Intended Use - Linde Debistar Notice D'utilisation

010
EN - Instruction for use - Debistar
Debistar - Medical flow selector
1. Foreword
The flow selectors described hereafter are medical devices classified as class IIa
according to the Medical Device Directive 93/42/EEC.
The Compliance with essential requirements of 93/42/EEC Medical Device
Directive is based upon ISO 15002 standard.

2. Intended Use

Debistar is a device intended for the administration of the following medical
gases in the treatment and care of patients:
- oxygen;
- medical air
The product is not intended to be used with air or nitrogen for driving surgical
tool.
This low pressure regulator is intended to be fitted to medical gas pipeline
system terminal units in hospital or ambulance car or to quick connector
outlet of medical regulator, with nominal pressures up to 5 bar.
• Using variants with maximum flow 50 l/min is necessary to be more
!
careful and outlet of the flow selector MUST NOT be connected directly to
the patient, for example via cannula.
3. Operational, transport and storage safety requirements
• Keep the product and its associated equipments away from
!
- heat sources (fire, cigarettes, ...),
- flammable materials,
- oil or grease (especially be carefull if hand cream is used)
- water,
- dust.
• The product and its associated equipments must be prevented
!
from falling over.
• Always maintain oxygen cleanliness standards.
!
• Use only the product and its associated equipments in well
!
ventilated area.