Essential Performance Charac; Teristics; Notification Requirement Of Serious Incidents; Only Use Genuine Parts - Air Techniques ProVecta 3D Prime Installation Instructions Manual

Important information
EN-
2.8 Essential performance char-
US
acteristics
The unit does not have any essential perform-
ance characteristics as set out in IEC 60601-1
section 4.3.
2.9 Notification requirement of
serious incidents
The operator/patient has to report any serious
incident related the product to the manufacturer
and the competent authority of the Member
State, in which the operator and/or patient is
established/resident.
2.10

Only use genuine parts

Only use accessories and optional items speci-
❯
fied or approved by Air Techniques.
Only use original working parts and spare
❯
parts.
Air Techniques accepts no liability for
damage resulting from the use of non-
approved accessories, optional items or
any parts other than original spare and
wear parts.
The use of non-approved accessories,
optional items or non-genuine wear
parts / replacement parts (e. g. mains
cable) can adversely affect the electrical
safety and EMC.
The following accessories may affect EMC:
– Mains cable (3.6 m; order no.: A7782)
– Exposure switch (order no.: A7801)
2.11

Transport

Only the original packaging ensures optimum
protection for the unit during transport.
If necessary, the original packaging for this unit
can be ordered from Air Techniques.
Air Techniques cannot be held responsi-
ble for any damage resulting from trans-
port in unsuitable packaging, even during
the warranty period.
Only transport the unit in its original packaging.
❯
Keep all packaging away from children.
❯
Reattach the transport locking devices.
❯
Do not expose the unit to any strong vibrations
❯
or shocks.
Do not bump or pull the unit.
❯
6
2.12

Disposal

Device
The units and electronic circuits may be disposed
of only in proper facilities for recycling and recov-
ery. Make sure to dispose of these objects in
compliance with the applicable laws and regula-
tions of the federal, national, state and municipal
authorities.
X-ray emitter
The X-ray emitter contains a tube that is poten-
tially capable of imploding, lead cladding and
mineral oil.
2.13

Protection from cybersecurity

threats
The unit is to be connected to a computer that
can be connected to the Internet. Therefore, the
system needs to be protected from threats from
the Internet.
Use antivirus software and update it regularly.
❯
Look for evidence of possible virus infection
and, if applicable, check with the antivirus soft-
ware and remove the virus.
Perform regular data backups.
❯
Provide access to units only to trustworthy
❯
users, e.g. by means of user name and pass-
word.
Make sure that only trustworthy contents are
❯
downloaded. Install manufacturer-authenti-
cated software and firmware updates only.
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