User's Manual

1 Warnings and Cautions
Warnings
1.2 RECOVER BP IABP/VAD System – Operator’s Manual
Warnings
NOTE: A warning indicates a situation that could result in injury or
death.
• The RECOVER BP System is not suitable for use in the presence
of a flammable anesthetic mixture with air or with oxygen or
nitrous oxide. It is also not suitable for use in an oxygen-enriched
atmosphere.
• The RECOVER BP Console does not contain any
user-serviceable parts. To reduce the risk of electric shock, do
NOT attempt to remove the Console housing or to replace the
Console Battery.
• Do NOT connect items to the RECOVER BP System that are not
specified as part of the System. All equipment intended for
connection to signal input, signal output, or other connectors
must comply with the relevant IEC standard (IEC 60950 for IT
equipment and IEC 60601 series for medical electrical
equipment).
In addition, all such combinations (systems) must comply with
IEC 60601-1-1, Safety requirements for medical electrical
systems. Equipment not complying with IEC 60601-1 must be
kept at least 1.5 m outside the patient environment, which is
defined in the standard and in the System Specifications section
of this manual.
• Do NOT simultaneously touch the patient and any part of the
RECOVER BP System exposed by removal, without the use of a
tool, of a connector or cover. In addition, do NOT simultaneously
touch the patient and any other equipment.
• Power the Console using its internal battery if the integrity of the
protective earth conductor is questionable.
• Per IEC 60601-1-1: Enclosure leakage current measured from or
between parts of the RECOVER BP System within the patient
environment must NOT exceed 0.1 mA. Enclosure leakage
current in the event of interruption of any non-permanently
installed protective earth conductor must NOT exceed 0.5 mA.