ev3 ARTISSE ISD-5 Mode D'emploi page 5

Switching "ON" the Artisse™ Detachment Device and Testing:
Press and hold the Push button for approximately 3 seconds to
switch ON the device. Battery Indicator and Detachment Indicator
shall flash. Upon successful self-diagnosis of the device, the Battery
Indicator shall turn GREEN to confirm the device is ready for use. If
the Battery and Detachment Indicators are AMBER, the device is in
System Error state and shall not be used.
After powering ON, the Artisse™ Detachment Device shall remain
ready until it receives user input, maximum idle time of 15min is
reached, or insufficient battery capacity reached.
STARTING THE DETACHMENT
a . Once the cable connection to the patient has been made,
the detachment may start. This is performed by pressing
the Push button on the device for at least 1/10 Sec but
not more than 3 Sec .
b . The Detachment Indicator shall continuously glow and
dim in BLUE without any audible tone throughout the
detachment cycle.
PRECAUTION
Before starting the detachment process, verify proper connection
of the Anode ("red") and Cathode ("black") Clips from the Artisse™
Detachment Device to the respective Pusher wire & Needle.
STOP THE DETACHMENT
In case of emergency, Artisse™ Detachment Device detachment
process may be stopped by pressing and holding the Push Button for
minimum 4 .5 Sec .
• "Starting a new detachment" – Artisse™ Detachment
Device to be powered ON by pressing push button for
minimum of 3 Sec .
SUCCESSFUL DETACHMENT
The device shall indicate the successful detachment to user with
interrupted flashing BLUE Detachment Indicator and interrupted
acoustic tone. User may acknowledge the indication by pressing
the Push Button for at least 1/10 Sec but not more than 3 Sec . After
acknowledgment, the device goes back into Ready state and a new
detachment process can be started .
CAUTION
DO NOT remove cathode/anode cable connector clips from
needle/pusher wire during detachment process.
Accidental connector Clip removal/disconnection from needle/
pusher wire during the detachment process may elicit a false
"Successful Detachment" indication. Always visually confirm
implant non detachment using fluoroscopy, before starting a new
detachment .
PRECAUTION
Before pulling out Pusher wire, visually confirm detachment
status using fluoroscopy.
Successful detachment of the Artisse™ Implant must be verified
by fluoroscopy to ensure that the Artisse™ implant has detached.
Once Artisse™ implant detachment has been detected and
visually confirmed using fluoroscopy, slowly remove the Clips from
the needle and pusher wire.
INTERRUPTION OF THE ELECTRICAL CONNECTION TO THE
PATIENT
If the connection to the patient is interrupted in the first 10 seconds
during the detachment process, the device will recognize this and
indicate with a continuous AMBER on Detachment Indicator and a
continuous acoustic tone for 20 seconds approximately. User may
acknowledge the indication by pressing the Push Button for at least
1/10 Sec but not more than 3 Sec . Ensure that the cable clips are
properly connected prior to starting a new detachment process.
MAXIMUM DETACHMENT TIME
The maximum detachment time has been set to 60 seconds . After
maximum detachment time has elapsed, the device will sound a
continuous acoustic tone with a continuous AMBER light ON visual
indication .
POWERING OFF THE Artisse™ DETACHMENT DEVICE
The Artisse™ Detachment Device may be powered OFF by pressing
and holding the Push Button for approximately 5 seconds. Confirm
Device has Powered OFF by visually observing Battery Indicator light
turning OFF .
REQUIRED ADDITIONAL ITEMS & ACCESSORIES
Always have an additional Artisse™ Detachment Device (in sterile
pouch) and extra Sterile needles (20 G or 22 G) available as backup .
PRECAUTIONS
The Artisse™ Detachment Device has been tested and found to
comply with the limits for medical devices to the IEC 60601-1-2:
2007/03/01 Ed: 4.0. These limits are designed to provide reasonable
protection against harmful interference in a typical medical
installation . This device generates, uses and can radiate radio
frequency energy and, if not installed and used in accordance with
the instructions, may cause harmful interference to other devices in
the vicinity. However there is no guarantee that interference will not
occur in a particular installation . If this device does cause harmful
interference to other devices, which can be determined by turning
the device off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
a . Reorient or relocate the receiving device .
b . Increase the separation between the devices.
c . Consult ev3™ .
WARNINGS
The Artisse™ Detachment Device must not be operated in the
proximity of or in connection with equipment that emits short
waves or microwave radiation nor with HF surgical equipment.
The Artisse™ Detachment Device is not suitable for use in the
presence of a flammable anesthetic mixture with air or with
oxygen or nitrous oxide.
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