Introduction
Applicable standards
GA 5750.4172 EN 14
9
1
When employed in a commercial or business
use, this product shall be entered in the inventory.
Accessories
Accessories or combinations of accessories may be utilised only as and when indicated in these
operating instructions.
Other accessories, combinations of accessories and consumable items may be used only if they
have a valid certification, are intended
expressly for the particular use and will not adversely affect performance, the prescribed ambient
conditions or safety requirements.
1.5.3
Applicable standards
The product satisfies the basic requirements set forth in Annex I to the 93/42/EU Directive drafted
by the Medical Products Council (Medical
Products Directive) as well as the applicable national (German) codes and the Medical Products
Act in Germany.
The applicable standards include the following:
• DIN EN ISO 15001 Anaesthetic and respiratory equipment - Compatibility with oxygen
• DIN EN 13544-1 Respiratory therapy equipment Part 1: Nebulising systems and their compo-
nents
1.5.4
Intended purpose
The hand-held nebuliser (REF 5750 7534) is intended for administering water-soluble inhalation
medication.
The medication is separated into tiny drops in the medication cup (aerosol size of 0.5 - 7 μm at
500 kPa) and supplied to the patient through the inhalation mask (approx. 2 ml / 10 min).
Only use the hand-held nebuliser in conjunction with a regulating unit (flowmeter, precision
regulation valve or pressure reducing valve with
O2 or Air flowmeter) which has a minimum litre capacity of 13 l/min and a pressure of 280 kPa -
600 kPa (e. g. FINA RV O / RV A, FINA FLOW
O15 / A15, S FLOW flowmeter O15 / A15, LS FLOW flowmeter O15 / A15 and O2 pressure
reducing valve with flowmeter).
The hand-held nebuliser is designed for temporary operation (up to 60 min). The unit is designed
to be used by medical personnel who, on the basis of their professional experience and
instruction in safety matters, are able to evaluate their activities and recognise the potential risks
associated with the work.
The hand-held nebuliser is connected to a regulating unit by means of a connection tube.
This is an active product used in conjunction with accessories for therapeutic treatment of
individual patients, in medically used rooms (hospital, medical practices etc.) or in clinical
environments or nursing care. The product is not invasive, cannot be implanted and has no direct
application at human organs.
Only use medications which can safely be atomised in combination with compressed air or
oxygen.