8
6� Only to be used by intended users who are familiar with the content of this manual,
as incorrect use might harm the patient�
7� Professionals performing the procedure should assess the choice of resuscitator
size and accessories (e�g� face mask, etc�) in accordance with the patient's specific
condition(s), as incorrect use may harm the patient�
8� Do not use the product if contaminated by external sources, as this can lead
to infection�
9� Ensure that either the splash guard or an Ambu PEEP Valve is attached to the
expiratory port� An open expiratory port can be accidentally blocked and result in
excessive air volume in the lungs, which could lead to tissue trauma�
10� The Manometer cap must always be put on the Manometer port when pressure is
not being monitored to avoid leakage, which may lead to reduced O₂ delivery to
the patient�
11� Always reprocess the Ambu Oval Plus Silicone Resuscitator if visible residues
or moisture are left inside the device, in order to avoid the risk of infection and
malfunction�
12� Do not override the pressure-limiting valve unless a medical assessment indicates
the necessity� High ventilation pressures may cause barotrauma�
13� Always ensure that the oxygen reservoir tube is not blocked, as blocking the tube
can prevent the compressible bag from reinflating, which can result in no possible
ventilation�
14� Adding accessories may increase inspiratory and/or expiratory resistance�
Do not attach accessories if increased breathing resistance would be detrimental
to the patient�
15� Do not reuse the resuscitator on another patient without reprocessing it due to
the risk of cross infection�
16� Do not use the product with an attached face mask when ventilating infants
with congenital diaphragmatic hernia due to the risk of insufflation� Switch to
an alternative to using a face mask for directing air to the patient, if available�
17� Be aware of complete/partial upper airway obstruction signs when using the
resuscitator attached to a face mask, as this will lead to no or limited oxygen
delivery� Always switch to an alternative to using a face mask for directing air to the
patient, if available�
18� Do not use the Ambu Oval Plus Silicone Resuscitator after reprocessing a maximum
of 30 times (15 times for the oxygen reservoir bag) in order to avoid the risk of
infection or malfunction of the device�
19� Do not use the Ambu Oval Plus Silicone Resuscitator when delivery of free-flow
oxygen is needed due to possible insufficient administration of oxygen, which can
lead to hypoxia�
20� When using the resuscitator with an attached face mask, ensure correct positioning
and sealing of the face mask, as improper sealing can lead to spreading of airborne
infectious diseases to the user�
CAUTIONS
1� Do not use substances containing phenols to clean the product� Phenols will
cause premature wearing and degradation of the materials resulting in reduced
product life span�
2� After cleaning, promptly remove all residues of detergent from the resuscitator,
as residues may cause premature wear or reduce the product lifetime�
3� Never store the resuscitator in a deformed state other than as folded when
delivered by the manufacturer, otherwise permanent distortion of the bag could
occur, which may reduce the ventilation efficiency� The folding zone is clearly
visible on the bag (only Adult and Pediatric versions may be folded)�
4� Always watch the movement of the chest and listen for the expiratory flow from
the patient valve in order to check the ventilation� Switch immediately to mouth-
to-mouth ventilation if ventilation with the resuscitator cannot be obtained�
5� Do not attempt to disconnect the patient connector from the patient valve as
these are permanently attached, and disassembly might lead to device damage
and malfunction�
