Braun manual Vista basic Instructions for Use 950787 Rev H 02/03

WARNINGS & CAUTIONS

The following should be observed to avoid patient/user injury. This Instructions for Use manual contains detailed instructions and warnings on the use of the Vista™ basic Infusion Pump. Please read it completely prior to using this device. This manual is intended to reinforce the teaching given to the user by a trained health care professional or an authorized B. Braun representative.

WARNINGS

♦B. Braun will assume no responsibility for incidents which may occur if the product is not used in accordance with product labeling.

♦Make sure the pump is stable, either fastened securely to the IV pole or resting on a flat surface.

♦Prior to use, always check the audible and visual alarms (and staff call, where applicable).

♦Connection of pump tubing to the patient should only be made after the tubing is loaded and the unit is turned on. Disconnect tubing from patient when changing solution containers to avoid the danger of incorrect dosage.

♦Ensure there are no kinks in the tubing.

♦Always read and follow the instructions that accompany the source container and IV administration sets you are using. Carefully follow the instructions for loading, removing, and reloading the set, as well as the recommended set change intervals.

♦Change pumping section on tubing every 24 hours. Do not use tubing for more than 72 hours or per current facility protocol.

♦Always check pump data prior to starting infusion.

Vista™ basic Instructions for Use 950787 Rev H 02/03

♦Do not operate this device in environments where there is an explosion hazard! A possible explosion hazard exists if the pump is used in the presence of flammable anesthetics.

♦The EMC-limits (Electro-magnetic compatibility) according to IEC/EN 60601-1-2 and IEC/EN 60601-2-24 are maintained. If the equipment is operated near other equipment which may cause high levels of interference (e.g. HF surgical equipment, nuclear spin tomography units, mobile telephones, etc.) maintain the recommended protective distances for these devices. Under certain conditions, malfunctions may occur which lead to a device alarm with permanent alarm tone. Interference may occur e.g. at electro-magnetic fields > 10 [V/m] resp. electro-magnetic discharges > [8 kV].

♦Monitoring of the patient and infusion status is necessary to ensure the infusion is being delivered as anticipated. The Vista basic has been designed to stop fluid flow to the patient under certain alarm conditions. Also, prior to starting an infusion, verify that no drops are falling in the drip chamber and the programmed information is correct.

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