Terumo CDI 550 Operator's Manual page 10

• Do not modify this equipment without written authorization from the
manufacturer.
• Equipment connected to the monitor's serial port shall meet IEC 60601-
1 current leakage specifications. The combination of the two pieces of
equipment shall be checked for safe system/leakage current.
• 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 System 550 for the following
parameters should not be relied on to make therapeutic decisions
when Methylene Blue has been used: pH, K
Bicarbonate, Oxygen Delivery, Oxygen Saturation, and Oxygen
Consumption.
• Blood conditions such as hemoglobinopathies, thalassemia, and
variety of anemic conditions (sickle cell, iron deficiency, macrocytic),
may affect the accuracy of hemoglobin and hematocrit measurements.
Independent external analysis is required for accurate determination of
these measurements as needed to guide therapeutic decisions.
• The CDI System 550 should only be used when there is blood flow
through the extracorporeal circuit. To perform accurately, the H/S
Cuvette requires blood flow rates shown in the following table:
H/S Cuvette Size
1/2"
3/8"
1/4"
The Terumo CDI Shunt Sensor requires a minimum of 35 ml/min.
Restoration of blood flow above the minimum through the CDI Shunt
Sensor or the Terumo 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. Certain parts that can be accessed
without the use of a tool (e.g. connectors or communication ports) may
contain live voltages.
• Independent external blood gas and blood chemistry analysis is
required for accurate determination of all measured parameters needed
to guide therapeutic decisions whenever intravascular dyes are
administered or when dyshemoglobins or elevated bilirubin levels are
present.
• Use caution when administering novel pharmacological agents when
the user is unfamiliar with the potential effect of such agents on the
CDI sensors.
Min Flow Max Flow
1.0 LPM 7.0 LPM
0.5 LPM 4.0 LPM
0.2 LPM 1.5 LPM
+
, Base Excess,
introduction 1-5