16 Instructions for use | Atlan A100 (XL), A300 (XL), A350 (XL) SW 2.1n
Safety-related information
Electrostatic discharge
Measures to protect from electrostatic discharge must be adhered to when handling
components carrying the ESD warning symbol. Otherwise, malfunctions may occur
which could put the patient at risk.
To prevent malfunctions, observe the following measures and train the relevant
personnel:
► Observe the ESD protective measures, e.g.:
– Wear antistatic clothes and shoes.
– Use gloves that are electrically insulating and antistatic.
– When establishing connections, touch a potential equalization pin.
► Observe the requirements for the electromagnetic environment. Observe the
following section: "Electromagnetic environment" (page 299).
Electromagnetic disturbances
Wireless communication devices (e.g., cellular phones) and medical electrical
equipment (e.g., defibrillators, electrosurgical devices) emit electromagnetic
radiation. When such devices are operated too close to this device or its cables, the
functional integrity of this device may be compromised by electromagnetic
disturbances. As a result, the patient could be put at risk.
► Maintain a distance of at least 0.3 m (1.0 ft) between this device and wireless
communication devices, to ensure that the essential performance of this device
is fulfilled.
► Maintain an adequate distance between this device and other medical electrical
equipment.
Magnetic fields can adversely affect the functional integrity of the medical device
and thus put the patient or user at risk.
► Do not use the medical device in rooms where devices for magnetic field
applications are used (e.g., magnetic resonance imaging).
The medical device meets the applicable limit values for electromagnetic fields. The
functioning of pacemakers can nevertheless be impaired by emissions.
► All wearers of pacemakers should maintain a distance of at least 25 cm (10 in)
between pacemaker and medical device.
2.9.11 Network security
Data interfaces
The prohibited use of data interfaces can lead to new dangers.
► Only establish connections with data interfaces if permission has been granted
by the IT representatives and device owners of the health-care facility appointed
by the operating organization.
► Observe the following information: "IT networks and cybersecurity", page 301.
Unauthorized access to the device can impair the device function.
► The LAN interface may only be used by specialized service personnel.
Authentication and a secure connection protocol are required. The data is
transmitted in encrypted form.
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