Inspiration Healthcare8
Inspiration Healthcare Limited © 2021 Inspiration Healthcare Limited
W inspiration-healthcare.com
700-307 Revision: 10
Inspiration Healthcare Limited © 2021 Inspiration Healthcare Limited
W inspiration-healthcare.com
700-307 Revision: 10
Intended Use
The Inspiration Healthcare Limited Patient Warming
System, consisting of an Inspiration Healthcare
Limited Controller and heated accessories, is a system
for use in supporting the maintenance of a Patient’s
core body temperature within the normothermic range
between 36.5°C and 37.5°C.
An independent device should be used to regularly
measure the patient’s core body temperature whilst
the system is in use.
Indication for Use
To support the maintenance of normothermia in
patients at risk or who may become at risk of
inadvertent hypothermia within a hospital setting.
The system should be used for all age ranges from
Neonatal to Adult.
Contraindications
It is the responsibility of the user to
determine whether warming is appropriate
for each individual patient. The Patient
Warming System should not be used on patients
where clinical considerations indicate that warming
of the patient is not advisable (e.g. aortic cross
clamping).
Caution should be used when using mattresses
and blanket were patients have ischemic limbs.
The Inspiration Healthcare Limited Patient
Warming System and all its accessories are not
MRI compatible.
A potential increase in delivery of transdermal
medications when in direct contact with either
mattresses or blanket (for example, skin patches)
may cause patient harm.
Avoid direct contact with mattress or blanket in
circumstances where patient’s skin is compromised.
Warnings
The user should carefully read the
instructions for use before using the
Patient Warming System AlphaCore
5
Controller, mattresses and blanket to become familiar
with the function of the equipment.
On a monthly basis, the user should check the
functionality of the thermal cut out by following the
instructions in Section 9. This functional test must
not be used when a patient is in contact with the
warming accessory.
Do not use the Patient Warming System if there is any
sign of damage. Ensure the surface integrity of the
mattresses and/or blanket and replace if necessary.
Do not use the Patient Warming System in the
presence of flammable anaesthetic gases or oxygen
enriched atmospheres (zone of high risk) as these
may pose an explosion hazard.
Do not position the AlphaCore
5
Controller in the path
of a direct X-ray beam (mattresses and blanket are
radiolucent and their performance will not be affected
by X-ray activity).
The time for the mattresses and blanket to reach a
set temperature of 37°C from ambient (23°C ± 2°C)
will vary depending on the size, with a maximum
estimated time of 30 minutes for the smallest to 45
minutes for the largest (these may increase over the
lifetime of the product).
The AlphaCore
5
Controller displays the heated
element temperature, not the patient contact
temperature. Whilst these may be very similar the
actual contact surface may be between 1 and 3°C
lower than the displayed temperature.
3. Safety
To Next Page
