Device Description; Explanation Of Symbols Used; Principle Of Operation - Ambu Mark IV Instrucciones De Uso

1.8. Potential adverse events
Potential adverse events related to resuscitation (not exhaustive): barotrauma, volutrauma,
hypoxia, hypercarbia and aspiration pneumonia.
1.9. General notes
If, during the use of this device, or as a result of its use, a serious incident has occurred,
please report it to the manufacturer and to your national authority.

2. Device description

The Ambu Mark IV can be connected to the Ambu® Disposable Pressure Manometer,
the Ambu PEEP valves and the Ambu face masks, as well as other breathing accessories
complying with EN ISO 5356-1 and EN ISO 13544-2.

3. Explanation of symbols used

Symbol indication Description
Adult
Intended ideal body mass greater than 15 kg.
15 kg
Baby
Intended ideal body mass up to 20 kg.
20 kg
Global Trade Item Number (GTIN™).
Symbol indication Description
Rx Only
Prescription use only.
Lot Number.
Country of Manufacturer.
CN
Medical Device.
MR Conditional.
A full list of symbol explanations can be found on https://www.ambu.com/symbol-explanation.
4. Product use

4.1. Principle of operation

The illustration on page 2 shows the ventilation gas flow into the bag and to and from
1
the patient during manual operation of the resuscitator.
Baby with oxygen reservoir bag, c Mark IV Baby with oxygen reservoir tube.
The gas flow is similar when the patient is breathing spontaneously through the device.
The oxygen reservoir is fitted with two valves, one allowing ambient air to be drawn
in when the reservoir is empty and one spilling out surplus oxygen when the reservoir bag
is full.
1.1 1.2
a Mark IV Adult, Mark IV
b
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