Molnlycke BARRIER EasyWarm+ Gebrauchsanweisung

Active self-warming blanket
Product description
The active self-warming blanket BARRIER EasyWarm+ is a non-sterile single-use
blanket, intended to help prevent the patient from cooling during the perioperative
period. The blankets are individually packed in vacuum bags. After removal of the
blanket from the vacuum bag, the warming pads will start to generate heat when
exposed to air. BARRIER EasyWarm+ upper and lower parts can easily be detached and
re-attached via a hook-and-loop function, to suit different surgical patient positions.
BARRIER EasyWarm+ consists of:
• Two layers (blue top layer and a white reverse side) of SMS (Spunbond Meltblown
Spunbond) nonwoven polypropylene fabric with pockets on the top side.
• The layers and pockets are sewn together with polyester thread and the edge is
closed with nonwoven polypropylene.
• Warming pads of air permeable bags containing iron powder, active charcoal, water,
salt and sodium acrylate, are placed inside the pockets of the blanket.
Indications for use
The active self-warming blanket is intended to help prevent the patient from cooling
during the perioperative period.
Contraindication(s)
• Do not use the product on patients below 18 years of age
• The blanket shall not be used on patients with severe impairment to peripheral
(including skin) circulation, e.g.
- severe hypotension;
- where prolonged hypotension can be expected;
- severe peripheral vascular disease;
- aortic surgery, distal to aortic cross clamping
- severe heart failure/cardiogenic shock
• The blanket must not be used in an oxygen-rich environment; i.e. blanket must not
be used in hyperbaric medicine and the warming pads should not come in contact
with the flow of oxygen-based therapy or devices.
Failure to take these contraindication into account may result in thermal injuries.
Warning(s)
• The blanket is not sterile. Take appropriate precautions, as necessary, to protect the
sterile field.
Precaution(s)
• Do not use BARRIER EasyWarm+ on a patient with known hypersensitivity to the
materials of the product.
• It is recommended to avoid direct skin contact in areas with bruising, swelling and
frostbite.
• The warming pads are magnetic and not translucent. The blanket must be removed
prior to images being taken by MRI or X-ray devices.
• Heat generated from the blanket may result in increased drug delivery from
transdermal medication systems (patches).
• Do not reuse. If reused performance of the product may deteriorate, cross
contamination may occur.
The blanket should not be folded over itself.
Fixation belts, tape, straps or supplemental
bedding shall not be used on top of the
blanket.
The blanket shall not be used on patients
with severe impairment to peripheral
(including skin) circulation.
Mölnlycke Health Care AB
Gamlestadsvägen 3C, Box 13080, SE-402 52 Göteborg, Sweden
www.molnlycke.com
Instructions for use
BARRIER EasyWarm+ should be
used by or under the supervision
of a qualified health care
professional.
BARRIER EasyWarm+ is intended
for perioperative use in hospitals.
BARRIER EasyWarm+ should be
used in ambient temperatures
18–24°C.
1. Remove from packaging by
tearing at pre-cut tab.
2. Open and unfold the blanket
completely.
3. Allow approx. 30 minutes for
the blanket to warm.
4. Place the blanket on the
patient with the white side
of the blanket towards the
patient. Correct side indicated
by "THIS SIDE UP" marking on
the blanket.
The blanket should not be placed
on patient's face.
Do not tuck the blanket under patient's arms, legs or body and do not place the blanket
under the patient. The anaesthetized patient's hands, arms and limbs should not be
placed on top of the blanket.
Fixation belts, tape, straps or supplemental bedding shall not be used on top of the
blanket.
No extra weight or pressure should be added to the top of the blanket including
supplemental bedding products, medical instruments and other weight bearing
objects.
Monitor cutaneous response regularly, according to clinical judgment.
When accessing the patient, turn or slide the blanket and do not fold the blanket over
itself.
The blanket can be detached and re-attached via the hook-and-loop, to suit different
surgical patient positions. See www.molnlycke.com for more information.
The maximum time duration that the blanket can be used is 10 hours.
Special storage conditions and handling conditions:
Disposal should be handled according to local environmental procedures.
Other information
If any serious incident has occurred in relation to the use of BARRIER EasyWarm+ it
should be reported to Mölnlycke Health Care and to your local competent authority.
The Mölnlycke and BARRIER
globally to one or more of the Mölnlycke Health Care Group of Companies.
Monitor cutaneous response regularly,
according to clinical judgment.
The warming pads must be facing up,
with the white side of the blanket towards
the patient. Correct side indicated by
"THIS SIDE UP" marking on the blanket.
NON
STERILE
RCD No. 001351852
EasyWarm trademark, name and logo are registered
® ®
Made in China