Storz IMAGE1 PILOT - Safety; Serious Incidents; Observing Ambient Conditions; Damage Due to Ingress of Liquid in Electrical Components

Safety
Instructions for use • IMAGE1 PILOT • HLI417_EN_V2.0_11-2021_IFU_CE-MDR 7
3 Safety
3.1 Serious incidents
A ‘serious incident’ includes incidents which, directly or indirectly, had, could have had or
could have any of the following consequences:
– Death of a patient, user, or another person
– Temporary or permanent serious deterioration in the medical condition of a patient, user,
or another person
– A serious threat to public health
The manufacturer and appropriate authority must be notified of all serious incidents.
3.2 Observing ambient conditions
If the device is stored, transported, operated or reprocessed under unsuitable conditions,
patients, users or third parties may be injured and the device can be damaged.
Observe the ambient conditions listed in the instructions for use and reprocessing.
3.3 Damage due to ingress of liquid in electrical
components
In the case of electrical products, individual components or the product itself may be live.
Liquid ingress into an electrical product may result in a short circuit or an unintentional transfer
of current. The product is damaged as a result and patients, users and third parties may be
injured.
Do not store liquids near the product or on the product.
If liquid has entered the product, pull out the plug and allow the product to dry completely.
3.4 Combination with other components
The use of unauthorized devices and components or unauthorized changes to the product can
result in injuries.
Additional devices connected to electrical medical equipment must comply with the relevant
IEC or ISO standards. Furthermore, all configurations must comply with the requirements for
medical electrical systems (see clause 16 of IEC 60601-1).
Only combine the product with devices and components that are approved for combined
use by the manufacturer.
Only use devices and components that have standardized interfaces and do not breach
the intended use of the product.
Observe the instruction manuals and interface specifications of the devices and
components used in combination.
Comply with national and local regulations.
Only make changes to the product if these changes are approved by KARLSTORZ.
3.5 Failure of devices
The product may fail during use.
Have a replacement product ready for each application.