Possible Adverse Effects; Technical Specifications - SpineGuard PediGuard Manual Del Usuario

4. IMPORTANT MEDICAL INFORMATION
4.1 Indications
The PediGuard is indicated for use during pedicle screw pilot hole drilling to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance
at the tip of the probe and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The PediGuard system is indicated for use in both open
and percutaneous (MIS) surgical approaches to the spine. PediGuard is also indicated for use with fluoroscopic guidance in percutaneous (MIS) surgical approaches to the
spine. The PediGuard also is specifically indicated for use in intraoperative electromyographic ("EMG") surveillance to assist in the location and evaluation of spinal nerves
during surgery of the spine, by administration of low voltage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated
with those nerves.
4.2 Contraindications
- Pathologies involving the vertebral cortex
- Patients who have received a pacemaker or any other active medical device.
4.3 Warnings
Do not use the device:
- In the presence of flammable anesthetics
- At room temperature above 30°C
- In a humid environment.
• Use of the PediGuard in conditions of extreme osteoporosis is not recommended. The condition of the bone in this situation must be closely evaluated prior to use of the
device.
• Only use components provided by SpineGuard. Using components from another manufacturer may cause malfunction of the device and be harmful to the patient.
• No modification of this equipment is allowed.
• Intraoperative use of muscle relaxants inhibits muscular contractions which are normally used as a means of detection. Use of muscle relaxants is therefore discouraged
when using the PediGuard System.
• Patient positioning on the operating table is critical: ensure that leg motions (if any) will not cause any injury to the patient or a fall from the operating table.
• Avoid any contact between the PediGuard and the patient while using an electrocautery device or defibrillator.
• Use of the device near the thorax may increase the risk of cardiac fibrillation.
• Using the PediGuard in association with another electronic device requires special precautions: perturbations on the patient's ECG monitor may be observed while the
PediGuard is in use. These abnormalities will stop as soon as the instrument is removed.
• IMPORTANT: Do not allow fluids or foreign bodies in the handle (immersion of the handle, even for a short period of time, is prohibited). In case of fluids or foreign bodies
ingress in the electronics casing, do not use the device.
• Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should be observed to verify that they are operating normally.
• Portable RF communications equipment (including peripherals such as antenna cables and externals antennas) should be used no closer than 30 cm (12 inches) to any
part of the PediGuard System. Otherwise degradation of the performance of this equipment could result.
• Operation in close proximity (e.g. 1m) to a shortwave or microwave therapy ME equipment may produce instability in the device output.
4.4 Precautions
• The choice of the PediGuard diameter is determined by the diameter of the screws the surgeon wants to place and by the pedicle size.
• When used as an EMG stimulator, do not let muscular contractions last too long to avoid undue patient fatigue.
• As with any surgical instrument, this device should be carefully inspected before use.
• Always check the integrity of the sterile packaging before use. Do not use instrument with opened or damaged packaging.
• If the PediGuard is accidentally dropped on the ground, do not use it.
• Do not use the PediGuard if no rhythmic beep is heard when dipped in a saline solution.
• If the green LED lights are on but do not flash when dipped in a saline solution (circuit is open), do not use the PediGuard
• Always make sure that the "beep" is heard and the green LED lights are on when the tip of the instrument touches the patient wound.
• Do not re-sterilize the instrument.

4.5 Possible adverse effects

The possible adverse effects while using the PediGuard
• Penetration of the vertebrae resulting in injury or paralysis;
• Muscular contractions induced by nerve root stimulation;
• Loss of neurological functions, appearance of radiculopathies, dural injuries and/or pain. Neurovascular insufficiency, including paralysis or other serious lesions.
Cerbrospinal fluid leak;
• Gastrointestinal, urological and/or reproductive tract disorders, including sterility impotence;
• Incapacity to resume the activities of normal everyday life;
• Soft tissue damage;
• Infection;
• Fracture of the vertebral body;
• Death.
5. CLINICAL USE (THE CLINICAL STUDY WAS CONDUCTED USING THE ORIGINALLY CLEARED PEDIGUARD MODEL (K030526)
A clinical study was performed in which 147 manual pedicle drillings were performed during 28 spinal surgeries using the PediGuard
techniques of detecting pedicle screw fracture. Investigators received PediGuard® output when detecting fractures in addition to their conventional surgical methods. A
total of 23 vertebral cortex perforations (16%) were confirmed, of which the PediGuard
6. STATEMENT [RELATED TO EUROPEAN REGULATION 93/42/EEC]
The PediGuard is not intended to be used in direct contact with the Central Nervous System. The contact with any part of the dura mater, may it be the part sheathing the
medulla spinalis or the part sheathing the roots of the nerves up to the spinal ganglia, shall be avoided.

7. TECHNICAL SPECIFICATIONS

Storage: Expiry date is mentioned on the outer package and must be respected. The PediGuard should be stored in a clean dry place.
Service life: Once ON, the PediGuard cannot be turned off. The PediGuard battery provides sufficient autonomy.
8. INFORMATION RELATED TO SINGLE USE DEVICES
PediGuard is a single use device. The retreatment and the re-use of the PediGuard are forbidden.
Several potential dangers related to the re-use of the PediGuard can increase the risk to the patient. Some technical characteristics of the PediGuard are not compatible
with the re-use of the instrument. Possible issues with re-sterilization and re-use are: non-functioning device, failure of some or all of the electronic functions, unknown
changes to the electronic function of the device, non-sterile device, transfer of disease, cleaning agents or disinfectants.
Additionally, the re-use of a single use device will result in the loss of traceability of the medical device and the loss of the technical documentation, as the instruction for
use.
ONLY USE INSTRUMENTS WITH INTACT PACKAGING.
DO NOT CLEAN, RE-STERILIZE, OR RE-USE THIS DEVICE.
CAUTION: FEDERAL LAW (US) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A LICENSED PHYSICIAN.
IF YOU HAVE QUESTIONS ABOUT THIS DEVICE, PLEASE CONTACT:
SpineGuard, S.A. (MANUFACTURER)
10, Cours Louis Lumière
94300 Vincennes - France
Phone: +33 (0) 1 45 18 45 19
Fax: +33 (0) 1 45 18 45 20
System are:
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detected 22. One false positive occurred during the study.
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device in addition to conventional
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