Side Effects; Contraindications; Reporting Serious Incident - Fresenius Medical Care T688 Series Instruction Manual

FRESENIUS MEDICAL CARE
1.3

Side Effects

None
1.4

Contraindications

There is no absolute contraindication for medical treatment chairs. But limitation of use in patients
with history of:
•
Allergy to covering material of chairs
•
Pressure sores
1.5

Reporting Serious Incident

Any serious incident that has occurred in relation to this medical device shall be reported to the
manufacturer and local health authority in accordance with the local regulations.
Within the EU the user must report any serious incident that has occurred in relation to the device
to the manufacturer according to the labelling
state in which the user is established.
Refer to section 5 for Manufacturer's contact information.
MEDICAL TREATMENT CHAIR
and the competent authority of the EU member
INSTRUCTION MANUAL - T688 Series
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IFU T688 EN V7 Apr 2021