Artisse™ Detachment Device; English - ev3 ARTISSE ISD-5 Mode D'emploi

English

Instructions for Use
Artisse™ Detachment Device
CAUTIONS
• It is important to read the instructions for use with careful
attention to cautions, notes and warnings prior to using this
device .
• Federal law (USA) restricts this device for sale, distribution, and
use by or on the order of a physician.
• This device should be used only in the hospital operating room
environment by physicians with a thorough understanding
of angiographic and percutaneous neuro-interventional
procedures .
• Do not use the device after the expiration date (Use By Date)
printed on the product label .
• Always confirm there are several backup Artisse™ Detachment
Devices, in their unopened sterile package, as well as extra
Sterile needles (20 G or 22 G) on the shelf before procedure .
Verify that all Artisse™ Detachment Devices are within their
indicated shelf life .
• Never open the main housing. Opening the main housing affects
proper device functioning .
• This device is designed to minimize the effects of uncontrolled
electromagnetic interference and other types of interference
from external sources. Avoid use of other equipment that may
cause erratic operation or degradation in the performance of
this device .
• The device must be kept dry. It must not be submerged or be
used in wet environment.
• The device should be used in the temperature range 10°C to
34°C .
• The device should be used in the Humidity range 30% to 85%.
• The device along with cables and clips is sterile and non-
pyrogenic. The device is sterilized using ETO. Do not use if
sterile packaging is compromised or damaged .
• The device is intended for SINGLE PATIENT USE ONLY. DO NOT
RESTERILIZE AND/OR REUSE. Re-sterilization may corrode the
device, resulting in device malfunction .
ESSENTIAL PERFORMANCE
Artisse™ Detachment Device shall not allow an output of
unintended current >2 .1mA
DESCRIPTION
The Artisse™ Detachment Device is a hand held, battery operated
device designed to initiate and control the detachment of the
Artisse™ Implant . The Artisse™ Detachment Device is designed
to apply a constant current through the device and to detect
detachment .
The Artisse™ Detachment Device is depicted on page 1 .
The device maintains constant current by:
1 . Sensing the amount of resistance to current flow through the
device and
2 . Adjusting the voltage required to maintain a constant
EN
current . Once detachment is completed, the device indicates
detachment with an audible and visual "Detach" signal and
stops the flow of current to the device.
WARNINGS
• No modification of this device is allowed. Device could be
damaged .
• Use of this device adjacent to or stacked with other devices
should be avoided because it could result in improper
operation. If such use is necessary, this device and the other
devices should be observed to verify that they are operating
normally.
• Portable RF communications equipment (including
peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any part
of this device. Otherwise, degradation of the performance
of this device could result .
Artisse™ Detachment Device
illustration
INDICATIONS FOR USE
The Artisse™ Detachment Device is intended for use only with the
Artisse™ Intrasaccular Device .
Device Dimensions:
Device Weight:
Climatic Class:
Atmospheric pressure:
1
Artisse™ Detachment Device
parts description
1 Cathode Wire Clip
2
Anode Wire Clip
3
Patient Connecting
Cable (CATHODE)
4 Patient Connecting
Cable (ANODE)
5
Detachment Indicator
6
Push Button
7 Battery Indicator
General Technical Data
130 mm x 40 mm x 30 mm
(L x W x D)
Approximately 100 grams
Operation at 10°C to 34°C
68 kPa to 110 kPa