Neuro-Tox Technical Manual TM047.01.002.000

Contents Introduction ... 4 1.

Description and operation... 5 1.1. Device function ... 5 1.2. Main specifications ... 5 1.3. Delivery set ... 8 1.4. Device structure and operation ... 9 1.4.1. Structure... 9 1.4.2. Device operation ... 13

2.

Proper use ... 14 2.1. Safety measures when using the device ... 14 2.2. Setting-up procedures ... 15 2.2.1. Setting-up procedures in the spontaneous activity recording EMG mode ... 15 2.2.2. Setting-up procedures in the electrical stimulation mode ... 17 2.3. Operation order ... 18 2.3.1. Spontaneous activity recording EMG mode ... 18 2.3.2. Electrical stimulation mode ... 18 2.3.3. Display backlight control ... 20 2.3.4. Indication of rechargeable batteries voltage ... 21 2.3.5. How to place/replace batteries ... 21 2.4. Troubleshooting ... 22

3.

Device current repair ... 24 3.1. General requirements ... 24 3.2. Device conservation ... 24 3.3. Remote control repair... 24

4.

Acceptance certificate ... 25

5.

Package certificate ... 26

6.

Delivery certificate ... 26

7.

Device transportation ... 27

8.

Warranty ... 27

9.

Storage... 28

10. Reclamation data ... 29 11. Repair data ... 30 Appendix. Electromagnetic emissions and immunity ... 31

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Portable Device for EMG/STIM-guided Injection Neuro-Tox

Introduction This technical manual (further ―the manual‖) is the combined document describing operation and servicing of the portable device for EMG/STIM-guided injection Neuro-Tox (further ―the device‖). The document certifies technical parameters of the device, which are guaranteed by the manufacturer. ATTENTION!!! Do not start working with the device before you have read this manual!

You can send your responses and recommendations to the following address: Post Office Box 10, Ivanovo, 153000, Russia or by e-mail: [email protected] You can find additional information on Neurosoft products in the Internet: www.neurosoft.ru or ask questions by phones: (4932) 24-04-37 (Service Department) (4932) 24-04-34

European representative SAS Neuromed 460chemin du tomple 84330 Le Barroux FR. Tel/fax +33 490650470 email [email protected]

4

Description and operation

1.

Description and operation 1.1. Device function The device is intended for localization of medication injection places such as BOTOX®, by means of EMG recording and electrical stimulation. The device can be used in hospitals, patient care institutions, diagnostics centers and experimental laboratories of the research institutions. The main requirement for the device application is its exploitation by qualified medical personnel.

1.2. Main specifications Table 1.1. Parameters

Values

Electrical Stimulator Pulse shape

rectangle

Stimulus duration

180 µs

Relative deviation of stimulus duration

within ±10%

Pulse amplitude

0.1 ÷ 25 mA

Relative deviation of amplitude

within ±20%

Pulse amplitude pitch change

0.1 mA

Stimulus frequency at repetitive stimulation

0.5 ÷ 3 Hz

Relative deviation of frequency

within ±5%

Pulse frequency pitch change

0.5 Hz

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Portable Device for EMG/STIM-guided Injection Neuro-Tox

Continuation of Table 1.1 Parameters

Values

EMG Amplifier Gain, max

50000

Bandpass at -3 dB

20 ÷ 10000 Hz

Noise level (rms)

not more than 0.9 µV

Common-mode rejection

not less than 110 dB

Suppression ratio of power frequency by notch filter

not less than 40 dB

Output acoustic signal power (built-in speaker)

3W

Amplifier output for headphones

yes

General Specifications and Parameters Power supply Continuous working time from rechargeable batteries with 2800 mAh capacity Electronic unit dimensions Electronic unit weight Safety

2 Ni-MH or Ni-Cd rechargeable batteries of AA type (R6) not less than 24 hours 1609830 mm not more than 0.4 kg BF type

Safety The electromagnetic compatibility (EMC) is achieved by the compliance with GOST R 50267.0.2-2005 (IEC 60601-12:2005) and IEC 60601-1-2:2001 standards requirements. The device is intended for operation in electromagnetic environment which features are specified in Appendix. As for safety, the device satisfies GOST R 502.67.0-92 (IEC 601-1-88), DIN EN 60601-1:1998 and IEC 60601-2-40:1998 standards requirements. The electronic unit is supplied from two re-chargeable batteries of AA type (R6) and has works parts of

6

Description and operation

BF type according to GOST R 50267.0-92 (IEC 601-1-88) and IEC 60601-1:1998 standards requirements. Interpretation of symbols on the electronic unit: 

Attention: consult user and technical manuals.



Work parts of BF type according to GOST R 50267.0-92 (IEC 601-1-88) and IEC 60601-1:1998 requirements.



Mark of conformance to 93/42/EEC ―Concerning Medical Devices‖ directive.



Mark of conformance to 2002/96/EC ―On waste electrical and electronic equipment (WEEE)‖ directive.

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Portable Device for EMG/STIM-guided Injection Neuro-Tox

1.3. Delivery set Table 1.2. Name

Document code or main specifications

Quantity, pcs.

Electronic unit Neuro-Tox

NSFT 047201.005

1

Remote control

NSFT 047201.004

1

Headphones for EMG listening

In-ear headphones

1

Touch-proof extension cable (3 wires)

NSFT 990103.025

1

Touch-proof cable for electrode connection with button type connector (green, red)

NSFT 990103.02602.05 NSFT 990103.02603.05

1 1

Disposable electrode (30 pcs. in 1) a set)

F9070 (Fiab, Italy)

1

Needle electrode with injection 1) needle

Spes Medica Srl, Italy (MIOBOT2530)

1

Charger with rechargeable batteries of AA type (R6) (batteries capacity is not less 1) than 2500 mAh)

GP PowerBank Smart 2 (model GP PB14)

1

Technical manual Neuro-Tox

TM047.01.003.000

1

Note: 1.

8

The accessories and consumables of analogous types can be used but their use should be permitted in the country of operation.

Description and operation

1.4. Device structure and operation 1.4.1. Structure The device is used with disposable electrodes only. The device delivery set includes electronic unit, remote control and also component parts and bought articles. The electronic unit combines two devices: EMG amplifier and electrical stimulator. The amplifier and the stimulator can not be used simultaneously that is why one and the same sockets are provided for EMG/EP electrodes and stimulation electrodes. The amplifier and the stimulator are separated galvanically and, when using the stimulator, you can leave the ground electrode connected and placed on the body. The appearance of electronic unit, control buttons and connectors is showed in Fig. 1.

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Portable Device for EMG/STIM-guided Injection Neuro-Tox

Fig. 1 On the device front panel there are the following control buttons and knobs (Fig. 1): 

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on/off button (

button);

Description and operation



amplifier mode button (



stimulation mode button (



single pulse output (



repetitive stimulation (on/off) (



stimulation frequency adjustment (2 buttons:



current amplitude adjustment (2 buttons:



display backlight control (



volume control;



Stimulation mode LED.

button); button);

button); button); and and

);

);

button);

On the rear panel of the electronic unit there are the following sockets (Fig. 1): 

three touch-proof sockets either for EMG electrodes or stimulating electrode connection (black - for negative, green - for grounding, red - for positive);



3.5 mm headphones socket (



2.5 mm remote control socket.

);

The battery compartment is located on the rear panel of the electronic unit. Battery mounting and replacement is made in accordance with item 5.5. The remote control (Fig. 2) is intended for distant (up to 1 m) control of the device in the electrical stimulation mode. The remote control allows changing the stimulus current value (

11

Portable Device for EMG/STIM-guided Injection Neuro-Tox

and buttons) and performing single pulse stimulation ( button).

Fig. 2

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Description and operation

1.4.2. Device operation The device can operate in the following modes: 

in EMG amplification (recording) mode;



in electrical stimulation mode (single or repetitive).

The structure chart of the device is given in Fig. 3.

Fig. 3 If you use the device in EMG amplification mode, the electrodes are connected to amplifier unit input via switching unit. In the amplifier unit the preliminary signal amplification and filtration are executed. After that the signal is transferred to peak detector and audio amplifier. The voltage from the peak detector corresponding to maximum signal level at the present moment is transmitted to A/D converter of micro control unit. There it is processed and displayed on LCD as a scale.

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Portable Device for EMG/STIM-guided Injection Neuro-Tox

The signal received by audio amplifier is extra multiplied and reproduced in inside speaker or outside headphones. If you use the device in electrical stimulation mode (single pulse and repetitive), the electrodes are connected to electrical stimulator unit input via switching unit. The amplitude, the frequency and the pulse duration are specified by the control unit. The information concerning the present pulse parameters is displayed on LCD.

2.

Proper use 2.1. Safety measures when using the device For safety purposes and avoidance of electric trauma of the medical staff and patients, the medical staff is PROHIBITED to:

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

operate the device which setting-up procedures were made with violations of the present technical manual;



connect any devices not included in the delivery set;



open and repair the devices included in the delivery set;



make studies when the casing of the electronic unit or other components of the device are open;



connect electrodes placed on the patient to the protective grounding or other conducting surfaces.

Proper use

2.2. Setting-up procedures 2.2.1. Setting-up procedures in the EMG spontaneous activity recording mode Before the operation, please, make sure that the device and accessories do not have any mechanical failures which can cause danger. 1.

Insert the rechargeable batteries in the battery compartment located at the rear panel of the electronic unit (see item 5.5).

2.

If necessary connect the remote control and the headphones to the corresponding sockets (Fig. 1, Fig. 2).

3.

Place electrodes on the patient.

In the EMG spontaneous activity recording mode the needle and passive electrodes are used. The electrode placement points depend on the doctor’s aim. The example of electrode placement is shown in Fig. 4.

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Portable Device for EMG/STIM-guided Injection Neuro-Tox

Fig. 4 1 – active electrode (negative, minus), 2 – passive electrode (positive, plus). 4.

Connect electrodes according to Fig. 1.

The needle and passive electrodes connection is made as follows: the needle (active) electrode is connected to the black (negative) socket and the passive (passive) electrode is connected to the red (positive) socket (Fig. 1). The ground electrode is connected to the green socket located on the rear part of the device. 5.

Switch on the power supply by pressing the amplification mode button for not less than 1 second (

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button).

Proper use

2.2.2. Setting-up procedures in the electrical stimulation mode Before the operation, please, make sure that the device and accessories do not have any mechanical failures which can cause danger. 1.

Insert the rechargeable batteries in the battery compart-

ment located at the rear panel of the electronic unit (see item 5.5). 2.

If necessary connect the remote control and headphones

to the corresponding sockets (Fig. 1, Fig. 2). 3.

Place electrodes on the patient.

The needle and passive electrodes are used as stimulating ones. The electrode placement and injection points depend on the doctor’s aim. The example of placement is shown in Fig. 4. 4.

Connect electrodes according to Fig. 1.

The needle and passive electrodes connection is made as follows: the needle (active) electrode is connected to the black (negative) socket and the passive (passive) electrode is connected to the red (positive) socket (Fig. 1). The ground electrode is connected to the green socket (ground lead) located on the end part of the device. Note: It is possible not to use the ground electrode in the electrical stimulation mode. Switch on the power supply by pressing the stimulation mode button for not less than 1 second (

button).

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Portable Device for EMG/STIM-guided Injection Neuro-Tox

2.3. Operation order 2.3.1. EMG spontaneous activity recording mode If you press (for not less than 1 second) the Amplification (EMG) mode button, you will switch on the spontaneous activity recording (EMG) mode. The signal level will be displayed on the screen and transferred to the speaker. In the EMG mode you can record the spontaneous activity. The signal can be listened with the use of the speaker built in the electronic unit or headphones. The spontaneous activity is recorded with the use of bar electrodes or needle electrode. The disposable needle for botulinum toxin can be used as a needle electrode. As a result of spontaneous activity signal listening, you can detect the place of injection introduction more exactly. The input signal level is displayed on the scale according to logarithmic law (Fig. 5). The half scale level corresponds to input signal with 1 mV amplitude.

AMPLIFIER

Fig. 5

2.3.2. Electrical stimulation mode If you press (for not less than 1 second) the Stimulation mode button, you will switch on the electrical stimulation mode. The pulse frequency (Hz) and current amplitude (mA) are displayed on the screen (Fig. 6).

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Proper use

STIMULATOR Frequency Current 0,5 Hz 0,1 mA Fig. 6 The pulse frequency and the current amplitude are changed with the corresponding buttons and . If you press either of the buttons (frequency or current button) for more than 1 second, the given value will increase/decrease for 0.5. If you press the Single pulse button, the single pulse with the specified current amplitude occurs. At that in the right top corner of the screen the symbol appears for a while and Stimulation LED lights up (Fig. 7).

STIMULATOR Frequency Current 0,5 Hz 0,1 mA Fig. 7 If you press the Repetitive stimulation button, the repetitive pulse generation with the specified frequency and current amplitude occurs. At that in the right top corner of the screen the symbol appears with each stimulus delivery and becomes dim simultaneously with the Stimulation LED (Fig. 8). If you press the Repetitive stimulation button again, the stimulus generation is stopped.

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Portable Device for EMG/STIM-guided Injection Neuro-Tox

STIMULATOR Frequency Current 0,5 Hz 0,1 mA Fig. 8

2.3.3. Display backlight control The display backlight control is done with the use of the button

. At that in the left part of the screen you can see the

symbol corresponding to the backlight level ( indicates the minimal backlight level) (Fig. 9). Each button pressing increases the backlight brightness by the quarter of the maximum value ( , , , ). If you press the button after the maximum brightness level achieving, you will switch off the backlight.

AMPLIFIER

Fig. 9

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Proper use

2.3.4. Indication of rechargeable batteries voltage The battery condition symbol is displayed in the left top corner of the screen in any device operation mode (amplification or stimulation). The correspondence of indicator symbol to batteries voltage is described in Table 2.1. Table 2.1 Battery condition symbol

Charge value, %

Voltage on one battery, V

Note

100

More than 1.25

Battery is charged completely

75

1.15 – 1.25

Battery is 25% discharged

50

1.1 – 1.15

Battery is half discharged

25

1.0 – 1.1

Battery is 75% discharged

0

Less than 1.0

Indicator blinks (replace battery)

2.3.5. How to place/replace batteries Open the battery compartment cover by pressing the arrow. Place or replace the batteries in accordance with the polarity marked inside the compartment. Close the battery compartment.

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