7
Warnings
•
When connecting the system in an IT-network:
•
Simultaneous connection of other equipment to the same Bluetooth network
may result in previously unidentified risks to patients, operators or third
parties. Such risks must be identified, analyzed, evaluated and controlled.
Subsequent changes to the Bluetooth network can introduce new risks that
require additional analysis. Changes to the IT-network include: changes to
its configuration, connecting additional items, disconnecting items, updates
and upgrades of connected equipment.
•
Clean the product only according to the cleaning instructions in this manual.
Before cleaning, make sure the device is switched off. Never use any
aggressive chemicals to clean the product.
2.4
Precautionary measures
Precautionary measures
•
When the distance between the Bluetooth PC receiver and the device
increases or when there are conducting materials in the straight line
between the Bluetooth PC receiver and the device, the signal transmission
is not as reliable.
•
Do not use an operating cellular phone within 50 cm of the device to avoid
excessive noise on the signals.
•
Sharp bends or winding the cables in a loop smaller than 5 cm diameter may
damage the cables.
•
When the product is not in use for a longer time (more than a few days) the
batteries have to be removed to prevent damage in case they start leaking.
•
Dispose of batteries according to local regulations.
2.5
Disclosure of residual risk
The risk analysis process for the product has determined that there are no residual risks which need
to be disclosed for the product.
2.6
Information for lay operators
Operators must convey the following information to patients in case they carry the product out of
the professional’s office:
•
Precautions to be taken with respect to environmental temperature and EM fields, ingress of
liquid
•
That wireless equipment (network, phone, walkie-talkie) should be kept >4 m away from the
device
•
How to deal with accessories and accessory cables
•
How to deal with information provided by indicators and the display
•
How to replace batteries
