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Dräger Medical

Draeger Reprocessing and Preparation of Devices Guide Aug 2015

Revision Not Listed

Draeger Breathing System

80 Pages

|3  Table of contents 1 Laws, standards and guidelines  8  2 Preparation methods for reusable medical products 		2... Classification of medical products 		2... Surface disinfection (for uncritical medical products) 		2... Manual disinfection 		2... Mechanical cleaning and thermal disinfection 		2... Sterilisation using validated sterilisation methods  9 9 10 11 11 11  3 Anaesthesia Workstations  		3... Fabius family 		3... Perseus A500 		3... Primus family 		3... Zeus IE  13 13 21 27 33  4 Intensive care ventilators  		4... Evita family / Savina 300 		4... 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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draeger_reprocessing_and_preparation_of_devices_gui.pdf

Page 1

D-8994-2011

D-91140-2013

|1

Reprocessing and preparation of devices

Page 2

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.

Page 3

|3

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

Page 4

4|

REPROCESSING AND PREPARATION OF DEVICES

Page 5

|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.

Page 6

6|

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.

Page 7

|7

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.

Page 8

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

Page 9

|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.

Page 10

10 |

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.

Page 11

| 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

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.

Page 12

12 |

REPROCESSING AND PREPARATION OF DEVICES |

ANAESTHESIA WORKSTATIONS

NOTES

Page 13

| 13

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.

Page 14

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.

Page 15

| 15

Washer disinfector

Sterilisation

/

/

/

/

/

/

/

/

/

/

Disposable accessories

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.

Page 16

16 |

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.

Page 17

| 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.

Page 18

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.

Page 19

| 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.

Page 20

20 |

REPROCESSING AND PREPARATION OF DEVICES |

ANAESTHESIA WORKSTATIONS

NOTES

Page 21

| 21

D-6833-2011

3.2 PERSEUS A500

This handbook does not replace the currently valid Instructions for Use

which remain valid, without restriction.

Page 22

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.

Page 23

| 23

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.

Page 24

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.

Page 25

| 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.

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