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1
Safety information definitions
Warning
A WARNING statement provides important information about a potentially hazardous situation which, if
not avoided, could result in death or serious injury.
Caution
A CAUTION statement provides important information about a potentially hazardous situation which, if
not avoided, may result in minor or moderate injury to the user or patient or in damage to the medical
device or other property.
Note
Provides additional information.
2
Definition of target groups
For this product, users and service personnel are defined as target groups.
These target groups must have the necessary training and knowledge to use, install, reprocess, or maintain the
product.
The product must be used, installed, reprocessed, or maintained exclusively by defined target groups.
2.1
Users
Users are persons who use the product in accordance with its intended use.
2.2
Service personnel
Service personnel are persons who are responsible for the maintenance of the product.
Service personnel must be trained in the maintenance of medical devices and install, reprocess, and maintain the
product.
3
For your safety and that of your patients
3.1
General safety information
The following WARNING or CAUTION statements apply to general operation of the medical device. WARNING or
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.
3.2
Strictly follow these instructions for use
Warning
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 purpose specified under Intended use
on page 45. Strictly observe all WARNING or CAUTION statements throughout these instructions for use
and all statements on medical device labels. Failure to observe these safety information statements
constitutes a use of the medical device that is inconsistent with its intended use.
Maintenance
3.3
Caution
Risk of medical device failure and of patient injury.
The medical device must be inspected and serviced regularly by service personnel. If the above is not
complied with, medical device failure and patient injury may occur. Observe chapter Preventive
maintenance / repair.
Accessories
3.4
The manufacturer only assumes responsibility for the safety, reliability and usability of the device if original devices or
original spare parts are used and only authorized persons repair the device. The statutory warranty period shall apply.
In case of a warranty claim, please contact your authorized specialist dealer.
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