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33373-001 Version A
Notices
EMC Notice
This equipment generates, uses, and can radiate radio frequency energy. If not installed and used
in accordance with the instructions in this manual, electromagnetic interference may result. The
equipment has been tested and found to comply with the limits set forth in EN60601-1-2 for Medical
Products. These limits provide reasonable protection against electromagnetic interference when
operated in the intended use environments described in this manual.
The ventilator has been tested to conform to the following specifications:
MIL-STD-461D:1993, MIL-STD-462D:1993, EN55011:1991, IEC 1000-4-2:1994, IEC 1000-4-
3:1994, IEC 1000-4-4:1994, IEC 1000-4-5:1994, QUASI-STATIC:1993
This ventilator is also designed and manufactured to comply with the safety requirements of IEC
601-1, IEC 601-2-12, CAN/CSA-C22.2 No. 601.1-M90, and UL 2601-1.
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 Vela Ventilator is intended to provide continuous or intermittent ventilatory support for the care
of individuals who require mechanical ventilation. The ventilator is a restricted medical device
intended for use by qualified, trained personnel under the direction of a physician. Specifically, the
ventilator is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs), who require
the following general types of ventilation support, as prescribed by an attending physician:
Positive pressure ventilation
Assist/Control, SIMV, or CPAP modes of ventilation
The ventilator is suitable for use in institutional and transport settings. It is not intended for use as
an emergency medical transport ventilator or for homecare applications.
Regulatory Notice
Federal law restricts the sale of this device except by or on order of a physician.
IEC Classification
Type of Equipment: Medical Equipment, Class 1 type B
Adult/Pediatric Lung Ventilator
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