
1. Introducon
CuroCell® UNO is an automated and modern air maress
system designed to provide good comfort while aiding in
the prevenon and treatment of pressure ulcers/pressure
injuries. The system idenes the user and automacally
manages all sengs to adapt the pressure according to the
user’s needs.
Unprevented/untreated pressure ulcers/pressure injuries can
very quickly deteriorate resulng in higher risk of
complicaons, pain and suering for the user.
Always read the instrucons for use prior to use.
For further quesons regarding installaon, use or
maintenance please contact Care of Sweden or your
local distributor.
1.1 General informaon
This system is a medical device with CE marking in accord‐
ance with MDR (EU) 2017/745.
The system has been fully or parally designed and
veried in accordance with the standards listed in
secon 9.2. Standards.
According to statutory regulaons made by the authories
regarding medical devices, the manufacturer is required to
report all accidents or incidents involving the products. We
would be very grateful for all informaon involving accidents
or incidents relang to our products, by reporng them
immediately to us, at Care of Sweden.
1.2 Intended use
The systems consist of a control unit acvely controlling and
managing the air ow in the maress, enabling them to be
used for prevenon and as an aid in the treatment of pres‐
sure ulcers/pressure injuries (PU/PI).
1.3 Indicaons
Suitable for a wide range of persons
with increased risk for pressure ulcers/
injuries, including those with superci‐
al ulcers, up to category 4 and unclas‐
sied PU/PI (unstageable and suspected deep ssue injury)1
(in associaon with an individualised plan of care).
The maresses are intended for use by persons of a recom‐
mended minimum length of 120 cm.
1.4 Contraindicaons
There are no known contraindicaons.
1.5 Intended user
The maress systems are intended to be used by all kind of
users, including lay persons.The maress systems are intend‐
ed to be used by all kind of users, including lay persons.
1.6 Intended use environment
The maress systems can be used in all kinds of health care
environments, including home care.
We recommend that posion changes are made regularly.
The me interval must be evaluated by the responsible
personnel, depending on the user’s status, diagnosis and
general condion. The maress should only be used lying in
the lengthwise direcon on the mat‐tress with the feet at the
end, marked with the feet symbol.
No training or special skills are required for the use of Curo‐
Cell® A4. It is designed to be easy to handle and understand,
reading the quick guide and the instrucons for use before
use is recommended. Prescripon shall be made by persons
authorized for prescripons and with clinical educaon. Note
that the user also may be the operator.
(1) European Pressure Ulcer Advisory Panel, Naonal Pressure
Injury Advisory Panel and Pan Pacic Pressure Injury Alliance. Pre‐
venon and Treatment of Pressure Ulcers/Injuries: Clinical Pracce
Guideline. The Internaonal Guideline. Emily Haesler (Ed). EPUAP/
NPIAP/PPPIA: 2019
1.7 Other informaon
Acon plan for pressure ulcers/pressure injuries
For the best possible results when using this product, we
recommend a structured and planned approach. Examples
that can be applied to the use of our products can be found
in the ‘Acon plan for pressure ulcers’ guidelines.
The Maress Guide
This guide provides guidance to personnel and prescribers
when choosing a maress from Care of Sweden. The
CuroCell UNO® is a maress in funcon group C.
This informaon can be obtained from our website, www.
careofsweden.com, or ordered from Customer Services
(see contact informaon on the nal page).
NOTE:
1. For certain users, e.g. amputees, the recommended length
measurement may not be reached. Users in these groups may,
however, require other sengs, as the enre surface is not
under load. For funcon controls, refer to secon 2.3.
2. When used together with posioning pillows, read the
pillow instrucons for use carefully for correct posioning of
the user.
3. Whenever this product is used with evacuaon equipment,
it is the responsibility of the authorised personnel to ensure
that evacuaon can be performed safely.
4. Be careful when using bed rails or other protecon on
the bed so that the maress does not become crushed
or damaged.
5. The maress must not be lied with a person lying on it, or
used for any other type of transport other than as
recommended in these instrucons.
6. This maress is unsuitable for use during x‐ray
examinaons because of the risk of blurred images or
artefacts that may lead to diagnosc errors.
7. If the system is used with an unreliable mains power supply,
the variant with a backup baery is recommended. In the
event of a power cut or similar, the maress will retain air for
at least eight hours.
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