Users Manual Part 1
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Nerve Integrity Monitor
• Remove detergent residues from the system by wiping it down with a soft, lint-free cloth dampened with puried water.
• Dry the units by wiping them with a clean, dry lint-free cloth until visible moisture has been removed.
Disinfection
The intermediate-level disinfection instructions detailed below apply to the NIM Vital cart, system monitor, patient interface and
able (if using a wired patient interface), muting detector and cable(s), printer and printer cable, power cords and a USB ash drive.
• Prior to disinfecting the system, ensure that the system has been cleaned per the cleaning instructions above and that cables are
disconnected from the system components.
• Disinfect the system by wiping its external surfaces with a soft, lint-free wipe soaked with one of the following solutions:
— a 70% solution of isopropyl alcohol (IPA) in puried water.
— a 0.5% solution of Accelerated Hydrogen Peroxide (AHP).
• Wipe in a single direction and away from system’s crevices.
• Allow the disinfectant to remain with system’s surfaces for a minimum of 10 minutes.
• If required due to air-drying, re-apply the disinfectant as described above to achieve the required minimum contact time.
Storage
Allow the NIM Vital system and accessories to thoroughly air-dry before storing them in a cool dry place. Refer to the “Technical
Specications” topic for more information.
Maintenance
Medtronic provides three ways to maintain your system to ensure optimal electrical and functional performance related to nerve
detection and stimulation. System self-tests are performed by the system at boot up. System Quick Check is performed by the user.
Planned maintenance is performed by Medtronic.
The maintenance schedule must comply with the policies of your institution’s infection control unit and/or biomedical department.
System self-tests
The system automatically performs a series of self-tests and reports any failures on-screen at start-up. Whenever a problem is
detected then a comprehensive testing should be performed by returning the console and patient interface to Medtronic Service
and Repair.
System quick check
The user can complete the functional and safety testing using the Annual System Quick Check checklist page included in this
manual.
Note: Refer to W30.
Annual planned maintenance
To help maintain performance and ensure optimal electrical and functional performance related to nerve detection and stimulation
Medtronic recommends returning the system for planned maintenance once per year or whenever a problem is suspected; or more
often as required by local statutory, hospital administration or business practice.
During the annual planned maintenance over 100 tests are performed. These include comprehensive visual, functional and
electrical safety testing; and Patient Interface battery check and replacement, if necessary. Medtronic returns systems to the
customer with a certicate indicating maintenance performed.
Contact Medtronic Service and Repair to schedule an annual planned maintenance.
Annual system quick check
User maintenance for the NIM Vital is limited to visual inspection before use and periodic cleaning. Annual “System Quick Check”
with Simulator and System Safety Checks according to IEC/EN60601-1 is recommended. Please see Warning W6h. If the user does
not have a patient simulator (CFN # 8253600), please contact Medtronic’s customer service to purchase one.
Model # ____________ S/N __________________ Tester _____________________ Date _______________
A. System quick check with Simulator (A. a - f) ________( )
Use Patient Simulator to conrm appropriate behavior.
Refer to the Patient Simulator Instructions for Use topic to conrm the following:
a. System Set-Up
_______( )
b. Conrming Electrodes _______
c. Electrode Lead O _______
d. Mechanical Stimulation _______
e. Stimulus: Set and Measure _______
f. Threshold Test _______
FCC use only, not for Medical use