Safety
7990087_030_03 – 2080492 – 2023-01-19 17
Instructions regarding the proper handling of the medical device
must be provided. However, training is not required when the
medical device is self-explanatory or instructions for a product
with the same design have already been provided.
Interconnected medical products, as well as those combined with
accessories, including software or other objects, may be operated
and used only if they are suitable for use in this combination,
taking into account their intended purpose and the safety of
patients, users, employees or third parties.
Before the medical device is applied, the user must ensure that the
product is operational and in an appropriate state and the user
must further have read the instructions for use as well as other,
attached, safety-relevant information and maintenance
instructions.
The instructions for use and the instructions provided with the
medical device must be stored in a way that ensures that the user
can access the information required for using the medical device
at any time.
The user and/or the patient must report any serious incidents
related to the use of the medical device to the manufacturer and
the relevant authorities of the member state of which the user
and/or the patient is a resident.
2.5 Malfunction caused by other devices
There are no known functional failures of the surgical light due to
other devices.
2.6 What to do in the event of a malfunction
In the event of a failure of the electrical functions of the surgical
light, the surgical light is to be disconnected from the power
supply and the Technical Customer Service notified.
2.6.1 Failure of the surgical light electrical functions
According to current state-of-the-art technology, failure of the
surgical light cannot be completely ruled out, with the result that
the electrical functions on the operating table are no longer
available. In this rare case, stop using the surgical light and notify
the Technical Customer Service.
2.7 Information notices
2.7.1 Safety instructions
– The information notices on the product provide information
about residual dangers during use, or provide additional useful
information.
– The device label and all information notices must be present
and be undamaged in the prescribed locations on the product.
A damaged, illegible or missing device label / information
notice must be replaced immediately.
– Observe the information notices on the product.
– The information notices must not be altered or removed.
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