9
connectors, shall comply with relevant IEC standard (e.g., IEC 60601 series for medical
electrical equipment). In addition, all such combinations of systems shall comply with the
standard IEC 60601-1-1, Safety requirements for medical electrical systems, alternatively
IEC 60601-1 ed.3
§
16, ME SYSTEMS. Any person who connects external equipment to
signal output, or other connectors, has formed a system and is therefore responsible for
compliance of the system with these requirements. If in doubt, contact a qualified
technician, or alternatively, a St. Jude Medical representative or technical support.
Do not use the QUANTIEN measurement system if it has been dropped or in any other way
exposed to mechanical or electrical damage. This can cause the user or patient to be
exposed to electric shock or cause faulty readings of data. Contact St. Jude Medical
representative or technical support for further instructions.
Do not use the QUANTIEN measurement system if there is reason to believe the system's
security has been compromised or if the system was unaccounted for a period of time (i.e.
misappropriated, modified or tampered with).
High frequency surgical equipment must not be used on a patient at the same time as
PressureWire™ guidewire and the QUANTIEN measurement system.
Do not use the QUANTIEN measurement system if liquid is suspected to have penetrated
the enclosure or the power supply unit. This can cause the user or patient to be exposed to
electric shock. Contact St. Jude Medical representative or technical support for further
instructions.
Do not sterilize the QUANTIEN measurement system or any of its parts. Do not use this
system or any of its parts if it has been sterilized.
The QUANTIEN measurement system contains a lithium battery for the system real-time
clock. Danger of explosion. Battery is not intended to be replaced.
Do not leave the QUANTIEN measurement system unattended when logged in as a Site
Administrator.
To protect the privacy and security of sensitive information, including electronic protected
health information (EPHI), and to protect the integrity of the system itself, the system should
be located in a physically secure, access controlled environment.
Cautions
The QUANTIEN™ measurement system is Type CF equipment and protected against the
effects of a discharge of a defibrillator. PressureWire™ guidewire readings may be affected
by defibrillation. After defibrillation restart procedure, i.e. re-zero and re-equalize
PressureWire guidewire.
If it is necessary to install the QUANTIEN measurement system adjacent to other equipment,
this system should be observed to verify normal operation. If abnormal performance is
observed, it is necessary to increase distance between equipment.
Notes
The QUANTIEN™ measurement system is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The customer or the user of
this system can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the
QUANTIEN measurement system. See Guidance and manufacturer’s declaration -
electromagnetic immunity (page 81).
Please refer to Tracing EM interference (page 53) for support in identifying possible sources
of EM interference.
State: Released
Date: 2019.03.06 22:30 GMT
