Cybersecurity: Mdcg 2019-16; Ambient Conditions; Disposal; License Agreements - Braun Aesculap OrthoPilot Elite OrthoPilot 4 FS112 Instrucciones De Manejo

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14.3 Cybersecurity: MDCG 2019-16

The cybersecurity measures listed below were implemented in the

® Elite

OrthoPilot

Hardware System:

■

Password protected system (BIOS)

■

USB Security Key Access Control

■

Kiosk mode as safety and integrity protection for the system configu-

ration (operating system and software products)

■

Complete data encryption via TPM chip and USB security key (data pro-

tection)

■

The system uses white-listing procedures, i.e. installation of software

can only be performed using the OrthoPilot Installer and its authorized

software, resulting in protection against third-party software or instal-

lation of modified software

■

The person authorized by Aesculap shall install software updates (soft-

ware patches) as required during annual maintenance

■

Bluetooth connections based on Security Mode 4 Level 3 (man-in-the-

middle protection and encryption)

■

Safe Bluetooth pairing between two devices (pin code is hardwired in

the device)

■

Protected environment, i.e. use of the OrthoPilot

tem only in the OR environment

■

Transport backup by USB security key

14.4 Ambient conditions

Operation

Temperature

10 °C to 30 °C

Relative

30 % to 75 %

humidity

Atmospheric

700 hPa to

pressure

1 060 hPa

15. Disposal

WARNING

Risk of infection from contaminated products!

►

Observe national regulations when disposing of or recycling the

product, its components, and their packaging.

Note

The user institution is obliged to process the product before its disposal, see

Chapter 8..

The recycling pass can be downloaded from the extranet as

a PDF document for each respective part number. (The

recycling pass is a disassembly guide of the device with

information on the professional disposal of environmen-

tally harmful components.)

Any product labeled with this symbol must be disposed of

separately together with electrical and electronic equip-

ment. Within the European Union, the manufacturer will

perform the disposal free of charge.

►

Detailed information concerning the disposal of the product is avail-

able from your national B. Braun/Aesculap representative, see

Chapter 12..

® Elite

Hardware Sys-

Storage

Transport

0 °C to 35 °C

-10 °C to 60 °C

10 % to 85 %

700 hPa to

1 060 hPa

16. License agreements

This system utilizes the following copyright protected software:

■

Microsoft Windows 8.1 Embedded Industry

■

Intel / McAfee Application Control

■

Xerces, Software developed by the Apache Software Foundation

(http://www.apache.org/) licensed under the Apache Version 2.0

license. Parts of this software is based originally on the following soft-

ware:

Software

http://www.ibm.com.

■

Pavlov

■

Grantlee Libraries (https://github.com/steveire/grantlee), under the

GNU Lesser General Public license Version 2.1

■

VMulti Virtual Multiple HID Driver (https://github.com/djpnew-

ton/vmulti) under the MIT license (MIT)

■

mlpack (http://www.mlpack.org) under the 3-clause BSD license

■

Armadillo (http://arma.sourceforge.net) under the Mozilla Public

license Version 2.0

■

FTDI Driver Software, Future Technology Devices International Limited,

Glasgow, Scotland

Aesculap acknowledges the licensing conditions relating to the above

software products. Any use in violation of the licensing conditions is pro-

hibited.

For

more information,

B. Braun/Aesculap agency.

17. Distributor in the US/Contact in Canada

for product information and complaints

Aesculap Implant Systems LLC

3773 Corporate Parkway

Center Valley, PA, 18034,

USA

1999,

IBM

Corporation.,

please

contact

your

national

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