bradycardia occurs. It should also be remembered that simultaneous compression of the carotid bulbs
must be avoided, as it can cause syncope due to arterial hypotension or severe bradyarrhythmias.
• The software allows for the generation of a patient report, the content of which must always be verified
by a physician expert in the method. DiaTecne s.r.l. assumes no responsibility for the final diagnosis.
• Install anti-virus software on the computer used with the PulsePen system.
• Periodically make backup copies of the patient archive as described in the software's online Help.
DiaTecne s.r.l. assumes no responsibility for the loss of data in the archive.
• Reduce the likelihood of radio interference occurring. Make sure that the WiFi and Bluetooth of the
computer and mobile phones are turned off while using the PulsePen or alternatively activate the
'airplane mode' on these devices.
• If it is not possible to activate 'airplane mode' on the computer and / or turn off WiFi and Bluetooth, use
a USB extender cable to connect the wRs1 unit, in order to keep the latter away from the computer itself.
• In the event of adverse events and / or serious accidents involving the medical device, the user is
required to notify the manufacturer and the competent authorities of his Country.
• Use the device only for the purposes specified in this manual.
• DiaTecne s.r.l. cannot be held responsible for damage caused to people, animals or things in the event
that the user does not scrupulously follow the instructions given in this manual.
Mutual interference with other systems
The PulsePen device has been designed to be immune to electrical, electromagnetic, electrostatic and
magnetic disturbances, normally present; similarly, the PulsePen produces a reduced quantity of
disturbances towards the other devices. However, it cannot be excluded that, in particular situations, there
may be operating anomalies also in the form of signal alteration: in this case it is necessary to remove all
potential sources of disturbance when possible or move to a more appropriate location. Considering the
"Intended use" of the device that requires a qualified medical operator, the latter can easily recognize an
abnormal operating situation, such as the presence of "noise" superimposed to the signal or alteration of
the morphology of the signal and follow the instructions suggested above.
Typical sources of disturbance are “hotspots” / WiFi devices, Bluetooth / Zigbee devices and any type of
transmitter in the 2.4 GHz frequency band.
⚠
Make sure that the WiFi and Bluetooth of the computer and mobile phones are turned off while
using the PulsePen or alternatively activate the 'airplane mode' on these devices.
• Electromedical devices require special precautions for electromagnetic disturbances (EMC) and must be
installed in accordance with the information in the following tables.
• Mobile radio frequency communication devices can disturb electromedical devices.
• For the correct functioning of the PulsePen device, the wEc1 and wTn1 units must be within a radius of 3
meters from the wRs1 unit. Greater distances may cause incorrect operation.
• The use of cables and accessories other than those supplied could adversely affect the performance of
the device.
• Respect the distances from other devices according to the following Tab. 4.
• The PulsePen device transmits radio frequency in the 2.4 GHz ISM band with MSK modulation, ERP = 2
dBm (P ≈ 1.6 mW).
• The PulsePen system meets the requirements indicated in the following tables.
15
User Manual
PulsePen
- V. 5.0_b
