B.Braun Aesculap PV481 Mode D'emploi/Description Technique page 6

Aesculap
2D camera heads PV481, PV482, PV485
Risk of injury due to electric shock!
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When installing a medical electrical system,
WARNING there is a risk of fire, short-circuit or electric
shock. Installation must be performed by quali-
fied personnel only.
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If a number of electrical devices are being used
in combination, observe Annex I of IEC 60601-
1:2006. Non-medical devices that comply with
the applicable IEC safety standards can be con-
nected only via a medical isolating transformer.
Do not connect any additional non-medical
devices to a medical electrical system.
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Signal lines from devices with a functional con-
nection, which are connected to different
branches of the mains power supply, must be
galvanically isolated at both ends.
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Connect the devices only to a power supply with
a protective earth conductor.
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After installing a medical electrical system, it
must be inspected according to IEC 62353.
Risk to the patient if the product is not used gen-
tly/a damaged product is used!
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Handle the product with appropriate care.
WARNING
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Do not use the product if it has been subjected
to strong mechanical stress or if it has been
dropped, and send the product to the manufac-
turer or an authorized repair center for inspec-
tion.
Risk to patient if the device power fails!
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Use the device only with an uninterruptible
WARNING power supply.
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To guarantee a continuous power supply a med-
ical emergency supply (USP) is suggested.
Device failure due to incorrect storage and usage
conditions!
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Store and operate the product only within the
WARNING
specified environmental conditions.
Restricted function if third party devices are used!
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Use the product only with the recommended
components and accessories.
CAUTION
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Full functionality is only guaranteed if the rec-
ommended components and accessories are
used.
4
®
Note
Accessories and/or peripheral devices which are connected to the inter-
faces of the medical device must be verified to comply with the relevant
specifications (e.g. IEC 60601-1).
Note
The medical electrical device may not be modified in any way.
Note
To guarantee optimal function of the product, use in controlled environ-
mental conditions is recommended (e.g. air-conditioned operating room).
Note
Always handle the medical device very carefully as it contains sensitive
optic, mechanic and electronic components. Do not strike or drop the cam-
era head.
Note
Ensure that all devices operated in the vicinity meet their relevant EMC
requirements.
Note
The camera components are used to visualize the inside of the body during
minimally invasive procedures. Do not use the components for diagnostic
purposes. This applies in particular with the use of image optimization
algorithms.
Note
Before putting into operation, check the compatibility of all components
using the accessories list.
Note
All accessories and spare parts must only be procured from the manufac-
turer.
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Remove the transport packaging and clean the new product, either
manually or mechanically, prior to its initial sterilization.
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Prior to use, check that the product is in good working order.
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Observe "Notes on Electromagnetic Compatibility (EMC)", see
TA022130.
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To prevent damage caused by improper setup or operation, and in order
not to compromise warranty and manufacturer liability:
– Use the product only according to these instructions for use.
– Follow the safety and maintenance instructions.
– Only combine Aesculap products with each other.
– Follow the application advisories acc. to standard, see Extracts from
relevant standards.
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Ensure that the product and its accessories are operated and used only
by persons with the requisite training, knowledge, or experience.
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Keep the instructions for use accessible for the user.
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Always adhere to applicable standards.