Press the blue button behind the DiamondTOUCH Delivery Syringe LCD display near the tubing to power the device
on. The LCD will display “Zero” for two seconds and then the device will be ready for use. At this point the syringe
will begin its incremental time keeping.
NOTE:
a.
The syringe will default to PSI mode when initially turned on. To change the pressure display to read ATM/
BAR, press and hold the blue button until “ATM/BAR” flashes four times. The display is now in “ATM/BAR”
mode. To change back to PSI, press and hold the blue button once again.
b.
When in PSI mode, the tick marks on the left of the display that represent pressure will be limited to 350 PSI
(23.8 ATM). If the DiamondTOUCH is pressurized past 350 PSI, the grouping of tick marks on the left will flash.
The numerical digits in the center of the display will continue to show actual pressure throughout the device’s
pressure range (-6 to 514 PSI). After pressure reading has been taken, a graph bar or tick mark will remain to
mark the highest point of pressure. Pressing the blue button once quickly will display last pressure reading
information and a indicator on the display. After the next pressure reading has started, the last tick mark will
disappear.
c.
To conserve power the backlight will automatically turn off after ten minutes of inactivity. However, the
microprocessor will continue to monitor the pressure. Pressing the blue button will reactivate the backlight.
The device will power itself off after 90 consecutive minutes at zero pressure.
d.
Squeeze the clutch and advance the plunger with enough force to completely remove any air present in the
syringe.
e.
Submerge the end of the extension tube in sterile water (or saline).
f.
Squeeze the clutch on the DiamondTOUCH Syringe and pull back the handle to fill the syringe with fluid. Do
so until the entire syringe is filled.
g.
While holding vertical, push handle against table or other solid surface to remove any air in syringe and
extension tube.
h.
If additional fluid is needed in the DiamondTOUCH Syringe, squeeze the clutch and pull back fully to aspirate
with sterile water (or saline).
i.
Optional device stickers are included to be attached to the DiamondTOUCH Syringe to identify the fluid
being used in the syringe. The white sticker may be used to identify sterile water, the blue sticker for saline,
and the yellow sticker for contrast (contrast not associated with the StabiliT MX Vertebral Augmentation
System).
j.
Mix bone cement per the StabiliT Cement and Saturate Mixing System IFU.
CAUTION:
If the DiamondTOUCH Syringe LCD displays anything besides the
pressure and time windows as shown above, the syringe is defective. Please
return the syringe to Merit Medical for credit.
Access the vertebral body using the StabiliT Introducer.
a.
Under image guidance direct the StabiliT Introducer into the vertebral body, while checking A/P and lateral
images to confirm proper device placement.
b.
Once the StabiliT Introducer is positioned in the vertebral body, remove the Stylet with a counterclockwise
turn, leaving the Working Cannula in place.
Assemble system components
a.
Prior to bone cement delivery (see Table 1.) remove the Filter and Funnel Assembly. Clean the Cement Syringe
of excess bone cement
b.
Completely thread the Cement Syringe onto the Cement Delivery Elbow.
c.
Thread the Master Syringe onto the Cement Syringe. Caution: Ensure Master Syringe is FULLY threaded onto
Cement Syringe before proceeding. Not doing so can cause user injury or device malfunction.
d.
Confirm the Hydraulic Coupler is securely attached to the Master Syringe
e.
Securely connect the Master Syringe with Coupler to the end of the DiamondTOUCH Syringe extension tube.
Caution: Do not begin bone cement delivery until saturation and preparation time is complete (see Table 1).
Create an access channel and a cement staging cavity for bone cement delivery using the SLO and the
PowerCURVE. WARNING: Use image guidance and follow the IFU to avoid patient injury.
a.
Use the SLO to create an access channel and a cement staging area in the bone:
•
Remove the Stylet from the SLO and set aside prior to inserting the SLO in the Working Cannula.
•
Remove the Stylet from the Working Cannula.
•
Using image guidance, advance the SLO through the Working Cannula. Once in contact with bone,
verify placement of the tip of the SLO at the intended location. The Introducer/SLO stop limits the SLO
shaft to extend 15 mm beyond the distal end of the Working Cannula. Always verify placement under
image guidance.
•
Using image guidance, advance the tip of the SLO to the desired location to carefully scrape or core the
bone. Caution: The location of the Working Cannula in the vertebra should be monitored before and
during advancement of the SLO.
•
When scraping or coring is complete, stabilize the Working Cannula and remove the SLO.
b.
Use the PowerCURVE to create targeted access channels and cement staging cavities in the bone:
•
The Articulating Tip is the distal portion of the PowerCURVE, the Tip Indicator points in the direction of
the articulating tip bending.
•
The Deployment Handle is the rotating portion of the PowerCURVE Handle.
1. Turning the Deployment Handle one (1) full 360° turn clockwise will cause the Articulating Tip to
fully bend.
2. Turning the Deployment Handle counter-clockwise will cause the Articulating Tip to straighten.
3. Do not turn the Deployment Handle greater than one (1) full 360° turn clockwise.
•
Ensure the Articulating Tip is fully extended in the straight position prior to insertion into the Working
Cannula.
•
Remove the stylet from the Working Cannula.
•
Insert the PowerCURVE into the Working Cannula until the first laser mark on the shaft is even with the
proximal end of the luer on the Working Cannula. Confirm by image guidance that the distal end of
the PowerCURVE is at the distal end of the Working Cannula before proceeding. When fully inserted
into Working Cannula, the shaft extends approximately 31 mm beyond the distal end of the Working
Cannula.
•
As the Articulating Tip exits the Working Cannula turn the Deployment Handle to bend the Articulating
Tip in the direction of the Tip Indicator on the PowerCURVE shaft.
•
The PowerCURVE can be advanced to the desired position using image guidance.
•
Care should be taken at all times to NEVER strike the arms of the Deployment Handle, especially when
rotated from its starting position.