• It is the responsibility of the healthcare provider to ensure
patient is educated on the proper use of the system.
• It is the responsibility of the healthcare provider to modify
Patient Guidelines provided with the pump as appropriate
for your patients' clinical status and medication prescribed.
CAUTIONS
•
Do not use if package is open, damaged or a
protector cap is missing.
•
Single use only. Do not resterilize, refill or reuse.
Reuse of the device could result in the following risks:
• Improper functioning of the device (i.e., inaccurate flow rate)
• Increased risk of infection
• Occlusion of the device (i.e., impedes or stops infusion)
• The pump is sterile and non-pyrogenic.
•
Product uses Di (2-ethylhexyl) phthalate (DEHP)
plasticized PVC:
• DEHP is a commonly used plasticizer in medical
devices. There is no conclusive scientific evidence
to date that exposure to DEHP has a harmful effect
on humans. However, the risk and benefit of using
medical devices with DEHP for pregnant women,
breastfeeding mothers, infants and children should be
evaluated prior to use.
• Certain solutions may be incompatible with the PVC
material used in the administration set. Consult
drug package insert and other available sources of
information for a more thorough understanding of
possible incompatibility problems.
• Do not underfill pump. Underfilling pump may
significantly increase the flow rate.
• Do not exceed maximum fill volume. (Table 1)
• Clamp is provided to stop the infusion. Do not remove or
break clamp. Do not use clamp as an intermittent
delivery device.
• Roll tubing between fingers to promote flow if clamped
for extended time.
• The fill volume, infusion rate, bolus dose and bolus
interval is labeled on the fill port.
• Avoid contact of cleansing agents (like soap and alcohol)
with the filter because leakage may occur from the air
eliminating vent.
• Do not tape over filter(s) as this could block the air vent
and impede the infusion.
• Do not immerse pump in water. Take care to protect the
pump during any activities, which could cause pump and
filter to get wet, such as showering.
4
• In the event of any leakage from pump or administration
set, close tubing clamp. Replace pump if necessary.
• Do not discard pump and contact I-Flow* for product
return instructions.
• Do not add unvented filter to end of the administration
set as this may impede or stop the flow rate.
• Do not remove the red tab until the tubing is completely
primed. Up to 5 ml bolus of air may be delivered if not
primed correctly.
• Flow rates may vary due to:
Fill volume
• Filling pump less than the labeled volume results in faster
flow rate.
• Filling pump greater than the labeled results in slower
flow rate.
• Viscosity and/or drug concentration
• Pump position - position pump at approximately the
same level as the catheter site:
• Positioning pump above this level increases flow rate.
• Positioning pump below this level decreases flow rate.
Temperature
• The ONDEMAND* device should be worn outside
clothing and kept at room temperature.
• To ensure flow rate accuracy, do not place heat or cold
therapy in close proximity to the flow controller.
• Temperature will affect solution viscosity, resulting in
faster or slower flow rate.
• ONDEMAND* device have been calibrated using
Normal Saline (NS) as the diluent and room
temperature (22°C, 72°F) as the operating
environment. Flow rate will increase approximately
1.4% per 1°F/0.6°C increase in temperature and will
decrease approximately 1.4% per 1°F/0.6°C decrease
in temperature.
• If refrigerated, allow pump to reach room temperature
before using.
• It may take approximately 12 or 15 hours (depending
on model) for a pump to reach room temperature. (See
table below.)
Fill Volume (ml)
Refrigerator to Room Temp (hr)
270
400
12
15