Resuscitator,hand-oper.,adult,set

General Description:
Resuscitator, hand-operated, adult, set.

Technical Specifications:
Resuscitator to ventilate adult (body weight over 30kg),
Resuscitator operated by hand,
Ventilation with ambient air,
Resuscitator shall be easy, to disassemble and reassemble, to clean and disinfect, and be autoclavable.
All parts must be manufactured from high-strength, long-life materials and require no special maintenance or storage conditions.

Resuscitator shall be supplied as a complete set with:
- Compressible self-refilling ventilation bag, capacity: 1475-2000ml ,
- Non-rebreathing patient valve with or without pressure limiting valve, patient connector outside/inside diameter (OD/ID): 22/15mm,
- Inlet valve with nipple for 02 tubing,
- Oxygen reservoir bag complete, capacity: 2000-2600ml,
- Masks, transparent, in 3 sizes:
1 mask, face shape type, size adult small/teenager,
1 mask, face shape type, size adult medium,
1 mask, face shape type, size adult large,
Resuscitator supplied in a box as a complete set, with clear instructions / diagrams for use and assembly in 3 languages (English, French, Spanish).

Materials: Latex-free
- Compressible self-refilling ventilation bag: silicone rubber,
- Non-rebreathing patient valve with pressure limiting valve: polycarbonate/polysulfone/silicone,
- Inlet valve with nipple for O2 tubing: polycarbonate/polysulfone
- Oxygen reservoir bag: plastic,
- Masks: transparent silicone rubber.

Resuscitator must be in conformity with:
European Medical Device Directive (MDD 93/42/EEC);
ISO10651-4: Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators;

Packaging and labelling:
Primary packaging: Unit of use
One (1) resuscitator set in a box with manufacturer's instructions for use.

Labelling on the primary packaging:
Name and/or trademark of the manufacturer,
Manufacturer's product reference,
Type of product and main characteristics,

Instructions for use:
Essential equipment for health structures and emergency rescue team (to be available in emergency room, delivery room, operating theater, intensive care unit, ambulance, etc.)
This resuscitator can be used to ventilate patients: adult (body weight over 30kg).
Resuscitator is used for ventilation assistance in critical situation of respiratory distress or failure.
Resuscitator is supplied with Manufacturer’s instructions manual including diagrams, covering the technical performances, the use and the maintenance of the resuscitator.
Resuscitator shall only be operated by a person who has received professional training in resuscitation.

Safety procedure:
The resuscitator and the mask(s) must be cleaned and disinfected after each use.
Important: After dismantling and cleaning, the resuscitator must be reassembled and tested to make sure that it is functioning properly, it is important to follow Manufacturer's instructions for use.

In view of its use, this item is an "emergency life-saving item", meaning: resuscitator set must always be readily available and in a good working condition.

Component of Kit:
S9908400 - Resuscitation kit, basic.