IGEA OSTEOSPINE User Manual page 29

IGEA
IGEA
The methods and type of signal used have been subjected to intensive studies at an international level,
which have demonstrated their therapeutic effectiveness and the complete absence of any adverse
effects.
6. MANUFACTURER'S RESPONSIBILITY
IGEA considers itself responsible for the safety, reliability and performance of OSTEOSPINE providing
that:
- The appliance is used in accordance with the instructions for use as indicated in the present
manual;
- Any modifications or repairs are made only by personnel authorized by IGEA;
- The appliance is neither opened nor tampered with by the user or unauthorized persons;
- The battery is charged with battery chargers exclusively of models of approved type as those
supplied;
- The battery charger is used solely for the charge of the OSTEOSPINE battery according to the
instructions provided in this manual;
- The electrodes used are solely those supplied or of type and dimensions as specified by the
manufacturer.
- The user regularly perform the operating parameters check recommended by IGEA.
For any other information or updates the user may contact the manufacturer itself:
Manufacturer:
IGEA S.pA. Via Parmenide 10/A 41012 Carpi (MO) ITALY
Tel. +39 059 699600 Fax. +39 059 695778 e-mail:
7. TECHNICAL DETAILS
OSTEOSPINE complies with MDD 93/42 EEC and subsequent amendments and is
under the control of IMQ.
OSTEOSPINE has a expected lifetime of five years.
OSTEOSPINE Generator
Model
Voltage
Max. absorbed current
Classification according to EN 60601-1
Classification according to MDD 93/42 EEC
Method of use: Appliance for continuous function not to be used in the presence of anaesthetic
mixtures which are inflammable on contact with air, oxygen and nitrous oxide. Appliance powered by
internal electrical power source (rechargeable power battery). Equipment not protected against the
penetration of liquids. The device remains safe after the proof required for the degree IP22.
Electrode piloting signal features: Sinusoidal signal with impulse train and activity time of 40 msec
followed by a pause time of 40msec
Maximum range
Maximum electrode output current
Therapeutic signal frequency
Electrode piloting frequency
Duty Cycle (operational time)
Charge Impedance validity field
The impedance validity range indicates the minimum and maximum values of the stimulator charge
impedance which does not produce any alterations to the signal parameters of over ± 30% as compared
to the nominal values.
OSTEOSPINE – User Manual
info@igeamedical.com
: OSTEOSPINE
: 9VDC
: 0,010 A
: Class II with Applied Part of Type BF
: IIa
: 20 Vpp (effectively 7V)
: 1500µA (effective value)
: 59 KHz ± 5%
: 12,5 Hz (80 msec)
: 50% (40 msec)
: Min. 500 ohm - Max. 7000 ohm (at nominal frequency)
OSTEOSPINE – User Manual EN
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