Emc Notice; Mri Notice; Intended Use Notice; Regulatory Notice - CareFusion AVEA Operating Instructions Manual

AVEA ventilator systems
Notices

EMC Notice

This equipment generates, uses, and can radiate radio frequency (RF) energy. If this equipment is not installed and
used in accordance with the instructions in this manual, electromagnetic interference may result.
This equipment has been tested and found to comply with the limits of acceptance set forth in Standard EN 60601-1-2
for Medical Products. These limits provide reasonable protection against electromagnetic interference (EMC) when
operated in the intended use environments described in this manual.
This ventilator is also designed and manufactured to comply with the safety requirements of Standard EN 60601-1,
IEC 60601-2-12, CAN/CSA-C22.2 No. 601.1-M90, and UL 2601-1.
This ventilator can be affected by portable and mobile RF communications equipment.
This ventilator should not be stacked with other equipment.
The following cables were used in the evaluation of this ventilator.
15619 – Normally Open Patient Call Cable (Length – 1.7 meters)
•
15620 – Normally Closed Patient Call Cable (Length – 1.7 meters)
•
70600 – Cable, Communications (Length – 1 meter)
•
70693 – Cable, Communications (Length – 3 meters)
•
Standard Centronics Printer Cable (Length – 2 meters)
•
Standard SVGA Monitor Cable (Length – 2 meters)
•
Use of other cables may result in increased emissions or decreased immunity.
See Tables 201, 202, 203, and 205 for further information regarding the AVEA Ventilator and EMC.

MRI Notice

This equipment contains electromagnetic components whose operation can be affected by intense electromagnetic
fields.
Do not operate the ventilator in a MRI environment or in the vicinity of high-frequency surgical diathermy equipment,
defibrillators, or short-wave therapy equipment. Electromagnetic interference could disrupt the operation of the ventilator.

Intended Use Notice

The AVEA is intended to provide continuous respiratory support in an institutional health care environment (e.g.
hospitals). It may be used on neonatal through adult patients. It should only be operated by properly trained clinical
personnel, under the direction of a physician.

Regulatory Notice

Federal law restricts the sale of this device except by or on order of a physician.
The benefit of treatment with medical respiratory support devices outweighs the remote possibility of exposure to
phthalates.
L2786 Rev. M
vii