Dräger Oxylog 3000 plus - Mandatory Reporting of Adverse Events

Instructions for use Oxylog 3000 plus SW 1.n 11
For your safety and that of your patients
– IEC 60601-1-8
Medical electrical equipment
Part 1-8: General requirements for safety
Collateral standard: General requirements,
tests and guidance for alarm systems in
medical electrical equipment and medical
electrical systems
If a device combination is not approved by Dräger,
proper operation of the devices can be
compromised.
The operator must ensure that the device
combination meets the applicable standards.
Strictly observe instructions for use and assembly
instructions of all connected devices.
Mandatory reporting of adverse events
Serious adverse events with this product must be
reported to Dräger and the responsible authorities.