

MT-1899-2008

D-64714-2012

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


40 |

REPROCESSING AND PREPARATION OF DEVICES |

INTENSIVE CARE VENTILATORS

DEVICES

Surface disinfection

Manual disinfection

Evita 2dura, 4, XL ✓ /

Savina 300 ✓ /

Evita V300/V500 ✓ /

Infinity C300/500 ✓ /

DEVICE COMPONENTS

Expiratory valve

Surface disinfection


Manual disinfection


Inspiratory Valve ✓ ✓

Flow sensor: Spirolife / ✓

Flow sensor: Spirolog / ✓

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


| 41

Washer disinfector Sterilisation Disposable accessories

/ /

/ /

/ /

/ /

Washer disinfector Sterilisation Disposable accessories



See current Accessories list

on page 78



/ ✓

/ /

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


42 |

REPROCESSING AND PREPARATION OF DEVICES |

INTENSIVE CARE VENTILATORS

DEVICE OPTIONS

Surface disinfection Manual disinfection

CO2 sensor ✓ /

CO2 cuvette

/ ✓

Humidifier, MR 850

Hose system, simple

Hose system, heated

Temperature sensor

✓ /

✓ /

✓ /

✓ /

Hose heating adapter ✓ /

Silicone masks

/ ✓

NovaStarTS

/ ✓

Nebuliser:

Aeroneb Basic device

✓ /

Nebuliser:

Aeroneb chamber

/ ✓

pneumat. nebuliser Evita ✓ ✓

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.


| 43

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

/ /



This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


44 | REPROCESSING AND PREPARATION OF DEVICES |

INTENSIVE CARE VENTILATORS

NOTES


| 45

4.2 CARINA

MT-8202-2005

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


46 | REPROCESSING AND PREPARATION OF DEVICES |

INTENSIVE CARE VENTILATORS

DEVICES

Surface disinfection

Manual disinfection

Carina ✓ /

ACCESSORIES

Surface disinfection Manual disinfection

Hose system, simple (except

for expiration and expiration

✓ /

leakage valve, disposable)

Hose system, heated (except

for expiration and expiration

✓ /

leakage valve, disposable)

Humidifier, MR 850 ✓ /

Temperatur sensor

✓ /

Hose heating adapter ✓ /

Silicone masks

/ ✓

NovaStarTS

/ ✓

Nebuliser: Aeroneb Basic

device

✓ /

Nebuliser:

Aeroneb chamber

/ ✓

PulmoVista 500 ✓ /

Oxygen monitor MX3001 ✓ /

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.


| 47

Washer disinfector Sterilisation Disposable accessories

/ /

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

/ /



This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


48 | REPROCESSING AND PREPARATION OF DEVICES |

INTENSIVE CARE VENTILATORS

NOTES


| 49

5 Neonatal workplace

D-18949-2010

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


50 | REPROCESSING AND PREPARATION OF DEVICES |

NEONATAL WORKPLACE

DEVICES: REANIMATION UNIT

Surface disinfection

Manual disinfection

Resuscitaire ✓ /

DEVICES: TRANSPORT SYSTEM

Surface disinfection

Manual disinfection

TI500/GT5400 ✓ /

DEVICES: WARMING THERAPY

Surface disinfection Manual disinfection

Isolette 8000 ✓ /

Isolette C2000 ✓ /

Caleo ✓ /

Babytherm WB 8000 ✓ /

Babytherm 8004/8010 ✓ /

DEVICES: VENTILATION/SCREEN

Surface disinfection Manual disinfection

Babylog 8000+ ✓ /

Babylog VN500 ✓ /

Infinity C500 (Screen) ✓ /

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


| 51

Washer disinfector Sterilisation Disposable accessories

/ /

Washer disinfector Sterilisation Disposable accessories

/ /

Washer disinfector Sterilisation Disposable accessories

/ /

/ /

/ /

/ /

/ /

Washer disinfector Sterilisation Disposable accessories

/ /

/ /

/ /

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


52 | REPROCESSING AND PREPARATION OF DEVICES |

NEONATAL WORKPLACE

DEVICES: JAUNDICE MANAGEMENT

Jaundice Meter

JM-103/JM-105

Surface disinfection

Manual disinfection

✓ /

DEVICES: LIGHT THERAPY

Surface disinfection Manual disinfection

Phototherapy PT4000 ✓ /

DEVICE COMPONENTS

Surface disinfection Manual disinfection

Hose guides/

Door sealing ring



Mounting arm ✓ /

Iris diaphragm ✓ /

Water tank ✓ ✓

Expiratory valve ✓ ✓

Neonatal flow sensor / ✓

Humidifier, MR 850 ✓ /

Temperatur sensor ✓ /

Hose heating adapter ✓ /

Humidifier chamber MR 850



This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


| 53

Washer disinfector Sterilisation Disposable accessories

/ /

Washer disinfector Sterilisation Disposable accessories

/ /

Washer disinfector Sterilisation Disposable accessories



/ /

/ / See Isolette 8000 Manual

✓ ✓ For Galeo, see manual



/ ✓

/ /

/ /

/ /



See current Accessories list

for Babylog 8000 & Babylog

VN500

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


54 | REPROCESSING AND PREPARATION OF DEVICES |

NEONATAL WORKPLACE

ACCESSORIES/DEVICES

Aeroneb

Aeroneb chamber

Surface disinfection Manual disinfection

✓ /

/ ✓

VarioLux light ✓ /

SoundEar ✓ /

ADDITIONAL ACCESSORIES

Developmental care

accessories Covers

Gel mattress/SoftBed/

foam mattress

Babyflow

Surface disinfection Manual disinfection

/ /

✓ /

/ ✓

Flow meter: DigiFlow ✓ /

Skin temp. probes

✓ /

Reusable hose system/

silicone/

Hytrel incl. hose heating



This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


| 55

Washer disinfector Sterilisation Disposable accessories

/ /

See Dräger Accessories

catalogue



See Dräger Accessories

catalogue

/ /

/ /

Washer disinfector Sterilisation Disposable accessories

with approved

washing machine

/

/ /



/ /

/ /



See Dräger Accessories

catalogue

See Dräger Accessories

catalogue

See Dräger Accessories

catalogue

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


56 | REPROCESSING AND PREPARATION OF DEVICES |

NEONATAL WORKPLACE

NOTES


| 57

6 Oxylog family

D-10888-2011

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


58 | REPROCESSING AND PREPARATION OF DEVICES |

OXYLOG FAMILY

DEVICES

Surface disinfection

Manual disinfection

Oxylog 1000 ✓ /

Oxylog 2000 ✓ /

Oxylog 2000plus ✓ /

Oxylog 3000 ✓ /

Oxylog 3000plus ✓ /

ACCESSORIES

Hose systems with

Ventilation valve with flow

sensor

Surface disinfection

Manual disinfection

✓ /

Silicone masks

NovaStarTS

/ ✓

/ ✓

Oxidem 3000 ✓ /

MR 100 (except for oxygen

container, disposable)

/ ✓

Testlung including mask

adapter

✓ /

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


| 59

Washer disinfector Sterilisation Disposable accessories

/ /

/ /

/ /

/ /

/ /

Washer disinfector Sterilisation Disposable accessories

✓ /

See Instructions for Use of

the respective device

See the respective device

Instructiona fo Use Manual



See Dräger Accessories

catalogue

✓ /

See Dräger Accessories

catalogue

/ /





This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


60 | REPROCESSING AND PREPARATION OF DEVICES |

OXYLOG FAMILY

NOTES


| 61

7 Patient monitoring

D-22375-2010

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


62 | REPROCESSING AND PREPARATION OF DEVICES |

PATIENT MONITORING

DEVICES

Surface disinfection Manual disinfection

Infinity C500/C700 ✓ /

Infinity Delta/Delta XL/Kappa/

GammaXL

Infinity M300/M540/M500/

PS250/P2500

✓ /

✓ /

ACCESSORIES

Surface disinfection Manual disinfection

Keyboard & mouse ✓ /

ECG: Cables

✓ /

Blood pressure cuffs and

Connection hose

✓ /

IBP: HemoMed pod

Pressure transducer plate

✓ /

IBP: PiCCO module ✓ /

IBP: Mpod – Quad Hemo ✓ /

etCO2 sensor IACS ✓ /

Temperature sensor



SpO2 sensor

Connection cable, sensors

✓ /

✓ /

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


| 63

Washer disinfector Sterilisation Disposable accessories

/ /

/ /

/ /

Washer disinfector Sterilisation Disposable accessories

/ /

/ /

/ /

/ /

/ /

/ /

See Accessories list,

No. 9038780

See Accessories list,

No. 9038780

/ /

/ /

/ /

/ /

See current Accessories list

on page 79

See current Accessories list

on page 79

See current Accessories list

on page 79

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


64 |

REPROCESSING AND PREPARATION OF DEVICES |

PATIENT MONITORING

ACCESSORIES

SpO2: Infinity Masimo SET

SpO2 module

SpO2: Infinity Nellcor Oximax

SpO2 module

Surface disinfection

Manual disinfection

✓ /

✓ /

FiO2 sensors ✓ /

Trident module ✓ /

Patient cable ✓ /

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


| 65

Washer disinfector Sterilisation Disposable accessories

/ /

/ /

/ /

/ /

/ /

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


66 | REPROCESSING AND PREPARATION OF DEVICES |

PATIENT MONITORING

NOTES


| 67

8 Workplace infrastructure

D-22044-2009

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


68 | REPROCESSING AND PREPARATION OF DEVICES |

WORKPLACE INFRASTRUCTURE

DEVICES

Surface disinfection Manual disinfection

Agila/Agila Lift/Agila EasyLift ✓ /

Forta Lift ✓ /

Gemia Duo ✓ /

Linea ✓ /

Mova Cart ✓ /

Movita/Movita Lift ✓ /

SoundEar ✓ /

Opera ✓ /

Patient Lifting Module ✓ /

Pendula ✓ /

Ponta ✓ /

Tower Supply Unit ✓ /

Polaris 50, 100/200, 5xx/7xx

(outer light parts)

✓ /

Polaris 50

(sterilisable handle)



Polaris 100/200, 5xx/7xx

(sterilisable handle)



Polaris camera SD/HD

(enclosure)

✓ /

Polaris camera SD/HD

(sterilisable handle)



Sola 300, 500/700

(outer light parts)

✓ /

Sola 500/700

(sterilisable handle)



This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


| 69

Washer disinfector Sterilisation Disposable accessories

/ /

/ /

/ /

/ /

/ /

/ /

/ /

/ /

/ /

/ /

/ /

/ /

/ /

/ ✓ Single use handle available



/ /



/ /

/ ✓

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


70 | REPROCESSING AND PREPARATION OF DEVICES |

WORKPLACE INFRASTRUCTURE

DEVICES

Surface disinfection Manual disinfection

MedView/MedView Module/

Remote control (enclosure)

✓ /

MedView/MedView Module

(sterilisable handle)



Stella (outer light parts) ✓ /

Stella (sterilisable handle) ✓ ✓

VarioLux light ✓ /

Medical displays ✓ /

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


| 71

Washer disinfector Sterilisation Disposable accessories

/ /

/ ✓

/

/ ✓

/ /

/ /

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


72 | REPROCESSING AND PREPARATION OF DEVICES |

WORKPLACE INFRASTRUCTURE

NOTES


| 73

9 Further ward equipment

D-28142-2009

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


74 | REPROCESSING AND PREPARATION OF DEVICES |

FURTHER WARD EQUIPMENT

FURTHER WARD EQUIPMENT

Surface disinfection Manual disinfection

Nebuliser: Inhalette

(Connetion hose only wiping



disinfection)

Flow meter/Compact

flow meter/DigiFlow

✓ /

Humidifier and bubbler

container for flow meter



(24 hour cycle)

Dräger hinged brackets for

standard rail

✓ /

Monitor holder/shelves for

standard rail



catheter basket

I.V. pole/tray for standard rail

✓ /

Suction/drainage

VarioAir/VarioVac/VarioO 2

✓ /

(Manometer/filter)

Suction/drainage

VarioVac



Suction/drainage

VarioAir/VarioO 2

✓ /

Continous drainage unit



Examination light/

reading light/VarioLux

Tropic plus (Nebuliser

chamber/

crystal oscillator)

Tropic plus

(Silicone hoses)

✓ /





This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


| 75

Washer disinfector Sterilisation Disposable accessories

✓ ✓

/ /



/ /



/ /

/ /



/ /



VarioSafe Filter MP00555,

ISO 10079-3

VarioSafe Filter MP00555,

ISO 10079-3

VarioSafe Filter MP00555,

ISO 10079-3

VarioSafe Filter MP00555,

ISO 10079-3

/ /



Medicin cup, single use

MP00006



See current Accessories list

on page 79

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


76 | REPROCESSING AND PREPARATION OF DEVICES |

FURTHER WARD EQUIPMENT

FURTHER WARD EQUIPMENT

Surface disinfection Manual disinfection

Tropic plus ✓ /

Pressure reducer/Oxett head/

oxator head/OxyLine

✓ /

Oxator trolley/

cylinder trolley/carrying frame

✓ /

OP suction, electr., Evac40

(Secretion jar/lid)



OP suction, electr., Evac40 ✓ /

Central gas supply hoses ✓ /

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


| 77

Washer disinfector Sterilisation Disposable accessories

/ /

/ /

/ /



/ /

/ /

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.


78 | REPROCESSING AND PREPARATION OF DEVICES |

ACCESSORIES LISTS

10 Accessories lists

GENERAL

Accessories catalogue 9066485

Anaesthesia workstations

Fabius See AL No. 9053093

Perseus See AL No. 9052630

Primus See AL No. 9039430

Zeus See AL No. 9039391

Intensive care ventilators

Evita V500/300 See AL No. 9039085

Carina See AL No. 9038970

Savina 300 See AL No. 9054256

Neonatal workplace

Caleo See IFU No. 9037571

Isolette 8000

See IFU No. MU19827

Resuscitaire

See IFU No. MU12149

Babytherm 8004/8010 See IFU No. 9029458

Babylog VN500 See IFU No. 9038982

Babylog 8000 plus See IFU No. 9028884

Transport Incubator TI500 See IFU No. MU06155

Transport Incubator GT5400 See IFU No. MU21700

Oxylog family

Accessories catalogue


| 79

Monitoring workstation

Accessories catalogue 9066485

IACS

See IFU No. MS28335

Workplace infrastructure

No disposable accessories avaiblable

Further ward equipment

Accessories catalogue 9066485


CORPORATE HEADQUARTERS

Drägerwerk AG & Co. KGaA

Moislinger Allee 53–55

23558 Lübeck, Germany

www.draeger.com

Manufacturer:

Drägerwerk AG & Co. KGaA

Moislinger Allee 53–55

23558 Lübeck, Germanyy

REGION EUROPE CENTRAL

AND EUROPE NORTH

Drägerwerk AG & Co. KGaA

Moislinger Allee 53–55

23558 Lübeck, Germany

Tel +49 451 882 0

Fax +49 451 882 2080

info@draeger.com

REGION EUROPE SOUTH

Dräger Médical S.A.S.

Parc de Haute Technologie d’Antony 2

25, rue Georges Besse

92182 Antony Cedex, France

Tel +33 1 46 11 56 00

Fax +33 1 40 96 97 20

dlmfr-contact@draeger.com

Locate your Regional Sales

Representative at:

www.draeger.com/contact

REGION MIDDLE EAST, AFRICA

Drägerwerk AG & Co. KGaA

Branch Office

P.O. Box 505108

Dubai, United Arab Emirates

Tel +971 4 4294 600

Fax +971 4 4294 699

contactuae@draeger.com

REGION ASIA / PACIFIC

Draeger Medical

South East Asia Pte Ltd.

25 International Business Park

#04-27/29 German Centre

Singapore 609916, Singapore

Tel +65 6572 4388

Fax +65 6572 4399

asia.pacific@draeger.com

REGION CENTRAL

AND SOUTH AMERICA

Dräger Panama Comercial S. de R.L.

Complejo Business Park,

V tower, 10th floor

Panama City

Tel +507 377 9100

Fax +507 377 9130

contactcsa@draeger.com

90 69 880 | 15.09-2 | Communications & Sales Marketing | PR | LE | © 2015 Drägerwerk AG & Co. KGaA

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