ev3 ARTISSE ISD-5 Mode D'emploi page 4

Humidity(relative, non –
condensing):
Maximum Operating Voltage:
Maximum Direct Current
Output:
Identification Plate:
Artisse™ Detachment Device Visual and Audible Indication
Visual Indication
Battery Detachment
Indicator Indicator
N/A N/A
GREEN OFF
Continuously
glowing and
GREEN
dimming
BLUE
Interrupted
GREEN flashing
BLUE
GREEN AMBER
30% to 85%
28 Volts
2 .1mA
ev3™ Artisse™ Detachment
Device
Chart
Audible
Device Status
Indication
• At power ON.
Single • On single
acoustic push button
tone press to start
detachment .
Device ready for
N/A
use .
Detachment
process is in
progress .
N/A
Note: Detachment
process will last for
60 seconds .
SUCCESSFUL
DETACHMENT
Precaution:
Successful
detachment must
Interrupted
be verified by
acoustic
fluoroscopy that
tone for
Artisse™ Implant
20 seconds
has detached .
On successful
detachment follow
instructions in Note
1 below.
Device encountered
error in detachment
or timed out
after 60 seconds
of continuous
Continuous
detachment
acoustic
process .
tone for 20
seconds
If error in
detachment is
encountered follow
instructions in Note
2 below.
AMBER AMBER
AMBER OFF
Note 1: User may acknowledge the indication by pressing the Push
Button for at least 1/10 Sec but not more than 3 Sec .
Note 2:
a . Ensure that the cables are properly connected.
i. If cables are not connected properly, connect the
cables properly.
ii. If cables are connected properly, check for the
detachment using fluoroscopy. If not detached,
restart detachment process .
b . Acknowledge the error by pressing the push button for at
least 1/10 Sec but not more than 3 Sec .
c . After acknowledgement, Battery Indicator will light
in GREEN and the device is ready for use for next
detachment .
Artisse™ Detachment Device Push Button Function Chart
To power ON device
To power OFF device
To start detachment
To acknowledge detachment
success
To acknowledge detachment
Error
Note: The device shall power OFF, If kept idle for 15 minutes.
Patient Connection and Cable Sets
Cables connection shall only be made after the Artisse™ Implant is
placed at the desired location and ready for detachment.
a . Insert a sterile needle (20 G or 22 G = 0 .7 or 0 .9 mm,
respectively) at the shoulder.
b . Press the end of the connector of the sterile black cable
so that the J-hook protrudes from the distal end and clip
it on the needle .
c . Press the end of the connector of the sterile red cable so
that the J-hook protrudes from the distal end and clip
to the proximal end of the pusher wire of the Artisse™
Implant .
Note: If the polarity is incorrect, detachment will not be possible.
2
Device has
encountered
N/A system error.
Discontinue use of
the device .
Device battery level
is Insufficient.
N/A
Discontinue use of
the device .
Press and hold Push Button for
minimum 3 Sec .
Press and hold Push Button for
minimum 4 .5 Sec .
Press Push Button for at least
1/10 Sec but not more than
3 Sec .
Press Push Button for at least
1/10 Sec but not more than
3 Sec .
Press Push Button for at least
1/10 Sec but not more than
3 Sec .