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System Overview
Warning
Computer equipment in the operating room environment may
interfere with the operation of existing monitoring or therapeutic
devices and may be susceptible to interference from such devices.
To ensure that such interference will not occur, care must be taken
in the selection of computer equipment to be interfaced with the
CDI OneView System and the manner in which this interface is
accomplished.
Maintain adequate levels of anticoagulation during extracorporeal
circulation by monitoring activated clotting time (ACT) or another
appropriate measurement. Use of a heparin treated device does
not substitute for adequate anticoagulation levels.
Do not modify this equipment without written authorization of the
manufacturer.
Devices connected to an External Data Module must be compliant
to IEC 60950-1 and/or IEC 62368-1, including any applicable
National Deviations.
Do not immerse the CDI Blood Parameter Module (BPM) or CDI
H/S Probe in liquid at any time. Immersion can cause damage to
electronic components within the fiberoptic head.
Avoid prolonged exposure to high humidity environments.
When Methylene Blue or similar dyes have been used prior to
or
during cardiopulmonary bypass, independent external blood gas
and blood chemistry analysis is required for accurate
determination of all measured parameters needed to guide
therapeutic decisions. Readings obtained from the CDI OneView
System for the following parameters should not be relied on to
make therapeutic decisions when Methylene Blue has been used:
pH, Potassium (K
+
), Base Excess (BE), Bicarbonate (HCO
−
3
), Oxygen
Delivery (DO
2
), Oxygen Saturation (SO
2
), and Oxygen Consumption
(VO
2
).
Blood conditions such as hemoglobinopathies, thalassemia,
and a variety of anemic conditions (sickle cell, iron
deficiency,
macrocytic), may affect the accuracy of Hgb and HCT
measurements. Independent external analysis is required for
accurate determination of these measurements as needed to
guide therapeutic decisions.
The CDI OneView System should only be used when there is blood
flow through the extracorporeal circuit. To perform accurately,
reference the minimum and maximum blood flow rates (Q
) as
listed in the H/S Cuvette Instructions for Use.
The CDI Shunt Sensor requires a minimum of 35 mL/min of blood
flow. Restoration of blood flow above the minimum through the
CDI Shunt Sensor or the CDI H/S Cuvette will restore performance
of the system.
Do not make simultaneous contact with the patient and certain
parts of non-medical electrical equipment.
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