Medtronic 8225720 Instructions for Use

NIM® SYSTEM INSTRUMENTS M708348B061 Rev. A

IMPORTANT INFORMATION ON THE NIM® SYSTEM INSTRUMENTS

INFORMATIONS IMPORTANTES SUR LES INSTRUMENTS DU SYSTÈME NIM®

INFORMACIÓN IMPORTANTE SOBRE EL INSTRUMENTAL DEL SISTEMA NIM®

WICHTIGE INFORMATIONEN ZU DEN NIM®SYSTEMINSTRUMENTEN

INFORMAZIONI IMPORTANTI SUGLI STRUMENTI DEL SISTEMA NIM®

BELANGRIJKE INFORMATIE OVER DE NIM® SYSTEEMINSTRUMENTEN

VIGTIG INFORMATION OMKRING NIM® SYSTEMINSTRUMENTERNE

VIKTIG INFORMATION OM NIM® SYSTEMINSTRUMENT

VIKTIG INFORMASJON OM INSTRUMENTER I NIM®SYSTEMET

TÄRKEITÄ TIETOJA NIM® JÄRJESTELMÄN INSTRUMENTEISTA

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INFORMAÇÃO IMPORTANTE SOBRE OS INSTRUMENTOS DO SISTEMA NIM®

DŮLEŽITÉ INFORMACE O NÁSTROJÍCH PRO SYSTÉM NIM®

TÄHTIS TEAVE SÜSTEEMI NIM® INSTRUMENTIDE KOHTA

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FONTOS INFORMÁCIÓK A NIM® RENDSZERMŰSZEREKHEZ

SVARĪGA INFORMĀCIJA PAR NIM® SISTĒMAS INSTRUMENTIEM

SVARBI INFORMACIJA APIE NIM® SISTEMOS INSTRUMENTUS

WAŻNE INFORMACJE DOTYCZĄCE INSTRUMENTÓW SYSTEMU NIM®

DÔLEŽITÉ INFORMÁCIE O SYSTÉMOVÝCH NÁSTROJOCH NIM®

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AUSTRALIAN SPONSOR:

DISTRIBUTED BY:

Medtronic Australasia Pty Ltd Medtronic Sofamor Danek USA, Inc. Medtronic B.V. Medtronic Xomed, Inc.

97 Waterloo Rd 1800 Pyramid Place Earl Bakkenstraat 10 6743 Southpoint Drive North
North Ryde, NSW 2113 Memphis, TN 38132 6422 PJ Heerlen Jacksonville, FL 32216-0980
Australia Telephone [phone] (In U.S.A.) The Netherlands USA
901 396 3133 (Outside U.S.A.) Tel: + 31 45 566 80 00
Fax [phone]

ENGLISH

IMPORTANT INFORMATION ON THE NIM® SYSTEM INSTRUMENTS

PURPOSE

This instrument is intended for use in surgical procedures.

DESCRIPTION

Monopolar Stimulator Instruments are available in a variety of designs. These instruments have a lead that ends with a
connector that plugs into the NIM® system.

Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MSD
Catalog or price list for further information about warranties and limitations of liability.

INTENDED USE

This device is intended for use as a stimulating accessory for the NIM® system. The NIM® system is intended for use in surgical
procedures for patient-connected intraoperative nerve monitoring, i.e. assisting the surgeon in locating and mapping motor
nerves through the use of electromyographic (EMG) signals and electrical stimulus of nerves.

INDICATIONS

This device is indicated for locating and identifying cranial and peripheral motor nerves during surgery, including spinal
nerve roots.

DIRECTIONS FOR USE

1. Plug the connector end of the stimulating instrument into the cathode (-) connection on the NIM® Patient Interface
STIM 1.

2. Place a subdermal EMG needle electrode (included) in the desired location to serve as the ground, or anode (+) for the
stimulator.

CONTRAINDICATIONS

The use of paralyzing anesthetic agents will significantly reduce, if not completely eliminate, electromyography (EMG)
responses to direct or passive neural stimulation. Whenever nerve paralysis is suspected, consult an anesthesiologist.

WARNINGS

1. MEDTRONIC does not and cannot warrant the use of these instruments nor any of the component parts upon which
repairs have been made or attempted except as performed by MEDTRONIC or an authorized MEDTRONIC repair
representative.

2. DO NOT IMPLANT THE INSTRUMENTS.

3. The NIM® does not prevent the surgical severing of nerves. If these devices are compromised, the surgical practitioner
must rely on alternate methods, or surgical skill, experience and anatomical knowledge to prevent damage to nerves.

4. To avoid patient burns:

a. Do not activate electrosurgical instruments while the stimulator is in contact with tissue.
b. Do not leave stimulating instruments in surgical field.
c. Do not store stimulating instruments in electrosurgical instrument holder
d. Do not allow a second surgeon (i.e. fat harvesting) to use electrosurgical instrument while stimulator is in use.
e. If NIM® accessories are used with stimulators other than the NIM(S) System, do not exceed an energy level of 50 mJ

per pulse (measured into a 1 kilo-ohm load). Note: The NIM® system does not exceed 50 mJ per pulse (measured
into a 1 kilo-ohm load).

f. If using this accessory with other monitoring equipment than NIM® Patient Interface STIM 1, special operator attention

may be required for current densities exceeding 2 mA RMS/cm2. Current, mA RMS is generally lower than the stimulator
current setting in mA. To calculate current, mA RMS, waveform morphology, pulse width, repetition rate, and the
stimulator current delivered must be considered.

5. High stimulator current may cause involuntary patient movement resulting in patient injury.

6. Direct stimulator contact may disrupt the operation of active implanted devices.

7. The surgical practitioner must choose the appropriate size instruments based on the procedure to be performed and
the stimulating current necessary for the application.

8. Avoid trans-thoracic stimulation; when possible, maintain anode and cathode stimulating sites in close proximity.

9. False negative responses (failure to locate nerve) may result from:

a. Shorted EMG electrode or cabling (conductive parts of applied needle electrodes or cables contacting each other).
b. Patient Interface STIM 1 or STIM 2 fuse blown.
c. Patient Interface defective.
d. Inadequate stimulus current.
e. Inadequate current for stimulation of nerve through hardware, such as pedicle screws or stimulus dissection

instruments, may vary based on the physical size, shape characteristics, and design of the hardware and proximity to
the nerve.

f. Neuromuscular fatigue from prolonged or repeated exposure to electrical stimuli.

10. While stimulating, it is recommended to use EMG monitor(s) equipped with active audio and/or visual current
delivered feedback systems to ensure delivery of current to intended tissues.

11. Proper handling, insertion, and placement of instruments is critical for safe and accurate EMG monitoring:

a. Improperly placed or bent needles increase the risk of needle breaking off in the patient.
b. Do not attempt to straighten bent needles because this may cause stress and weaken device, causing needle to break

off in patient.

c. Extreme care must be taken when handling instruments with sharp points or edges.

PRECAUTIONS

1. Inadequate stimulus current flow may be caused by non-flush contact between the stimulating instrument and the
nerve, inadequate stimulator instrument electrical contact surface area, or high impedance.

2. Electrode integrity should be checked (by pressing electrodes check on the NIM®) after electrode insertion and before
electrode removal to give additional assurance that electrode continuity was maintained throughout the entire
procedure. If electrode impedance is very high, discontinue use and replace.

3. Inability to deliver stimulus current flow may be caused by:

a. Stimulator return electrode not connected, or other incomplete electrical connection between the NIM®, electrode

and stimulator instrument.
b. Patient Interface STIM 1 or STIM 2 fuse blown.
c. Stimulus set to 0.00 mA.
d. Defective instrument.

4. Avoid accidental contact between connected but unapplied electrodes and other conductive parts.

5. Reuse of single use instruments increase the risk of infection and may cause degraded or ineffective monitoring.

6. Contaminated single use instruments must be disposed of in an appropriate sharps biohazard container in
accordance with hospital or other user facilities policy.

7. When using the probes (8225719, 8225747, and 8225759), insertion past the blue insulative material is not recommended.