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1
Introduction
These air mattress systems may be used as an
aid to prevent and treat pressure
ulcers/pressure injuries.
CuroCell® iA Automatic is a control unit that
sets the air pressure in the mattress based on
the patient's length, weight, and position
without need for manual settings. It offers the
operator the option to adjust program and
comfort.
CuroCell® iA Manual is a control unit where the
operator must manually adjust the pressure in
the mattress based on the weight of the
patient.
CuroCell® iA Automatic and CuroCell® iA
Manual are compatible with six different
mattresses: CuroCell® Ci10, CuroCell® Ci17,
CuroCell® Ci20, CuroCell® Ci10 PRO, CuroCell®
Ci17 PRO and CuroCell® Ci20 PRO. See more
information about the mattresses in section
6.3.
Always read the instructions for use
prior to use.
1.1
General information
The system is a medical device with CE marking
in accordance with MDR (EU) 2017/745.
According to this regulation the manufacturer
is required to report all accidents or incidents
involving the products. All information
involving accidents or incidents relating to our
products, shall be reported immediately to
Care of Sweden.
1.2
Intended purpose
The mattress system consists of a control unit
and a mattress and is intended to be used for
prevention and as an aid in the treatment of
pressure ulcers/pressure injuries (PU/PI).
1.3
Intended user
The mattress system is intended to be used by
all kind of patients, including lay persons. Note
that the patient and operator could be the
same person. The mattresses are intended for
use by patients of a recommended minimum
length of 120 cm.
The specifications for weight are listed in the
following table.
Mattress
CuroCell® Ci10
CuroCell® Ci17
CuroCell® Ci20
CuroCell® Ci10 PRO
CuroCell® Ci17 PRO
CuroCell® Ci20 PRO
1.4
Intended use environment
The mattress system is intended to be used in
all kinds of health care environments, including
home care.
1.5
Indications
Suitable for a wide range of patients with
increased risk for pressure ulcers/injuries,
including those with superficial ulcers, up to
category IV in association with an individualized
plan of care.
1.6
Contraindications
There are no known contraindications. It is
necessary for the prescriber of the mattress to
make an individual assessment of the patient
and decide whether the characteristics of the
mattress is beneficial for the patient based on
diagnosis.
3
Recommended
patient weight
≤ 170 kg
≤ 200 kg
≤ 230 kg
≤ 180 kg
≤ 210 kg
≤ 240 kg
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