LivaNova CP5 - Operational safety

CP5 • Safety
CP_SEM_60-00-60.001 11
2.2.3 Operational safety
See separate ope-
rating instructions
for the overall sys-
tem
◗ The safety guidelines for the overall system within which the CP5 is operated also apply to the CP5.
◗ The CP5 is only intended for use with the S5 or C5 (or a compatible system).
◗ The CP5 may only be used with the Revolution
®
.
◗ Do not mount the Revolution
®
until after you have read the separate operating instructions
thoroughly and are familiar with the functions of the device!
◗ For reasons of safety, an additional Revolution
®
should be kept ready for use! Ensure you are
familiar with the procedure for replacing the Revolution
®
during an emergency.
!
◗ Before using the system, check all cables, tubing, connectors and other accessories to make sure
that they are connected correctly, are not leaking and are in perfect working order. Replace all
damaged components immediately.
◗ Do not use the HLM until you have read the separate operating instructions thoroughly and are
familiar with the functions of the device.
!
◗ The CP5 and the HLM may only be operated when monitored at all times by a trained user. Non-
compliance with the responsibility of monitoring the device may put the patient at risk! The safety
features of the overall system (alarm signals etc.) are intended to support the user and do not free
him/her from his/her responsibility to monitor the system conscientiously and at all times.
◗ Do not use the CP5 until you have read the operating instructions thoroughly and are familiar with
the functions of the device!
◗ Monitor the perfusion process at all times so that you can carry out appropriate adjustments when
required.
◗ Monitor the venous reservoir with increased care and attention. The level must not drop below the
minimum value.
◗ Before using the device, always carry out a level alarm and bubble alarm simulation to ensure
correct functioning.
◗ The CP5 may only be used for an optimised bypass in combination with Air Purge Control (APC) and
a tubing clamp (ERC) with an additional bubble sensor.
!
◗ The APC suction line must be fitted with a safety check valve (one-way safety valve). When
installing the safety check valve, be sure to observe the direction of flow.
◗ When using the function for calculating the inlet pressure, the pressure on the outlet side
(pressure side) of the Revolution
®
before the oxygenator must be calculated.
◗ The ventilation line should never be connected directly to the venous line.
!
◗ Ensure that the cables and tubing run as straight as possible, and do not kink or twist them. Kinked
or twisted cables and/or tubing pose a hazard to any persons present (by causing them to stumble
or get caught).