Braun Easypump II ST Mode D'emploi page 11

Operating Instructions
Directions for filling
Elastomeric pumps are to be filled with reasonable care and
only by qualified personnel.
Prior to usage, please inspect for any damage. Don't use
if damaged.
Elastomeric pumps can be filled with a Luer Lock syringe
or other similar filling devices using an aseptic technique.
The tubing should be primed with diluent before adding
medication.
Priming (use aseptic technique):
1. Unfold the outer layer properly prior to start the filling
process.
2. Close the clamp.
3. Flip open the comfort cap.
4. Twist off the closing cone from the filling port and
place it on a sterile surface.
5. Attach the filling device to the filling port.
6. Inject diluent. Repeat as often as necessary.
7. Remove the filling device from the filling port, reat-
tach the closing cone on the filling port and close all
caps.
8. Open the closing cone of the patient connector.
9. Open the clamp and prime the system.
10. Close the clamp and reattach the closing cone of the
patient connector. Do not re-open the clamp until the
pump is connected to the patient.
Specific priming instructions for drugs prone to precipitation
(e.g. 5-Fluorouracil):
• Follow steps 1– 5 mentioned under "Priming".
• Initially fill Easypump® II with approximately 10 ml of
diluent.
• Follow steps 7–10 listed under "Priming".
Note: If not primed correctly, blockage or slow flow can
occur due to crystallization in the area highlighted below.
Filling - Adding medication (use aseptic technique):
Always refer to drug manufacturer's package insert for drug
reconstitution/dilution, storage procedures and handling.
Repeat steps 2-6 until required volume is achieved.
After adding the medication, flush the filling port with 0.9 %
sodium chloride solution to avoid high concentration of the
drug inside the filling area.
Note: Please make sure, closing cones of filling port and
patient connector are properly closed after filling and prior
to use!
At completion, the tubing will be filled exclusively with dilu-
ent, protecting from precipitation, while the pump reservoir
will contain the medication until the infusion is started.
Patient Connection:
1. Open the closing cone of the patient connector.
2. Connect the patient connector of the pump to the
patient's access device.
3. Make sure, that the flow restrictor is completely taped
on the patient's skin.
4. Make sure, that the filter is not covered by any dressing.
5. Open the clamp for starting the infusion.
Duration of use
See over- and underfilling table in the Appendix
Disposal
The product Easypump II ST/LT is made of raw materials
that both in combination and for themselves do not need
to be disposed separately. If used correctly according to the
Instructions For Use, no thermal or chemical influences can
alter the used materials in a manner that would require
separate disposal. Disposal of used devices has to be ensured
by the healthcare provider to be in accordance to clinical
waste management regulation in each respective country
where the medical devices are used.
Notice to the user
If, during the use of this product or as a result of its use,
a serious incident has occurred, please report it to the manu-
facturer and/or its authorized representative and to your
national authority.
Material
Materials of the elastomeric pumps that constitute the fluid
path are: MVQ, PVC (DEHP-free), PMMA, PES, ABS, glass,
e-PTFE
Classification
Easypump® elastomeric pumps are manufactured accord-
ing to ISO 13485 and are in conformity with the following
standards:
• European Community (CE Mark) class IIb Medical Device
Directive (MDD)
• Product certified by TÜV Product Service No. 0123 in
accordance with 93/42/EEC
• ISO 28620 Medical devices – Non-electrically driven
portable infusion devices
Date of last revision: 2020-05-28
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