Intended Use - Ambu Mark IV Resuscitator Mode D'emploi

1. Intended use

The Ambu® Mark IV and Ambu® Mark IV Baby is a reusable resuscitator intended for
pulmonary resuscitation.
The range of application for each version is:
- Mark IV: Adults and children with a body weight more than 15 kg (33 lbs.)
- Mark IV Baby: Neonates, infants and children with a body weight up to 20 kg (44 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 (22lbs.), 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.
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.
Do not force the outer cover of the bag to bulge locally by closing the patient
connector and squeezing the bag so hard with your hand that a local bulge
appears on the outer cover - this has an extreme impact on the material.
3. Specifications
The Ambu Mark IV and Ambu Mark IV Baby resuscitators are in conformity with
the product specific standard EN ISO 10651-4. The Ambu Mark IV and Ambu
Mark IV Baby are in conformity with Council Directive 93/42/EEC concerning
Medical Devices.