Plum A+
®
Infusion Systems
System Operating Manual
9
Accessory equipment connected to the analog and digital
interfaces must be certified according to the respective IEC
Standards (e.g. IEC 60950 for data processing equipment and
IEC 60601-1 for Medical Equipment). Furthermore, all
configurations shall comply with the system standard IEC
60601-1-1. Any person who connects additional equipment to
the signal input or output part configures a medical system, and
is therefore responsible for ensuring that the system complies
with the requirements of the system Standard IEC 60601-1-1. If
in doubt, consult the technical service department or your local
representative.
Indications for Use
U
SER
Q
UALIFICATION
The Plum A+ is intended for use at the direction or under the
supervision of licensed physicians or certified healthcare
professionals who are trained in the use of the infuser and the
administration of parenteral, enteral, and epidural fluids and
drugs and whole blood or red blood cell components. The
training should emphasize preventing related IV complications,
including appropriate precautions to prevent accidental infusion
of air. The epidural route can be used to provide anesthesia or
analgesia.
WARNING
A D M I N I S T E R O N L Y A N E S T H E T I C S / A N A L G E S I C S
APPROVED FOR EPIDURAL ADMINISTRATION (AS
I ND I CA T E D O R A L L O WE D BY T H E D R UG S ’ F D A
APPROVED LABELING). EPIDURAL ADMINISTRATION OF
DRUGS OTHER THAN THOSE INDICATED FOR EPIDURAL
USE COULD RESULT IN SERIOUS INJURY TO THE PATIENT.
430-95597-004.book Page 9 Friday, March 9, 2007 8:30 AM
