Safety And Warning; Serious Incidents; Observing Ambient Condition; Combination With Other Components - Storz IMAGE1 S CONNECT Instructions For Use Manual

3 Safety and warning

WARNING
Danger due to non-observance of warnings and safety notes
This chapter contains warnings and safety notes structured according to hazards and risks.
1. Carefully read and observe all warnings and safety notes.
2. Follow the instructions.

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 condition

If the device is operated in an environment which is not suitable, patients, users and third
parties may be injured.
Always store and operate the product in the prescribed ambient conditions.

3.3 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.
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 normal use of the product.
Do not modify this equipment without authorization of the manufacturer.
3.4 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.
Instructions for use • IMAGE1 S • 705LZA_EN_V2.1_05-2022_IFU_FDA
Safety and warning
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