!Warnings
•
The supervisor of the infusion must decide whether the Configuration chapter should
be kept in the present IFU.
•
We recommend the default codes of the pump to be changed ( through the configuration
menu) in order to secure the access to different actions related to each code.
• The supervisor of the infusion should decide to whom each code and its related actions
should be distributed. Incorrect pump programming could result in death or serious injury
to the patient.
•
For those patients who are likely to be adversely affected by unintended operations
and failures, including interrupted medication or fluid delivery from the device, close
supervision and provision for immediate corrective action should be provided.
•
The Rythmic™ Evolution is not to be used to deliver blood.
•
Always inspect the Rythmic™ Evolution pump and its accessories for damaged plastic
parts, wires and presence of liquids on its surface, prior to use. If the pump or accessories
are dropped, hit, subjected to excessive moisture and/ or beyond temperature limits,
immediately take it out of use and return it to authorized service department for inspection.
•
Infusion system characteristics, such as medication viscosity, catheter size and high
delivery rate may affect delivery accuracy.
•
Only Rythmic™ Administration sets shall be used with the pump. Use of other than
Rythmic™ Administration sets may impair the operation of the pump and the accuracy of
the infusion.
•
Always inspect the integrity of the package and the administration set included.
•
Frozen medication must be thawed at room temperature only. Do not heat medication
and administration set in an oven as this may damage the medication, the Rythmic™
Administration set and, cause leakage.
•
Ensure that the medication administered is indicated for the therapy / route and in
accordance to healthcare provider drug / medication protocol and official drug prescribing
information.
•
Ensure that the administration set used to deliver medication is the appropriate one
for the specific medication and for the therapy that will be used.
•
When using the pump for secondary delivery, ensure that the fluids being administered
are chemically and physically compatible with each other.
•
When additional medication is infused through Y connector then over delivery of
medication may occur.
•
Ensure that during delivery the vertical distance between the pump and the injection
site should be one meter height maximum.
•
When using administration set with Y connector ensure a closed cap is used on the Y
port when not in use.
•
Do not prime the administration set while it is connected to a patient, as this may
result in air embolism or over- delivery of medication. Always disconnect the line from
patient before priming.
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