Description; Warning And Safety Instructions; Compliance - Kinetec Centura B&W Manual De Empleo

Description

Warning and safety instructions

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Compliance:

The device Kinetec Centura B&W™ meets the requirements of the Medical Directive No. 93/42/EEC. It bears the EC mark.
The device Kinetec Centura B&W™ complies with the standards in force: IEC 60601-1-2 concerning the electromagnetic
compatibility of medical devices, IEC 60601-1 concerning electrical safety and IEC 60601-1-11 concerning the utilisation in home
care environment.
The device Kinetec Centura B&W™ meets the requirements of the Machinery Directive No. 2006/42/EC.
Kinetec Centura B&W™
The machine must be installed and commissioned according to the information provided in this
manual.
If you need any assistance in the assembly, use or maintenance of the device, please contact
your Kinetec distributor.
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The practitioner determines the protocol and ensures its proper implementation (settings, session
duration and frequency of use).
Run a cycle with the device unloaded before installing the patient on the machine.
For optimum safety, always give the hand control to the patient before starting the system. The
patient must know the start/stop/reverse function on the hand control (see page 9).
To avoid the parameters being changed, lock the machine's hand control before giving it to the
patient.
Danger, risk of explosion: Do not use the machine with anaesthetic gas or in an environment that
is rich in oxygen.
For Type B Class I devices, and to avoid all risks of electric shock, the machine should only be
connected to a power supply that has protective earthing, see page 8.
Before using this machine, always check that the electrical socket is in good condition and is
suitable for the splint power supply cord. Only use the original cable supplied with the machine.
Check that the cables remain free around the device so that they do not get damaged.
Before using this machine, always check that the machine is not damaged, in particular the
protective housings.
In case of electromagnetic interference with other devices move the device.
Please do not touch the fixed or moving parts while the unit is running: pinching or crushing risk.
Keep children and pets away from the machine.
Modifying the machine in any way is strictly forbidden.
Always check the motion parameters displayed on the hand control before starting the device.
Only the accessories, spare parts and supplies described in this manual should be used with this
machine.
Do not connect the device to other devices not described in this manual.
If unforeseen events or malfunctions occur, please contact your Kinetec
Before each use, always check that the various locking knobs have been tightened (see pages 6
and 7).
Wireless communications devices, such as domestic wireless devices in networks, mobile
phones, wireless telephones and their base stations and walkie-talkies, may affect the machine.
You are recommended to keep at least a distance d between these devices and the machine.
See the table on page 24.
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distributor.
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