Environmental Conditions - Bowa 101-150 Manual Del Usuario

Reprocessing cycles 200
Reprocessing step Description
Manual pre-cleaning
Soak the product at room temperature (<25°C) for at least 15 minutes immediately,
but no later than 2 hours after use. Only use enzymatic, aldehyde-free disinfectants
1
which are suitable for disinfecting medical devices (e.g., DGHM or FDA approval or
1 Soaking
CE marking). Remove all visible impurities with a soft plastic brush.
BOWA recommends the use of Gigasept® Instru AF (Schülke & Mayr GmbH).
Rinse the product thoroughly for at least 1 minute at room temperature (<25°C) under
2 Rinsing running tap water (at least drinking water quality).
Allow residual water to drip off sufficiently.
Automatic cleaning, thermal disinfection and drying
Use a washer-disinfector (WD) with tested effectiveness (according to ISO 15883) and
a neutral to alkaline (max pH 11.5) enzymatic cleaning agent. Depending on the
concentration, agents including alcohol- and/or aldehyde-containing ingredients may
be used.
2
Ensure that the cables are not kinked or jammed.
3 Automatic cleaning
BOWA recommends the use of neodisher® MediClean forte (Chemische Fabrik Dr.
Weigert) at 55°C for 10 minutes.
The intermediate rinsing must include at least two rinsing steps (at least 1 minute each
at >10°C) with fully demineralised water (deionised water).
An A value of >3000 must be maintained.
0
3
4 Thermal disinfection BOWA recommends a temperature of 90°C for at least 5 minutes and the use of
demineralised water.
Drying is carried out according to the WD programme and depends on the total
5 Drying demand. The maximum temperature is 100°C for 25 minutes.
If necessary, dry with filtered compressed air at max. 3 bar.
After machine cleaning and disinfection, carry out a visual inspection for residues.
Inspection
If necessary, repeat the reprocessing process.
Steam sterilisation
BOWA recommends steam sterilisation using the fractionated vacuum method with a
sterilisation time of 3–20 minutes and a temperature of 134–137°C in a suitable
6 Steam sterilisation 4
sterilisation packaging.
BOWA has validated:
Soaking with GigaseptR Instru AF (Schülke & Mayr GmbH), 3% v/v
1
Neodisher® MediClean forte (Chemische Fabrik Dr. Weigert), 0.5% v/v
2
Thermal disinfection at 90°C for 5 minutes
3
Half-cycle with 3 pre-vacuum phases at 132°C for 1.5 minutes, packaging: double packaging, in paper/film sterilisation bag
4

6 Environmental conditions

6.1 Transport and storage
BOWA recommends storing the products in their original packaging until their first use.
Store the products in a location where they are protected against direct sunlight.
Transport or store the instrument in a dry environment.
6.2 Operation
Use the product at room temperature, protected from mechanical force such as pulling or bending.
7 Disposal
Dispose of the medical devices, packaging material and accessories in accordance with the respectively
applicable country-specific regulations and laws.
8 Symbols to bear in mind
Symbol Meaning
Follow the instructions for use
Product number
Batch
Quantity
CE mark
Caution: Sale and prescription
restricted to physicians. For the
treating physician only.
Medical device
Printed in Germany
Subject to technical and design changes
Copyright by BOWA-electronic GmbH & Co. KG, Gomaringen | Germany
12394-S1
Symbol Meaning
Keep away from direct sunlight
Keep dry
Conforms to Russian standards
Manufacturer
CE mark and identification number
of Notified Body (class IIb)
0123
WEEE symbol:
Indicates separate collection for waste
of electric and electronic equipment.
Caution
BOWA-IFU-12394-NEUTRAL-ELECTRODE-CABLE-REUSABLE-S1-ML-20210701
Tel. +49 7072-6002-0
BOWA MEDICAL
Fax +49 7072-6002-33
BOWA-electronic GmbH & Co. KG
info@bowa-medical.com
Heinrich-Hertz-Str. 4-10
www.bowa-medical.com
72810 Gomaringen/Germany
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