6
KOHJ-H-13-EN1-2.0-19042022
2 Introduction
2.1 Intended use and target patients
A mattress system for the prevention and treatment of pressure ulcers in prematurely
born patients (> 500 g) with high and very high risk of pressure ulcers or in newborn pa-
tients, i.e. in mature infants under 28 days of age and older children weighing up to 6 kg.
2.2 Operating environment and user profile
Intended for use in incubators (Neo
ICU
) as well as in neonate warmers and baby stations
(Neo
IW
) in professional healthcare environments (standard wards and intensive care).
The user can be a healthcare professional who has read the user’s guide and understands
the basic operating principle and use of the mattress system.
2.3 Indications
The indications include use in healthcare for the patient group mentioned in section 2.1
– in the treatment and prevention of pressure ulcers in burn patients
– in the prevention of pressure ulcers in special patient groups, such as patients who
undergo extracorporeal membrane oxygenation (ECMO) or therapeutic hypothermia
or who have spinal or other severe or unstable fractures
– in the treatment of pressure ulcers, regardless of the classification or stage (I–IV) of
the pressure ulcer, including stage non-specific ulcers/injuries.
The devices are also indicated for pain management in the above-mentioned patients.
2.4 Contraindications
No known contraindications.
2.5 System description
Carital
®
Neo
ICU
and Neo
IW
mattress systems have tunnel-shaped cells that adjust to the
body of the patient. The cells are interconnected, forming three separate adjustment
regions (head, torso, feet). All cells respond to the weight, profile and position of the
body, distributing the load evenly across all cells.
1. Initial situation
2. Adjusted mattress
3. The shape of an adjusted
mattress without a patient.
The Carital
®
principle: Maximizes contact area,
minimizes contact pressure and tissue deformation.
Operating principle of Carital
®
: maximizes contact surface area, minimizes contact pressure and tissue deformation
1. Initial situation
2. Adjusted mattress
3. Shape of the adjusted mattress with no patient
IET-H-01-1.1-en
