•
When the Articulating Tip is substantially deployed, the PowerCURVE should not be rotated.
1. The rotation limiting mechanism will slip if the large handle is rotated while the Articulating Tip is
substantially articulated in dense bone. Caution: The location of the Working Cannula in the vertebra
should be monitored before, and during advancement of the PowerCURVE through the Working
Cannula.
•
When cavity creation is complete, use imaging guidance to straighten the Articulating Tip by returning
the Deployment Handle to its starting position. Caution: Straightening the Articulating Tip should
be done slowly and under imaging guidance while carefully monitoring the position of the tip of the
device. Straighten the device by turning the Deployment Handle counter clockwise.
•
Under imaging guidance, remove the PowerCURVE from the StabiliT Introducer’s Working Cannula.
•
The location of the StabiliT Introducer Working Cannula in the vertebra should be monitored and
adjusted if necessary after removal of the PowerCURVE.
•
Using image guidance (and stabilizing the Working Cannula), the PowerCURVE can be carefully
withdrawn and advanced multiple times to scrape or core bone until the desired cavity (size and
location) is created.
Cement delivery
a.
Confirm that the DiamondTOUCH Syringe trigger is released to ensure that the plunger is locked in position.
b.
Prime the LDC with bone cement by rotating the DiamondTOUCH Syringe handle in the CLOCKWISE
direction. Once bone cement exits the LDC tip, stop cement flow by squeezing the trigger on the
DiamondTOUCH Syringe. Release trigger to lock the plunger in the withdrawn position. Wipe LDC tip clean.
c.
Under image guidance, stabilize the Working Cannula and insert the LDC until the rotating wheel contacts
the Working Cannula luer. Rotate the LDC wheel to lock the LDC to the Working Cannula.
d.
When prepared to deliver bone cement squeeze the DiamondTOUCH Syringe trigger and push the handle
forward until resistance is met and release the trigger. Under image guidance, deliver bone cement by
rotating the handle in the CLOCKWISE direction.
e.
To stop bone cement delivery, squeeze the trigger on the DiamondTOUCH Syringe. Release trigger to lock
the plunger in the withdrawn position. To re-engage, squeeze the trigger and push the handle forward
until resistance is met, then release trigger. Continue delivering bone cement by rotating the handle in
the CLOCKWISE direction.
Caution:
To protect the threads of the lock release handle, the quick release
mechanism should be used to stop flow and relieve pressure when the gauge indicates 25 ATM or lower.
Caution:
The quick release mechanism will activate (signaled by a clicking sound) if the operator exceeds the
maximum pressure for the DiamondTOUCH Syringe. Once this has occurred, the quick release mechanism
may disengage at lower pressures during subsequent attempts to increase pressure.
Caution:
Following
completion of bone cement delivery, remove the LDC from the Working Cannula within 1 minute and
immediately insert and lock the Stylet in the Working Cannula. If no additional bone cement delivery is
required, remove Introducer (Cannula with Stylet).
Warning:
Removal of the Working Cannula should only
be performed after insertion of the Stylet by rotation and axial motion. DO NOT bend Working Cannula
sideways, patient injury may occur.
Table 1: Timing of Various Activities at Different Ambient Temperatures
Activity
Approximate Cumulative Time From
Initiation of Saturation (minutes)
@ 18-19 °C
(65-67 °F)
@ 20-23 °C
(68-74 °F)
Bone Cement Saturation and
Preparation
(See Bone Cement IFU)
0-10 minutes
0-5 minutes
Bone Cement Delivery
10-45 minutes (35 minutes
working time)
5-40 minutes (35 minutes working
time)
Table 2: Effect of Ambient Temperature on Cement
Temperature ºF (ºC)
Minimum Setting Time (minutes)
81 (27)
35
73 (23)
51
66 (19)
82
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RADIO FREQUENCY (RF)
COMMUNICATIONS EQUIPMENT AND THE DIAMONDTOUCH™ SYRINGE
The DiamondTOUCH Syringe is intended for use in an electromagnetic environment in which RF radiated
disturbances are controlled. The user of the DiamondTOUCH Syringe can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the DiamondTOUCH Syringe as recommended below, according to the maximum output power
of the communications equipment.
Separation distance according to frequency of transmitter (in meters) m
Rated maximum output
power of transmitter (in
watts) W
150kHz to 80 MHz
d=[1.2] √ P
80 MHz to 800 MHz
d=[1.2] √ P
800 MHz to 2.5 GHz
d=[2.3] √ P
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74
1
1.2
1.2
2.3
10
3.7
3.7
7.4
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance (d)
in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1:
At 80 MHz and 800 MHz, the separation distance for the higher frequency applies.
NOTE 2:
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY
The equipment is intended for use in the electromagnetic environment specified below. The customer or the user
of the equipment should ensure that it is used in such an environment.
Immunity Test
IEC 60601 test level Compliance level
Electromagnetic environment-
guidance
Electrostatic discharge
(ESD) IEC 61000-4-20
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Increasing relative humidity will
reduce the potential for ESD
related difficulties