For Your Safety And That Of Your Patients; General Safety Information; Mandatory Reporting Of Adverse Events; Strictly Follow These Instructions For Use - Dräger Infinity Acute Care System Instructions For Use Manual

For your safety and that of your patients

General safety information

The following WARNING and CAUTION
statements apply to general operation of the
medical device.
WARNING and CAUTION statements specific to
subsystems or particular features of the medical
device appear in the respective sections of these
instructions for use or in the instructions for use of
another product being used with this device.

Mandatory reporting of adverse events

Serious adverse events with this product must be
reported to Dräger and the responsible authorities.

Strictly follow these instructions for use

WARNING
Risk of incorrect operation and of incorrect
use
Any use of the medical device requires full
understanding and strict observation of all
sections of these instructions for use. The
medical device must only be used for the pur-
pose specified under "Intended use"
on page 16.
Strictly observe all WARNING and CAUTION
statements throughout these instructions for
use and all statements on medical device
labels. Failure to observe these safety infor-
mation statements constitutes a use of the
medical device that is inconsistent with its
intended use.
8 Instructions for use - Infinity

Maintenance

WARNING
Risk of medical device failure and of patient
injury
The medical device must be inspected and
serviced regularly by service personnel.
Repair and complex maintenance carried out
on the medical device must be performed by
experts.
If the above is not complied with, medical
device failure and patient injury may occur.
Observe chapter "Maintenance".
Dräger recommends that a service contract is
obtained with Dräger-authorized service per-
sonnel and that all repairs are performed by
Dräger-authorized service personnel. For
maintenance Dräger recommends the use of
authentic Dräger repair parts.
NOTE
Dräger will submit all documents needed for repair
on request.

Accessories

WARNING
Risk due to incompatible accessories
The use of incompatible accessories may ad-
versely affect the functional integrity of the
product. Personal injury and property damage
may occur as a consequence.
Use only compatible accessories. The acces-
sories that are compatible with this product
are listed in the list of accessories supplied
with the product.
® Acute Care System - Infinity ® Medical Cockpits