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Device Information
Description of the Device
The two principle components of the SAPPHIRE SERIES® Static Low-Air-Loss Mattress
Replacement System are a specialized air inflatable bladder (air mattress) and an electrically
powered Blower / Control Unit.
Purpose of the Device
The purpose of the Sapphire Series® Static Low-Air-Loss Mattress Replacement System is to
provide therapeutic benefit to patients at risk or suffering from pressure ulcers.
The active component that has contact with the patient is a specialized, multi-cell air mattress
sized to fit a standard medical bed frame. The air mattress serves as a replacement mattress and
is equipped with 4 air hoses with connectors that mate with the Blower / Control Unit. The
Control Unit is a self-contained, totally enclosed module that hangs by hinged hooks on the bed
frame at the foot of the bed or sits on the floor under the bed.
The Sapphire Series® Static Low-Air-Loss Mattress Replacement System has a detachable
hospital grade electrical cord and a control panel with selector switches and indicator lights. The
switches and indicators are protected under a flexible membrane to keep out liquid spills and
enhance clean-up and sanitation. Inside the Control/Blower Unit is a variable output blower, a
valve motor and air valves that allow the air mattress to operate in static mode. There is also a
printed circuit board, which provides the electrical controls.
Indications for Use
The Sapphire Series® Static Low-Air-Loss Mattress Replacement System is a 3-zoned Clinically
Effective Low Air Loss therapy mattress with optimal pressure redistribution therapeutic
mattress that provides either active or reactive pressure redistribution. When mobility, moisture
and/or inactivity are healthcare concerns, it is indicated for the prevention and treatment of
pressure ulcers and other skin related injuries.
