Introduction; T Care Compact Intended Use; Applied Standards - easytech T CaRe Compact User Manual

1. INTRODUCTION

1.1 T CaRe Compact intended use

T CaRe Compact
is a device for
the area of physical rehabilitation; it is an active therapeutic medical device class IIb
(according to the definitions of Directive 93/42/EEC, as amended in accordance with the
Directive 2007/47/EC).
It is a device to be used under medical supervision.
T CaRe Compact
With
origin), bruising, muscle or joint injuries and to perform analgesics and myorelaxant
treatments.
The results achievable with the use of
vascularization in the treated area with consequent acceleration of the recovery processes,
increased lymphatic drainage, reduction of inflammatory states.
T-Care Compact
Operation of
the use of endogenous energy, which is achieved through the recall in the area to be treated
of electrical charges (ions) present in the tissues.
The adopted model of reference is that of the condenser, in fact, T-Care operates on the
basis of technologies that use a generator at a frequency between 400 and 1000 KHz
connected to a movable electrode and a reference electrode, which make up the two
armatures of the condenser, among which the biological tissue is interposed becoming an
electrical conductor of the second class. The energy supply provided by the generator
produces a concentration of electrical charges in the most resistive points (the less
vascularized ones) of the tissue, hence involving the muscles, bones, tendons and ligaments.
The interaction caused determines bio-stimulation as an increase in energy transformations
(ATP production) and oxygen consumption that activate the arterial and lymphatic
microcirculation, as well as an increase of endogenous temperature with consequent
dilation of blood vessels and increase in flow blood.

1.2 Applied standards

The device T CaRe Compact is made in accordance with Directive 93/42/EEC and
subsequent amendments, applying the current version of the standards listed below:

EN 60601-1:
Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance
With reference to this Norm, the device is classified as Class I Type BF applied part;

EN 60601-1-2:
Medical electrical equipment. Part 1: General requirements for basic safety and
essential performance – Collateral standard:
Requirements and tests.

EN 60601-1-6:
Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance - Collateral standard: Usability

EN 60601-2-6:
Medical electrical equipment - Part 2: Particular requirements for the basic safety and
essential performance of microwave therapy equipment

EN 62304:
Medical device software – Software life-cycle processes
Easytech s.r.l. – User Manual T CaRe Compact
capacitive
-
it is possible to treat arthritis, edema (traumatic or inflammatory
T CaRe Compact
is based on the principle of energy transfer obtained through
resistive diathermy
are: analgesic effect, increased
Electromagnetic compatibility –
rev. D
endothermy)
( to be used in
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