Intended Use - Ambu SPUR II Instrucciones De Uso

1. Intended use

The Ambu® SPUR® II resuscitator is a single patient use 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 30 kg (66 lbs).
- Infant: Neonates and infant with a body weight up to 10kg (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 profes-
sional 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.
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.
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.
For single patient use only. Use on other patients can cause cross infection. Do not
soak, rinse, or sterilize this device as these procedures may leave harmful residues
or cause malfunction of the device. The design and material used are not compati-
ble with conventional cleaning and sterilization procedures.
Never store the resuscitator in a deformed state other than as folded when deliv-
ered 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 SPUR II resuscitator is in conformity with the product specific standard
EN ISO 10651-4. The Ambu SPUR II is in conformity with Council Directive 93/42/EEC
concerning Medical Devices.
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