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 Mark IV 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 compression 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 due to the
risk of cross-infection.
16. Do not use the product with 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 signs of complete/partial upper airway obstruction 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 Mark IV 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 Mark IV 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 attached face mask, ensure correct positioning
and sealing of the face mask, as improper sealing can lead to spreading of airborne
infectious disease to the user.
8
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 product lifetime.
3.
Never store the resuscitator in a deformed state, otherwise permanent distortion of
the bag could occur, which may reduce the ventilation efficiency.
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 achieved.
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.
6.
Do not attempt to disassemble the resuscitator further than described in these
instructions 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 Mark IV may influence product performance. Please
consult the manufacturer of the third-party device to verify compatibility with
Ambu Mark IV and obtain information on the possible performance changes.
9.
Always keep components from same device together during reprocessing
to avoid reassembly of components with different durability leading to the risk
of product failure.
10. U.S federal law restricts this device to sale by or on the order of a licensed health
care practitioner.