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Technical Specifications

Specification summary for the CloudTMS machine


1. Description

The CloudTMS machine is a repetitive transcranial magnetic stimulation (rTMS) system. This computerized medical device produces non-invasive, repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex for the treatment of Major Depressive Disorder.

The CloudTMS machine principle of operation is based on the discharge of high voltage capacitor (1.8 kV) through a stimulation coil; the pulsed magnetic field generated by the discharge current (up to 10 kA) penetrates through neuromuscular tissues nearby to induce electrical currents in cortical neurons.

The CloudTMS machine consists of the following main components:


2. Intended use

The CloudTMS system is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.


Magnetic field intensity 120% Motor threshold
Frequency 10Hz
Train duration 4 sec
Inter-train interval 11 sec
Number of trains 75
Magnetic pulses per session 3000
Treatment session duration ~19 min
Sessions/week 5
Treatment schedule 5 daily sessions for 6 weeks
Area of brain to be stimulated Frontal cortex

4. Coils

Coils (including optional accessories) FEC-02-100-C, AFEC-02-100-C FEC-02-100 (optional), AFEC-02-100 (optional)
Configuration Figure-of-eight coil
Core material Air core
Cooling FEC-02-100-C & AFEC-02-100- C: Liquid cooling
FEC-02-100 & AFEC-02-100
Optional accessories: None
Coil parameters FEC-02-100-C Inner diameter – 47×50 mm1
Outer diameter – 97×100 mm1
Area = 184725 mm2
Average Inductance 10 μH
Flat spiral winding
N = 16 (4 turns/wing x 2 wings x 2 layers)

AFEC-02-100-C Inner diameter – 36×51 mm1
Outer diameter – 84×106 mm1 Area = 184725 mm2
Average Inductance 10 μH Flat spiral winding
N = 16 (4 turns/wing x 2 wings x 2 layers)

FEC-02-100 Inner diameter – 47×50 mm1
Outer diameter – 97×100 mm1 Area = 91560 mm2
Average Inductance 10 μH Flat spiral winding
N = 16 (4 turns/wing x 2 wings x 2 layers)

AFEC-02-100 Inner diameter – 36×51 mm1
Outer diameter – 84×106 mm1 Area = 87200 mm2
Average Inductance 10 μH Flat spiral winding
N = 16 (4 turns/wing x 2 wings x 2 layers)

5. Machine output parameters

Amplitude in Standard Motor Threshold (SMT) units FEC-02-100-C 0 – 1.89 AFEC-02-100-C 0 – 2.38
FEC-02-100 0 – 1.92
AFEC-02-100 0 – 2.33
Waveform Biphasic sinusoid
Active pulse width (μs) 280
Max initial dB/dt (kT/s) near the coil surface FEC-02-100-C 25
AFEC-02-100-C 38
FEC-02-100 25
AFEC-02-100 32
The system will automatically be disabled when the coil temperature
exceeds:
41 C (106 F)
Frequency range (Hz) 0.1 – 30 (Stand-alone)
0.1 – 100 (with PC)
Pulse train duration range(s) 0.5 – 100
Inter-train interval range (s) 0 – 300
Maximum trains per session 4800 = 2400 s [max session] / (0.5 s [min train]+ 0 s [min pause])
Maximum number of pulses per session 72,000(Stand-alone) = 2400 s [max session] *30 Hz 240,000(with PC) = 2400 s [max session] *100 Hz
Electrical safety Complies with AAMI/ANSI ES 60601-1:2005/(R)2012 and IEC 60601-1-2
ISO Standards met Company complies with DIN EN ISO 13485: 2012
ISO 10993-1: 2009
ISO 14971: 2007


Fig.1 – Coil for magnetic stimulator

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