Indications For Use - Halyard ON-Q Instrucciones De Uso

• 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 the 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 labeled flow rate and fill volume are identified 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 the pump in water. Take care to protect
the pump during any activities, which could cause the
pump and filter to get wet, such as showering.
• In the event of any leakage from the pump or
administration set, close clamp. Replace pump
if necessary.
• Do not discard the pump and contact Halyard Health for
product return instructions.
• Flow rates may vary due to:
Fill volume
• Filling the pump less than the labeled volume results in
faster flow rate.
• Filling the pump greater than the labeled volume
results in slower flow rate.
Viscosity and/or drug concentration.
Pump position - position approximately 16" (40 cm)
below the catheter site
• Positioning the pump above this level increases
flow rate.
4
• Positioning the pump below this level decreases
flow rate.
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.
• 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.
• The flow controller should be in direct contact with the
skin (88°F/31°C).
• If refrigerated, allow pump to reach room temperature
before using. It may take 8–15 hours for a pump to reach
room temperature. See table below.
Nominal Fill Volume (ml)
Refrigerator to Room Temp (hr)
Storage
• Storage of a filled ON-Q* Pump for more than 8 hours
prior to starting infusion may result in a slower
flow rate.
External pressure
• External pressure such as squeezing, laying on the pump
increases flow rate.

Indications for Use

• The ON-Q* Pump is intended to provide continuous
delivery of medication (such as local anesthetics) to or
around surgical wound sites and/or close proximity to
nerves for preoperative, perioperative and postoperative
regional anesthesia and/or pain management. Routes
of administration include: intraoperative site, perineural,
percutaneous and epidural.
• ON-Q* Pump is indicated to significantly decrease pain
and narcotic use when used to deliver local anesthetics
to or around surgical wound sites, or close proximity
to nerves, when compared to narcotic only pain
management.
Contraindications
• ON-Q* Pump is not intended for blood, blood products,
lipids, fat emulsions, or Total Parenteral Nutrition (TPN).
• ON-Q* Pump is not intended for intravascular delivery.
100 200 270 400
8 12 12 15