Resuscitator,hand-oper.,neonate,set

General description:
Resuscitator, hand-operated, neonate, set

Technical specifications:
Self-inflating neonatal resuscitator bag,
Hand operated, portable, reusable
Translucent and made from silicone rubber, capacity 220 – 280ml
Resuscitator to provide positive pressure ventilation (PPV) to pre-term babies, low birth weight and term babies <5kg
For ventilation with ambient air or with oxygen via intake valve with nipple for oxygen tubing
Bag supplied with a non-rebreathing patient valve and with a pressure-limiting valve
Pressure limiting valve shall ensure airway pressure does not exceed 40 – 45cmH2O (or 4 – 4.5 kPa) (and shall generate an airway pressure of at least 30 cmH2O (or 3 kPa)

Materials:
All parts manufactured from high-strength, long-life materials that require no special maintenance or storage conditions
• Intake valve and nipple: made from polycarbonate/polysulfone
• Bag: made of transparent silicone rubber
• Non-rebreathing patient valve with pressure limiting valve: made of polycarbonate or polysulfone
• Inlet valve with nipple for O2 tubing: made of polycarbonate/polysulfone

Supplied with:
• Masks, transparent in 2 sizes:
- Size 0 for preterm and low-weight baby, round type, diameter 35–50 mm
- Size 1 for term baby, round type, diameter 50–65 mm translucent
• Reservoir bag of approx. 600 ml capacity
Resuscitator 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 teams (to be available in emergency rooms, delivery rooms, operating theaters, intensive care units, ambulances, etc.)
This resuscitator can be used to ventilate patients: preterm, new-born, small infant (body weight 0-5 kg).
Resuscitator is used for assisted ventilation in critical situations of respiratory distress or in apnoeic patients.
Resuscitator is supplied with Manufacturer’s instruction manual including diagrams indicating technical performance, 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 and Reprocessing:
Resuscitator shall be easy, to disassemble, clean, disinfect, and reassemble,
It shall be autoclavable
Clear instructions/diagrams for disassembly, cleaning, disinfection and reassembly must be included in and/or on the packaging
The resuscitator and the mask(s) must be cleaned and disinfected after each use.
Important: After disassembly 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: the resuscitator set must always be readily available and in a good working condition
Component of Kit:
S9908400 - Resuscitation kit, basic.