sorin XTRA - Operating Conditions; Warning; Cautions; Adverse Effects

Introduction and Safety
1-14
20077/021 US XTRA Operator’s Manual
67. Although it is possible to configure some of the acoustic notifications that the machine makes,
any modification on the audible signals might make the operator take longer to realize the
machine has made a notification.
68. It is possible to temporarily deactivate some of the controls that the machine does. The operator
can make use of this possibility, under his own responsibility, therefore directly managing those
controls.
69. At the end of installation verify that the bowl outlet is not crushed or obstructed.
70. In the case of malfunction of the integrated vacuum pump, use an alternative vacuum source,
i.e., the vacuum present in the operating room, possibly connected to a pressure regulator.
71. If the values regarding volumes, hematocrit, supernatant removal and waste color line are
important for the patient, it will always be necessary to use other standard measurement
instruments of the hospital.
Operating Conditions
Warning
1. Do not use the unit in the presence of inflammable anaesthetic gases. do not expose to heat
sources. Avoid any operating situation where the blood may be exposed to temperatures
exceeding 37 °C (98.6 °F).
Cautions
1. When the unit is operating, the following conditions must be met:
- Room temperature: 10 - 35 °C (50 - 95 °F)
- Relative humidity: 30-75%
- Atmospheric pressure: 80 - 106 kPa
2. Conditions that cause the unit to overheat when operating must be avoided.
Adverse Effects
The company is not aware of documented adverse effects when this device is used according to this
Operator's Manual.
Installation of the Unit
Installation
The XTRA and XVAC systems are medical electrical equipment and need special precautions regarding
electromagnetic compatibility (EMC). They need to be installed and put into service according to the
EMC information provided in
Appendix A: Safety Standards EN 60601-1-2 .
Portable and mobile radio frequency (RF) communications equipment can affect the X
TRA and XVAC.
WARNING
The XTRA and XVAC should not be used adjacent to or stacked with
other equipment. However, if adjacent or stacked use is necessary,
the X
TRA and XVAC should be observed to verify normal operation is
occurring in the configuration in which they are used.