NeuroSoft

Neuro-MS-D and MS Coils for Magnetic Stimulators Technical Manual TM058.02.003.000 March 2016

Technical Manual

39 Pages

File Type: PDF

File Size: 4.17 MB

File Name: NeuroSoft - Neuro-MS-D and MS Coils for Magnetic Stimulators Technical Manual TM058.02.003.000 March 2016 - 2016-03.pdf

Preview

Page 1

Technical Manual

RC-02-100, RC-02-150, SFEC-02-50, FEC-02-100, AFEC-02-100, RC-02-150-C, FEC-02-100-C, AFEC-02-100-C, FEC-02-100-P, AFEC-02-100-P, AFEC-02-100-C-P, AFEC-02-125, RC-03-100, RC-03-125, FEC-03-100, AFEC-03-100 Coils for Neuro-MS/D and Neuro-MS Magnetic Stimulators

TM058.02.003.000 (30.03.2016)

Table of Content Introduction ... 4 Important Safety Instructions ... 5 1.

Description and General Information Concerning Coil Operation ... 6 1.1. Coil Specifications ... 7 1.2. Coil Description and Principle of Operation... 12 1.3. Recommendations on Cooled Coil Use ... 15 1.4. Recommendations For Use Of Two Coils With One Cooling Unit ... 17 1.5. Coil Labeling... 20

Coil Application ... 21 2.1. Selecting the Right Coil... 21 2.2. Coil Positioning... 22 2.2.1. Impact of Pulse Waveform on Coil Positioning ... 22 2.2.2. Impact of Coil Type on Coil Positioning ... 25 2.3. Applied Coils... 26 2.3.1. RC-02-150, RC-02-150-C and RC-03-125 Coils... 26 2.3.2. RC-02-100 and RC-03-100 coils... 27 2.3.3. FEC-02-100, FEC-02-100-C and FEC-03-100 Coils ... 28 2.3.4. AFEC-02-100, AFEC-02-100-C and AFEC-03-100 Coils... 30 2.3.5. SFEC-02-50 Coil ... 31 2.3.6. AFEC-02-100-P, FEC-02-100-P Coils ... 32 2.3.7. AFEC-02-125 Coil ... 32

Coil Disinfection ... 33

Delivery Set, Package and Acceptance Data ... 34

Storage Regulations... 35

Disposal ... 36

Warranty... 36

Reclamation Data ... 37

Repair Data ... 39

Coils for Magnetic Stimulators (Technical Manual)

Introduction This technical manual (hereinafter is referred to as “the manual”) is the combined document describing operation and servicing of coils for Neuro-MS/D and Neuro-MS magnetic stimulators. The document certifies technical parameters of the product, which are guaranteed by the manufacturer. Read carefully this manual before starting to work! 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 on our website: www.neurosoft.com or ask questions by phone: +7 (4932) 59-21-12 (Service Department); +7 (4932) 24-04-37 +7 (4932) 95-99-99; +7 (4932) 24-04-34. You can also contact SAS Neuromed Company, Authorized European Representative of Neurosoft Ltd. (to Mr. Pierre Scholl) by the following address: Chemin du tomple 84330 Le Barroux, France Phone: +33 490-650-470, +33 622-748-384 Fax: +33 490-650-470 E-mail: [email protected]

Description and General Information Concerning Coil Operation

Important Safety Instructions Intended use The coils described in this manual are used with Neuro-MS/D and Neuro-MS magnetic stimulators and are intended for non-invasive magnetic stimulation of the brain, spinal cord, peripheral nerves and muscular tissues. Warning and precautions Always check the coil for the absence of cracks and other defects.

It is prohibited to immerse the coil in water, ice or refrigerate to cool it off.

Coils for Magnetic Stimulators (Technical Manual)

Description and General Information Concerning Coil Operation The information about the coils for Neuro-MS/D and Neuro-MS magnetic stimulators is represented in Table 1. Table 1. Coils for Neuro-MS/D and Neuro-MS magnetic stimulators Coil Type

Ring coil (RC) 100

Non-cooled

Size, mm

RC-02-100 Small ring coil, 100 mm, NS058304.001

150

RC-03-125 Big ring coil 125 mm, NS063304.002

RC-02-150 Big ring coil, 150 mm, NS058304.002

SFEC-02-50 Small figure-ofeight coil, 50 mm NS058304.005

Angulated figure-of-eight coil (AFEC)

100

FEC-02-100 Figure-of-eight coil, 100 mm NS058304.013

100

FEC-03-100 Figure of eight coil, 100 mm NS063304.008

FEC-02-100-P Figure-of-eight coil, 100 mm (placebo) NS058304.004

–

Cooled

RC-03-100 Small ring coil 100 mm, NS063304.001

Figure-of-eight coil (FEC) 125

–

RC-02-150-C Cooled big ring coil, 150 mm NS058304.003

–

FEC-02-100-C Cooled figure-ofeight coil, 100 mm NS058304.010

AFEC-02-100 Angulated figureof-eight coil, 100 mm NS058304.014

AFEC-03-100 Angulated figure of eight coil, 100 mm NS063304.011

AFEC-02-125 Angulated figureof-eight coil (double cone) 125 mm NS058304.017

–

AFEC-02-100-P Angulated figureof-eight coil, 100 mm (placebo) NS058304.009

–

AFEC-02-100-C Cooled angulated figure-of-eight coil, 100 mm NS058304.012 AFEC-02-100-C-P

Cooled angulated figure-of-eight coil, 100 mm (placebo) NS058304.011

125

1.1. Coil Specifications Table 2 contains the main specifications of coils for Neuro-MS/D and Neuro-MS magnetic stimulators Table 2. Main Specifications of Coils Related document

Inductunce, µH

Coil

Magnetic field gradient, kT/s

Maximal induction, 100%, T

Standard pulse

Internal diameter, mm

External diameter, mm

Power pulse*

NeuroMS/D

NeuroMS

NeuroMS/D

NeuroMS

NeuroMS/D

NeuroMS

Number of pulses before warm-up Biphasic pulse at 80% intensity, 4 Hz, 25°C

Monophasic pulse at 75% intensity, 0.5 Hz, 25°C

RC-02-100

NS058304.001

1.5±0.15

2.2 ± 0.15

250

RC-03-100

NS063304.001

3.2±0.15

4.8±0.15

100

> 120

RC-02-150

NS058304.002

1.1±0.15

1.5 ± 0.15

155

400

1.3±0.15

1.9 ± 0.15

160

10000 (at 24º C)

2.5±0.15

3.5±0.15

125

> 240

2.5±0.15

3.3 ± 0.15

18 (2)

47 (2)

1.2±0.15

1.7 ± 0.15

4750 (2)

97100 (2)

720

1.1±0.15

4750 (2)

97100 (2)

10000 (at 24º C)

RC-02-150-C RC-03-125

NS058304.003 NS063304.002 NS058304.005

SFEC-02-50 FEC-02-100 FEC-02-100-C

NS058304.013 NS058304.010

1.6 ± 0.15

FEC-03-100

NS063304.008

1.5±0.15

2.0±0.15

40(2)

114(2)

> 370

FEC-02-100-P

NS058304.004

< 0.3

−

< 0.4

−

AFEC-02-100

NS058304.014

1.4±0.15

2.0 ± 0.15

3651 (2)

84106 (2)

680

1.5±0.15

2.2 ± 0.15

3651 (2)

84106 (2)

10000 (at 24º C)

AFEC-02-100-C

NS058304.012

AFEC-03-100

NS063304.011

1.8±0.15

2.6 ± 0.15

40(2)

115(2)

> 290

AFEC-02-100-P

NS058304.009

< 0.2

< 0.3

−

900

AFEC-02-100-C-P

NS058304.011

< 0.03

< 0.04

−

AFEC-02-125

NS058304.017

1.4±0.01

2.0 ± 0.15

130

270

Application

Facial nerve stimulation, and superficial peripheral nerve stimulation Transcranial stimulation of extensive brain areas, peripheral nervous system stimulation

Study of phrenic, facial, median and ulnar nerves, somatosensory evoked potentials and F-wave Cortical stimulation and stimulation of spinal roots

Placebo-controlled trials

Motor cortex stimulation, depression treatment

Placebo-controlled trials

Deep brain stimulation

* The power pulse is longer than the standard one for 1.4 ms. The power pulse can be generated with Neuro-MS/D if the expansion unit is used. The power pulse can be generated with Neuro-MS if two stimulator units are used with 0 ms interpulse interval.

Coils for Magnetic Stimulators (Technical Manual)

The maximal amplitude of the magnetic pulses generated by the stimulator depends on the stimulation frequency and decreases while the stimulation frequency increases. When you set the amplitude higher than the stimulator can generate, the first pulse in train (pulse series) will be generated with the specified amplitude, the intensity of next stimuli will decrease. After several stimuli the amplitude will be equal to maximal one at this frequency. In this case “Ready” indicator will not light. The dependence of maximal amplitude of Neuro-MS/D standard biphasic pulse on the stimulation frequency estimated without use of expansion unit and extra power supply unit is shown in Table 3. Table 3. Dependence of maximal biphasic pulse amplitude on stimulation frequency (standard pulse generated without use of expansion unit and extra power supply unit) Frequency, Hz

Maximal amplitude, % RC-02-100 RC-02-150, RC-02150-C

SFEC-0250

FEC-02100-C

AFEC-02100, AFEC-02100-C

FEC-02100

AFEC-02125

100

Description and General Information Concerning Coil Operation

The dependence of maximal amplitude of Neuro-MS/D standard biphasic pulse on the stimulation frequency when using extra power supply unit is given in Table 4. Table 4. Dependence of maximal biphasic pulse amplitude on stimulation frequency when using extra power supply unit Frequency, Hz

Maximal Amplitude, % RC-02-150-C

FEC-02-100-C

AFEC-02-100-C

AFEC-02-125

100

Coils for Magnetic Stimulators (Technical Manual)

Measured values of magnetic field induction amplitude for standard biphasic pulse of Neuro-MS/D in the area with its maximum density for coils (AMPLITUDE is set to 100%) are shown below (Fig. 1, Fig. 2). In ring coils the area of maximal magnetic induction is situated on the border of the internal hole (edge of inner circle). As for the figure-of-eight coil, the maximum density of the magnetic field is situated on the borders of the internal holes (edges of inner circles) opposite the area where the two windings meet.

Fig. 1. The dependence of maximal amplitude of magnetic field at standard biphasic stimulation on a distance from the coil surface (at 0…70 mm distance).

Fig. 2. The dependence of maximal amplitude of magnetic field at standard biphasic stimulation on a distance from the coil surface (at 20…70 mm distance).

Description and General Information Concerning Coil Operation

The amplitude dependence in pulse series at theta-burst stimulation using Neuro-MS/D stimulator and extra power supply unit is given in Table 5. Table 5. The amplitude dependence in pulse series at theta-burst stimulation using Neuro-MS/D stimulator and extra power supply unit.

Pulse №

50 Hz 80%

60%

Pulse №

40%

100 Hz 80%

60%

40%

FEC-02-100-C 1

100%

84%

85%

94%

75%

77%

86%

70%

78%

91%

57%

64%

76%

65%

74%

84%

43%

54%

71%

61%

72%

88%

39%

48%

68%

RC-02-150-C 1

100%

90%

93%

81%

83%

90%

83%

91%

92%

68%

73%

87%

78%

89%

91%

58%

63%

83%

75%

88%

91%

51%

60%

80%

AFEC-02-100-C 1

100%

76%

86%

93%

69%

74%

80%

61%

80%

91%

53%

59%

72%

59%

75%

84%

41%

50%

64%

55%

75%

89%

35%

42%

59%

AFEC-02-125 1

100%

89%

98%

96%

85%

89%

91%

83%

97%

93%

73%

77%

91%

78%

97%

93%

64%

68%

87%

76%

94%

91%

55%

66%

82%

Coils for Magnetic Stimulators (Technical Manual)

1.2. Coil Description and Principle of Operation During the pulse the high-intense alternating current (8 kA) flows via the coil. At that moment the alternating magnetic field emerges near the coil. It induces the current in patient’s tissues located closely generating the nerve excitation as during the common electrical stimulation. Structurally the non-cooled coil is made of copper wire. The current flowing through this wire provokes the heating of operating coil surface. The contact with this heated surface can cause the patient’s hyperaemia or burn. The higher is the pulse amplitude and stimulation frequency, the quicker is the heating of the operating surface of the coil and the lesser is the pulse number provided by the coil before the warm-up. To control the temperature of the operating surface, the coil is supplied with the temperature sensor. The readings of this sensor are monitored by the stimulator control system. In case the coil heats up to 41 C, the stimulation is stopped till the coil temperature decreases to the safe value. The use of coils with the force cooling allows increasing the time of the continuous operation without overheating. In this type of coils the coil winding is made of copper tube where the cooling liquid (cooling agent) circulates. The cooling process occurs in the cooling unit. The external views of the ring coils, figure-of-eight coils and angulated figure-of-eight coil of version 02 are shown in Fig. 3 (a, b, c, d). 1

1 2 4

a) ring coil

b) figure-of-eight coil

2 2

c) small figure-of-eight coil SFEC-02-05

d) angulated figure-of-eight coil AFEC-02-125

Fig. 3. External views of ring and figure-of-eight coils, version 02.

Description and General Information Concerning Coil Operation

The figures on Fig. 3 indicate the following: 1.

Stimulation coil. The arrow on the case shows the direction of current flowing in the coil (coils) at the moment of pulse delivery.

“Trigger” button duplicating “Trigger” button located on the front panel of the main unit;

“Ready” indicator duplicating the “Ready” indicator located on the front panel of the main unit.

Marker to position the coil. It indicates the center of the area where the intensity of the induced electric field has the maximum value. The maximum intensity of stimulation of nervous structures is reached at this point.

The external views of coils of version 03 are shown in Fig. 4 (a, b).

a) RC-03-100 coil

b) FEC 03-100 coil

Fig. 4. External views of coils of version 03:

The figures on Fig. 4 indicate the following: 1.

Stimulation coil. The arrow on the coil case shows the direction of current flowing in the coil (coils) at the moment of pulse delivery.

“Trigger” button combined with “Ready/Overheating” indicator. 13

Coils for Magnetic Stimulators (Technical Manual)

The indicator lights:  red – the coil is overheated, stimulation is impossible1;  green – the coil is ready to produce a pulse. A pulse is generated by pressing the “Trigger” button. If the double interlock option is enabled press together with the “Trigger button” on the coil the “Trigger” button on the main unit or press the pedal of the footswitch. If you use a coil with buttons on both sides, press both “Trigger” buttons on the coil. If the stimulator is in disarmed state, press and hold the “Tigger” button and press “+” button to start capacitor charge1 (the same as to press the “ARM” button on the front panel of the stimulator). 3.

“-” button. Press this button to decrease pulse intensity1.

“+” button. Press this button to increase pulse intensity1.

The connectors for coils attachment to Neuro-MS/D stimulator are shown in Fig. 5 and Fig. 6. The cooled coil differs from the non-cooled one by presence of hoses with quick connect couplings for cooling unit connection.

Fig. 5. The cooled coil connector for Neuro-MS/D.

Only for Neuro-MS stimulator

Fig. 6. The non-cooled connector for Neuro-MS/D.

Description and General Information Concerning Coil Operation

1.3. Recommendations on Cooled Coil Use In case you use the cooled coil, it is sometimes required to change it often (several times per day). In this case the connecting pipes of cooled coil hoses collect the dirt and dust. It can result in early damage of connecting pipe valve and leaking of cooling agent when disconnecting. To prolong the life time of the coil, it is recommended to apply the replaceable hydraulic system adapters. They are included in Neuro-MS/D delivery set2 (Fig. 7).

Fig. 7. The cooled coil (1) and hydraulic system adapters (2).

If you purchased the magnetic stimulator before March 2014, it is recommended to purchase the hydraulic system adapters. To do it, address to your local distributor of Neurosoft Ltd. or the commercial department of Neurosoft Ltd.

Coils for Magnetic Stimulators (Technical Manual)

Before the use the adapters are attached to the connecting pipes of the coil as it is shown in Fig. 8. Then the adapter pipes are attached to the cooling unit.

Fig. 8. The cooled coil with the connected hydraulic system adapters.

When the coil is to be changed, the adapter pipes are disconnected from the cooling unit (Fig. 9). At that the adapters are plugged in to the coil hoses. Replace the adapters if oil leakage occurs.

Fig. 9. Disconnection of the adapters from the cooling unit.

Description and General Information Concerning Coil Operation

1.4. Recommendations For Use Of Two Coils With One Cooling Unit In some cases there is a necessity to use different types of cooled coils with one stimulator. If one cooling unit is used, two cooled coils can be connected sequentially through the hydraulic connecting hose (Fig. 10).

Fig. 10. Hydraulic connecting hose.

Such coil connection allows to prolong the life time of the cooling unit as coils are permanently attached to the cooling unit and do not require to be changed over as during the use of one coil. If two coils are occasionally connected to one cooling unit, the hydraulic connecting hose should be attached to connecting pipes of hydraulic system adapters. Hydraulic system adapters should be connected to coil cooling hoses. It is recommended to attach the hydraulic connecting hose directly to coil cooling hoses if these coils are permanently connected to one cooling unit.

Coils for Magnetic Stimulators (Technical Manual)

To ensure the correct work of two coils connect them to the cooling unit in accordance with Fig. 11.

Fig. 11. Connection of two cooled coils via the hydraulic connecting hose to one cooling unit.

Description and General Information Concerning Coil Operation

The coil which is not used during the stimulation should be positioned on the K-8 holder. The holder is placed on the left/right side of T-2 trolley for magnetic stimulator (Fig. 12).

Fig. 12. Fixation of two cooled coils during connection to one cooling unit.

K-8 holder.

K-3 flexible arm for coil positioning.

Neuro-MS/D main unit.

Neuro-MS/D cooling unit.

Hydraulic connecting hose.

T-2 trolley.

Coils for Magnetic Stimulators (Technical Manual)

Coil is changed when the stimulator is switched off (or when the stimulator is in the standby mode) or after “Coil change” button (combined with “High voltage” indicator) on the front panel of the main unit is pressed. During coil changing it is prohibited to twist and bend cooling hoses.

1.5. Coil Labeling On the coil there is a label denoting the type and the serial number (Fig. 13). The explanation of the symbols and figures on the coil is shown in Fig. 14.

Fig. 13. Example of coil labeling.

The explanation of symbols on the label:

– attention: consult operational documentation. – mark of conformance to 93/42/EEC “Concerning Medical Devices” directive. – sign of conformance to Russian standards requirements. – work parts of BF type according to IEC 60601-1. – manufacturer by ISO 15223-1-2012. – number according to catalogue by ISO 15223-1-2012. – serial number by ISO 15223-1-2012.

Coil Application

The explanation of the coil type denotation is shown in Fig. 14.

XХX-XX-XXX-X Coil type:  C – cooled  P – placebo Coil diameter, mm Coil version:  02 – is used with Neuro-MS/D magnetic stimulators  03 – is used with Neuro-MS magnetic stimulators ТCoil type/shape:  RC – ring coil  FEC – figure-of-eight coil  AFEC – angulated figure-of-eight coil

Fig. 14. The explanation of the coil type denotation.

Coil Application 2.1. Selecting the Right Coil While selecting this or that coil, the peak intensity of magnetic field is considered (T) and, correspondingly the peak intensity of electrical field (V/m) and also the shape and size of the coil. The specific properties of generated magnetic and electrical fields depend greatly on the coil construction. The most widely spread coils are ring, figure-of-eight and angulated figure-of-eight ones. 3-dimensional images of induced electric field intensity for ring and figure-of-eight coils are different because of their different geometric shapes (Fig. 15). The highestlevel intensity for a ring coil (Fig. 15, 1) is obtained by the rim of the inner ring and has no peaks, while a figure-of-eight coil (Fig. 15, 2) has one main peak with maximal induction in the area of coils intersection and two peaks with lower induction over each of two coils. Use of figure-of-eight and angulated figure-of-eight coils allows to induce a well-focused electrical field.

Previous Page Next Page