Introduction - Care of Sweden CuroCell UNO Instructions For Use Manual

1. Introduction

CuroCell® UNO is an automated and modern air mattress
system designed to provide good comfort while aiding in
the prevention and treatment of pressure ulcers/pressure
injuries. The system identifies the user and automatically
manages all settings to adapt the pressure according to the
user's needs.
Unprevented/untreated pressure ulcers/pressure injuries can
very quickly deteriorate resulting in higher risk of
complications, pain and suffering for the user.
Always read the instructions for use prior to use.
For further questions regarding installation, use or
maintenance please contact Care of Sweden or your
local distributor.
1.1 General information
This system is a medical device with CE marking in accord‐
ance with MDR (EU) 2017/745.
The system has been fully or partially designed and
verified in accordance with the standards listed in
section 9.2. Standards.
According to statutory regulations made by the authorities
regarding medical devices, the manufacturer is required to
report all accidents or incidents involving the products. We
would be very grateful for all information involving accidents
or incidents relating to our products, by reporting them
immediately to us, at Care of Sweden.
1.2 Intended use
The systems consist of a control unit actively controlling and
managing the air flow in the mattress, enabling them to be
used for prevention and as an aid in the treatment of pres‐
sure ulcers/pressure injuries (PU/PI).
1.3 Indications
Suitable for a wide range of persons
with increased risk for pressure ulcers/
injuries, including those with superfici‐
al ulcers, up to category 4 and unclas‐
sified PU/PI (unstageable and suspected deep tissue injury)1
(in association with an individualised plan of care).
The mattresses are intended for use by persons of a recom‐
mended minimum length of 120 cm.
1.4 Contraindications
There are no known contraindications.
1.5 Intended user
The mattress systems are intended to be used by all kind of
users, including lay persons.The mattress systems are intend‐
ed to be used by all kind of users, including lay persons.
1.6 Intended use environment
The mattress systems can be used in all kinds of health care
environments, including home care.
We recommend that position changes are made regularly.
The time interval must be evaluated by the responsible
personnel, depending on the user's status, diagnosis and
general condition. The mattress should only be used lying in
the lengthwise direction 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 instructions for use before
use is recommended. Prescription shall be made by persons
authorized for prescriptions and with clinical education. Note
that the user also may be the operator.
NOTE:
1. For certain users, e.g. amputees, the recommended length
measurement may not be reached. Users in these groups may,
however, require other settings, as the entire surface is not
under load. For function controls, refer to section 2.3.
2. When used together with positioning pillows, read the
pillow instructions for use carefully for correct positioning of
the user.
3. Whenever this product is used with evacuation equipment,
it is the responsibility of the authorised personnel to ensure
that evacuation can be performed safely.
4. Be careful when using bed rails or other protection on
the bed so that the mattress does not become crushed
or damaged.
5. The mattress must not be lifted with a person lying on it, or
used for any other type of transport other than as
recommended in these instructions.
6. This mattress is unsuitable for use during x‐ray
examinations because of the risk of blurred images or
artefacts that may lead to diagnostic errors.
7. If the system is used with an unreliable mains power supply,
the variant with a backup battery is recommended. In the
event of a power cut or similar, the mattress will retain air for
at least eight hours.
(1) European Pressure Ulcer Advisory Panel, National Pressure
Injury Advisory Panel and Pan Pacific Pressure Injury Alliance. Pre‐
vention and Treatment of Pressure Ulcers/Injuries: Clinical Practice
Guideline. The International Guideline. Emily Haesler (Ed). EPUAP/
NPIAP/PPPIA: 2019
1.7 Other information
Action 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 'Action plan for pressure ulcers' guidelines.
The Mattress Guide
This guide provides guidance to personnel and prescribers
when choosing a mattress from Care of Sweden. The
CuroCell UNO® is a mattress in function group C.
This information can be obtained from our website, www.
careofsweden.com, or ordered from Customer Services
(see contact information on the final page).
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