Neurosoft Neuro-MMG User manual

Technical Manual
Neuro-MMG
MMG Unit with Sensors
TM077.01.001.000
(23.04.2018)
(for veterinary purposes)

Neurosoft Ltd. © 2018
5, Voronin str., Ivanovo, 153032, Russia
P.O. Box 10, Ivanovo, 153000, Russia
Phone: [phone] Fax: [phone]
E-mail: [e-mail] Internet: www.neurosoft.com

3
Contents
Introduction...............................................................................................................4
Abbreviations............................................................................................................5
Important Safety Instructions ..................................................................................5
Intended Use.......................................................................................................5
Contraindications.................................................................................................6
Warnings and Precautions...................................................................................6
Possible Side Effects...........................................................................................6
1. Description.........................................................................................................7
1.1. Main Specifications.......................................................................................7
1.2. Delivery Set..................................................................................................8
1.3. Principle of Operation...................................................................................8
1.4. Controls, Connectors and Indicators.............................................................9
1.5. Labeling......................................................................................................10
2. Assembly and Installation...............................................................................11
2.1. Requirements to Personnel Conducting Assembly and Installation.............11
2.2. Room Selection and Placement..................................................................11
2.3. Unpacking and Delivery Set Check.............................................................12
2.4. Assembly and Connection to Computer......................................................12
3. Proper Use .......................................................................................................13
3.1. Setting-Up Procedures................................................................................13
3.2. Getting Started............................................................................................14
3.3. Test Completion..........................................................................................17
3.4. Troubleshooting..........................................................................................18
3.5. Actions in Emergency.................................................................................18
4. Maintenance.....................................................................................................18
4.1. General Requirements................................................................................18
4.2. User Maintenance.......................................................................................19
4.3. Disinfection.................................................................................................19
4.4. System Lifetime..........................................................................................19
5. Current Repair .................................................................................................20
5.1. USB Cable for MMG Unit............................................................................20
5.2. MMG Sensor Cable....................................................................................20
6. Acceptance, Delivery Set and Package Data.................................................21
7. Disposal ...........................................................................................................21
8. Warranty........................................................................................................... 21
9. Reclamation Procedure...................................................................................22
Annex 1. Electromagnetic Emissions and Immunity............................................23

Neuro-MMG Technical Manua)
4
Introduction
This technical manual (hereinafter referred to as “manual”) is the combined document
describing the functioning and maintenance of Neuro-MMG mechanomyographic unit
with sensors (hereinafter referred to as “MMG unit”).
This manual is the document which certifies Neuro-MMG specifications guaranteed by
the manufacturer.
Do not start working with MMG unit before you have read this document!
You can send your responses and recommendations to Neurosoft Company by
the following address:
P.O. Box 10, Ivanovo, 153000, Russia
or by e-mail:
[email protected].
You can find additional information on Neurosoft products in the Internet:
www.neurosoft.com
or ask questions by phones:
[phone]; [phone] (Service center),
[phone]; [phone].
You can also contact SAS Neuromed Company, Authorized European Representa-
tive of Neurosoft Company (Mr. Pierre Scholl) by the following address:
Chemin du tomple
84330 Le Barroux, France
Phone: [phone]
Fax: [phone]
E-mail: [e-mail]
[phone]

Important Safety Instructions
5
Abbreviations
IOM — intraoperative neurophysiologic monitoring
MMG — mechanomyography
PC — personal computer
Important Safety Instructions
Intended Use
The Neuro-MMG is intended to detect and measure the mechanical activity in muscle,
to assess the neuromuscular blockage and tremor, and also during the surgeries
where the motor nerves are at risk.
The Neuro-MMG is used together with the following Neurosoft medical devices:
Neuro-IOM system for intraoperative monitoring, Skybox (Neuro-MEP-5) digital
neurophysiological system for EMG and EP with a built-in dedicated keyboard,
Neuro-MEP digital neurophysiological systems for EMG, EP, ERG and OAE,
Neuro-MEP-Micro 2-channel digital neurophysiological system for EMG and EP with
the built-in miniature dedicated keyboard, Neuron-Spectrum-5 digital neurophysio-
logical system for EEG, EP and EMG, Neuro-MS and Neuro-MS/D magnetic stimula-
tors. It can be also used with other medical equipment that complies with IEC 60601-1
requirements.
The Neuro-MMG can be used in different health care facilities, intensive care units,
diagnostic centers, neurosurgery clinics (also during surgeries) and experimental la-
boratories of the research institutions, where the neuromonitoring and EMG tests are
required.
It is intended for use only by qualified operators who have received training on these
devices.
The target population for the system includes all ages.

Neuro-MMG Technical Manua)
6
Contraindications
During the intraoperative neuromonitoring where muscle response is
recorded with Neuro-MMG, it should be noted that the use of muscle
relaxants may result in partial or complete suppression of spontaneous
and stimulation mechanomyography. That is why their use must be
restricted. Be attentive that the results obtained with these techniques
are false when the muscle relaxants are effective. Wait till it wears off.
If the function to be monitored is lost completely or for a long time,
the use of Neuro-MMG for IONM monitoring is not recommended.
Use the MMG sensors with caution if the skin, where these sensors are
positioned, is damaged.
Warnings and Precautions
To perform safe and reliable monitoring, read carefully the related
operating documentation for the medical equipment. Make sure
the application techniques are performed properly.
It is prohibited to:
·expose the MMG unit and sensors to mechanical damages.
·store the MMG unit and sensors in a room with aggressive
environment (hydrogen sulfide, acid and alkali vapors);
·use the MMG unit and sensors if their integrity is compromised;
·use sharp instruments to clean the MMG unit and sensors
(scalpels, needles, forceps, etc.).
Possible Side Effects
There are no clinically significant side effects during Neuro-MMG. In rare cases
the skin irritation and allergic reactions to the adhesive surface of medical tape.

Description
7
1. Description
1.1. Main Specifications
Table 1. Main Specification of MMG Unit
Parameter
Value
Number of simultaneously connected MMG sensors up to 8
Insulation resistance 4 kV
Acceleration measurement range from –2 to +2 g
Power consumption < 2 W
Transportation Conditions
Temperature -25 till +60°C
Humidity from 20 till 95%
(non-
condensing)
Atmospheric pressure 70 kPa
Storage Conditions
Temperature +5 till +40°C
Humidity from 30 till 85%
(non-
condensing)
Atmospheric pressure from 70 to
106 kPa
Safety and Electromagnetic Compatibility
Electromagnetic compatibility (EMC) is ensured in compliance with the requirements
of IEC 60601-1-2-2007 standard.
The Neuro-MMG is intended for operation in electromagnetic environment, which
special features are specified in Annex 1.
The mobile radio-frequency equipment can impact the Neuro-MMG.
The use of accessories not listed in Table 2 of this technical manual can cause the in-
crease of electromagnetic emissions or decrease of the electromagnetic immunity of
Neuro-MMG.
As for safety, the MMG unit complies with the requirements of IEC 60601-
1:1998+A1:1991+A2:1995 and IEC 60601-1-2-2007 standards. The MMG unit is sup-
plied via USB cable of the computer (PC) or Neuro-IOM unit and has applied parts of
CF type according to IEC 60601-1:1998+A1:1991+A2:1995.

Neuro-MMG Technical Manua)
8
1.2. Delivery Set
The delivery set is listed in Table 2.
Table 2. The Delivery Set
Name
Order code or specifications
Quant
.
,
pcs.
Electronic unit NS077201.001 1
MMG sensor NS077356.001 8
Operating Documentation
“Neuro-MMG MMG Unit with Sensors” technical manual TM077.01.001.000 1
Package
Transportation package (set) NS077901.001 1
1.3. Principle of Operation
The MMG unit consists of pod and USB adapter interfaced via RS-485. The MMG
sensors (included to the delivery set) are connected to this pod. The USB adapter is
connected to the system unit of the personal computer or Neuro-IOM electronic unit
via USB. The block diagram of the MMG unit is shown in the Fig. 1.
Fig. 1. The block diagram of MMG unit.
The MMG sensors are intended to detect the mechanical activity by measuring
the acceleration. The pod controls the functioning of the sensors and ensures the gal-
vanic isolation. The pod interfaces with the PC/Neuro-IOM via USB adapter. This USB
adapter transfers the control commands and data.

Description
9
1.4. Controls, Connectors and Indicators
The front and side panels of MMG unit are shown in Fig. 2.
Fig. 2. The front and side panels of the MMG unit.
1. Indicator:
·orange — the power is on;
·green — the acquisition is in progress.
2. Inputs to plug in the MMG sensors.
3. Communication cable.
4. USB adapter.
The external view of MMG sensor is shown in Fig. 3.
Fig. 3. The MMG sensor.
1. Accelerometer.
4
3
1
2
4
3
2
3

Neuro-MMG Technical Manua)
10
2. MMG sensor cable.
3. Connector to plug in MMG unit.
1.5. Labeling
The sample of MMG unit labeling is shown in Fig. 4.
Fig. 4. The sample of labeling.
Interpretation of Symbols on MMG Unit:
-applied parts of CF type according to IEC 60601-1.
-catalogue number by ISO 15223-1.
-serial number by ISO 15223-1.
-manufacturing date by ISO 15223-1.

Assembly and Installation
11
2. Assembly and Installation
2.1. Requirements to Personnel Conducting
Assembly and Installation
The Neuro-MMG should be installed by the person who is authorized by the manufac-
turer or the technical personnel of the medical institution which is going to use it. It is
necessary to know that safety and quality of operation depend on the proper assem-
bly of the unit. Further assembly and installation requirements which define the prod-
uct safety will be marked by bold and italic font in the text.
2.2. Room Selection and Placement
Before Neuro-MMG mounting and installation, it is necessary to select a place for it,
taking into consideration power wiring and protective ground in the room, and also to
read the following requirements and recommendations:
Requirements concerning the room selection and the equipment placement:
·The recommended distance from the electronic unit to the short-wave or microwave
therapeutic equipment is not less than 5 meters. It can cause the unstable opera-
tion.
·The recommended distance from the electronic unit to the nearest mains is not less
than 3 meters.
·It is recommended to place the MMG unit on the maximum possible distance from
power cables, switchboards, and different powerful electrical devices which can
emit electromagnetic fields of mains frequency.
·The use of mobile radio-frequency communication facilities near the unit is prohibit-
ed. It can cause its unstable operation.
·Besides avoid the unit placement near hot or cold sources, direct sunlight and air
flows.
·The patient environment (within 1.5 meters) should contain only
the electronic units being the medical devices with the required safety level.
The fact is that the safety level of the computer equipment is insufficient for
the use in the patient environment. Hence, a patient must not contact with
the metal parts of computer equipment cases and the personnel must not
touch simultaneously these parts and patient body. The computer equipment
used in the unit should comply with IEC 60601-1 requirements or be connect-
ed via the isolation transformer (specialized power supply unit – for notebook
PC) complying with above-mentioned requirements.

Neuro-MMG Technical Manua)
12
Requirements to mains:
·The use of electric mains in which the neutral conductor and protective
ground are combined is strongly prohibited.
·Before the unit placement, the electrician must check the quality of standard
tripolar sockets and the integrity of the protective ground circuit.
·In case the MMG unit is connected to system unit of PC or Neuro-IOM elec-
tronic unit plugged to several tripolar sockets, make sure they are grounded
to the same protective ground circuit. Otherwise, there is a danger of several
tens of Ampers leveling current leakage through the unit connecting cables
that leads to the equipment breakdown.
2.3. Unpacking and Delivery Set Check
If the box with the Neuro-MMG was under conditions of the excessive moisture or low
temperature which differs sharply from working conditions, it is necessary to place it in
the room and leave for 24 hours in normal conditions.
Unpack the box and extract the Neuro-MMG. The delivery set should comply with
the packing report list.
Check visually the system components to make sure that there are no visible damag-
es.
2.4. Assembly and Connection to Computer
If you purchase the Neuro-MMG together with the computer, it is delivered with in-
stalled and configured software. If you purchase the Neuro-MMG separately, install
the software using the supplied electronic media (USB flash drive, CD, etc.).
The software must be installed before the first connection of MMG unit to
the computer. Study carefully the corresponding chapter of the Neuro-
IOM.NET or Neuro.MEP.NET user manual before starting to work.
If the distributive is missing, you can download all required software mod-
ules and latest software version from our site:
http://neurosoft.com/en/index/downloads. To get an access to the files, en-
ter login and password that you can inquire in commercial department of
Neurosoft Ltd.

Proper Use
13
3. Proper Use
3.1. Setting-Up Procedures
Operating Limitations:
·Temperature:+10 till +35°C
·Humidity: 30 – 85% (non-condensing)
·Atmospheric pressure: from 70 kPa to 106 kPa
Before power supply switching, make sure that the cases of MMG unit and computer
have no apparent mechanical failures which can represent a danger.
Plug the MMG unit in USB port of PC (Fig 5) or Neuro-IOM unit (Fig. 6) using
the related technical manual.
Fig 5. ConnectingMMG unit to system unit of PC.

Neuro-MMG Technical Manua)
14
Fig. 6. Connecting MMG unit to Neuro-IOM unit.
Plug the MMG sensors in the related inputs of MMG unit.
3.2. Getting Started
The MMG unit must be used by the qualified medical personnel trained to operate on
it and knowledgeable of intraoperative neurophysiological monitoring application.
Before exam carrying out, it is necessary to perform the visual examination of MMG
unit, MMG sensors and cables to exclude the damages.
Customize the Neuro-IOM.NET or Neuro-MEP.NET software and other equipment
taking into consideration the related user manual recommendations.
There is no need to prepare the skin before MMG sensor placement.
Position the MMG sensor to patient skin on the target muscle area considering
the symmentry relative to the sagittal line. In some cases it is possible to place MMG
sensors on woven/non-woven fabric that fits closely to skin, for example, the com-
pression stockings.
Fix the MMG sensors on patient’s skin using the adhesive medical tape.

Proper Use
15
Start Neuro-IOM.NET software on the PC (see Neuro-IOM.NET user manual). Select
“MMG test” test (Fig. 7).
Fig. 7. Selecting “MMG test”.

Neuro-MMG Technical Manua)
16
After that the monitoring window shall be opened (Fig. 8). Run the monitoring by
pressing “Monitoring” button or [F6] key on the keyboard. The obtained traces shall
appear in the monitoring window. When the target muscle starts twitching, the high-
amplitude signals should be observed at the screen (Fig. 8).
Fig. 8. Monitoring window.
Stop the monitoring by pressing “Monitoring” button or [F6] key on the keyboard
again.

Proper Use
17
If you use Neuro-MEP.NET software, start it and select “Tremor” test. In the appeared
window set up the required parameters. The detailed information on how to perform
the acquisition is stated in Neuro-MEP.NET user manual.
Fig. 9. Selecting “MMG test”.
Use the sensor connected in accordance with Fig 5.
3.3. Test Completion
Upon the test completion remove the MMG sensors from the patient and disconnect
them from MMG unit. Disinfect the sensors as stated in section 4.3 “Disinfection”.

Neuro-MMG Technical Manua)
18
3.4. Troubleshooting
The possible troubles that can be removed by a user are listed in Table 3. If
the trouble is not listed in the table, address to the service center for the repair.
Table 3. Troubleshooting.
Trouble Symptom
Possible Cause
Way of Removal
At monitoring start
the “Neuro-MMG error”
message is displayed.
The MMG unit is not
connected to the computer. Check the MMG unit connection to the computer.
The signal monitoring is not
run. The MMG sensors are not connected. Check the connection of MMG sensors to Neuro-MMG unit.
One or several MMG
sensors are faulty. Check the functioning of MMG unit with each MMG sensor
separately.
The isoline is recorded
through one or several
channels.
One or several MMG
sensors are not connected. Check the connection of MMG sensors to MMG unit.
3.5. Actions in Emergency
If electrical insulation of Neuro-MMG component is disturbed in the result of
the emergency (fire, mechanical failure, flood, medical staff evacuation) and electrical
trauma risk for patient or staff occurs, de-energize the unit completely.
4. Maintenance
4.1. General Requirements
Safety measures when servicing conform to the ones described in “Important Safety
Instructions” and in the section 3 “Proper Use”.
Qualification requirements of the medical staff are listed in 2.1 “Requirements to Per-
sonnel Conducting Assembly and Installation”.
When detecting troubles it is recommended to use the information stated in
3.4 “Troubleshooting” section. If the trouble can’t be eliminated using control tools of
MMG unit or by restart, it should be switched off and checked by a specialist.
The Neuro-MMG should have periodic maintenance. The volume of the servicing is
stated in 4.2 “User Maintenance” section.
The delivery set is compared with the device packing report.

Maintenance
19
4.2. User Maintenance
The user maintenance of the MMG unit includes the external examination, check of
connectors and cable, removal of contaminations from the surface of unit and sensors
according to recommendations stated in section 4.3 “Disinfection”.
4.3. Disinfection
1. Before cleaning the MMG unit and sensors, switch the electronic unit off. Discon-
nect the sensors from the MMG unit. As you clean, visually inspect the unit and its
components for damage or wear. Contact Neurosoft if you notice damage to
the exterior of the component.
2. For routine cleaning of MMG unit and sensors use a cloth gently wrung in phe-
noles (Bacillotex® etc.) or 70% alcohol, 0,5% chlorohexidine.
3. If hepatitis or any other dangerous virus contamination is suspected use alde-
hydes (Cidex® etc.) or chlorinates (Diversol BX®).
4. Be careful not to drip disinfectant directly into the input and output plugs and other
openings in the cover.
5. Remove disinfectant with a dry cloth.
Do not use abrasive or solvent silicon-based cleaning agent, scrubbing pads or other
abrasive applicators.
Keep all cleaning fluids away from electrical connectors.
If you notice unusual wear or breakage, disconnect the cable or cord immediately, and
contact Neurosoft for replacement.
4.4. System Lifetime
The system lifetime is 3 years from the shipment date.
The manufacturer is obliged to ensure technical support of the MMG unit during its
lifetime.

Neuro-MMG Technical Manua)
20
5. Current Repair
The MMG unit is undismountable.
The current repair of MMG unit includes the repair of communication cable performed
in accordance with the section 5.1 “USB Cable for MMG Unit”.
Unplug the communication cable from the PC/Neuro-IOM electronic unit before start-
ing the repair to avoid the accidents or irreparable damage of the equipment. Switch
off the MMG unit before the cable repair.
5.1. USB Cable for MMG Unit
The communication cable is examined externally for damages.
If any damage is detected, it should be repaired by shortening the length (remove
the damaged cable fragment and couple together the wires of the related colours).
5.2. MMG Sensor Cable
The repair of the MMG sensor cable requires the special training of the technical staff
and special equipment that is available in the Service center of the manufacturer or
authorized representative.
If the MMG sensor cable is broken, address to the Neurosoft Service center (see
chapters 8 “Warranty” and 9 “Reclamation Procedure”.