Dräger Perseus A500 Bedienungsanleitung

Perseus A500

Anesthesia workstation

Reprocessing instructions

WARNING

To properly use this medical device, read and comply

with the instructions for use and this supplement.

Perseus A 500

2 Reprocessing instructions | Perseus A500

Supplement to the instructions for use

Perseus A500

1 Supplement to the instructions for use

●Keep this supplement with the instructions for use.

This supplement updates the information of the instructions for use in the following

chapters.

2 Information about this document

2.1 Trademarks

2.1.1 Trademarks owned by Dräger

The following web page provides a list of the countries in which the trademarks are

registered: www.draeger.com/trademarks

2.1.2 Trademarks owned by third-party manufacturers

WARNING

To properly use this medical device, read and comply with the instructions

for use and this supplement.

Instructions for use Part number Edition

Perseus A500 9510595 2017-02 – and higher

Trademark

Perseus®

Trademark Trademark owner

Dismozon®

BODE Chemie

Mikrobac®

Korsolex®

Neodisher mediclean®Dr. Weigert

acryl-des®

Schülke & Mayr

Mikrozid®

Perform®

Actichlor®

Ecolab USA

Oxycide®

BruTab 6S®Brulin

Dispatch®Clorox

Klorsept®Medentech

Descogen®

Antiseptica

Oxygenon®

Reprocessing instructions | Perseus A500 3

Information about this document

SteriMax®Aseptix

Cleanisept®Dr. Schumacher

Trademark Trademark owner

4 Reprocessing instructions | Perseus A500

Reprocessing

3 Reprocessing

3.1 Safety information.................................................................................... 5

3.2 Information on reprocessing................................................................... 6

3.3 Classifications for reprocessing............................................................. 6

3.3.1 Classification of medical devices .................................................... 6

3.3.2 Classification of device-specific components ................................. 7

3.4 Before reprocessing ................................................................................ 7

3.4.1 Patient-specific accessories and consumables .............................. 7

3.4.2 Device-specific components ........................................................... 9

3.5 Validated reprocessing procedures ....................................................... 20

3.5.1 Overview of the reprocessing procedures of the components........ 20

3.5.2 Surface disinfection with cleaning................................................... 21

3.5.3 Machine cleaning with thermal disinfection .................................... 24

3.5.4 Special reprocessing measures...................................................... 30

3.5.5 Storage and transport..................................................................... 31

3.6 Other agents and reprocessing procedures.......................................... 31

3.6.1 Disinfectants ................................................................................... 31

3.6.2 Reprocessing procedures............................................................... 32

3.7 After reprocessing ................................................................................... 33

3.7.1 Assembling and fitting device-specific components ....................... 33

3.7.2 Preparation before next use of device ............................................ 43

Reprocessing instructions | Perseus A500 5

Reprocessing

3.1 Safety information

WARNING

Risk due to inappropriately reprocessed products

Reusable products must be reprocessed, otherwise there is an increased

risk of infection.

– Follow the infection prevention policies and reprocessing regulations of

the health-care facility.

– Follow the national infection prevention policies and reprocessing

regulations.

– Use validated procedures for reprocessing.

– Reprocess reusable products after every use.

– Follow the manufacturer's instructions for cleaning agents, disinfectants,

and reprocessing devices.

WARNING

Risk of infection

If no breathing system filters are fitted to the Y-piece or the expiratory port,

the breathing system will become contaminated or the patient infected by

pathogens from the breathing system.

– Reprocess the breathing system before initial operation.

– Reprocess the breathing system after every change of patient.

– To prevent future contamination, use breathing system filters close to the

patient. Observe the instructions on configuring the breathing circuit and

filters, (refer to the table with recommended hose configurations in the

chapter "Assembly and preparation" in the instructions for use).

WARNING

Risk due to faulty products

Signs of wear, e.g., cracks, deformation, discoloration, or peeling, may

occur with reprocessed products.

Check the products for signs of wear and replace them if necessary.

CAUTION

Risk of flow measurement failure

Improper reprocessing and soiling, such as residues or particles, can damage the

flow sensor:

– Clean and disinfect the flow sensor in accordance with the corresponding

instructions for use.

– No machine cleaning or disinfection

– No plasma sterilization or radiation sterilization

– No water jets, compressed air, brushes or the like

– No ultrasonic bath

– No hot-steam sterilization with Spirolog and Infinity ID flow sensors

– For disinfecting the flow sensor, use only clean disinfectant solutions.

6 Reprocessing instructions | Perseus A500

Reprocessing

3.2 Information on reprocessing

Follow the national infection prevention policies and reprocessing regulations.

Follow the infection prevention policies and reprocessing regulations of the health-

care facility (e.g., concerning the reprocessing cycles).

3.3 Classifications for reprocessing

3.3.1 Classification of medical devices

The classification depends on the intended use of the medical device. The risk of

infection transmission through the application of the product to the patient without

proper reprocessing is the basis of the Spaulding classification.

WARNING

Risk of infection

Sample lines are contaminated as a result of the breathing gas passing

through.

Replace the sample lines in accordance with the corresponding instructions

for use.

CAUTION

Risk of injury to patients due to failure of accessories

Disposable products, such as the sample line and water trap were designed,

tested, and manufactured for single use only. Reuse, reprocessing, or sterilization

can lead to the failure of accessories, incorrect measurements and injuries to the

patient.

– Do not reuse disposable products.

– Do not reprocess disposable products.

– Do not use any disinfectants.

– Do not reprocess with elevated pressure from syringes or compressed air.

Classification Explanation

Non-critical Components that come only into contact with skin that is

intact

Semi-critical Components that carry breathing gas or come into contact

with mucous membranes or pathologically altered skin

Critical Components that penetrate skin or mucous membranes or

come into contact with blood

Reprocessing instructions | Perseus A500 7

Reprocessing

3.3.2 Classification of device-specific components

The following classification is a recommendation from Dräger.

Non-critical

– Device surfaces

– Trolley and holders

Semi-critical

– Breathing system

– Housing (upper part and lower part)

–Ports

– APL valve

– Inspiratory valve (red) and expiratory valve (blue)

– Absorber container and absorber insert

– TurboVent 2 blower module

– Flexible breathing bag arm (option)

– CLIC adapter (option)

Critical

The device does not contain any components classified as critical.

3.4 Before reprocessing

Observe before disassembly

1. Switch off the device and all devices connected to it.

2. Disconnect all power plugs.

3.4.1 Patient-specific accessories and consumables

The patient-specific accessories and consumables must be removed from the

device and, if necessary, disassembled.

Reusable products:

●If the reusable product has its own instructions for use, perform reprocessing in

accordance with the separate instructions for use. Further information can be

found in the list of accessories.

●If no separate instructions for use are available for the reusable product, perform

reprocessing in accordance with the instructions in this supplement (see

"Reprocessing procedures", page 32).

Disposable products:

●Dispose of the disposable products.

8 Reprocessing instructions | Perseus A500

Reprocessing

3.4.1.1 Removing accessories and consumables

Remove the following accessories:

– Sample line (A)

– Breathing bag hose with breathing bag (B)

– Breathing hoses (C)

– Filter (D)

Removing the sample line

●Remove the sample line (A) from the water trap and at the Y-piece, and dispose

of it if necessary. Follow the instructions for use for the water trap and the

sample line.

Removing the breathing bag

●Remove the breathing bag hose (B) together with the breathing bag.

49664

WARNING

Risk of infection

Used sample lines and water traps may be infectious due to the breathing

gases passed through them.

– To prevent infectious fluids from spurting out from the water trap, first

remove the sample line from the water trap.

– Leave the water trap fitted for the moment and only remove it after the

surface disinfection.

ABC

Reprocessing instructions | Perseus A500 9

Reprocessing

Removing the breathing hoses

●Remove the breathing hoses (C) from the ports on the breathing system. When

removing the breathing hoses, always hold them by the connection sleeve and

not by the hose itself.

Removing the filters

●Remove the filters at positions (D) or (E).

3.4.2 Device-specific components

The device-specific components must be removed from the device and, if

necessary, disassembled.

Remove the following components:

–CO

2absorber

– Flexible breathing bag arm (option)

– Breathing system

– Flow sensors

– Inspiratory port and expiratory port

– Lower part of the breathing system and upper part of the breathing system

– APL valve

– Inspiratory valve (red) and expiratory valve (blue)

– CLIC adapter (option)

– TurboVent 2 blower module

10393

10 Reprocessing instructions | Perseus A500

Reprocessing

3.4.2.1 Removing the CO2absorber

●Remove the CO2absorber:

– Reusable CO2absorber

– CLIC absorber (disposable absorber)

Reusable CO2absorber

1. Unscrew the CO2absorber (A) from the breathing system in the direction of the

arrow.

2. Remove and dispose of the dust filter (B).

3. Empty out the used soda lime. Dispose of it in accordance with its own

instructions for use.

4. Remove the absorber insert (C) from the absorber container. The sealing ring

(D) remains on the absorber insert.

CAUTION

Risk of chemical burns

Soda lime is caustic and is a strong irritant for eyes, skin, and airway.

Handle the soda lime carefully and do not spill it.

3867135662

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