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3. Product Description
3.1 Intended Medical Use
3.1.1 Product name
Resuscitator
3.1.2 Intended Use
Provide or assist ventilation in patients whose breathing is inadequate.
3.1.3 Indications
The different models are indicated for different people according to their weight.
3.1.4 Contraindications
1. Adult resuscitator
No existing contraindications for using resuscitator to adult people.
2. Child resuscitator
No existing contraindications for using resuscitator to child people.
3. Infant resuscitator
a) Meconium‐stained baby depressed at birth
b) Congenital diaphragmatic hernia
3.1.5 Patient Group
The adult resuscitator is for people with a body weight of more than 30 kg (66 lbs.)
The child resuscitator is for children with a body weight between 7 and 30 kg (15‐66 lbs.)
The infant resuscitator is for infants with a body weight up to 7 kg (15 lbs.)
3.1.6 Intended User
This product is intended for use by qualified medical or emergency personnel trained in pulmonary
ventilation and advanced cardiac life support techniques.
3.1.7 Principles of Operation
Assembly view of an artificial respiration system (A)
(A) Non‐rebreathing (duckbill) Valve (B) Compressed Bag (C) All in 1 intake valve (D) Oxygen Reservoir. The Oxygen
Reservoir may be removed if supplemental oxygen is not to be supplied.