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Intended Use - Stryker InTouch FL27 Wartungshandbuch

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Introduction

INTENDED USE

This manual is designed to assist you with the maintenance of Stryker InTouch® Critical Care Bed Model
FL27 (2151/2152,
2153/2154, 2155/2156) .
Carefully read this manual thoroughly before using the equipment or beginning maintenance on
it . To ensure safe operation of this equipment, it is recommended that methods and procedures be established for
educating and training staff on the safe maintenance of this
bed .
This Maintenance Manual is an integral part of the bed and should be included if the bed is sold or transferred .
BRIEF PRODUCT DESCRIPTION AND INTENDED USE STATEMENT
INTENDED MEDICAL INDICATIONS: In-touch is an AC-powered adjustable hospital bed designed to position patients
for procedures, therapy, and recovery in healthcare environment, transport patients between bays and procedural rooms,
provide patient security, measure and display patient weight, allow patients to alert caregiver when the patient requires
emergency assistance or any assistance to improve comfort levels, and monitor patient position to alert caregiver of a
deliberate exit or potential fall . The bed has thirty-nine prerecorded clinical phrases in 24 languages and offers music
therapy .
INTENDED PATIENT POPULATION: The intended patient population is acute-care human patients . The safe working load
(i .e . the sum of the patient, the mattress, and accessory weight) for InTouch is 550lbs (250kg) . This bed is not intended
for use with patients 35 inches or less and/or patients that weigh less than 50 pounds .
INTENDED PART OF THE BODY: InTouch is intended to support a patient . It is intended to be used with a sleep surface .
The Frame can come in contact with human skin but a patient should never be on the frame without a support surface .
INTENDED USER PROFILE: InTouch is intended for use in Acute Care settings . These settings may include critical
care, step down, progressive care, med/surg, sub-acute care, and post anesthesia care unit (PACU) or other locations
as prescribed . Intended operators are health care professionals (nurses, nurse aids, doctors) which can use all bed
operations (e .g ., bed motion functions, nurse call, siderail communications, bed exit, therapy options), patient and
bystander, which can use bed motion functions, nurse call & siderail communications, and trained professionals for
installation, service, and calibration .
INTENDED CONDITION OF USE AND EXPECTED LIFE: Stryker Medical Bed products are designed for a 10 year
expected service life under normal use, conditions, and with appropriate periodic maintenance as described in the
maintenance manual for each device . Stryker warrants to the original purchaser that the welds on its Bed products will
be free from structural defects for the expected 10 year life of the Bed product as long as the original purchaser owns
the products .
The product is intended to be used in a healthcare environment, including hospitals, surgery centers, long term acute
care centers, and rehabilitation centers . The intended environmental conditions are 10 to 40 degrees Celsius and 30 to
75% RH . The product is compatible with 35" x 84" surfaces, the facility nurse call system, standard Med-Surg equipment,
and the facility infrastructure . InTouch is intended to be used with a 6"-8 .5" sleep surface; asleep surface or overlay
greater than 6" that offers therapeutic value may be used with, patient supervision .
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2151-109-006 REV A
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