Warning And Safety Instructions; Compliance - Kinetec Breva User Manual

5. Warning and safety instructions

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6. Compliance

The device KINETEC
EC mark.
The device KINETEC
electromagnetic compatibility of medical devices and IEC 60601-1 concerning electrical safety.
The device KINETEC
Breva
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.
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 7.
To avoid the parameters being changed, lock the machine's hand control
before giving it to the patient, see page 7.
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 6.
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
distributor.
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 20.
Breva complies with the standards of Directive 93/42/EEC, and bears the
®
Breva complies with the standards in force (IEC 60601-1-2) concerning the
®
Breva meets the requirements of the Machinery Directive No. 2006/42/EC.
®
EN 3/20