Introduction; Contraindications; Intended Use Of Product; Expected Service Life - Stryker SofCare Manual De Operación Y Mantenimiento

Introduction

This manual is designed to assist with the operation and maintenance of the SofCare Powered Support Surface. Carefully
read this manual thoroughly before using or beginning maintenance on the support surface. To ensure safe operation of
this equipment, it is recommended that methods and procedures are established for educating and training staff on the
safe operation of the support surface.

CONTRAINDICATIONS

Air support therapy is not recommended when spinal stability is a concern. This support surface is not intended to
support a patient in the prone position.

INTENDED USE OF PRODUCT

SofCare is a constant low pressure powered support surface intended to provide pressure redistribution to aid in the
prevention and treatment of pressure ulcers. The system consists of a control unit combined with a mattress. The air cells
redistribute the patient's weight over the surface and aid in the reduction of tissue interface pressure. It is recommended
that the product be operated by personnel who are qualified to perform general nursing procedures and have received
adequate training in the prevention and treatment of pressure ulcers.
This support surface is intended to be used with human patients in a general hospital, nursing home or homecare
environment and for patients at risk of developing pressure ulcers, as well as those who require therapy for pre- existing
pressure ulcers. The safe working load for SofCare is 159 kg /350 lbs; the patient must not exceed safe working load
specified by the support surface, frame, and accessories. Patients shall meet the minimum age requirement of 2 years
old.
SofCare shall be used with a mattress cover at all times.
The support surface is not intended to be a sterile product nor is it intended to include a measuring function.

EXPECTED SERVICE LIFE

The products are intended to offer safe and reliable operation when in use or installed according to the instructions
provided by Stryker Medical. Stryker Medical recommends that the system be inspected and serviced by authorized
technicians if there are any signs of wear or concerns with device function and indication on products. Otherwise,
service and inspection of the devices generally should not be required. SofCare has an expected service life of 2 years.
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