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TD Meb9600

This technical document summarizes the specifications of the Nihon Kohden MEB-9600 EMG/EP measuring system, including its performance characteristics, acquisition functions, triggers, electric and auditory stimulators, visual stimulators, external devices, safety standards, environment requirements, power requirements, dimensions, weight, and requirements from international standards. The system provides EMG and EP measurement and stimulation capabilities with high input impedance amplifiers, adjustable time bases, trigger options, current and intensity controlled stimulators, and complies with relevant safety standards.

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0% found this document useful (0 votes)
191 views

TD Meb9600

This technical document summarizes the specifications of the Nihon Kohden MEB-9600 EMG/EP measuring system, including its performance characteristics, acquisition functions, triggers, electric and auditory stimulators, visual stimulators, external devices, safety standards, environment requirements, power requirements, dimensions, weight, and requirements from international standards. The system provides EMG and EP measurement and stimulation capabilities with high input impedance amplifiers, adjustable time bases, trigger options, current and intensity controlled stimulators, and complies with relevant safety standards.

Uploaded by

Gazmend Bojaxhiu
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Technical Data

EMG/EP Measuring
System
MEB-9600

TD.MEB-9600

This technical data may be revised or replaced by Nihon Kohden at any time without notice.
Some products may not be available in your country.
Specifications

Performance

Amplifiers
Input impedance
200 MΩ ±20% (in differential mode, when no breakout box is connected)
100 MΩ or more (in differential mode, when the breakout box is connected)
≥ 1,000 MΩ (common mode)
Noise
0.6 μVrms or less (1 Hz to 10 kHz)
4.5 μV p-p or less (1 Hz to 10 kHz)
Rejection ratio
110 dB or more (at 60 Hz) (balanced mode)
112 dB or more (at 60 Hz) (isolation mode)
Sensitivity
1, 2, 5, 10, 20, 50, 100, 200, 500 μV/div ±5%
1, 2, 5, 10 mV/div ±5%
Frequency characteristic
Low-cut filter:
0.01, 0.02, 0.05, 0.1, 0.2, 0.5, 1, 2, 5, 10, 20, 50, 100, 200, 500 Hz, 1 k, 2 k, 3 kHz (6 dB/OCT)
(Difference between –3 dB attenuation frequency and set value is within ±20%)
High-cut filter:
10, 20, 50, 100, 200, 500 Hz, 1 k, 1.5 k, 2 k, 3 k, 5 k, 10 k, 20 kHz (12 dB/OCT)
(Difference between –3 dB attenuation frequency and set value is within ±20%)
AC interference notch filter
50 Hz or 60 Hz (Rejection ratio: < 1/20)
Calibration voltage (CAL)
1 μV, 10 μV, 100 μV, 1 mV, 10 mV ±5%
Temperature measurement
0 to 45°C ±0.1°C (25°C ≤ Temp ≤ 45°C), ±0.2°C (0°C ≤ Temp <25°C)
(32 to 113°F ±0.2°F (77°F ≤ Temp ≤ 113°F), ±0.4°F (32°F ≤ Temp <77°F))

Acquisition
Monitor time base
5, 10, 20, 30, 50 ms/div (within ±5%)
0.1, 0.2, 0.5, 1 s/div (within ±5%)
Time base modes
Individually selected for each channel
Analysis time base
With the list box: 0.1, 0.2, 0.5, 1, 2, 3, 5, 10, 20, 30, 50 ms/div ±5%
0.1, 0.2, 0.5, 1 s/div ±5%
With the keyboard: 0.1 to 0.9 ms (0.1 ms steps), 1 to 99 ms (1 ms steps), 0.1 to 1 s (0.01 s steps)

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Number of averages
With the list box: 10, 20, 50, 100, 200, 500, 1,000, 2,000, 3,000, 4,000, 8,000
With the keyboard: 1 to 9,999
Artifact reject inhibit range
OFF, 0.1 to 5.0 div (0.1 steps)

Triggers
Trigger mode
Recurrent, Random, Single stimulation, Signal, External signal, Foot switch, Somato control box
Trigger wave mode
Single, Double, Train
Stimulation rate
With the list box: 0.1 to 0.9 Hz (0.1 Hz step)
1 to 10 Hz (1 Hz step)
13, 15, 17 Hz
20 to 100 Hz (10 Hz step)
±5% of the frequency of 95% of set value
With the keyboard: 0.1 to 100 Hz in 0.1 Hz steps (within ±5%)

Electric Stimulators
Output current
0 to 100 mA (0.1 mA step)
<2 mA, Setting value + 5%
2 to 100 mA, ±5%
Stimulation pulse duration
With the list box: 0.01, 0.02, 0.03, 0.05, 0.1, 0.2, 0.3, 0.5, 1 ms
0.01 to 0.03 ms: Set value or less
0.05 ms: ±20%
0.1 ms to 1 ms: ±10%
With the keyboard: 0.01 to 1 ms (0.01 ms steps)
0.01 to 0.04 ms: Set value or less)
0.05 to 0.09 ms: ±20%
0.1 to 1 ms: ±10%

Auditory Stimulators
Examination side
Left, Right, Both
Stimulation waveform
Click (CLICK), Tone burst (TONE)
Stimulation phase (polarity)
Condensation (positive), Rarefaction (negative), Alternating
Stimulation intensity
0 to 135 dB SPL
±2 dB
(6.33 V ±20% at 135 dB SPL)
(633 mV ±20% at 115 dB SPL)

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Contralateral white noise masking
OFF, –50, –40, –30, –20, –10, 0 dB ±5 dB
Click pulse duration
0.1, 0.2, 0.3, 0.5, 1 ms ±5%
Tone burst frequency
With the list box: 125, 250, 500, 1 k, 1.5 k, 2 k, 3 k, 4 k, 6 k, 8 k ±5%
With the keyboard: 50 to 125 Hz in 25 Hz steps (within ±5%)
150 to 450 Hz in 50 Hz steps (within ±5%)
500 to 2.9 kHz in 100 Hz steps (within ±5%)
3 k to 10 kHz (500 Hz steps) ±5%
Plateau time of tone burst
With the list box: 0, 1, 2, 5, 10, 20, 50, 100, 200, 500, 1,000 ms ±5%
With the keyboard: 0 to 1,000 ms (1 ms step) ±5%
Rise/fall time of tone burst
With the list box: 0.1, 0.2, 0.3, 0.5, 1, 2, 3, 10 ms ±5%
With the keyboard: 0 to 3,000 ms (0.1 ms step) ±5%

Visual Stimulators
Stimulation modes
Pattern reversal, LED goggles
Pattern reversal
Field format: Full, Left, Right, Upper, Lower, Upper left, Lower left, Upper right, Lower
right
Patterns: Checkerboard, horizontal bars, vertical bars
Number of horizontal divisions:
4, 8, 16, 32, 64, 128
LED goggles
Side: Both, Left, Right

External Devices
External trigger input
Amplitude: 4 V (positive) or more
0.5 V (negative) or less
Pulse duration: Available for pulse whose duration is 10 μs or longer
External trigger output
Amplitude: Within 5 V ±10% (positive)
0.5 V (negative) or less
Pulse duration: Within ±20%

Safety Standards
• IEC 60601-1:2005+Amendment 1:2012
• IEC 60601-1-6:2010
• IEC 60601-1-9:2007
• IEC 60601-2-40:2016

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• IEC 62366:2007+Amendment 1:2014
• IEC 62471:2006
• CAN/CSA-C 22.2 60601-1:14
• ANSI/AAMI ES 60601-1:2005/(R)2012, AND C1:2009 AND
A2:2010(R)2012 (CONSOLIDATED TEXT)

Classification
Type of protection against electrical shock
Class I
Degree of protection against electrical shock
Type BF applied parts (signal input, electric stimulator, auditory stimulator, visual stimulator
(GOGGLE), thermistor probe, response switch)
Degree of protection against harmful ingress of water
Foot switch: IPX6 (Protected against powerful water jets),
IPX8 (Protected against the effects of continuous immersion in water)
Method of sterilization or disinfection
By chemical liquid
Degree of safety of application in the presence of a flammable anaesthetic mixture with air, oxygen
or nitrous oxide
Equipment not suitable for use in the presence of FLAMMABLE ANESTHETIC MIXTURE WITH
AIR, OR WITH OXYGEN OR NITROUS OXIDE
Mode of operation
CONTINUOUS OPERATION
ME EQUIPMENT type
Indoor portable

Environment

Storage and Transport Environment


Temperature: –20 to +65°C (–4 to +149°F)
Humidity: 20 to 80%RH
Atmospheric pressure: 700 to 1,060 hPa

Operating Environment
Temperature: 10 to 35° C (50 to 95° F)
Humidity: 30 to 80%RH (noncondensing)
Atmospheric pressure: 700 to 1,060 hPa

Power Requirements
Line voltage
100 to 240 V ±10%

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Power input
When no power supply unit is used:
150 VA or less
When the SC-900B or SC-900BK power supply unit is used:
400 VA or less
When the SC-230B or SC-230BK power supply unit is used:
1,250 VA or less
Line frequency
50 Hz/60 Hz ±1 Hz

Dimensions
DC-960B main unit
320 (W) × 42 (H) × 370 (D) mm
JB-962B electrode junction box
100 (W) × 135 (H) × 40 (D) mm
JB-964B electrode junction box
185 (W) × 174 (H) × 30 (D) mm

Weight
DC-960B main unit
2.2 kg
JB-962B electrode junction box
0.32 kg
JB-964B electrode junction box
0.51 kg

Requirements from International Standards

IEC 60601-1:2005+Amendment 1:2012


Pollution degree classification
class 2
Material group classification
Ⅲb
Rated operating altitude
2,000 < a ≤ 3,000 [m]
Movement conditions
Electrodes or connection cable are not connected
Operator position during normal use (Section 7.1.2)
a) Operator: 30 cm away from the following
- The front side of the system (Only the front side has the devices to control
the system.)
- The sides of the electrode junction box that have electrode jacks and cable
sockets
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b) Service personnel: 30 cm away from the system exterior or the indications attached inside of the
system components
Operator position during normal use (Section 9.6.2.1)
a) Patient and surgeon: 5 m away from the system components
b) Person who is operating the device:
30 cm away from the system components

ENVIRONMENTAL IMPACT during NORMAL USE (IEC 60601-1-9:2007)


Consumption during NORMAL USE
• Energy: Not applicable
• Consumable materials/parts:
CR2032 lithium coin battery (for the GG-961 control unit)
• Disposables: Disposable electrodes
• Water: Not applicable
• Gasses: Not applicable
• Chemicals/reagents: Not applicable
Emissions during NORMAL USE
• WASTE water: Not applicable
• WASTE consumable materials:
Not applicable
• Acoustic energy: Not applicable
• Heat: Not applicable
• Gasses: Not applicable
• Vapours: Not applicable
• Particulates: Not applicable
• HAZARDOUS SUBSTANCES and other WASTE:
Not applicable
• HAZARDOUS SUBSTANCES, radioactive sources and induced radioactive materials:
Not applicable

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