Braun Infusomat Space - Contact Persons

11
PATIENT SAFETY
PATIENT SAFETY
Read Instructions
for Use prior to
operation. The
infusion device
should only be
used by trained
healthcare
professionals.
Indications for Use
The Infusomat® Space Volumetric Infusion Pump System is intended for use on
adults, pediatrics, and neonates for the intermittent or continuous delivery of
parenteral fluids, medications, blood and blood products through clinically
accepted routes of administration.
Th
ese routes include intravenous, intra-
arterial, subcutaneous, and epidural.
Infusomat® Space Volumetric Infusion Pump System is intended to be used by
trained healthcare professionals in healthcare facilities.
Dedicated Disposables
The Infusomat Space is intended to be used with only dedicated disposables
labeled for the different routes of administration.
Warnings and Cautions
• The initial training of
th
e Infusomat® Space is to be performed by B. Braun
sales and/or clinical personnel or other authorized persons. After each soft-
ware update, the user must refer to the Instructions for Use to review
changes to the device and software.
Caution: Ensure the unit is properly positioned and secured (see ch.
Infusomat® Space Overview). Do not position pump above patient or in
a position where a pa
tie
nt could be harmed , should the pump fall.
• Prior to administration, visibly inspect the pump for damage, missing
parts or contamination and check audible and visible alarms during
selftest.
• Only connect to patient once the line has been correctly inserted and
completely primed (chapter 1.1). Disconnect from patient during line change
to prevent unintended delivery.
Caution: Insure the infusi
on lin
e is free of kinks.
Caution: Do not operate in the presence of flammable anesthetics or in
a hyperbaric oxygen chamber.
• Not be used adjacent and stacked with other equipment except B. Braun
Space devices.
Caution: The Infusomat Space System is unsafe to use in proximity to
magnetic resonance imaging (MRI) equipment.
• Compare the displayed value with the entered value prior to starting
inf
usio
n.