Intended Use - Ambu Oval Plus Silicone Resuscitator Instrucciones De Uso

1. Intended use

The Ambu® Oval Plus Silicone resuscitator is a reusable resuscitator intended for
pulmonary resuscitation.
The range of application for each version is:
- Adult: Adults and children with a body weight more than 30 kg (66 lbs).
- Paediatric: Infants and Children with a body weights up to 10 ~ 30 kg (22 ~ 66lbs).
- Neonate: Neonates and infant with a body weight up to 10 kg (22 lbs).
2. Warning and caution statements
Failure to observe these precautions may result in inefficient ventilation of the
patient or damage to the equipment.
WARNING
Oil or grease should not be used in close proximity to oxygen equipment.
Do not smoke or use open flame when oxygen is in use – fire may result.
Never override the pressure-limiting valve (if available) unless medical and
professional assessment indicates the necessity. High ventilation pressures
may cause lung rupture to certain patients. If the pressure-limiting valve is
overridden in patients with a bodyweight less than 10 kg (22 lbs.), a manometer
must be used to monitor the ventilation pressure to avoid the possibility of a
lung rupture.
By adding accessories, it may increase inspiratory and/or expiratory resistance.
Do not attach accessories if increased breathing resistance would be detrimental
for the patient.
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CAUTION
US federal law restricts this device to sale by or on the order of a physician
(USA and Canada only)
For use by trained personnel only. The proper application of a facemask to
obtain tight seal should be trained in particular. Make sure that the personnel
are made familiar with the content of this manual.
Always inspect the resuscitator and perform a functional test after unpacking,
cleaning, assembly and prior to use.
If the resuscitator with attachments is placed on standby for emergency use,
it should be inspected at regular intervals to assure integrity.
Always watch the movement of the chest and listen for the expiratory flow
from the valve in order to check the ventilation efficiency. Switch immediately
to mouth-to-mouth ventilation if efficient ventilation cannot be obtained.
Insufficient, reduced, or no airflow may result in brain damage to the patient
being ventilated.
Do not use the resuscitator in toxic or hazardous atmosphere.
Never store the resuscitator in a deformed state other than as folded when
delivered by the manufacturer, otherwise permanent distortion of the bag will
occur which may reduce the ventilation efficiency. The folding zone is clearly
visible on the bag (only Adult and Paediatric versions may be folded).
3. Specifications
The Ambu Oval Plus Silicone resuscitator is in conformity with the product
specific standard EN ISO 10651-4. The Ambu Oval Plus Silicone is in conformity
with Council Directive 93/42/EEC concerning Medical Devices.