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2 Equipment Introduction
2.1 Intended Purpose
The infusion pump is intended for use for the delivery of medications, solutions,
nutrition, lipids, blood and blood components indicated for infusion therapy.
• This pump is intended for use only by clinical professionals or under their
guidance. It must only be used by persons who have received adequate
training in its use. Anyone unauthorized or untrained must not perform any
operation on it.
• According to the conclusion of clinical evaluation and residual risk
evaluation, for the intended patients, there is no known side effects that can
occur during or after the use of the medical device. And there is no need for
the operator to make extra preparations. Thus, no residual risk associated
with using the medical device should be disclosed.
2.1.1 Indication for Use
Infusion pumps are for patients who need receive various types of medications,
solutions, nutrition, lipids, blood and blood components in controlled amounts through
an intravenous (IV) route or enteral route.
2.1.2 Intended Users
The infusion pump is intended to be used by trained healthcare professionals.
2.1.3 Intended Patient Population
The Infusion pump is intended for use on adult, pediatric and neonate.
2.1.4 Intended Medical Conditions
The infusion pump is intended to be used in professional healthcare facilities.
2.1.5 Contra-indications
None.
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