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3.
Safety-related information
3.1.
General safety-related information
All serious incidents related to the device must be reported to the manufacturer and the competent authority of the Member State where the user and/or the patient
is resident.
3.2.
Safety instructions
Assembly, modifications or repairs may only be carried out by authorised qualified personnel who guarantee compliance with the EN 60601-1 standard (international
standard on Medical Electrical Equipment and Systems, in particular part 1: General requirements for basic safety).
The electrical installation must comply with the regulations of the IEC (International Electrotechnical Commission).
Medical devices should be handled with care with regard to electromagnetic compatibility. Special safety measures must therefore be taken.
The device is not suitable for operation in explosive areas or in flammable atmospheres.
3.3.
Warnings
Danger
Warning of a danger that will directly result in serious injury or death
Warning of a danger that can result in serious injury or death
Warning
Caution
Warning of a danger that can result in minor injury
Attention
Warning of a danger that can result in extensive damage to property
Safety-related information
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EN
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