Ambu SPUR II, Instructions For Use Manual

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1. Important information – Read before use
Read these safety instructions carefully before using the Ambu® SPUR® II Resuscitator. 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 the Ambu SPUR II Resuscitator.
1.1. Intended use
The Ambu SPUR II Resuscitator is a single patient use resuscitator intended for
pulmonary resuscitation.
1.2. Indications for use
The Ambu SPUR II Resuscitator is intended to be used in situations where a manual
cardio-pulmonary resuscitator is needed for assisted ventilation.
The Ambu SPUR II Resuscitator is indicated for ventilation and oxygenation of patients
until a more definitive airway can be established or the patient has recovered.
1.3. Intended patient population
The size range of applications for each version is:
–
Adult:
Adults and children with a body weight more than 30 kg (66 lb).
– Pediatric: Infants and Children with a body weight from 6 kg to 30 kg (13 – 66 lb).
– Infant: Neonates and infant with a body weight up to 10 kg (22 lb).
Please note that not all Ambu SPUR II Resuscitator configurations are available for all three
patient ranges.
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 and oxygenation
of the patient or damage to the equipment.
WARNINGS
1. Do not use the resuscitator for more than 4 accumulated hours over a maximum
time span of 1 week, in order to avoid the risk of infection.
2. Do not reuse the resuscitator if visible moisture or residues are left inside the
device, in order to avoid the risk of infection and malfunction.
3. Ensure that either the Splash Guard or 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 can lead to tissue trauma.
4. Avoid the use of the resuscitator in toxic or hazardous environments, to avoid the
risk of tissue damage.