Fresenius Kabi COM Instrucciones De Uso página 6

1 Introduction
This document is written to the attention of:
End users of Amika / Amika+ / Ambix nova with Smart Holder COM.
1.1 Scope
These Instructions for Use (IFU) are applicable to the Smart Holder COM referred to as
holder. The holder is compatible with Amika enteral feeding pump, Amika+ enteral
feeding pump and Ambix nova ambulatory infusion pump, which are referred to as
pump in this IFU.
CAUTION
The user must follow the instructions specified in this IFU. Failure to observe
these instructions may result in damage to the equipment, injury to patients
or injury to users. Specific texts are highlighted using the symbols described
Symbol descriptions.
in
1.2 Intended use
The holder can be positioned on authorized support such as a pole, rail, bed,
wheelchair, table and table stand. It allows the pump to be attached to it to ensure the
pump is securely positioned.
It is intended to supply the operating power and to charge the battery for the pump
installed on it when it is connected to the mains power supply.
It is intended to connect a pump to an external Nurse Call system to transmit a pump
alarm state.
It is intended to connect a pump to a PC for service activities via Amika and Ambix nova
Partner software.
It is intended to communicate between a pump and a third party system PDMS (Patient
Data Management System).
1.2.1 Intended user population
The holder must only be used by trained healthcare professionals, patients, and any
other relevant users. For training guide, contact your Fresenius Kabi sales
representative.
1.3 Use environment
The holder is intended to be used inside the hospital, nursing station, home, biomedical
office and any other areas involved in technical service.
CAUTION
The holder should be used under specified operational, storage and
▪
transport conditions listed below.
DO NOT USE : in ambulance, helicopter and aircraft
▪
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in Magnetic Resonance Imaging (MRI) environments