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2. therapy

NIM-ECLIPSE® System Accessory
Disposable Corkscrew Needle Electrodes
Product Information and Instructions
Device Description
945DME2002/DME2002 - This device is a sterile, stainless steel, corkscrew subdermal needle electrode with
color coded 1.5 mm protected pin connector designed for use with the NIM-ECLIPSE System 945EEX901/
EEX901 Stimulator Extender.
945MEP1001/MEP1001 - This device is a sterile, dual twisted pair, stainless steel, corkscrew subdermal needle
electrode with single hub and keyed 1.5 mm protected pin connector. The 945MEP1001/MEP1001 is specifically
designed for use with the NIM-ECLIPSE System 945OPM660/OPM660 Patient Interface Module (PIM).
The electrode leads and connectors are not color coded as stimulation polarity or scalp placement are not
concerns. Additionally, the electrode provides a low impedance interface between stimulator and patient.
Indications for Use
This device is a system component/accessory to the NIM-ECLIPSE system. Refer to the system manual for
indications.
Contraindications
Refer to NIM-ECLIPSE System manual for contraindications. This product is not recommended for use with
children under 2 years old and should not be used for fetal monitoring.
Warnings
1. The NIM-ECLIPSE System 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.
2. High stimulator current and/or transcranial motor stimulation may cause involuntary patient movement
resulting in patient injury.
3. High stimulator current and/or transcranial motor stimulation activating of the fifth cranial nerve or
mastication muscles may cause tongue lacerations.
4. False negative responses (failure to elicit MEP response) may result from:
• Shorted EMG monitoring electrode or cabling (conductive parts of applied needle electrodes or cables
contacting each other).
• Patient Module Interface (PIM) not connected or defective.
• Inadequate stimulus patient current.
• Stimulator electrodes open or not connected.
• Improper placement of transcranial stimulation electrode.
• Excessive muscle relaxant anesthesia.
5. The surgical practitioner must choose the appropriate placement of electrodes, based on the procedure to be
performed, and the stimulating voltage necessary for the application.
6. Proper handling, insertion, and placement of electrodes is critical for safe and accurate EMG monitoring.
7. Improperly placed or bent needles increase the risk of needle breaking off in the patient.
8. Extreme care must be taken when handling instruments with sharp points or edges.
9. Special operator attention may be required for stimulus currents exceeding 2 mA RMS/cm2. The RMS value
of current is generally lower than the stimulator current setting in mA. To calculate RMS current, waveform
morphology, pulse width, repetition rate, and the stimulator current delivered must be considered.
10.Avoid trans-thoracic stimulation. Maintain anode and cathode stimulating sites in close proximity.
11.To avoid alternate site patient burns or lesions: Do not activate electrosurgical instrument for prolonged
periods while ESU is not in contact with tissue, Do not activate electrosurgical instrument near the recording
or stimulating electrodes, Do not allow patient interface boxes or recording / stimulating electrodes sites
to be flooded with saline. Do not allow excessive stray AC or DC leakage currents from patient connected
equipment; Avoid creating a unintended grounding path through applied electrodes.
12.Practitioner is responsible for proper use, periodic safety certification of patient connected equipment, and
AC power grounding in accordance to the appropriate IEC 60601-1 and/or IEC 60601-1-1 medical safety
standard.
Precautions
1. Avoid accidental contact between connected but unapplied electrodes of other conductive parts.
2. Reuse of single use electrodes and probes increases the risk of infection and may cause degraded or
ineffective monitoring.
3. Contaminated single use electrodes and probes must be disposed of in an appropriate sharps biohazard
container in accordance with hospital or other user facilities policy.
4. Inability to deliver stimulus current flow may be caused by:
• Stimulator electrodes not connected or other incomplete electrical connections between the NIM-ECLIPSE
System and/or PIM.
• Stimulus voltage set to low.
• Defective PIM.
Instructions For Use
1. The transcranial stimulation electrodes are typically placed at the C3 and C4 scalp locations of the
international 10-20 system or other placement at the direction of the surgeon. See figure below.
2. Locate and mark the stimulation sites on the scalp.
3. Attach the electrodes to the scalp by turning the electrode clockwise one complete rotation. Do not screw the
electrode into the scalp bone. Attach one electrode to C3 and the second to C4. Polarity is not a concern.
4. 945MEP1001/MEP1001 - Connect the electrode lead plug to the MEP connector of the PIM, 945OPM660/
OPM660. Note that the connector is keyed and will fit properly when the plug is correctly aligned with the
connector. Do not force the connection.
5. 945DME2002/DME2002 - Connect the electrode lead plugs to the MEP connectors of the NIM-ECLIPSE
System 945EEX901/EEX901 Stimulator Extender. Connect the darker and lighter color leads to the cathode
and anode of the electrical stimulator respectively. The anode terminal of the stimulator will elicit responses
preferentially to the ipsilateral side.
6. Refer to the NIM-ECLIPSE System User Manuals for additional information.
Limited Warranty
A.This LIMITED WARRANTY provides assurance for the customer who purchases a Medtronic Xomed
Product (hereinafter the “Product”) that should the Product fail to function to Medtronic Xomed’s published
specifications during the term of this LIMITED WARRANTY (one year from the date of shipment for new
Product, 90 days from date of shipment for refurbished or used Product), Medtronic Xomed will either replace,
repair, or issue a credit (adjusted to reflect the age of the Product) for the Product or any portion thereof. This
LIMITED WARRANTY is extended only to the buyer purchasing the Product directly from Medtronic Xomed
or from its affiliate or its authorized distributor or representative.
B. To qualify for this LIMITED WARRANTY, the following conditions must be met:
(1)The Product must be used on or before its “Use By” or “Use Before” date, if applicable.
(2) The Product must be used in accordance with its labeling and may not be altered or subjected to misuse,
abuse, accident or improper handling.
(3)Medtronic Xomed must be notified in writing within thirty (30) days following discovery of a defect.
(4)The Product must be returned to Medtronic Xomed within thirty (30) days of Medtronic Xomed receiving
notice as provided for in (3) above.
(5)Upon examination of the Product by Medtronic Xomed, Medtronic Xomed shall have determined that:
(i) the Product was not repaired or altered by anyone other than Medtronic Xomed or its authorized
representative, (ii) the Product was not operated under conditions other than normal use, and (iii) the
prescribed periodic maintenance and services have been performed on the Product.
C. This LIMITED WARRANTY is limited to its express terms. THIS LIMITED WARRANTY IS IN LIEU OF
ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED WHETHER STATUTORY OR OTHERWISE,
INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE. In no event shall Medtronic Xomed be liable for any consequential, incidental, prospective or other
similar damage resulting from a defect, failure, or malfunction of the Product, whether a claim for such damage
is based upon the warranty, contract, negligence or otherwise.
D. The exclusions and limitations set out above are not intended to, and should not be construed so as to,
contravene mandatory provisions of applicable law. Users may benefit from statutory warranty rights under
legislation governing the sale of consumer goods. If any part or term of this LIMITED WARRANTY is held by
any court of competent jurisdiction to be illegal, unenforceable, or in conflict with applicable law, the validity
of the remaining portion of the LIMITED WARRANTY shall not be affected, and all rights and obligations
shall be construed and enforced as if this LIMITED WARRANTY did not contain the particular part or term
held to be invalid.
Customer Service
Medtronic Sofamor Danek
Phone: 800 933 2635
Fax: 800 468 9705
Monday - Friday 7:00 a.m. - 7:00 p.m. CST
Note: When contacting Customer Service and Technical Support, please have the appropriate product number,
date of purchase, and nature of inquiry available.
The information contained in this document is accurate at time of publication. Medtronic reserves the right to
make changes to the product described in this manual without notice and without incorporating those changes to
products already sold. Released documents are available to view or print at manuals.medtronic.com.
Medtronic Xomed, Inc.
6743 Southpoint Drive North
Jacksonville, FL 32216 U.S.A.
medtronic.com
manuals.medtronic.com
904 296 9600
800 874 5797
Distributed in the USA by:
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132, USA
800 933 2635
800 876 3133
The following is a trademark or registered trademark of Medtronic, Inc. in the United States and other countries:
NIM-ECLIPSE®. All other trademarks, service marks, registered trademarks or registered service marks are the
property of their respective owners in the United States and other countries.
© Medtronic 2013
68E4143 B 06/2013
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