Neurosoft Neuro-MMG Bedienungsanleitung

Technical Manual

Neuro-MMG

MMG Unit with Sensors

TM077.01.001.000

(23.04.2018)

(for veterinary purposes)

5, Voronin str., Ivanovo, 153032, Russia

P.O. Box 10, Ivanovo, 153000, Russia

Phone: +7 (4932) 24-04-34; +7 (4932) 95-99-99 Fax: +7 (4932) 24-04-35

E-mail: info@neurosoft.com Internet: www.neurosoft.com

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)

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:

+7 (4932) 59-21-12; +7 (4932) 24-04-37 (Service center),

+7 (4932) 24-04-34; +7 (4932) 95-99-99.

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: +33 490-650-470, +622-748-384

Fax: +33 490-650-470

E-mail: bscholl@orange.fr

(4932) 24-04-34

Important Safety Instructions

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)

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

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)

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

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.

Neuro-MMG Technical Manua)

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.

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