8 2 Warnings, cautions and notices
fabian +nCPAP evolution | SW V5.1.x
Ref: 122003.EN / Date : 26Jan2021
2.2 Maintenance
The fabian +nCPAP evolution device is a ventilator classified as Class IIb (for prolonged use more
than 24 hours and less than 30 days) according to the European Medical Device Directive, as
such:
• Inspection according to manufacturer specifications is required every 12 months.
• Maintenance must be performed by ACUTRONIC Medical Systems trained personnel with
access to appropriate test and measuring equipment.
ACUTRONIC Medical Systems AG representatives are strongly recommend for service
agreements and repairs.
Only use original ACUTRONIC Medical Systems parts for repairs.
Note chapter ”14: Ventilator service and maintenance intervals”.
2.3 Liability for functionality / damages
In the event of improper equipment maintenance or repair by any person not associated with
ACUTRONIC Medical Systems AG Service or improper use, any and all liability for the
functionality is transferred to the owner or operator.
ACUTRONIC Medical Systems AG assumes no liability for damages caused by the non-
observance of preceding notices. The preceding notices do not extend the warranty and liability
terms of the ACUTRONIC Medical Systems AG sales terms and delivery conditions.
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