Stryker 0711-001-000, Instructions For Use Manual

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6 6..1 10 0.. G Gllo ossssa arryy
A Alle errtt C Co on nd diittiio on n– a potential or actual hazardous situation
exists for which user AWARENESS or RESPONSE is
required.
IIn nvva alliid d M Ma an niiffo olld d– a manifold that may have been altered,
damaged, or previously exposed to suction and has since
expired.
A Ap pp plliie ed d P Pa arrtt– 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.
L Lo ow w P Prriio orriittyy A Alle errtt– – indicates user AWARENESS is
required [product safety has indicated future action may be
needed to address alerts.]
B BS S E EN N IIS SO O 1 10 00 07 79 9--1 1:: 2 20 00 09 9,, cclla au usse e 9 9..4 4– 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.
M Me ed diiu um m P Prriio orriittyy A Alle errtt– indicates PROMPT user
RESPONSE is required.
B BS S E EN N IIS SO O 1 10 00 07 79 9--1 1:: 2 20 01 15 5 + + A A1 1:: 2 20 01 19 9,, cclla au usse e 9 9..1 11 1–
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.
N Ne ew w M Ma an niiffo olld d– a valid manifold; suction has never been
applied to the manifold.
D Do occkke err--R Ro ovve err IIn ntte errffa acce e– 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.
N No ottiiffiicca attiio on n– indicates a low priority alert condition that will
not prevent use of the rover. The rover will remain fully
functional after experiencing a notification.
E Errrro orr– indicates a medium priority alert condition, including
a software or hardware fault, or an unexpected operating
condition.
O Offff L Lo oa ad diin ng g– the contents of the rover canister is emptied
into a facility waste disposal drain during docking.
E Exxp piirre ed d M Ma an niiffo olld d– indicates 36 hours have elapsed since
the new manifold was first exposed to suction.
P Prre effiillll F Fllu uiid d– 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.
F Fllu uiid d L Le evve ell S Se en nsso orr– 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.
P Prre effiilllliin ng g– adding prefill fluid to the rover canister.
F Fllu uiid d S Stta acckkiin ng g– 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.
U Usse ed d M Ma an niiffo olld d– a valid manifold exposed to suction, but
not yet expired.
EN 74 700000969828 Rev-AA
DRAFT
NOT
FOR
SALE