ENGLISH
Intended Use
The A
S
Neonatal A
G
®
™
rctic
un
rctic
el
for use with the A
S
Temperature Management
®
rctic
un
System, to provide energy (heat) transfer between the
patient and the temperature-controlled water circulating
through the Neonatal A
G
Pads in order to provide
™
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el
targeted temperature management.
Indications for Use
The A
S
Temperature Management System is a
®
rctic
un
thermal regulating system, indicated for monitoring and
controlling patient temperature in adult and pediatric
patients of all ages.
Contraindications
• There are no known contraindications for the use of a
non-invasive thermoregulatory system.
• Do not place the Neonatal A
G
rctic
has signs of ulcerations, burns, hives or rash.
• Do not remove the fabric release liner of the Neonatal
A
G
Pad and expose the hydrogel.
™
rctic
el
• Do not place the Neonatal A
G
rctic
immature (non-keratinized) skin or premature babies.
• While there are no known allergies to hydrogel
materials, caution should be exercised with any patient
with a history of skin allergies or sensitivities.
Warning
Do not place the Neonatal A
G
rctic
el
transdermal medication patches as warming can
increase drug delivery and cooling can reduce the drug
delivery, resulting in possible harm to the patient.
Cautions
• Federal law restricts this device to sale by or on the
order of a physician.
• The Neonatal A
G
Pad is only for use with the
™
rctic
el
A
S
Temperature Management System.
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un
• This product is to be used by or under the supervision of
trained, qualified medical personnel.
• The clinician is responsible for determining the
appropriateness of use of this device and the
user-settable parameters, including water temperature,
for each patient.
• Due to underlying medical or physiological conditions,
some patients are more susceptible to skin damage
from pressure and heat or cold. Patients at risk
include those with poor tissue perfusion or poor skin
integrity due to edema, diabetes, peripheral vascular
disease, poor nutritional status, steroid use, or high
dose vasopressor therapy. If accessible, examine the
patient's skin under the Neonatal A
especially those patients at higher risk of skin injury.
• Skin injury may occur as a cumulative result of
pressure, time and temperature.
• Possible skin injuries include bruising, tearing,
skin ulcerations, blistering, and necrosis.
• Do not place bean bags or other firm positioning
devices under the Neonatal A
rctic
• Do not place any positioning devices under the pad
manifolds or patient lines.
• If warranted, use pressure relieving or pressure
reducing devices under the patient to protect from
skin injury.
• Do not allow urine, stool, antibacterial solutions or other
agents to pool underneath the Neonatal A
Urine, stool and antibacterial agents can absorb
into the pad hydrogel and cause chemical injury,
skin irritation, and loss of pad adhesion over time.
Replace pads immediately if these fluids come into
contact with the hydrogel.
• Do not place the Neonatal A
G
rctic
an electrosurgical grounding pad. The combination of
heat sources may result in skin burns.
• If needed, place defibrillation pads between Neonatal
A
G
Pad and the patient's skin.
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• The Neonatal A
G
Pad is non-sterile for single
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el
patient use only. The water content of the hydrogel
affects the pad's adhesion to the skin and conductivity,
and therefore, the efficiency of controlling patient
temperature. Periodically check that pads remain moist
and adherent. Replace pads when the hydrogel no
longer uniformly adheres to the skin. Replacing pads at
least every 5 days is recommended.
Pads are intended
• The Neonatal A
use. Do not reprocess or sterilize. If used in a sterile
environment, pads should be placed according to
the physician's request, either prior to the sterile
preparation or sterile draping.
• Use pads immediately after opening.
• Do not store pads in opened pouch.
• The Neonatal A
with sharp objects. Punctures will result in air entering
the fluid pathway and may reduce performance.
• The Neonatal A
5 days of use.
• Do not allow circulating water to contaminate the
sterile field when lines are disconnected.
• Discard used Neonatal A
with hospital procedures for medical waste.
Pad on skin that
™
el
Directions
1.
Place the patient (1.8 - 4.5 kg; 4.0 - 9.9 lb) on the
pad. Avoid placing the patients over the manifolds
Pad hydrogel on
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el
or other high pressure locations. The rate of
temperature change and potentially the final
achievable temperature is affected by pad surface
area coverage, placement, patient size, and water
temperature range.
2.
The pad surface must be contacting the skin for
optimal energy transfer efficiency.
Pad over
™
a) If desired, the center section of the pad can be
wrapped around the patient's torso and secured in
place using the Velcro tabs provided.
• If this option is in use, ensure that the edges of the
pad are away from articulating areas of the body
to avoid irritation.
• Place pads to allow for full respiratory excursion.
(e.g. ensure free movement of the chest and
abdomen are guaranteed).
• The pads may be removed and reapplied if
necessary.
• Pads should be placed on healthy, clean skin only.
3.
Due to the small patient size (1.8 - 4.5 kg;
4.0 - 9.9 lb) and the potential for rapid patient
temperature change, it is recommended to use the
following settings to the A
Management System:
• Water Temperature High Limit: ≤40°C (104°F)
• Water Temperature Low Limit: ≥10°C (50°F)
• Control Strategy: 2
4.
Due to the small patient size (1.8 - 4.5 kg; 4.0 - 9.9 lb)
it is recommended to use the Patient Temperature
High and Patient Temperature Low alert settings.
G
Pad often;
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rctic
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5.
Place a core patient temperature probe
and connect to the A
Management System Patient Temperature
1 Connector for continuous patient temperature
feedback. A rectal or esophageal temperature
probe is recommended.
6.
Verify patient core temperature with an
G
Pad.
™
el
independent temperature probe before and at
regular intervals during use.
7.
Attach the pad's line connectors to the fluid delivery
line manifolds.
8.
See A
Operators Manual and help screens for detailed
instructions on system use.
G
Pad.
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rctic
el
9.
Begin treating the patient.
10.
If the pad fails to prime or a significant continuous
air leak is observed in the pad return line, check the
connections, then if needed, replace the leaking pad.
Once the pad is primed, assure the steady state flow
rate displayed on the control panel is appropriate.
Pad directly over
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el
The minimum flow rate should be 1.1 L/m.
11.
When finished, purge water from pad.
Any serious incident that has occurred in relation to the
device should be reported to the manufacturer and the
competent authority of the Member State in which the
user and/or patient is established.
G
Pads are for single patient
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rctic
el
G
Pad should not be punctured
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rctic
el
G
Pad must be replaced after
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el
G
Pad in accordance
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el
S
Temperature
®
rctic
un
S
Temperature
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rctic
un
S
Temperature Management System
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rctic
un
3
Symbols Glossary
The FDA required English symbols glossary for Becton
Dickinson (BD) is located at https://www.bd.com/en-us/
symbols-glossary.
FRENCH/FRANÇAIS
Indication
Les coussinets néonataux A
S
rctic
un
sont conçus pour être utilisés avec le système de
gestion de la température A
S
rctic
un
transfert d'énergie (thermique) entre le patient et l'eau
à température contrôlée circulant dans les coussinets
néonataux A
G
pour une bonne gestion de la
™
rctic
el
température ciblée.
Indications d'utilisation
Le système de gestion de la température A
est un système de régulation thermique, permettant de
surveiller et de contrôler la température des patients
adultes et pédiatriques de tous âges.
Contre-indications
• Il n'existe aucune contre-indication connue concernant
l'utilisation d'un système de régulation thermique non
invasif.
• Ne pas placer le coussinet néonatal A
peau présentant des traces d'ulcérations, de brûlures,
d'urticaire ou d'éruption cutanée.
• Ne pas ôter la doublure en tissu du coussinet néonatal
A
G
et exposer l'hydrogel.
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rctic
el
• Ne pas placer l'hydrogel du coussinet néonatal
A
G
sur une peau immature (non kératinisée)
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rctic
el
ni sur les bébés prématurés.
• Bien qu'il n'existe aucune allergie connue aux
matériaux de l'hydrogel, il convient d'être prudent
face à des patients qui présentent des antécédents
d'allergies ou de sensibilité cutanées.
Avertissement
Ne pas placer le coussinet néonatal A
patchs de médicament transdermiques, car la chaleur
peut augmenter la libération du médicament et le froid
peut au contraire réduire la libération du médicament,
ce qui peut être nocif pour le patient.
Mises en garde
• Selon la loi fédérale américaine, ce produit ne peut
être vendu que par un médecin ou sur ordonnance
médicale.
• Le coussinet néonatal A
G
™
rctic
el
utilisé uniquement avec le système de gestion de la
température A
S
.
®
rctic
un
• Ce produit doit être utilisé par du personnel médical
qualifié et formé ou sous sa supervision.
• Le clinicien doit déterminer si l'utilisation de ce
dispositif est appropriée. Il doit aussi établir les
paramètres réglables par l'utilisateur, notamment la
température de l'eau, qui sont appropriés pour chaque
patient.
• Du fait de pathologies ou de particularités
physiologiques sous-jacentes, certains patients sont
plus sensibles aux lésions cutanées dues à la pression,
au froid ou à la chaleur. Les patients à risque incluent
les patients présentant une mauvaise perfusion
tissulaire ou une mauvaise intégrité de la peau en
raison d'un œdème, d'un diabète, d'une maladie
vasculaire périphérique, de carences nutritionnelles,
de l'utilisation de corticoïdes ou d'un traitement par
vasopresseur à forte dose. Si possible, examiner
fréquemment la peau du patient sous le coussinet
néonatal A
G
, en particulier pour les patients
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présentant un risque élevé de lésion cutanée.
• Une lésion cutanée peut résulter de l'association de
la pression, du temps d'application et de la température.
• Les lésions cutanées possibles incluent ecchymose,
déchirure, ulcérations cutanées, ampoules et nécrose.
• Ne pas placer de systèmes de support (beanbags) ou
autres dispositifs de positionnement fermes sous le
coussinet néonatal A
G
.
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rctic
el
• Ne placer aucun dispositif de positionnement sous les
conduits du coussinet ni sur les lignes de patient.
A
G
®
™
rctic
el
, pour assurer le
®
S
®
rctic
un
G
sur une
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rctic
el
G
sur des
™
rctic
el
est prévu pour être