Kimberly-Clark B BRAUN Easypump C-block RA, Instructions Manual

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IMPORTANT INFORMATION
Please read the entire document before operating the Easypump
®
C-bloc* RA
™
device. Follow all instructions carefully to ensure the safety of patient and/or user.
WARNING
Flow rate is adjustable and bolus is deliverable on demand. To reduce potential adverse
effects, medication dosing should be based on the Total Flow Rate.
• Total Flow Rate refers to bolus + basal rate. To reduce potential adverse events:
• Medication dosing should be based on the maximum basal flow rate (7 or 14 ml/hr).
Flow rate may vary ± 20%.
• Regardless of the prescribed flow rate, only fill pump with medication dosage that is
appropriate to administer at the total flow rate.
• Refer to the drug manufacturers’ package insert for complete information.
• Due to risk of ischemic injury, vasoconstrictors such as epinephrine are not
recommended for continuous infusions for the following routes of administration:
intraoperative site, perineural and percutaneous (excluding epidural).
• Medications or fluids must be administered per instructions provided by the drug
manufacturer. Physician is responsible for prescribing drug based on each patient’s
clinical status (such as age, body weight, disease state of patient, concomitant
medications, etc.).
• There is no alarm or alert when flow interruption occurs, therefore, life-supporting
medications whose usage may cause serious injury or death due to stoppage or under-
delivery are not recommended for infusion with the Easypump
®
C-bloc* RA
™
device.
• There is no indicator of pump infusion status, therefore, use caution where over-
delivery of medications could result in serious injury or death.
• Epidural infusion of analgesics is limited to uses of indwelling catheters specifically
designed for epidural delivery. To prevent infusion of drugs not indicated for epidural
use, do not use IV set with additive ports. It is strongly recommended that devices used
for administration of medication via epidural routes be clearly differentiated from all
other infusion devices.
• To avoid complications, use the lowest flow rate, volume and drug concentration
required to produce the desired result. In particular:
• Avoid placing the catheter in the distal end of extremities (such as fingers, toes,
nose, ears, penis, etc.) where fluid may build up as this may lead to ischemic injury
or necrosis.
• Avoid placing the catheter in joint spaces. Although there is no definitive established
causal relationship, some literature has shown a possible association between
continuous intra-articular infusions (particularly with bupivacaine) and the
subsequent development of chondrolysis.
• Avoid tight wrappings which can limit blood supply or fluid diffusion.
Easypump
®
C-bloc
*
RA
™
with Select-A-Flow* Variable Rate Controller and PCA Device
• PCA device: To prevent continuous over delivery of medication significantly greater
than the Total Flow Rate, close the clamp if any of the following conditions occur:
• The red tab is not removed or breaks while removing.
• The orange bolus refill indicator is not near the top at all times except within
60 minutes of pressing the bolus button.
• The bolus button will not latch except within 30 minutes of pressing the bolus button.
PCA device - If the bolus button does not pop back up within 30 minutes of pressing it,
check position of orange indicator:
• If orange indicator is in the bottom position, close the clamp. Continuous medication
delivery may be occurring significantly greater than the Total Flow Rate.
• If orange indicator is in the top position: something may be impeding the flow.
Check for tubing kinks, closed clamp or patency of connected devices such as
catheter or unvented filter (verify patency) according to your standard protocol.
• It is the responsibility of the healthcare provider to ensure patient is educated in the
proper use of the system.
• It is the responsibility of the healthcare provider to modify Patient Guidelines provided
with pump as appropriate for your patients’ clinical status and medication prescribed.
CAUTION
• 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 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 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 pump during any activities, which
could cause pump and filter to get wet, such as showering.