Neuro-MS-D Magnetic Stimulator Technical Manual TM058.07.001.000 March 2017

Contents Introduction ... 5 Safety Requirements ... 6 Indications for Use ... 6 Contraindications ... 7 Possible Side Effects ... 9 Warnings and Precautions ... 12 Patient Safety... 15 1.

Description... 17 1.1 Main Specifications ... 17 1.2 Delivery Set... 20 1.3 Structure and Operation ... 24 1.4 Controls, Connectors and Indicators... 27 1.4.1 Controls, Connectors and Indicators of Main Unit... 27 1.4.2 Controls, Connectors and Indicators of Cooling Unit... 33 1.4.3 Controls, Connectors and Indicators of Extra Power Supply Unit... 35 1.4.4 Coil Controls, Connectors and Indicators... 37 1.5 Synchronization... 38 1.6 Labeling... 39

2

Setting-Up Procedures... 41 2.1 Requirements to Personnel Conducting Stimulator Assembly and Installation ... 41 2.2 Room Selection and Placement ... 41 2.3 Unpacking and Check of Delivery Set ... 44 2.4 Assembly and Connection of Stimulator ... 45 2.4.1 General Requirements to Assembly ... 45 2.4.2 Preparation of Cooling Unit to Operation ... 45 2.4.3 System Assembling ... 46

3

Operating Order... 55 3.1 Operation in Stand-alone Mode... 55 3.2 Operation in PC-mode... 57 3.3 Operation in Control Mode via Trig-in ... 57 3.4 Operation in Syncronization Mode with External Device via Trig-out ... 58 3.5 Acquisition of Evoked Potentials... 58 3.6 Actions in the Emergency... 59 3.7 Troubleshooting... 59

4

Servicing ... 61 4.1 General Requirements ... 61 4.2 Maintenance Service... 61 4.3 Cleaning and Disinfection... 61 4.4 Life Time ... 62 4.5 Service Menu of Main Unit... 63 4.6 System Information ... 64

3

5

Packing and Transportation ... 66

6

Storage Data ... 66

7

Conservation... 66

8

Disposal ... 66

9

Delivery Set and Package Data... 67

10 Warranty... 67 11 Reclamation Data ... 69 Annex 1... 70 Electromagnetic Emissions and Immunity ... 70 Annex 2... 74 Safety Screening Questionnaire for Transcranial Magnetic Stimulation (TMS)... 74 Annex 3... 76 Patient Treatment Record Form ... 76 Annex 4... 77 PC-mode 77 1. Getting Ready... 77 2. First Visit of a Patient ... 77 3. Second and Next Visits... 89 Annex 5... 92 Stand-alone Mode... 92 1. Getting Ready... 92 2. First Visit of a Patient ... 92 3. Second and Next Visits... 100 References ... 103

4

Introduction

Introduction This user manual (hereinafter referred to as “manual”) is the combined document describing operation and servicing of Neuro-MS/D magnetic stimulator (hereinafter referred to as “stimulator”). This manual is the document which certifies the stimulator specifications guaranteed by the manufacturer. Do not start working with stimulator 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 (Service department), +7 (4932) 95-99-99; +7 (4932) 24-04-34. You can also contact SAS Neuromed Company, Authorized European Representative 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: [email protected]

5

Neuro-MS/D Technical Manual

Safety Requirements Indications for Use The Neuro-MS/D stimulator is intended for noninvasive diagnostics (together with digital EMG/EEG systems) and therapeutic intervention to motor cortex, peripheral nervous system and spinal cord by magnetic pulses. The stimulator can be applied in different areas of medicine including neurology, psychiatry, epileptology, neurosurgery, orthopedy, pediatrics, electrodiagnostics and others at:  complex diagnostics, to study the motor pathway integrity at wide range of motor function disorders; localization of speech center, motor cortical representations, etc.  treatment of wide range of disorders including pain syndrome, depression, motor disorders (including Parkinson’s disease), amyotrophic lateral sclerosis, multiple sclerosis, epilepsy, impairment of consciousness, Alzheimer's disease, tinnitus, anxiety disorders, obsessive-compulsive disorders, auditory hallucinations and negative symptoms at schizophrenia, alcohol, nicotine, medicine withdrawal and etc. The stimulator can be used in patient care facilities, diagnostics centers, neurosurgical clinics, experimental laboratories of scientific and research institutes.

6

Description

Contraindications Although the magnetic stimulation in single pulse mode is a safe procedure, before the treatment start each patient must be screened for contraindications.

The absolute contraindications include implanted devices that are activated or controlled in any way by physiological signals (examples: cardiac implants, deep brain stimulators, cochlear implants, and vagus nerve stimulators, see Table 1).

All the rest contraindications are relative ones. In each individual case the benefit of the test should be weighed against possible adverse effects. This judgment is best left to a skilled clinician familiar with the characteristics of the device. The written informed consent of the patient should be obtained. The safety and effectiveness of TMS therapy has not been established in the following patient groups or clinical conditions: 1. patient suffering from epileptic seizures and syncope in the anamnesis; 2. patients suffering from nervous system diseases and taking the drugs that may decrease seizure threshold; 3. pregnant women; 4. patients who have conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head or within 30 cm of the treatment coil (examples: magnetically activated dental implants, ferromagnetic ocular implants, pellets, bullets and its fragments, facial tattoos with metallic ink, metal cuts, aneurysm clips or coils, carotid or cerebral stents, implanted chips, implants with radioactive drugs, etc.) 5. severe chronic cardiovascular disease or recently occurred acute state (for example, myocardial infarction).

7

Neuro-MS/D Technical Manual Table 1. Devices that are known to be adversely affected by the treatment.

Magnetically activated dental implants Aneurysm clips or coils

X

Carotid or cerebral stents Cochlear, otologic implants C SF shunt Ferromagnetic ocular implants Pellets, bullets, fragments <12 in. (<30 cm) from coil Facial tattoos with metallic ink EEG electrodes DBS electrodes Metallic devices implanted in the head Cardiac Pacemakers, ICD’s

X X X X

Device/Object may overheat

X

X

Potential Consequences of Operator Inaction

Patient injury X

X X

X X X

Serious patient injury or death Patient injury or death Patient injury Patient injury Patient injury

X

X

X

Patient injury, inflation

X

X

X

Patient injury, inflation

X X

X X X

Patient injury Patient injury or death Patient injury or death

X X

X X X

X X

X

X

Vagus Nerve Stimulator

X

X

Wearable cardioverter defibrillator (WCD) Wearable infusion pumps

X

X X

X

Implanted insulin pump

X

X

Stents, filters, heart valves Magnetically programmable shunt valves Cervical fixation devices Staples, sutures Radioactive seeds

X X

X

VeriChip microtransponder Wearable physiologic monitors Bone growth stimulators Portable glucose monitors Hearing aids

X

1)

Device/ Object may dislodge or move

Possible Interaction with the Neuro-MS/D Therapy System

Device/Object becomes disabled

Remove device from patient area

Keep treatment coil >12 in. (>30 cm) from device/object

Device or Object

TMS treatment is contraindicated

Action required by Operator before treatment

X

X X X

X X X

X X

X

X X

X X X

X X X

X

X

Affected therapy; patient injury Affected therapy; patient injury Affected therapy; patient injury Affected therapy; patient injury Affected therapy; patient injury Patient injury or death Affected therapy; patient injury Patient injury Patient injury Affected therapy; patient injury Inconvenience Inconvenience Inconvenience Inconvenience Inconvenience

The safety and effectiveness of TMS therapy has not been established in the following patient groups or clinical conditions: 1.1 pregnant women; 1.2 patients suffering from epilepsy; 1.3 patients with family history of convulsions; 1.4 patients suffering from sleep deprivation during rTMS procedures;

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Description

1.5 patients suffering from excessive alcohol consumption; 1.6 patients taking tricycling antidepressants, neuroleptic agents or any other drugs that may decrease seizure threshold; 1.7 patients taking epileptogenic drugs; 1.8 patients with increased intracranial pressure; 1.9 patients suffering fron uncontrolled migraine; 1.10 patients with severe heart disease; 1.11 patients with brain injures that may change the seizure threshold. 2)

Before the treatment start the patient should take off and remove from patient area all removable devices and objects that may be affected by magnetic field: adornments (for example earrings), eyeglasses, cell phones, MP3 players, PDA devices, headphones, coins.

Possible Side Effects 1. Increase of hearing threshold. According to the publications, some patients suffered from the transient hearing threshold increase after TMS. However the majority of studies have shown that the negative impact of TMS on hearing is missing when the earplugs are used. Thus it is recommended to:  use the approved hearing protection (earplugs or ear muffs) by specialists trained to insert these devices;  refer a patient for the auditory examination if she/he complains of hearing loss, tinnitus or aural fullness after TMS procedure;  make a decision on TMS performing only in cases of a favorable risk/benefit ratio in patients with pre-existing noise induced hearing loss, under concurrent treatment with ototoxic medications (Amynoglycosides, Cisplatine) and also young children.  avoid performing the TMS in patients with cochlear implants. 2. Epileptiform abnormalities in EEG. In some publications it is stated that patients with brain damage, drug treatment or discontinuation of the treatment are more vulnerable to TMS. In such patients the epileptiform abnormalities recorded with EEG during or after repetitive TMS (in an hour) may occur. 3. Seizures. The published data have revealed that the risk of rTMS to induce seizures is very low. 9

Neuro-MS/D Technical Manual

Before the publication of the safety guidelines with stimulation parameter limits (Wassermann, 1998) it was reported about seven cases of TMS-induced seizures after high-frequency rTMS. Seven of them occurred in healthy subjects during the studies intended to define the safety limits and one of them is in patient suffering from depression. In the above-mentioned cases the parameters outside the safety limits were used and were later included to safety guidelines. Also other possible factors that might contribute for seizures were also considered (for example, taking antidepressants or antipsychotic drugs that change the cortex excitability). After the recommendations were published, four cases of TMS-induced seizures with parameters outside the safety limits and four cases were occurred with rTMS parameters considered safe. In three cases of four (both with use of permissible stimulation parameters and with parameters exceeded the permissible ones) the TMS-induced seizures were observed in patients taking pro-epileptogenic medications or with a history of sleep deprivation. The detailed analysis of clinical features evidences that the episode was a syncope rather than a seizure in two cases of four with recommended stimulation parameters (it is related to the case of generalized tonic clonic seizure in a patient with tinnitus at rTMS reported by Nowak in 2006) and in one case of four with the use of stimulation parameters exceeding the recommended ones. A recent review have shown that the risk of seizures in epileptic patients at rTMS is 1.4%. No cases of induced status epilepticus was reported in such patients. 4. Syncope Vasodepressor (neurocardiogenic) syncope is a common response to anxiety and psycho-physical discomfort. It is a common reaction that can occur both at magnetic stimulation and other noninvasive and minimally invasive procedures. In spite of the fact that syncope may occur more often in comparison with the induced seizures during the TMS, the risk of syncope occurrence is still rather low. 5. Local pain, headache, discomfort Most patients consider the single pulse stimulation to be painless. The pain intensity at rTMS depends on the individual susceptibility, scalp location, coil design, intensity and frequency of stimulation. In 2% of cases the pain intensity requires to discontinue the treatment. 6. Cognitive changes TMS can produce both positive and negative changes. Most of them do not result in any stable changes. 7. Acute psychiatric changes  Treatment-emergent mania

10

Description

 Anxiety  Agitation  Suicidal ideation  Insomnia In all cases described in the publications the acute psychiatric changes listed above were transient with the spontaneous resolution or were controlled with the use of pharmacological treatment. 8. Other biological effects 

The brain tissue heating at single pulse stimulation is very low and is less than 0.1°C by publication review. The closer is the coil to the stimulated tissue, the higher is the probability of tissue temperature increase. It may be important with infarction area tissues or cysts. However there is no significant tissue temperature change at TMS which is proved by clinical data evidencing the absence of hazardous effect of rTMS.



In spite of the reported possible hazardous effect of rTMS at the structural and cellular level of the brain (Matsumiya et al., 1992) reported microvascular changes in the neuropil portion of cortical layers II-VI in rats stimulated with 2.8 Tesla at 100 stimuli) no other experimental evidence of neuropathological damage of variable magnetic field to nervous tissues is obtained.



The effect of TMS on hormonal state is still being studied. Thus, some researchers (Bridgers, Delaney, 1989; Wassermann et al., 1996) reported a decline of prolactine in blood serum and no change in concentration of thyroid-stimulating hormone, follicle-stimulating hormone and cortisol after rTMS. Other studies (George, 1996; Szuba, 2001) have shown the transient increase of thyroid-stimulating hormone with other hormones of hypothalamopituitary system unaffected. Evers (2001) performed the placebo-controlled cross-over trial. The left dorsolateral prefrontal cortex was stimulated using rTMS stimuli of suprathreshold and infrathreshold intensity by 10 Hz and 20 Hz protocols. He reported the reliable moderate decrease of cortisol level and thyroid-stimulating hormone level only after the infrathreshold stimulation, the concentration of prolactine and follicle-stimulating hormone remained unaffected. Considering that cortisol and thyroid-stimulating hormone are released in stressful situations, the decrease of these hormones suggests a relaxing effect by this type of rTMS in healthy subjects. According to Padberg (2002) the plasma concentrations of neuroactive steroids were not affected by rTMS when using depression treatment protocol approved by FDA.



The effect of rTMS on neurotransmitters is described in some studies. Keck (2000) and Strafella (2001) reported on increased dopamine release in some brain areas including the hippocampus. Theoretically, such effect should induce the beneficial effect on parkinsonian symptoms, mania and other

11

Neuro-MS/D Technical Manual

abnormalities. The stimulation of the left dorsolateral prefrontal cortex (20 Hz, 20 min per day) may change cortical glutamate/glutamine levels not only close to the stimulation site but also in remote cortex areas (Michael, 2003). 10 Hz rTMS of left dorsolateral prefrontal cortex can modulate the tryptophan and 5-hydroxytryptamine metabolism in limbic areas in normal subjects without inducing behavioral changes (Sibon, 2007). 

The effect on the immune system is still studied. In few publications related to the after-effects of rTMS on immune system there are no data that rTMS may impact negatively to immune system.



The effect of rTMS on antonomic functions was reviewed in some studies. Thus, rTMS (500 ms, 20 Hz, 70-90% with maximum intensity) induced a short lasting increase in heart rate and blood pressure (Foerster, 1997). Udupa (2007) concluded the improvement of sympathovagal balance in patients with depression. Vernieri (2009) noted that rTMS may decrease the vaso-motorreactivity that should be taken into account when using rTMS to treat acute stroke patients.

Warnings and Precautions Read carefully the following warnings and precautions before starting to use NeuroMS/D magnetic stimulator. During rTMC session you must keep watching over the signs of seizure and terminate the treatment session if those signs appear. If patient has taken a medication that may alter the seizure threshold, detect the motor threshold before the treatment session start! The risk of seizure during rTMC session is increased in patients having history of convulsion including of unknown etiology, patients with epilepsy, head injuries, stroke, severe headache, neurological diseases that that may affect a seizure threshold altering and also patients taking tricycling antidepressants, neuroleptic agents and other epileptogenic drugs. During the treatment observe carefully the patients for clinical worsening of depression and suicidality. If the signs of worsening of depression and suicidality (behaviour) continue to appear, terminate the treatment with the use of Neuro-MS/D magnetic stimulator.

12

Description

Do not start working with stimulator before you have read this document! The stimulator must be used by the qualified medical personnel trained to operate on it and knowledgeable of magnetic stimulation application. During the work on the stimulator it is required to observe the working regulations concerning the safety rules while operating on electrical installations.

High voltages (1800V) are presented within the stimulator. To provide safety measures and exclude the hazard of medical staff’s or patient’s electric shock, the medical staff is PROHIBITED:  to use the stimulator which was mounted and installed incorrectly, without following this manual instructions;  to eliminate faults connected with opening of the components included in the delivery set;  to work with the stimulator when the electronic unit box, computer or other devices used together with the stimulator are open. Always check the stimulator and coils for the absence of cracks and other defects. Do not open and do not try to repair the electronic units of magnetic stimulator! Before the stimulation make sure, that there are no patient cables or electrodes connected to a patient and also metal parts contacting with a patient in impact area (within 5 cm and less from the coil) as far as the electromagnetic field can create the electrical current leaking through a patient.

Do not allow the coil to come into close proximity (less than 1 meter) with electronic equipment (monitor, computer, etc.) and also the magnetic carriers (credit cards, floppy disks, CD disks, audio recording tapes, hotel room keys, electronic automotive ignition keys, watches, etc.). The magnetic field emitted by the coil can result in its damage and information loss.

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Neuro-MS/D Technical Manual

It is prohibited to immerse the coil in water, ice or refrigerate to cool it off. Do not use Neuro-MS/D stimulator near water or other liquids. Do not place liquids on/near the case of magnetic stimulator, its cables and coils. It is prohibited to use cooled coils without cooling unit. It can cause coil surface overheating (even after the stimulation stop), patient’s burn and magnetic stimulator damage.

The stimulus evoked by the stimulator generates a loud click that can frighten a patient. Tell a patient about the stimulation start and give her/him the ear plugs.

Hearing protection is also advised for the clinical operator if he/she is located within 3 meters of coil during patient treatment.

The stimulator must not be used in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.

The operator must be protected from the continuous impact of the magnetic field. It is recommended to use the holder to fix the coil.

If the coil heats over 41°C, the magnetic stimulator stops the stimulation and indicates the overheating. As far as the coil temperature on its surface still grows even after the stimulation stop owing to the thermal lag, it is required to remove immediately the coil from the patient surface to avoid the patient’s burn and discomfort.

To protect a patient from excessive impact by the electromagnetic field, generate the minimal required number of pulses.

Keep out of the reach of children.

14

Description

It is recommended to replace the coil with a new one after a year of use.

Patient Safety The general principles of safety regulations are stated in:  “Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the safety of repetitive magnetic stimulation, June 5-7. 1996” by Eric M. Wassermann (accepted for publication: 23 May 1997).  “Safety of different inter-train intervals for repetitive transcranial magnetic stimulation and recommendations for safe ranges of stimulation parameters” by Robert Chen, Christian Gerloff, Joseph Classen, Eric M. Wassermann, Mark Hallet, Leonardo G. Cohen (accepted for publication: 23 May 1997).  “Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice.and research” by Simone Rossi, Mark Hallet, Paolo M. Rossini, Alvaro Pascual-Leone and The Safety of TMS Consensus Group (accepted for publication: 21 August 2009). The main issues to consider are intensity, frequency, train duration and intertrain interval (Table 2, Table 3 and Table 4).

a

Table 2. Table of safe train duration (s) of single trains of rTMS based on the NINDS experience Frequency (Hz)

Intensity (% of Motor threshold) 100

110

120

130

140

150

160

170

180

190

200

210

220

1

>1800

>1800

360

>50

>50

>50

>50

27

11

11

8

7

6

5

>10

>10

>10

>10

7.6

5.2

3.6

2.6

2.4

1.6

1.4

1.6

1.2

10

>5

>5

4.2

2.9

1.3

0.8

0.9

0.8

0.5

0.6

0.4

0.3

0.3

20

2.05

1.6

1.0

0.55

0.35

0.25

0.25

0.15

0.2

0.25

0.2

0.1

0.1

25

1.28

0.84

0.4

0.24

0.2

0.24

0.2

0.12

0.08

0.12

0.12

0.08

0.08

a) Based on Wassermann et al. (1996), [6] and Rossi et al. (2009), [4].

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Neuro-MS/D Technical Manual Table 3. Safety recommendations for inter-train intervals for 10 trains of rTMS at < 20 Hz Inter- train interval (s)

Stimulus intensity (% of MT) 100%

105%

110%

120%

5

Safe

Safe

Safe

Insufficient data

1

Unsafe (3)

Unsafe

a

Unsafe (2)

Unsafe (2)

a

Unsafe (2)

Unsafe (3)

a

0.25

Unsafe

Unsafe

a)

These stimulus parameters are considered unsafe because adverse events occurred with stimulation of lower intensity or longer inter-train interval, but no adverse event was observed with these parameters. Table 4. Parameter safety issues: commonly employed stimulation parameters rTMS frequency

No. of studies

4-9Hz

>10

Variable

Variable

Variable

10 Hz

>50

5-6 pulse-trains for 400-500 ms

3,2 s

250

20-25 Hz

>20

10 pulse-trains for 400-500 ms

17,1 s

80

a)

16

Average train duration

Based on Rossini P.M. et al. (1994) [5].

Average inter-train interval

Average no. of trials

Description

1.

Description 1.1 Main Specifications Table 5. Main Specifications

Parameters

Values

Stimulation Parameters Pulse duration:  standard biphasic

250–330 µs

Maximum frequency at maximum power  without extra power unit  with extra power supply unit

1

5 Hz 1 20 Hz Power Supply

Supply voltage

(22022)/(23023) V 50 or 60 Hz

Maximum power consumption during the stimulation:  main unit  cooling unit  extra power supply unit

≤1000 V·A ≤1000 V·A ≤3000 V·A

Trig-in/out Trig-in

TTL/CMOS

Trig-out

TTL/CMOS

Trig-in pulse width

≥ 200 µs

Stimulus delay relative to trig-in signal

100...200 µs

Trig-out pulse width (user-defined)

10 µs…50 ms

General Specifications and Parameters Interface

USB

Safety

I

Work parts Cooling unit tank volume while filling up to the maximal level Type of cooling agent Ingress protection

BF type 3.5 l Silicone oil 5 cSt IP20

Operation temperature

(10–35)º C

Relative air humidity

≤80%

Dimensions:  main unit  cooling unit  extra power supply unit

460215520 mm 470215520 mm 360170520 mm

depends on coil type. The data is given for RC-02-150 coil.

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Neuro-MS/D Technical Manual

Table 5. Continued

Parameters

Values

Weight:  main unit  cooling unit filled with cooling agent  extra power supply unit

not more than 24 kg not more than 27 kg not more than 12 kg

Cooling agent pressure in coil while cooling unit operating

not more than 0.15 MPa

Table 6. Range of Controlled Parameters and Frequency Step Parameter

Range of Permissible Values

Frequency Step

Stimulation Parameters Stimulation frequency in repetitive stimulation mode

(0.1–30) Hz (Stand-alone mode) (0.1 – 100) Hz (PC mode)

0.1 Hz (0.1 -10 Hz)

50 – 100 Hz (PC mode)

1 Hz

Pulse train duration range

(0.5 – 100) s

0.5s (0.5-9.5 s) 5s (10-100 s)

Inter-train interval range

(0 – 300) s

0.5s (0-29.5s ) 1s (30-100 s)

Session

(0.5-40) min

0.5 min

Stimulation frequency in burst* mode

1 Hz (10-100 Hz)

Capacitor Charge Control Delay for the capacitor charge start (analysis epoch)**

(0–9.90) s

0.01 s (0–0.99 s), 0.1 s (1.00–9.90 s)

10 µs, 1 ms–50 ms

1 ms

Trig-out Trig-out pulse width

*The burst mode is available only if you use Neuro-MS.NET software. **To avoid the noise impact from the power supply while joint operation with EMG equipment during the response acquisition, the delay of capacitor charge start is provided in single pulse mode.

18

Description

The FDA recommended parameters for Major Depressive Disorder treatment are listed in Table 7. Table 7. Recommended treatment parameters Parameters Magnetic field intensity

Values 120% of the MT

Frequency

10 Hz

Train duration

4 sec

Inter-train interval

26 sec

Number of trains

75

Magnetic pulses per session

3000

Treatment session duration

~ 37.0 min

Sessions/wk

5

Treatment schedule Area of brain to be stimulated

5 daily sessions for 6 weeks Frontal Cortex

The specifications of coils are provided in the Technical Manual “Coils for NeuroMS/D and Neuro-MS Magnetic Stimulators”.

Table 8. Dependence of Maximal Stimulus Amplitude on Stimulation Frequency While Working with/without Extra Power Supply Unit with Use of RC-02-150 Big Ring Coil Stimulation Frequency, Hz

Maximum Power Without Extra Power Supply Unit

With Extra Power Supply Unit

5

100%

100%

10

69%

100%

15

53%

100%

20

43%

100%

25

37%

89%

30

30%

79%

Safety and Electromagnetic Compatibility Electromagnetic compatibility (EMC) is ensured by conformance to International standard IEC 60601-1-2:2007 requirements. The magnetic stimulator is intended for operation in electromagnetic environment, as specified in the Annex 0. As for safety, magnetic stimulator complies with IEC 60601-1:2005 requirements, it is referred to class I and has BF type work parts complying with IEC 60601-1:2005 requirements.

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Neuro-MS/D Technical Manual

1.2 Delivery Set The delivery set includes the electronic units with the set of coils and cables. The delivery set of the stimulator corresponds to Table 9 and Table 10. The figures in “Quantity, pcs.” column of Table 9 and Table 10 indicate: 1 - Neuro-MS/D magnetic stimulator (configuration 1 – diagnostic). 2 - Neuro-MS/D magnetic stimulator (configuration 2 – therapeutic). 3 - Neuro-MS/D magnetic stimulator (configuration 3 – advanced therapeutic). The assembled stimulator (configuration 3) is shown in Fig. 1.

Fig. 1. Assembled magnetic stimulator.

1

20

Cooled angulated figure-of-eight coil 100 mm AFEC-02-100-C (the cooled coil is used together with the cooling unit);

Description

2

Flexible arm for coil positioning К-3;

3

Trolley with custors for magnetic stimulator (4 shelves);

4

Touchscreen computer (is not included in the delivery set);

5

Main unit;

6

Cooling unit;

7

Extra power supply unit;

8

Coil holder (trolley/wall mounted) K-8.

Table 9. Base Delivery Set

Order code or main specifications

Name

Quantity, pcs. 1

2

3

Main unit

NS058201.014-020

1

1

1

Cooling unit

NS058201.017-020

–

1

1

Extra power supply unit

NS058201.016-020

–

–

1

NS058105.002

1

1

1

NS058213.001 NS058213.001-01

– –

10 10

10 10

NS058998.005

–

1

1

Big ring coil 150 mm RC-02-150

NS058304.002

1

–

–

Small ring coil 100 mm RC-02-100

NS058304.001

1

–

–

Figure-of-eight coil 100 mm FEC-02-100

NS058304.013

1

–

–

Cooled angulated figure-of-eight coil 100 mm AFEC-02-100-C

NS058304.012

–

1

1

NS058214.001

–

2

2

Control cable for Neuro-MS/D cooling unit

NS058103.070

–

1

1

HV (high-voltage) cable for extra power supply unit connection to Neuro-MS/D

NS058103.102

–

–

1

Equipotential cable

NS058103.032-050

–

1

2

IEC C13 – IEC C14 mains supply cable (to connect cooling unit)

220 V, 10 A, 1,8 m (3G×0.75 sq.mm.)

–

–

1

СЕЕ 7/7 – IEC C13 mains supply cable

220 V, 10 A, 1,8 m (3G×0.75 sq.mm.)

1

2

2

NS007103.005

1

1

1

End cap Patient cap:  size 42-54  size 54-66 Silicone oil Coils:

Hydraulic system adapter Cables:

USB cable (A→B)

21