AirSep VisionAire V Patiëntenhandboek - Pagina 17
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Conformity with EN 60-601 (
"
The manufacturer, assembler, installer or importer are not considered to be responsible themselves for the
consequences on the safety, reliability and characteristics of a device unless:
- The assembly, fitting, extensions, adjustments, modifications or repairs have been performed by persons
authorized by the party in question,
- The electrical installation of the corresponding premises complies with IEC regulations.
- The device is used in accordance with the instructions for use. "If the replacement parts used for the
periodic servicing by an approved technician do not comply with the manufacturer's specifications, the
latter is absolved from all responsibility in the event of an accident. Do not open the device while in
operation: risk of electrical shock. This device complies with the requirements of the 93/42/EEC European
directive but its operation may be affected by other devices being used close by, such as diathermy and
high frequency electro-surgical equipment, defibrillators, short wave therapy equipment, mobile
telephones, CB and other portable devices, microwave ovens, induction plates or even remote control toys
and more generally electromagnetic interferences which exceed the levels specified by the ECN 60601-1-2
standard.
Classification
Type of protection against electric shock:
Class II
Protection from electric shock is achieved by DOUBLE INSULATION.
Protective earthing or reliance upon installation conditions are not required.
Degree of protection against electric shock:
Type B
Equipment providing a particular degree of protection against electric shock, particularly
regarding:
1) Allowable leakage current;
2) Reliability of protective earth connection (if present).
Not intended for direct cardiac application.
Method of cleaning and infection control allowed:
Please refer to your Equipment Provider and the VisionAire V Service Manual.
Degree of safety of application in the presence of flammable gases:
Equipment not suitable for such application.
Mode of operation: Continuous duty.
AVERTISSEMENT
Cet appareil produit de l'oxygène à concentration élevée, favorisant une
combustion rapide. Ne pas permettre de fumer ou des flammes nues dans
un rayon de 5 pieds (1,5 mètre) de : (1) cet appareil ou (2) tout accessoire
contenant de l'oxygène. Ne pas utiliser de produits à base d'huile, de
graisse ou de pétrole sur ou à proximité de l'unité. Déconnecter le cordon
d'alimentation de la prise électrique avant de nettoyer ou de faire
l'entretien de l'unité.
AVERTISSEMENT
Risque de choc électrique. Ne pas enlever les couvercles lorsque l'unité
est branchée. Seuls votre fournisseur d'équipement ou un technicien de
service qualifié devrait enlever les couvercles ou faire l'entretien de
l'unité.
§ 6.8.2 b):
§
14
MN156-1 rev B
08/11