Safety Prescriptions; In General; Warnings Concerning Installation, Maintenance And Regular Inspections - easytech Isokinetic Genu Iso User Manual

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2. SAFETY PRESCRIPTIONS

2.1 IN GENERAL

These devices have been designed in compliance with current laws and standards.
However, the safety of patients and operators can be guaranteed only if the instructions
concerning installation, warnings and regular inspections are duly followed. The
following paragraphs illustrate in detail the warnings and prescriptions that must be
followed, grouped by specific topics.
The device must to be used by qualified personnel only
2.2 WARNINGS CONCERNING INSTALLATION, MAINTENANCE AND REGULAR
INSPECTIONS
The installation site must be fitted with an electric system that is compliant with
the requirements of current standards.
ATTENTION: to prevent the risk of electrical shocks, these devices must be
connected to grounded power supplies only. The devices are fitted with a
connection for the equipotential node of the room in which they are installed. The
manager of the center where the device is installed must regularly verify that this
connection is not damaged.
Verify that the rating of the power supply matches the requirements printed on the
device nameplate.
Before installing the device, verify that the packaging and its content are not
damaged.
Only use the power cord supplied with the device or, in all cases, the spare power
cords supplied by Easytech. Although it is possible to purchase similar cable that
offer good performances, their characteristics are not suitable to guarantee the
compliance with standards according to which the device has been manufactured.
In particular:
➢ The lead section of the cable network must be at least 1mmq.
The length of mains cable must NOT be greater than 2m.
Leads with an insufficient section or an excessive length or both do not guarantee
the safety of the electrical components.
As quoted in standard EN 60601-1-2 regarding electromagnetic compatibility: "the
use of cable other than those specified in ....... may increase emissions and reduce
the immunity of the device".
Do not use adaptors, multiple sockets or extensions to connect the device to the
mains.
Do not place heavy or sharp objects above the power cord in order not to damage
it.
Do not place the device next to heat sources or expose it to direct sun light. Install
the device in an adequately ventilated room.
Do not install the device in rooms with rapid temperature excursions or where
humidity, dust, chemical vapors and vibrations are present.
For information concerning electromagnetic interferences, refer to following
paragraphs.
electromagnetic interferences (like portable or mobile radio-communication
devices or medical devices that generate electromagnetic energy for therapeutic
Easytech s.r.l. – Genu Iso/Plus User's Manual
Avoid
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