MOFN205
NIM-Response 3.0
®
Nerve Integrity Monitoring System
MOFN205
NIM-Response® 3.0 System
Leading Through Innovation.
To help improve patient safety and surgeon peace-of-mind, Medtronic ENT introduced
the first NIM® intraoperative nerve monitor in 1989. Our NIM system evolves with your
needs, because we listen to you and combine your experience with ours.
The new NIM-Response® 3.0 is built on 20 years of continuous innovation, experience,
and leadership in nerve monitoring. With remarkable and innovative technology, it
delivers advanced monitoring features in an easily accessible system.
Improved Safety and Peace-of-Mind
Easier to Use
The first and only nerve monitor with these features.
Redesigned software.
• Monitors simultaneously during bipolar cautery
• Three simple user environments:
Setup, Monitoring, and Reports
• Real-time continuous monitoring with APS™ electrode*
• Artifact detection feature
• Setup and Reports Wizards
• Default and customized procedure settings
• Electrode and nerve placement guides
More Convenient
For you and your O.R. staff.
• I ncrementing Probe allows surgeon to adjust
stimulus levels and print or save data
• Ergonomic design for easy setup
• Ability to use two stimulators at once
• Multiple USB ports for saving data
• Customizable for your needs
Why Monitor?
It helps reduce the risk of nerve
damage during surgery by
monitoring EMG activity in multiple
cranial and peripheral nerves by
providing audible and visual alerts
if the nerve is activated.
*Initial release of the APS™ electrode will be limited.
MOFN205
Nerve Integrity Monitoring System
Intuitive Navigation Bar
Three User Environments
• Always at top of screen
• Side tabs access other settings
• Setup, Monitoring, Reports
Better, Faster Touchscreen
• Navigate NIM® software more
quickly and easily
Snapshot Button
• Provides flexible reporting options
Adjustment Knobs
• Instantly prints and saves current
screen image
• Q
uickly change stimulus or
volume levels
Visual Enhancements
• Larger and easier-to-read displays
• Greatest EMG response is highlighted
Sleeker Design
• M
ore compact system takes
up less space
• N
ew cart reduces clutter with
streamlined cord management
and storage
MOFN205
Setup Mode
Fast and Easy Setup
3 Easy Steps to Begin Monitoring
1. Choose procedure or surgeon settings.
2. Review settings, place and check electrodes.
1. Choose procedure or surgeon settings
3. Begin monitoring.
Nerve and Electrode Placement Guides
• Color-coded to help reduce confusion
• Choose by procedure, nerve, or customized settings
More Convenient Electrode-Checking
• Quick, one-touch access
• Built-in audio and visual alarms ensure
proper monitoring
2. Place and check electrodes
“Help” Button
Audio EMG Samples
• Helps to explain the sounds you hear and
provides examples of each
Electrode Placement Guides
• Allows you to review the recommended
placement by nerve or procedure
3. Begin monitoring
N I M - R e s p o ns e ® 3.0
Adjust additional settings easily
MOFN205
Leading Through Innovation Monitoring Mode
First and Only Nerve Monitor with
These Innovative Features
Simultaneous Monitoring During Bipolar Cautery
• No need to mute or turn off monitoring when using bipolar cautery
• Provides expanded monitoring capabilities
Artifact Detection Software
• Distinguishes between artifact and EMG signals
• Mutes most artifacts for a more quiet surgery
APS™ Monitoring (Automatic Periodic Stimulation)*
Artifact Detection Feature
• Provides real-time continuous monitoring
• Stimulating electrode is placed on the nerve
• Allows for early detection and warning of a change
in nerve function
Enhanced On-Screen
Information
• More Visible EMG Values and Settings
•
Expanded Amplitude and Time Scales
• I ntuitive Buttons and Tabs for Easy
Access to Advanced Settings
*Initial release of the APS™ electrode will be limited.
N e r v e I n t e g ri t y M o ni to rin g S y s t e m
MOFN205
Monitoring Mode
Leading Through Innovation
Stim Bur Guard
• Combines an electric drill with stimulation
• Works with Visao® High-Speed Otologic Drill
and Integrated Power Console (IPC™) system
• Warns surgeon of bur’s proximity to facial
nerve during otologic surgery
Versatility within the
Surgical Field
Surgeon Mini Screen
• Displays monitoring information on small screen
• Attaches to any I.V. pole
Incrementing Probe
• Adjusts the stimulus from 0.01 mA to 30 mA
• Prints or saves the current screen
Two Independent Stimulators
• Enables more flexibility in stimulus options
Better Quality EMG Information
Increased Sensitivity
• Improved signal-to-noise ratio
• Enables you to hear and see lower-level
EMG responses due to less background noise
• Helps minimize nerve manipulation during surgery
Improved Muting Detector
• More sensitive to EMG signals
• Less sensitive to external and
internal interference
• Only one muting port versus four
T h e N I M - R e s p o ns e ® 3.0
MOFN205
Reports Mode
Leading Through Innovation Quick and Easy Documentation
Report Wizard
• Create custom reports
• Enter case information and customize data fields
• S ave or print patient’s EMG activity to document for electronic medical records, reimbursement, etc.
• Utilize snapshot or log reports
Multiple USB Ports
• A
ttach a printer, USB stick, keyboard, or other data storage devices
• Save reports as an Adobe® Acrobat® PDF
Service and Support
Dedicated Service
and Support
• Large, dedicated sales force
• 20 years of experience in nerve monitoring
• On-site training for you and your staff upon
installation
• Ongoing in-servicing and training
• NIM® Technical Helpline is available 8 am to 6 pm EST
Monday through Friday. Call 800.874.5797
N e r v e I n t e g r i t y M o ni to r in g S y s t e m
MOFN205
Ordering Information
Accessories
8253010 8253030
NIM-Response® 3.0 System Set
NIM-Response 3.0 Mainframe NIM-Response 3.0 Patient Interface
Universal Patient Simulator NIM® Muting Probe Power Cord, 6 meter NIM-Response 3.0/NIM-Neuro® 3.0 User’s Guide
NIM 3.0 System Cart
NIM 3.0 System Printer Package
Paired Subdermal Electrodes, 12 mm, 2-channel set
Paired Subdermal Electrodes, 12 mm, 4-channel set
Incrementing Probe, Prass Standard Tip
NIM Contact® EMG Endotracheal Tube, 6 mm NIM Contact EMG Endotracheal Tube, 7 mm NIM Contact EMG Endotracheal Tube, 8 mm 1
1
1
1
1
1
1
1
1
1
3
1
1
1
Surgeon Mini-Screen (includes cable)
Keyboard, Medical Grade
1
1
For further information, please call Medtronic ENT
at 800.874.5797 or 904.296.9600. You may also
consult our website at www.MedtronicENT.com.
Medtronic ENT
Medtronic USA, Inc.
6743 Southpoint Drive N
Jacksonville, FL 32216
USA
www.MedtronicENT.com
Toll free: (800) 874-5797
Fax: (800) 678-3995
1 set
International Telephone Numbers
Adriatic Regional Office 385-1-488-1120
Australia 1800-668-670
Baltic Regional Office 37-1-67560226
Belgium 32-2456-09-09
Canada 1800-217-1617
China 86-21-50800998
Czech Republic 420-2-9657-9580
France 33-470-679-800
Germany 49-2159-8149-209
Greece 30-210-67-79-099
Hong Kong 852-2919-1312
Hungary 36-30-5052987
India 91-22-26836733
Israel 972-9-972-4400
Italy 39-02-24137-324
Japan 81-6-4795-1506
Korea 82-2-3404-3600
Lebanon 961-1-370-670
Luxembourg 32-2456-09-09
Netherlands 31-45-566-8800
Poland 48-22-465-6942
Russian Federation 7-495-580-73 77
Singapore 65-6776-6255
South Africa 27-11-466-1820
Spain 34-91-625-05-40
UK 44-1923-205-166
USA 1-904-296-9600
®Registered mark of Medtronic, Inc. ™Trademark of Medtronic, Inc. Adobe®, Acrobat® are registered marks of Adobe Systems Incorporated.
©2009, Medtronic, Inc. All rights reserved. This literature is intended for the exclusive use of physicians. Rx only.
890478 05.09 2009-061
8254063
Set Includes:
8253001
8253200
8253600
8220325
1897821 8253050
8253020
8253027
8227410
8227411 8225825 8229506
8229507
8229508
MOFN205
MOFN205
MOFN205
MOFN205
Technical Specifications
Technical Specifications
Physical Dimensions
Size:
Weight:
Operational Environment
Operating Temperature range:
Humidity:
Atmospheric Pressure range:
Mode of Operation:
Transport and Storage Environment
Shock and Vibration
Ambient Temperature range:
Relative Humidity range:
Atmospheric Pressure range:
Amplifier
NIM-Response® 3.0 Ch. 1-4 NIM-Neuro® 3.0 1-8
Input Sensitivities:
Sensitivity Selection:
Bandpass:
Input Noise:
Input Impedance
DC offset Rejection
Common Mode Rejection:
Channel Enable/Disable Controls:
Event Threshold Control and Display:
Patient Isolation
Impedance Measurement
Control:
Measuring Signal:
Measurement Range:
Artifact Detection and Rejection
Stimulus Artifact:
Bipolar Electrocautery Rejection:
Electrocautery (ESU) Interference:
Muting Detector Input ESU Sensitivity:
Muting Console Input Sensitivity:
Muting Detector Input ESU Immunity:
Electrode Lead Off:
Display / Touch Screen
Type:
Resolution:
Dedicated Function Event Touch Screen Controls:
Vertical Display:
Event Capture:
Time Scale:
Stimulator 1 and 2
Stimulus Type Constant:
Stimulus Range
30 cm W x 33 cm H x 27 cm D
6.8 Kg
10 to 40 ºC (Operating)
30-70% RH non-condensing
700 kPa to 1060 kPa
Continuous duty
Verified to Standard ISTA 2A
- 40 °C to + 70 °C
10 % to 100 %, including condensation
500 kPa to 1060 kPa
Individually and simultaneously selectable.
5 – 10,000 μV peak-to-peak AC-coupled
Automatically zeroed
15 Hz - 1.85 kHz (± 3 db @ 500 Hz) EMG Display 200 Hz - 1.0 kHz (-6, +3 db
@ 500 Hz) Audio EMG Speaker
3-14 mV p-p, < 5 uV RMS @ DC - 4 Hz, inputs shorted
> 10 Meg Ohm
± 1.00 VDC Rejection
>80 dB @ 60 Hz, balanced inputs, >66 dB @ 60 Hz, 1 KOhm imbalance
Dedicated function touch pads for independent Ch. enable/disable.
Adjustable Graduated Touch Bar with Voltage threshold displayed.
1,000Vrms 60Hz < 100 μA
Automatic CHECK ELECTRODE feature.
10mV peak-to-peak, 400 Hz Sinewave.
0-200KOhm ± 20% or ± 100Ohm.
Synchronized and adjustable muting.
Continuous Monitoring During Bipolar Cautery < 40 watts
Automatic detection, and muting.
ESU Cut / Coag Contact 5 - 100 Watts Air-Discharge 10-100 Watts
Muting (0.6 - 2.0 Volts Vrms) Non-Muting (<0.3 Volts Vrms)
ESU < 100 Watts Cut / Coag or (<3.0 Vrms 100-800 KHz Sq. Wave)
Automatic detection, muting and warning.
High contrast, digital, graphic Color, visible in complete darkness.
Display 1024 H x 768 W pixels, Touch Panel 256 H x 256 W
For Amplitude, Time Display and Capture.
20, 100, 500, 1000, 2000, 10,000, 50 K, and 100 KμV display modes.
Enable/disable capture mode indicator on touch screen.
25 mS, 50 mS, 100 mS or 20 S display modes.
Constant Current
0-30 mA, a minimum of 80 V compliance 80 volts (80 V- 10 %) tested into a
10 K load)
100 - 10 KOhms (0 - 3 mA): Compliance 10 V (3.5 - 30 mA): Compliance 60 V
Load Impedance Range: As long as the load impedance X
stimulation current is less or equal the compliance voltage
Stimulus Control:
Digitally controlled, range – dependent adjustment increments of 0.01, 0.05,
0.1, .5 and 1.0 mA
Stimulus Output Accuracy:
± .01 mA (or ± 10% of reading at 1K load) over Stimulus Range.
Stimulus Adjustment:
Graduated Touch Screen Control with display of command current and
delivered current.
Stimulus Measurement Accuracy
± .02 mA (or ± 10% of reading at 1K load) over Stimulus Range.
Internal Fuse
32 mA Type F, 250 V 5 x 20 mm (It must be Xomed #8253075, other similar
fuses may not give the same degree of protection. Order 8253075 Fuse Kit for
replacements.
Stimulus 1 and 2 Characteristics
Waveform:
Monophasic, square pulse, no DC component
Duration:
Software selectable, 50, 100, 150, 200 or 250 μs (± 10 % of setting)
Rise Time to 30 mA:
Less than 10 μs
Rate STIM 1 and 2:
Software selectable, 1, 4, 7 or 10 Hz (±10 % of setting)
Rate STIM 2 APS™ STIM repetition rates:
(Slow) 1, 2, 4, 8, 10 per minute (Fast) 1, 2 Hz (±10 % of setting) (APS™ feature
NOT available on the NIM-Pulse®)
Stimulus Probe:
Monopolar (standard) or bipolar
Stimulus Trigger Input
TTL compatible remote switch for Selection of APS: OFF, SLOW, and FAST
repeating sequence (NOT for NIM-Pulse®)
Audio Output
Transducers:
Built-in 3.0 x 3.0 inch speaker Piezioelectric Sounder
Baseline Audio Sound Level
.63 ± 4 db SPL C Weighted (30.5 cm)
Change in Baseline with added Channels
< ± 4 db SPL C Weighted (30.5 cm)
32
Nerve Integrity Monitor
MOFN205
Technical Specifications
Change in Baseline due to EMG and Tones
Max Audio Sound Level
EMG & Event Tone Signals:
Volume Preset and Limiter:
“Current Delivered” Tone Signals:
Power-Down / Power-up Tone
Touch Screen Key Click:
Connection:
Headphones:
Headphone Output:
Audio Accessories Verified Compatible
Headphones:
Audio Amplifier:
Audio Extension Cable:
I/O - Printer Output / Disk Drive Output
Printer Interface:
Connection:
Printer Verified Compatible
Printer:
Printer Power Supply
Data Output
USB Compact Flash Memory
Video Output
Interface:
Connection:
Electrical
Input Voltage
Frequency
Total Power Consumption:
Auxiliary AC output (For Use With Approved NIM®
Accessories Only):
Line Isolation:
Internal Fuse
Patient Connections
Patient Isolation
Patient Connection Capacitance
Classifications:
Type of Protection against electrical shock:
Degree of protection against electrical shock:.
Incress of water, dust, or solids IEC 60529
Use with flammable anesthetics mixtures, with air, oxygen,
and nitrous oxide:
Nerve Integrity Monitor
> + 20 db SPL C Weighted (30.5 cm)
102 ± 4 dB SPL C Weighted (30.5 cm)
Continuously processed EMG and/or activity-level dependent event tones for
each channel.
Volume Power Up Pre-set Default and a Low Volume Limiter. Volume Presets
for Main, Tones, Voices, and EMG Volumes
Signal occurs when 80% of set current is measured over range of 0.05-30 mA.
Constant Power-up / Decaying Power-down Tone
Selectable ON/OFF
RCA Phone Jack
Impedance @1KHz is 25 Ω or greater SPL 107 ± 4 dB. Plug 3.5 mm Stereo
Nickel Plated
60 to 83 dB ± 6 dB SPL C- Weighted
Radio Shack Headphones P/N 33-1223 (Sennheiser P/N HD497)
Radio Shack Volume Amplifier P/N 33-1109 Radio Shack
Radio Shack 16’ Shielded Audio cable P/N 42-2493 Radio Shack
Hewlett-Packard DeskJet PCL5 compatible
USB (2)
Hewlett-Packard: Model: HP DeskJet 6840 printer.
NIM® Printer Medical Grade Power Supply (Medtronic 8253025)
SanDisk Brand Cruzer Mini SanDisk Brand Cruzer Micro
XVGA Compatible, 1024 x 768 resolution
15-pin HD
100 V, 120 V
50/60 Hz
62 W Nominal <78 W Peak (Total 33 W Console, 10 W Printer, and 19 W
Mini-Screen)
NIM® Printer Power Supply (# )150 VA Max.
4000 V Peak-to-Peak 60Hz dielectric withstand from Line Connections to
Signal Ground
5 x 20 mm, 2.5 Amp, 250V, Time-llag, Low breaking capacity, Xomed Part #
11270068. Order 8253075 Fuse Kit for replacements.
All patient probes and electrodes are Type BF applied parts
90-264 Vrms 50-60 Hz < 100μA (Mains on applied part N.C.)
100 pF +/- 30 % @ 1 kHz (All patient probes and electrodes combined to Safety
GND)
Class I Medical Device per IEC/EN60601-1:1988/A1:1992/ A2:1995/A:13:1995
Type BF applied parts
IPX1
Not suitable for use in the presence of flammable anesthetic mixtures.
33