Hygienic Plan - Atmos E 341 Battery Operating Instructions Manual

5.5 Hygienic plan

What
Parts to be reprocessed
Surfaces
Housing
Device base
Hose reel
Wall and device support
Power supply and recharging
unit
Secretion canister system
DDS secretion canister
Outer canister lid (DDS)
Inner canister lid (DDS)
Float ball (DDS)
Filter holder
Sealing ring
Bacterial fi lter
Fingertip
Support for canister system
Suction hose (DDS)
Vacuum hose
Recommended disinfectants
Surface disinfection for coated surfaces:
• Green & Clean SK (ATMOS)
• Dismozon pur (Bode Chemie)
®
• Dismozon plus (Bode Chemie)
®
• Kohrsolin FF (Bode Chemie)
®
• Kohrsolin extra (Bode Chemie)
®
• Perform (Schülke & Mayr)
®
• Terralin Protect (Schülke & Mayr)
®
Other surfaces:
• Dismozon pur (Bode Chemie)
®
• Dismozon plus (Bode Chemie)
®
• Kohrsolin FF (Bode Chemie)
®
• Kohrsolin extra (Bode Chemie)
®
• Mikrobac forte (Bode Chemie)
®
• Perform (Schülke & Mayr)
®
• Terralin Protect (Schülke & Mayr)
®
• SaniCloth Active (Ecolab)
®
• Incidin Active (Ecolab)
®
• Mikrozid Sensitive Wipes (Schülke
®
& Mayr)
GA3GB.320100.0 2017-11 Index: 02
40 Cleaning and disinfection
Cleaning and disinfection plan
ATMOS C / E 341 Battery
®
How
C D S
X X Wipe cleaning and disinfection
X X Wipe cleaning and disinfection
1
X X Wipe cleaning and disinfection
1
X X Wipe cleaning and disinfection
Wipe cleaning and disinfection with a damp
X X
cloth. Do not immerse into any liquid!
Cleaning with a brush; cleaning and
X X X disinfection (automatic or manual),
1 2
sterilization is possible
Cleaning with a brush; cleaning and
X X X disinfection (automatic or manual),
1 2
sterilization is possible
Cleaning with a brush; cleaning and
X X X disinfection (automatic or manual),
1 2
sterilization is possible
Cleaning with a brush; cleaning and
X X X disinfection (automatic or manual),
1 2
sterilization is possible
Cleaning with a brush; cleaning and
X X X disinfection (automatic or manual),
1 2
sterilization is possible
X X Cleaning and Disinfection
1
Exchange. If the fi lter is blocked it must also
be exchanged.
Exchange.
X X Cleaning and Disinfection
1
X X X When using without suction catheter
1 2
X X X When using with suction catheter
1 2
X X Cleaning and Disinfection
Manual disinfection of instruments:
• Mucocit -T (Merz Dental)
®
• Gigasept FF neu (Schülke & Mayr)
®
• Sekusept PLUS (Ecolab)
®
For concentrations, contact time, tem-
perature, material compatibility, please
see the relevant information from the
manufacturer.
Wrong concentration of
disinfectants may lead to
material damage!
Notices
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Important information
Wipe cleaning and disinfection:
All surfaces have to be wiped with
a clean (disposable) wipe which is
damped with disinfectant solution.
The entire surface has to be wiped
thoroughly and may not be dried
afterwards.
Preferred: mechanical cleaning and
1)
disinfection in the washer disinfector
with a device according to the ISO
15883-1 (Program: Rinsing 1 min with
cold water, cleaning 5 min at 55°C,
neutralisation 1 min with 1/3 cold and
2/3 warm water, rinsing 1 min with
purifi ed water, thermal disinfection 5
min at 93°C with purifi ed water)
If required hot-steam sterilization at
2)
134°C, 3 x fractionated pre-vacuum
method, sterilization time 5 min with a
device according to EN285
* Homecare, unless there is no change
in patient.
When Who
Qualifi ed and trained staff who
are familiar with reprocessing
X
X
X
X
X
X
X
X
X
X
X
X X
X
X
X
X
X
The above stated hygiene requirements are based on
the regulations according to the Medical Devices Act, the
Medical Devices Operator Ordinance, §18 IfSG and the
recommendations of the Robert Koch Institute.
Defi nition of the required reprocessing steps result
from the recommendations of the Robert Koch Institute:
„Requirements for the reprocessing of medical products",
from Robert Koch Institute. The medical products were
categorised in the risk groups uncritical, semi-critical and
critical. The reprocessing measures mentioned in this
cleaning and disinfection plan are a recommendation
of ATMOS MedizinTechnik. Any additional reprocessing
measures are at the operator's discretion.
All the recommended disinfectants which are stated
herein are listed disinfectants (VAH/RKI) and have been
tested on their suitability of use on the ATMOS
341 Battery. ATMOS MedizinTechnik cannot be hold
liable for any damage caused by wrong concentration
of the disinfectants or by the application of any other
disinfectants.
Patients with suspicion of a clinical disease or who
developed a transmissible spongiform encephalopathy
(CJK, vCJK, etc.) have to be treated at facilities which are
able to provide for the necessary preventive measures
against infection. The reprocessing of the reusable
instruments and material may only be performed
at facilities which have an externally certifi ed QM
Management acc. to DIN EN ISO 13485.
The Medical Devices Act, IfSG, the RKI directives, BGR 250
and TRBA 250 always have to be considered.
ATMOS MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Str. 16  79853 Lenzkirch/Germany
Phone +49 7653 689-0  Fax +49 7653 689-190
info@atmosmed.de  www.atmosmed.com
C / E
®