Stryker InZone Mode D'emploi page 9

• All five indicator lights are lit at once.
If all five indicator lights are lit at the same time, the InZone
Detachment System has detected that it is not working properly or
cannot accurately regulate current output. If this occurs, do not use
the detachment system. Replace the device and notify your Stryker
Neurovascular representative.
• System will not power on.
Once the coil delivery wire butts against the inside of the InZone
Detachment System, it takes one second for the system to power on.
If the system remains powered off for more than one second, slide the
system completely off the delivery wire and then back on, again allowing
the system one second to power on. If after several insertion attempts
there is still no power, replace the device and notify your Stryker
Neurovascular representative.
• System sounds a single beep and no indicator light is lit.
If the system sounds a single, one-second, monotone beep, with no
corresponding indicator light shining, then the delivery wire was
removed or lost electrical contact before the cycle completed. To restart
detachment, simply reinsert the wire to establish the contact connection
and begin the detachment process per the Operational Instructions
section of this document.
• System will not come out of Sleep Mode.
If pressing and releasing the DETACHMENT BUTTON does not bring the
system out of Sleep Mode, the coil delivery wire has lost contact with
the InZone Detachment System. Slide the system completely off the wire
and then back on again to reset the system.
13. TECHnICaL DESCrIPTIOn
Detachment System Specification
The InZone Detachment System operates with the following:
Power
Battery
Expected Battery Life
IZDS Connecting Cable – UPN
®
M00345110250 (sold separately), for
use in detaching GDC or Matrix
® 2®
Detachable Coils only
Current
Voltage
Operating Temperature
Environmental (Transit) Temperature -25°C to +55°C
Environmental (Transit) Humidity
Unit Size
®
3V from two series alkaline batteries
Two (2) AAAA (1.5 V) alkaline
batteries, factory-installed
Minimum 20 detachments
Negative (Cathode); use with sterile
20- or 22-gauge uncoated stainless
steel hypodermic needle
2.4 mA maximum direct current (DC)
28 VDC maximum output
+10°C to +40°C
30% to 85% relative humidity
5.8 cm (2.3 in) X 14.0 cm
(5.5 in) X 2.8 cm (1.1 in)
Unit Weight
Target Coil Cycle Max Time
®
GDC Coil & Matrix Coil Cycle
2
Max Time
Power Source Location (EN 60601-1) Internally Powered Equipment
Device Classification (EN 60601-1)
Compatibility with Flammable
Anaesthetic Mixtures (EN 60601-1)
Protection against Ingress of
Water (EN 60601-1)
Mode of Operation (EN 60601-1)
Guidance and manufacturer's declaration - electromagnetic emissions
The InZone Detachment System is intended for use in the
electromagnetic environment specified below. The customer or the user
of the InZone Detachment System should ensure that it is used in such
an environment.
Emissions test Compliance
RF emissions
Group 1
CISPR 11
RF emissions
Class B
CISPR 11
Harmonic emissions
Not applicable
IEC 61000-3-2
Voltage
fluctuations/flicker
Not applicable
emissions
IEC 61000-3-3
9
80 g (2.8 oz)
10 Seconds
75 Seconds
Type BF
Equipment not suitable for use
in the presence of a Flammable
Anaesthetic Mixture with Air or
with Oxygen or Nitrous Oxide
IPX0
Continuous Operation
Electromagnetic environment -
guidance
The InZone Detachment System
uses RF energy only for its
internal function. Therefore,
its RF emissions are very low
and are not likely to cause any
interference in nearby electronic
equipment.
The InZone Detachment
System is suitable for use in
all establishments other than
domestic and those directly
connected to the public low-
voltage power supply network
that supplies buildings used for
domestic purposes.