Emc Information; Functional Test - Bowa 901-011 Manual De Instrucciones

All serious incidents arising in connection with the
product must be reported to the manufacturer and
the competent authority of the member state in
which the user is established
3.3.

EMC information

Medical electrical devices are subject to special
EMC precautions, so please observe the
following directions.
BOWA accessories are only provided for
connection to BOWA HF devices.
The use of the accessories on medical devices
from manufacturers other than those described
may lead to elevated emissions or reduced
interference immunity.
When medical devices are combined safety will
only be assured if
▶ the instructions for use in question allow the
desired combination or
▶ the interface specification of the products
used in the combination are compatible.
901-011, 901-021, 901-031, 901-032:
Magnetic fields can have an undesirable
influence when using HALL sensors. Magnetically
conductive materials should also be kept out of
the immediate vicinity of the foot switch.
3.4.

Functional test

The plug of the connection cable must be
connected to the ARC generator using the
corresponding connection socket (see instructions
for use for the ARC generator). The socket must be
secured by tightening the circlip clockwise.
Carry out a functional test before each use.
3.5. Functions
901-011:
Blue pedal: activates coagulation
Orange button: change in function or output
901-012:
White pedal: activates cutting or coagulation
901-021, 901-022:
Yellow pedal: activates cutting
Blue pedal: activates coagulation
901-031, 901-032:
Yellow pedal: activates cutting
Blue pedal: activates coagulation
Orange button: change in function or output on
the ARC generator.
4. Environmental conditions
Environmental Transport
Operation
conditions and storage
+10°C to -20°C to
Temperature
+40°C +50°C
30 to 75%,
Relative 0 to 90%, non-
non-
humidity condensing
condensing
700 to 500 to
Air pressure
1060 hPa 1060 hPa
5. Cleaning and disinfecting
The product is delivered unsterile. Disinfect the
product before each use.
It is necessary to ensure that insulated parts do
not come into contact with hard, sharp or heavy
products during preparation as this can harm the
electrical insulation and make the product
unusable.
Foot switches may not be cleaned with metal
brushes, abrasive materials or other methods that
may harm the surface. Damp cotton material
should be used, for example, to clean the tip area.
Preparation cycles
All medical devices are subject to a certain
degree of wear caused by normal use. A careful
visual inspection should therefore be carried out
regularly before use (products that are
malfunctioning, are sluggish, have damage to
the insulation or defective switches, etc. mean
an increased risk for the patients and therefore
must not be used).
BOWA MEDICAL
BOWA-electronic GmbH & Co. KG
Heinrich-Hertz-Strasse 4-10
72810 Gomaringen | Germany
Soaking
Soak the product immediately, no later than two
hours after use. Only use aldehyde-free
disinfectants for this (recommendation: Gigasept
Instru AF) that are suitable for the wipe
disinfection of products (e.g. DGHM or FDA
approval or CE mark).
Do not place the product in the ultrasound bath.
Coagulation residue (incrustations) are to be
softened in a cleaning solution and wiped off with
a damp cleaning cloth.
Cleaning/disinfecting
BOWA recommends the use of neutral to mildly
alkaline (pH 9.5-11.5) cleaning agents or cleaning
agents and disinfectants that are suitable for medical
devices made of plastic and metal.
Alcoholic and/or aldehyde contents are
permissible depending on the concentration.
Where necessary, blow-dry with filtered
compressed air.
Only dry products with compressed air at <3 bar
to avoid possible damage.
An automated process is not suitable for the
products mentioned.
The use of other types of cleaning agents and
disinfectants is not the manufacturer's
responsibility. The recommendations of the
manufacturers of the cleaning agents must be
complied with.
6. Repair and maintenance
Defective foot switches may not be repaired
and must be replaced.
The foot switches are maintenance-free.
7. Disposal
The medical devices, the packaging material
and the accessories must be disposed of
according to state-specific laws and regulations.
8. Technical data
Standards
IEC 60601-1: 2005 + Cor.1(2006) + Cor.2
(2007) + A1:2012
IEC 60601-1-2: 2014
IEC 60601-2-2: 2017;
IEC 60529:
1989+A1:1999+A2:2013+Cor.2:2015
ISO 14971: 2007
ISO 13485: 2003 + Cor.1 (2016)
Type of protection of the housing
IP X8
Flame/explosion protection
AP-suitable
Classification according to MDR 2017/745
IIb
Performance features
901-012, 901-022
15 V DC, max. 1A
901-011, 901-021, 901-031, 901-032
10 V DC, max. 20 mA
Regulation on Medical Devices
This product complies with EU Regulation
MDR 2017/745 on medical devices.
fr - Mode d'emploi
Pédales BOWA pour générateurs ARC
Symbole
Suivre le mode d'emploi
Code article
Numéro de série
Quantité
Phone +49 7072 6002-0
Fax +49 7072 6002-33
info@bowa.de | bowa-medical.com
Symbole
Rx only
IPX8
IMPORTANT !
Veuillez lire attentivement toutes les
informations !
Ces conseils d'utilisation ne remplacent pas le
mode d'emploi de l'appareil chirurgical
électronique utilisé ! Lire le mode d'emploi de
l'appareil chirurgical et consulter BOWA ou
votre distributeur en cas de doutes !
1.
Instrument électrochirurgical pour la coupe et la
coagulation de tissus.
0123
La pédale, en tant qu'accessoire, permet
d'activer les générateurs ARC BOWA prévus à
cet effet.
2.
Les pédales doivent être utilisées conformément
Signification
au tableau d'affectation en combinaison avec les
générateurs ARC BOWA :
Pédale
901-011
901-012
901-021
901-022
901-031
901-032
BOWA-IFU-MN031-729-FOOTSWITCH-S1-ML-20210416
Signification
Dispositif médical
Attention : restriction de l'achat et de
la prescription aux médecins.
Réservé au médecin traitant.
Classe de protection
Sigle d'homologation européen
0123
Fabricant
Date de fabrication
Sigle d'homologation russe
Plage de pression atmosphérique, dans
laquelle l'appareil peut être exposé
Prudence : Fragile !
Protéger des rayons du soleil
Conserver au sec
Limite de température
Plage de l'humidité de l'air, dans
laquelle l'appareil peut être exposé
Pendant l'activation (de l'appareil HF),
l'énergie HF utilisée se situe dans le
spectre de radiofréquence utilisé
de 9 kHz à 400 GHz qui produit un
rayonnement électromagnétique
Convient pour une utilisation avec
des solutions anesthésiques à base
d'air
Marquage des appareils électriques et
électroniques conformément à la
directive 2002/96/CE (DEEE), voir
élimination
Utilisation conforme et destination du
produit
1.1. Indication
Utilisation conforme
ARC BOWA
900-250, 900-303, 900-351,
900-400, 900-600
900-100
900-250, 900-303, 900-600
900-250, 900-303, 900-600
900-250, 900-303, 900-351,
900-400, 900-600
900-250, 900-303, 900-351,
900-400, 900-600
3