baxter 35700BAX2, Operator'S Manual, Page: 17 / 180

Introduction and Safety 11
SIGMA Spectrum Infusion System Pump Operating Software Version 8.00
Operator’s Manual For Use With MDL Version 8.0
WARNING
IV Set Usage.
Do not use an IV set for longer than the manufacturer’s labeled set
change interval to reduce risk of infection and to maintain flow rate
accuracy.
WARNING
Unloading an IV Set.

Do Not Allow Uncontrolled Gravity Flow.

Before unloading a primed IV set, ensure the roller clamp below
the Pump is in the closed position. To open the Pump door, the IV
set’s slide clamp must first be closed (thus providing “set-based
anti-free flow” protection).

Do not open the slide clamp when the door is open or during and
after IV set unloading. This can cause dangerous, uncontrolled
free flow to occur.

During IV container changes, always close the set’s roller clamp.
When the set is in the Pump and the door is closed, the slide
clamp can safely be opened.

If gravity flow is to be used, the Pump door will be open or the set
will be outside the Pump. Verify gravity flow is maintained at the
intended rate whenever the Pump door is open and when the set is
outside of the Pump.
WARNING
Radio Frequency Interference.
The SIGMA Spectrum Infusion System meets the electromagnetic
compatibility (EMC) requirements as specified in the International
Electrotechnical Commission’s (IEC) 60601-1-2 (2001-09) standard
for emissions and immunity. There may be potential difficulties if the
Pump is not kept separated from other equipment, such as hand-held
transmitters, cellular phones and electrosurgical equipment that may
generate strong radio frequency interference (RFI). See “Immunity –
Separation Distances” on page 153 for the recommended minimum
distance.
Procedural Cautions
CAUTION
Service Personnel Must be Trained by Baxter.
Servicing the SIGMA Spectrum Infusion Pump is restricted to
qualified, Baxter trained, service personnel who employ Baxter
authorized parts and procedures. Use of other parts and servicing
procedures is prohibited.
CAUTION
Sequester Pumps Pending Evaluation.
Devices that are believed to have malfunctioned and/or were involved
in an adverse event should be immediately removed from service and
quarantined pending their evaluation and/or returned to Baxter for
inspection and service.