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2 FCE1385B (PIC-00391)
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Revision: 03/26/20
TABLE OF CONTENTS
ENTRAPMENT .......................................................................................................................... Page 3
Summary of FDA’s Dimensional Recommendations .......................................................... Page 4
SPECIAL NOTES AND WARNINGS ........................................................................................ Page 5
SAFETY SUMMARY AND OPERATING INFORMATION ...................................................... Page 6
SPECIFICATIONS ..................................................................................................................... Page 7
LOCATING THE SERIAL NUMBER.......................................................................................... Page 7
PACKAGING AND HANDLING ................................................................................................ Page 8
INSTALLING OPTIONAL HEAD AND FOOTBOARDS .......................................................... Page 9
INSTALLING OPTIONAL ASSIST RAILS ................................................................................ Page 10
BED OPERATION ..................................................................................................................... Page 12
ELECTRONICS .......................................................................................................................... Page 12
BATTERY BACKUP ................................................................................................................... Page 13
TROUBLESHOOTING ............................................................................................................... Page 14
ACTUATOR REPLACEMENT ................................................................................................... Page 16
BED SCHEMATIC ...................................................................................................................... Page 17
REPLACEMENT PARTS ........................................................................................................... Page 18
REORDER GUIDE ..................................................................................................................... Page 19
MAINTENANCE ........................................................................................................................ Page 20
MAINTENANCE SCHEDULE ................................................................................................... Page 21
WARRANTY INFORMATION .................................................................................................. Page 24
ENTRAPMENT
WARNING: REDUCING THE RISK OF ENTRAPMENT
Proper patient assessment and monitoring, along with proper maintenance and use of the
hospital bed system is required to reduce the risk of entrapment. The term “hospital bed
system” encompasses the bed frame and its components, including the mattress, side rails,
head and footboards and accessories to the bed. Variations in bed rail dimensions and
mattress thickness, size and/or density could increase the risk of entrapment.
The FDA and The Hospital Bed Safety Workgroup (HBSW) have developed written guidance
that outlines specific potential entrapment zones in hospital bed systems, “Hospital Bed
System Dimensional and Assessment Guidance to Reduce Entrapment”. The entrapment
zones represent the relationship of the various bed system components which are under the
control of the bed user and the healthcare facility. Compliance to the FDA guidelines to reduce
entrapment risk is ultimately the responsibility of the bed user and the healthcare facility. It
is strongly recommended that all personnel involved with hospital bed system maintenance,
service or use, should understand the FDA Guidelines. Visit the FDA website at http://www.
fda.gov to acquire a copy of the guidelines and learn about the risks of entrapment.
The Medline FCE1385B bed system and corresponding rails (FCE1232RSR, FCE1232RSRN,
FCE1232RSRXT, FCEQRSIDE and FCE1232ABN) meet or exceed the FDA guidelines and are in
accordance with this document for recommended Zones 1-4 when used with Medline brand
mattresses.
The FDA guidance document also recognizes potential entrapment Zone 6, the area between
the head or foot board and the side rail, but has not yet determined proper dimensions or
requirements for safety in this zone. The document references standard IEC60601-2-38 as
a source for measurements in this area, but the FDA has not completed harmonization with
the measurements in this IEC document. The Medline side rails listed above do meet the
dimensional requirements for the Zone 6 area that are defined by IEC60601.
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