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:
- Main unit of the magnetic stimulator
- Cooling unit
- Extra power supply unit
- Cooled figure-of-eight coil FEC-02-100-C
- Cooled figure-of-eight coil AFEC-02-100-C
- Figure-of-eight coil FEC-02-100 (optional)
- Figure-of-eight coil AFEC-02-100 (optional)
- K8 coil holder
- K3 flexible arm for coil positioning
- Trolley with casters
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.
3. Recommended standard treatment
| 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
5. Machine dimensions & weight
Each CloudTMS module is W24 x D24 x H12 and the cart built is W28 x D28 x H44.
The weight of the machine including the cart is approximately 215 lbs.