Dräger Perseus A500 User manual

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
DE

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
Or
– 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
C
D

Reprocessing instructions | Perseus A500 11
Reprocessing
CLIC absorber (disposable absorber)
Observe the instructions for use for the CLIC absorber.
1. Press the release button (A). The CLIC adapter flips open.
2. Pull the CLIC absorber (C) out of the holder (B) in the direction of the arrow.
3. Fold the holder back again until it engages audibly.
4. Dispose of the CLIC absorber in accordance with the instructions for use.
3.4.2.2 Removing the flexible breathing bag arm (option)
1. Unfasten the knurled screws (A) on the attachment piece for the breathing bag
arm.
2. Remove the attachment piece (B) with the breathing bag arm from the socket
(C) on the breathing system. Remove the breathing bag arm.
3901149668
C
B
A

12 Reprocessing instructions | Perseus A500
Reprocessing
3.4.2.3 Removing the breathing system
1. Fold up the breathing system cover (A) and set it aside.
2. To unlock the breathing system, turn the lever (B) by approx. 120°
counterclockwise.
NOTE
To prevent accidental penetration of soda lime into the breathing system, make
sure that the reusable CO2absorber has been removed.
3868838675
CAUTION
Risk of injury due to breathing system warmer
When the breathing system warmer is switched on, the bottom side of the
breathing system and the heating plate beneath it can become very hot.
Allow the breathing system to cool off before removing.

Reprocessing instructions | Perseus A500 13
Reprocessing
3. Remove the breathing system (C) straight upwards out of the breathing system
mount.
38676

14 Reprocessing instructions | Perseus A500
Reprocessing
3.4.2.4 Disassembling the breathing system
Overview
38829
No. Designation Remarks
A Upper part of the breathing system
B Lower part of the breathing system
C CLIC adapter (option) Reprocessing is carried out in accordance with their own
instructions for use.
D Incident flow mesh, expiration Remains in the expiratory port.
E Expiratory port
F Inspiratory port
G Bag elbow Remains on the breathing system.
H Flexible breathing bag arm (option) When the flexible breathing bag arm is used, there is no bag
elbow fitted to the lower part of the breathing system.
I Incident flow mesh, inspiration Remains in the lower part of the breathing system.
J Flow sensors Reprocessing is carried out in accordance with their own
instructions for use.
K Expiratory valve (blue)
L Inspiratory valve (red)
M APL valve

Reprocessing instructions | Perseus A500 15
Reprocessing
Removing the CLIC adapter (optional)
1. Unscrew the CLIC adapter (A) from the breathing system in the direction of the
arrow.
2. Press the release button (B). The holder (C) flips open.
3. Insert the cleaning plate (D) into the adapter until it reaches the stop.
4. Close the holder (C) so that it engages.
Removing the flow sensors and the ports
3867738830
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.

16 Reprocessing instructions | Perseus A500
Reprocessing
1. Unfasten and pull out the expiratory port (A).
2. Remove the expiratory flow sensor (B).
3. Unfasten and pull off the inspiratory port (C).
4. Remove the inspiratory flow sensor (D).
Removing the upper part of the breathing system
1. To unlock, turn the 3 levers (A) counterclockwise by approx. 120°.
38831
NOTE
When the flexible breathing bag arm is used, there is no bag elbow fitted to the
lower part of the breathing system.
38678

Reprocessing instructions | Perseus A500 17
Reprocessing
2. Lift off the upper part of the breathing system (B).
Removing the APL valve
●Using the lower knurled nut (A), unscrew the APL valve from the upper part of
the breathing system.
39299
WARNING
Risk of damage to breathing system
If the APL valve is not removed before the breathing system is reprocessed,
it may be damaged by the reprocessing measures. This can lead to leaks in
the breathing system.
Always remove the APL valve prior to reprocessing.
38832

18 Reprocessing instructions | Perseus A500
Reprocessing
Removing the inspiratory valve and the expiratory valve
●Carefully remove the red inspiratory valve (A) and the blue expiratory valve (B)
from the lower part of the breathing system.
To do this, proceed as follows:
1. Place your finger at the side of the lower edge of the valve. Using gentle
pressure, push the valve upwards. When the valve is released, carefully remove
it.
2. Only grasp the valve by the valve cage. Do not touch the valve disks when doing
this.
NOTE
Do not use any tools.
3883350135

Reprocessing instructions | Perseus A500 19
Reprocessing
3.4.2.5 Removing the TurboVent 2 blower module
1. Unfasten the quick release screws (A) by turning them 90° counterclockwise.
2. Remove the TurboVent 2 blower module (B) from the breathing system mount.
3930039301

20 Reprocessing instructions | Perseus A500
Reprocessing
3.5 Validated reprocessing procedures
3.5.1 Overview of the reprocessing procedures of the components
Components Surface disinfec-
tion with cleaning
Machine cleaning
with thermal dis-
infection
Description of the
procedure
Device surfaces
Yes No
(see "Surface disin-
fection with clean-
ing", page 21)
Breathing system
mount
(see "Surface disin-
fection with clean-
ing", page 21)
Upper part of the
breathing system
and lower part of
the breathing sys-
tem
No Yes
(see "Upper part of
the breathing sys-
tem", page 25)
Inspiratory port and
expiratory port
(see "Inspiratory
port and expiratory
port", page 26)
Inspiratory valve
(red) and expiratory
valve (blue)
(see "Inspiratory
valve and expira-
tory valve",
page 27)
APL valve (see "APL valve",
page 26)
Absorber container
and absorber insert
(see "Absorber
insert", page 28)
TurboVent 2 blower
module
(see "TurboVent 2
blower module",
page 29)
Flexible breathing
bag arm (option) Yes1)
1) Cleaning with thermal disinfection is required for effective, hygienic reprocessing
Yes
(see "Flexible
breathing bag arm
(option)", page 27)