en
9
6� Do not attempt to disassemble the resuscitator further than described in this
instruction due to the risk of device damage and malfunction�
7� If applicable, please see accessory packaging for more specific information
about the individual accessory as incorrect handling may lead to malfunction of
the entire product�
8� The use of third-party products and oxygen delivery devices (e�g� filters and
demand valves) with the Ambu Oval Plus Silicone Resuscitator may influence
product performance� Please consult the manufacturer of the third-party device
to verify compatibility with the Ambu Oval Plus Silicone Resuscitator and obtain
information on the possible performance changes�
9� Always keep components from the same device together during reprocessing to
avoid reassembly of components with different durability leading to the risk of
product failure�
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 Oval Plus Silicone Resuscitator 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 30 kg
Pediatric
Intended ideal body mass from 10 kg
to 30 kg
Neonate
Intended ideal body mass up to 10 kg
Symbol indication
Description
Symbol indication
Description
Global Trade Item
Number (GTIN™)
Lot Number
CN
Country of
Manufacturer
Medical Device
MR Conditional
A full list of symbol explanations can be found on ambu�com/symbol-explanation�