Standards; Standardized Symbols; Technical Specifications - CefarCompex Mi-Theta 600 Manual Del Usuario

6 - Standards

CefarCompex Mi Theta 600/Theta 500 is
designed for use by health profession-
als and as such complies with relevant
medical standards and regulatory
requirements.
To guarantee your safety, CefarCom-
pex Mi Theta 600/Theta 500 has been
designed, manufactured, and distributed
in compliance with the requirements of
the European Directive 93/42/EEC on
medical devices.
CefarCompex Mi Theta 600/Theta 500
also complies with the IEC 60601-1
standard on general safety requirements
for medical electrical devices, the IEC
60601-1-2 standard on electromagnetic
compatibility, and the IEC 60601-2-10
standard on particular safety require-
ments for nerve and muscle stimulators.
CefarCompex Mi Theta 600/Theta 500
also complies with Directive 2002/96/
EEC on waste electrical and electronic
equipment (WEEE).

7 - Standardized symbols

Read the operating instructions before
use.
CefarCompex Mi Theta 600/Theta 500
is a class II device with internal electric
power and type BF applied parts.
Waste electrical and electronic equip-
ment (WEEE) marking according to EN
50419 standard.
0473
In compliance with the requirements of
the European Directive 93/42 EEC on
medical devices.

8 - Technical specifications

A) General information
Battery 941213: Nickel metal hydride
(NiMH) rechargeable battery
(4.8 V, 2000 mAh).
Battery chargers: Only battery chargers
bearing the following information can be
used to recharge the batteries supplied
with MiTheta 600/Theta 500 stimulators.
Europe
683010
Type TR1509-06-E-133A03
Input 90-264 VAC /47-64 Hz/0.5 A max.
Output 9 V/1.4 A/15 W
UK
683012
Type TR1509-06-U-133A03
Input 90-264 VAC /47-64 Hz / 0.5 A max.
Output 9 V/1.4 A /15 W
B) Neurostimulation
All electrical specifications are given
for an impedance of 500-1000 Ohm per
channel.
Channels: Four individually adjustable
channels that are electrically isolated
from each other and earthed.
Impulse shape: Constant rectangular
current with pulse compensation to
eliminate any direct current component
to prevent residual polarization at skin
level.
Maximum pulse intensity: 120 mA
Pulse intensity increments: Manual
adjustment of stimulation intensity: 0-
999 (energy units) – Minimum increment:
0.5 mA
Pulse width: 30 to 400 microseconds
Maximum electrical charge per pulse: 96
microcoulombs (2 x 48 μC, compensated)
Standard pulse ramp-up time: 3 micro-
seconds (20%-80% of maximum current)
Pulse frequency: 1-150 Hz.
ENG
7