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1. Important information – Read before use
Read these safety instructions carefully before using the Ambu® Mark IV Resuscitator
(for adult and children > 15 kg, referred to as Ambu Mark IV Adult) and Ambu® Mark IV Baby
Resuscitator (for neonates, infants and children up to 20 kg, referred to as Ambu Mark IV
Baby), collectively referred to as Ambu Mark IV. The Instructions for use may be updated
without further notice. Copies of the current version are available upon request. Please be
aware that these instructions do not explain or discuss clinical procedures. They describe
only the basic operation and precautions related to the operation of the resuscitator. Before
initial use of the resuscitator, it is essential for operators to have received sufficient training
in resuscitation techniques and to be familiar with the intended use, warnings, cautions, and
indications mentioned in these instructions. There is no warranty on Ambu Mark IV.
1.1. Intended use
The Ambu Mark IV is a reusable resuscitator intended for pulmonary resuscitation.
1.2. Indications for use
The Ambu Mark IV is indicated in situations where a manual cardio-pulmonary resuscitator
is needed for assisted ventilation of patients.
The Ambu Mark IV is indicated for ventilation and oxygenation of patients until a more
definitive airway can be established or the patient is recovered.
1.3. Intended patient population
The range of application for each size is:
•
Size Adult: Adults and children with a body weight more than 15 kg (33lb).
•
Size Baby: Neonates, infants and children with a body weight up to 20 kg (44 lb).
1.4. Intended user
Medical professionals trained in airway management such as anesthesiologists, nurses,
rescue personnel and emergency personnel.
1.5. Contra indications
None known.
1.6. Clinical benefits
The basic airway management technique using a manual resuscitator allows for ventilation
and oxygenation of patients until a more definitive airway can be established or the
patient has recovered.
1.7. Warnings and cautions
Failure to observe these precautions may result in inefficient ventilation of the patient or
damage to the equipment.
WARNING
1.
Always reprocess the Ambu Mark IV after each use in order to avoid the risk of infection.
2.
Avoid the use of the resuscitator in toxic or hazardous environments to avoid the
risk of tissue damage.
3.
When using supplemental oxygen, do not allow smoking or use of the device near
open flame, oil, grease, other flammable chemicals or equipment and tools, which
cause sparks, due to the risk of fire and/or explosion.
4.
Always visually inspect the product and perform a functionality test after
unpacking, assembly and prior to use, as defects and foreign matter can lead to no
or reduced ventilation of the patient.
5.
Do not use the product if the functionality test fails, as this can lead to no or
reduced ventilation.
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, PEEP valve, 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 cause infection.
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