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Instructions for Use
Description
Easypump® II ST/LT is intended to infuse medication for
either continuous, intravenous, subcutaneous or epidural
infusion. Chemotherapy, antibiotics, anesthesia and IV pain
management are the most common therapies.
For detailed information about the range of drugs typically
administered via elastomeric pumps please refer to the Drug
Stability List. Medications and/or fluids must be administered
per instructions provided by the drug manufacturer.
Easypump® II is a non-electrically driven portable infusion
device, enabling the patient to be treated in an ambulatory
manner.
Medication is delivered to the patient by positive pressure
applied by the elastomeric membrane. The flow rate is deter-
mined by the combination of the flow regulation device
(flow restrictor) and the positive pressure of the elastomeric
membrane. This pressure delivers the solution against the
back-pressure of catheters and blood pressure in the veins.
Back-pressure affects the flow rate.
Intended purpose
Single use only.
Indication
Easypump® II is designed to give clinicians and nurses the
option of delivering pre-determined amounts of medication
to the patient in a continuous and accurate manner.
Patient population
Easypump® II is for patients who receive a treatment in an
ambulatory setting and/or at home. In general, the device is
not restricted to a special gender. Easypump® II can be used
for both adult and pediatric patients.
Intended User
Elastomeric pumps should only be applied by healthcare
workers who have been adequately trained in this technique.
Contraindications
Elastomeric pumps are contraindicated for the delivery of
blood, blood products, insulin, total parenteral nutrition,
lipid emulsions and for intra-articular use as well as for life
saving drugs (e.g. catecholamines).
Precautions / Cautions
•
Temperature dependency: Easypump® is designed
to work at room temperature 23 °C +/– 2 °C (73 °F
+/– 3.6 °F). The flow restrictor is calibrated to work at
31 °C (88 °F). To maintain a stable flow rate the flow
restrictor should be in close contact with the patient’s
skin at all times (31 °C). For every 1 °C above or below
this temperature, the flow rate will increase or decrease
by approximately 3 %. An increase in temperature
results in an increase in flow rate and vice versa.
•
If Easypump® II needs to be stored in the refrigerator or
freezer, allow the unit to warm up to room temperature
before usage. Storage should not exceed a maximum
duration of 30 days, deducting the pump specific nomi-
nal infusion time (Example: Maximum 30 days – nomi-
nal infusion time 5 days = 25 days maximum storage).
•
If storage in freezer is intended, line must not be primed
since the filter can be damaged.
•
MRI compatible.
•
During epidural application the flow rate may increase.
•
Delivery time can increase significantly as a result of
extended storage time.
•
Underfilling and /overfilling: Filling the pump less than
nominal volume generally results in a shorter delivery
time. Filling the pump more than the nominal volume
results in a longer delivery time.
•
Diluent dependency: Easypump® flow rates are cal-
culated on basis of using 0.9 % NaCl. Using dextrose
(D5W) as diluent or the addition of any drug of a
higher viscosity than normal saline will increase deliv-
ery time (e.g. by 10 % in case of dextrose [D5W], see
figure 1).
•
The system should not be primed when the pump is
filled with Dextrose, as the flow rate could decrease
significantly.
•
An uneven inflation of the pump during the filling pro-
cess has no effect on the flow rate.
•
Air bubbles in the silicone sleeve would not affect the
functionality of the pump. There is an air vent in the
filter which is capable to filter out the entrapped air
bubbles. The silicone sleeve has the properties of gas
permeability, therefore the air entrapment in the sili-
cone sleeve can be diffused out of the pump.
External pressure such as squeezing or laying on the pump
increases the flow rate.
When filled to nominal volume and under the environmental
conditions described here, the flow accuracy is +/- 15 % of
the labeled flow rate for Easypump®.
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+ 10%
- 10%
Fig. 1
FLOW RATE ml/h
Nominal FLOW RATE
10% below
nominal FLOW RATE
Fig. 1
0.9% NaCl
Flow Duration
Flow Rate
D5W
Fig. 1
Warning
–
Do not use if package has been opened or is damaged.
–
Single use only. Do not re-sterilize or re-use.
–
Re-use of single-use devices creates a potential risk for
patient or user. It may lead to contamination and/or
impairment of functional capability. Contamination and/
or limited functionality of the device may lead to injury,
illness, or death of the patient.
–
Elastomeric pumps should not be used in patients with
known hypersensitivity to any of the materials of the
device.
–
Elastomeric pumps should only be applied by health-
care workers who have been adequately trained in this
technique.
–
There is no alarm or alert when flow interruption occurs
which would advise the user of the potential for serious
injury or death due to stoppage or under delivery.
