En- User Manual; Technical Description - SpineGuard PediGuard Manual Del Usuario

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USER MANUAL
In no case can the PediGuard replaces the surgeon's experience or knowledge of anatomic structures. It is intended to assist the surgeon in the decision-making process
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during surgery in the operating room.
1. INTRODUCTION
The PediGuard System is used in drilling pilot holes into the spinal vertebrae. The System serves to alert the surgeon to a possible vertebral cortex fracture while drilling
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a pedicle screw pilot hole.

2. TECHNICAL DESCRIPTION

The PediGuard is a sterile single use instrument; its handle contains an electronic circuit. The tip of the instrument is the applied part.
The PediGuard is a battery-operated device with a maximum output current of 5.5 milliamps ("mA"). Published literature suggests that threshold level monitoring requires
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at least 8-10 mA. The PediGuard
Essential Performances:
1. Mechanics essential performance: the cutting ability during the pedicle drilling.
2. Electronics essential performance: sound and visual signals lead the surgeon during the pedicle drilling. Those informing signals convey the conductivity information
which characterizes the tissues in contact with the sensor tip.
DSG Connect only:
An optional feature is available to transmit the conductivity data to an external display to allow signal visualization and recording. The PediGuard® devices equipped with
this feature are labelled DSG Connect and are equipped with a communication module which transmits data through radio frequency (RF) communication (2.40–2.48 GHz,
GFSK modulation and maximum RF output power of 9.9 dBm)
3. FOR USE
Power-on
To activate the PediGuard , pull the contact tab out of the Handle. Activation is confirmed by a beeping sound and green LEDs.
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Safety features
The PediGuard has several safety features which allow easy checking of proper operation:
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Green LEDs
Yellow LEDs
Sound
Case
The instrument is ON. Either the tip of the instrument does not make contact with tissue or is in contact with bone that has very low conductivity.
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The tip of the instrument is in contact with tissue.
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The battery is too low: do not use the instrument.
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Either the instrument is not ON, or the battery does not work. Verify that the instrument is ON. If the instrument is ON but the LEDs remain OFF, do not use the
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instrument.
The instrument tip is not functioning properly: do not use the instrument.
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If the LEDs are not visible through the clear wall of the handle, do not use the PediGuard
Preliminary checks
Check the PediGuard System for accurate assembly and function by placing the tip of the instrument in saline (0.9% sodium chloride). A high rate high-pitched sound
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should be heard. The green LEDs should flash at a high rate. If a metal bowl is used, do not touch the bowl. If no sound is heard, it may be necessary to clean the tip of
the instrument using a mild scrubber (e.g. electrocautery scrubber).
Connection to the DSG Connect App (optional)
The PediGuard® devices equipped with the DSG Connect feature can be paired to an external display. The pairing instructions and specific instructions for use are
available within the DSG Connect App.
Surgical technique
Surgical technique – Open Techniques
The surgeon should prepare the intended entry points for the pedicle screws using preferred open techniques to expose the posterior surface of the spine. The correct location for
the entry point and angle of entry may be checked by using fluoroscopy.
Each hole should be drilled using the following technique:
• Prepare the entry point for drilling by removing the cortical bone.
• Direct the tip of the PediGuard
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• Position the PediGuard at the entry point and advance its tip through cancellous bone in the expected position of the screw. Use constant hand pressure and gentle
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alternate rotating motions (never use mallet blows).
Muscular contractions may occur if the cortex has been fractured. In this case, the surgeon must stop advancement of the tip, and check the trajectory. If redirection is
necessary, instrument should be pulled back before to adjust trajectory.
Before drilling a new hole, clean the tip of the instrument with a soft cloth impregnated with saline solution.
Surgical technique – MIS or percutaneous Techniques
The surgeon should locate the intended entry point for the pedicle screws using fluoroscopy, and determine the anticipated angle of entry using his knowledge of MIS
procedure for pedicle screw placement including the analysis of pre-op images of the spine of the patient.
Each hole should be drilled using the following technique:
• In the case of a percutaneous procedure, directly introduce the PediGuard
• In the case of a mini-open procedure, use the specific retractor provided with the pedicle screw instrumentation set until the entry point can be directly visualized. Then
refer to open technique for usage of the PediGuard
• Position the PediGuard at the pedicle entry point and along the desired angle of entry using fluoroscopy, and perforate the cortical bone with the tip of the PediGuard
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• Advance the PediGuard tip through cancellous bone in the expected position of the screw. Use constant hand pressure and gentle alternate rotating motions.
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• Progress of the positioning of the tip of the PediGuard
Muscular contractions may occur if the cortex has been fractured. In this case, the surgeon must stop advancement of the tip, and check the trajectory. If redirection is
necessary, instrument should be pulled back before to adjust trajectory.
Before drilling a new hole, clean the tip of the instrument with a soft cloth impregnated with saline solution. After surgery
The instrument must be discarded after the surgical procedure.
Discard the instrument in appropriate containers so that destruction can be performed in a manner that preserves the environment. For detailed information concerning this
procedure, please contact your local SpineGuard representative.
, which does not perform threshold recordings, is not intended to be used as a substitute for a threshold level monitoring device.
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ON
OFF
None Rated sound
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to the soft tissue (wound) to initiate a rated high-pitched "beep".
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through the body of the vertebral pedicle and into the vertebral body may be routinely checked with fluoroscopy.
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PediGuard
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Single-use
Flashing OFF
OFF OFF
ON
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.
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through soft tissues.
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OFF OFF
OFF ON
None None
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EN
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