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6.
Security
Aesculap Aeos does not support any specific security measures.
It is assumed that Aesculap Aeos is used within a secured environment. It
is assumed that a secured environment includes at a minimum:
■
Firewall or router protections to ensure that only approved external
hosts have network access to Aesculap Aeos.
■
Firewall or router protections to ensure that Aesculap Aeos only has
network access to approved external hosts and services.
■
Any communication with external hosts and services outside the
locally secured environment use appropriate secure network channels
(e.g., such as a Virtual Private Network (VPN)).
►
If using a keyboard, verify that no external device (e.g. keystroke
recorder) is attached to the USB cable connection.
►
If you are using DICOM connection, verify that no external device is
attached between device and the IT network to avoid any manipula-
tion of data.
►
Do not install and/or use third-party software, such as word processors
or games.
►
Delete patient data that is no longer needed and especially before the
system is shipped.
►
Store patient data on a regular base to avoid data loss.
►
Stop using the device and contact technical support if a cyber security
event is detected.
7.
Maintenance and service
7.1
Maintenance
Maintenance of the system according to the maintenance protocol in an
interval of 12 month is mandatory.
Maintenance has also to be carried out after each kind of repair, if the
device or one component was dropped or damaged or if the medical
device was not used according to its intended use.
Maintenance includes the following activities:
■
Visual inspection
■
Updating software and firmware
■
Function check of all components
■
Carrying out safety measurements
■
Documentation of the test results
Maintenance may only be performed by a person specially trained and
authorized by Aesculap.
►
For corresponding services, contact your national B. Braun / Aesculap
representative, see Chapter 7.2.
7.2
Technical Service
DANGER
Danger to life of patients and users if the product malfunctions
and/or protective measures fail or are not used!
►
Do not perform any servicing or maintenance work under any cir-
cumstances while the product is being used on a patient.
CAUTION
Modifications carried out on medical technical equipment may result
in loss of guarantee/warranty rights, system liability and forfeiture of
applicable licenses.
►
Do not modify the product.
►
Do not break warranty seal (attached to front and rear cover).
►
For service and repairs, please contact your national
B. Braun/Aesculap agency.
Service addresses
Aesculap Inc.
Attn. Aesculap Technical Services
615 Lambert Pointe Drive
Hazelwood
MO, 63042 USA
Aesculap Repair Hotline
Phone:
+1 (800) 214 -3392
Fax:
+1 (314) 895 -4420
Other service addresses can be obtained from the address indicated
above.
8.
Disposal
WARNING
Risk of infection due to contaminated products!
►
Adhere to national regulations when disposing of or recycling the
product, its components and its packaging.
Note
The user institution is obliged to reprocess the product before its disposal,
see Chapter 5..
The recycling pass can be downloaded from the Extranet
as a PDF document under the respective article number.
(The recycling pass includes disassembling instructions for
the product, as well as information for proper disposal of
components harmful to the environment.)
Products carrying this symbol are subject to separate col-
lection of electrical and electronic devices. Within the
European Union, disposal is taken care of by the manufac-
turer as a free-of-charge service.
►
Detailed information concerning the disposal of the product is avail-
able through your national B. Braun/Aesculap agency, see Chapter 7.2.
Page 33 of 36
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