Healthniture HBB500, Instructions For Use Manual

Page: 12 / 61

2. Clinical Applications
Intended purpose
The bed is suitable for use in Application Environments 1, 2 and 3 as
defined in UNI CEI EN 60601-2-52:2016
Application Environment 1
Intensive/critical care provided in a hospital where 24-hour medical
supervision and constant monitoring is required, e.g. ITU, ICU and
CCU.
Application Environment 2
Acute care provided in a hospital or other medical facility where
medical supervision and monitoring is required, e.g. general medical
and surgical wards.
Application Environment 3
Long term care in a medical area where medical supervision is
required and monitoring is provided if necessary, e.g. nursing homes
and geriatric facilities.
Indications
and intended patient
group
This bed is for adults (UNI CEI EN 60601-2-52:2016) and it is
appropriate for high dependency obese patients who pose a
movement and handling risk and/or whose clinical condition requires
that they are positioned with minimal physical handling.
The use of this bed is reserved for medical personnel, professionals
and/or people aware of the content of this IFU.
Patients with a moderate amount of independence can, at the
carer’s discretion, use the controls to adjust their own position.
The mattress platform can be positioned to assist with treatment of a
patient as required within the clinical settings defined in Application
Environments 1, 2 and 3.
The correct use of this medical device, according to this IFU,
represents a valid support to improve patient’s health.
IFU-HBB500-ENG-2021#ed02-May 12