66..1100.. GGlloossssaarryy
AAlleerrtt CCoonnddiittiioonn– a potential or actual hazardous situation
exists for which user AWARENESS or RESPONSE is
required.
IInnvvaalliidd MMaanniiffoolldd– a manifold that may have been altered,
damaged, or previously exposed to suction and has since
expired.
AApppplliieedd PPaarrtt– a component of an electrical medical device
that comes into physical contact with the patient during
normal use to perform its function. The fluid suction tubing
is an applied part.
LLooww PPrriioorriittyy AAlleerrtt– – indicates user AWARENESS is
required [product safety has indicated future action may be
needed to address alerts.]
BBSS EENN IISSOO 1100007799--11:: 22000099,, ccllaauussee 99..44– the
requirements in IEC 60601-1:1988, clause 16 apply; also
the housing shall be constructed of fire-retarding material
which withstands the needle-flame test specified in IEC
60695 2-2 when the flame is applied to any point on the
inside or outside surface of the housing for 20 seconds.
MMeeddiiuumm PPrriioorriittyy AAlleerrtt– indicates PROMPT user
RESPONSE is required.
BBSS EENN IISSOO 1100007799--11:: 22001155 ++ AA11:: 22001199,, ccllaauussee 99..1111–
interruption and restoration of the power supply to the
suction equipment shall not cause any hazard, and the
vacuum and flow rate shall not vary by more than 10% from
the set value.
NNeeww MMaanniiffoolldd– a valid manifold; suction has never been
applied to the manifold.
DDoocckkeerr--RRoovveerr IInntteerrffaaccee– includes four elements: (1)
docker electromagnets attract and hold the rover strike
plates to facilitate physical connection, (2) the docker
power coupler provides electrical energy to the rover during
docking, (3) rover and docker fluid couplings provide
pathways for fluid waste outflow and clean water inflow to
the rover canisters, and (4) infrared communication is used
to exchange information between the docker and rover.
NNoottiiffiiccaattiioonn– indicates a low priority alert condition that will
not prevent use of the rover. The rover will remain fully
functional after experiencing a notification.
EErrrroorr– indicates a medium priority alert condition, including
a software or hardware fault, or an unexpected operating
condition.
OOffff LLooaaddiinngg– the contents of the rover canister is emptied
into a facility waste disposal drain during docking.
EExxppiirreedd MMaanniiffoolldd– indicates 36 hours have elapsed since
the new manifold was first exposed to suction.
PPrreeffiillll FFlluuiidd– the rover canister is prefilled with a water and
detergent solution after each docking cycle; the solution
initiates the breakdown of fluid waste collected during use.
FFlluuiidd LLeevveell SSeennssoorr– a sensor located in the collection
canister that determines the current fluid volume level. The
presence of prefill fluid ensures the sensor is always
floating.
PPrreeffiilllliinngg– adding prefill fluid to the rover canister.
FFlluuiidd SSttaacckkiinngg– if the rover has sufficient fluid volume
capacity in the collection canister, it may be used for more
than one surgical procedure; fluid waste is ‘stacked’
between procedures.
UUsseedd MMaanniiffoolldd– a valid manifold exposed to suction, but
not yet expired.
EN 74 700000969828 Rev-AA
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