!
required for the examination: this is to reduce the exposure time to the electromagnetic radiations due to
radio signal transmission, although the radio-frequency power is very limited.
• Use only 1.5V batteries of the indicated type. Insert them as stated and check their condition before each
use (dead or damaged batteries may cause leakage of acid).
• Do not switch on or use the device if the covers of the battery compartment are not correctly closed.
• Insert the patient cable
CV010
connectors only into the corresponding sockets of the
wEc1
unit. Do not
connect those plugs in any other way.
• The equipment must never be used together with a defibrillator, since it has not been designed for such
use.
• During Carotid pressure signal recording, the compression of the Carotid bulbs may accidentally produce
reduction of heart rate. This kind of phenomenon could be more common in old aged patients with
accentuate vagal sensitivity. It is highly recommended to stop the examination upon appearance of
bradycardia. We furthermore remind that simultaneous compression of both Carotid bulbs is absolutely
forbidden, considering that this can cause syncope by arterial hypotension and severe bradyarrhythmias.
• Install antivirus software on the computer used for the
PusePen
system.
• Make backup copies of the patient archive on a regular basis, as described in the software on line Help.
• Reduce the probability of radio interference following prescriptions of the next section.
• Use the equipment only for the purposes stated in this manual.
• DiaTecne s.r.l. cannot be held responsible for any damages caused to persons, animals, or things if the
user does not scrupulously follow the indications given in this manual.
Reciprocal Interferences with other Equipments
The
PulsePen
device was designed to be immune to electrical, electromagnetic, electrostatic and
magnetic disturbances that are present in normal environment; likewise, the
PulsePen
produces a small
amount of disturbances for other equipments. It cannot however be excluded that, in particular situations,
some functional anomalies could appear also in the form of signal alteration; in this case it is necessary to
remove all potential sources of disturbance when possible, or to move to a more appropriate location.
Considering that the “Intended Use” of the device requires a qualified medical operator, he/she may easily
recognize any anomalous functional situation, such as the presence of “noise” superimposed to the signal or
alteration of the morphology, and follow the indications suggested above.
Typical noise sources are the “hotspot”/WiFi devices, Bluetooth / Zigbee devices and any kind of
transmitter in the 2,4 GHz frequency band.
⚠
Ensure that the WiFi / Bluetooth functions of the computer and cellular phones are switched off
during the use of the
PulsePen
. When available activate the ‘flight/airplane mode’ on these devices.
• Medical devices require special cautions for electromagnetic disturbances (EMC) and must be installed/
used according to instructions in the following tables.
• Mobile devices for radio frequency communications may disturb electromedical devices.
• For the correct use of the
PulsePen
, the
wEc1
and
wTn1
units must be in a 3 meters radius from the
wRs1
unit. Higher distance could influence the correct operation.
• The use of cables and accessories different from those in the original package could adversely influence
the performances of the device.
• Respect distances from other devices according to the following Tab. 4.
• The
PulsePen
device transmits radio frequency in the ISM 2.4 GHz band with MSK modulation,
ERP = 2 dBm (P
≈
1.6 mW).
• The
PulsePen
system meets the requirements of the following tables.
!
9
User Manual
PulsePen
- V. 4.6
