Neuro-MS-D and MS Coils for Magnetic Stimulators Technical Manual TM 004 2018 Dec 2017

Contents Introduction ... 4 Important Safety Instructions ... 5 Intended Use ... 5 Safety Measures... 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 ... 16 1.5. Coil Labeling... 19

2.

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... 28 2.3.3. FEC-02-100, FEC-02-100-C and FEC-03-100 Coils ... 29 2.3.4. AFEC-02-100, AFEC-02-100-C and AFEC-03-100 Coils... 30 2.3.5. SFEC-02-50 Coil ... 32 2.3.6. AFEC-02-100-P, FEC-02-100-P Coils ... 32 2.3.7. AFEC-02-125 and DCC-03-125-C Coils ... 33

3.

Maintenance... 34 3.1. General Requirements... 34 3.2. User Maintenance... 34 3.3. Disinfection ... 34 3.4. Life Time... 35

4.

Current Repair ... 36

5.

Packing and Transportation ... 36

6.

Storage... 37

7.

Conservation... 37

8.

Disposal ... 37

9.

Acceptance, Delivery Set and Package Data ... 38

10. Warranty... 39 11. Reclamation Data ... 40

3

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 (hereinafter are referred to as “the coil”, “coils”). 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; +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 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]

4

Important Safety Instructions

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.

Safety Measures 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.

5

Description and General Information Concerning Coil Operation The information about the coils for Neuro-MS/D and Neuro-MS magnetic stimulators is shown 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

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

–

1

Figure-of-eight coil (FEC) 125

150

50

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

100

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

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

1.

DCC-03-125-C coil does not have CE marking.

–

–

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

–

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

Angulated figure-of-eight coil (AFEC)

Double cone coil (DCC)

100

125

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 125 mm NS058304.017

–

DCC-03-125-C Cooled double cone coil 125 mm NS063304.016

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

1

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. Coil

Order code

Inductunce, µH

Maximal induction, 100%, T

Standard pulse

Magnetic field gradient, kT/s

Power pulse

Internal diameter, mm

External diameter, mm

2

Neuro-MS/D

Neuro-MS

Neuro-MS/D

Neuro-MS

NeuroMS/D

Neuro-MS

1.5 ± 0.15

–

2.2 ± 0.15

–

35

–

38

94

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

250

–

RC-02-100

NS058304.001

10

RC-03-100

NS063304.001

13

–

3.2 ± 0.15

–

–

–

66

10

100

–

more than 90

RC-02-150

NS058304.002

10

1.1 ± 0.15

–

1.5 ± 0.15

–

22

–

55

155

400

–

RC-02-150-C

NS058304.003

10

1.3 ± 0.15

–

1.9 ± 0.15

–

30

–

50

160

10000 (at 24°С)

–

RC-03-125

NS063304.002

13

–

2.5 ± 0.15

–

3.5 ± 0.15

–

45

10

125

–

more than 450

SFEC-02-50

NS058304.005

10

2.5 ± 0.15

–

3.3 ± 0.15

–

58

–

18 (2)

47 (2)

60

–

FEC-02-100

NS058304.013

10

1.2 ± 0.15

–

1.7 ± 0.15

–

25

–

4750 (2)

97100 (2)

720

–

FEC-02-100-C

NS058304.010

10

1.1 ± 0.15

–

1.6 ± 0.15

–

26

–

4750 (2)

97100 (2)

10000 (at 24°С)

–

FEC-03-100

NS063304.008

10

–

1.5 ± 0.15

–

2.0 ± 0.15

–

34

40 (2)

114 (2)

–

more than 200

FEC-02-100-P

NS058304.004

–

not more than 0.3

–

not more than 0.4

–

–

–

−

−

−

–

AFEC-02-100

NS058304.014

10

1.4 ± 0.15

–

2.0 ± 0.15

–

32

–

3651 (2)

84106 (2)

680

–

AFEC-02-100-C

NS058304.012

10

1.5 ± 0.15

–

2.2 ± 0.15

–

37

–

3651 (2)

84106 (2)

10000 (at 24°С)

–

AFEC-03-100

NS063304.011

11

–

1.8 ± 0.15

–

2.6 ± 0.15

–

48

40 (2)

115 (2)

–

more than 450

AFEC-02-100-P

NS058304.009

−

not more than 0.2

–

not more than 0.3

–

–

–

−

−

900

–

AFEC-02-100-C-P

NS058304.011

−

not more than 0.03

–

not more than 0.04

–

−

–

−

−

−

–

AFEC-02-125

NS058304.017

23

1.4 ± 0.15

–

2.0 ± 0.15

–

22

–

96

130

270

–

DCC-03-125-C

NS063304.016

21

1 ± 0.15

–

1.4 ± 0.15

–

17

–

96

130

10000 (at 24°С)

–

2

The power pulse is longer than the standard one in 1.4 times. 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 amplitude of Neuro-MS/D standard biphasic pulse on stimulation frequency (standard pulse generated without use of expansion unit and extra power supply unit). Frequency, Hz

Maximal amplitude, %

RC-02- RC-02- RC-02- SFEC- FEC- AFEC- AFEC- FEC- AFEC- DCC100 150 150-C 02-50 02-100- 02-100 0202-100 02-125 03C 100-C 125-C

8

3

100

100

100

100

100

100

100

100

100

100

4

100

100

96

97

91

100

90

100

100

100

5

100

100

85

82

82

100

79

100

100

97

6

100

100

80

75

75

100

73

100

100

−

7

92

95

74

68

69

97

65

96

90

−

8

86

88

68

64

61

90

60

90

84

−

9

80

82

62

59

57

83

56

83

77

−

10

73

78

53

55

52

77

51

79

72

64

15

56

60

41

40

39

57

38

62

55

48

20

44

49

34

33

31

49

31

51

45

39

25

39

41

29

28

26

42

26

42

38

33

30

35

38

26

25

23

37

23

38

35

30

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 amplitude of Neuro-MS/D standard biphasic pulse on stimulation frequency when using extra power supply unit Frequency, Hz

Maximal Amplitude, %

RC-02-150-C

FEC-02-100-C AFEC-02-100C

AFEC-02-125 DCC-03-125-C

4

100

100

100

100

100

5

100

100

100

100

100

10

100

100

100

100

100

15

100

100

100

100

100

20

96

90

88

100

100

25

82

77

74

97

91

30

72

68

64

86

80

35

65

60

58

76

73

40

58

53

54

69

67

45

53

49

48

63

61

50

49

44

45

60

58

55

45

39

41

55

53

60

42

35

37

49

49

65

39

33

35

43

47

70

37

29

33

39

45

75

35

26

29

35

43

80

31

23

26

30

40

85

29

21

24

24

39

90

25

18

20

20

36

95

22

16

18

17

35

100

20

14

16

15

35

9

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 between the internal holes (edges of inner circles) in 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)

10

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%

100%

100%

1

100%

100%

100%

2

84%

85%

94%

2

75%

77%

86%

3

70%

78%

91%

3

57%

64%

76%

4

65%

74%

84%

4

43%

54%

71%

5

61%

72%

88%

5

39%

48%

68%

RC-02-150-C 1

100%

100%

100%

1

100%

100%

100%

2

90%

93%

93%

2

81%

83%

90%

3

83%

91%

92%

3

68%

73%

87%

4

78%

89%

91%

4

58%

63%

83%

5

75%

88%

91%

5

51%

60%

80%

AFEC-02-100-C 1

100%

100%

100%

1

100%

100%

100%

2

76%

86%

93%

2

69%

74%

80%

3

61%

80%

91%

3

53%

59%

72%

4

59%

75%

84%

4

41%

50%

64%

5

55%

75%

89%

5

35%

42%

59%

AFEC-02-125 1

100%

100%

100%

1

100%

100%

100%

2

89%

98%

96%

2

85%

89%

91%

3

83%

97%

93%

3

73%

77%

91%

4

78%

97%

93%

4

64%

68%

87%

5

76%

94%

91%

5

55%

66%

82%

DCC-03-125-C 1

100%

100%

100%

1

100%

100%

100%

2

92%

82%

96%

2

85%

93%

91%

3

77%

73%

85%

3

66%

78%

89%

4

66%

75%

76%

4

59%

67%

83%

5

64%

73%

77%

5

55%

63%

84%

11

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 coils of 02 version are shown in Fig. 3 (a, b, c, d). 1

2

1 2 4

3

3

a) ring coil

1

b) figure-of-eight coil

3

1 3

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, figure-of-eight and angulated figure-of-eight coils, version 02

12

Description and General Information Concerning Coil Operation

The figures 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.

2.

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

3.

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

4.

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 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.

2.

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

13

Coils for Magnetic Stimulators (Technical Manual)

The indicator lights:  red – the coil is overheated, stimulation is impossible3;  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 charge (the same as to press the “ARM” button on the front panel of the stimulator). 3.

“-” button. Press this button to decrease pulse intensity3.

4.

“+” button. Press this button to increase pulse intensity3.

5.

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 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

3

14

Only for Neuro-MS stimulator

Fig. 6. The non-cooled coil 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 set4 (Fig. 7).

2

1

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

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

4

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.

15

Coils for Magnetic Stimulators (Technical Manual)

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

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.

16

Description and General Information Concerning Coil Operation

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. 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

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-4/A trolley for magnetic stimulator (Fig. 12).

17

Coils for Magnetic Stimulators (Technical Manual)

2

3

1

6

4

5

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

1.

K-8 holder.

2.

K-3 flexible arm for coil positioning.

3.

Neuro-MS/D main unit.

4.

Neuro-MS/D cooling unit.

5.

Hydraulic connecting hose.

6.

T-4/A trolley.

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.

18

Description and General Information Concerning Coil Operation

1.5. Coil Labeling On the coil there is a label denoting the type and the serial number (Fig. 13).

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. – mark of conformance to 2012/19/EC “On waste electrical and electronic equipment (WEEE)” directive. – work parts of BF type according to IEC 60601-1. – number according to catalogue by ISO 15223-1-2012. – serial number by ISO 15223-1-2012. – manufacturer by ISO 15223-1-2012. – date of manufacturing by ISO 15223-1-2012.

19

Coils for Magnetic Stimulators (Technical Manual)

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  DCC – double cone coil Fig. 14. The explanation of the coil type denotation

Equipment is identified with the GS1-128 barcode that includes the GTIN code and the serial number (Fig. 15). GTIN

( 01 ) ( 0 465007533 009 8 ) 1

2

3

4

5

( 21 ) ( ХХХХХХХХ ) 6

7

Fig. 15. The GS1-128 barcode

1 - identification key: GTIN; 2 - start digit; 3 - company number; 4 - article reference; 5 - check digit; 6 - serial number identifier; 7 - serial number. GTIN – global trade item number can be used by a company to uniquely identify all of its trade items. GS1 defines trade items as products or services that are priced, ordered or invoiced at any point in the supply chain.

20

Coil Application

To ensure automatic data reading the GS1-128 code is integrated to the barcode in DataMatrix format (Fig. 16).

Fig. 16. DataMatrix barcode

DataMatrix code is a two-dimensional barcode, consisting of black and white "cells" or modules arranged in either a square or rectangular pattern. The DataMatrix code is described in ISO/IEC 16022:2006 standard. To decode the information about the item DataMatrix code can be read by a scanner or a smartphone camera as a two-dimensional image.

2.

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. 17). The highestlevel intensity for a ring coil (Fig. 17, 1) is obtained by the rim of the inner ring and has no peaks, while a figure-of-eight coil (Fig. 17, 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.

21