XVIVO 11.01.201, Instructions For Use Manual, Page: 29 / 40

11.01.601.7c EN Page 29 of 40
•
Maintenance and servicing of the device may only be performed by XVIVO-certified
personnel. Unauthorized repair or modifications, including replacement of batteries,
will void the warranty and may violate the conformity of the Liver Assist with the
requirements of the Medical Device Directive 93/42/EEC. Maintenance and
servicing are not permitted while the device is functioning.
•
The USB connection shall not be connected during perfusion, the USB connection
should only be used for servicing activities by XVIVO-certified personnel.
•
The device does rely on essential performance:
▪
Perfusion temperature between 0°C & 43°C
▪
Pressure below safety limit
P(T)=2.41∙T+40.76 (HA)
P(T)=0.207∙T+21.381 (PV)
In the unlikely event that electromagnetic interference does occur and degradation
of the essential performance above is observed, please try one or more of the
following measures:
▪
increase the distance between the Liver Assist and adjacent systems
▪
connect the Liver Assist to an outlet on a separate circuit from that to which
adjacent systems are connected
•
Use of t
he ‘Liver Assist’ adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should be observed to verify that they are
operating normally.
•
The use of accessories, transducers and cables other than those specified, with the
exception of replacement parts sold by XVIVO, could result in increased
electromagnetic emissions or decreased electromagnetic immunity of the ‘Liver
Assist
’ and result in improper operation.
•
Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to
any part of the ‘Liver Assist’, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could result.
•
The emissions characteristics of this equipment make it suitable for use in industrial
areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for
which CISPR 11 class B is normally required) this equipment might not offer
adequate protection to radio-frequency communication services. The user might
need to take mitigation measures, such as relocating or re-orienting the equipment.
•
In the unlikely event that interruption caused by ESD discharge occurs, restart the
device and confirm correct functioning. In case of malfunction, e.g. flow
measurement, continue preservation using static cold storage.
•
The Liver Assist is not intended to be in contact with the patient and therefore falls
outside the definition of applied part. The disposable set is in contact with the
subsequent isolated organ.
However, the following part are treated as type B applied parts since they are in
direct contact with the perfusion fluid:
- Pressure sensor cables
- Temperature sensors
- Flow sensors
- Magnetic pump coupling