PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 11, 2012
Applications
Description
The Primo
is a therapeutic mattress equipped with a pressure control system
™
designed to operate in continuous (or static) low-pressure mode. The Primo
therapeutic solution by I-mmersion
shearing effects on the surface of the patient's skin.
The Primo™ comprises a mattress and an external control unit.
It offers the following functionality:
• a CPR valve to facilitate external cardiac massages;
• a maximum inflation mode for greater patient mobility.
Indication
The Primo
therapeutic mattress helps to prevent and treat pressure ulcers in low
™
to moderate risk adult patients, within the recommended patient weight limits of 30
to 150 kg, in order to achieve clinical performance assessed in all the usual
positions of the adjustable head section.
It can be used as a mattress in the following environments, as defined in the
standard IEC 60601-2-52:
• application environment 2 (short-term care in hospitals or other medical
establishments);
• application environment 3 (long-term care in medical establishments);
• application environment 4 (care administered at home);
• application environment 5 (outpatients or ambulatory care).
The Primo
is intended to be used with a sheet between the patient skin and the
™
surface of the mattress.
In accordance with the NPUAP/EPUAP directives
condition of each patient be regularly checked. For patients with special needs,
we recommend the use of the more suitable I-mmersion
Caregivers are responsible for taking this decision, in accordance with modern
care practices.
Contraindication
The Primo
must not be used with patients:
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• suffering from an unstable fracture of the spine.
For any other unstable fractures, a medical examination is necessary to
decide whether the use of the device is appropriate;
• with atypical anatomies;
• suffering from cervical or trans-bone traction.
1. NPUAP / EPUAP - Pressure Ulcer Prevention - Quick Reference Guide, January 2010
NPUAP / EPUAP - Pressure Ulcer Treatment - Quick Reference Guide, December 2009
170924(2) - EN - Primo
that distributes pressure and reduces the
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User manual
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, we recommend that the
1
Therapy system.
™
is a
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